Who is an expert?
The Commission of the Russian Academy of Sciences accused the Ministry of Health of concealing expert opinions on clinical trials of drugs. The claim with reference to FL-61 "On the circulation of medicines" states that the Ministry of Health is obliged to publish these data.
According to the representatives of the commission, the expert opinions contain information on the basis of which a decision is made on the effectiveness and safety of the medicine and, therefore, it should be publicly available.
The situation was commented on by the general director of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev: “the research results are the property of the company or the sponsor who orders these studies and falls under the law on trade secrets. Today, conducting clinical trials is quite financially expensive procedure and takes from a year to several years. Patent rights are often violated by competitors, generics enter the market which did not conduct these studies, but used the result of the “others” clinical trial, which we are talking about. Data on side effects of the drug, data that is necessary for the doctor and patient, is never hidden. This data is always open. ”
It turns out that the RAS commission on countering the falsification of scientific research questioned the competence of colleagues who conduct research on drugs and put their signatures in conclusion. As a rule, the main researchers are the opinion leaders in their fields, and quite often they are corresponding members and full members of the RAS.
This is not the first time we hear the far-fetched accusations of commission agents against the Ministry of Health. It is worth recalling the story when some representatives of the commission called homeopathy a pseudoscience, presenting this as the conclusion of the entire scientific community. As it turned out later, the commission did not consider this issue, while the colleagues had a diametrically opposite opinion.
“It is time to normatively consolidate not only the status of an expert, but also his responsibility for his conclusions. Today, everybody call themselves experts, even a caricature on the subject has appeared on the Internet. If in 1980, an expert was an experienced scientist, in 1990 - became his graduate student, in 2000 - a journalist of an industry publication, and in 2010 - a girl from Facebook. Is it necessary to respond in 2019 to instagram users calling themselves experts? ”, Victor Dmitriev emphasized.
Most supporters of the disclosure of a complete clinical trial dossier for pharmaceutical companies cite European experience. But in Europe, the ability to disclose information that is a trade secret is similar to the Russian one. Our legislation complies with international experience and international obligations.
Reference: procedure for state registration of drugs
The procedure for state registration of medicines is provided in Chapter 6 of the Federal Law "On the Circulation of Medicines".
State registration of medicines is carried out according to the results of the examination of medicines. An expert institution evaluates the quality of the drug and the ratio of the possible risks and benefits of the use of the drug based on the data submitted by the applicant.
The information on the medicinal product for medical use contained in the conclusions of the expert commission contains confidential information related to trade secrets (composition, production technology, control methods and others), and therefore cannot be provided to third parties without the consent of the drug developer .
Relations associated with the establishment, amendment and termination of the trade secret regime in relation to information that has real or potential commercial value due to its unknowingness to third parties are regulated by Federal Law of July 29, 2004 No. 98-FL “On Commercial Secret”.
Clause 1 of Part 1 of Article 27 of the Federal Law establishes that the authorized federal executive body places on its official website on the Internet the relevant conclusions of an expert commission.
The procedure for posting on the official website of the Ministry of Health of Russia information related to the state registration of medicines for medical use is approved by order of the Ministry of Health and Social Development of Russia dated August 26, 2010 No. 747n.
The provision provided for in paragraph 1 of Part 1 of Article 27 of the Federal Law was implemented through the placement by the Ministry of Health of Russia on its official website on the Internet of the conclusions of the examination of medicines on the page: http://grls.rosminzdrav.ru, and in order to protect confidential information to applicants personal entry into the appropriate database for registration of drugs on the official website is provided.
Clause 1 of Part 1 of Article 27 of the Federal Law does not contain a requirement to publish on its official website on the Internet the relevant conclusions for the general public.