New Rules in Pharmaceutical Industry


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Since 01.09.2009 Russia introduced new rules which will affect almost all companies operating in the national pharmaceutical market, such as: domestic producers of medicines, foreign producers importing medicines into Russia, drugstores, clinical trial centers, state authorities supervising pharmaceutical industry and some others.

Implementation of new rules will be connected with the Federal Law dated 12.04.2010 "On circulation of medicines" (New Law) coming into force. This Law replaces the Federal Law dated 22.06.1998 "On medicines" (Law No. 86) and aims to bring into order all regulations related to medicines and adapt them to present conditions in pharmaceutical industry. As a consequence, New Law stipulates powers of the respective state bodies, regulates in detail proceedings previously familiar to participants of the pharmaceutical market and implements certain new proceedings. Within the scope of this overview we have concentrated on new regulations applicable to the state registration of medicines and powers of the state bodies involved in this procedure.

1. Changes to competence of state authorities

Despite the fact that the list of state authorities' powers with respect to pharmaceutical industry became much longer in comparison with Law No. 86, involvement of state bodies in regulation process remains almost the same. The reason is that significant part of powers previously was stipulated by secondary legislation. Now they are listed in the Law (e.g. powers with respect to state regulation of pricing on certain medicines).

Both Law No. 86 and New Law stipulate that all medicines produced in Russia or imported into Russia are subject to state control. State bodies exercise the state control on all stages of medicines' circulation:

- preclinical and clinical trials;
- producing, storing, transportation and importing into Russia;
- advertising, selling, application and destruction.

Control of preclinical and clinical testing is conducted by the state bodies in course of state registration process which is the topic of the present overview.

2. State registration of medicines

As earlier, the state registration of medicines with the special register is prerequisite to their circulation on the market (production, wholesale and retail selling, application, etc.). Roszdravnadzor, an executive body responsible for control and supervision of health care and social development, is in charge of medicines' registration and maintenance of the register. Registration with the register must be preceded by the following stages:

1) preclinical trial of a medicine;
2) applying for state registration of a medicine;
3) document expertise for obtainment of permission to carry out clinical trial;
4) ethic expertise;
5) clinical trial;
6) medicine's quality expertise and expertise of medicine's benefit/risk ratio.

If the creator of a medicine properly fulfills its obligation on each stage and achieves positive results in trials, Roszdravnadzor registers the medicine. The New Law obliges all state authorities and medical organizations to carry out the whole procedure for the time period no more than 210 days (from submitting an application to registration of medicines). It is necessary to outline the most important features of each stage.

2.1. Preclinical trial of a medicine

Preclinical trial may be organized in scientific research organizations, educational institutions possessing necessary equipment and skilled staff. While conducting preclinical trial the testing organization shall apply scientific estimation methods to obtain evidence of security, quality and efficiency of the medicine. Preclinical testing must be organized in accordance with the Good Clinical Practice, internationally recognized rules for clinical trials. Similar to other countries they were extended throughout Russia by the respective resolution of internal executive body which is charge of health care (the Russian Ministry of Health Care).

2.2. Submitting an application for state registration of a medicine

All proceedings following preclinical trial take place after submitting an application by the creator of the medicine for its state registration coupled with supplements as required by New Law. After consideration of documents provided Roszdravnadzor within 5 days issues requests addressed to the expert organizations whereby asks them to conduct the following expertises:

1) document expertise for obtainment of permission to carry out clinical trial;
2) quality expertise.

If the applicant submits the document improperly, Roszdravnadzor refuses to issue expertise request.

2.3. Document expertise for obtainment of permission to carry out clinical trial

This expertise is one of 3 expertise carried out with respect to the medicine (along with quality expertise and expertise of medicine's benefit/risk ratio). It is shall be carried out by the authorized state budget institution. From the documents expertise are exempted those medicines which have been allowed to be applied in Russian more than 20 years ago and with respect of which it is impossible to organize bioequivalence research and those which have been checked in multi-central clinical trials (including trials in Russia).

2.4. Ethic expertise

Ethic expertise, i.e. expertise of possibility to organize clinical testing is carried out to issue a conclusion concerning ethic reasonableness to organize clinical testing of the medicine. It must be conducted by the ethic council to be established at Roszdravnadzor. Currently another institution - the ethic committee Ė functions at Roszdravnadzor. It established in accordance with Law No. 86 and performs duties similar to those to be performed by the ethic council as stipulated by New Law. Once New Law comes into force, it will become clear whether a new body will be formed or the ethic councils' duties will be delegated to the ethic committee.

2.5. Clinical trial of the medicine

Then the applicant shall submit the results of document expertise and ethic expertise to Roszdravnadzor. The latter considers them and decides on possibility or impossibility to issue permission for clinical trial. It must notify the applicant on the decision made. Clinical trial may be organized only on those conditions that Roszdravnadzor positively decided the issue and the applicant filed with it the respective request.

As earlier, clinical trials shall be carried out only in those medical organizations, which are accredited by the Ministry of Health Care pursuant to the Good Clinical Practice. At the same time, New Law regulates the entire procedure in more details in comparison with Law No. 86, stipulates rights and obligations of patients and medical staff involved in clinical trials. In particular, there are special measures to guarantee and protect the rights of patients participating in clinical trial such as voluntariness of participation in clinical trial, keeping patients informed on the medicine's characteristics, confidentiality of information related to participation in clinical trial, prohibition to carry out clinical trial with participation of certain categories of individuals. All conditions of clinical trial shall be stipulated in the agreement between the producer of the medicine which obtained permission to carry out clinical trials and the medical organization conducting them.

2.6. Medicine's quality expertise and expertise of medicine's benefit/risk ratio

After clinical trials the new medicines shall go through the following expertises:

1) medicine's quality expertise, i.e. expertise of quality control methods recommended by the medicine's producer and expertise of medicine's samples provided by the producer with use the above methods;
2) expertise of medicine's benefit/risk ratio.

Both expertises shall be carried out by the authorized state budget organizations grounding on the results of clinical trial. The overall period for conducting both expertises shall not exceed 110 days after the expert organization received requests for them. Roszdravnadzor examines the results of the expertises and check compliance with requests. Then it decides on registration or refuse to register the new medicine. The reasons for refusal may be conclusion of Roszdravnadzor on one of the following:

- results of prior tests and trials do not confirm effectiveness of the medicine;
- risk of damage to health exceeds effectiveness from use.

Roszdravnadzor's refusal may be challenged in court. Repeated filing for registration of the medicine earlier not completed or obtained refusal in registration is treated as registration of a new medicine and shall go through the entire procedure from the beginning. It is obligatory regardless changes in characteristics, name, etc.

This is how the new framework for registration of medicines according to new Federal Law "On Circulation of Medicines" looks like. Experts in pharmaceutical industry, lawyers, state officials and others expect that a number of sublegislative acts will follow, and they will allow to better understand new regulations as a whole and work in the new framework accordingly.

ABOUT THE AUTHOR: Zakhar Polezhaev, Senior Associate
Lidings is a leading Russian law firm, dedicated to advising foreign companies on all aspects of Russian law. Founded in 2006 and initially specializing in real estate, corporate and commercial law, and arbitration and litigation, the firmís offices in Moscow and St. Petersburg now comprise more than 20 lawyers providing specialist advice across nine dedicated practice areas.

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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.