Pharma 2020: problems and prospects

The significance of the PHARMA 2020 Strategy
STRF.ru

President Dmitry Medvedev, noting the importance of the development of the domestic pharmaceutical industry, acknowledged that there is no holistic strategy in the development, testing, production of medicines and their use in medicine. Why this situation has developed, read in an analytical article prepared by our journalists.

What are the main arguments in favor of the intensive development of the domestic pharmaceutical industry? In our opinion, all their diversity boils down to four main ones.

1. National securityFrom the point of view of most experts, one of the most compelling arguments is ensuring national security.

First of all, we are talking about the uninterrupted supply of ready-made medicines (GLS) to the population of the country in case of any critical situations. This is a really serious theoretical premise, but it must be borne in mind that at the level of the simplest medicines, our pharmaceutical industry will be able to provide the population of the country in any situation. According to statistics and according to surveys conducted by the publication STRF.ru According to a number of leading clinics, the share of Russian drugs in the nomenclature of medicines reaches about 70 percent. Yes, there are almost no Russian drugs among the newest, innovative GLS, but this is not a determining factor in the case of natural or military disasters. Another thing is that national security issues have not so much a military-political context as an economic one. Import substitution, especially in conditions of currency instability, is an obvious priority of the state social policy, as it directly affects the basic constitutional values.

The global pharmaceutical industry ranks second in terms of investment in research and development. This conclusion is contained in the analytical review "R&D Scoreboard 2006" prepared by the Ministry of Trade and Industry of Great Britain, which provides information on 800 English and 1,250 global companies that invest most in R&D. Pharmaceutical companies took a step between hardware manufacturers (technology hardware, first place) and automakers (third place), and software companies were in fifth place.

2. Development of high technologies and economyThe pharmaceutical industry is considered one of the most high-tech.

Consequently, its development, at least, should be given serious attention to the implementation of state policy to change the structure of the Russian economy, shifting it from raw materials to high-tech industries. The economic indicators of the Russian pharmaceutical market – the volume, dynamics, and availability of stable demand - give grounds for increased attention of the state. Despite the fact that these indicators are achieved by a small number of employees employed in the industry (65-70 thousand). The strength of any high-tech industry is that its competitive development significantly stimulates scientific research. The innovations provided by the pharmaceutical industry are the result of the achievements of biological and medical sciences. But not only that. The development of pharmaceuticals contributes to the development of chemistry, physics, mathematics, etc. Which, in turn, provides educational institutions with additional demand for the production of highly qualified specialists. Thus, it can be argued that a strong pharmaceutical industry provides demand for the results of research and development of academic and industry scientific organizations, and also contributes to the growth of economic employment. On the one hand, pharmaceutical enterprises receive an order from medicine for the production of certain drugs, receive information about ongoing developments, on the other hand, companies themselves push these developments and formulate an order to scientists, offer new ideas. Thus, they influence both fundamental research and applied development.

At all stages of the innovation chain – from scientific research to technology development and production itself – a well-educated workforce with modern technologies is needed.

3. Improving the quality of life of the population

On a national scale, the pharmaceutical industry acts as an intermediary implementing a number of social functions aimed at improving the quality and life expectancy of the population of the Russian Federation. Of course, these functions cannot be fully implemented when we do not have the technology, we do not have the creative force that encourages us to conduct more and more research. Without creating and using high technologies, without owning a sufficient number of them, without owning the infrastructure for the constant reproduction of innovations in this area, it is impossible to achieve a serious improvement in the quality of medical care. Yes, scientific research will be conducted in Russia, new knowledge will appear, but the dominance of imported innovations cuts off the way to the development of infrastructure for the production of new drugs and the development of new methods of treating people. The lack of a connecting link – a full–fledged pharmaceutical industry - determines the poor quality of medical care, the lack of demand for entire fields of science. Of course, we can repeat and use the best practices available abroad. But we will not be able to work legally with the best of them: we get what they sell us, what has already been "in circulation" abroad. In other words, Russian citizens are doomed to "second-class" medicine.

4. Entering the international pharmaceutical and biotechnological marketIn recent years, Russia has lost almost all of its positions in the international market of pharmaceutical and biotechnological products.

The restoration of presence in such a market is another significant step from the "raw materials economy" to a qualitatively different participation in the international division of labor.

