Act XCVIII of 2006
on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products
Having taken into consideration the unique role that medicinal products and medical aids have in the preservation of health, in the identification and prevention of disease and its cure, and in the improvement of the quality of life,
having regard for the fact that achieving success in the endeavor of preventing disease does not eliminate individual inequalities stemming from diseases and poor health in general, and that in the interest of reducing these disparities state regulations for the realization of impartiality, justice and efficacy are necessary,
recognizing that the economic and effective appropriation of funds from the social security system and individual outlays for medicinal products and medical aids is an important societal value,
in the conviction that a modern health-care system cannot be realized without the transformation of Pharmacology and that for this transformation to happen, national traditions, international standards and practices must be relied upon,
recognizing that the industrialization of the production and marketing of medicinal products, the latest trends in consumer habits and demands, furthermore, the development of information technology has brought about significant changes in the retail distribution of medicinal products,
taking into consideration that the State must adopt regulations guaranteeing that an adequate range of medicinal products are safely placed at the disposal of patients, in the appropriate places and on time,
acknowledging that medicinal products are purchased by persons who feel vulnerable due to their sickness and that they do not possess any expertise in connection with medicinal products, and that in the interest of protecting consumers of medicinal products it is essential that the distribution of medicinal products be enforced by stricter regulations than those which generally apply to commercial practices,
and keeping in mind that in light of the characteristics of the retail supply of medicinal products regulated competition is favorable to consumers, improving their access to medicinal products and the quality of care,
Parliament has adopted the following Act:
General Provisions
Section 1.
This Act contains provisions relating to the distribution - including the related commercial practices -, and public financing of medicinal products for human use and medical aids, to the measures intended to provide access to the financing of medicinal products and medical aids and the safe and reliable supply of medicinal products and medical aids to the general public, and laying down the basic principles for the retail supply of medicinal products and the activities of suppliers of medicinal products.
Section 2.
(1) The purpose of this Act is to guarantee the transparency of the definition of provisions available within the compulsory social security system, to offer foresight and safety to the relevant operators, to improve the feasibility and the equitable and more effective use of the financial means available to the compulsory social security system, and to lay down the basic requirements for the activities of direct suppliers of medicinal products to the general public.
(2) The retail supply of medicinal products is authorized in pharmacies and, under special circumstances, in commercial establishments other than pharmacies subject to the requirements laid down in this Act and in specific other legislation adopted under authorization conferred by this Act.
(3) Pharmacy means a health service and retail facility that may operate in the form of a public pharmacy, an institutional pharmacy, branch pharmacy and dispensing pharmacy.
(4) The responsibility of pharmacies within the entire healthcare system is to dispense medicinal products to the general public, and to provide information and advice in connection with medicinal products with a view to the prevention of diseases within the framework of cooperation with patients.
Section 3.
For the purposes of this Act:
1. 'medicinal products' shall mean any substance as defined in Point 1 of Section 1 of Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products (hereinafter referred to as "MPH");
2. 'medicinal products with public financing' shall mean those medicinal products and dietary supplements for special nutritional needs, whose prices are subsidized under specific other legislation from the central budget or by the Health Insurance Fund (hereinafter referred to as "H. Fund") to those eligible;
3. 'medicinal products with special funding' shall mean medicinal products for which subsidies are provided under a public contract between the health insurance administration agency and the manufacturer/distributor/supplier in accordance with specific other legislation;
4. 'marketing authorization' shall mean an official decision issued by the authority of competence and jurisdiction authorizing a certain medicinal product for human use;
5. 'marketing authorization holder' shall mean a natural or legal person or business association lacking the legal status of a legal person, to whom the authority vested with competence and jurisdiction has granted authorization for the marketing of a specific medicinal product;
6. 'medical aid' shall mean any medical device made available for personal use to patients suffering in a temporary or persistent disability or incapacity (including in vitro medical devices with diagnostic facilities for self-inspection purposes), and other technical devices for nursing purposes, which are not treated as medical devices, designed for use without the continued presence of a healthcare professional. Personal use shall mean where the medical aid is worn, applied or administered in body cavities with exterior opening, whether natural or artificial, or on the body, and the use of equipment for supporting or moving the body for the diagnostics purposes or for the purpose of therapy, rehabilitation or nursing;
7. 'therapeutic preparations which are not classified as medicinal products' shall mean a substance or compound which is not treated as a pharmaceutical product, but which has been registered by the authority of competence and jurisdiction with authorization granted for marketing designated as a therapeutic preparation which is not classified as a medicinal product;
8. 'inexpensive gift' shall mean any benefit provided in kind whose value including value added tax, or failing this, its purchase price or production cost including value added tax is less than 5 per cent of the prevailing monthly minimum wage;
9. 'reasonable support' shall mean any support where the costs of the event per person does not exceed the amount specified in Paragraph h);
10. 'commercial practice' shall mean any act, omission, course of conduct or representation, commercial communication including marketing, directly connected with the promotion, prescription, procurement, sale or supply of a medicinal product or medical aid. In the case of public pharmacies, the concept of commercial practices shall not cover the medical services relating to the information to be provided when dispensing medicinal products or medical aids, and also in connection with medicinal products as prescribed by law, and it shall not include consultation by pharmacists;
11. 'advertising' shall mean the commercial advertising defined in Paragraph d) of Section 3 of Act XLVIII of 2008 on the Basic Requirements and Certain Restrictions of Commercial Advertising Activities, excluding the following:
a) the labels and package leaflets of medicinal products described in specific other legislation, and the user’s manual of medical aids,
b) the factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions relating to medicinal products or medical aids, furthermore
c) trade catalogues and price lists, provided they include no product claims concerning the efficacy of medicinal products or the application of medical aids;
12. 'persons qualified to prescribe or supply medicinal products and medical aids' shall mean physicians, pharmacists, and manufacturers and traders of medicinal products and medical aids holding the appropriate authorization and engaged in their commercial distribution;
13. 'ATC-group' shall mean the system of classification of medicinal products according to anatomical, therapeutic and chemical actions;
14. 'reference medicinal product' shall mean the medicinal products in a specific (fixed) subsidy group, for which subsidy is provided at a specific percentage fixed for the ATC-group in question based on its gross retail price as defined in specific other legislation and its market share;
15. 'reference medical aid' shall mean the medical aids in a specific (fixed) subsidy group - other than any custom-made product for an individual patient, and other than the medical aids of a specific function group which are contained in the simplified list of subsidized products, and those subsidized under the three-month therapy limit (fixed sum) -, for which subsidy is provided at a specific percentage fixed for the subsidy group in question based on its price as defined in specific other legislation serving the basis for public financing, its rental fee and market share;
16. 'public pharmacy' shall mean a facility that is engaged in supplying medicinal products directly to patients and customers;
17. 'branch pharmacy' shall mean a facility that functions as the satellite of a public pharmacy and is engaged in supplying medicinal products directly to patients;
18. 'institutional pharmacy' shall mean a health-care facility installed in an inpatient institution engaged in supplying medicinal products to the general public and to patients treated in the inpatient institution;
19. 'dispensing pharmacy' shall mean a method of supply of specific medicinal products by general practitioners and general pediatricians (hereinafter referred to as "general practitioner");
20. 'independent pharmacy operation right' shall mean an authorization granted to an experienced pharmacist to operate a public pharmacy (hereinafter referred to as "independent right");
21. 'direct supply of medicinal products to the public' shall mean the activity where the pharmacy supplies medicinal products directly or indirectly by way of home delivery to the patients and customers, including the instructions for application, or the activity performed by a person holding an authorization to distribute medicinal products, enabling patients and customers to purchase certain specific medicinal products specified in specific other legislation in their original packaging as approved;
22. 'home delivery' shall mean the transport of medicinal products or medical aids to the address the buyer has indicated within the framework of the direct supply of medicinal products to the public or the retail supply of medical aids, with the involvement of a company holding an authorization for the direct supply of medicinal products to the public or for the retail supply of medical aids, or with the involvement of the agent of such company;
23. 'new pharmacy' shall mean a pharmacy that did not have an operating permit before the time of this Act entering into force;
24. 'subsidy volume agreement' shall mean the agreement defined in Section 30/A of Act LXXXIII of 1997 on the Services of the Compulsory Health Insurance System (hereinafter referred to as "HIS");
25. 'consumer' shall have the meaning defined in the Act on the Prohibition of Unfair Business-to-Consumer Commercial Practices;
26. 'consultation by pharmacist' shall mean an activity performed - and documented - by pharmacists on a voluntary and prudential basis, aiming to improve - in collaboration with the doctors affected - the efficiency, reliability and cost-effectiveness of treatment using medicinal products, and to promote the education of patients for better health awareness, to provide technical assistance for the administration of medicinal products, for improving their disposition to cooperate and to improve their quality of life, in a controlled environment.
27. 'official manager' shall mean a pharmacist appointed by a regulatory decision for the temporary operation of a public pharmacy.
28. 'subsidy group' shall mean a group of products which are subsidized at a specific (fixed) sum determined based on the percentage rate fixed for the price of the group’s reference medical aid;
29. 'distributor of medical aids' shall mean the manufacturer of medical aids if manufactured in Hungary, or the importer of medical aids manufactured outside of Hungary, operating as a private entrepreneur or in the form of a business association;
30. 'qualified distributor' shall mean a distributor admitted to the approved list of suppliers of the health insurance administration;
31. 'durable medical aid' shall mean any medical aid with an approved period of use of over six months;
32. 'simplified list of subsidized products (ETJ)' shall mean a list described in specific other legislation containing subsidized function groups where the doctor enters the description or the ISO code of the function group on the prescription, and the health insurance administration sets the same amount of subsidy for each and every product within a specific function group.
PART I
Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids
Chapter I
BASIC PRINCIPLES FOR THE COST-EFFECTIVE PRESCRIPTION AND DISTRIBUTION OF MEDICINAL PRODUCTS AND MEDICAL AIDS
Section 4.
(1) The rate of social security subsidy claimed for the price of medicinal products containing the same active ingredients or of the same therapeutic efficacy may not exceed the rate of subsidy established for the reference medicinal products.
(2) Subject to the exception set out in specific other legislation, the rate of social security subsidy claimed for the price of medical aids within the same group in terms of function may not exceed the rate of subsidy established for the reference medical aid.
Section 5.
In the process of admission into the sphere of subsidized products by the simplified procedure, the preparations containing the same active ingredients and having the same therapeutic effect as medicinal products already approved for subsidies will be granted preferential treatment if their price is lower than that of the said subsidized medicinal products, as well as the medical aids within the same group in terms of function with those already approved for subsidies, if their price is lower and if they possess the same or better value in terms of use.
Section 6.
Outside the provisions of this Act, it is prohibited to engage in any activity for the promotion or sponsorship of any medicinal products or medical aids which may be prescribed at a price with a social security subsidy.
Section 7.
Marketing authorization holders are required to pay a contribution in the amount specified in this Act in connection with the medicinal products they supply with a social security subsidy, consistent with the volume of turnover of such medicinal products, to enhance the cost-effectiveness of the supply of medicinal products which are available in exchange for the contributions paid on behalf of the persons insured under the social security system.
Section 8.
The doctors prescribing medicinal products and medical aids shall inform their patients concerning the availability of another lower priced medicinal product having the same active ingredient or therapeutic efficacy, or another lower priced medical aid of the same function, and shall disclose the price of the product in question, the amount of social security subsidy available and the difference between that and the price the patient is required to pay.
Section 9.
Any dispenser of medicinal products and medical aids shall inform their patients, in a manner that is accessible and understandable to handicapped persons as well, concerning any lower priced medicinal products having the same active ingredient or therapeutic efficacy, which are subsidized by the health insurance administration agency, as well as any lower priced medical aid of the same function, and shall disclose the price of the product in question, the amount of social security subsidy available and the difference between that and the price the patient is required to pay.
Section 10.
The health insurance administration agency has powers to determine the conditions - within the framework of this Act - for the procedures of the prescription of medicinal products and medical aids for doctors engaged under contract in terms of financing or subsidization, and shall have powers to inspect and supervise the conduct of doctors in terms of prescription of medicinal products and medical aids, and to take action in accordance with the provisions of specific other legislation in the event of any infringement or breach of contract.
Section 11.
(1) A financing contract or an agreement granting entitlement for the prescription of subsidized medicinal products and medical aids may be concluded with the medical service providers who satisfy the requirements set out in this Act concerning the cost-effectiveness of medicinal products and medical aids, as well as the conditions prescribed by the health insurance administration agency, such as the use of an approved computer program designed to enhance cost-efficiency in the prescription of medicinal products.
(2) Subject to the exceptions set out in Subsections (3)-(4), the supply, rental and repair of medical aids may be conducted if authorized by the government body in charge of the healthcare system, and may be performed only in a commercial establishment that is in conformity with the requirements set out in specific other legislation.
(3) Where a pharmacy employs a medical aid sales specialist, the authorization referred to in Subsection (2) is not required. In the absence of a medical aid sales specialist, without the authorization referred to in Subsection (2) only mass produced medical aids may be supplied, and no repair and rental services may be offered. The prohibition of repair and rental activities shall not apply to the enforcement of guarantee and warranty obligations whether specified in specific other legislation or fixed under contract between the parties.
(4) Any service provider with the right to exercise the freedom to provide services according to the Act on the General Provisions Relating to the Taking Up and Pursuit of the Business of Service Activities shall notify the government body in charge of the healthcare system of his intention to engage in the supply, rental and repair of medical aids in the form of cross-border services. The health insurance administration specified in specific other legislation may also conclude the contracts referred to in Subsection (2) of Section 30 of Act LXXXIII of 1997 on the Services of the Compulsory Health Insurance System with a service provider with the right to exercise the freedom to provide services.
(5) The government body in charge of the healthcare system shall maintain a register of the persons authorized according to Subsection (2), and of the service providers with entitlement to engage in the supply, rental and repair of medical aid, notified according to Subsection (4). Information may be disclosed from the register solely for the verification of authorization for the said activity.
Chapter II
PROVISIONS RELATING TO THE PROMOTION OF MEDICINAL PRODUCTS AND MEDICAL AIDS AND TO BUSINESS-TO-CONSUMER COMMERCIAL PRACTICES RELATING TO MEDICINAL PRODUCTS AND MEDICAL AIDS
General Provisions
Section 11/A.
All forms of commercial practices relating to any medicinal product which does not have a valid marketing authorization shall be prohibited.
Section 11/B.
(1) Commercial practices relating to medicinal products and medical aids shall encourage the rational use of the medicinal product or medical aid, by presenting it objectively and without exaggerating the properties of the medicinal product or medical aid.
(2) The information conveyed in a commercial communication relating to a medicinal product or medical aid shall be in conformity with the information contained in the label and package leaflet of the medicinal product as approved in the authorization for placing the medicinal product on the market, or with the information contained in the user’s manual of the medical aid.
(3) In the commercial communication of a mono-component homeopathic medicinal product, apart from the label information no other information may be communicated.
(4) The detailed regulations relating to the contents of information contained in commercial communication for medicinal products or medical aids are laid down in specific other legislation.
Promotion of Medicinal Products and Medical Aids
Section 12.
(1) The promotion of medicinal products and medical aids (hereinafter referred to as “promotion”) shall mean commercial practices pertaining to medicinal products and medical aids applied for or against healthcare professionals with proper entitlement for the prescription and distribution of medicinal products and medical aids, including instructions as to the use of such medical aids and information provided in connection with the composition and efficacy of the medicinal products and for the application of medicinal products and medical aids.
(2)
(3) Where
a) the holder of the marketing authorization of a medicinal product, the authorized distributor of a medicinal product, or the manufacturer or distributor of medical aid, or
b) another economic operator on behalf of the persons referred to in Paragraph a),
[the persons referred to in Paragraphs a) and b) hereinafter referred to collectively as “promoter of medicinal products”) wishes to engage in promotional activities, they shall notify the health insurance supervisory authority thereof.
