How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it. Pursuant to section 143 of the Health-care System Act, the state organs in Hungary, such as the
parliament (as the legislative body), the government, the responsible minister, the state administrative organ responsible for health care, health insurers, municipalities, national health councils (NHCs) and regional health councils (RHCs), are charged
with the tasks of organising and governing the health-care system. In the interests of promoting and protecting the general health of the population, the state supports and promotes the lawful activities of professional associations and public bodies in the health-care system. One of the paramount tasks of the parliament is the adoption of a national health development programme (the NHDP) which is the basis and foundation of the medium-term strategic planning in the health-care sector. The NHDP contains, among other things, an outline of the state of health of the general population with special emphasis on the more problematic areas, a determination of the aims to develop and protect the population’s health, the tasks that need to be fulfilled and the means necessary to achieve those aims.
At a ministerial level, the government is, among other things, charged with the preparation of the NHDP and its submission to parliament. It also determines the basic principles and aims of the policies in the health-care sector, leads and coordinates the
execution of the administrative tasks in the health-care sector, takes care of its obligations under international treaties, performs certain duties to prevent disasters and assumes other roles assigned to it by legislation.
Other bodies, such as the NHCs, RHCs, health insurances and local municipalities fulfil the tasks further down the hierarchy. For example, the local municipalities ensure that their respective territories are appropriately supplied with general practitioners, paediatricians, dentists, etc, whereas health insurers need to ensure the financing of the services performed.
More specifically, Act LXXX of 1997 (the Social Insurance Act) elaborates on how to finance the health-care system and with it all sorts of medical care. Pursuant to section 2(1) of the Social Insurance Act, Hungarian citizens and – if certain legislative conditions are fulfilled – residents living in Hungary have to be part of a so-called collective risk-sharing community. This collective risk-sharing is
realised by a mandatory social security system that the participants have to support financially according to their income, that is, they have to make contributory payments. The persons and entities liable for payment and the amount of the payment of the contribution depend on the status and income of the insured person. For instance, if the insured person is an employee, both the employer and the employee are liable to bear a certain percentage of the contribution depending on the income of the employee.
Compliance – pharmaceutical manufacturers
As such, distributors of medicinal products and manufacturers of medical aids or their authorised representatives may engage in promotional activities upon being registered and authorised by the National Medical Official's Office. The aforementioned
request must indicate the applicant’s name and address, the name and address of the agent and the company registration number. The holder of the authorisation must notify the National Medical Official's Office of any changes in the particulars contained in the application or in the authorisation itself within eight days.
The registry of licences contains – among other things – the names of persons carrying out the promotional activities, data on the promoter’s qualification and the promoter’s declaration that he or she has no conflict of interest. A promoter is deemed in
a conflict of interest if he or she is engaged in the promotion of medicinal products – not including scientific activities under copyright protection – in a medical institution with which he or she has a contractual relationship in accordance with section 7(2) of Act LXXXIV of 2003 on Health-care Professionals (eg, if he or she is a volunteer, entrepreneur, public servant, clerical person, etc.). The aforesaid shall not apply to persons engaged in the network of medical sales representatives of the government body for pharmaceuticals.
For further rules and principles applying to advertising aimed at health-care professionals, please see question 9. Further regulations on additional issues related to the above are laid down in Regulation No. 3/2009 of the Minister for Health Care. In practice, it is important that advertisers register with the National Medical Official's Office and that they pay the fees, which may be considerable. In the case of some medications, the advertiser has to prove his or her qualification, the procedure of which is laid out in Act XCVIII of 2006 and Regulation No. 3/2009 of the Minister for Health Care.
Please also note that the Health Insurance Supervisory Authority, which was until September 15, 2010 the competent authority of the mentioned registrations, applied a contra legem definition of ‘advertisement aimed at health-care professionals’. According to
an official opinion dated 2 September 2009, which is contrary to section 5 of Regulation No. 3/2009 of the Minister for Health Care, it considered the provision of information that can also be aimed at consumers an advertising activity aimed at health-care professionals if such information is directly transmitted to health-care professionals. This interpretation of the Health Insurance Supervisory Authority is contrary to section 5 of Regulation No. 3/2009 of the Minister for Health Care, as information provided to consumers
(ie, patients) is not treated as an advertisement aimed at health-care professionals.
Where advertisers provide the aforementioned kind of information without having obtained the necessary permit, they can be fined up to E100,000. This fine can be contested in court, but there is no case law on the matter. It is submitted that the Health Insurance Supervisory Authority interpreted the above-mentioned provision in a very broad way because it tries to force advertisers to obtain a
permit and to pay corresponding fees even where they may not be obliged to do so under the aforementioned provision. The fees can be as high as 400,000 forints.
The relevant definition of Regulation No. 3/2009 of the Minister for Health Care changed on 1 October 2009 and renders the definition more accurate. However, it is by no means certain that the now competent National Medical Official's Office will not follow a similar practice.
Section 14(2) goes on to provide that any entertainment or hospitality functions provided by medical sales representatives during events and programmes 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 health-care professionals and persons engaged in the supply and distribution of medicinal products or medical aids may be invited to such trade and promotional events.
