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Delay in adoption of a special law hindered clinical trials of cellular therapy drugs

May 11, 2016

In 2010, the Ministry of Health and Social Development of the Russian Federation announced development of the Law on Biomedical Cellular Products. Here is an extract from Department press release of that time: “Today, legal regulation on biomedical cellular technologies in Russia bears fragmentary, but not a system character, and has a great number of gaps, that hinder development of biomedical cellular technologies. We have worked out a draft law that is the first in the area”, claims Veronica Skvortsova, the Deputy Head of the Ministry of Health and Social Development of the Russian Federation. She underlines that development and application of biomedical cellular technologies is the most important strategic development direction for the modern medicine that “allows not only to improve treatment results, but also to make curable the diseases that nowadays remain incurable”.

Concurrently with manifestation of its plans, the Ministry has limited all the pre-existing possibilities for conduction of clinical trials and registration of cellular drug products (previously, they were subject to the Law on Medicinal Products). Refusals were justified then by the fact that the special law on Biomedical Cellular Products had not been adopted yet. For this reason developers have been deprived of opportunity to introduce cellular drugs in this country for more than five years.

There is information about at least two cases when companies applied for international clinical trials conduction and got a refusal from the Ministry of Healthcare. One case described a drug for prostatic carcinoma treatment, the other – for advanced renal cell carcinoma treatment.

Meanwhile, performance of international clinical trials of cellular drugs has aroused a profound interest in this country. However, the current situation makes pharmaceutical companies and contract research organizations refuse from applying for such trials conduction. As a result, many international programs intended for studying cellular drug products pass Russia by.

In April 2015, the State Duma adopted in the first reading the Federal Law Draft on Biomedical Cellular Products, developed by the Ministry of Healthcare of Russia. A year has passed, but the draft law has not been provided for the second reading. Still, there is no possibility to apply for cellular products clinical trials conduction, just as there is no confidence that the law will be adopted in a short run.

Procrastination in adopting the law intended for developing cellular technologies in Russia has caused a complete freeze in this area. At the same time, in the world there is a rapid growth in biomedical cellular technologies and regenerative medicine – revolutionary areas in oncologic, neurologic, cardiological, endocrinologic and other diseases treatment.

In the absence of the special law, performance of clinical trials of cellular products and registration of such over the last five years could have been subject to the Law On Circulation of Medicines. Cellular drugs are just a special case, a separate type of a medicinal product. Essentially, the draft law on Biomedical Cellular Products repeats all the principal provisions of the Law On Circulation of Medicines, and a part concerning clinical trials performance is copied in complete extent from the previous version of the above mentioned law.

The Association of Clinical Trials Organizations pleads the State Duma of the Russian Federation to activate adoption of the Federal Law on Biomedical Cellular Products, and asks the Ministry of Healthcare of Russia to follow the current legislation on circulation of medicinal products while the Law is being adopted. Such procedure will promote performance of international clinical trials of cellular products within the Russian Federation and provide the access to patients to the newest world developments today, but not in a few years.