Provisions of the most recent Medicinal Products in Human Medicine Amendment Bill, concerning the pharmaceutical sector

July 2019


On 5 July 2019 with an unusual legislative technique the Ministry of Healthcare (MH) published, in order to “preliminary inform the public”, an Amendment bill to the Medicinal Products in Human Medicine Act (MPHMA) and a dozen other Acts regulating the healthcare sector. At present, the Bill is yet to be officially published for a public discussion within the meaning of Art. 26, Paragraph 3 of the Statutory Instruments Act.

Since the amendments are quite vast, herein we will focus solely on the more significant changes concerning the Bulgarian pharmaceutical sector, and in particular – the Marketing Authorization Holders of medicinal products (MAHs).

 Amendments to the MPHMA

  • The Bill implements provisions of Delegated Regulation (EU) 2016/161, namely – the obligations of the MAHs, wholesalers and retailers of medicinal products for medicinal product verification. The Bill introduces new administrative sanctions in case of incompliance with the new obligations;
  • The vast majority of the provisions of the Ordinance on the conditions, rules and order for regulation and registration of medicinal product prices (the “Pricing Ordinance”) are to be introduced in the MPHMA. For the most part, the provisions of the MPHMA are identical to the provisions of the Pricing Ordinance, with several notable exceptions:
  • The Bill explicitly lays down the requisites of the decisions of the National Council on Pricing and Reimbursement of Medicinal Products („NCPRMP“) for inclusion, change and exclusion of medicinal products from the Positive Drug  (PDL). The Decisions of the NCPRMP shall necessarily include the criteria for assessment of therapy effectiveness of the medicinal product, if applicable;
  • An explicit provision sets forth that the decisions of the NCPRMP may be appealed before the courts even if they have not been appealed before the competent authority – the Transparency Commission. At present the case law is on the contrary opinion;
  • The Bill introduces a rule in the MPHMA, previously laid down in a transitional provision of the Pricing Ordinance (effective until 31 December 2019), that MAHs may not apply for increase of the registered prices of OTC medicinal products with a percentage higher than the registered inflation. Thus, this restriction, introduced in 2013 as a temporary anti-crisis measure, will remain for good;
  • A new field is introduced in the Annexes to the PDL – type of the medicinal product, determined during its marketing authorization procedure;
  • Generic medicinal products with well-established use may be included in the PDL even if they are not reimbursed in at least five of the reference countries in the EU;
  • The Bill establishes a procedure for off-label prescription and use of medicinal products. Such off-label use of the medicinal product will not be reimbursed by the National Health Insurance Fund (NHIF).

Amendments to the Health Insurance Act (HIA)

  • The Bill introduces changes to the reimbursement procedure of medicinal products the effectiveness of the therapy with which is being monitored. The price of such products will be reimbursed by the NHIF. However, if the medicinal product turns out to be ineffective, the MAH shall pay back any reimbursement funds received;
  • The Bill introduces much more detailed provisions in the HIA regarding the Mechanism for guaranteeing predictability and sustainability of NHIF’s budget (the „Mechanism“). Under the Bill, the Mechanism will not be specified in Ordinance # 10 of 2009, but rather – will be annually approved with a decision of the Supervisory Board of the NHIF, to be promulgated in the State Gazette by the manager of the NHIF. It may be disputed whether such act will comply with the applicable requirements under the Statutory Instruments Act and the Administrative Procedure Code;
  • The Bill introduces a sanction for the MAHs, which do not enter into an agreement with the NHIF to join the Mechanism – their medicinal products, included in the PDL, will not be reimbursed by the NHIF;

Additional amendments regarding the monitoring of therapeutic effectiveness are introduced in the Medical-Treatment Facilities Act (MTFA). The MTFA sets forth the obligations of the medical-treatment facilities which shall monitor the effect of the therapy with certain medicinal products, as well as sanctions for violation of these obligations. In addition to the above, the Bill introduces several provisions of the Medical Devices Act (MDA), concerning additional information to be included in the List of the Bulgarian Drug Agency of medical devices that may be paid from the budget of the NHIF. Pursuant to the Bill, the List shall also lay down the invoiced sale price of medical devices imported from third countries, as well as the price under which the device has been paid by the NHIF, MH or the respective healthcare institution.

For further information contact:

Ilya Komarevski, Partner

Philip Kiossev, Associate

This article has an informative purpose and is not representative of detailed legal advice. If you are interested in receiving advice in the context of a certain situation, we can happily assist you. The law firm is not responsible for any harm caused by acts or omissions undertaken due to this text.

©TBK, 2019