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Moscow, June 15, 2009
ACTO comments on the draft Federal law «On Circulation of Medicines»

The Ministry of Health and Social Development of the Russian Federation sent draft law «On Circulation of Medicines» intended to replace the current law «On Medicinal Products» for approval to the relevant departments. The draft will be considered by the Government of the Russian Federation in two weeks, Health and Social Development Minister Tatyana Golikova said.

ACTO considers that the adoption of draft the Federal law will result in irreparable damage to the innovation sector of pharmaceutical market, and most importantly will put patients at a disadvantage. In particular, the law includes expert examination into the state registration procedure. Thus, the power of the authorized federal executive body will be reduced to technical functions - issuance of registration certificates while evaluation of efficacy, safety and quality of medicines will pass under the control of certain federal autonomous institution. As a result state represented by the authorized federal executive body will not be liable for registration of unsafe and ineffective medicines, and certain federal autonomous institution will become monopoly.

Unjustified tightening of requirements for investigators will entail hard consequences for Russian pharmaceutical market. In accordance with the draft Federal law, an investigator shall have a medical qualification corresponding to the clinical trial of the medicinal product to be conducted, with at least five-year experience on programs of clinical trials of medicinal products. This proposal not only contradicts international practice, but 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. 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.

The adoption of the Federal law will stop the development of medicines to treat AIDS, cancer, hepatitis and prophylactic medicines including vaccines against influenza (virus H1N1) because specifics of these drugs are not taken into account in the rigid classification of clinical trials proposed in the document.

«The proposed changes will create hindrances to the innovative development of the pharmaceutical market and reduce availability of effective medicines for Russian citizens. One might conclude that the strategy of innovative development of Russian pharmaceutical market is not more than populist slogan», said the Executive Director of ACTO Svetlana Zavidova.