Pharma 2020: neither catch up nor overtake
Lag strategyVladislav Dorofeev, Appendix to the newspaper "Kommersant" dated 17.05.2010
Published on the website "For beauty and health"
Oleg Medvedev, Professor, Head of the Department of Pharmacology of the Faculty of Fundamental Medicine of Lomonosov Moscow State University, believes that the idea of import substitution, which is very attractive from a bureaucratic point of view, raises many questions from a medical point of view, the main one of which is whether the quality of treatment of Russian patients will improve at the same time? Because in this situation, patients will have to use cheaper outdated drugs, generics.
– The "Strategy for the development of the pharmaceutical industry of the Russian Federation until 2020" declares the acceleration of import substitution.– The idea of import substitution is very attractive from a bureaucratic point of view, but it raises many questions from a medical point of view, the main one of which is whether the quality of treatment of Russian patients will improve at the same time?
The "Strategy for the development of the pharmaceutical industry of the Russian Federation until 2020" aims to increase the share of domestic manufacturers from the current 20% to 50% and increase the share of innovative medicines from domestic manufacturers from less than 5% (now) to 50% in 2020. The set goals are unattainable for the following reasons.
The creation of one new drug in the world now requires about $ 1 billion. The costs of leading pharmaceutical companies for scientific and technological research (R&D) amount to several billion dollars each for the development of new drugs. Now, according to the data provided in the document "Strategy for the development of the pharmaceutical industry of the Russian Federation until 2020", Russian firms spend a ridiculous $50 million a year on R&D. It is assumed that by 2020 the industry will be able to allocate about $1 billion for R&D. Obviously, at world prices, this will allow us to create (at best) one new world-class drug.
In addition, now there is not a single company in Russia that is able to create a drug from scratch and bring it to the international market. Taking into account the fact that the full cycle of creation of the drug is from 10 to 15 years, it is obvious that it is absolutely impossible to achieve 50% of the production of domestic innovative drugs by 2020.
Finally, it is a mistake to think of pharmaceuticals as an ordinary conveyor for the high-quality production of consumer goods. The creation of a new original drug is based on a high level of fundamental research in the field of biology and medicine. Without a radical improvement in the situation in Russian science, it is impossible to set a goal to reach the level of 50% of innovative domestic drugs by 2020.
It should be emphasized that the creation of new pharmaceutical industries, the development of new technologies, the compliance of factories with GMP (good manufacturing practice) requirements is a necessary, but insufficient condition for avoiding imported drug dependence.
Therefore, the main emphasis of the published document is on the release of generics (generics), that is, drugs that are obsolete, for which patent protection has expired. These are drugs created more than 20 years ago. The emphasis on generics leaves us behind in world medicine for at least 20 years. I'm afraid that as presented, this strategy is a planned backlog program.
– What is the optimal share of imported medicines on the market?– I believe that such a statement of the question is wrong.
It's like asking about the optimal share of foreign cars in the car market. It is necessary not to establish in advance the optimal percentage of imported medicines, but to assess what percentage of domestic drugs are able to compete with imported ones in terms of effectiveness, safety, ease of use, etc., that is, according to their consumer, pharmacological properties. Unfortunately, the situation in Russian science, in the pharmaceutical industry, in conditions for business development, the huge pressure of bureaucratic structures, the inflexibility and clumsiness of procurement systems for scientific equipment and reagents, laboratory animals and many other things that are necessary for scientific research, the problems created by the customs services leave little chance to achieve the declared goals.
I have extensive experience working in scientific laboratories of Western pharmaceutical companies and universities. If I have funds on the grant, I can order a reagent or equipment and tomorrow I start working with it. It seems like an unattainable fairy tale in Russia.
– How can you explain that it is in the state programs for the purchase of medicines that the share of Russian medicines is less than in pharmacy chains?– A large share of imported drugs in state programs improves the quality of treatment of Russian patients.
This is a positive consequence. Sometimes the press explains this fact by corruption of officials. But I can't blame anyone for this, since I don't have any evidence. I think it would be good to publish the results of randomized controlled trials (the methodology that gives the most reliable results) when comparing the clinical efficacy of domestic and foreign drugs with a similar mechanism of action and indications for use. It is such studies that are the basis of "evidence-based medicine", which underlies the decision-making on the inclusion of a particular drug in the group of vital ones, justifies the choice of drugs for public procurement. Unfortunately, in Russia it is not accepted to objectively justify certain decisions of state bodies.
– One of the significant, but not always discussed obstacles to import substitution is the distrust not only of patients, but also, most importantly, of doctors to the quality of domestic medicines.– Distrust of domestic drugs is part of the general distrust of domestic medicine.
This is facilitated by both the mass media and the behavior of many representatives of the political and business elite, government authorities and even the Orthodox Church who are being treated abroad. The layman naturally gets the impression that Russian medicine, Russian drugs are not as effective and safe as their foreign counterparts. Does this mean that all Russian drugs are significantly worse than their foreign counterparts? Of course not. First of all, because most of the drugs produced in Russia are made from foreign substances.
– Maybe you are skeptical about the very idea of import substitution?– I am really skeptical about the installation of import substitution of medicines.
With the appearance of new domestic drugs that will compete on an equal footing with the best drugs of Western firms, their number will determine the percentage of import substitution. An objective criterion for the creation of such drugs will be their appearance not only in pharmacies in Russia, but also abroad of our homeland. There is a complete analogy with the automotive industry.
What is the percentage of import substitution in the automotive industry? Using an administrative resource, customs duties on imports, etc., you can set any percentage of import substitution. But will our citizens drive good and safe cars at the same time? The answer is obvious. Why, when it comes to medicines, does such an answer require additional evidence?Portal "Eternal youth" http://vechnayamolodost.ru