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Reply letter to S Zavidova Ares (2011) 384252-06.04.2011

April 25, 2011

Russian Ministry of Health and Social Development Misrepresents Outcome of International Talks

“There are no mutual recognition agreements on clinical trials. The European Union accepts the clinical trials performed in accordance with Good Clinical Practices,” runs the official answer by the European Commission to a request filed by ACTO (Association of Clinical Trials Organizations) about legal feasibility of signing agreements for mutual recognition between the European Union and Russia.

Earlier, Health Minister Tatyana Golikova said that Russia and the European Union “are now very close to being able to address issues … of mutual recognition of the results of clinical trials.” “Russia and the European Union are prepared to move fast to finalize all issues leading up to an agreement which will set rules for mutual recognition of clinical trials’ results,” the minister said on February 24, as she met with the European Commissioner for Health and Consumer Policy John Dalli (http://www.minzdravsoc.ru/health/cooperation/14).

The requirement for mutual recognition of the clinical trials’ results between countries was introduced by the law “On Circulation of Medicines.” Beginning September 1, 2010, for a new medicine to be registered in Russia it has to go through local clinical trials, even if the international ones are available. Repetitive tests involving humans that are conducted without real need are considered unethical practice across the world. Moreover, local trials are not statistically reliable. This is exactly why they conduct full-scale international trials.

However, the Health Ministry insisted on introduction of this requirement, although it clearly impedes innovative medications becoming available on the Russian market. The ministry came under heavy criticism and was forced to make two exclusions from the rule: pharmaceutical companies were allowed to go without local trials, if Russia took part in the international trial or if Russia is party to an agreement for mutual recognition signed with the country, which conducted the trial.

ACTO has stated on several occasions that mutual recognition of the clinical trials’ results between the countries makes no legal sense. The outcome of clinical trials cannot be the subject of international treaties for the simple reason that such outcomes are produced by pharmaceutical companies, not governments. There are no such stipulations in any law of any other country. For registration purposes, the developed countries accept the results of trials conducted in compliance with the ICH GCP standards, and the location of such studies is of no consequence.

The European Commission’s answer confirmed that the mutual recognition requirement makes no sense and any agreement for mutual recognition is fiction. The response provided by the European Commission also reveals that the Health Ministry misrepresented the results of talks with the European Union.

The companies that have conducted international trials found themselves over a barrel: they now have to either drop the idea of registering the medicine in Russia, or conduct redundant and ethically or scientifically unjustified repetitive tests.

“The Russian Health Ministry cut Russian patients off from access to modern therapy. Innovative medicines that could become available in the pharmacies and hospitals now, will show up in Russia only one or two years later,” said Svetlana Zavidova, executive director at ACTO.

About ACTO

Association of Clinical Trials Organizations was founded in 2007 and comprises corporate members of the Russian clinical trials market. Today, 26 pharmaceutical companies and contract research organizations are members of ACTO.

The goal of ACTO is to promote the Russian market of clinical studies by balancing the interests of its participants, patients, medical community and state, harmonizing Russian legislation and the international standards, and promoting ethical business standards.