Pharmaceutical production in Russia: wash the old ones or make new ones?
We will conduct an audit of old medicinesMarina Muravyeva, STRF.ru
To increase the share of domestic drugs in the Russian market from 20 to 50 percent in 10 years is the goal set in the Pharma 2020 strategy, akin to the construction of communism.
You can only believe in it and try to do something. And by the way, the results can be quite good. Building communism, we raised heavy industry, virgin soil, flew into space.
To the questions STRF.ru Andrey Lisitsa, Deputy Director of the V.N. Orekhovich Institute of Biomedical Chemistry of the Russian Academy of Medical Sciences, laureate of the Russian Federation Government Prize in Science and Technology for Young Scientists (2004), Candidate of Biological Sciences, answers.
How do you assess the prospects for the development of the pharmaceutical industry in Russia? What could be the key problems?– At the moment, the state of the pharmaceutical industry is such that the possibility of its reincarnation has either already been missed, or it is about to happen.
The system of departmental institutes in which medicines were developed was practically self-destructed. The N.N. Semenov Research Institute of Chemical Physics of the Russian Academy of Sciences is a vivid example of the remnants of this kind of infrastructure. The development of a drug, first of all, rests on the availability of infrastructure. In the field of medicines, there cannot be a lone inventor who somewhere in the garage will create something commensurate in importance with Google. In the IT sphere, it is possible to break into the leaders in this way, and in medicines - it is unlikely that anyone will succeed. Medicine is conservative, a lot of tests are required. At different stages – from the development of a prototype to the creation of a ready–made drug - a huge number of people are involved.
Now it is extremely important to unite all the teams that are engaged in drug development in Russia. The "National Biological Screening Network" project initiated by a number of leading organizations in this field is of particular interest as an attempt at consolidation. It is necessary to analyze the existing potential, taking into account not only mega-projects, but also small research projects. If this work is not done, then in the absence of infrastructure, talk about the restoration of the pharmaceutical industry is extremely doubtful. And in five years it will be just ridiculous to talk about it.
Some experts say that in Russia, scientific research for the pharmaceutical industry has never developed in principle, and therefore everything was limited to the production of generics. In your opinion, what is the scientific potential in this area?– I would not be so categorical in my assessments.
If we compare it with such giants of the pharmaceutical industry as Hoffman, then we can say that nothing is being done in our country at all. I am skeptical about the prospects of creating fundamentally new medicines in Russia. These may be isolated cases when Russian teams are able to achieve some result as a result of a twenty-year backlog.
In my opinion, it would be wise to focus on developing new ways of drug delivery. That is, in this case, we are not talking about the development of drugs, their testing. We attach a different function to a well-known medicine. Ideally, a new application. In another (also quite possible) – this is an increase in the effectiveness of the drug due to the fact that it is delivered to the lesion, kills the virus in a more targeted way. Perhaps these are some combinations of drugs that affect several targets, and due to this a certain effect is achieved.
That is, there is no need to invent new things, because there is not enough strength – it is worth concentrating on the revision of the old, and among the already known medicines to find some new patent-suitable properties, and thereby expand the market. This is a format of innovation, which, it seems to me, will be available for Russia if there is an appropriate infrastructure. And if this idea generation infrastructure is launched. By the way, this is also a fairly wide field. And in this case, it also concerns a fairly high level of innovation, requiring post-genomic technologies. This is high-tech.
If we talk about generics, then, in principle, I don't see anything wrong with them. Just do not allow R&D money to be spent on them. When they argue that supposedly we are so far behind that the state needs to allocate additional funds to the industry in this direction, it sounds stupid. But the fact that the business is modernizing production (or building new plants for generics) is a good trend. This is how management experience accumulates. We know how to produce generics. However, I am not sure that these productions can be reoriented to innovative ones in the future. It's easier to build new ones – for a new medicine.
The Pharma 2020 strategy aims to increase the share of domestic drugs in the Russian market from 20 to 50 percent in 10 years. Do you think it is achievable? What needs to be done for this?– I don't see a logical chain that leads to such a forecast.
Therefore, I cannot dispute it or agree with it. This is goal setting. In this case, you can only believe and jerk to achieve the result. Therefore, comments here are meaningless. If someone came to this conclusion by reasoning, one could say: everything looks convincing here, or - you were wrong. But since this goal was simply set as the one that sounded – "to build communism" – it is not worse than her. Building communism, we raised all heavy industry, virgin land, hydroelectric power plants, and flew into space. We did not build communism, but a huge amount of work was done in parallel, a lot of good things were achieved.