(4) In addition to the data specified in the Act on the General Provisions Relating to the Taking Up and Pursuit of the Business of Service Activities, the notification referred to in Subsection (3) shall contain:
a) the name, home address or registered office, and the registered number of the medical sales representative;
b) in connection with medicinal products, the name of the holder of the marketing authorization or the authorized distributor of the medicinal product or products proposed to be represented, or their authorized agent; as regards medical aids the authorization shall contain the name of the manufacturer, distributor of the medical aid or aids proposed to be represented, or their authorized representative;
c) the natural identification data of the person or persons referred to in Section 13, engaged in promotional activities acting in the name and on behalf of the promoter of medicinal products;
d) a statement from the medical sales representative referred to in Section 13 that he is not exposed to any conflict of interest as prescribed in Subsection (3) of Section 13;
e) the number of the diploma of the medical sales representative referred to in Section 13, and his registration number, where specific qualification is required for the promotional activity according to specific other legislation.
(5) The promoter of medicinal products referred to in Subsection (3) shall forthwith notify any change in the particulars contained in the notification to the health insurance supervisory authority.
(6) The provisions of this Act shall also apply to activities for the promotion of medicinal products and medical aids by a service provider with the right to exercise the freedom to provide services according to the Act on the General Provisions Relating to the Taking Up and Pursuit of the Business of Service Activities in the form of cross-border services.
(7)-(8)
(9) Upon the notification of promotional activities as prescribed in Subsection (3), and upon the notification of any changes in the particulars notified, the notifier shall be liable to pay an administrative service fee.
Section 13.
(1) Promoters of medicinal products must have a natural person notified according to Section 12 engaged under contract of employment or some other form of employment relationship, who satisfies the requirements decreed by the minister in charge of the healthcare system in terms of training and qualifications (hereinafter referred to as “medical sales representative”).
(2)
(3) With the exception set out in Subsection (4), a conflict of interest shall exist where a medical sales representative is engaged in activities for the promotion of medicinal products - exclusive of scientific activities under copyright protection - in a medical institution with which the representative is engaged under contract for the provision of healthcare services, or for participating in such activities.
(4) The conflict of interest referred to in Subsection (3) shall not apply to the persons engaged in the network of medical sales representatives of the government body for pharmaceuticals.
Section 13/A.
(1) The health insurance supervisory authority shall maintain a register of promoters of medicinal products and medical sales representatives relying on the notifications made under Section 12. The register shall contain the data specified in Subsection (4) of Section 12.
(2) The health insurance supervisory authority shall issue an official certificate to medical sales representatives at the time of registration, that contains the medical sales representative’s surname and forename, along with other information prescribed by the minister in charge of the healthcare system in a decree.
(3) The provisions of the Act on the General Provisions Relating to the Taking Up and Pursuit of the Business of Service Activities pertaining to notifications, to the monitoring of activities subject to notification and to the registration of service providers engaged in activities subject to notification shall also apply to the notification procedures described in Section 12 and to the registers of promoters of medicinal products and medical sales representatives, subject to the exceptions set out in this Act, regardless of whether the activities of promoters of medicinal products are recognized as service activities.
Section 14.
(1) Promoters of medicinal products and medical sales representatives may not provide, offer or promise any gifts, pecuniary advantages or benefits in kind to persons qualified to prescribe or supply medicinal products or medical aids, unless they are inexpensive and they are related to the healthcare activity in which the persons with entitlement for the prescription and distribution of medicinal products is engaged. Promoters of medicinal products and medical sales representatives may not provide, offer, or promise money in any way or form.
(2) Any entertainment and hospitality functions provided by promoters of medicinal products and medical sales representatives during events and programs held solely for the promotion of medicinal products and medical aids shall always be reasonable in scope and remain subordinate to the main objective of the meeting. Only healthcare professionals and persons engaged in the supply and distribution of medicinal products and/or medical aids may be invited to such trade and promotional events.
(3) Any support provided - whether directly or indirectly - for events and programs for purely professional and scientific purposes shall always be reasonable in scope and remain subordinate to the main scientific objective of the meeting. Only healthcare professionals and persons engaged in the supply and distribution of medicinal products and/or medical aids may be invited to such trade and scientific events. Representation of medicinal products may be carried out during events and programs held for purely professional and scientific purposes, if the promotional activity (a lecture concerning the application of a specific product, demonstration of a specific product, leasing of exhibition space) - whether performed directly or indirectly - is clearly distinguished from the trade and scientific programs.
(4) Support may be provided in kind to persons engaged in healthcare or scientific activities for participating in trade events and training courses. This type of in-kind support may be provided to cover only the expenses (such as, in particular, travel expenses, accommodations, entry fees) arising directly out of or in connection with attending the above-specified events.
(5)-(6)
(7) The prohibitions and restrictions specified in Subsections (1)-(4) shall not concern the conditions laid down in specific other legislation regarding the prices, markup, discounts and any other commercial allowances of medicinal products and medical aids for operators active in the commercial supply of medicinal products.
(8) Persons qualified to prescribe or supply medicinal products and medical aids shall not solicit or accept any inducement prohibited under Subsection (1) or contrary to Subsections (2)-(4) of this Section.
(9) Promoters of medicinal products referred to in Subsection (3) of Section 12, shall furnish a certificate to persons qualified to prescribe or supply medicinal products and/or medical aids to enable them to satisfy their tax payment obligation; such certificate must be in compliance with the tax regulations in force, where the conditions therefor exist.
(10)
Section 15.
Further provisions concerning promotional activities, including the regulations pertaining to free product samples and donations that may be provided to persons qualified to prescribe or supply medicinal products or medical aids are contained in specific other legislation.
Section 16.
Provisions Relating to Unfair Business-to-Consumer Commercial Practices in Connection with Medicinal Products and Medical Aids
Section 17.
(1) Medicinal products for human use may be advertised to the general public if they may be dispensed from a pharmacy without a prescription, or if no subsidies are available as regards medical aids if:
a) the product in the advertisement is clearly identified as a medicinal product or as a medical aid;
b) the advertisement includes the name of the medicinal product, as well as the internationally used common name if the medicinal product contains only one active substance, or the name of the medical aid;
c) the advertisement contains the information necessary for correct use of the medicinal product or medical aid;
d) the advertisement demonstrates the medicinal product and the medical aid based on the summary of the product characteristics or the user's manual, respectively;
e) the advertisement contains the information leaflet and warning specified in specific other legislation as necessary for the correct use of the medicinal product or medical aid;
f) the advertisement contains an express, legible invitation to read carefully the instructions for the application of the medicinal product or the user's manual of the medical aid.
(2) The advertisement referred to in Subsection (1) shall not contain any reference or expression which:
a) claims or gives the impression that a medical consultation or surgical operation is unnecessary or redundant;
b) suggests that the effects of taking the medicinal product are guaranteed, or are unaccompanied by adverse reactions;
c) suggests that the medicinal product is a foodstuff or cosmetic product;
d) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
e) could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
f) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product or a medical aid on the human body or parts thereof;
g) refers to a recommendation by scientists, health professionals or celebrities;
h) suggests that the health of the subject could be affected by not taking the medicinal product or by not using the medical aid.
(3) Subsection (1) of this Section shall not apply to the advertising of any non-prescription medicinal products or medical aids for which no social security subsidies are available, if it contains only the registered name of the medicinal products or medical aids in question, the name or trademark of its manufacturer (flash-back advertising). Such flash-back advertising may be published through radio or television, only as part of the same advertising package, and following the display of a commercial message which satisfies the requirements laid down in Subsections (1)-(2).
(4) Medicinal products may not be advertised to the general public if they can be dispensed from the pharmacy solely with a prescription and which are approved for social security subsidies, as well as medical aids subsidized under the social security system.
(5) The prohibition set out in Subsection (4) above shall not apply to public service information conveyed by the government body in charge of the healthcare system:
a) for promoting vaccination campaigns,
b) relating to campaigns to help smokers giving up smoking,
and to information on the medicinal products connected to the campaigns referred to in Paragraphs a) and b).
(6) Advertising may not be published if:
a) it concerns a medicinal product or medical aid that is not authorized to be marketed or used in Hungary;
b) it concerns a medicinal product that contains narcotics or psychotropic materials, as defined in specific other legislation;
c) it concerns an investigational medicinal product;
d) is directed at children;
e) it concerns a non-prescription medicinal product that bears the same name as a prescription medicinal product that is in circulation;
f) it concerns a non-prescription medicinal product, whose price is subsidized according to specific other legislation by the central budget or by the H. Fund to those eligible;
g) it concerns a medical aid that bears the same name as a medical aid for social security subsidies that are available, that differs only in designation or number.
(7)
(8) Apart from the product samples defined in specific other legislation, it is prohibited to provide or offer any gifts, product samples or gift certificates (coupons) to patients and customers directly, or by way of doctors or dispensers of medicinal products and medical aids, that is intended to sponsor or promote the use of a specific medicinal product or the products of a specific manufacturer of medicinal products, or a specific medical aid that is subsidized by the social security system, if such use is made a precondition.
Vested Responsibilities
Section 18.
(1) Subject to the exceptions set out in Subsections (3) and (4), liability for any infringement of the regulations laid down in this Act and in the decree adopted by authorization conferred under Paragraph j) of Subsection (2) of Section 77 of this Act (for the purposes of Sections 18-19 hereinafter referred to as “Decree”) on commercial practices relating to medicinal products and medical aids shall lie with the person who, in commercial practices, is acting for purposes relating to his trade or business and who is directly connected with the promotion, sale or supply of medicinal products or medical aids to which the commercial practice in question pertains.
(2) The person referred to in Subsection (1) shall be held liable also if the commercial practice is carried out under contract by another person acting on behalf of or for the said person referred to in Subsection (1).
(3) Liability for any infringement of the regulations pertaining to promoters of medicinal products shall lie with the promoter of medicinal products; whereas for the infringement of regulations pertaining to medical sales representatives, liability shall lie with the medical sales representative affected.
(4) Liability for any infringement arising in connection with the representation of commercial communication shall also lie with the person who uses means suitable for the publication of commercial communication to disseminate commercial communication, and with the person professionally involved in producing or creating commercial communication in the context of his economic activities, or in providing other related services, with the exception if the infringement originates from the carrying out of the instructions of the person referred to in Subsection (1).
(5) The aforesaid persons shall bear joint and several liability with the persons referred to in Subsection (1) for damages resulting from the unlawful commercial practices mentioned in Subsection (4).
Rules of Procedure
Section 18/A.
(1) Subject to the exceptions set out in Subsection (2), the authority specified in the Act on the Prohibition of Unfair Business-to-Consumer Commercial Practices shall have jurisdiction in connection with any infringement of the provisions relating to business-to-consumer commercial practices set out in this Act and in the Decree in connection with medicinal products and medical aids. The competent authority shall proceed in accordance with the relevant provisions of the Act on the Prohibition of Unfair Business-to-Consumer Commercial Practices.
(2) In connection with any infringement of the provisions of Subsections (4) and (6) of Section 17 the consumer protection authority shall have jurisdiction according to the provisions set out in the Act on Consumer Protection.
(3) The non-governmental organizations active in the field of protection of patients’ rights shall be treated as a party as well in the proceedings referred to in Subsections (1) and (2).
(4) Having regard to the provisions relating to business-to-consumer commercial practices set out in this Act and in the Decree in connection with medicinal products and medical aids, the government body for pharmaceuticals and the government body in charge of the healthcare system shall also have jurisdiction to enforce such regulations as pertaining, respectively, to medicinal products and medical aids.
(5) The provisions relating to business-to-consumer commercial practices set out in this Act and in the Decree in connection with medicinal products and medical aids are treated as consumer protection regulations in the application of the Act on Consumer Protection.
(6) Eighty per cent of any fine imposed in connection with any infringement of the provisions relating to business-to-consumer commercial practices set out in this Act and in the Decree in connection with medicinal products and medical aids which are subsidized by the social security system shall comprise revenue for the H. Fund.
Section 18/B.
(1) The implementation of Regulation (EC) No. 2006/2004 of the European Parliament and of the Council shall be conferred upon:
a) the consumer protection authority and the Hungarian Competition Authority in the cases referred to in Subsection (1) of Section 18/A, in line with the distribution of powers and competencies laid down in the Act on the Prohibition of Unfair Business-to-Consumer Commercial Practices,
b) the consumer protection authority in the cases referred to in Subsection (2) of Section 18/A,
with a view to any intra-Community infringements of national laws on the transposition of Articles 86-100 of Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council.
(2) In connection with mutual assistance, the authorities mentioned in Subsection (1) shall proceed in accordance with Commission Decision 2007/76/EC, as amended by Commission Decision 2008/282/EC.
(3) For information purposes, the minister in charge of the judicial system shall publish on the official website of his Ministry the list of legislation on the transposition of Articles 86-100 of Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council.
Section 19.
(1) The proceedings in connection with any infringement of the provisions laid down in this Act and in the Decree pertaining to the promotion of medicinal products and medical aids shall be conducted by the health insurance supervisory authority.
(2) If the promoter of medicinal products, a medical sales representative, the holder of the marketing authorization of a medicinal product, a manufacturer of medical aids, a person qualified to prescribe or supply medicinal products and/or medical aids or the authorized representative of any of these persons has infringed upon the provisions of this Act or the Decree pertaining to the promotion of medicinal products or medical aids, the health insurance supervisory authority:
a) may contact the competent trade association requesting ethics proceedings, where applicable;
b) may order the infringer to eliminate the discrepancies within the prescribed deadline and may suspend his authorization until the said discrepancies are eliminated;
c) shall declare the fact of infringement, may order the state of infringement to be terminated and prohibit continuation of the illegal conduct;
d) may impose a fine of between five hundred thousand and twenty-five million forints;
e) in connection with a repeated or grave infringement, shall ban the promoter of medicinal products governed under Subsection (3) of Section 12, that is held accountable for the infringement, from engaging in promotional activities for a period of between six months and three years;
f) in connection with a repeated or grave infringement, shall contact the health insurance administration agency that has entered into a financing contract with the infringer, or an agreement granting entitlement for the prescription of subsidized medicinal products and medical aids for the suspension of prescription and distribution rights within the subsidized system.
(3) The amount of the fine shall be determined with regard to all applicable circumstances, in particular, the scope and gravity of the injury caused to patients and persons qualified to prescribe or supply medicinal products and/or medical aids, and the duration of the illegal conduct. Repeat offenders shall be penalized accordingly. In the case of multiple violations the amount of fines imposed may be cumulative. Unpaid fines shall be enforced in the same manner as taxes.
(4) Eighty per cent of any fine imposed in connection with any infringement of the provisions governing the promotion of prescription medicinal products and medical aid subsidized by the social security system shall comprise revenue for the H. Fund.
(5) In the application of Paragraphs e) and f) of Subsection (2), and also Subsection (3):
a) repeat infringement means if the infringer or his authorized representative in this capacity, or the principal had been found guilty of any infringement of the provisions of this Act or the Decree by final decision within the last two years;
b) grave infringement means where the unlawful commercial practices relating to medicinal products or medical aids represent twenty-five million forints or more at fair market value.
Section 19/A.
The health insurance supervisory authority may adopt a ruling that may be declared enforceable irrespective of any appeal for the cessation or prohibition of the infringement for the period ending upon the passing of the resolution or the ruling for the termination of the proceedings, where such action is deemed urgently necessary with a view for any delay is likely to cause considerable or irreparable harm. The health insurance supervisory authority shall adopt this ruling in expedited proceedings. The authority’s ruling may be appealed separately.
Section 20.
