We are pleased to present to you our periodical legal update on developments in the Russian pharmaceutical sector. It is intended to give you brief outline on key regulations and other important activities and trends in the industry.
Draft Amendment to the Federal Law "On the circulation of drugs"
The Russian Government approved the draft of amendment to the Federal Law "On the circulation of drugs". The amendment is aimed to improve the procedure for determining the mutual replaceable drugs. According to the draft, the Russian Government will develop a procedure and criteria for determining which drugs can be considered mutually replaceable. It is expected that the new procedure will be used for state procurement purposes. The draft has not yet been submitted for the first hearing.
The maximum retail price for essential drugs
On 6 June 2019 the president of the Russian Federation signed Federal Law No. 134-FZ of 06.06.2019, according to which (i) the price cannot be changed more frequently than once a year, and (ii) if the maximum price is decreased by the Russian Government, the applicant must have the actual price updated in the register accordingly.
The Legal Community is Discussing the Ideas on Creation of the Register of Active Pharmaceutical Ingredients Protected by Patents
Within the frameworks of the International Intellectual Property Forum held in Moscow on 25 April 2019, the legal representatives and industry specialists have come up with the idea (described in the resolution of the forum) on creation of the State Register of the Active Pharmaceutical Ingredients (APIs) protected by the Russian patents for inventions.
The Register may help to prevent the state registration of pharmaceuticals which infringe on existing patents. This will facilitate struggling with patent infringers, which otherwise currently takes enormous time and efforts and is not always efficient, allowing the infringing medicines to enter the market and be supplied to state entities and pharmacies.
The Register is considered to be used by the state authority (Russian Ministry of Health) at the stage of state registration of pharmaceuticals, so that the upcoming patent infringement can be detected and prevented already at this stage.
Such proposal is intended to be further discussed with state authorities which, if successful, may result in the creation of the draft bill to be submitted to the legislative authorities of the Russian Federation.
Creation by Rospatent of an interdepartmental working group on Pharma IP
The working group (WG) consists of representatives of ministries, departments, the State Duma of the Russian Federation, the Eurasian Patent Authority, pharmaceutical associations and large pharmaceutical companies. On 4 July 2019, the WG held its first meeting to discuss the first proposals on amending the Law on the Circulation of Pharmaceuticals. The WG's final proposals and decisions are planned to be included in a separate section of the strategy for the development of the Russian pharmaceutical industry for the period until 2030, which is currently being drafted.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.