Pharmaceutical industry development strategy until 2020: forecast of the Ministry of Industry and Energy
Natalia is Ready, "Profile" No. 20(575) dated 05/26/2008
Sergey Tsyb, Director of the Department of Chemical and Technological Complex and Bioengineering Technologies of the Ministry of Industry and Energy of Russia, told Profil about how work is going on to create a Strategy for the development of the pharmaceutical industry until 2020.
– How much are the government's costs estimated for the entire period of the strategy and for the next few years?– Right now there is a broad discussion about the nomenclature and scale of specific activities within the framework of the Pharma 2020 strategy, and, as you understand, the final estimates will depend on the results of this discussion.
However, today we can say that the "cost" of transferring the development of the domestic pharmaceutical industry to an innovative model, and so that domestic medicines occupy a dominant position in their own market, can cost an amount comparable to the annual turnover of the entire Russian pharmaceutical market. And the share of budget funds may be a significant part of this amount.
– Could you tell us more about possible financing schemes for the development of innovative medicines, which the strategy provides for by 2020?– Today there is a gap between what stage our academic science can bring developments to, and from what point the industry can "pick up" and implement them.
Venture funds are partly designed to fill this gap, but their development is also at the initial stage of formation, and they are not ready to take on the risks that exist in drug development, especially at the initial stages.
Therefore, the state should, at the expense of a system of grants and specialized financial instruments, provide financing for the development of new drugs until the moment when these developments can be continued at the expense of extra-budgetary funds. According to experts, before the I–II phase of clinical trials of new drugs.
According to our estimates, by 2017, public funds can be replaced by extra-budgetary funds, and the state will retain the traditional role of financing academic science.
– What benefits and preferences does the strategy provide for developers and manufacturers of innovative medicines?– Of course, there should be incentives for those who are engaged in development.
Now the tax base is the same for everyone, which means an additional burden in the form of payroll taxes for organizations engaged in scientific research, since the cost structure of such organizations mainly consists of salaries. But taxes are a matter of state policy, which, given the general innovative vector of development, will probably change in the near future. In addition, there are compensatory tools to stimulate development, which are also considered when discussing the strategy.
– Is it planned to create a state corporation or a company on PPP terms, which would act as a customer for R&D and the subsequent stage of commercialization of the product?– First you need to determine the goals and objectives of the state.
Everyone gets the impression that state corporations are key to the development of a particular industry. In fact, the opposite is true: they close the system of actions where it is really necessary and appropriate.
– How will private co-investors be selected during product development?– In most cases, the co-investor should be the state, and not vice versa, since it is private capital that should set priorities for the development of innovations and thereby maximize the likelihood of the introduction and further commercialization of the product.
– What will happen if a scientific development seems very promising, but a private co-investor has not been found to bring it to the market?– There are different mechanisms, for example, we can talk about option agreements, when a private co-investor undertakes to buy a development in the future for a specified price or start financing it in a certain amount, while at this stage he signs an option agreement and makes a symbolic option payment.
– On what principle will research centers for the development of original medicines be created and funded?– The optimal model, of course, would be integrated structures of developers and manufacturers based on public-private partnership, but the specific mechanisms of such structures have yet to be worked out.
– How many will there be, will they be created from scratch or on the basis of existing research institutes?– Both options are possible, but we must understand that mixing a planned and market economy is a non–trivial task, and whether we can take advantage of the traditionally strong potential of our natural science schools will depend on the success of its solution.
– How is it supposed to select personnel for these centers, will there be conditions in this case for the return to Russia of scientists working abroad?– Of course, the return of our compatriots, who have experience primarily in applied science and work in the Western industry, is one of the most powerful tools for the transfer and development of the most advanced technologies that have appeared in the West in recent decades in the field of living systems.
Russia, since the time of Peter the Great, has always been strong in the prompt elimination of technological failures, primarily due to the transfer of technology and people from the West.
– The strategy states that "anti-dumping measures will be strengthened, as well as measures to exclude unfair competition in the Russian pharmaceutical market." What is meant by anti-dumping measures? Will import duties on the import of drugs increase?– Now this is the subject of active discussion.
In particular, some experts talk about the positive experience of the "automobile model", which stimulated the construction of assembly plants on the territory of the Russian Federation. At the same time, the initially raised export duties will gradually decrease as local production develops and the "degree of production" of components in the local market increases. However, anti-dumping measures in international practice are also understood as additional charges for certain imported goods or raw materials for which dumping policy is carried out at the state level of the respective exporters. This ensures fair conditions for local producers.
– Is it possible to change the licensing procedure for foreign manufacturers of original drugs in Russia?– Of course, if the FDA and EMEA inspections go out and inspect laboratories and production facilities around the world and you cannot supply a medicine or research service to the American market without it, then Russian regulatory authorities should do something similar in relation to what is produced outside of Russia, whether it is ready-made dosage forms., substances or results of clinical or preclinical studies.
At the same time, mutual recognition of inspections of all GP (good practice) is a civilized way to reduce the costs of such on-site inspections. But everything should be absolutely symmetrical, consistent with international practice.
– What can you say about encouraging foreign pharmaceutical companies to place innovation centers in Russia?– As for stimulating the research of Western firms on their territory – this is the way China and India will get the latest Western technologies.
It is in the field of research and "production of innovations" that Russia could take a worthy place in the international system of labor distribution. But to do this, it is necessary to quickly master new methods that already exist on the international market, including using tools such as benefits and preferences.
– In this regard, the question is often raised about the Russian practice of expertise and activities related to preclinical and clinical trials of an innovative tool. Will something change in this area?– Postgenomic technologies (molecular biological technologies that appeared after the decoding of the human genome, which are based on working with living systems, in particular protein networks.
– "Profile") provide a wide variety of preclinical research technologies that make it possible to make more effective and safe drug candidates. We need to use the results of globalization and quickly master these new tools that allow us to determine the molecular mechanisms of action of drugs and develop them in a targeted and effective manner. Stimulating such biomedical laboratories of a "new type" is a priority task.
– How is the state going to support the development and commercialization of innovative methods for diagnosing diseases?– Of course, global trends in the development of medicine are shifting to the field of preventive and personal medicine, and this is primarily the development of diagnostic tools, including completely new diagnostic devices based on biomarkers, etc.
This is a necessary element of it, and without the comprehensive development of all parts, the development of the healthcare system as a whole is impossible.
– What other Russian projects in the field of medical biotechnologies can be considered a priority and how does the state intend to support them?– Indeed, biotechnological medicines demonstrate higher growth rates in the world than traditional synthetic ones, and it is in this area that Russia has a significant technological lag.
The development and production of the latest therapeutic proteins, including antibodies, are practically absent in our territory. Therefore, in this direction, special activity of the state is needed both in the field of creating production infrastructure and training personnel, and in large-scale support for research and development. This is the future of pharmaceuticals.
– Are there any plans to make changes to the existing practice of providing medicines to the population under DLO programs?– In developed countries, national health systems are arranged in such a way that the state largely compensates for the costs of drugs through various mechanisms.
At the same time, being a "professional buyer", it is not inclined to overpay for the trade names of drugs. This leads to a market structure where either innovative drugs or high-quality generics are presented on it, and the percentage of branded generics is minimized. This situation, in turn, stimulates the innovative development of the industry, since it is unprofitable for pharmaceutical companies to invest in advertising only brands, and they direct most of their profits to the development of innovations to obtain more profitable original products in their product portfolios. For us, this is only a long-term prospect, but strategically we should strive for this.
Portal "Eternal youth" www.vechnayamolodost.ru27.05.2008