(1) The health insurance supervisory authority shall monitor compliance with the provisions of Section 14.
(2) With a view to ascertaining the relevant facts of the case, any person and organization contacted by the health insurance supervisory authority shall be liable to make available data from their records and copies of documents in their possession with facilities for reading and copying to the health insurance supervisory authority. The health insurance supervisory authority shall have powers to make a hard mirror image of the data medium held by any person, and to inspect the contents through this image if there is reason to believe that it contains information concerning the infringement of the provisions of Section 14.
(3) The health insurance supervisory authority shall be entitled to inspect and process - in connection with monitoring compliance with the provisions of Section 14 - the personal data of the party to the case and other persons who may be tied to the party. Where a means of evidence contains personal data that does not pertain to the investigation, and if this data cannot be detached without compromising the probative value of the evidence, the health insurance supervisory authority shall be entitled to process all personal data affected, however, the entitlement to inspect the personal data that does not pertain to the investigation is valid only to the extent required to ascertain that the data is not connected to the infringement investigated.
(4)
(5) Any data, or document recording such data, created during or for the purpose of communications between the party and his defense attorney may not be admissible as evidence in the proceedings of the health insurance supervisory authority, they may not be examined or seized, and the holder of such documents may not be compelled to produce them for the purpose of inspection.
(6)
(7) In the course of enforcement of the provisions of Section 14, the health insurance supervisory authority shall be empowered to search any premises, to enter such premises under probable cause under his own authority, without the consent of the owner (tenant) or any other person in the premises, and to open any sealed-off area or building for this purpose. In the process of the search the acting officer shall have powers to demand information, written or oral, from the client, the client's representative (former representative) or employee (former employee), and may gather intelligence in any other way. An on-site inspection may be carried out in the private domain, including vehicles and other premises, if it is in the use of any former or current executive officer of the party, employee or representative, or any other person who effectively exercises control or who used to exercise control.
(8) The investigative measures specified under Subsection (7) shall be carried out in possession of a prior court order. The written request of the health insurance supervisory authority submitted for court order shall be decided upon by the Municipal Court of Budapest within seventy-two hours from the time of receipt of the request in a non-judicial procedure. The court's decision may not be appealed and may not be reviewed. The court shall authorize the above-specified investigative measure if the health insurance supervisory authority is able to substantiate probable cause that any other investigative measure is unlikely to produce the required results, and if there is reason to believe that the source of information indicated - relating to the illegal activity investigated - is in the location for which the court order is requested and it is presumed that this information will not be surrendered voluntarily or that it would be destroyed. If the investigative measure is only partially accepted, the court shall specify the type of procedure and the person who is the subject of such procedure. On the basis of having in possession the court order the investigative measure may be carried out within a period of ninety days from the date of issue.
(9) Regarding the investigative measure carried out under Subsection (8) the persons affected shall be informed verbally at the time the investigative measure commences, and it shall be carried out if possible in the presence of these persons. Before the investigative measure is carried out the court order shall be presented and the purpose of the investigative measure shall be communicated.
Chapter III
SUPPLY GUARANTEES FOR MEDICINAL PRODUCTS AND MEDICAL AIDS
Section 21.
(1) In the process of the admission of certain medicinal products, dietary supplements and medical aids into the social security subsidy system the health insurance administration agency may render such admission contingent upon a commitment for keeping such products on the market within the subsidized system for a fixed period of minimum three years, or - in cases under specific other legislation - upon a commitment for keeping a specific quantity of such products on stock.
(2) The holder of the marketing authorization of a medicinal product, the distributor of dietary supplements or the manufacturer of the medical aid, or its authorized representative, for which social security subsidies are granted under Subsection (1), if failing to discharge the supply or stocking commitment for reasons within its control, shall be liable to bear the extra costs stemming from the purchase made under Subsection (4).
(3) The holder of the marketing authorization of a medicinal product or the manufacturer of the medical aid, or its authorized representative, that has been admitted into the social security subsidy system shall notify the health insurance administration agency at least half a year in advance if it plans to terminate the distribution of subsidized preparations or products in Hungary.
(4) Where the holder of the marketing authorization of a medicinal product that is in commercial circulation in Hungary with public financing intends to discontinue or is unable to continue the marketing of such product that is already in circulation, temporarily or for any extended duration, in the territory of Hungary, however:
a) if being deprived of the medicinal product in question is likely to result in severe or persistent disability for the patients treated with such products; and
b) there is no other medicinal product of similar active ingredients, pharmaceutical form and strength available in the territory of Hungary,
the administrator of state healthcare, emergency and safety reserves shall have powers to purchase the medicinal products in question from any legal person or business association lacking the legal status of a legal person as laid down in specific other legislation that is authorized in a State other than Hungary to engage in the wholesale distribution and/or retail supply of medicinal products.
(5) Business associations authorized for the wholesale distribution of medicinal products shall be required to procure and supply the medicinal products to which their authorization for wholesale distribution pertains. To this end they are required to maintain a purchase and inventory management system with facilities to ensure the transparency and controllability of the distribution and supply.
(6) Business associations authorized for the wholesale distribution of medicinal products, apart from the obligation referred to in Subsection (5), shall be required to cooperate with the administrator of state healthcare, emergency and safety reserves, and shall partake - as prescribed in specific other legislation - in ensuring the availability of the Central Healthcare Reserve and continuous replacement in order to maintain quality.
(7) The detailed regulations for maintaining a wholesale stock of medicinal products and specifying the products which are to be kept in compulsory reserve, and for their distribution shall be laid down in specific other legislation.
(8) Wholesale distributors and retail suppliers of medicinal products are required to carry reference medicinal products.
(9) In connection with mass produced medical aids and custom-size medical aids made in a series, wholesale distributors and retail suppliers of medical aids are required to carry reference products.
(10) The government body in charge of the healthcare system shall withdraw the operating permit of a wholesale distributor or retail supplier of medical aids if it finds that the wholesale distributor or retail supplier has repeatedly and seriously infringed upon the relevant provisions concerning the distribution of medical aids.
(11) The health insurance administration agency may prescribe rules for the distribution of medicinal products, dietary supplements and medical aids subsidized under the social security system with a view to ensure the continuous and safe supply of the general public.
Section 21/A.
The health insurance administration agency shall display an online medical aid catalogue containing information on subsidized medical aids - as described in specific other legislation - on its official website with a view to lend assistance to doctors wishing to prescribe medical aids, as well as to patients for enabling them to make an informed decision.
Chapter IV
GENERAL RULES FOR THE ADMISSION OF MEDICINAL PRODUCTS AND MEDICAL AIDS INTO THE SOCIAL SECURITY SUBSIDY SYSTEM
Section 22.
Unless otherwise prescribed by law, social security subsidies may be granted to medicinal products and medical aids if:
a) the holder of the marketing authorization of a medicinal product, the distributor of dietary supplement or the manufacturer of medical aid, or its authorized representative, applies for subsidies within the compulsory health insurance system for the product in question;
b) in connection with medicinal products, the authority vested with powers under specific other legislation has recognized the safety and efficacy of the product, and authorized the release of the product into free circulation;
c) the cost-effectiveness of the medicinal product, dietary supplement or medical aid in question has been verified;
d) the medicinal product, dietary supplement or medical aid in question is effectively available for therapeutic use;
e) the person applying for subsidies undertakes - by way of the means and for the duration prescribed in Section 26 and also by specific other legislation - to comply with the regulations pertaining to insurance costs;
f) the funds required are or can be made available within the social security system;
g) the holder of the marketing authorization of a medicinal product, the distributor of the dietary supplement or the manufacturer of medical aids, or its authorized representative undertakes the commitment for the distribution and stocking of the subsidized product.
Section 23.
(1) Proceedings concerning the admission of medicinal products and dietary supplements for subsidies under the social security system are opened upon request, notification or ex officio where:
a) if opened upon request, the application may pertain to the admission of medicinal products and dietary supplements - which have already been authorized for marketing - into the social security subsidy system, for the review of the subsidy category, the type and rate of subsidy, and for any subsequent modification of these;
b) if opened upon notification, the application may pertain to the notification of changes in the particulars referred to in Subsection (4) of Section 29;
c) if opened ex officio, the proceedings of the health insurance administration agency may pertain to the total and partial review of the list of subsidized medicinal products and dietary supplements in accordance with Subsections (7)-(8).
(2) The application and the notification referred to in Paragraphs a) and b) of Subsection (1), respectively, shall be submitted by the holder of the marketing authorization of the medicinal product or the distributor of dietary supplement to the health insurance administration agency subject to the formal and content requirements prescribed by specific other legislation.
(3) The health insurance administration agency shall adopt a decision concerning the admission of medicinal products and dietary supplements - which have already been authorized for marketing - into the social security subsidy system, including the subsidy category, the type and rate of support, and the first day from which the social security subsidy can be claimed (hereinafter referred to as “initial day of sponsorship”), furthermore, concerning exclusion from social security subsidies and any change in the particulars referred to in Subsection (4) of Section 29, within ninety days, with the exception of the case set out in Subsection (4).
(4) By way of derogation from Subsection (3) above, the health insurance administration agency shall adopt its decision within sixty days if:
a) the request for admission into the social security subsidy system pertains to a medicinal product that is a generic of a reference medicinal product that contains an active ingredient which is or has been subsidized; or
b) the price of the preparation to which Paragraph a) does not apply is lower than the price of medicinal product(s) - regulated under specific other legislation - that contains an active ingredient which is or has been subsidized.
(5) The applicant shall be charged an administrative service fee in accordance with the provisions of specific other legislation for the proceedings referred to in Subsections (3)-(4).
(6) The health insurance administration agency shall - based on criteria set out in Subsection (7) - routinely review the scope of subsidized medicinal products.
(7) Covered by the review referred to in Subsection (6), the health insurance administration agency shall ex officio open proceedings:
a) in the event of any doubt arising in terms of cost-efficiency with respect to products already approved for subsidies;
b) where any product that has already been approved for subsidies imposes an unreasonable burden upon the budget of the Health Fund relative to the advantage it offers in terms of therapeutic efficacy;
c) where so justified by any changes in the relevant legislation;
d) where ex officio proceedings are prescribed by the relevant legislation;
e) where the extension of the commitment defined in Section 21 for the distribution of products within the subsidized system or for keeping them on stock is justified with a view to ensure the continuous and safe supply of the general public.
(8) In the cases described in Subsection (7) above, the health insurance administration agency shall adopt its decision within ninety days concerning the exclusion of subsidized medicinal products or for modifying the rate of subsidy, for making any changes in the subsidy category or the type of subsidy, or for the extension or prescribing of the commitment defined in Section 21 for the distribution of products within the subsidized system or for keeping them on stock.
(9) The health insurance administration agency shall conduct the proceedings referred to in Paragraph a) of Subsection (1) using the regular or simplified technique.
Section 24.
(1) The health insurance administration agency shall determine the rate of subsidy under Subsections (2)-(4) of Section 23 as a percentage (percentage base and rate) or as a specific (fixed) sum. Subsidy may be set as a fixed amount for medicinal products containing the same active ingredients, or for a group of medicinal products formulated to treat the same disease.
(2) Groups of medicinal products for fixed subsidies are set up on a regular basis, where the information relating to producer prices are made available to the public. The detailed regulations for making proposals, publicity, for determining the amount of subsidies whether at a percentage rate or in a fixed amount, for setting up groups and for the admission procedures shall be laid down in specific other legislation.
(3) The resolutions containing the decisions referred to in Subsections (3)-(4) and (6) of Section 23 as prescribed in specific other legislation shall contain explanations based on the objective and verifiable criteria.
(4) The health insurance administration agency - relying on the final and enforceable resolutions and in consideration of what is contained in Subsection (6) - shall publish on its official website the complete list of subsidized medicinal products by the 20th of each calendar month for information purposes.
(5) The health insurance administration agency shall send the notice referred to in Paragraph b) of Subsection (4) to the European Commission and to the health insurance supervisory authority.
(6) The notice referred to in Subsection (4) shall indicate the registration number of the medicinal products, including its name, packaging, producer price, gross retail price, the amount of subsidy, the retail price with the amount of subsidy deducted (retail price as charged), and the initial day of sponsorship under the social security system.
(7) An appeal against the resolution of the health insurance administration agency adopted under Subsections (3)-(4) and (6) of Section 23 shall be adjudged within sixty days.
Section 25.
(1) If the marketing authorization holder wishes to change the price of a medicinal product approved for subsidies and for marketing after the operative date of the resolution the health insurance administration agency has adopted according to Section 23, a new application shall be submitted for authorization for subsidies.
(2) In the case where the health insurance administration agency has adopted a decision following the proceedings referred to in Subsection (6) of Section 23:
a) for the termination of subsidies for a certain medicinal product or dietary supplement, the date of termination of subsidies, or the day of cutting back the subsidies to zero per cent may not be set inside a ninety-day period following the date of the resolution,
b) for reducing the rate or amount of subsidies for a certain medicinal product or dietary supplement, the initial day of sponsorship at the new rate shall be set for the first day of the quarter following the date of the resolution.
(3) A request for reopening the case may not be submitted in the proceedings conducted under Subsection (2) of Section 23.
(4) The health insurance administration agency may declare its resolution of the first instance enforceable irrespective of any appeal.
(5) The health insurance administration agency, with a view to ensure publicity relating to its proceedings under Sections 23-25 shall publish on its official website by way of electronic means:
a) applications submitted in due compliance with formal requirements, within five working days following the date of receipt; and
b) the final resolution adopted in the case - or the resolution that may be declared enforceable irrespective of any appeal -, in addition to having it delivered to the applicant, together with the notice published for information purposes in accordance with specific other legislation by the fifth day of the month following the date of the decision adopted in connection with the application.
Section 26.
(1) Medicinal products are approved for social security subsidies in different categories. In the various subsidy categories all sponsorship methods specified according to Section 28 may be applied. The amounts of subsidies as per the various sponsorship methods shall be calculated based on the percentage rates indicated in the tables containing the ATC-groups specified in specific other legislation in due observation of the current health-care policy objectives. The maximum percentage rates available in the various subsidy categories, and the classification of the ATC-groups in the percentage subsidy categories are contained in specific other legislation.
(2) The health insurance administration agency, with a view to enforce the relevant budgetary limits, may enter into a subsidy volume agreement with respect to products which are already or recently have been approved for subsidies, including their subsidy categories and indications.
(3) A preparation may be subsidized solely under a subsidy volume agreement if:
a) it contains an active ingredient which has not yet been approved for subsidies,
b) the applicant is requesting admission for subsidies based on an indication which has not yet been approved for special subsidies or premium subsidies, where it is contingent upon indication for maximum percentage rates available under specific other legislation.
(4) A subsidy volume agreement may be concluded for a maximum term of four calendar years.
(5) The payment obligation stipulated in the subsidy volume agreements may be determined:
a) in proportion to the price subsidies provided for any batch sold with price subsidies;
b) on the basis of the difference between the full amount of price subsidies provided during the life of the agreement for one or more product and the limit value fixed in the agreement;
c) based on the estimated costs arising upon the lack of expected efficacy and the lack of therapeutic efficacy relative to the efficacy result fixed in the agreement;
d) in the event of lack of compliance with the criteria fixed in the agreement relating to the activities intended to enhance patient cooperation in connection with specific treatments.
(6) In respect of any one preparation the provisions contained in Paragraphs a)-d) of Subsection (5) may be applied concurrently.
(7) In connection with agreements concluded for a period of over one calendar year, the health insurance administration agency may prescribe prepayment obligations.
(8) The mandatory layout for subsidy volume agreements, the conditions for contracting and for the application of certain types of agreements, and the rules concerning the disclosure obligation of the health insurance administration agency shall be laid down in specific other legislation.
Section 27.
