THE PROCEDURES OF BIOBANKS WITH BIOLOGICAL MATERIAL (SERUM, BODY FLUIDS, FROZEN CELLS, DNA SAMPLES FROM DONORS)– POLISH LAW IN THE LIGHT OF INTERNATIONAL CASES
In the US, in the context of the case of donor 1558 a legislative initiative has been launched to protect the parents of children conceived using genetic material taken from a donor.
In the case widely discussed in the press, 27-year-old Steven Gunner died of a drug overdose. His biological father was sperm donor number 1558 who according to the biobank’s description, was a brown-eyed student who played guitar and hockey. After the tragedy, Steven’s parents learned that the sperm donor suffered from schizophrenia and died the same way as Steven – from a drug overdose. As a result of their actions, Republican Senator Gallivan introduced a draft legislation to waive the donor’s confidentiality for a period of five years back so their medical records could be checked.
The questions that arise in connection with regulations relating to the testing of donors of genetic material are, above all, whether we are able to determine in advance what quality the material will ultimately be. It seems that the technological level of today’s medicine does not allow us to predict with a hundred percent certainty what the medical conditions will be of a person whose fertilisation will take place using donor material. The factors determining pathologies are not only genes but also the environment in which a person lives. It can also be difficult to determine responsibility for unforeseen diseases. Are they the result of a mistake in the analysis of the material or did the environment have a decisive influence? Determining these issues will be crucial in determining possible compensation for medical error. Rigorous screening of potential donors would also have an impact on the price of fertility treatments.
On the other hand, people involved in fertility treatment programmes should be as confident as possible that the material used in the process has been properly tested and that there are no potential risks.
Another question worth asking is what exact information the banks can collect about donors. What should be their accuracy and scope? Is it only medical, in terms of the presence of possible diseases? Would they also include psychological profiling of the donor along with his personality traits? It is also extremely important what information would be given to those who would make the donation choice? Knowledge about the donor that participants in the programme will receive should not be given at the expense of disseminating personal data.
There is also an ethical question here, i.e. how far can a parent go in controlling their child’s characteristics. Are physical characteristics such as eye or hair colour sufficient, or will personality traits be equally important. This question will arise more and more frequently with the development of gene modification technology.
Regulation of biobanking in Poland
The main legal sources regulating the issue of biobanks in Poland are:
- Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;
- The Act of June 25, 2015 on the treatment of infertility and executive regulations;
- Other legal sources regarding diagnostic laboratories and clinics.
As for medically assisted procreation centers and germ cell and embryo banks in Poland, the medically assisted procreation centres carry out the management of reproductive cells and embryos in order to carry out a medically assisted procreation procedure consisting of:
1) harvesting reproductive cells from donors;
2) the use of germ cells and embryos in a medically assisted procreation procedure, including processing, testing, preservation and distribution.
Handling of reproductive cells and embryos for the purpose of medically assisted procreation, consisting in the collection of reproductive cells from donors in a partner donation for direct use, may be carried out in a medical entity other than a medically assisted procreation center, which performs therapeutic activities in the form of stationary and round-the-clock health services.
The germ cell and embryo banks carry out the management of germ cells and embryos for medically assisted procreation, consisting in the collection, storage and distribution of germ cells and embryos intended for human use in a medically assisted procreation procedure.
The germ cell and embryo bank enters into an agreement for the storage of germ cells or embryos with donors who have given these germ cells or embryos for storage.
The agreement specifies:
1) the authority to store reproductive cells or embryos and to transfer them;
2) the bank of reproductive cells and embryos, to which the stored reproductive cells or embryos will be transferred in the event of the liquidation of the bank of reproductive cells and embryos or the cessation of its activity in the field of storage of reproductive cells or embryos, also in the event of the withdrawal of the authorization;
3) the method of financing and the cost of storing reproductive cells or embryos and the manner in which it is borne by donors who donate reproductive cells or embryos for storage;
4) the shelf life of the embryos.
The bank of reproductive cells and embryos immediately informs donors who have placed reproductive cells or embryos in that bank about the withdrawal of the authorization, and on the liquidation of the bank or the cessation of its activity in the field of storage of reproductive cells or embryos.
Permission to perform activities by centers of medically assisted procreation and banks of reproductive cells and embryos is issued by the minister competent for health to perform these activities. The said permits are granted for a period of 5 years.
Current legislation does not define the group of entities that can offer and perform testing and storage of genetic material. In the current legal situation genetic tests are performed by genetic laboratories, including those functioning in health care institutions, non-public health care institutions and private entities offering/performing tests outside the health care system.
Despite work on a draft law regulating genetic research, the assumptions of legal regulations are limited to genetic tests performed for health purposes and the issue of biobanking was excluded from the work.
The regulation of storage of genetic information was introduced indirectly by the provisions on GDPR which introduces into the legal order the concept of genetic information as personal data concerning inherited or acquired genetic characteristics of an individual which reveal unique information about the physiology or health of that individual and which result in particular from the analysis of a biological sample from that individual. The GDPR sets out, inter alia, the legal basis for processing and imposes a number of obligations on the controller of personal data, including, the obligation to implement appropriate technical and organisational measures to such an extent as to demonstrate that the processing is carried out in accordance with the GDPR taking into account: the nature, scope, context of the processing, purposes of the processing, risk of violation of the rights or freedoms of natural persons with different probability and seriousness of the threat (the measures applied shall be updated and reviewed as necessary), documentation of a personal data breach.
Conditions for donors to join the programme
Today, the entities that offer this type of service determine the principles according to which they select sperm donors. Usually, the donation of sperm is preceded by a detailed interview, including a detailed medical history – the candidate is asked about past medical conditions, possible genetic predispositions, sexual activity, life situation and so on. In most cases, the candidate is required to sign a clause, according to which the concealment of certain data or providing false data will result in the necessity to cover the costs of tests and even pay compensation to the clinic.
The candidate usually undergoes personality tests and also a psychological examination, which not only confirms the mental health of the potential sperm donor, but also serves to make him aware of the legal and emotional consequences associated with donating genetic material to a sperm bank.
The next stage is to examine a semen sample, as well as blood and urine. The quality of the semen needs to be assessed, but above all the health condition of the potential donor. The purpose of the tests is to exclude: genetic abnormalities (e.g. karyotype and blood group are determined), sexually transmitted diseases (such as HIV, hepatitis, cytomegalovirus, syphilis, gonorrhoea, chlamydiosis).
If the test results are satisfactory, the sperm is often frozen for a six-month quarantine period. After this time, the sperm donor is required to be retested for infectious diseases. Only after these have been ruled out again is the genetic material collected made available to those who need it.
Sources:
2: https://www.nik.gov.pl/aktualnosci/nik-o-bezpieczenstwie-badan-genetycznych.html
3: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32004L0023
4: https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20150001087
