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Innovative development of the pharmaceutical and biotech industry in Russia: keys to success
7 June 2019
10:00—11:15
KEY CONCLUSIONS
Russian market is attractive for producaers of innovative medications and medical equipment

A whole set of medications and medical equipment was developed at and introduced in the Russian market, some were supplied abroad. <…> Schwabe did a great job with neonatal equipment. <…> Botkin.AI is fairly well-known at the market and uses artificial intelligence technologies for better diagnostics of certain cancers. <…> Eidos is very successful, and it started with international markets. There are success stories, there is an obvious trend of using a cross-disciplinary approach and big data combined with biotechnologies and engineering — Arkady Dvorkovich, President, World Chess Federation (FIDE); Chairman, Skolkovo Foundation .

Russia is an important market for us. It has a great potential and it is full of innovative projects. For example, Almazov Centre — Max Wegner, Senior Vice President, Head of Regulatory Affairs, Pharmaceuticals Division, Bayer AG.

ISSUES
Innovation growth rates in Russia’s pharmaceutical industry remain low

Global growth rates of biotechnological innovations are higher than the ones of the venture capital market. While the global venture capital market has shown an increment of 40%, its biomedical segment <…> has grown by 50%, and the investment volumes in this segment are breathtaking. Russia has pretty much the opposite situation. <…> The share of the biomedical segment in the venture capital market is just several per cent, while globally it is second biggest after software — Alexey Basov, Deputy General Director, Investment Director, Member of the Management Board, RVC JSC.

Regulation has room for improvement. Innovations face a difficult market launch

We have an underdeveloped system for launching breakthrough medications or technologies. There is barely any difference between launching a regular pharmaceutical and an innovative one — Arkady Dvorkovich, President, World Chess Federation (FIDE); Chairman, Skolkovo Foundation .

Russia has fairly limited opportunities to speed up product launch. There is Fast Track in Europe and the US: it is a set of initiatives that help with a fast market launch — Max Wegner, Senior Vice President, Head of Regulatory Affairs, Pharmaceuticals Division, Bayer AG.

On one hand, we talk innovations. <…> On the other hand, our legislators are approached with such initiatives as competition limitations through mandatory lincensing or the ‘odd man out’ initiative, and others — Yury Krestinskiy, Chief Executive Officer, Healthcare Industry, Sberbank .

Contradictions appear on the legislative level. Because, on one hand, we say we need to develop Russian innovations, while, on the other hand, we have what we have when it comes to intellectual property protection in the pharmaceutical industry. <…> There is an enormous pressure as far as pricing is concerned — Vadim Kukava, Executive Director, Innovative Pharma Association of Pharmaceutical Companies.

Attracting financing is difficult

What does it take to persuade a Russian bank to issue a loan for investing in R&D? <...> They fear it as the devil fears the holy water. If you succeed, you need to include production sites, property rights for real estate, etc. RVC along with some other development institutions offer financing mechanisms, but it is not enough — Vasiliy Ignatiev, CEO, R-Farm.

Limited market

You need to aim global markets from the start. Nevertheless, obvious problems – both insititutional and political ones – make it hard to enter international markets from Russia — Arkady Dvorkovich, President, World Chess Federation (FIDE); Chairman, Skolkovo Foundation .

SOLUTIONS
Developing international cooperation and expanding the market

Innovations are not about local markets. <…> Pharma is 100% about being integrated in the international research and development infrastructure. In this department, we count on our international partners — Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation .

We should aim to create conditions and find tools for significant market expansion — Airat Farrakhov, Deputy, Member of the Committee on Budget and Taxes, State Duma of the Federal Assembly of the Russian Federation.

Acknowledging each other <…> on the intergovernmental level under agreements would help products from various countries enter international markets. That would be a more efficient mechanism — Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation .

We need cooperation, a cooperation between a large number of stakeholders — Daniela Drago, Director, Regulatory Affairs Programs, Clinical Research and Leadership, School of Medicine and Health Sciences, George Washington University.

Government support for development of new medications and their market launch

As for extra tools needed for developing innovative medications, this year we took a shot at creating a venture fund <…> together with the Russian Venture Company. We expect other development institutes to join in, including Skolkovo — Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation .

We need to teach scientists to take what they create to the market. We need to come up with mechanisms to transfer the most cutting-edge innovations from universities to commercial operations — Alexey Basov, Deputy General Director, Investment Director, Member of the Management Board, RVC JSC.

Improving intellectual property protection

Just 15 companies that are global members of our Association made an unprecedented investment in innovation last year – USD 10 billion. <…> This is long-term high-risk investment that should be properly protected. <…> We need to create a culture of treating intellectual property with respect and awe — Vladimir Shipkov, Executive Director, Association of International Pharmaceutical Manufacturers (AIPM).

We need to <…> teach scientists, companies, and students basic mechanisms of creating patent protected property — Alexey Basov, Deputy General Director, Investment Director, Member of the Management Board, RVC JSC.

The material was prepared by the Russian news agency TASS