Farewell to the monopoly on pharmaceuticals!
Resolution No. 877 of April 12, 2013 of the Cabinet of Ministers of Ukraine was issued on the grounds of the right to apply compulsory licensing under the Doha Declaration to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
The main point of the Resolution is to expand the market for patent medicines in Ukraine and abroad, and to simplify a procedure for obtaining Permit to use or import patented medicines. One of the requirements legislation specifies is granting permits on conducting licensed pharmaceutical activities using patented medicine by third parties provided that it is transferred together with the part of an enterprise where it is used. A company with a license for import, wholesale and retail trade of pharmaceuticals also has the right to get the Permit to use the patented invention. But we should not rejoice in advance. This Resolution as all the other ones in Ukraine has its own advantages and disadvantages.
Let’s start with the positive points. For example, the owner of patented medicine or one of the ingredients of a drug is not able to produce a drug on its own. They may at their own discretion sell the patent to the pharmaceutical company which has a license for production of medicines. If an applicant is unreasonably refused to sell the patent, one has the right to file a petition to the Ministry of Health. Given compliance with all the requirements, the Ministry of Health shall oblige the owner to sell the patent to an applicant. This is the whole idea of patent enforcement what will trigger the development of the domestic market of Ukraine. Since a patent for medicine bought from foreign companies provides for its resale to other pharmaceutical companiesat a price set by the Ministry of Health. As a consequence, prices for licensed medicines in the wholesale and retail markets are expected to decrease which provides a great advantage for Ukraine at this stage of development. Also, it will lead to the fact that the number of those wishing to engage in trade and production of medicines in Ukraine will increase.
However, this Regulation also has possible negative consequences for medicines, given the responsibility of domestic producers, most of which focus solely on the profitability of their own pharmaceutical companies. And such an attitude leads to consumer’s distrust of the medicine quality. We can only hope that the Ministry of Health thoroughly controls licensed medicines produced by pharmaceutical companies for compliance with quality standards, as the final word on granting licenses and permits for the use of patented products for medicine production rests with the Ministry of Health.
Specialists of COLARES will provide you with advice regarding the adopted regulation and help you to obtain a license for production, export and import of pharmaceuticals.