The government has proposed to cancel data protection of clinical trials of medicines. To lift the ban on the free use clinical studies of new drugs in September of this year instructed the Ministry of health, the Ministry of industry and trade and the Ministry of education, Deputy Prime Minister Arkady Dvorkovich (a copy of the order is at). The health Ministry has placed the bill on the portal of projects of normative acts regulation.gov.ru Thursday, October 27. A public discussion document which the developer took two months — until December 29. The representative Dvorkovich and the Ministry of health did not respond to a request.
The initiative of the government will allow the pharmaceutical companies that produce drugs-generics, similar in composition and properties of already existing drugs, to have unimpeded access to the research of original products. It is much cheaper and will accelerate the bringing to market of generics, explained project Manager pharmaceutical company Vegas Lex Maria Borzova. The bill of the Ministry of health, in her opinion, is a form of support of domestic pharmaceutical companies specializing in the sale of analogues of foreign drugs.
Clinical research of drugs is a mandatory procedure for pharmaceutical companies, bringing to market a new and unique medicines. The cost of these studies amounts to tens of millions of dollars, according to the Executive Director of the Association of clinical research (AOKI) Svetlana Zavidova. Research manufacturers prove to the authorities the efficacy and safety of its drug.
Manufacturers of generic drugs usually prove the effectiveness of their medicines under the simplified scheme. For market entry it is enough to refer to the study of the original drug and to prove that the generic has the same chemical and biological properties.
Due to the fact that the creation of original products — a much more costly and labor-intensive process than the development of generics, in most developed countries the state has provided the so-called ban on the use of clinical trials by pharmaceutical companies. Implies that during the period of the ban pharmaceutical companies-innovators can recoup their development costs exclusive of the drug and to avoid competition from manufacturers counterparts. Mode the ban severely limits the generic companies to use both closed and already published data from clinical trials of the original drug.
The Russian ban
In Russia the principle of the protection of published data of clinical trials of drugs acts since 2012. The introduction of protection for the free use of scientific developments in pharmacology were required for Russia’s accession to the world trade organization (WTO).
Rules of protection studies has varied. First, the ban was in force for six years from the date of registration of the original drug. During this period, the generic manufacturers could use the clinical trial data only with the permission of the original manufacturer. In 2016 a ban on the use of clinical trial data was reduced from six years to four. But after the lifting of the ban manufacturers counterparts have no right to withdraw its generic to market for another two years.
Slightly different mode of the ban on the use of studies for biologics, which include vaccines, insulins, allergens. In this case, the ban on the use of data — three years. But to display the analogues on the market after the lifting of the ban, they can not for another three years.
Now the government wants to lift the ban on the use of clinical trial data at all. If this initiative comes to the state Duma deputies will approve it, it would be difficult to justify the need for the introduction of new rules among the member countries of the WTO, I’m sure Borzov.
Russia will not escape trial with the WTO confirms the partner of legal firm Lidings Sergey Patrakeev. Usually in such cases, he says, the organization makes the state the violator to take steps to eliminate regulatory barriers that have a discriminatory effect on foreign players compared to internal. But Russia can defend your approach, if you can prove that it is necessary for the security of the country. This possibility is spelled out in the Marrakesh agreement establishing the world trade organization of 15 April 1994.
Innovators don’t come
Modes of data protection of clinical research encourage companies to invest in research and development in pharmacology in those countries where this ban is in effect, said the Director of Association “Pharmaceutical innovation” Vadim Kukava. “If in our country the regime of data exclusivity is violated, it will undermine the confidence of foreign investors to the Russian market”, — said the expert.
The Russian government and so cannot increase the number of international clinical trials, but comes out with suggestions that can make this work to no, supports the colleague City. Conducting international research is important for the development of pharmacology and medicine in General, they help professionals better understand global trends and learn about the latest developments, argued the expert.
Support the domestic manufacturer
The initiative of the government will strengthen price competition in the pharmaceuticals market, as support will be provided to manufacturers of generic drugs, says the General Director of the analytical company DSM Group Sergey shuljak.
First of all, according to the expert, from the lifting of the ban will benefit Russian companies “R-Pharm”, BIOCAD, “f-Synthesis” (“Nativ”), “farm-Synthesis” and “pharmasyntez”. These companies spetsializiruyutsya on the import substitution of high-tech drugs for cancer, HIV, hepatitis and other diseases, the treatment of which is costly.
The lifting of the ban will really accelerate the entry into the Russian market innovative expensive medicines, agrees Director of market development BIOCAD Dmitry Mordvintsev. But this measure will support not only Russian but also foreign generic companies on the domestic market, said the expert. In the end, the Russian market, he predicts, it will be easier to get the generic Iranian, Chinese, Indian and Korean production.