Ukraine. Marketing authorization and pricing of pharmaceutical products, including generic drugs regulatory acts
- Resolution of the Cabinet of Ministers of Ukraine dated 26 May 2005 No. 376 on Approval of Procedure for State (re-)Registration of Drugs and State (re-)Registration Fee Amount;
- Decree of the Ministry of Health of Ukraine dated 26 August 2005 No. 426 on Approval of Procedure for Expert Examination of Drug Registration Materials Submitted for State (re-)Registration and Expert Examination of Materials on Amendments to Registration Materials within Registration Certificate Validity Term;
- Resolution of the Cabinet of Ministers of Ukraine dated 14 September 2005 No. 902 on Approval of Procedure for State Quality Control of Medicinal Products Imported to Ukraine;
- Resolution of the Cabinet of Ministers of Ukraine dated 17 October 2008 No. 955 on Measures for Stabilisation of Medicinal Products and Medical Products Prices;
- Resolution of the Cabinet of Ministers of Ukraine dated 25 March 2009 No. 333, Certain Issues of State Regulation of Drug and Medical Product Prices;
- Resolution of the Cabinet of Ministers of Ukraine dated 13 August 2012 No. 794, Issues of Declaring the Changes in Wholesale- Selling Prices for Medicinal Products which are Purchased at the Expense of State and Local Budgets;
- Decree of the Ministry of Health of Ukraine dated 3 February 2012 No. 78 on Approval of the List of OTC Medicinal Products Permitted for Use in Ukraine Sold in Pharmacies and their Structural Subdivisions;
- the Law on Principles of Counteraction and Prevention of Corruption dated 7 April 2011 No. 3206-VI;
- the Law on Advertising dated 3 July 1996 No. 270/96-BP;
- Decree of the State Drug Quality Control Inspectorate of the Ministry of Health of Ukraine dated 31 October 2011 No. 723 on Approval of Licensing Conditions for Exercise of Medicinal Products Manufacturing, Wholesale and Retail;
- the Law on Amending Certain Laws of Ukraine as regards Medicines Import Licensing and the Definition of the Term 'Active Pharmaceutical Ingredient' dated 4 July 2012 No. 5038-VI; and
- Decree of the Ministry of Health of Ukraine, dated 20 February 2013 No. 143 on Approval of Licensing Terms on Conducting of Economic Activity Regarding Medicinal Products Import.
Which bodies are entrusted with enforcing these regulatory rules?
The Cabinet of Ministers of Ukraine is the main decision-making body regarding the pricing and reimbursement of medicinal products. It approves wholesale and retail mark-ups for medicines and medical devices included on the national list of essential medicines and medical devices; and to the compulsory minimal assortment (socially oriented) of medicines and medical devices for pharmacies.The Ministry of Health of Ukraine ensures state registration and control of manufacturing, storage, sale and quality of drugs and stipulates unified qualifying requirements for persons exercising pharmaceutical activity. The State Service of Ukraine for Medicinal Products; the State Expert Centre of the Ministry of Health of Ukraine; and the State Price Control Inspectorate are also entrusted with enforcing the regulatory framework for the marketing, authorisation and pricing of medicinal products in Ukraine.
The Antimonopoly Committee of Ukraine (AMCU) is the state authority that ensures protection of competition including combating misleading advertising.
Which aspects of this legislation are most directly relevant to the application of competition law to the pharmaceutical sector?
The main anti-competitive issues in the pharmaceutical sector appear to be distribution of misleading information in drugs advertising; non-provision of information in due time or provision of untrue, incomplete or inexact information requested by the AMCU; violation of public procurement procedures; anti-competitive concerted actions: relations of manufacturers with distributors, solid distributing programmes, bonuses and discounts, etc. Pricing is also relevant to the application of competition law to the pharmaceutical sector.Article 15-1 of the Law on Protection against Unfair Competition dated 7 June 1996 No. 236/96-BP defines distribution of misleading information as communication by a business entity directly or through another person to one or several persons or to an undefined circle of persons, inter alia, of incomplete, inaccurate or untrue data, in particular the results of the chosen means of expressing or concealing separate facts or inaccurate formulations which influenced or may influence the intentions of these persons as to the purchase (ordering) or realisation (sale, supply, performance or provision) of goods, works or services from this business entity.
Misleading information (including in advertisements) in the meaning of article 15-1 covers, in particular, information containing incomplete, inaccurate or untrue data about the manufacturer, quality, completeness, suitability to application, standards, characteristics, peculiarities of goods' realisation, etc.
As stated above, the authority exercising control over compliance with legal entities with article 15-1 is the AMCU, which may request information, conduct inspections and initiate cases, and impose fines and other sanctions for infringement of the law on fair competition.
Source: Arzinger
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