EDITORIALS

Current concerns in transplantation

Luc Noël¹

Department of Essential Health Technologies, World Health Organization, 20 avenue Appia, 1211 Geneva 27, Switzerland

As long as the global supply of tissues, cells and organs for transplant does not meet needs, desperate patients are easy prey for unscrupulous individuals. Yet countries including Spain and the United States of America have shown that it is possible to make progress towards self sufficiency in transplants by meeting these needs with altruistic donations. Achieving national self-sufficiency is not easy. It requires a level of commitment from society that very few countries have been able to garner, but building this commitment arguably costs much less in the long term than relying on the payment of "volunteers"- inevitably the poor and vulnerable.

In contrast to organs, most human tissues and cells destined for transplantation can be processed, preserved and stored, often for long periods. Their transportation can be very easy and shipping across national boundaries is sometimes necessary to best meet patients' needs. Risks of ethical breaches arise at all stages; from consent to donation through to the allocation of transplants, and the clinical care of donors and receipients. Recent cases of cadaveric tissue theft have shown how unethical behaviour in tissue procurement bypasses the safety barriers designed to decrease the risk of transmitting infectious diseases to receipents.^1,2 The international circulation of human cells and tissues may also be an opportunity for hefty profit. Those who wish to profit from this trade do so by taking advantage of both poor people and their need for income, and of wealthy patients' needs and their ability to pay.

The international organ trade is widely referred to as "transplant tourism". This entails cross-border travel by any participant in transplantation (recipients and/or surgeons and/or live donors) for the purpose of obtaining an organ in exchange for cash or goods. The profit motive predominates in this trade, more than the interest of the patients, and care for the live organ donor is secondary or non-existent.

This issue of the Bulletin contains two papers on transplantation: the first is dedicated to the ethical aspects of cell and tissue transplantation,³ the second is an attempt to produce a picture of the international organ trade.⁴

Both papers are outputs of WHO's consultation process in response to Resolution 57.18 of the 2004 World Health Assembly on updating the 1991 Guiding Principles for Human Organ Transplantation. Resolution 57.18 requested WHO's Director-General to collect global data on all aspects of transplantation - including ethical issues. With the support of the Spanish government, WHO has contributed to a global knowledge base on transplantation designed to document the global situation of legitimate transplantation from official sources in most Member States.⁵

However, there is no such official source of data on transplant tourism. This trade is illegal wherever relevant laws exist. Measuring the extent of this illicit trade is impossible, and Shimazono's paper⁴ takes the necessary, but limited, first step of gathering available information in order to form a first estimate. This paper is further limited by its identification of transplant activities from publications and in only two languages. It does not attempt to quantify the activity of concealed organizations and undercover networks which are known to exist. The paper thus underestimates activity while providing an important basis for future work. It confirms that transplant tourism is a global issue deserving a global response. It stresses the importance of drafting and implementing legislative frameworks for transplantation. Indeed, the legislative frameworks banning commercial transplantation that China and Pakistan adopted in 2007 have already resulted in the closure of web sites advertising commercial transplantation services in these countries, and foreign candidate recipients have been sent back to their own countries.

The global consultation process that WHO undertook in order to update the Guiding Principles reinforced the spirit of these principles as they were originally drafted in 1991.⁶ Cells, tissues and organs should only be donated freely without monetary payment or other rewards of monetary value. Purchasing - or offering to purchase - cells, tissues and organs for transplantation or their sale by living persons or by the next of kin for deceased persons should be banned.

WHO's draft update of the Guiding Principles stresses the importance of tracing transplants from donor to recipient and vice versa. This is a quality and safety requirement necessary both for investigations of disease transmission and the recall of sub-standard human cell and tissue products. Traceability also indicates the origin of the transplant and contributes to maintaining ethical practices in transplantation. WHO is advocating for global coding standards to facilitate trans-national tracing. Guiding Principle 11 addresses transparency as an essential prerequisite to building public trust and fostering the will to donate. Transparency should encompass all transplantation organizations, activities, and outcomes, while maintaining the necessary anonymity and privacy of donors and recipients.

References

1. Order to Cease Manufacturing and to Retain HCT/Ps. US Food and Drug Administration, Center for Biologics Evaluation and Research; 2006. Available at: http://www.fda.gov/cber/compl/bts013106.htm        

2. Order to Cease Manufacturing and to Retain HCT/Ps. US Food and Drug Administration, Center for Biologics Evaluation and Research; 2006. Available at: http://www.fda.gov/cber/compl/bts013106.htm        

3. Schulz-Baldes A, Biller-Andorno N, Capron AM. International perspectives on the ethics and regulation of human cell and tissue transplantation. Bull World Health Organ 2007; 85:941-948.        

4. Shimazono Y. The state of the international organ trade: a provisional picture based on integration of available information. Bull World Health Organ 2007; 85:955-962.        

5. Global Observatory on Donation and Transplantation. Available at: http://data.transplant-observatory.org/paginas/informes/DatosUsuario.aspx        

6. Draft guiding principles on human organ transplantation. Geneva: WHO. Available at: http://www.who.int/ethics/topics/transplantation-guiding-principles/en/        

1 Correspondence to Luc Noël (e-mail: noell@who.int).