(1) The admission of new products of the same group of efficacy into a subsidy category upon the request of the holder of the marketing authorization of a medicinal product that contains the new active ingredient shall be decreed by the minister in charge of the healthcare system - in agreement with the minister in charge of public finances - in the light of the opinion of the health insurance administration agency and of the opinion of local and international experts of medicine and pharmacology.
(2) Where the health insurance administration agency receives a request for subsidies for a medicinal product that contains a new active ingredient whose ATC-group, subsidy category within the ATC-group and the rate of subsidy is not contained in the specific other legislation, the health insurance administration agency shall suspend the proceedings for the approval of the medicinal product in question until the resolution of the minister in charge of the healthcare system - made in agreement with the minister in charge of public finances - becomes operative, not to exceed ninety days following the date of submission of the request, and shall notify the party affected accordingly.
(3) If the legal regulation referred to in Subsection (2) is not amended, the health insurance administration agency shall adopt a decision after the 90-day time limit on the basis of the legal provisions in force at that time.
(4) The special subsidies or premium subsidies which are contingent upon indication are subject to indication and entitlement for prescription. The subsidy approved for a specific medicinal product may differ according to the types of diseases it is intended to treat and the function of the health service provider that prescribed the medicinal product in question, and depending on the recommendation of a specialist required for the approval of the medicinal product. The name of the group of diseases and the areas of indication for special subsidies or premium subsidies and entitlements for prescription of these subsidized products shall be decreed by the minister in charge of the healthcare system in agreement with the minister in charge of public finances.
(5) Where the health insurance administration agency receives a request for subsidies for a medicinal product in connection with which a new group of diseases and areas of indication for special subsidies or premium subsidies has to be defined for they are not contained in the specific other legislation, such new group of diseases and the areas of indication for special subsidies or premium subsidies and entitlements for prescription of these subsidized products shall be decreed - based on the recommendation of the health insurance administration agency - by the minister in charge of the healthcare system in agreement with the minister in charge of public finances. Until this decision is adopted the health insurance administration agency shall proceed in accordance with Subsections (2)-(3).
(6) The social security subsidies provided for medicinal products with special funding may be claimed based on a special agreement between the medical institutions - a list of which is published by the health insurance administration agency each year - where the medicinal products in question are dispensed, and the health insurance administration agency. The terms and conditions and the mandatory layout of these agreements are contained in specific other legislation.
(7) The list of medicinal products with special funding shall be decreed by the minister in charge of the healthcare system -in agreement with the minister in charge of public finances - indicating the active ingredients of the medicinal products and the group of diseases.
(8) In connection with any request for subsidies for a medicinal product that contains an active ingredient that is not listed in the legal provision referred to in Subsection (7), the proceedings under Subsections (2)-(3) shall be applied as appropriate.
Section 28.
(1) The health insurance administration agency shall use the following sponsorship methods in connection with the medicinal products approved for social security subsidies:
a) percentage-based subsidy;
b) fixed amount subsidy:
ba) fixed amount based on the active ingredient,
bb) fixed support based on therapeutic efficacy;
c) subsidy volume agreement;
d) special subsidies for medicinal products purchased by public procurement;
e) subsidies reduced by a specific amount or percentage.
(2) The detailed regulations concerning sponsorship methods are laid down in specific other legislation.
Section 29.
(1)
(2) The health insurance administration agency shall adopt its decisions concerning the approval of medicinal products within the time limit specified in Subsection (4) of Section 23 if the request pertains:
a) to a medicinal product that is a generic of a reference medicinal product that contains an active ingredient which is or has been subsidized;
b) to a dietary supplement or a medicinal product that has been authorized for release for free circulation and is listed in the Catalogue of Standard Prescriptions or in the Pharmacopoeia, or authorized for increasing its price serving as the basis for public financing;
c) to a preparation to which Paragraph a) does not apply, whose price is lower than the price of the medicinal product(s) - regulated under specific other legislation - that contains an active ingredient which is or has been subsidized.
(3) The health insurance administration agency shall adopt its decisions concerning the approval of medicinal products within the time limit specified in Subsection (3) of Section 23 if the request pertains:
a) to a new pharmaceutical form and a new method of administration;
b) to a novel indication;
c) to a novel active ingredient;
d) to a novel combination, if any active ingredient it contains is not approved for subsidies;
e) to increasing its price serving as the basis for public financing, with the exception set out in Paragraph b) of Subsection (2);
f) to any change in the subsidy category;
g) to cases of a combination specified in specific other legislation;
h) with the exception set out in Subsection (2), to a novel medicinal product that contains an approved active ingredient;
i) to a medicine offering significant therapeutic advantages, approval at a higher price and to the granting of subsidies;
j) to a medicinal product that contains an active ingredient which is or has been subsidized if:
ja) offered in a new packaging,
jb) it features higher potency,
jc) offered in a novel pharmaceutical form with the same method of administration,
jd) offered in a novel combination.
(4) In the cases other then those specified under Subsections (2)-(3), the marketing authorization holder - or the distributor submitting a request for subsidies in connection with a dietary supplement - shall notify:
a) in connection with its medicinal product that contains an active ingredient which is or has been subsidized, or dietary supplement:
aa) any changes in terms of dispensing,
ab) any changes in its name,
ac) any changes in its registration number,
ad) if removed from the register,
ae) any price reduction;
b) any revision intended in the subsidy category of its subsidized medicinal product that results in the transfer of the preparation in question to preparations which are not included in the social security subsidy system;
c) if its product that has been authorized for marketing in Hungary with social security subsidies has been authorized for marketing by the European Commission in a central registration procedure;
d) any change in the person of the holder of authorization listed in the register of medicinal products.
(5) Discharging the obligation of notification under Subsection (4) shall be exempt from any administrative service fee.
(6) The health insurance administration agency shall publish the notices under Subsection (4) on the first day of the month following notification.
Section 30.
(1) A preparation that contains an active ingredient which has not yet been approved may be approved for social security subsidies only if the producer price that the holder of the marketing authorization of a medicinal product has indicated in the request is not higher than the price of a medicinal product indicated in specific other legislation that contains the same or a similar active ingredient that has the lowest price among the products actually in circulation in any Member State of European Union or in any State that is a party to the Agreement on the European Economic Area.
(2) The health insurance administration agency shall carry out an audit at least once a year - based on the mechanism and criteria set out in specific other legislation - for the purpose of comparison of the prices of medicinal products approved for social security subsidies within seven digit ATC-groups, recognized to consume substantial subsidies in accordance with specific other legislation, with the prices of medicinal products actually in circulation in any Member State of European Union or in any State that is a party to the Agreement on the European Economic Area in accordance with specific other legislation, that contain the same or a similar active ingredient. Relying on the findings of such ex officio proceedings, the health insurance administration agency shall adopt a decision concerning the medicinal product in question, in terms of granting subsidies, for modifying the rate of subsidy or for the withdrawal of subsidies.
Section 31.
(1) The health insurance administration agency shall withdraw the social security subsidy from any medicinal product:
a) that does not have a valid marketing authorization;
b) in the event of justified doubts in terms of cost-efficiency;
c) that imposes an unreasonable burden upon the budget of the H. Fund relative to the advantage it offers in terms of therapeutic efficacy;
d) if the holder of its marketing authorization was found guilty of any infringement of the provisions of specific other legislation pertaining to the advertisement and promotion of medicinal products by final decision of the authority vested with powers and jurisdiction under advertising control proceedings on two occasions within one year in connection with the same medicinal product;
e) whose cost-effectiveness cannot verified;
f) that is not available on the market for over six months, or three months in the case of reference preparations;
g) whose marketing authorization had been withdrawn;
h) in the case of medicinal products approved for fixed amount subsidies based on the active ingredient, the cost of the medicinal product if used for a daily therapy, or its unit price if according to its active ingredient it exceeds at least by 30 per cent the daily cost of the reference preparations;
i) in the case of medicinal products approved for fixed support based on therapeutic efficacy, if the cost of the medicinal product when used for a daily therapy exceeds at least by 60 per cent the mathematical average of the daily costs of the medicinal products comprised in the group.
j) if - based on the findings of the price comparison conducted - the producer price of the medicinal product in question is at least 40 per cent higher than the mathematical average of the prices of five medicinal products indicated in specific other legislation that contain the same or a similar active ingredient that have the lowest price among the products actually in circulation in any Member State of European Union or in any State that is a party to the Agreement on the European Economic Area.
(2) The health insurance administration agency shall withdraw the subsidy from any medicinal product that is cancelled from the register of medicinal products effective as of the first day of the fourth month following the date of cancellation.
(3) The health insurance administration agency shall have authority to exclude any medicinal product from the social security subsidy system if the marketing authorization holder fails to satisfy the obligation of marketing and for keeping a specific quantity of such products on stock under Subsection (8) of Section 21.
Section 31/A.
The use of an oxygen supply system, including cylinder and auxiliary equipment, in the patient’s home shall be fixed in an agreement between the patient and the supplier, subject to the relevant provisions of the Civil Code on rental arrangements.
Section 32.
(1) Proceedings concerning subsidies available for medical aids under the social security system are opened upon request or ex officio.
bh) for changing its size according to specific other legislation,
(2) The application can relate:
a) to medical aids for which no social security subsidies are available,
aa) requesting subsidies,
ab) requesting the award of daily rental fees for products which are made available only by way of rental;
b) to medical aids which have already been approved for subsidies,
ba) requesting the award of higher daily rental fees for products which are made available only by way of rental,
bb) requesting the reduction of daily rental fees for products which are made available only by way of rental,
bc) requesting transfer to another function group (sub-group),
bd) requesting to have the name of the medical aid changed pursuant to specific other legislation,
be) requesting to have its price serving as the basis for public financing reduced,
bf) requesting to have its price serving as the basis for public financing increased,
bg) requesting its removal from the subsidy system,
bh) requesting to have its size changed according to specific other legislation or the award of subsidies for the new version.
(3) The application referred to in Subsection (2) above - except for the collective applications under Subsection (11) - may be submitted only by a qualified distributor shown in the list of suppliers referred to in Section 32/B of the health insurance administration distributor to the health insurance administration agency.
(4) The health insurance administration agency:
a) shall adopt a decision concerning the requests referred to in Paragraphs aa), ab), ba), bc) and bf) of Subsection (2), subject to the requirements set out in specific other legislation, within ninety days under the normal procedure;
b) shall - by way of derogation from Paragraph a) - adopt a decision concerning the requests referred to in Paragraphs aa), ab) and bc) of Subsection (2), subject to the requirements set out in specific other legislation, within sixty days under the accelerated procedure where the distributor of medical aids
ba) indicates in the application a price serving as the basis for the lowest public financing in respect of his product that is below the price of a product that has already been admitted into a function group (sub-group) by 10 per cent or more, or
bb) produces the findings of a clinical trial conducted in Hungary involving at least one hundred patients.
(5) The health insurance administration agency shall adopt a resolution concerning the requests referred to in Paragraphs bd) and bh) of Subsection (2), subject to the requirements set out in specific other legislation, by the simplified procedure within thirty days of the time of submission.
(6) The distributor of subsidized medical aids shall be subject to the obligation of notification in the cases of Subparagraphs bb), be) and bg). The health insurance administration agency shall publish these notifications under the conditions set out in specific other legislation within fifteen days of the time of submission.
(7) The resolutions adopted under Subsections (4)-(5) - except for resolutions of refusal - shall indicate in due consideration of the provisions laid down in specific other legislation relating to the award of subsidies:
a) the name and description of the medical aid, its function group (sub-group) and ISO code;
b) the presentation of the medical aid;
c) in connection with any equipment
ca) that can be made available by ways other than rental, the price serving as the basis for public financing,
cb) which are made available only by way of rental, the daily rental fee serving as the basis for public financing;
d) the rate of the subsidy and the means by which it is provided;
e) the net amount of the subsidy;
f) the approved period of use and the maximum quantity that can be prescribed for the approved period;
g) the actual conditions for prescription (indication, qualification requirements and other medical specifications);
h) the initial day of support, whether for new products or for products already included in the list of subsidized products, and approved for continued support under modified conditions;
i) as to whether the medical aid in question can be supplied under the fully subsidized public healthcare system;
j) in connection with medical aids where title of ownership may be transferred to the patient upon expiry of the rental period, the rental fee index number assigned to the equipment’s function group (sub-group) in accordance with specific other legislation;
k) in connection with durable medical aids, the flat-rate repair charges applicable to the given function group (sub-group);
l) the price the patient is required to pay for the medical aid.
(8) The distributor shall be charged an administrative service fee in accordance with the provisions of specific other legislation for the proceedings referred to in Subsections (4)-(5).
(9) A request for reopening the case may not be submitted in connection with the proceedings described in Subsections (4)-(5) above.
(10) The health insurance administration agency, with a view to ensure publicity shall publish on its official website by way of electronic means:
a) applications submitted in due compliance with formal requirements, within fifteen working days following the time of receipt of the application or upon the time of supply of missing information, if any; and
b) its final resolution adopted in the case of the resolution that may be declared enforceable irrespective of any appeal, within ten working days of the time of conclusion of the case.
(11) In connection with custom-made medical aids, all distributors of such medical aids engaged under contract with the health insurance administration agency for entitlement to social security subsidies, or the authorized representatives of such distributors shall be able to submit collective applications under specific other legislation relating to the type of the device only jointly. The rules relating to the admission of custom-made medical aids for subsidies shall be governed by specific other legislation in accordance with this Act.
(12) The application referred to in Subsection (11) above may be submitted to the health insurance administration agency solely with respect to Subparagraphs aa), be), bf) and bg) of Subsection (2).
(13) The health insurance administration agency may declare its resolution of the first instance enforceable irrespective of any appeal.
Section 32/A.
(1) The health insurance administration agency shall routinely carry out full or partial review of subsidized medical aids along the criteria set out in Subsection (2).
(2) As part of the review procedure referred to in Subsection (1) above, the health insurance administration agency shall initiate proceedings ex officio:
a) if the subsidized medical aid imposes an unreasonable burden upon the budget of the Health Fund relative to the advantage it offers in terms of therapeutic efficacy;
b) where justified by changes in the relevant legislation;
c) where ex officio proceedings are prescribed by the relevant legislation;
d) where there is any doubt as to the quality and/or conformity of a medical aid.
(3) In the process of carrying out the review procedure under Subsection (1), the health insurance administration agency shall have powers - conferred under specific other legislation - for excluding a subsidized medical aid from the subsidy system, for changing the rate of subsidy, for clarifying the name of a medical aid shown in the subsidy list, for changing the approved period of use or the quantity that can be prescribed for the approved period and the actual conditions for prescription, and for transferring it to another function group (sub-group).
(4) Where a new function group (sub-group) is opened by way of the procedure under Subsection (2) of Section 34, or if a new function group (sub-group) is proposed or an existing one is terminated under other grounds, the health insurance administration agency must carry out the procedure referred to in Subsection (1) above.
(5) The health insurance administration agency shall ex officio conduct the fixation procedure prescribed in specific other legislation semi-annually with a view to re-establishing the subsidy groups of medical aids.
Section 32/B.
(1) The health insurance administration agency, shall rate distributors of medical aids, and shall admit the ones who satisfy the conditions set out in specific other legislation into the list of suppliers described in specific other legislation.
(2) The rating of suppliers shall be subject to the payment of an administrative service fee prescribed in specific other legislation.
Section 33.
(1) The resolutions containing the decisions referred to in Subsections (4)-(5) of Section 32 and Subsection (1) of Section 32/A shall contain explanations which are based on objective and verifiable criteria.
