What hinders the development of the St. Petersburg pharmaceutical cluster?
Pills with bitterness
Anna Romanova, Rossiyskaya Gazeta – Economy of the North-West No. 82-2013
The creation of a medical cluster in St. Petersburg was announced in 2009, and the project was fully promised to be implemented in 2014. Since then, the successes and prospects of this undertaking have been reported annually, but there are so many pitfalls in pharmaceuticals that one association of manufacturers in a cluster cannot solve them. The correspondent of "RG" tried to find out what problems remained relevant for pharmaceutical industries during the years of the formation of the St. Petersburg cluster.
With good intentionsExperts agree that it is impossible to achieve the development of domestic pharmaceutical industries and give life to scientific developments without the participation of the state.
Therefore, when the cluster model of industry development was supported at the state level, it was perceived as good news.
– If the cluster is created correctly, it is a very effective model, it is followed by many countries of the world, – said the head of the Association of Russian Pharmaceutical Manufacturers Viktor Dmitriev. – This system is important because any business community has chances for multiple benefits under this system – tax, rental. Business can count on support from the authorities in terms of attracting labor, scientists, educational programs for future specialists.
However, the participants of pharmaceutical clusters in St. Petersburg and other regions complain: since the announcement of several cluster projects, problems are being solved very slowly. Manufacturers are still waiting for changes in laws, adaptation to international standards, timely engineering training, and a system for the supply of qualified personnel.
The St. Petersburg cluster promisesIt was assumed that in 2014 the company "Pharmasynthesis" will implement on the basis of the St. Petersburg pharmaceutical cluster its unique investment project of a research and production complex for the production of antitumor drugs, with an investment volume of more than two billion rubles.
However , the company 's president Vikram Punia stated: during the preparation of the project, we had to face a lot of bureaucratic problems, although it is possible that we will still be able to meet the promised deadlines. Last year, this company, like several others, encountered an unpleasant surprise during the implementation of a cluster project – an unprepared infrastructure. Then it became known that residents of the SEZ "Novoorlovskaya" could not "enter" the territory on time with full rights and use all the necessary preferences – the engineering part was not ready. And this is fraught with a loss of money: projects become more expensive in the waiting process, since the presence in the SEZ without preferences is unprofitable. The authorities assured that these were technical delays, and they were not catastrophic.
Experts emphasize that all cluster attempts do not make sense without a parallel adjustment of the legislative framework. For example, the creation of the St. Petersburg and other Russian pharmaceutical clusters was announced several years ago, and the upcoming accession to the WTO was known in advance. However, the issue of bringing documents to international standards, the problem of certification of our production facilities according to GMP quality standards, has only now been discussed, unlike in Ukraine, where they did the opposite, and now the cluster participants are there in more comfortable conditions.
The issue of personnel for promising clusters also remains relevant. As Viktor Dmitriev explained, so far most of the Russian market is generic drugs. To work on the creation of new drugs, scientists and professionals are needed to promote products to the market. And, according to business representatives, there has been almost no progress in this area over the years of the cluster's creation, although personnel programs for clusters are constantly being talked about.
– The cluster approach requires not just the presence of a manufacturer, but also the training of specialists focused on working according to such a scheme, – Dmitry Boldov, General Director of Marbiopharm, told the correspondent of RG. – In order for the pharmaceutical business to somehow survive in modern conditions, it is necessary to provide it with ready-made qualified specialists, who are now almost impossible to find on the market. We need to take them still "small" and grow them into "big" professionals who are needed. This is given by close cooperation with universities. At the same time, the manufacturer thinks one thing, and medical institutions with daily practice of using medicines have a completely different vision of the tasks of pharmaceutical production. Starting from the training of specialists and ending with practicing doctors, it is necessary to build a scheme of the entire chain of treatment with the manufactured medicine. We have to consider the issue of cooperation within the framework of contracts with hospitals and universities separately, and this requires many years of work.
The businessman also stressed that in order to bring any medicinal product to the market in the country, even an existing and registered one, a huge amount of time is needed for numerous procedures. What can we say about an innovative cluster product if standard processes are so delayed.
Before it's too lateFor the further development of the domestic pharmaceutical market, many regulatory legal acts need to be improved, and first of all, the authorities took up the "Law on the Circulation of Medicines".
However, after reviewing the draft amendments, the participants of the profile clusters stated, giving evidence that these changes would lead to the opposite result, and proposed to finalize them. In February of this year, the Union of Pharmaceutical and Biomedical Clusters addressed its problems to the Deputy Prime Minister of Russia Olga Golodets.
According to representatives of the St. Petersburg, Kaluga and Moscow region "Northern" clusters of pharmacology, all the proposed changes completely negate efforts to improve the system of drug provision in the country. The bill not only does not eliminate regulatory barriers previously recognized as excessive, but also introduces a number of new restrictions that will further strengthen the positions of foreign manufacturers in the Russian pharmaceutical market.
Pharmacists are also afraid of many points of the new amendments. For example, fixing the impossibility of interchangeability of biological medicines will lead to limited competition, exclude import substitution of strategically important drugs. The restriction of the interchangeability of medicines will also have a negative impact on competition – according to the new proposals, the indications for use and the dosage form of original and reproduced medicines (generics) should be completely identical. If the original has a patent, they will no longer be able to reproduce it one-on-one for import substitution in the cluster. It is also supposed to limit the number of reproduced drugs registered under the accelerated procedure. This privilege is offered only to the first of the registered reproducible drugs, despite the fact that all subsequent generics are cheaper for the consumer. Cluster members fear that this will lead to a stable overestimation of prices in the market. In addition, there are other problems: the complication and delay of the procedure for obtaining a permit for a clinical trial, excessive regulatory barriers, the preservation of the monopoly right to conduct examinations.
Portal "Eternal youth" http://vechnayamolodost.ru17.04.2013