Pharma 2020: from generics to innovative drugs
The reason for discussing the problems of the pharmaceutical industry was the "Strategy for the development of the pharmaceutical industry of the Russian Federation until 2020" (Pharma-2020) developed by the Ministry of Industry and Energy. In the autumn, the document will be sent to the government for consideration, but in the meantime, everyone can take part in its revision.
Sergey Tsyb, the head of the Department of Chemical and Technological Complex and Bioengineering Technologies of the Ministry of Industry and Energy of the Russian Federation, introduced the main provisions of the Strategy to the audience, stressing that he considers it important to hold this round table within the walls of the Ministry of Education and Science: to solve the problems of the pharmaceutical industry, it is necessary to combine the efforts of departments.
The Russian drug market is estimated at $11 billion today, and it should grow at least three times by 2020. The problem is that 80% of this market (in monetary terms) is occupied by Western pharmaceutical manufacturers, which is regarded by some experts as a threat to the national security of the country (this, in particular, was said by State Duma Deputy Andrei Kokoshin). If no measures are taken to develop the domestic pharmaceutical industry, the share of imports will grow and reach 90% in the next 10 years.
Thus, the primary tactical task, as defined by the Strategy, is import substitution. According to its authors, it will be possible to redistribute market shares over the next five to seven years, for which measures will be taken to increase the Russian production of generics and licenses for the production of innovative drugs (at least 40 licenses) will be purchased from Western companies. The procurement policy of the state should also change: by purchasing drugs of similar quality from less well-promoted manufacturers instead of brand generics, the state, according to the calculations of the Ministry of Industry and Energy, could save about two billion dollars a year.
Simultaneously with the solution of tactical tasks, it is necessary to solve strategic ones – to recreate the domestic pharmaceutical industry and increase the innovative component in the industry. By 2020, according to the Strategy, at least two hundred innovative drugs produced in Russia will be put on the market, which will allow to equalize the market shares of domestic and Western pharmaceutical manufacturers.
"We recognize that the tasks are ambitious, but at the same time we have no doubt that they are achievable," Sergey Tsyb stressed. "There is sufficient scientific potential in the country, scientists only need help in implementing their developments. In our opinion, the role of the state in this process should acquire key importance."
According to the authors of Pharma 2020, the growth of the innovative component of the industry can be ensured only if the volume of investments in it reaches about $ 200 million per year. A significant part of these costs, most likely, will have to be borne by the state: Russian manufacturers today spend a total of about 50 million a year for these purposes. The authors of the Strategy have laid down some measures that should stimulate the inflow of investments into the industry. In particular, it is proposed to form a list of drugs whose full production cycle will be established in Russia, as well as to approve a mechanism for guaranteed purchases of a number of drugs within the framework of tenders. In addition, it provides for the possibility of introducing protectionist policies to protect domestic producers, including anti-dumping sanctions against products imported from developing countries.
Strategy: pros and consThe participants of the round table agreed with the main provisions of the Strategy.
For example, Evgeny Oreshkin, Deputy Dean of the MSU Biofac and First vice-president of the Biomak Consortium, spoke positively about the project, calling the document "very reasonable".
Alexey Konov, Investment Director of Bioprocess Capital Partners Management Company LLC, agrees that one of the steps to implement the Strategy should be public procurement of licenses from Western companies. In general, he believes that the pharmaceutical industry in Russia needs to be recreated according to the same model as the automotive industry – attracting foreign firms to the Russian market. Foreign manufacturers may be granted preferences in the Russian market, provided that they invest a guaranteed profit from the sale of medicines in their production in Russia. "In the next two or three years we will have to put up with the import of medicines," Alexander Konov said, "But at the same time we will build new plants. In the medium term, within 7 years, this will provide Russians with high-quality medicines produced in Russia and, accordingly, not so expensive. And after 7 years, we will get a base on which we can create innovative medicines, as planned in the Strategy."
Discussing the idea of the Ministry of Industry and Energy to develop 200 innovative drugs, the participants of the round table were not so unanimous. First of all, according to experts, it is necessary to agree on terminology: generics produced under the original trademark can also be understood as "innovative" drugs today. "Only those medicines that have a patented substance can be considered truly innovative," said Andrey Ivashchenko, head of the HimRar High Technology Center. – It is necessary to distinguish: there are drugs first in their class, that is, with a new mechanism of action and subsequent: second, third, which repeat this mechanism, but at the same time are innovative in their class (the so–called "classmates") - improved drugs that have either new biological properties or higher efficiency, which allows them to be patented."
