ON THE BENEFITS OF PARALLEL IMPORT AND FORCED LICENSING OF MEDICINAL DRUGS
The staff of the antimonopoly body discussed it with representatives of French pharmaceutical market
On 21 February, the French Embassy hosted a Health Care Club focusing in regulatory novelties of the pharmaceutical market in Russia. The 9th Club session was traditionally organized by the Office on Trade and Investments at the French Embassy.
Recently there have been vivid discussions in mass media and in the society regarding a prospective pricing method for medicinal drugs, forced licensing and parallel import. These were the issues discussed by the Club with representatives of the antimonopoly body upon an initiative of the French ambassador in Russia, Sylvie Bermann. In his welcoming remarks, Philippe Brunel, a minister-advisor for the Economic Service of the French Embassy, emphasized the importance of every Club session: It is a possibility to once again acknowledge the importance of economic relations between Russia and France. France is one of the largest investors in Russia. Nine French companies are among 50 biggest employees in Russia, particularly, in the health care sector. Since establishing the Club, we have wanted to offer its members an opportunity of a direct, constructive dialogue with the authorities. Our Club has become a platform for supporting companies in their operations on the Russian market and in the economies of the Eurasian Union”.
Andrey Tsyganov, Deputy Head of FAS, informed participants about the main health care issues in FAS focus and emphasized that it is one of the priorities of the work of the Antimonopoly Service, the importance of which is highlighted by the President of the Russian Federation.
“The National Competition Development Plan1 approves the list of the sectors of the economy where the state supports development of competition. Health care is on the first place (out of 13!). It involves a package of measures designed to develop competition in the health care segment. Moreover, all federal executive bodies must analyze the existing administrative barriers that prevent advancement of healthy competition, and devise the so-called Road Maps for developing competition. This work must be performed rather promptly. The Road Map for developing competition in health care, discussed by FAS with the Ministry of Health Care, is approved by the Government”, stated Andrey Tsyganov.
Introduction of parallel imports is an important area of FAS work in the pharmaceutical sector.
“Our task is to persuade colleagues in the Government and business that parallel import is useful. We are in possession of a fresh ruling of the Constitutional Court of the Russian Federation, which analysis shows that overall the Court is positive towards the idea of parallel import, directly associating it with minimizing discrimination and possible competition restrictions on the markets”, said Deputy Head of FAS.
Forced licensing is another important item for FAS.
Today there is a risk of abusing dominance by the right-holders in the form of fixing and maintaining economically unreasonably high prices, refusal to manufacture or supply the necessary drugs and medical products to the Russian Federation.
The relevant amendments to the Civil Code of the Russian Federation are drafted by FAS and submitted to the Government. To protect health and safety of the population, they assign the powers to the Government to establish the procedure for granting permits to use inventions, utility models or industrial prototypes without the patent-holder consent, notifying the latter as soon as possible and paying an adequate compensation.
Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev pointed out that “the project of forced medicine licensing is not considered as a permanent method of forcing price reduction. It is rather a mechanism for protecting the rights of citizens in case of any excesses, for example, when pharmaceutical companies refuse to manufacture or supply the necessary drugs and medical products to the Russian Federation in case of serious threats to health and safety of the population”.
He informed participants about the expected changes in the procedure of registering the maximum ex-works prices in the Russian Federation or the drugs included in the list of vital and essential medicines.
Nadezhda Sharavsksya, Deputy Head of FAS Department for Control over Social Sphere and Trade, made several important clarifications and answered questions regarding the draft Guidelines.
[1] No. 618 Order of the President of Russia "On the main areas of the state policy for developing competition" of 21.12.2017 (together with the National Plan for Developing Competition in the Russian Federation in 2018 - 2020")