In order to ensure the country's drug safety and increase the availability of medicines, a balance in the field of legal regulation is needed. This was discussed at the session on intellectual property "Space for innovative competitiveness: the search for boundaries". The meeting, which took place at the St. Petersburg International Economic Forum (SPIEF), brought together government officials, lawmakers and pharmaceutical manufacturers.

Participants of the intellectual property session "Space for innovative Competitiveness: the search for boundaries" / Photo: Roscongress

As the participants of the discussion noted, the field of pharmacology has become a driver for improving patent legislation.

"The development of competition in the industry requires dialogue and a careful approach to legal relations in order to maintain a balance between copyright holders, users and the state," said Lilia Gumerova, moderator of the session, Chairman of the Federation Council Committee on Science, Education and Culture. She stressed that the key task today is to find a middle ground that will allow the industry to develop dynamically, while maintaining the availability of social guarantees for citizens.

The position of domestic pharmaceutical manufacturers was expressed by Petr Bely, MD, Chairman of the Board of Directors of the innovative biopharmaceutical company Promomed. The expert noted that fundamental changes have taken place in the industry over the past year. They are related to the decisions of the Supreme and Constitutional Courts of the Russian Federation, which emphasized, on the one hand, the stability of the domestic patent system and guarantees for the protection of exclusive rights, and, on the other, the primacy of the interests of society.

Doctor of Medical Sciences, Chairman of the Board of Directors of Promomed Peter Bely Photo: Roscongress

"Access to therapy is an aspect of protecting the constitutional order," concluded Petr Bely. - If the necessary therapy is not enough, the state can and should intervene. The decision-making criteria were formulated by the Constitutional Court in relation to Article 1362 of the Civil Code of the Russian Federation. Accessibility, sufficiency, and price come to the fore as a factor in the availability of medicines. One of the key questions is whether the importance of the price factor will influence the development of law enforcement practice under Article 1360 of the Civil Code of the Russian Federation.

The representative of the pharmaceutical business stressed that the growth in exports of domestic products, in particular technologically complex drugs, amounted to more than 30 percent - this is a huge indicator and a very serious item for the national economy.

Svetlana Chupsheva, Director General of the Agency for Strategic Initiatives (ASI), recalled that currently, on behalf of the country's leadership, active work is underway to improve the investment climate.: "Business and science need a clear understanding of global markets and the search for promising niches in which technologies are developing. This area requires rules regarding the protection of intellectual property and patenting."

According to her, such a platform will be created by 2027 as part of the joint activities of Rospatent and the Ministry of Finance. The expert also stressed the importance of combating "patent trolls" and abuse of exclusive rights as such. Work is already underway to prevent registration of rights without the intention to use them: this practice creates real barriers for bona fide market participants.

The topic of monopolistic market manipulation was continued by the head of the Republic of Mordovia, Artyom Zdunov. In an unstable geopolitical situation, he called for supporting domestic producers, focusing on quality and price factors, while preserving the opportunities of those wishing to enter the market.

- We have to find better and cheaper ones. And we must be sure that the medicines we purchase will be available in five or ten years, regardless of the situation in the world and the international situation," stated the Head of the Republic of Moldova. - Security is what the regions need. In the republic, we are constantly expanding the program of state guarantees, and the tasks are growing accordingly, while the means to ensure them remain the same. What should the region do? We have to look for new, high-quality, proven ways, so we set the task of finding new innovative solutions for our universities and enterprises.

Elena Maksimkina, Head of the Federal Center for Planning and Organization of Drug Provision for Citizens, stated that the domestic pharmaceutical industry is at a high level today. Among the main problems, the expert noted the lack of negotiability of individual manufacturers who are not ready to make concessions. In her opinion, some patents have become a monopoly pricing tool. Because of this, many solutions are simply inaccessible to Russian patients. Elena Maksimkina supported the idea of creating a competitive environment in the Russian pharmaceutical industry: "We must buy the drug, and let our trade wars be decided on the judicial platform." As a measure to stimulate intellectual competition, it was also suggested to consider the possibility of granting a monopoly forla is the first generic drug localized in the Russian Federation.

Photo: Roscongress

Sergey Glagolev, Deputy Minister of Health of the Russian Federation, drew attention to the fact that two thirds of sales on the Russian market relate to patented drugs. In this regard, the social component is of particular importance along with the commercial one. The plans include joint work to improve law enforcement, including through the activities of the national Center for the Transfer of Medical Technologies, which can advise those who wish on patent protection issues.

And the head of Rospatent, Yuri Zubov, called for a scrupulous assessment when considering applications for permits from the Government of the Russian Federation. According to him, inattention can undermine the value of intellectual property and disrupt the attractiveness of access to the Russian market. Returning to the issue of articles of the legislation of the Russian Federation aimed at issuing compulsory licenses, the head of the department said that today proposals are being received from all sides to optimize this mechanism.

- It is necessary to move towards the unification and centralization of this practice, - said Yuri Zubov.

Olga Ruzakova, Deputy Chief of Staff of the State Duma Committee on State Construction and Legislation, noted that lawmakers are regularly working to strengthen the protection of intellectual property.

- Some issues, of course, are resolved at the level of judicial interpretation. We see this in today's discussion. Of course, the experience of foreign countries is important. And the changes that are being prepared require discussion with the Intellectual Property Council, the Chairman of the Federation Council, and the community," the State Duma representative said.

Summing up the discussion, Director of the Scientific and Educational Center for Legal Support of Bioeconomics and Genetic Technologies at the O. E. Kutafin University (MGUA) Oleg Grin stated that the problem of abuse of exclusive rights does exist and the implementation of the proposals made at the session is impossible without improving Russian legislation. According to the expert, now we should be talking about fine-tuning regulation and creating a so-called code of good practices, rather than hastily introducing momentary amendments to the law.

Sources

1. rg.ru