It is worth noting that the Strategy relies on the development of innovative odnoklassniki: they are planned to produce about 140 names, while first-in-class medicines are only 20.
And a billion dollars for personnel?The participants of the round table did not doubt that Russia can develop innovative drugs, according to the general opinion, there are still scientific foundations and strong teams of scientists in the country.
The main questions are who, where and how will implement them into production?
"There are no large pharmaceutical companies in Russia yet," said Valery Danilenko, head of the Department of Postgenomic Biotechnology at the Institute of General Genetics of the Russian Academy of Sciences. "We should not seriously think that we will be able to establish the production of hundreds of innovative drugs by 2020 if such companies do not appear in the near future."
The pharmaceutical manufacturers present at the meeting were not so pessimistic. "I believe that it is necessary to focus attention on breakthrough molecules that we could bring to the global market," said Rahimjan Rosiev, Director of NPP Medbiopharm LLC. – Today, customers of active molecules and substances are primarily large pharmaceutical companies in the West, such as Pfizer or Novartis. They are ready to invest heavily in the search for new molecules, and are ready to cooperate with all research institutes that can offer new products. So we need to actively cooperate with our Western colleagues and, having found a market there, establish appropriate production in Russia."
Some participants of the round table also challenged the approach to solving the personnel problem proposed by the authors of the Strategy. According to the calculations of the developers, in order to launch innovative processes in the pharmaceutical industry, by 2015 it will be necessary to attract at least 4-5 thousand young scientists capable of understanding the technologies of modern drug development to the industry. And to do this, you need to invite at least 500 foreign specialists who will be able to form research groups and train young people to work at a level acceptable in the world's leading pharmaceutical companies. The budget is proposed to spend about a billion dollars only on training personnel and paying for invited specialists.
"Why should there be 500 invited, and not 480 or 520?" asked the representative of the Medical Academy. Sechenova Valery Bykov. – I think such a system is not very suitable for us. Our medical schools are able to cope with the training of highly qualified specialists themselves. For example, within the framework of the national project "Education", we have significantly improved the curriculum, allocated over a thousand hours (this is 5 semesters) to study pharmaceutical technology, including industrial production, along with biotechnology."
Good intentions and the road from the pitsThe development of an innovative drug can take up to 14 years, the costs reach a billion dollars.
At the same time, the risks for the investor are very high:
– only one of the ten molecules that showed activity at the preclinical stage, after passing all the tests, becomes a drug;
– only one of the three drugs that hit the market makes a profit that fully covers the development costs;
– the probability of creating a blockbuster (a drug that is super-successful from a commercial point of view) tends to zero at all. Last year, Pharmaceutical Research and Manufacturers of America counted only 112 blockbusters out of hundreds of thousands of drugs produced in the world.
Time, cost and risks are the main parameters that determine the features of the innovation process in the pharmaceutical industry, only very large companies by world standards can cover all its stages. There are no such manufacturers among Russian manufacturers, therefore, the issue of the distribution of investment risks between various participants in the process of developing and introducing new medicines becomes particularly relevant for us. It is obvious that in the current conditions, the state will also have to take on some of these risks and implement special mechanisms to support innovations in the industry.
According to the participants of the round table, there are no such mechanisms in Russia today. Private investors and venture funds usually consider those drug developments that have already passed the second or third stages of testing as a potential investment object, but the developer often simply does not have enough funds to bring the project to this level. "It is important to develop seed forms of financing in the pharmaceutical industry," Andrey Ivashchenko stressed. "The state should finance the development until the business is interested in it."
Many participants of the round table spoke about this gap (abyss, pit – different definitions were used). Inna Bilenkina, Deputy Head of the Federal Agency for Science and Innovation of the Russian Federation, was among the first to speak about the gap between the stages of innovative product development and production at the round table. In terms of the volume of state investments, the "Living Systems" direction occupies one of the leading places, second only to nanotechnology – 25% of the total funding under the Federal Target Program is allocated for research in this area. "We support the most interesting and promising developments," Inna Bilenkina stressed. – There is a good scientific foundation in the country, strong teams of scientists who could create both effective medicines and necessary medical equipment. The problem is that these developments are not yet very much in demand by business. So bridging the gap between fundamental science and industry, I think, is a top priority."
