The law "On the circulation of medicines" – for revision!

Open Letter
To the President of the Russian Federation Dmitry Anatolyevich Medvedev
from the Deputy Chairman of the Formulary Committee at the Presidium of the Russian Academy of Medical Sciences
Professor P.A. Vorobyov (published in Novaya Gazeta on 09.04.2010)

Dear Dmitry Anatolyevich,

On behalf of the Formulary Committee of the Russian Academy of Medical Sciences, I appeal to you with a request to suspend the approval of the Law "On the Circulation of Medicines" and return it for revision to the State Duma of the Russian Federation due to the absence of important provisions and norms in it, which will worsen the already difficult situation with the provision of medicines to citizens of the country. FC consistently tried to correct the text of the document at all stages of the passage of the law, doing this both by officially introducing amendments (more than 60) and by contacting the developers of the law through the press. None of the proposals were taken into account.

One of the most important provisions: there is no novel of rarely used drugs in the law. Currently, about 500 such drugs are registered in Europe and the USA, about 50 in our country, 17 are actually available to patients. This situation discriminates against a part of Russian citizens who cannot receive adequate treatment and either die (hereditary metabolic disorders, tumors) or become profoundly disabled (rheumatic diseases, blood diseases). Rarely used medicines in the world have special technologies for registration, research, logistics, their use is paid for at the expense of consolidated budgets of countries. The emergence of sustainable financing within the framework of the state target program will lead to the creation of domestic analogues (there are already examples of this – blood clotting factors, growth hormone, antitumor drugs) and will significantly – at times – reduce the cost of treatment. The draft Federal Target Program for Rare Medical Technologies, including the development of this sector of the domestic pharmaceutical industry, was developed by the Formulary Committee, approved by the Presidium of the Russian Academy of Medical Sciences and submitted in accordance with the established procedure to the Ministry of Energy in the fall of 2009. If the new law does not include the topic of rarely used drugs, further work on the program is likely to be fruitless.

The second novel is biotechnological preparations. This topic is closely related to rarely used drugs. Biotechnologies are sufficiently developed in our country and, as part of the implementation of innovative projects, could become a powerful impetus for the development of the domestic pharmaceutical industry. It is important that these drugs are recognized all over the world not as copies of the original ones. They are not subject to patent restrictions that do not allow the development of new tools before the expiration of patent rights. The adopted law restricts this direction of development of the domestic pharmaceutical industry for many years to come.

The most important omission of the law is the absence of a novel on the regulation of conflicts of interest of experts when making decisions in the field of circulation of medicines, ensuring transparency of decisions, reaching consensus. The law concerns a large number of legal entities that are in varying degrees of dependence on each other and these issues should be carefully regulated by law.

The law introduced a novel about biologically active additives and medicinal cosmetics. To date, these words have not been used in any law of the country: this is the vocabulary of marketers, not legislators. Parapharmaceutical products occupy from 40 to 70% of the turnover of pharmacies, but have nothing to do with ensuring health. Now doctors and paramedics can legally sell all this in their offices, along with pharmacies, this "muddy" flow will go through their hands directly to patients. The world does not know such provisions.

There is nothing in the law regarding the regulation of prescription and over-the-counter medicines, state guarantees of the availability of medicines for the population. There is no other law on medicines, these most important elements of the circulation of medicines will not be regulated with the adoption of the new law.

Deputy Chairman of the Formulary Committee
at the Presidium of the Russian Academy of Medical Sciences
Professor P.A. Vorobyov

Portal "Eternal youth" http://vechnayamolodost.ru 09.04.2010