Human Tissues and Cells

The EDQM/Council of Europe reinforces the need for strong ethical, safety and quality measures in the donation, handling and transplantation of human tissues and cells.

Founded in 1949, the Council of Europe is the oldest and largest of all European institutions and now numbers 47 member states. One of its founding principles is that of increasing co-operation between member states to improve the quality of life for all Europeans.

 

Within this context of intergovernmental cooperation in the field of health, the Council of Europe has consistently selected ethical problems for study. One of the most important of these ethical issues relates to the non-commercialisation of human substances i.e. blood, organs, tissues and cells.

Transplant medicine and transplantation have progressed during recent decades in a way nobody would have imagined years before. Tissue from one deceased donor may be transplanted into as many as 100 people. As with organs, the demand for some transplantable tissues and cells far outweighs the available supply. This has critical implications, considering that human cells and tissues for transplantation can save lives or restore essential functions, e.g. a corneal graft can restore sight in corneal blindness, having skin available for a traumatic burn can be critical for patient survival, and transplantation of haematopoietic stem cells can cure congenital or acquired diseases, including some leukaemias, and free recipient patients from long-term anti-coagulation therapy.

Saving and improving lives through tissue and cell allografts would not be possible without the altruistic and generous gift of donation from donors and their families. Although the pain of loss and grief is overwhelming for many tissue donor families, they often find support by honouring the donation wishes of their loved ones or by making a donation decision on their behalf. If a deceased individual has consented to the use of any part of their body for the treatment of others (or their relatives have authorised this after their death), much can done to fulfil this wish: bone, heart valves, skin, corneas, ligaments, cartilage, connective and adipose tissue, glands and nerves can all be used for therapeutic purposes.

Similarly, the hard work of healthcare professionals helps to save lives and improve the quality of life of many people. Nevertheless, healthcare professionals should never forget that the tissues and cells that can save or improve the life of millions of patients come from the selfless donation of a fellow human. Therein lie the ethical challenges for the use of such donations.

 

Ethical Aspects of Tissue and Cell Transplantation

 

The person donating tissues or cells may be living or deceased, these tissues or cells may be used almost immediately or stored for long periods of time and they may or may not be extensively processed. Whatever the case, handling and disposal of human tissues should be carried out in a manner that shows respect for fundamental rights and for the human body. The Council of Europe, through the Oviedo Convention: Protection of human rights and dignity of the human being with regard to the application of biology and medicine (European Treaty Series #164) and the Additional protocol to the convention on human rights and biomedicine concerning transplantation of organs and tissues of human origin (European Treaty Series #186), lays strong grounds for the preservation of human dignity, rights and freedoms, through a series of principles and prohibitions against the misuse of biological and medical materials. These were the first legally-binding international texts to specifically establish the prohibition of financial gain from the use of a part of the human body, to protect the dignity and identity of all persons concerned and to guarantee, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to transplantation of organs and tissues of human origin.

 

Voluntary unpaid donation, long promulgated as the only ethical basis for donation of bodily material, should continue to play a central role in the donation process. Physicians, health professionals and health insurers should not engage in transplantation procedures, nor cover such procedures, if the cells or tissues concerned have been obtained without appropriate donor consent or through exploitation or coercion of the donor or the next of kin of deceased donors.

 

Tissue banks storing and supplying fresh human tissues have developed largely in response to the increasing demand for supplies of human tissue for therapy and research. The costs associated with tissues do not reflect their value, which is priceless, but rather the expenses incurred through their recovery, processing and storage. Payments should never exceed the justifiable fees for these services. Professional bodies should ensure that their guidelines reflect their members’ responsibilities in the acquisition and supply of human tissues. Tissue banks should operate as professional organisations on a non-profit-making basis and not as commercial organisations.

 

Quality and Safety of Tissues and Cells

 

Every medical procedure comes with risks and benefits. As with all transplanted material of human origin, human cells and tissues carry risks of disease transmission, which must be controlled by the application of stringent donor selection criteria and comprehensive quality systems. High-quality, safe and efficacious procedures are essential for donors and recipients alike. The level of safety, efficacy and quality of human cells and tissues for transplantation, as health products of an exceptional nature, must be maintained and optimised on an on-going basis. This requires implementation of quality systems, including traceability and vigilance, and the reporting of adverse events and reactions, both nationally and for exported human products.

The European Committee (Partial Agreement) on Organ Transplantation of the Council of Europe (CD-P-TO) has, since 2002, been publishing the Guide to the Safety and Quality Assurance for the Transplantation of Organs, Tissues and Cells. As of 2013, specific guidance for tissues and cells will be published in the 1st edition of the Guide to the Quality and Safety of Tissues and Cells, which will provide sound information and guidance for all professionals involved in donation, banking, release, distribution and transplantation of tissues and cells, and inspection of the associated establishments. The CD-P-TO supports the concept of a uniform, global coding and labelling system to enhance traceability and recipient safety. The combination of all these standards will help optimise the quality and minimise the risks of these complex procedures, which will ultimately help improve the rate of successful tissue and cell clinical applications.