Background

The Russian Federation has a long-standing practice of consultations on draft laws at the level of state authorities as well as public discussions. Public discussions takes place at various venues and with interested representatives of professional communities and public organizations, including patient communities.

The Resolution of the Government of the Russian Federation "on measures to improve the legislative activities" (2009) provides that a Bill that has been approved by Governmental bodies and Executive authorities is placed on a special website for public discussion. Comments and suggestions provided by citizens are posted on or submitted through the same website. Replies to the suggestions are also posted on the website. These replies are prepared by the Ministry of Health, employees of the Department of Medical Care and the Legal Department, with the involvement of expert groups.

In addition, public discussions on draft laws are held with various target audiences: the professional community, including academics, representatives of faiths, patient organizations, representatives of the public chamber, where the diversity of civil society is represented.
 

Bills are amended based on the views gathered. If adoption of the draft law is considered to violate or restrict human rights, such bills may be re-directed for public comment.

The question

The law of the Russian Federation of 1992 "on transplantation of human organs and tissues" permits organs to be removed from the body of an adult person after his death, if there is no record of this being against the persons wish. In other words, a presumed consent based on an opt-out system. The legislation focuses on organ transplantation and has significant gaps in issues related to human rights in organ donation

There has been a discussion about whether relatives should participate in the decision on organ donation from a deceased person, including whether they have a right to refuse organ donation when the person has not registered their wish.

Another discussion relates to organ donation from children. The law of 1992 prohibits live donations from children under the age of 18, and requires informed consent of one of the parents (explicit consent, “opting –in”) in order to remove an organ from a deceased child.

New legislation, proposed in 2016, aimed to improve legislation in the field of organ donation in order to fill in legal gaps related to the rights of organ donors; to balance the rights of donors, recipients, their relatives, and specialists of medical organizations; and improve the legal and ethical aspects of donation.

Another aim was to inform the population about the importance of organ donation and the current legislation, including its development and improvement.

Method

The proposed amendments were subject to public consultation and debate, as required by the Bill from 2009.

Discussions took place in different forms. Online debate was mainly attended by ordinary citizens, mainly over the age of 40 years old, who discussed the proposed bill and expressed their views regarding organ donation. Their attitudes to organ donation were mainly negative or neutral.

Discussion on organ donation, amongst the younger generation, took place in social media.

Detailed debate of the draft law took place in the professional community, in meetings with experts. Expert opinions were analyzed in accordance with the rules for preparing a draft law for submission to the Government. The analyses were responded to by the Ministry that prepared the draft law.

Outcome

The outcome of the debates allowed the Ministry to improve the provisions of the draft law and to improve programs for informing citizens about organ donation.

The part of the law that allows for donation from deceased children is constantly criticized. The debate showed that Russian society is not ready for organ donation from deceased children, although this is already regulated by law, and there are no obstacles to the implementation of this provision.

The proposed amendments to the law received a lot of criticism, and the new law was stopped before it reached Parliament (Duma).

Notable features and lessons learned

Organ donation is a very sensitive issue for Russian society because of the importance placed on the integrity of the body of deceased persons. It was possible to reach consensus among experts on many issues, but there are still difficulties in regulating the rights of relatives of donors.

One of the most important lessons learned is that the debate will only be effective if people have a full understanding of the subject, especially when the subject raises human rights issues. The debate should be preceded by a broad information campaign, with detailed explanations of all the provisions discussed in the current and new legislation.

The discussion of the draft new law continues, and the most difficult is to overcome the negative attitudes to organ donation among citizens over the age of 50-60 years, who are very actively involved in public discussions on this issue.

Public debate should be adapted to the cultural context. Perhaps this issue has its own historical and cultural roots, since the Russian Federation is a multi-ethnic and multi-confessional country where it has always been important to preserve the integrity of the body of a deceased person before burial.