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Moscow, July 17, 2009
ACTO comments on the amendments to the Federal law «On Medicinal Products» ¹86-FZ dated June 22, 1998

Last week the Ministry of Health and Social Development sent the draft Federal law «On Introducing Amendments to the Federal Law «On Medicinal Products», prepared by the Ministry of Health and Social Development and the Ministry of Industry and Trade, to the relevant departments. The document would be agreed and forwarded to the Government of the Russian Federation until July 20, the representative of the Ministry of Health and Social Development said.

ACTO considers that the developers of the project did not evaluate risks and possible consequences of its adoption for the innovation sector of the pharmaceutical market, in particular, for clinical research.

Firstly, the document proposes to tighten requirements for investigators. In accordance to the document, investigator shall have at least five-year experience on programs of clinical trials of medicinal products. The current law requires two-year experience.

The proposed approach contradicts international practice and the strategy of innovative development of the pharmaceutical industry because it imposes a restriction inhibiting the development of the essential sector of innovations - clinical studies.

It also ignores the fact that the Russian market of clinical trials is under development. Only 850 of 9,000 hospitals in Russia are involved in clinical trials. Thus, more than 90% of hospitals do not enjoy advantages of participating in clinical studies, namely: access to cutting-edge technologies, experience exchange with colleagues etc. Participation in clinical trials provides for Russian patients not only the opportunity to receive innovative products, but also, in some cases, hope for life.

If this provision is implemented, the way to clinical studies for the remaining 90% of hospitals and their patients will be closed. It will be also impossible to find investigators with five-year experience on programs of clinical trials of orphan medicinal products.

ACTO supposes that number of investigators will be reduced at 25-35% as a result of requirements’ tightening. The concentration of clinical trials among a few investigators will low the quality of clinical trials.

Secondly, the document introduces that non-clinical and clinical trial data shall be considered confidential information which is inadmissible in international practice and contradicts public interests.

At the moment, generic drugs manufacturers should not conduct non-clinical and clinical trials to receive marketing authorization provided that their formulation has exhibited bioequivalence to the innovator product. Generic drug manufacturers may receive marketing authorization based on the studies of the innovator product but only after the period of data exclusivity has expired (currently from 5 to 11 years). Data exclusivity guarantees additional market protection for originator products by preventing health authorities from accepting applications for generic medicines during the period of exclusivity.

The proposed provision does not resolve the problem of protection - instead of protecting a manufacturer against unfair commercial use it establishes a more rigid regime corresponding to commercial confidentiality. However, the regime of commercial confidentiality may not be established with respect to non-clinical and clinical trial data. So, according to World Medical Association Declaration of Helsinki «negative and inconclusive as well as positive results should be published or otherwise made publicly available».

«The proposed amendments require serious examination. Unadvised decision will not only hamper the development of innovative pharmaceutical industry, but also reduce the availability of effective medicines for Russian citizens», said the Executive Director of ACTO Svetlana Zavidova.