Collection of cells, tissues and organs from a deceased person. What about the consent of the family?

Director of the BRPO's Administrative and Economic Law Team Piotr Mierzejewski asks the director of the Health Ministry's Legal Department Anna Skowronska-Kotra for her views on the matter.

The ROP is receiving requests from citizens regarding amendments to the July 1, 2005 law on the collection, storage and transplantation of cells, tissues and organs as to the presumption of consent of a deceased person for the procurement of tissues and organs. They point out that the failure to obtain free and informed consent from the donor is incompatible with the Charter of Fundamental Rights of the European Union.

Analysis of the case law of the European Court of Human Rights influenced the ROP to raise doubts about the completeness of the Polish legislation.

There are generally two ways to regulate consent for ex mortuo tissue or organ procurement in European legislation. Explicit, firm consent is required in the so-called American-Canadian model - the opting-in system. The condition for ex mortuo donation will be that the prospective donor agrees to the removal of tissues or organs from his cadaver after his death. It must be expressed before death and in an explicit manner - in writing or orally in the presence of witnesses. In the absence of a written statement or declaration in the forms given above, there remains the possibility of determining through appropriate procedures the actual will of the deceased, or the possibility of ex mortuo donation after obtaining consent from the next of kin. This system has been adopted in the US, Denmark, Greece, Sweden, Norway, Switzerland and the UK.

Presumed consent to cell, organ harvesting after death is adopted by the so-called French opting out model. A person is presumed to have consented to the donation until it is proven that he or she objected to organ explantation after death. Unless there is such an objection, the person is presumed to have consented to the donation and is treated as a potential donor. Such a regulation is in effect in Austria, Finland, Belgium, France, Italy and Portugal.

In Poland, the model of implied consent has been adopted. As argued in the doctrine, this is in line with the recommendations of the Council of Europe (Council of Europe Resolution No. 29 of May 11, 1978 on the harmonization of legislation related to the procurement and transplantation of human cells, tissues and organs. Article 10 requires that the removal of organs ex mortuo take into account the express or implicit objection expressed during life.

In response to interpellation no. 28897 on supplementing the functionality of the account on patient.gov.pl with the possibility of entering consent for organ transplantation, the then Deputy Minister of Health indicated that, according to current legislation, the procurement of cells, tissues or organs for transplantation from a deceased person can be carried out if the deceased person's objection does not appear in the Central Register of Objections, or has not been expressed in the form of a written statement or in the form of a verbal statement made in the presence of two witnesses, confirmed by them in writing, as referred to in Article 6(1)-(3) of the aforementioned law on procurement. At the same time, he argued that under the current legal regulations, the will of the family of the deceased should not affect the legality of the intake. However, accepted practice indicates that in the absence of a confirmed objection from the deceased, an interview with the family is carried out in order to obtain information about any objection from the deceased expressed verbally and to collect, extremely important in transplantation medicine, a medical history. The purpose of the interview with the family should therefore not be to obtain their consent to organ procurement, but only to determine what the deceased person's wishes were. The absence of a confirmed objection from the deceased person, not an objection aseffectively expressed by the relatives of the deceased, makes it possible to carry out a legitimate cell, tissue or organ procurement.

ECHR case law recognizes that relatives of the deceased's memorial veneration have their own subjective rights subject to Convention protection (including the right to respect for private life set forth in Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms).

In a January 13, 2015 judgment - concerning the protection of the rights of family members of the deceased in connection with the removal of tissue from human cadavers without the consent and knowledge of the immediate family members (Case No. 61243/08 Elberte v. Latvia) - the ECtHR pointed out that "... respect for human dignity is the essence of the Convention. Treatment is considered 'degrading' within the meaning of Article 3 of the Convention when, among other things, it humiliates an individual, showing a lack of respect for human dignity." The applicant's suffering was caused not only by the violation of her rights as a close family member of the deceased and the subsequent uncertainty of what operations were carried out at the forensic institute, but also by the invasive nature of the operations carried out on her husband's corpse and the pain the applicant suffered as a member of her immediate family in doing so."

This ruling deals with a slightly different legal situation - despite the existing provisions of domestic law, the applicant was not asked to consent to the donation. However, it clearly indicates that the relatives of the deceased have conventionally protected subjective rights. Consequently, Article 13 of the ECHR is also applicable to them. It stipulates that anyone whose rights and freedoms enshrined in the Convention have been violated has the right to an effective remedy before a competent state body, including when the violation has been committed by persons exercising public functions.

Legal protection for the cult of the deceased is also provided under Polish criminal and civil law.

There is no indisputable solution to the problem of who has the authority to decide the fate of a dead body. Nevertheless, in the context of ex mortuo transplantation, given the accepted practice of talking to the family of a deceased person, it might be advisable - given the low public awareness of transplantation - to legally regulate the inclusion of the family in the decision-making process about the donation of organs of a deceased relative.

Source: RPO