Ukrainian Parliament enacted new regulations in pharmaceutical industry

Ukraine

On 02 June 2020, the Ukrainian Parliament adopted a new law (the “Law”) with the aim of facilitating the movement of generic products and products produced from donor blood in the Ukrainian market.

Introducing the Bolar Exemption 

In an attempt to harmonise the Ukrainian law with the EU standards, the Law introduces a form of marketing authorization defense of generic products into Ukrainian patent law (i.e., the so called “Bolar exemption”).

The Bolar exemption allows a generic producer to apply for marketing approval for a generic product before the expiration of a patent of the original medicine product and, as a result, market its product straight after the expiry of the patent protection.

For instance, the Law allows generic producers to carry out the preparatory steps for market authorization, including  importation of the medicines produced with help of patent protected information for the purpose of conducting research, which will be used for preparation and submitting of information in registration of medicines. Such import will not be considered as IPR violation.

The new Law should reduce the time for bringing generic products to the market and give patients the opportunity to get faster access to treatment.

New opportunities for blood processing companies

 

The Law also introduces the following measures relevant to private companies’ activities in blood donorship industry (collection, storage, processing of blood, plasma, and its fractionation):

  • Private companies that have a respective license are allowed to extract plasma for fractionation on condition of the conducting processing and usage of plasma for manufacturing blood products on the territory of Ukraine.
  • The plasma may be also purchased from special healthcare facilities, responsible for donor blood collection.
  • State authorities and private companies are allowed to cooperate under public-private partnership or concession rules with the aim to ensure the access to safe and quality donor blood;
  • The grounds for exporting donor blood and its components are expanded, though subject to strict governmental control.

The Law will come into effect upon signing and promulgation by the President of Ukraine.

 

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