To solve it, according to scientists, it is not necessary to invent a bicycle, it is enough to follow the principle: "Roads are made where paths are trodden." "Historically, almost all the intellectual power of the country is concentrated in the public sector, in research institutes. We have practically no opportunities for interaction with business," said Alexander Ginzburg, Director of the N.F. Gamalei Research Institute of Epidemiology and Microbiology. – If the process of technology transfer is not legalized, then any talk about innovation is an empty phrase. All the research institutes that have survived to date have retained their human resources only at the expense of spin–off enterprises, these small companies exist at institutions, and for a long time - only without legal grounds, on the rights of tenants. It is necessary to approve that state institutions have their share in them. Only then will scientific developments be effectively implemented."
Finally, another gap in the innovation process is formed at the stage of the transfer of intellectual property rights. It is also not specific to the pharmaceutical industry, but it is here that the obstacles for developers and investors are the greatest. "Who owns the rights to developments created on the terms of co-financing with the state? – Andrey Ivashchenko raised the question. – If the rights are assigned to the developer, then innovative processes will be launched. If he received the rights jointly with the state, he will not be able to sell this patent, issue a license for it, or promote the commercialization of his products. What to do with this patent? Except to hang it on the wall."
Inna Bilenkina tried to object: "Rosnauka advocates that all rights to developments belong to the contractor. Unfortunately, this does not apply only to developments in the field of human health and defense. So the question here is not what the customer wants, but the legislation. Rosnauki does not have such levers to influence the situation."
It is not the first time that scientists have advocated the adjustment of the regulatory framework in the field of pharma, moreover, they emphasize the need for an integrated approach: the norms governing the circulation of medicines, including customs codes, laws on medicines, technical standards, and so on, should be changed. At the round table, Andrei Kokoshin, Deputy Chairman of the Committee on Science and High-Tech Technologies of the State Duma of the Russian Federation, responded to this request: "We are ready to accept all proposals from scientists to finalize the legislative framework, including in matters of intellectual property. I can make a commitment that they will be dealt with as closely as possible in the Duma. In addition, we are ready to raise the issue of creating divisions in the government that would seriously deal with the problems of the development of our pharmaceutical industry and biotechnologies in general."
Will there be any suggestions?In addition to criticism, specific proposals for the development of the pharmaceutical industry were also made at the round table (all of them will be included in the list of recommendations that the organizers of the round table will pass on to the developers of the Strategy).
For example, representatives of pharmaceutical companies urged to determine the priorities of development. It is obvious that Russian manufacturers will not be able to cover the entire front of medicines, so you need to choose 5-7 strategic directions, on which all attention will be focused, resources will be concentrated.
"The Ministry of Health requires a clear policy regarding those medicines that need to be developed and produced. For example, in Soviet times, our country held a leading position in the development of vaccines," recalled Dmitry Morozov, CEO of the Biocad company. – The epidemic of polyemielitis in Japan was stopped with the help of our vaccine. Now we have to import vaccines from abroad. Is it really impossible to cope with such a task, in general, feasible for us? After all, this is a matter of national security of the country."
Russian State Duma deputy Sergei Kolesnikov proposed to begin the revival of the corporate science sector, which was destroyed in the early 1990s. To do this, it is necessary to provide certain preferences and benefits to pharmaceutical companies, both Russian and foreign, who want to work in our market.
"It is also very important to create an expert community (possibly on the rights of a self–regulatory organization) that will determine the rules of the game when purchasing drugs and financing scientific developments," the State Duma representative stressed. – Moreover, it is simply unacceptable to create such a body under the Ministry. As a result, all this will come down not to a competition of ideas, but a competition of lobbyists close to those who distribute money."
All the discussions about the prospects for the development of the Russian pharmaceutical industry, one way or another, were reduced at the round table to the need to catch up with Western indicators. But as the developers of the Strategy themselves admit, the goals are set based on the linear development of the pharmaceutical industry until 2020, while a serious paradigm shift in the development of the pharmaceutical industry is expected in the world.
Firstly, Western companies are running out of patents for their blockbusters, there are no new ones coming out of development yet. Therefore, it is possible that the blockbuster model itself will change.
Generic firms from South-East Asia themselves began to develop innovative drugs, so new major players may appear on the market from among them.
Finally, personalized medicine is actively developing.
But there is still little talk about all these long-term trends in the expert community of the Russian pharmaceutical industry.
Portal "Eternal youth" www.vechnayamolodost.ru10.06.2008