Key issues to discussWhat is the draft strategy "Pharma 2020"?

If we do not focus on the details, then we have an industry strategy aimed at supporting Russian pharmaceutical companies ("Russian pharmaceutical companies" means enterprises of any organizational and legal form that provide a full cycle of drug production in Russia). Pharma 2020 was built taking into account the prospects of the growing market of the domestic pharmaceutical industry, and the expediency of investing state resources in its development was evaluated accordingly. The authors of the strategy state that its main goal is to create conditions for the "transition to an innovative development model" of the Russian pharmaceutical industry, but at the same time they schematically designate both mechanisms and tools that ensure such a transition. This is not surprising, since it was an industry-type strategy that was created in conditions when it is impossible to ensure interdepartmental coordination and coordination of various industry approaches in practice.

In fact, the strategy does not affect the "borderline" issues in any way: medical care of the population, other programs for the development of science and technology, new legal relations arising from the interaction of science, business and production.

What are the key points on which attention needs to be focused and which will prove decisive for success or failure in the implementation of the strategy?

1. Lack of development of mechanisms of state financing of innovationsThe innovative component (namely, we intend to pay special attention to it within the framework of this collection) is key in the formation of a full–fledged pharmaceutical industry.

Are there funds for this?

Significant financial resources that could be used to support pharmaceuticals are concentrated within the framework of the priority direction "Living Systems" of the federal target program "Research and Development ... for 2007-2012" (customers are the Ministry of Education and Science and Rosnauka), where there are projects related to the production and development of new medicines. Scientists submit applications for original works, the results of which are not only not inferior, but often surpass foreign analogues. However, the peculiarities of state legal regulation lead to the fact that financial state support for bio-pharmaceuticals works occurs with violations.

The task of this Federal Target Program is to finance those developments that will be put on the market in a fairly short (three to four years) period. During this time, it is impossible to create a new drug, at best it is possible to "bring" a new drug to the stage of preclinical trials. But the Federal Target Program alone will not be enough for this stage, and the Ministry of Health and Social Development of the Russian Federation, theoretically being the ultimate beneficiary, is neither a coordinating nor a financing party. In this regard, it is very important to improve the regulatory framework governing this and related areas, up to the level of interdepartmental procedures.

In the process of creating innovative drugs and substances, there are critical areas recognized by all market participants, where it is impossible to attract non-state financing. Science and business demonstrate their readiness to switch to an innovative development model – both sides are interested in establishing high-quality and effective cooperation in the field of drug development. The only question is how to minimize the risks. In many countries, it is the state that plays a significant role in financing the early stages of research for pharmaceutical manufacturers. And if Russia aims to modernize the sectoral structure of the economy, the state should be ready to actively finance fundamental research and applied developments in the field of creating new medicines.

Effective research groups are mainly concentrated in academic institutes (RAS and RAMS), universities and the most powerful industry universities. These groups choose the most interesting research topics from their point of view, following the "mainstream" directions set by the world scientific periodicals. The domestic pharmaceutical business, if it is ready to innovate, is at a fairly low scientific level, mainly limited to the search for so-called odnoklassniki molecules for the development of technologies for creating high-quality analogues (improving generic drugs). The Russian pharmaceutical business is not ready, cannot afford to spend money and time on the development of innovative drugs.

Thus, there is a significant potential for the development of science-business cooperation. Firstly, it must be recognized that with the exception of a dozen organizations, there are no branch institutes in the country specializing in pharmacology and maintaining an acceptable level of research activity. Secondly, a significant number of academic and university specialized research groups cannot compete in the field of exploratory scientific research at the world level, but they can quite perform applied research in which business is interested. The question is to create conditions for the organization of such cooperation.

2. Lack of quality regulation stimulating the development of this industryIf you look at the situation "as a whole", then there are no problems in the dynamics of the last five years at all.

