The global market for stem cells has been estimated at 12 billion US dollars in 2016 and is projected to reach 26.6 billion by 2021, with annual growth rate of 13,7% during the forecast period 2016 to 2021. Several factors, though, restrain market growth. Such products cost very high, moreover, ethical issues arise about them frequently as well as regulatory complications develop. Also, the clinical efficacy of cellular products is still questionable for today – for example, in recently completed MASTERS trial multipotent adult progenitor cells were proven ineffective in stroke recovery.
In Russia, the industry of cellular product is still in the early development phase because the use of cellular products is anecdotal and the purpose is mostly scientific. Recently, however, regulatory authorities in Russia started to develop the legislative basis for cellular products.
On January 1st, 2017 law N 180-ФЗ regarding the medical use of cellular products came into force. There is a void of questions and imperfections in this law, experts say. Pavel Vorobiev, head of Moscow City Scientific Society of Internal Medicine Physicians criticizes the new law as proposed definition of cellular product is very vague. Mr. Vorobiev also states that the law opens a huge way for bureaucracy and does not provide any benefits for industry or science. Law N 180-ФЗ virtually mirrors law 61-ФЗ (on the circulation of medical products for human use), but cells are different from other medications and specific approach to them is most certainly needed.
For example, the new law implies the concept of the international non-proprietary name onto cellular products. Hypothetically, bone particles grown from bone progenitor cells could have international non-proprietary name “mesenchymal cell line” and trade name “bone particle for heel”, which doesn’t make any sense. Expert considers that new law will not promote cellular products development in Russia, but, on the contrary, many laboratories will have to stop their work under bureaucratic pressure.
Nevertheless, recently Russian Ministry of Health opened brand new draft laws regarding approval of clinical trials of cellular products, cellular sample collection and quality control, expert consultation on cellular products and considering the order of import of cellular product for the treatment of individual subjects for public discussion. A bunch of draft documents has also been released earlier this year.
Such an active discussion gives hope that when all practical issues will be considered market of cellular products in Russia will follow general trend to growth and development.