Sunday, 19 February 2017

Biological cell products

On the 1st of January 2017 the new Law On Biological Cell Products took force to regulate procurement and preservation of human bodily material for medical therapy (art. 1). It was specifically mentioned that it did not cover not only blood donation or assisted reproductive technologies, but also circulation of biosamples for research purposes, thus being an analog for the European directives on advanced medical treatment.
These limits in Russia look weird, as nowadays it is extremely difficult to draw a line between medical therapy and science as most of biosamples are procured not only for making a single end product but for future research as well. Even the end product should be tested and monitored during the whole period of its use to understand its benefits and pitfalls so in most cases any collected biosamples are stored in biobanks to enable researchers and pharmacists use it again and again. Although art. 37 of the law delegated the Ministry of Health to draw provision on biobanks, all these norms would formally cover only biobanks for medical purposes and thus all others would stay be left beyond the scope of any regulation.
Just the same way the scope of biomaterial usage principles (art. 3) is limited by the scope of the law and despite some of them being clear, others seem to be quite controversial. The principle of gratuitous donation of bodily material was said to be the main pillar of the whole biological cell products turnover and was undoubtfully influenced by international and European legislation. However, further in the same art. 3 another principal was specifically mentioned with slightly different wording, namely a prohibition for bodily material to be sold, thus raising many questions about whether other contracts for consideration were allowed. For instance, was it possible to exchange biosamples or handle it as a subject matter for a contract of service? A negative answer would obstruct any disposition of biosamples thus this construction would inevitably fail, while a confirmative answer for a singly contract would make the prohibition the formality too easy to skirt. Moreover nothing prevents scientists from deriving a cell line to transfer it instead of original bodily material, as a cell line is not biosamples… 
It is unclear in which relationship the latter mentioned prohibition should work. If the legislator bore in mind the procurement relationship, the prohibition would double the principle of gratuitous donation and thus is unnecessary. It only made sense to apply this prohibition is relationships between the procurer and third parties thus making us draw two further conclusions.
First of all, in this case the prohibition to sale biosamples will almost inevitably be interpreted as general principal for Russian legislation, with its scope far beyond the limits originally expressed in art.3 of the law. It will be connected with art. 21 of the Oviedo Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, stating that ‘human body and its parts shall not, as such, give rise to financial gain.’ Although there is no such wording in the current Russian law, it echoes ideas of gratuity in blood and gametes donation outlined above, and has some historical tradition in the abolished Basics of Legislation on Human Health Protection.
However, the second point should be eventual failure to enforce the prohibition as the whole development of medical research, court practice and legislation in the recent decades has shown sheer impossibility to stop commodification of human body. And it is this commercializing process that make the Parliament let to exchange blood for value either for donor or for a third party, a vast market of sperm and oocytes exists completely legally, and many other examples of biosamples commodification were mentioned above or can be thought of. So total prohibition of valuable biospecimen disposition would definitely stop scientific research and trials as procurement, collection and preservation would not be paid for. It is absolutely clear that either medics or pharmacists have quite a different goal; hence the commodification of tissues and cell will increase.
Reading the donor’s rights as they outlined in the art. 34 of the law one cannot avoid a question what patients should donate their specimens for. Even for blood donation with its quite a long history based on total altruism of a participant it is proved to be impossible to reserve enough blood without paying for it. However a principle of gratitude is much easier argued for blood transfusion than for producing commercially successful drugs out of tissues or cells. So, although a donor should definitely have rights, named in art. 34 such as a right to deny getting samples, a right to be informed of any potential risks on the intervention or a right for ‘protection of health’, the law in general provides no guarantees or mechanisms for donors to obtain any benefit from the research, even in a form of personal involvement.
Then, according to art. 33 of the law not only should biomaterial procurement be made by a licensed medical entity, but for some reason just upon a contract with a manufacture of biological cell products and for its expense. The lawmakers thus tend to consider medical entity as an agent of a manufacture so any property rights should directly be vested in the latter. However it is completely unclear what were the reason and the aim of this restriction. Whatever the reason was, the rule is too easy to skirt as procurement for purposes other than producing biological cell products is expressly stated to be beyond the scope of the law. So one can at any time procure samples ‘for scientific purposes’ and then transfer them to manufacture… Unfortunately huge amount of these unnecessary formalities clearly shows poor quality of the whole law. These gaps would probably be filled by Minister of Health who was delegated a right to decree procurement procedure rules as well as an informed consent form for the donation (see art (2)33 and art. (8)33).
Finally art. 38 provides that any unclaimed cell lines as well as any body material after use should be eliminated in the same way as other medical waste (these rules were outlined above).
In conclusion one can easily seen that the new law directly regulates some aspects of procurement, turnover and destruction of biomaterial in one particular area, namely manufacturing of biological cell products. Although its general provisions will obviously enrich all neighboring fields of practice and contribute to system development of the legislation, there are too many ambiguities in the wordings.