(2) Subject to the exceptions set out in Subsections (3)-(4), the resolutions shall set the initial day of assistance, whether under the previous or modified conditions:
a) inside a 365-day period following the operative date of the resolution,
b) in connection with mass produced medical aids and custom-size medical aids made in a series, if the resolution referred to in Subsection (4) of Section 32 results in the increase of the price of a product serving as the basis for public financing, and if this price is the same or lower than the price of the reference product, after the 181st day following the operative date of the resolution.
(3) In the case where the health insurance administration agency has adopted a decision following the proceedings referred to in Subsection (1) of Section 32/A for the exclusion of a certain medical aid from the subsidy system, for changing the rate or amount of subsidies, or for transferring it to another function group (sub-group), the date of termination of subsidies, the initial day of change in the rate of subsidies, or the initial day of transfer to another function group (sub-group) may not be set before the first day of the quarter directly following the date of the resolution, or after the first day of the second quarter following the date of the resolution.
(4) In the case where the health insurance administration agency has adopted a decision following the proceedings referred to in Subsection (1) of Section 32/A, that was opened pursuant to Paragraph b) of Subsection (2) of Section 32/A, for the exclusion of a certain medical aid from the subsidy system, for changing the rate or amount of subsidies, for transferring it to another function group (sub-group), for clarifying the name of a medical aid, for changing the approved period of use or the quantity that can be prescribed for the approved period and the actual conditions for prescription, the date of termination of subsidies, the initial day of change in the rate of subsidies, the initial day of assistance in another function group (sub-group), under the modified period of use or with a modified quantity that can be prescribed for the approved period, or under a different name shall be the effective date of the legislation upon which the underlying procedure was initiated.
(5) An appeal against the resolution of the health insurance administration agency adopted under Subsections (4)-(5) of Section 32 and Subsection (1) of Section 32/A shall be heard within sixty days.
(6) The health insurance administration agency - relying on the final and enforceable resolutions - shall publish on its official website the complete list of subsidized medicinal products - with the particulars prescribed by specific other legislation - by the 20th of each calendar month for information purposes.
Section 34.
(1) If the manufacturer of the medical aid or its authorized representative wishes to change the price of a medical aid approved for subsidies and for marketing after the operative date of the resolution the health insurance administration agency has adopted according to Section 32, a new application shall be submitted for authorization for subsidies.
(2) If the health insurance administration agency receives a request for subsidies for a novel medical aid, whose function group (sub-group), or the rate subsidy for that specific function group (sub-group) is not contained in specific other legislation, the health insurance administration agency shall suspend the proceedings for the approval of medical aid for subsidies until the amendment of the specific other legislation enters into force, or for a maximum period of 180 days following the submission of the request, and shall notify the party affected accordingly.
(3) If the legal regulation referred to in Subsection (2) is not amended, the health insurance administration agency shall adopt a decision after a 180-day time limit on the basis of the legal provisions in force at that time.
(4)
(5) Persons employed by the institutions which are involved in the proceedings referred to in Subsections (4)-(5) of Section 32 under contract of employment or other similar relationship and the persons directly involved in the administration of the proceedings shall file a statement declaring their independence from the distributor who filed the underlying request in terms of any business or other similar interest, and the distributor of another device that belongs to the same function group.
(6) The home delivery of subsidized medical aids is authorized to distributors (vendors specializing in medical aids or pharmacies) holding an operating permit, if they are able to meet the conditions set out in specific other legislation.
(7) Subsidized dressings and bandages may be dispensed by pharmacies and vendors specializing in medical aids.
(8) The health insurance administration agency, with a view to enforce the relevant budgetary limits, may enter into a subsidy volume agreement with respect to medical aids which are already or recently have been approved for subsidies.
(9) The provisions for making payments are laid down in the subsidy volume agreement concluded between the manufacturer or its authorized representative and the health insurance administration agency.
Section 35.
(1) Distributors of medicinal products, in the process of dispensing:
a) may not exceed the maximum retail price approved by the health insurance administration agency in proceedings for the approval for subsidies,
b) may not differ from the amount of subsidy and the amount of compensation established by the health insurance administration agency in proceedings for the approval for subsidies.
(2) Distributors of medical aids, in the process of dispensing:
a) may not exceed the price approved by the health insurance administration agency serving as the basis for public financing in proceedings for the approval for subsidies,
b) may not differ from the amount of subsidy and the amount of compensation established by the health insurance administration agency in proceedings for the approval for subsidies.
(3) The detailed regulations for the admission of medicinal products, dietary supplement and medical aids into the social security subsidy system is contained in specific other legislation.
(4) Electronic communication as referred to in Section 28/B of the APA shall be carried out via the IT systems of the health insurance administration in connection with proceedings for the admission of medicinal products and medical aids for subsidies within the social security system.
(5) Changes in the particulars referred to in Subsection (4) of Section 29 shall be notified on the official website of the health insurance administration agency.
(6) A medical aid may be prescribed under the fully subsidized public healthcare system only if not admitted to the function group mentioned in Subsection (7), and if - within the group - it is either a reference product, or a product sold at a price (or rented at a daily rental fee) with public financing that is the same or lower than the price of the reference product.
(7) The function groups that cannot be dispensed under the fully subsidized public healthcare system are contained in specific other legislation.
Chapter V
PROVISIONS INTENDED TO ENSURE THE CONTINUOUS SUPPLY OF MEDICINAL PRODUCTS AND THE ENFORCEMENT OF THE APPROPRIATION OF MEDICINAL PRODUCT SUBSIDIES
Section 36.
(1) Holders of the marketing authorization of medicinal products, or - if they are not engaged in any distribution activities in Hungary as fixed in an agreement with a distributor subject to the approval of the state tax authority - the distributor, furthermore, the person submitting a request for subsidies in connection with a dietary supplement if other than the distributor of the dietary supplement in question (for the purposes of this Chapter hereinafter referred to collectively as “holder of the marketing authorization of a medicinal product”), shall be required to pay twelve per cent on the producer price or import price (hereinafter referred to collectively as “producer price”) of all its medicinal products and dietary supplements (for the purposes of this Chapter hereinafter referred to collectively as “medicinal product”) sold in pharmacies with public financing - other than the medicinal products specified in Subsection (1) of Section 38 - based on and consistent with (producer price/retail price) the amount of social security subsidies shown under the volume of sales under prescription for the month. The amount payable shall be calculated separately for each product and subsidy type. Social security subsidy shall be understood as a subsidy comprising value added tax (gross), retail price shall mean the gross retail price, and producer price shall be applied exclusive of value added tax (net).
(2) Business associations authorized for the wholesale distribution of medicinal products, and business association authorized for the wholesale distribution of dietary supplements (hereinafter referred to collectively as “authorized wholesale distributor of medicinal products”) shall be required to pay two-and-a-half per cent of the wholesale price margin on all their medicinal products sold during the month in public pharmacies and in institutional pharmacies engaged in supplying medicinal products to the general public with public financing, based on the amount of social security subsidies.
(3) Any authorized operator of a public pharmacy and any institutional pharmacy engaged in supplying medicinal products to the general public (hereinafter referred to collectively as “authorized operator of a public pharmacy”) whose aggregated quarterly price margin from the sale of medicinal products with public financing exceeds the amount referred to in Section 39 shall be required to pay a pharmacy solidarity tax.
(4) The promoter of medicinal products referred to in Subsection (3) of Section 12 shall be required to pay four hundred and sixteen thousand forints a month for all medical sales representatives they employ under contract in connection with medicinal products, and eighty-three thousand forints in connection with medical aids. Where the contract of employment is opened or terminated during the month, the payment liability shall apply with the above-specified prorated amount for the duration of employment expressed in days as commensurate for the calendar days of the month.
(5) The payment obligations specified under Subsections (1)-(4) of this Section and in Section 42 shall be subject to the provisions of Act XCII of 2003 on the Rules of Taxation (hereinafter referred to as "RTA"), with the exceptions set out in this Act.
(6) The state tax authority, if granting approval for the agreement between the holder of the marketing authorization of a medicinal product and the distributor, shall notify the health insurance administration agency thereof within eight days of the date of approval.
(7) A person who is the holder of a marketing authorization for a medicinal product shall be eligible for up to 20 per cent allowance from the payment obligations described under Subsections (1) and (4) of Section 36 and Subsections (1)-(6) of Section 42 in respect of the costs of research and development if carried out under the conditions laid down in detail in specific other legislation, if having satisfied all payment obligations described in this Act. The investments made by the said holder of a marketing authorization in R&D projects - as specified in specific other legislation - and those of any other companies involved in consolidation according to the Accounting Act shall be taken into account on the aggregate.
Section 37.
(1) The health insurance administration agency vested with authority to manage the Health Insurance Fund shall communicate to the person affected the information concerning subsidies and turnover for compliance with the payment obligations specified in Subsections (1)-(2) of Section 36 by the tenth day of the second month that follows the current month, and the information concerning subsidies and turnover for compliance with the payment obligations specified in Subsection (3) of Section 36 by the tenth day of the second calendar month that follows the current quarter, and shall post them on its official website as well.
(2) Holders of the marketing authorization of medicinal products and business associations authorized for the wholesale distribution of medicinal products shall be required to file a declaration on the payment obligations specified in Subsections (1)-(2) of Section 36 by the twentieth day of the third calendar month following the current month, using the standard form prescribed by the state tax authority, and shall pay the sum required to the account of the state tax authority opened at the treasury for this particular purpose.
(3) Authorized operators of public pharmacies whose aggregated quarterly price margin from the sale of medicinal products with public financing exceeds the sum referred to in Subsection (1) of Section 39, shall be required to file a declaration on tax advances, on the payment obligations specified in Subsection (3) of Section 36, applying the brackets defined in Subsection (2) of Section 39 by the twentieth day of the third calendar month following the current quarter, using the standard form prescribed by the state tax authority, and shall pay the sum required to the account of the state tax authority opened at the treasury for this particular purpose.
(4) The persons engaged in promotional activities in accordance with Subsection (3) of Section 12 shall be required to file a declaration on the payment obligations specified in Subsection (4) of Section 36 by the twentieth day of the third calendar month following the current month, and shall pay the sum required to the account of the state tax authority opened at the treasury for this particular purpose.
(5)
(6) The health insurance administration agency vested with authority to manage the Health Insurance Fund shall disclose the data required for the audit of the operators subject to payment obligations, concurrently with supplying the data referred to in Subsection (1), to the state tax authority by way of electronic means.
(7) The health insurance supervisory authority shall forthwith notify the state tax authority by way of electronic means concerning the notification specified in Subsection (3) of Section 12, the notification of the termination of activities and on the prohibition of promotional activities.
Section 38.
(1) Holders of the marketing authorization of medicinal products shall be exempt from the payment obligation prescribed in Subsection (1) of Section 36:
a) in connection with any medicinal product in a specific (fixed) subsidy group whose daily cost based on therapeutic efficacy is at least fifteen per cent lower than the reference price during the period when the price margin applies;
b) as regards the amount of subsidy paid on medicinal products with special funding; and
c) as regards the amount of subsidy provided in addition to the regular rate of social security subsidy for medicinal products supported under special consideration.
(2) Holders of the marketing authorization of medicinal products may be granted an allowance up to the full amount of their payment obligation broken down according to medicinal products, calculated separately for each product and the types of subsidies, if they undertake to reduce the producer price for the medicinal products they supply with social security subsidies according to Subsection (1) of Section 36. In this case, the payment obligation prescribed in Subsection (1) of Section 36 pertaining to the products affected by the price reduction shall be decreased consistent with the applicable rate of reduction for the period to which the price reduction pertains, for a maximum period of one year from the operative date of the price reduction.
(3)
(4) Holders of the marketing authorization of medicinal products shall deduct the amount paid under the subsidy volume agreement pertaining to the subject period from the amount of the payment obligation prescribed under Subsection (1) of Section 36.
Section 38/A.
The promoter of medicinal products referred to in Subsection (3) of Section 12 shall be exempt from the payment obligation specified in Subsection (4) of Section 36 in respect of the medical sales representatives they employ under contract to whom either of the provisions contained under Paragraphs a)-g) apply:
a) who is drawing sick-pay, benefits for accident-related injuries, pregnancy-maternity benefits or child-care benefits, for the duration of drawing such benefits;
b) who is drawing child-care allowance, for the duration of drawing such benefits, except if the beneficiary is working during that period;
c) who is unable to work due to incapacity;
d) who is on leave of absence without pay;
e) who is drawing attendance allowance, for the duration of drawing such benefits, except if the beneficiary is working during that period;
f) who is drawing child-rearing allowance, for the duration of drawing such benefits, except if the beneficiary is working during that period;
g) who has been detained, for the duration of detention.
Section 39.
(1) The aggregate price margin referred to in Subsection (3) of Section 36 is ten million forints.
(2) If the aggregated quarterly price margin of an authorized operator of a public pharmacy is:
a) between 10,000,001 and 11,000,000 forints, the amount payable is 1.5 per cent of the aggregated quarterly price margin;
b) between 11,000,001 and 12,500,000 forints, the amount payable is 165,000 forints plus 2.5 per cent of the sum over 11,000,000 forints;
c) between 12,500,001 and 15,000,000 forints, the amount payable is 202,500 forints plus 4 per cent of the sum over 12,500,000 forints;
d) over 15,000,000 forints, the amount payable is 302,500 forints plus 6 per cent of the sum over 15,000,000 forints.
Section 40.
The state tax authority shall forthwith transfer:
a) the sums collected under Subsections (1)-(2) and (4) of Section 36 to the account of the H. Fund opened at the treasury according to specific other legislation;
b) the sums paid according to Subsection (3) of Section 36 to the appropriation account of the ministry governed by the minister in charge of the healthcare system opened at the treasury according to specific other legislation.
Section 41.
(1) Any business association that operates or plans to open a public pharmacy (pharmacies) in a community where the supply of medicinal products for the entire community is ensured or planned to be ensured by only one public pharmacy and - as regards an existing public pharmacy - the aggregated price margin from the sale of subsidized medicinal products over a specific period fails to reach the measure specified in specific other legislation in spite of prudent and effective management - on account of the population to be supplied or due to the pharmacy’s geographical location -, shall be entitled to financial support to cover its operating expenses from the appropriation chapter of the Ministry referred to in Paragraph b) of Section 40 according to the annual budget act. The Ministry shall publish the names of the companies to whom such financial support was provided on its official website, including the amount of support.
(2) The financial support referred to in Subsection (1) shall be treated as budgetary subsidies by definition of the RTA. The provisions of the RTA shall apply concerning the requests for and disbursement of such subsidies. The conditions for entitlement are laid down in specific other legislation.
Section 42.
(1) If the amount of social security subsidies paid out for approved medicinal products based on their volume of sales for the year - exclusive of the sums available for medicinal products with special funding and the sums for subsidizing medicinal products under special and equitable circumstances - exceeds the sum appropriated as shown on the first day of the year, the surplus shall be financed - according to the provisions of Subsections (2) to (3) - by the operator of the H. Fund and by the holders of marketing authorizations.
(2) The surplus amount shall be determined by deducting the sums received from the payment obligation specified under Subsections (1)-(2) and (4) of Section 36 as applicable for the months of January through December of the subject year from the amount of social security subsidies paid out based on the volume of sales for the year, and the positive differential of the appropriation available on the first day of the current year and on the first day of the preceding year under the Medicinal Product Subsidies account of the H. Fund.