There is obviously a significant increase in the financing of academic science, including budgetary scientific funds, specialized departmental and federal target programs. A number of State development institutions have been established. Programs for small innovative businesses have been launched. The relevant federal legislation has been substantially revised in the direction of improvement. Nevertheless, the situation with the effectiveness of research and development is changing extremely slowly. The results in this case are understood to be the commercialization of R&D. This is especially true for areas related to pharmacology. The state is not ready to transfer to business the results of the work carried out at the expense of budget financing, is not ready to assist in the development of specialized high-tech business without dictating the rules of the game at all stages. The state has fallen into the trap of public administration reform, which has resulted in a set of competing departmental programs with an unimaginable number of criteria and regulations, including inspections. All this has led to the fact that due to the lack of agreement between the departments in the details of the implementation of the stated policy, moreover, sometimes in understanding the essence of the policy itself, all the documents necessary for the effective implementation of this policy - by–laws, instructions, etc. – are very vague and contradictory. If this problem is not resolved now, then all further steps and programs for the development of the innovative component of the pharmaceutical industry will be ineffective.

The interaction of the Ministry of Health and Social Development with other departments and players of the pharmaceutical market is still insufficiently established. The development of the pharmaceutical industry according to the innovative scenario should be based on the entire innovation chain – from scientific developments to the distribution of the received medicines. Therefore, without a detailed study of the mechanisms of interaction with departments and relevant state institutions, this strategy is unlikely to be full-fledged.

Now there are very active and quite effective negotiations between two key departments for the development of the domestic pharmaceutical industry (especially at its first stage) – the Ministry of Industry and Trade and the Ministry of Health and Social Development. The first is responsible for this industry as such, the second is a determining player in the pharmaceutical market, in particular: a) regulates legal aspects for most parameters of the process of production and distribution of medicines; b) has subordinate industry organizations participating in this market; c) is one of the main buyers in the market of medicines.

For a long time, the policy of the Ministry of Health and Social Development did not contribute to the development of the domestic pharmaceutical industry. If sound decisions were made at the highest level, then they did not always end with effective implementation at the level of performers. The possibilities of our bureaucratic apparatus to "wrap up" the issue and ensure the safety of a convenient model for themselves were truly fantastic. In the current conditions of a tough economic situation, such games may not take place. Moreover, now, with the change of the leadership of the Ministry of Health and Social Development, the policy of this department has finally begun to change, and quite concrete steps have been proposed to stimulate the domestic drug market. And there is reason to believe that their implementation will provide a solution to the task.

3. Ambiguity in matters of intellectual property protectionThe second problem that significantly complicates the creation of Russian medicines is the imperfection of the legislative regulation of the distribution of property rights to the results of the activities of developers and manufacturers of drugs.

The processes of transferring rights to developments created with the participation of state funding are extremely complex. Their mechanism is sometimes useless: there are no specific, well-structured procedures at the level of by-laws and departmental instructions; each participant in joint work can interpret the mechanisms for the implementation of these laws in his own way. The inspection bodies, in particular, the Prosecutor's Office, have their own interpretation of these legal foundations. For example, it turned out that the Federal Agency for Science and Innovation violates the law, according to which, when using the results of work together, there should also be their joint patenting. Only the terms of joint patenting are not legally defined, and it is not surprising that in conditions of legal uncertainty, joint work with scientists becomes uninteresting for business.

The complicated situation with copyrights is fraught with very high risks for foreign companies, it is easier for them to negotiate with a scientist who will reproduce their results abroad. To put it simply, buy one or two heads and get the result, so that later these studies can be brought to their logical conclusion in understandable conditions – either at an enterprise, or in a research institute, or in small research companies.

4. Lack of national priorities for the development of medicine and pharmaceuticalsThis is one of the key problems, without solving which development will occur "blindly".

Investment and technological cycles in the pharmaceutical industry are quite large, and business owners want to be sure that a particular drug, the creation and market launch of which has spent a lot of effort, will not be unclaimed.

The development of a system of priorities – in other words, the approval of those main areas of medicine for which innovative drugs are needed – is the task without which effective and reliable development of the pharmaceutical industry is impossible or extremely difficult. Whether these priorities lie in the fight against cancer, cardiovascular, infectious or other diseases is a question that can and should be answered right now, taking into account Russian realities, the opinions of scientists and clinicians.

The development of priorities, of course, is not limited to the list of groups of diseases that need to be fought in the first place. It is equally important – especially for high–tech biopharmacology - to establish priorities in the field of creating multifunctional techniques and universal platforms for the development and creation of new molecules, substances and drugs, whether it is the development of recombinant proteins or the development of targeted drug delivery techniques in the human body.

