The bill on licensing of medicines, that would allow Russian companies produce medicines that are under patent, will be passed in the State Duma soon. Authorities could decide on legalization of coping original medicines, that were either denied the right to cope by patent holders, or band from export to Russia die to the economic sanctions, or groundlessly high price on medicine. The bill also includes rules on mandatory licensing and determination of factory- producer.
Head of the department if control of social sphere and trade if the Federal Antimonopoly Service of Russia, Timofey Nizhegorodtsev noted that the mandatory licensing will be implemented according to the international norms.
“In some countries this decision is made by the court, in others by antimonopoly bodies, or by the Government. Russia does not have mechanism to make such a decision and the MP together with the Government have to develop the mechanism. Mandatory licensing was used by Canada, India, UAE, Brazil and other countries. Thereofre, Russian is not the first one to implement such practice,” Mr. Nizhegorodtsev.
The advantages and disadvantages of the new policy will be discussed at the Third Partnering “Russia’s medicines. An interdisciplinary dialogue” which is organized by the Antimonopoly Service of Russia, Health Ministry of Tatarstan, and the Association of the Russian Pharmaceutical Manufacturers. The topics of Federal Law 44, the project “Odd man out”, serialization of medicines, preferences for local producers, control of the market and perspectives of the medical insurance will be discussed at the meeting.
“The partnering is another opportunity to meet with authorities, professional unions and pharmaceutical producers in order to discuss key issues of the industry’s future development. Such a dialogue always has its benefits. It gives a chance to exchange opinions on current regulatory issues, analyst market trends, share legal practice, and present achievements in import substitution,” said Director General of “Geropharm”, Petr Rodionov.
The Third Partnering would bring together representatives of the Federal Antimonopoly Service, Health Ministry Ministry of Trade, the Roszdravnadzor, medical producers, professional unions and associations. Information partner of the event are “Pharmacevtichesky Vestnik”, “Moscovskie Apteki”, “Remedium”, “Novosti GMP”, “Aptechniy Souz”. The event will take place in training center of the FAS in Kazan on September 25, 2015.
For further information reach:
The Association of the Russian Pharmaceutical Manufacturers
tel: + 7 (495) 231 42 53