(3) An overdraft of up to nine per cent of the predetermined budget shall be covered collectively by the operator of the H. Fund and the marketing authorization holders according to the following brackets:
a) the first bracket covers the first 5 per cent of overdraft, where fifty per cent of the overdraft shall be covered by the operator of the H. Fund and the other fifty per cent by the marketing authorization holders;
b) the second bracket covers the overdraft between 5.01 and 6 percent, where forty per cent of the overdraft shall be covered by the operator of the H. Fund and the remaining sixty per cent by the marketing authorization holders;
c) the third bracket covers the overdraft between 6.01 and 7 percent, where thirty cent of the overdraft shall be covered by the operator of the H. Fund and the remaining seventy cent by the marketing authorization holders;
d) the fourth bracket covers the overdraft between 7.01 and 8 percent, where twenty per cent of the overdraft shall be covered by the operator of the H. Fund and the remaining eighty per cent by the marketing authorization holders;
e) the fifth bracket covers the overdraft between 8.01 and 9 percent, where ten per cent of the overdraft shall be covered by the operator of the H. Fund and the remaining ninety per cent by the marketing authorization holders.
(4) Any overdraft of over nine per cent of the predetermined budget shall be financed - in addition to the payment obligations specified in Subsection (3) - by the marketing authorization holders.
(5) The payment obligation stemming from the diversified system of risk assumption shall be shared by the marketing authorization holders - in due observation of what is contained in Subsection (2) - based on the same percentage as the amount of subsidies paid for the products of each marketing authorization holder relying on the prescription sales records of pharmacies during the current year and the positive differential of the subsidies paid from the appropriation available on the first day of the year preceding the year in question under the Medicinal Product Subsidies account of the H. Fund to each marketing authorization holder relative to the subsidies paid during the previous year. As regards any medicinal product that is authorized for free circulation, the marketing authorization holder shall be exempt from the payment obligation stemming from the diversified system of risk assumption in the calendar year when his product is approved for subsidies.
(6) If the amount of subsidies paid out during the first nine months for approved medicinal products - in the application of Subsections (1)-(2) - exceeds three-quarters of the sum appropriated as shown under the Medicinal Product Subsidies account of the H. Fund on the first day of January of the year in question, the marketing authorization holder - based on the information supplied by the health insurance administration agency vested with authority to manage the Health Insurance Fund concerning subsidies in accordance with Subsections (2)-(5) by 10 November shall be required to declare to the state tax authority and pay an advance by 20 December of the current year, using the standard form prescribed by the state tax authority, to the account of the state tax authority opened at the treasury for this particular purpose.
(7) The health insurance administration agency vested with authority to manage the Health Insurance Fund shall communicate to the marketing authorization holders the information concerning subsidies for compliance with the payment obligations stemming from the diversified system of risk assumption by 15 February of the year following the year to which it pertains.
(8) Marketing authorization holders shall declare the payment obligation stemming from the diversified system of risk assumption by the twenty-fifth day of the month following the time referred to in Subsection (7), using the standard form prescribed by the state tax authority, to the state tax authority, and shall pay the sum that remains taking into account the advance paid under Subsection (6) to the account of the state tax authority opened at the treasury for this particular purpose.
(9) The state tax authority shall forthwith transfer the sums collected from the payment obligations stemming from the diversified system of risk assumption to the account of the H. Fund opened at the treasury - as prescribed by specific other legislation - for this particular purpose.
(10) The health insurance administration agency vested with authority to manage the Health Insurance Fund shall disclose the data for three-quarters of the year as required for the audit of the operators subject to the payment obligations stemming from the diversified system of risk assumption by 10 November, and the data from the current year by 15 February of the calendar year following the current year, to the state tax authority by way of electronic means.
(11) Holders of the marketing authorization of medicinal products shall deduct the amount paid for the current year under the subsidy volume agreement pertaining to the current year from the amount of the payment obligation stemming from the diversified system of risk assumption.
Section 43.
(1) With a view to prevent and check any disturbance in the market in medicinal products and to maintain equilibrium of the market of medicinal products, the Government shall have powers to prohibit by decree any increase in the prices shown at the time of promulgation of the decree adopted under this Subsection in the agreement between the manufacturer and the distributor for medicinal products for human use and dietary supplements for special nutritional needs - including the price specified in the legal regulation mentioned in Subsection (1) of Section 226 of Act IV of 1959 on the Civil Code - for a maximum period of two years, and that the manufacturers and distributors may not make any contract offer to one another for a higher price for a maximum period of two years from the time of promulgation of the said decree.
(2) If the measure specified in Subsection (1) had been ordered, an inquiry shall be conducted at least once a year to determine as to whether it should be continued without changes with a view to maintain equilibrium of the market of medicinal products. Within ninety days following the time of opening the inquiry, the competent authority shall make an announcement concerning any price increases or reductions, if applicable.
(3) The price may be increased relative to the one specified in Subsection (1) only upon the prior consent of the health insurance supervisory authority granted if requested. The consent may be granted if:
a) the medicinal product in question is the only product available for the primary treatment of a specific disease (first selection); and
b) the manufacturer or the distributor is able to verify that the cost to produce the medicinal product in question is higher than the highest price that can be charged under Subsection (1).
(4) A decision concerning the request referred to in Subsection (3) shall be adopted within ninety days. In justified cases this time limit may be extended once, by an additional sixty days. The health insurance supervisory authority shall publish a notice without delay concerning its consent granted according to Subsection (3).
(5) During the period referred to in Subsection (1), a price above the highest price specified or approved by the Government may not be charged in commercial circles.
(6) If the price is not expressly fixed in the contract, the price specified under the aforesaid measure shall be applied for the product in question. This price shall also apply if the companies involved stipulated a different price unlawfully.
(7) If the price specified in Subsection (1) is abolished between the time when the contract is signed and discharged, the contract shall be discharged at the price stipulated, unless otherwise prescribed by law.
Chapter VI
PROVISIONS CONCERNING THE PRESCRIPTION OF MEDICINAL PRODUCTS AND MEDICAL AIDS WHICH ARE EFFICIENT AND OF GOOD QUALITY
Section 44.
(1) In the process of prescription of medicinal products and medical aids - including where medicinal products and medical aids are prescribed for treatment in inpatient medical institutions - the doctor shall inform the patient, in a manner that is accessible and understandable to handicapped persons as well and in due compliance with the relevant professional standards and legal provisions on medical treatment, concerning any alternative for the medicinal products and medical aids prescribed for treatment, the difference between the estimated costs to the patient of medicinal products having the same active ingredient and those of the same fixed subsidy group as well as bio-equivalent medicinal products, and medical aids within the same function group, and on any potential substitutes available according to specific other legislation.
(2) The pharmacist - if the doctor did not preclude substitution on the prescription - shall inform the patient according to the potential substitution available under specific other legislation that a substitute medicinal product is available at a lower price instead of the medicinal products prescribed.
(3) The pharmacist shall replace the medicinal product prescribed, subject to the patient's consent, with a product specified in Subsection (2) whose price that is payable by the patient is lower.
(4) The patient is required to verify receipt of the information referred to in Subsection (1) in the doctor's records, and shall concurrently sign the statement he has made according to the HIS in accordance with specific other legislation.
Section 44/A.
Any authorized operator of a public pharmacy and any institutional pharmacy engaged in supplying medicinal products to the general public, in the case of each reference product from among the medicinal products approved for fixed amount subsidies based on the active ingredient, shall be eligible for certain benefits under specific other legislation if dispensing products whose daily cost based on therapeutic efficacy is lower than the daily cost of the reference products.
Section 45.
(1) The service providers and doctors prescribing medicinal products and medical aids with social security subsidy shall perform these activities using an approved computer program with facilities to make recommendations - in accordance with specific other legislation and taking into consideration the provisions contained in Subsection (2) - concerning any alternative for the medicinal products and medical aids prescribed for treatment, to provide information concerning the difference between the estimated costs to the patient and the Health Fund of medicinal products having the same active ingredient and those of the same fixed subsidy group as well as bio-equivalent medicinal products, and medical aids within the same function group, and to make recommendations for medicinal products, medical aids, reference medicinal products and reference medical aids which constitute the least amount of financial burden upon the patients.
(2) The doctor may prescribe a treatment using medicinal products or medical aids other than those referred to in Subsection (1) in consideration of what is required for the individual patient and for the sickness in question, and in light of the venue where the treatment is provided, after providing the information specified in Subsection (1) of Section 44. The aforesaid substitution shall be recorded in the patient file with a detailed explanation attached.
(3) Any recommendation for medication requiring outpatient treatment, and also the hospital's final report shall indicate the active ingredient, as well as the strength and the pharmaceutical form of the medicinal product, if necessary.
Section 46.
(1) The health insurance administration agency shall assess the performance of health service providers in terms of their practice for the prescription of medicinal products which are efficient and of good quality based on their practice for prescription in the ATC-groups described in specific other legislation, taking into account the indicators showing the extent of use of the medicinal products with the lowest subsidy rate calculated for one day from among the products available for the specific therapy in question.
(2) If the assessment finds that a service provider has violated the provisions set out in specific other legislation concerning the prescription of medicinal products which are efficient and of good quality, the health insurance administration agency shall order the service provider affected to attend a compulsory training course in accordance with specific other legislation.
(3) The detailed regulations for assessment and the related criteria, and for compulsory training are contained in specific other legislation.
Section 47.
(1) The health insurance administration agency shall monitor compliance with the professional standards pertaining to the prescription of medicinal products and medical aids when processing prescriptions, and also through the doctors of its supervisory network.
(2) Where a doctor is found engaged in the prescription of medicinal products and/or medical aid without proper eligibility or unlawfully, the health insurance administration agency shall forthwith notify the doctor affected and the health service provider concerning the said discrepancies, and shall proceed according to Section 37 of the HIS.
PART II
GENERAL PROVISIONS FOR THE SUPPLY OF MEDICINAL PRODUCTS
Chapter I
implementation and operation of pharmacies
Section 48.
(1) Pharmacies may be operated only in possession of a operating permit. The government body in charge of the healthcare system shall adopt a decision concerning the authorization for the implementation and operation of a new pharmacy (hereinafter referred to collectively as "operation") in a single proceeding, within sixty days from the date of submission of the application for the operation of the pharmacy. The authority shall communicate its resolution for the authorization for the implementation and operation of the new pharmacy to the local government of the community where the pharmacy is located as well.
(2) The application may be submitted in writing, and it shall contain:
a) the type of the new pharmacy;
b) the address of the new pharmacy;
c) the proposed date of opening of the new pharmacy;
d) if it is a public pharmacy, the name of the pharmacist having the independent right for managing the pharmacy;
e) if it is a branch pharmacy, the applicant's statement of his intention to operate the branch pharmacy throughout the entire year or only during specific periods (seasons);
f) a statement from the operator of the pharmacy that, under the circumstances defined by law, the operator or the owner of the property will consent for the assignment of an official manager.
(3) With a view to public health considerations the government body in charge of the healthcare system may declare its resolution for authorizing the operation of a pharmacy enforceable, irrespective of any appeal.
Implementation of Public Pharmacies
Section 49.
(1) In any community without a public pharmacy, the government body in charge of the healthcare system shall authorize the operation of a new public pharmacy, if the conditions set out in this Act and in other legislation are satisfied.
(2) In a community that has a public pharmacy, the government body in charge of the healthcare system shall authorize a new public pharmacy if:
a) each of the public pharmacies, including the new pharmacy, serve on average at least five thousand residents, and if the existing public pharmacies and the new public pharmacy are at least 250 meters apart, from entrance to entrance, in a community of a population of at least one hundred thousand, or 300 meters apart elsewhere; or
b) in the community of a population of five thousand or more as indicated in the application, there is no other public pharmacy within a 1 km radius of the proposed pharmacy, or within a 5 km radius elsewhere; or
c) the new public pharmacy is proposed to be located at the main offices or other premises of a health service provider designated for emergency duty services, or within a 250-meter radius of these, provided that there is no other public pharmacy at the main offices or other premises of the said health service provider, or within a 250-meter radius of these, and the operator agrees to adjust the emergency opening and regular business hours of the new pharmacy to that of the aforesaid health service provider.
The minimum distance between an existing and a new public pharmacy shall be understood as the shortest way over public domain.
(3) The implementation of a new pharmacy may be authorized irrespective of compliance with the conditions set out under Paragraphs a)-c) of Subsection (2) in a community referred to in Subsection (2), if the applicant agrees:
a) to stay open 24 hours a day, or
b) to stay open on a weekly basis:
ba) for at least 60 hours, or
bb) for 40 hours and provide stand-by services at all times;
c) and - under Paragraph ba) and bb) - to deliver the medicinal products to the patients specified in specific other legislation at their request, inside an area of a 2 km radius, free of charge, or to operate a website for accepting orders for medicinal products electronically, and to deliver the medicinal products ordered in this fashion, for a period of at least three years from the day of opening of the new public pharmacy.
(4) Within the building where the pharmacy is located only one public pharmacy may be authorized.
Implementation of Branch Pharmacies
Section 50.
(1) In any community without a public pharmacy, the implementation of a branch pharmacy may be authorized upon request. The operation of the branch pharmacy may be authorized for a specific period (season), which has to be so indicated in the resolution authorizing its operation.
(2) The operation of a branch pharmacy shall be authorized, first and foremost, to the operator of the nearest public pharmacy, depending on transport and accessibility. The operator of a public pharmacy may not be authorized to operate more than three branch pharmacies.
(3) A branch pharmacy shall function as the satellite of the public pharmacy for which it was authorized.
Institutional Pharmacies
Section 51.
(1) Institutional pharmacies may be authorized upon request for inpatient medical institutions, and for operators engaged in the supply of medicinal products to inpatient medical institutions. Institutional pharmacies may dispense medicinal products for use in the inpatient medical institution and as a direct supply of medicinal products to the public.
(2) Operators of institutional pharmacies must provide the necessary facilities separately for institutional supply and for the direct supply of medicinal products to the public. The professional standards for the operation of institutional pharmacies, personnel and material conditions, mandatory business hours, and the necessary facilities for institutional supply and for the direct supply of medicinal products to the public are governed in specific other legislation.
Dispensing Pharmacies
Section 52.
(1) In any community without a public pharmacy or a branch pharmacy, upon the request of a general practitioner the operation of a dispensing pharmacy may be authorized. Such authorization is valid for the applicant only.
(2) A dispensing pharmacy may be authorized for a geographical area where the general practitioner has a practice, provided that there is no public pharmacy or branch pharmacy in the community in a specific calendar period of the year.
(3) If a public pharmacy or branch pharmacy is authorized for a community where a dispensing pharmacy functions as authorized, the authorization for the dispensing pharmacy shall be amended or withdrawn effective as of the day of the opening of such pharmacies.
(4) The medicinal products that may be stocked in a dispensing pharmacy must be purchased in a public pharmacy.
(5) The general practitioner may dispense medicinal products from the dispensing pharmacy to his own patients and only based on his own prescription, with the exception of cases of emergency.
(6) In a contract specified in specific other legislation for entitlement to prescribe medicinal products with social security subsidies the health insurance administration agency may define the list of subsidized medicinal products which the general practitioner may dispense from his dispensing pharmacy consistent with professional standards and the principle of cost-efficiency.
Authorization of Pharmacies
Section 53.
(1) A pharmacy may commence to operate if:
a) the operator has sufficient liability insurance coverage for damages that the pharmacy may cause; and
b) the pharmacy's furniture, equipment and stock is in conformity with the requirements set out in specific other legislation.
(2) The insurance policy referred to in Paragraph a) of Subsection (1) shall be presented to the government body in charge of the healthcare system before commencing operations, and the opening of the pharmacy shall be notified.
Section 54.
(1) The operation of pharmacies is supervised by the government body in charge of the healthcare system. The authority shall withdraw the operating permit if it finds that the operator of the pharmacy has repeatedly and seriously infringed upon the relevant professional standards concerning:
a) the stocking of medicinal products;
b) the order of service;
c) the dispensing of medicinal products, including the prices of medicinal products; and
d) the pharmacy's furniture, equipment and products authorized for marketing.