Thanks to the DLO and public procurement system, the Ministry of Health and Social Development is currently one of the main buyers in this market. This department, in fact, affects a large part of this market, without a clear policy of the Ministry of Health, as a player and buyer, nothing much will change in domestic pharma.

In this collection, we intend to cover all the listed problems in as much detail as possible and give an opportunity to express our point of view to those who are already involved in the creation of modern drugs, technologies and enterprises in the biotechnological and pharmaceutical fields with their own hands and intellect.

Appendix: "PHARMA-2020. Problems and prospects" (pdf, 130 pages, 1.3 Mb)

contentintroduction

business

Biopharma:
how to overcome the "valley of death" between research and implementation?
Andrey IVASHCHENKO: "The level of pharmaceutical development is an indicator of the innovativeness of the entire economy of the state"
The concept of innovative development of the domestic pharmaceutical industry
Recipes for Russian pharma
Lev DENISOV: "The applied significance of work in the pharmaceutical industry changes the nature of specialists"
Oleg MIKHAILOV: "The first steps require not money, but political will"
Andrey MALYANTSEV: "The Ministry of Health does not deal with the health of citizens"
Veniamin MUNBLIT: "The pharmaceutical industry does not need a strategy. We need quality management"

SCIENCE AND MEDICINE
Alexander BELYAVSKY: "It would be ideal if academic institutions were allowed to form their own small enterprises"
Fazoil ATAULLAKHANOV: "Our method of assessing the state of the blood coagulation system in the future should be used by every laboratory of hemostasis analysis"
Alexander GABIBOV: "Doctors should set tasks for pharma"
Vladimir MAKAROV: "I regularly ask the management to increase the number of bids for young researchers"
Anatoly MIROSHNIKOV: "I can't believe that the long-term gap will be overcome before 2020"
Nikolay BOVIN: "Glycochips can make a revolution in pharma"
Alexander ARSENYEV: "The platform is ready, but we didn't have time to finish a number of components"
Boris MARGULIS: "There is no closeness and mutual understanding between science and business"
Nikolai NIFANTIEV: "The future of pharma is behind carbohydrates"
Yuri NEKRASOV: "It is dangerous to invest money in science today"
Alexander SOBOLEV: "Our project is a penny – only 300 thousand rubles a year"
Evgeny SVERDLOV: "Who will get medicines from the shelf?"
Valery CHARUSHIN: "The pharmaceutical industry will not develop without the participation of the state"
EXPERT OPINION. Problems of Russian pharma: an inside Look
Andrey POKROVSKY: "Gene therapy needs an appropriate legal framework"
Arseniy KAPRELYANTS: "The effectiveness of modern vaccines leaves much to be desired"
Dmitry PYSHNY: "We consider our developments patentable and try to promote them"
Evgeny RYZHIKOV: "Epitope technology allows both to treat and diagnose"
AIDS can be effectively combated – only the will of the state is needed
Georgy GURSKY: "Antiviral drugs should always be "at hand" in the country"
Ivan RAZUMOV: "We did not reach the negotiating table with pharma"
Valery LIPKIN: "Cooperation in conducting clinical tests is beneficial for both scientists and pharma"
Protection of neuroprotectors!
Sergey BACHURIN: "Pharma 2020 needs a coordinating body"
Yuri BUBNOV: "Some scientists are ready to give their developments for free"
Alexander MARTYNOV: "Neither the patent nor other documents that are issued today protect anyone"
Dmitry CHUDAKOV: "Fluorescent proteins are widely used in the development of pharmaceuticals"
Yuri LEBEDEV: "The most important thing for us is the implementation of the result"
Valentin VLASOV: "We are not 10 times behind, but much more"
Evgeny GRISHIN: "The development of a new drug costs half a billion dollars"
Vladimir DEMKIN: "While we spin on our own"
Andrey KUSKOV: "When communicating with production workers, it did not go beyond interest"

PRESSIntellectual property of scientific organizations and the problem of its ownership

How to develop an innovative medicine in one year?
Sow culture
The price of progress

conclusion: The next necessary actions to detail the strategy

Portal "Eternal youth" http://vechnayamolodost.ru01.09.2009