Any support provided – whether directly or indirectly – for events and programmes for purely professional and scientific purposes shall always be reasonable in scope and remain subordinate to the main scientific objective of the meeting. Only health-care professionals and persons engaged in the supply and distribution of medicinal products or medical aids may be invited to such trade and scientific events. Promotional activities may be carried out during such events and programmes if the promotional activity (eg, a lecture -concerning the application of a specific product, demonstration of a specific product, leasing of exhibition space) is clearly distinguished from the trade and scientific programmes. For the aforementioned purposes, it makes no difference whether the promotional activity is performed directly or indirectly.
Section 14(4) provides that persons engaged in health-care or scientific activities may be provided with in-kind support for participating in trade events and training courses. Such support may be provided to cover expenses (such as travel expenses,
accommodations, entry fees, etc) arising directly out of or in connection with attending the events. Other specific legislation may contain further provisions with respect to 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.
10. What are the most common infringements committed by manufacturers with regard to collaboration with health-care professionals? The most common infringements committed by manufacturers with regard to collaboration with health-care professionals are the violation of the rules on the marketing and promotion of drugs provided by Act
In certain cases, manufacturers, through the medical representatives of such manufacturers, provide unlawful benefits in consideration for prescribing or otherwise soliciting their products. In some other cases, manufacturers do not enter into
a contract with their medical representatives in the prescribed form of contracts, but as research consultants and other types of subcontractor, evading some taxation duties and the yearly state fees to be paid according to the number of the employed medical representatives. Due to increased control during the past couple of years, the frequency of such violations has significantly decreased.
According to Act LVII of 1996 on the Prohibition of Unfair Trading Practices and Unfair Competition (the Competition Act), a dominant position is not sanctioned per se, but only the abuse of it. A company is deemed in a dominant position if it can determine its
practices without considering the reactions of other competitors, suppliers or consumers. If a company in such a position pursues activities that, for example, aim to exclude or hinder other competitors, or force other parties to accept unwanted conditions, the HCA will start proceedings against such company.
Restrictive agreements among competitors are also generally forbidden, both horizontally and vertically. Horizontal agreements are those between market players on the same level of the market (eg, two manufacturers), while vertical agreements are those
between market players on different levels of the market (eg, a manufacturer and a distributor). Exceptions apply pursuant to article 13 of the Competition Act to agreements of minor importance (where the combined market share of the parties does not exceed 10 per cent) or in the case of companies which are under the same management. The Hungarian government may grant exemptions from these rules by an act of legislation (a governmental regulation if, for instance, the agreement is conducive to market development within that particular industry. Please note that exemptions and exceptions are not the same. Exceptions are statutory derogations from the rule, while exemptions are granted on an ad hoc basis by the Hungarian government by way of
Compliance – medical device manufacturers
15. Which legislation sets out the regulatory framework for granting marketing authorisations and placing medicines on the market? The main framework is laid down in Regulation 52/2005 of the Minister for Health Care.
Medicines with isotopes require additional documentation. For the authorisation of isotope generators, a detailed description of the system has to be handed in that also describes the quality and -composition of the daughter isotopes, as well as qualitative
and quantitative descriptions of the eluate or sublimate. Homeopathic and traditional medicines may be subject to a simplified procedure if the label of homeopathic medicines contains no therapeutic advice, they are applied externally or taken
orally and their dilution guarantees that they are harmless. Traditional medicines may be subject to the simplified procedure if they have already been used therapeutically for at least 30 years, are applied externally or taken orally and the available information on the medicine is sufficient to guarantee a usage based on tradition.
The National Institute of Pharmacy can also issue a temporary marketing permit for medicines that have not yet completed the clinical trial, but are likely to have a positive benefit–risk ratio compared to any other medicine, or that are used to halt the
spread of toxic, nuclear, contagious or chemical epidemics. This permit is valid for one year only. Furthermore and under exceptional circumstances, the temporary marketing permit can also be issued if the positive risk-benefit ratio of the medicine cannot be proven, but only rendered likely, due to the low number of test patients available to the clinical trials.
Pricing and reimbursement of medicinal products
During the issuance of the marketing licence, some medicines are determined to be used only for inpatient treatment. The price of these prescribed medicines is completely refunded by the NHIF. The NHIF will only subsidise medicines to the extent
described on the label. In case of off-label prescription, the costs of the medication may only be reimbursed at the discretion of the NHIF.
Medicine quality and access to information
Every member of the distribution chain has to have a valid licence issued either by a Hungarian or another EU member state authority. The National Institute of Pharmacy monitors all legal distribution of medicines from the importation to the final resale.
It also supervises pharmacies and commercial resellers allowed to market prescription-free medicines. To suppress the possibility of illegal medicines on the legal market, medicines destined for resale may only be purchased from authorized wholesalers. Online pharmacies may only operate if they operate from a licensed ‘real’ pharmacy.
Holders of marketing authorisation, pharmacists engaged in wholesale or distribution, and doctors are obliged to report all noticed quality deficiencies to the competent authority. This authority will then investigate the medicine and take appropriate actions that be as far-reaching as removing it from the market. Further detailed rules are laid down in Regulation No. 52/2005 of the Minister for Health Care.