On 5 December 2011 the Hungarian Parliament adopted a bill amending, inter alia, the Medicinal Thrift Act (Act No. XCVIII of 2006) and the Drug Act (Act. No. XCV of 2005) (the "Bill"). The Bill is currently awaiting the signature of the Chairman of the Parliament before it will be sent to the President for signing. The Bill will enter into force on 1 January 2012.

The most significant provisions to be introduced by the Bill include, among others, the following:

  • The set-up of a so-called health register by the competent authority. The health register shall include non-personalised data of patients and the treatment received (including data on the prescription of medicinal products and medical aids). Only the marketing authorisation holder of a given medicinal product or a medical aid and research institutions shall be granted access to the health register; however, the latter shall only have access to the database if the information is necessary for statistical research purposes.
  • The possibility to impose a maximum fine of HUF 400,000 (that is approx. EUR 1,350) on medical device manufacturers or distributors should the statutory obligations with respect to the reporting obligation for– among others – clinical trials, obligatory periodic reviews, reporting unexpected events etc. be violated. The aim of the introduction of the fine is to raise awareness amongst medical device distributors as to the need to undertake the reporting – whenever necessary – so that the competent authority is in the position to provide precise information to the European database.
  • The patient's cooperation (adherence) – meaning the patient's lifestyle and his/her practice to take medicinal products – will also be taken into consideration when setting the subsidy for a medicinal product. Thus, the amount of subsidy of a given medicinal product will be subject to the patient adherence; consequentially, in lack of adherence, the amount of subsidy may be lowered in respect of the given patient. Most likely, further detailed regulation will be set out in a Decree.
  • Harmonisation with the pharmacovigilance regulations of the Directive 2010/84/EC. Thus, the Drug Act will be amended with the new pharmacovigilance regulations including the ability of the competent authority to oblige the marketing authorisation holder to conduct post-authorisation safety studies if risks surrounding the concerned medicinal product are detected.
  • Introduction of the basic rules on subsidising biological medicines. New regulations of the Medicinal Thrift Act include among others the definition of the reference price range of biological medicinal products and/or the fact that the social subsidy will be withdrawn from biological products which are priced at least 30% higher than the price of the reference biological product. Further, only subsidised biological products may be prescribed for new patients and the Bill strictly stipulates that biological products may not be interchanged. The detailed rules on the subsidising procedure will, however, be laid down in a Ministerial Decree.
  • Wholesalers and retail suppliers of medicinal products will be required to not only supply reference medicinal products but also medicinal products and biological medicinal products within the reference price range.
  • A new regulation which prohibits pharmacies from providing donations to public, childcare or healthcare institutions that can be connected to the order and supply of medicinal products to the given institution, their members or the persons treated at the given institution.

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The original publication date for this article was 08/12/2011.