(2) In addition to what is contained in Subsection (1), the operating permit shall be withdrawn within ten working days upon gaining knowledge of the grounds for withdrawal if:
a) the public pharmacy fails to commence operations within one year of the effective date of the operating permit, or fails to satisfy the conditions specified in Subsection (3) of Section 49, if it agreed to such conditions previously;
b) in connection with a dispensing pharmacy:
ba) a public or branch pharmacy opened in the community indicated in the operating permit of the dispensing pharmacy;
bb) the person authorized to operate it no longer satisfies the requirements for authorization;
c) the bodies vested with authority to oversee the operation of pharmacies find any discrepancies, on account of which the pharmacy has to be suspended once again within a period of two years;
d) the operating permit of the institutional pharmacy has to be withdrawn, if the inpatient medical institution is terminated.
(3) The operating permit shall be withdrawn:
a) in the case referred to in Paragraph a) of Subsection (2), upon expiry of the time limit;
b) in the case referred to in Paragraph b) of Subsection (2), on the day when the change occurs;
c) in the case referred to in Paragraph c) of Subsection (2), on the day of gaining knowledge.
Guarantees for the Supply of Medicinal Products
Section 55.
(1) Unless otherwise prescribed by law, medicinal products may be dispensed to patients and customers, doctors and veterinarians by pharmacies.
(2) Pharmacies shall operate an information center in their customer area or on their website, if available, or to afford access to an existing electronic information center free of charge. The information center shall have facilities to compare the prices of medicinal products which are interchangeable, or in connection with medical aids, the prices of products within the same group in terms of function, which are available in the pharmacy, and to offer information to customers concerning the administration of non-prescription medicinal products before making a decision whether to buy the medicinal products in question. The person dispensing medicinal products to handicapped persons and to persons in need of help shall provide assistance for obtaining information concerning the administration and use of the product.
(3)
(4) Pharmacies shall keep stock of the medicinal products specified in specific other legislation, in the quantities defined therein. In connection with pharmacies under contract for the marketing of medicinal products with public financing, the health insurance administration agency may stipulate additional contractual conditions in terms of their service obligation, including the range of medicinal products, dispensing unavailable medicinal products at a later time, the price at which they are dispensed, and the detailed rules for the settlement of subsidies.
(5) Medicinal products may not be dispensed to persons under fourteen years of age. The dispenser of medicinal products - upon providing proof of his own entitlement upon request - may request the person wishing to purchase medicinal products to produce proof of his/her age. In the absence of adequate proof of age the medicinal products may not be dispensed.
(6) With the exception of institutional pharmacies, publicly subsidized medicinal products may not be provided, supplied or offered to pharmacies without any valuable consideration.
(7) The personnel and material conditions for the operation of pharmacies, including the floor plan type and quantity of furniture and equipment required, and the requirements for information technology and records systems are contained in specific other legislation. Public pharmacies may enter into an agreement with other public pharmacies for the preparation of certain magistral medicinal products. The agreement shall be presented to the government body in charge of the healthcare system.
Independent Pharmacy Operation Right
Section 56.
(1) Public pharmacies - other than the public pharmacies operated by inpatient medical institutions - shall be authorized to function only under the guidance of a pharmacist vested with independent right by authorization of the government body in charge of the healthcare system. The authorization of independent right may be requested by a pharmacist who is able to satisfy the requirements set out by law.
(2) Independent right may be authorized for a pharmacist, who after receiving a diploma in pharmacology has obtained - with the exceptions set out in Subsections (3) and (4) - at least five years of experience (hereinafter referred to as "practical experience") in a public, branch or institutional pharmacy in any Member State of the European Economic Area (hereinafter referred to as "EEA"), or any State enjoying equal treatment with EEA Member States by virtue of an agreement with the European Communities or with the EEA (hereinafter referred to as "EEA Member State"). For the purposes of authorization of independent right, the practical experience obtained outside the territory of EEA Member States may also be taken into consideration.
(3) Two years of practical experience is required for a pharmacist who was engaged in practicing pharmacy:
a) in connection with pharmacology:
aa) in scientific, educational activities,
ab) in administrative activities;
b) in connection with the manufacturer and supply of medicinal products;
c) in a pharmacy in a country other than any Member State of the European Union or a State that is a party to the Agreement on the European Economic Area,
for at least three years, within a period of three years since the termination of this activity [Paragraphs a)-c) hereinafter referred to collectively as "professional experience"].
(4) One year of practical experience is required for a pharmacist who:
a) has practical experience in excess of ten years;
b) has the professional experience specified in Subsection (3),
obtained within a period of three years since the termination of this activity.
(5) The three-year period referred to in Subsections (3) and (4) shall mean the period between the termination of the activity and the date of filing the application.
Section 57.
(1) Independent right shall not be authorized to a pharmacist:
a) whose independent right was withdrawn, for a period of five years from the operative date of the resolution ordering the withdrawal;
b) who has a prior criminal record or has been restrained by court order from exercising the profession of pharmacist.
(2) Independent right may be surrendered in writing submitted to the government body in charge of the healthcare system. The operation of a public pharmacy that was operated under independent right may not be terminated within six months from the time of notice, unless another public pharmacy started operating in the same community.
Section 58.
The authorization for independent right shall be withdrawn if:
a) the holder of the independent right acted in bad faith during the proceedings for the authorization of the independent right;
b) the holder of the independent right manages a public pharmacy and:
ba) the government body in charge of the healthcare system has appointed an official manager for the same public pharmacy within the last three years at least on two occasions for reasons attributable to the holder of the independent right; or
bb) fails to manage the public pharmacy in person in spite of repeated warning by the government body in charge of the healthcare system;
c) the holder of the independent right has been convicted of a criminal offense by final court verdict, or has been restrained by court order from exercising the profession of pharmacist.
Section 59.
(1) The independent right shall terminate if:
a) the holder of the independent right:
aa) has surrendered it,
ab) has died;
b) the resolution ordering the withdrawal of the independent right has become final.
(2) The decision for the withdrawal of independent right lies with the government body in charge of the healthcare system.
Section 60.
The government body in charge of the healthcare system shall maintain a register on the pharmacists holding independent rights. The register shall indicate the independent right holder's:
a) name,
b) place and date of birth,
c) pharmacist registration number,
d) the number of the resolution for authorizing the independent right.
Section 60/A.
(1) Enclosed with the application for authorization of independent right the applicant shall produce official documentary evidence to verify that he has no prior criminal record and that he is not restrained by court order from exercising the profession of pharmacist, or a statement requesting the body operating the penal register to disclose information to the government body in charge of the healthcare system based on its official request lodged for the purpose of assessment of the application for authorization of independent right. In this context, the government body in charge of the healthcare system shall be entitled to request the data mentioned in Subsection (2) from the body operating the penal register.
(2) The government body in charge of the healthcare system shall check in the course of a regulatory inspection conducted during the period of exercising the independent right as to whether the pharmacist has no prior criminal record and that he is not restrained by court order from practicing the profession of pharmacist. The government body in charge of the healthcare system shall have powers to request information from the penal register for the purpose of regulatory inspection. The data request shall be limited to the information necessary to determine as to whether the pharmacist having the independent right has no prior criminal record and that he is not restrained by court order from practicing the profession of pharmacist.
(3) The government body in charge of the healthcare system shall be authorized to process the personal data obtained under Subsections (1) and (2):
a) until the final and binding conclusion of the authorization procedure concerning the independent right; or
b) for the duration of the regulatory inspection if the authorization for the independent right is granted, or until the final and binding conclusion of the procedure for the withdrawal of the authorization.
Management of Pharmacies
Section 61.
(1) With the exception of dispensing pharmacies, pharmacies may be managed only by authorized pharmacists.
(2) A pharmacy may be managed by a pharmacist who:
a) obtained a diploma in pharmacology in a Hungarian university, or whose diploma in pharmacology received in a foreign university had been adopted or provided with a certificate of equivalence, or is recognized;
b) is registered in the register of pharmacists.
(3) In addition to what is contained in Subsection (2), pharmacists who are foreign nationals shall provide proof of their command of the Hungarian language in accordance with specific other legislation.
(4) The following persons may not be authorized to manage a pharmacy:
a) any person who is under guardianship or conservatorship;
b) any person who was banned from practicing pharmacy by final court decision, during the period of the ban.
Section 62.
(1) Unless otherwise prescribed in this Act, public pharmacies may be managed only by pharmacists vested with independent right. Holders of independent right may not assign management of the public pharmacy to others, with the exception of another pharmacist with independent right, interim manager or official manager.
(2) Managers of pharmacies may manage only one pharmacy - not including the branch pharmacy of his public pharmacy and any public pharmacy that was established by the transformation of a branch pharmacy according to Subsection (2) of Section 86 -, and may not enter into an employment or public service relationship with another pharmacy.
(3) Pharmacy managers shall supervise the work performed in the pharmacy, including the branch pharmacy of the public pharmacy. Pharmacy managers have the authority to oversee the work of the pharmacy's staff and to provide professional guidance and give instructions to them.
Section 63.
(1) Where the holder of independent right is unable to attend to his/her duties in person relating to the management of the pharmacy for a specific period of time, an interim manager may be appointed in his/her stead to manage the pharmacy.
(2) An interim manager may be a pharmacist who is able to satisfy the requirements set out in Subsection (2) of Section 61. If an interim manager has to be installed for an estimated period of more than sixty days, the person employed must satisfy the requirements laid down in Section 56 for pharmacists vested with independent right.
(3) If an interim manager has to be installed for a period of less than sixty days, the appointment of the interim manager shall be notified to the government body in charge of the healthcare system.
(4) If an interim manager has to be installed for an estimated period of more than sixty days, the appointment of the interim manager is subject to the consent of the government body in charge of the healthcare system.
(5) The authorization for the appointment of an interim manager shall be withdrawn if:
a) independent right is terminated, on the day of termination of the independent right;
b) the interim manager is vested with independent right, on the operative date of the resolution authorizing independent right;
c) the interim manager is unable to manage the pharmacy for reasons within his control, or if an official manager has to be appointed for the pharmacy in question.
(6) Any person who does not have a diploma in pharmacology may assist in the preparation of medicinal products only under the guidance and supervision of a pharmacist. As regards medicinal products supplied by mail or by way of home delivery, the manager of the pharmacy shall be held liable for the medicine dispensed. Prescription medicinal products may be dispensed only by pharmacists or qualified pharmacy staff. Conditions for entitlements to dispense medicinal products and for the training of employees who participate in the operation of pharmacies without a diploma in pharmacology are laid down in specific other legislation.
Government Control of Pharmacies
Section 64.
(1) Responsibility for supervising the operation of pharmacies lies with the State. The government body in charge of the healthcare system is vested with supervisory powers for controlling pharmacies in connection with the distribution of medicinal products and medical aids, exclusive of the provisions on commercial practices relating to medicinal products and medical aids, and the provisions contained in Section 76. In terms of other products sold in pharmacies, other than medicinal products, supervisory powers shall be conferred upon the consumer protection authority for the enforcement of regulations laid down in specific other legislation pertaining to the marketing of such products, and shall take action as specified in the Act on Consumer Protection in the event of any infringement of these provisions.
(2) The government body in charge of the healthcare system shall inform the health insurance administration agency and the health insurance supervisory authority concerning the measures adopted under its supervisory powers according to specific other legislation.
Section 65.
The government body in charge of the healthcare system may appoint an official manager for a public pharmacy if it is the only public pharmacy in the community for supplying medicinal products and:
a) the independent right was terminated; or
b) following notification of the surrender of independent right in writing, the operator did not notify the replacement pharmacist vested with independent right within six months from the date of the said notification; or
c) the holder of independent right or the interim manager ceased management of the public pharmacy without notice, for reasons within his control; or
d) the holder of independent right has seriously violated the relevant professional standards, in particular the provisions relating to the stocking of medicinal products and the order of service.
Section 66.
(1) A pharmacist with entitlement to manage a pharmacy, and who is not currently engaged in the management of a public pharmacy, may be appointed as an official manager.
(2) The official manager shall be required to take all measures necessary to maintain the operation of the public pharmacy.
(3) The remuneration of the official manager shall be covered by the pharmacy for which he was appointed.
(4) The appointment of the official manager shall be withdrawn before the original term of appointment if the official manager has breached his obligations specified in Subsection (2) repeatedly in spite of warning.
Chapter II
MARKETING MEDICINAL PRODUCTS BY ENTITIES OTHER THAN PHARMACIES
Section 67.
(1) Companies which are not authorized to operate pharmacies may engage in the retail supply of medicinal products subject to compliance with the requirements set out in other legislation governing trade and commercial activities and in this Act, and also other legal regulations adopted under authorization conferred by this Act.
(2) Medicinal products may be supplied by entities other than pharmacies if:
a) they may be dispensed in pharmacies without a prescription; and
b) before applied, self-diagnosis can be clearly obtained, and any error is unlikely or it is not presumed to result in grave consequences; and
c) the risk factor it carries (side-effect, interaction) is insignificant even in the event of a massive overdose.
Requirements for Authorization
Section 68.
(1) Commercial establishments authorized to operate under specific other legislation may engage in the supply of medicinal products if so authorized by the government body in charge of the healthcare system. The government body in charge of the healthcare system shall communicate its resolution authorizing the retail supply of medicinal products also to the authority that has issued the operating permit to the commercial establishment in question. The government body in charge of the healthcare system shall authorize the supply of medicinal products if the commercial establishment is able to comply with the requirements set out in this Act and in specific other legislation.
(2) The commercial establishment referred to in Subsection (1) may engage in the retail supply of medicinal products if:
a) it has facilities for the proper storage of medicinal products, safely isolated from all other products, in compliance with the instructions contained in the marketing authorization of the medicinal products; and
b) it has an approved information center that is available during the business hours of the commercial establishment, or is able to afford access to an existing electronic information center free of charge for providing information to consumers for the safe use of medicinal products;
c) notifies to the government body in charge of the healthcare system the person placed in charge in the commercial establishment to enforce the legal regulations pertaining to medicinal products.
(3) A commercial establishment authorized for the retail supply of medicinal products may purchase medicinal products only from authorized wholesale distributors of medicinal products, and may sell them only to the final consumers.
Section 69.
(1) Medicinal products may not be displayed in the commercial establishment in places which are directly accessible to consumers; they must be kept in locked cabinets.
(2) The quantity of medicinal products or a certain specific group of medicinal products that may be dispensed at any one time may be limited under specific other legislation.
(3) Medicinal products may not be dispensed to persons under fourteen years of age.
(4) In order to enforce the age limit specified in Subsection (3), the person acting on behalf of the retail supplier of medicinal products - upon providing proof of his own entitlement upon request - may request the person wishing to purchase medicinal products to produce proof of his/her age. In the absence of adequate proof of age the medicinal products may not be dispensed.
Information Obligations
Section 70.
(1) In addition to what is contained in Paragraph b) of Subsection (2) of Section 68, commercial establishments engaged in the retail supply of medicinal products are required to display in their customer area all information material provided to patients in connection with the medicinal products supplied - as specified in the marketing authorization - in printed format to enable the customers to access the information relating to the administration of the product in question before making a decision as to whether to buy the medicinal products in question.
(2) Commercial establishments shall - in their Standard Operating Procedures - designate a person appointed to provide assistance to handicapped persons and to persons in need of help in obtaining the information concerning the administration and use of medicinal products as specified in Subsection (2) of Section 66 and in Subsection (1) of this Section.
Section 71.
(1) The provisions relating to discounts provided directly to consumers shall also apply to the retail supply of medicinal products by entities other than pharmacies.
(2) The list of medicinal products that may be supplied by entities other than pharmacies and professional standards for their selection, and the detailed regulations for marketing shall be laid down in specific other legislation.
(3) The provisions of Subsections (2)-(3) of Section 73 and Subsections (2)-(4) of Section 76 of this Act shall also apply in connection with the retail supply of medicinal products by entities other than pharmacies.
