Baker & McKenzie: Law on Circulation of Medicines

 

On April 12, 2010 the President of the Russian Federation signed the new Federal Law “On the Circulation of Medicines” (the “New Law”) thus completing the procedure of its adoption. The New Law is to replace the existing Federal Law No. 86-FZ “On Medicines” dated June 22, 1998, as amended (the “Law on Medicines”).

The initial draft of the New Law attracted a great deal of attention and criticism when it was published on the website of the Russian Ministry of Healthcare and Social Development on July 8, 2009 and a substantially redrafted version was presented to the Russian Parliament on December 26, 2009. Its subsequent review and adoption was quite rapid for a law of this size and complexity. The New Law will come into force from September 1, 2010.

In this document we discuss only the most important aspects of the regulation, which will be introduced by the New Law relating to the medicines for human use.

 

1. State Registration of Medicines

The New Law establishes a detailed regulation of the state registration of the medicines in Russia compared to essentially one article devoted to this issue in the Law on Medicines. Most importantly, the New Law interlaces the clinical trials of the medicine with the procedure of its state registration. In doing so, however, the New Law appears to leave room for only one clinical trial within the registration process, since it does not establish a possibility for the applicant for state registration of the medicine to apply for permission to conduct a second clinical trial after successful completion of the first clinical trial within the registration process, e.g., a next phase to obtain more information on the medicine for the purposes of its state registration. The possibility of submitting documents and obtaining permits to conduct several phases of clinical trials within the state registration of the medicine is questionable under the New Law. At the same time the New Law allows to use the results of international multi-center clinical trials, part of which was conducted in Russia, for the purposes of the state registration of the medicine.

Further, the New Law details the expert examinations of the medicine to be performed in the process of its state registration, as well as describes the interaction of the authorities with the bodies, performing expert examinations. The applicant for the state registration of the medicine under the New Law will no longer deal with these expert bodies directly.

The New Law now allows registration of generic medicines based on, inter alia, results of their bioequivalence studies (in the terminology of the New Law it is a subtype of the clinical trials), however this possibility does not apply to immunobiological medicines, insulins and newly registered medicines.

Registration certificates will be indefinite in term but for medicines newly registered in Russia the state registration will need to be confirmed after five years from the initial date of their registration.

 

2. Clinical Trials

The types of clinical trials that may be conducted in Russia (outside of the context of state registration of the medicine and not including bioequivalence and therapeutic equivalence studies) are limited in the New Law to international multi-center clinical trials and post-registration clinical trials.

Under the New Law clinical trials of the safety of a medicine for healthy volunteers or their tolerance to it (i.e., phase I clinical trials) may not be conducted in Russia for a medicine manufactured abroad.

Further, the New Law modified requirements to the agreement for performance of clinical trials, which should be entered into between the entity that received permission to conduct the trial and the duly accredited healthcare institution. This agreement now needs to state the overall cost of the clinical trial program and specifically the sum to be paid to the investigators and co-investigators and does not need to include provisions on the insurance coverage.

At the same time the New Law details the requirements to the insurance within the clinical trials. Only one type of mandatory insurance (life and health insurance for the patients) is still required for clinical trials and the New Law sets a minimum level of insurance coverage, for example, of 2,000,000 rubles (currently approximately 86,500 US dollars) for the death of each patient.

The New Law also toughens the requirements for principal investigators within clinical trials, who should have a medical specialization matching the clinical trial and 5 years of experience in clinical trials.

 

3. Pricing Regulations

The New Law introduced the detailed regulation of the pricing issue with respect to of the medicines included into the Essential Drugs List, which are very similar to the currently existing regulations established mostly by the Decrees of the Russian Government. Most importantly, the New Law establishes that not all medicines, but only the medicinal preparations are subject to this regulation (thus excluding active pharmaceutical substances and bulk medicines from the regulations’ application). Further, the New Law does not contain a provision that prices for other medicines may also be regulated. In the absence of this reference in the New Law, the legislative basis for the currently existing regional pricing regulation of medicines not included into the Essential Drugs List may be viewed as effectively abolished.

 

4. Other Novelties

The New Law also contains other important provisions, such as new pharmacovigilance rules, permission to wholesalers to sell medicines to healthcare institutions directly, amended labeling rules, listing of the organization allowed to store the medicines, provisions governing state pharmacopoeia, etc.

 

5. State Fees

Amendments to the Russian Tax Code accompany the New Law forming a “package of laws” with it and reflect its novelties in the registration of medicines and their clinical trials. The price of the expert examinations under these amendments will no longer be paid to the expert institution directly, but rather as a state duty to the relevant budgets. The overall state duties on expert examinations during the state registration of a medicine when its clinical trial is conducted within the registration process will be 300,000 rubles (currently approximately 10,250 US dollars). For state registration of a medicine using the results of an international multi-center clinical trial performed outside of the registration process, the overall state duties for expert examinations will be 425,000 rubles (currently approximately 14,550 US dollars).

 

Questions regarding this issue may be addressed in Moscow to Alexey Trusov, +7 495 787 27 00, Sergei Lomakin, +7 495 787 27 00, or in St. Petersburg to Maxim Kalinin, +7 812 303 90 00.

 

 

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