International Perspectives on the Ethics and Regulation of Human Cell and Tissue transplantation/Points De Vue Internationaux Sur L'ethique et Al Reglementation De la Transplantation De Cellules et De Tissues humains/Perspectivas Internacionales Sobre la Etica Y la Regulacion De Trasplante De Celulas Y De Tejidos Humanos
Schulz-Baldes, Annette, Biller-Andorno, Nikola, Capron, Alexander Morgan, Bulletin of the World Health Organization
From its origins with the first successful transplant of banked cadaveric tissue in the first half of the 20th century, the transplantation of human tissues (HTs) has become a widely practised surgical procedure. (1) Today, HTs are transplanted across the globe not only to save lives, but also to improve lives through reconstructive and cosmetic interventions. Due to the growing demand for HTs and the increasing quality and safety standards required in tissue banking, many of the original hospital-based tissue banks, designed to meet local needs, have been replaced by national or multinational HT organizations which sell their products internationally and may operate on a for-profit basis.
In parallel, the transplantation of human cells (HCs)--haematopoietic progenitor cells in particular--has evolved into a widely used clinical activity. After the first successful bone marrow transplants in the 1960s, subsequent advances in immunosuppressive and antibiotic therapy have made haematopoietic progenitor cell transplantation an established treatment for a wide variety of genetic and malignant diseases. (2) As with HT, haematopoietic progenitor cells are exchanged globally today, (3) driven by the need to find a donor that closely matches the human leucocyte antigen type of the recipient. Profit-making has also been introduced into the field with the establishment of for-profit (private) autologous cord blood banks and a growing number of clinics offering experimental cell transplants. (4,5)
Current practices in HC/HT transplantation raise several questions that need to be addressed jointly by clinicians, scientists, health regulators and ethicists as well as representatives of civil society, in particular HC/HT donors and recipients. The increasing commercialization of HC/HT products has multiplied opportunities for profit-making and increased the risk of clinically unsafe and unethical practices (particularly in HT procurement). Recent scandals in the United States of America (6,7) and other countries (8,9) involving nonconsented procurement underline the urgent need for a common global technical and ethical framework. Although a number of regulations on HC/HT transplantation have been adopted in the past several years or are currently under discussion, (10-12) national regulation and oversight of HC/HT transplantation is nonexistent or inefficient in many countries.
Moreover, regulation is no longer merely a national matter because HCs/ HTs can be processed, preserved and easily transported around the globe. While the international circulation of HCs/HTs can facilitate access, it can also spread tainted material, create global inequities in donation or accentuate inequities in access to HC/HT services. The lack of ethical guidance and the existence of unmonitored or unregulated HC/HT procurement and distribution represent a serious international risk to both donors and recipients of cells and tissues.
WHO has given special attention to human cell and tissue transplantation in the process of updating its 1991 Guiding principles on human organ transplantation, (13) an activity which has been ongoing since 2004. (14) As part of this process, WHO's Departments of Essential Health Technologies and Ethics, Trade, Human Rights and Health Law held a meeting jointly with the Institute of Biomedical Ethics, University of Zurich, in July 2006. The meeting involved an international group of experts on transplantation medicine, nursing, ethics, social sciences, law and policy-making. Meeting participants were: Tsuyoshi Awaya (Okayama University, Japan), Nikola Biller-Andorno (University of Zurich, Switzerland), Arlinke Bokhorst (Bio Implant Services, Leiden, Netherlands), Alexander Capron (WHO, Geneva, Switzerland), Mar Carmona (WHO, Geneva, Switzerland), Francis Delmonico (Transplantation Society, Boston, MA, United States), Deirdre Fehily (Centro Nazionale Trapianti, Rome, Italy), Gregorio Garrido Cantarero (Organizacion Nacional de Trasplantes, Madrid, Spain), Jens Gobrecht (WHO, Geneva, Switzerland), Alois Gratwohl (University of Basel, Switzerland), Bernadette Haase-Kromwijk (Dutch Transplant Foundation, Leiden, Netherlands), Marisa Herson (Asociacion Latinoamericana de Bancos de Tejidos, Sao Paulo, Brazil), Roman Hitchev (Osteocentre Bulgaria FAD, Sofia, Bulgaria), Liisa Kok (Dutch Ministry of Health, Netherlands), Jan Koller (Central Tissue Bank, Bratislava, Slovakia), Theo Le Roux (University of Pretoria National Tissue Bank, South Africa), Nabila Metwalli (WHO EMRO, Cairo, Egypt), Conrad Miiller (Swiss-transplant, Berne, Switzerland), Alessandro Nanni Costa (Centro Nazionale Trapianti, Rome, Italy), Aziz Nather (National University of Singapore, Singapore), Luc Noel (WHO, Geneva, Switzerland), Jan Pierce (American Association of Tissue Banks, McLean, VA, United States), Virender Sangwan (LV Prasad Eye Institute, Hyderabad, India), Volker Schmidt (National University of Singapore, Singapore), Annette Schulz-Baldes (University of Zurich, Switzerland), Naoshi Shinozaki (Cornea Center, Ichikawa, Japan), Magi Sque (University of Southampton, United Kingdom), Caroline Trouet (European Commission, Brussels, Belgium), Yongyudh Vajaradul (Siriraj Hospital, Bangkok, Thailand), Riidiger von Versen (German Institute for Cell and Tissue Replacement, Berlin, Germany) and Kathryn Wood (Transplantation Society, Oxford, United Kingdom). …