Voluntary and unpaid donation of tissues and cells
The Committee on the Environment, Public Health and Food Safety adopted the own-initiative report by Marina YANNAKOUDAKIS (ECR, UK) on voluntary and unpaid donation of tissues and cells in response to the Second Report from the Commission on the subject.
It notes with concern that half of Member States state that they regularly face a lack of human tissues and cells, particularly spinal marrow, gametes and tissues such as corneas and skin; believes that the policies and laws in force should therefore be reviewed, as they are not adequate to meet the challenge of self-sufficiency in the European Union. Members recall that while 11 countries have official policies in place to endeavour to promote self-sufficiency of tissues and cells, 17 other countries have bilateral agreements with the same aim of ensuring national supplies of human tissues and cells.
Non-remuneration, consent and safeguarding health: the report states that the removal of tissue and cells must be subject to the following principles: anonymity (except in the case of removal from a living person for a relative), non-remuneration, consent, the obligation to share organs for transplant fairly among patients, and safeguarding the health of donors and recipients.
Members go on to stress that donation should be voluntary, unpaid and anonymous (except in the case of procurement from a living person for a relative), governed by protective legal and ethical rules that respect the integrity of the person. They call on the Commission to
· report on current national practices and criteria for compensation of living donors, especially as regards egg cell donation;
· carefully monitor developments in the Member States, to examine carefully any reports from civil society or in the media about violation of the principle of unpaid donation, and to take appropriate action, including, if necessary, infringement proceedings.
Member States are asked to clearly define the conditions under which fair and proportionate financial compensation may be granted, bearing in mind that compensation is strictly limited to conditions making good the expenses incurred in donating tissues and cells, such as travel expenses, loss of earnings or medical costs related to the medical procedure and possible side effects, thereby prohibiting any financial incentives and avoiding disadvantages for a potential donor. Such compensations must be transparent and regularly audited.
Any compensation provided to donors must be compatible with ethical principles. The committee advises that particular attention should be paid to this issue where the compensation is given not to the donor, but to the donor’s family after death. Four countries provide forms of compensation or incentives to relatives of deceased donors;
Anonymity, traceability, transparency and information: the committee calls on all Member States to:
· set up rules for ensuring the traceability of tissues and cells of human origin from donor to patient and vice versa, as well as a system for the regulation of imports of human tissues and cells from third countries, ensuring that equivalent standards of quality and safety will apply.
· step up their public information and awareness-raising campaigns to promote the donation of tissues and cells and to ensure the provision of medical information that is clear, fair, scientifically based and conclusive and of data enabling the public to make informed choices;
· take coordinated actions to prevent the development of a black market in gametes on the Internet, as such a market risks both undermining the quality and safety of tissues and cells and raises legal, ethical and public health problems.
Exchanging best practice and reinforcing European and international cooperation: the report calls on Member States to step up exchanges of good practices, particularly with regard to the supply of tissues and cells, the protection of the quality of tissues and cells while they are being transported, raising awareness of donating and training health staff. The Commission and Member States should consider the possibility of setting up a Europe-wide database of donors and potential recipients in order to manage supply in the general interest and avoid shortages where possible. Members particularly applaud the role in this field of Eurocet, which has played a crucial role in acting as the central European database for the collection of data on tissue and cell donation and transplantation activities. They call on Member State authorities to reinforce their collaboration with Eurocet in order to agree further common standards in the donation of cells and tissues and thereby enable healthcare professionals to improve the matches offered to European citizens.
Cord blood and stem cells: Members recognise the significant scientific advances made in the cord blood field, which is a very promising therapeutic alternative in the treatment of many diseases, including children’s illnesses. They call therefore on the Commission and Member States to take appropriate measures to establish a regulatory framework which could stimulate increased availability of umbilical cord blood stem cells.
The committee regrets that at present, stem cells from umbilical cord blood are only stored at 1% of total births in the EU. Member States are asked to raise awareness of public cord blood banking through information campaigns that may take place, for example, during antenatal classes, and proposes that in compliance with the provisions of the Charter of Fundamental Rights of the European Union.
Furthermore, comprehensive, objective and accurate information should be provided about the advantages and disadvantages of cord blood banks. The report proposes that Member States consider adopting and enforcing operational and ethical standards for public and private cord blood banks that uphold the principle of non-commercialisation of the human body and its parts, for example, and ensure traceability. It expects all Member States to establish at least one public stem cell bank, and calls for European standards and requirements for private stem cell banks.
Members note that collaboration models and opportunities between public and private sectors already exist in some Member States, and they encourage public and private cord blood banks to collaborate closely in order to increase the availability and exchange of national, European and international cord blood and tissue samples. They call on Member States to appropriately regulate both public and private banks to guarantee the fullest transparency and safety of cord blood, and also highlight the development of non-intrusive procedures of harvesting stem cells using peripheral blood stem cell collection (PBSC).
Whilst emphasising that it is for the Member States to decide whether to allow, prohibit or regulate research with human embryonic stem cells and in vitro fertilization, Member States must respect the rules set out in Directive 2004/23/EC,
The Commission is asked to:
· propose a revision of Directive 2004/23/EC in order to bring it into line with the principles governing organ donation laid down in Directive 2010/45/EU, and to take into account the new legal situation after the entry into force of the Lisbon Treaty, scientific developments, the practical experience of those involved in the sector and the recommendations of this report;
· propose a revision of Regulation (EC) No 1394/2007 in order to include a provision that guarantees the application of the principle of unpaid donation similar to that referred to in Directive 2010/45/EU and to take into account the problems that have occurred in respect of the implementation of the regulation, especially for SMEs.