Control of the Retail Supply of Medicinal Products by Entities Other Than Pharmacies
Section 72.
(1) The government body in charge of the healthcare system is vested with authority to supervise the retail supply of medicinal products by entities other than pharmacies in terms of the requirements set out in this Act and in other legislation adopted by authorization conferred under this Act.
(2) In the control proceedings the government body in charge of the healthcare system shall establish the facts, and shall take the measures consistent with the nature and severity of any discrepancies and irregularities, and shall monitor their implementation.
(3) Where the government body in charge of the healthcare system finds that a retail supplier of medicinal products is in non-compliance with the requirements set out in this Act or any other legislation adopted by authorization of this Act, or is in breach of the obligations conferred upon it, the government body in charge of the healthcare system shall:
a) order the state of infringement to be terminated;
b) prohibit continuation of the illegal conduct;
c) order the medicinal product or the production batch that is deemed harmful to life, health or physical safety to be removed from the market;
d) order the infringer to eliminate the discrepancies within the prescribed deadline and may suspend the further supply of medicinal products until the said discrepancies are eliminated;
e) withdraw the authorization of repeat offenders for the supply of medicinal products in the commercial establishment.
(4) If the infringement is committed by a retail supplier of medicinal products that is part of store chain, the decisions specified in Paragraphs c)-e) of Subsection (3) may be applied with respect to all commercial establishments in that chain.
(5) The government body in charge of the healthcare system shall have powers to impose penalties upon the person having committed the infringement. In the case of multiple violations the amount of fines imposed may be cumulative.
(6) The amount of the fine shall be determined with regard to all applicable circumstances, in particular, the scope and gravity of the injury caused to consumers and the duration of the illegal conduct. Repeat offenders shall be penalized accordingly. The fine shall be minimum one hundred thousand forints, or maximum one per cent of the perpetrator's net domestic sales of the product in question in the previous calendar year, the maximum amount of which can be ten million forints for 2007. Unpaid fines shall be enforced in the same manner as taxes.
Miscellaneous Provisions
Section 73.
(1) The business association that operates a pharmacy may not give instructions to the pharmacy's managerial staff nor to persons providing specialized services in the pharmacy regarding technical matters relating to the supply of medicinal products, such as the dispensation and storage of medicinal products, and information provided to patients in connection with medicinal products.
(2) Operators of pharmacies may not enter into any agreement and shall not accept any inducement that may jeopardize or compromise the safe and reliable supply of medicinal products to consumers. Members of the technical staff of pharmacies may not undertake any contractual obligation and shall not accept any inducement that may restrict or compromise their independence, in particular that could affect their impartiality or objectivity toward patients.
(3) The prohibition of accepting any inducement shall not apply - with the exception contained in Subsection (6) of Section 55 - to the use of discounts based on generally accepted prices and other contractual terms, nor the fulfillment of contractual obligations applied by the health insurance administration agency in connection with medicinal products with public financing.
(4) Monitoring compliance with the provisions contained in Subsections (1)-(3) shall fall within the competence of the health insurance supervisory authority.
Section 74.
(1) A business association may operate a public pharmacy if the pharmacist vested with independent right, who manages the pharmacy, has a participating interest in the business association that operates the pharmacy.
(2) The articles of association shall be presented to the government body in charge of the healthcare system when the company is established, and any subsequent amendment shall be notified within thirty days of their effective date.
(3) Where an authorized manufacturer of medicinal products or a business association authorized for the wholesale distribution of medicinal products, or a doctor with entitlement for the prescription of medicinal products which are subsidized in accordance with specific other legislation has a share constituting considerable influence - directly or indirectly - within the meaning of Point 4 of Subsection (2) of Section 3 of Act C of 2000 on Accounting in a business association that operates a pharmacy contracted to dispense medicinal products with public financing, the person exercising such influence shall notify the health insurance supervisory authority accordingly.
(4) The health insurance supervisory authority shall check as to whether any undesirable concerted practices exist among pharmacies marketing medicinal products with public financing under contract, manufacturers and distributors of medicinal products, and doctors with entitlement for the prescription of medicinal products which are subsidized in accordance with specific other legislation, that may jeopardize or compromise the safe and reliable supply of medicinal products to consumers. Where undesirable concerted practices are implemented, the health insurance supervisory authority shall approach the health insurance administration agency to terminate the contract in which the right for supplying subsidized products is granted.
Section 75.
(1) In connection with any concentration of business associations engaged in the operation of pharmacies the provisions contained in Chapter VI of Act LVII of 1996 on the Prohibition of Unfair Trading Practices and Unfair Competition (hereinafter referred to as "UMPA") shall be applied with the exceptions set out in this Section.
(2) Authorization from the Office of Economic Competition shall be required for the concentration of business associations engaged in the operation of pharmacies if:
a) the combined net sales revenue from the supply of medicinal products of all groups of companies involved, and the net sales revenues of the companies controlled jointly by members of the groups of companies involved with other companies engaged in the retail supply of medicinal products in the previous financial year exceeded one billion forints; and
b) among the groups of companies involved there is at least one group involved in the supply of medicinal products with net sales revenues from the retail supply of medicinal products of one hundred million forints or more in the previous year together with the net sales revenues of companies controlled by members of the same group jointly with other companies; and
c) in consequence of the proposed concentration the company or group in question is set to gain control - directly or indirectly - of more than ten per cent of the pharmacies situated within:
ca) a geographical area of a 25-km radius from the newly controlled pharmacy in a township;
cb) a geographical area of a 5-km radius from the newly controlled pharmacy in a city; or
cc) a geographical area of a 2-km radius from the newly controlled pharmacy in Budapest.
(3) Concentration shall not be authorized if it would bring the percentage referred to in Paragraph c) of Subsection (2) to over twenty-five per cent.
(4) The provisions contained in Subsections (1)-(3) shall not pertain to any person who had any right of control before the time of this Act entering into force in exercising this right of control.
(5) In the application of Subsections (1)-(2) the definitions contained in Sections 23-26 of the UMPA shall apply in terms of the interpretation of the terminology used therein.
(6) In connection with the competition control proceedings opened under Subsection (2), if the turnover of the companies involved in the concentration is below the threshold referred to in Section 24 of the UMPA, the procedural fee shall be twenty per cent of the value specified in Section 62 of the UMPA.
Section 76.
(1) The pharmacist who operates a public pharmacy under independent right - not including the case when the holder of independent right is a member of a business association - shall be treated as a private entrepreneur as regards the application of social security and financial regulations.
(2)-(5)
Section 77.
(1) The Government is hereby authorized to decree:
a) the provisions for the prescription of medicinal products which are efficient and of good quality;
b) the conditions for providing financial support to cover the operating expenses of pharmacies;
c) the regulations for the fines to be imposed in connection with any infringement of the provisions governing the promotion of medicinal products and medical aids, including the conditions for their payment and their appropriation;
d) the regulations concerning the conditions of eligibility for the benefits referred to in Section 44/A, as well as for the rate, amount and payment of such benefits.
e) the detailed rules concerning the 20 per cent allowance from the payment obligations described under Subsections (1) and (4) of Section 36 and Subsections (1)-(6) of Section 42 of the Medicine Act in respect of the costs of research and development.
f) the detailed regulations relating to subsidy volume agreements.
(2) The minister in charge of the healthcare system is hereby authorized to decree:
a) professional standards for the operation of institutional pharmacies, personnel and material conditions, mandatory business hours, and the necessary facilities for institutional supply and for the direct supply of medicinal products to the public;
b) the medicinal products and other products that may be sold in pharmacies, and the detailed regulations for dispensing them;
c) the list of medicinal products and therapeutic preparations which are not classified as medicinal products that may be supplied by entities other than pharmacies and the professional standards for their selection, the personnel and material conditions for supplying them, and the rules for maintaining a stock of them;
d) the order of service of pharmacies;
e) the list of medicinal products to be kept in compulsory reserve in pharmacies;
f) the requirements concerning the floor plan and type and quantity of furniture and equipment required for pharmacies;
g) the records and administration procedures of pharmacies;
h) the provisions for maintaining the register of pharmacist;
i) the detailed rules for the approval of the computer program for the prescription of medicinal products;
j) the detailed regulations pertaining to the promotion of medicinal products and medical aids, and the detailed conditions for the pursuit of promotional activities, the detailed procedural rules for the notification of promotional activities and for maintaining the register of promoters of medicinal products and medical sales representatives, for the issue and any subsequent amendment of the certificates of medical sales representatives and the contents of such certificates other than personal data, furthermore, the sanctions for any infringement of the provisions of the relevant legislation or of the resolutions adopted by the competent authorities pertaining to the promotion of medicinal products and medical aids and the provisions relating to business-to-consumer commercial practices in connection with medicinal products and medical aids;
k) the ATC-groups and parameters for the assessment of procedures for the prescription of medicinal products which are efficient and of good quality.
l) the information to be disclosed in the notice published under Subsection (4) of Section 24 and Subsection (6) of Section 33 concerning the medicinal products, dietary supplements and medical aids which are subsidized under the social security system.
m) the detailed regulations concerning the list of suppliers and the rating of suppliers;
n) the detailed regulations concerning the online medical aid catalogue of the health insurance administration agency;
o) the rules relating to the procedures for providing subsidies for custom-made medical aids;
p) the detailed regulations concerning the simplified list of subsidized products, and the rules for claiming medical aids contained in the simplified list of subsidized products under a function group, and those approved for subsidies under the three-month therapy limit.
(3) The minister in charge of supervising the food supply chain is hereby authorized to decree:
a) the regulations concerning institutional pharmacies operating in veterinary institutions, and for the stocking of medicinal products in the dispensing pharmacies of veterinarians;
b) the conditions for the supply of packaged products used solely for veterinary purposes.
(4) The minister in charge of the healthcare system is hereby authorized to decree, in agreement with the minister in charge of taxation, the types of administrative service fees, including their amounts and other regulations relating to payment terms and conditions:
a) according to Subsection (9) of Section 12;
b) for all proceedings opened upon request for the admission of medicinal products, dietary supplements for special nutritional needs and medical aids into the social security subsidy system, for proceedings relating to determining the amount of subsidies to be provided for the rental costs of medical aids, for changing their approved period of use or indication, for increasing its price serving as the basis for public financing, for changing its name or size, and for the related remedy procedures;
c) for the certification procedure relating to the manufacture and supply of custom-made medical aids;
d) for the administrative services provided by the health insurance supervisory authority under this Act;
e) for the approval of the computer program for the prescription of medicinal products and medical aids;
f) for the certification procedure relating to the electronic information center designed to enhance the supply of medicinal products by entities other than pharmacies.
g) for the rating of suppliers.
(5) The minister in charge of the healthcare system is hereby authorized to decree, in agreement with the minister in charge of social policies, the function groups that cannot be dispensed under the fully subsidized public healthcare system.
Sections 78-82.
Transitional and Closing Provisions
Section 83.
(1) This Act - subject to the exceptions set out in Subsection (2) - shall enter into force on 29 December 2006.
(2) The following provisions of this Act shall enter into force as follows:
a) Sections 4-35 and 43-47 - with the exception set out in Paragraph c) - on 1 January 2007,
b) Sections 36-42 on 15 January 2007,
c) Subsection (2) of Section 25 and Subsection (3) of Section 34 on 1 April 2007.
(3)-(6)
(7)
(8) The Government shall present a report to Parliament by 1 October 2010 concerning the practical implementation of the rules concerning the foundation of public pharmacies based on the comparison of the effects intended and those actually materialized.
Section 84.
(1) In the application of Subsections (1)-(4) of Section 36, the period beginning on 15 January 2007 and ending on 31 December 2007 shall be understood as the year 2007. The payment obligation defined in Subsection (4) of Section 36 shall apply to the period beginning on 15 January 2007 and ending on 31 December 2007 as commensurate.
(2) In the application of Subsections (1)-(2) of Section 37, the period beginning on 15 January 2007 an ending on 31 January 2007 shall be understood as the month of January of 2007.
(3) In the application of Subsection (3) of Section 37, the period beginning on 15 January 2007 an ending on 31 January 2007 shall be understood as the month of January of 2007, with the exception that the authorized operator of a public pharmacy shall be required to pay an advance with respect to this period if his price margin from the supply of medicinal products with public financing exceeds one-twenty-fourth of the amount specified in Subsection (1) of Section 39, with applying the sums corresponding to one-twenty-fourth of the brackets defined in Subsection (2) of Section 39.
(4) In the application of Subsection (6) of Section 42, the period beginning on 15 January 2007 an ending on 31 January 2007 shall be understood as the month of January of 2007, with the exception that the marketing authorization holder shall be required to pay an advance with respect to this period if the amount of monthly subsidies paid in connection with subsidized medicinal products exceed one-twenty-fourth of 287 billion forints, exclusive of the sums available for medicinal products with special funding and the sums for subsidizing medicinal products under special and equitable circumstances.
Section 85.
Section 86.
(1)-(4)
(5) The persons having a relative independent right at the time of this Act entering into force shall be authorized to operate a public pharmacy - in accordance with the provisions of the PhA in effect on the day immediately preceding the operative date of this Act, governing the operation of public pharmacies under relative independent rights - until the period of eligibility shown in the register of persons with relative independent right.
(6)-(7)
Section 87.
(1) The provisions of Sections 22-35 of this Act shall apply to the proceedings opened after the operative date of this Act.
(2) The minister in charge of the healthcare system is hereby authorized to decree the detailed conditions for the procedures relating to the authorization and notification of activities for the supply, repair and rental of medical aids, the contents of the register other than personal data, and the detailed procedural rules for operating the register, furthermore, the sanctions for any infringement of the provisions of the relevant legislation or of the resolutions adopted by the competent authorities pertaining to the supply, repair and rental of medical aids.
(3)-(4)
(5) The minister in charge of the healthcare system is hereby authorized to decree the time from which medicinal products with social security subsidies will be dispensed and medical aids and medical treatment will be provided only if the prescription is made out using the computer program specified in Subsection (1) of Section 45.
(6) The provisions of Chapter II and of the decree adopted by authorization conferred under Paragraph j) of Subsection (2) of Section 77 shall remain to apply in connection with business-to-consumer commercial practices relating to therapeutic preparations already placed on the market at the time of this Act entering into force, which are not classified as medicinal products, until 1 April 2011. Therapeutic preparations which are not classified as medicinal products may be sold by commercial establishments holding an operating permit and authorized to supply medicinal products in due compliance with the provisions of specific other legislation.
Section 88.
(1) This Act - in conjunction with the regulations adopted for its implementation - serves the purpose of conformity with the following legislation of the Communities:
a) Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by Directives 2002/98/EC, 2004/24/EC and 2004/27/EC of the European Parliament and of the Council,
b) Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems,
c) Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy, as amended by Council Directives 85/484/EEC and 90/658/EEC, and Directive 2001/19/EC of the European Parliament and of the Council, having regard to the Act of Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded,
d) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products.
(2) This Act contains provisions for the implementation of the following legislation of the Communities in connection with the duties and proceedings of the consumer protection authority and the Hungarian Competition Authority:
a) Regulation (EC) No. 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws, Article 4 (1) [Subsection (1) of Section 18/B];
b) Commission Decision 2007/76/EC of 22 December 2006 implementing Regulation (EC) No. 2006/2004 of the European Parliament and of the Council on cooperation between national authorities responsible for the enforcement of consumer protection laws as regards mutual assistance [Subsection (2) of Section 18/B];
c) Commission Decision 2008/282/EC of 17 March 2008 amending Decision 2007/76/EC implementing Regulation (EC) No. 2006/2004 of the European Parliament and of the Council on cooperation between national authorities responsible for the enforcement of consumer protection laws as regards mutual assistance [Subsection (2) of Section 18/B].
Section 89.
