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.
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