It's the same in pharma: a certain goal has been set so that people can see a landmark – what, in fact, they need to strive for. I believe that something will be done in this area. Maybe I'm naive. But I see that people are still working, some projects are coming from the Ministry of Industry and Trade, they are being reviewed, they are trying to find a grain of common sense against the background of all this conjuncture and the system of relations between academics. I am observing a certain trend towards trying to do something. From this point of view, the goal of 50 percent of the market for domestic production is not bad. Although many will say that it is completely unrealistic.
If there is a scientific reserve in Russia, if we focus on some new tasks - for example, a new drug delivery, in which case will Russian pharmaceutical manufacturers be interested in introducing these developments? Will you be able to reach them?– I think so, but on condition that the Russian pharmaceutical manufacturer is provided with a patent-clean situation, that is, to explain that the development was not done with public money, that the state does not claim it.
If you show a business partner a pilot industrial site, demonstrate a sealed package, a beautiful design of the drug and a test report that has passed through the Ministry of Health and Social Development, it will attract his attention. A pharmaceutical manufacturer will remain indifferent if a scientist comes with a prototype of a drug, with ideas about what it could be, with stories that something unusual happened to him on mice…
How can it be brought to such a stage of readiness without the support of the state, business? Scientists themselves probably won't be able to achieve this. First we need to find some investors…– There are venture funds, the Ministry of Industry and Trade.
The state must deal with the rights. It seems to be coming to this. If the rights belong to the performer, then it is quite possible to imagine a consortium of such persons, which includes commercial structures, the affiliation of performers to them is broadcast, and then an object of intellectual property arises for budget money, but free from state participation. If the contract states that the rights belong to (including) In the Russian Federation, then business will run like hell from incense. Every self-respecting investor will ask some analytical company beforehand to find out the prospects of development. People will look for the roots of where the money came from, allowing them to achieve such a result, as far as these funds are free from further obligations to the state, and therefore from uncontrolled manipulation. It's all being solved. Even within the framework of existing legislation – albeit with a creak, when responsibility is transferred to the head of the institution, and he must get out of it. And if you change the position a little bit here, loosen the reins a little more, everything will be fine.
By the way, about the legislation. How do you assess the regulatory framework in this area?– She is in the embryonic stage.
Whichever of the laws regulating this sphere, take it – it is from the experience of its application, simply because it arose recently (in new conditions), is rudimentary. It does not work, has not acquired the necessary by-laws, creates and contains elements lobbied by structures that pursue their goals. But nothing can be done. For a person to grow up, time must pass. I am not an expert in law, but it seems to me that no one can immediately write an ideal law regulating an entire sphere of relationships. The problem is that while a strong legislative framework is being created, we may lose the remaining infrastructure. This is the main thing: to assemble the infrastructure, to force scientists to do at least something together and achieve some significant results.
Is it possible to do this by some kind of programs?
- Yes. The program-target method is the most optimal in this regard. This should be a federal target program, but not in the "Research and Development" format, where point-based research is supported by a wide front. First, it is necessary to draw up a "roadmap" of developments, after that – the Federal Target Program, which not only determines the amount of funding, but specifically gives the topics and dynamics of their deployment over time. Indicators should not be formalized in order to simply calculate profits, but more close to reality.
One of the key problems is the lack of competent managers in this area. In our country, even if five institutions come together, they are equal on a parity basis, it will be difficult for them to obey some single governing center that would have a hard impact on them. This can greatly complicate the implementation of measures of such a scale as the Federal Target Program, where we are talking about the formation of a state scientific and technical policy (in the absence of strict management, already in fact, when the group receives money). Probably, this can be replaced to one degree or another with a strategy or a "road map" so that there are no different families.
Therefore, first I would like to see the "road map" – how people imagine the further course of development. Suppose the Ministry of Industry and Trade creates a national network of biotechnological screening, then certain centers will use it to produce such and such medicines (it is unlikely that those people who create the network do not see potential users). If consumers confirm this, then there will be the next stage. The federal target program should probably combine the stages from finding a prototype to clinical trials. From the very beginning, you need to assume where to get the money for the latter. That's what I mean by the development roadmap.
Portal "Eternal youth" http://vechnayamolodost.ru02.06.2010