Commentary: The World Health Assembly Resolution on Human Organ and Tissue Transplantation

On May 21, 2010, the 63rd World Health Assembly (WHA) endorsed the World Health Organization (WHO) Guiding Principles on human cell, tissue, and organ transplantation (1). These principles and the accompanying resolution, Sixty-Third World Health Assembly—WHA 63.22 (2), are published on pages 229–235, and their adoption marks a seminal day in the history of transplantation. This means that Minister of Health of each country with transplantation practices has now agreed to these principles. The representatives of the member states that commented on the Resolution and Guiding Principles were Australia, Chile, China, Gabon, Germany, Iraq, Nepal, Pakistan, Peru, Thailand, South Africa, Spain, Taiwan-China, and United States. All spoke in strong support of the resolution and these principles, and there was not a negative sentiment in the room. These guiding principles should, thus, be expected to guide your government. The WHA urged governments to take actions that you will applaud, but which may lead to changes in your environment with respect to transparency, allocation, regulation of safety, and in general with respect to oversight of transplantation practices. There is, for example, a request to encourage the implementation of globally consistent coding systems for human cells, tissues, and organs to assist in traceability. The resolution also turns back to the WHO and requests that the Director General to undertake seven actions, which between them provide an ongoing workload for the WHO Secretariat—the WHO has thus been requested to stay on the job. Governments of the world are concerned about organ trafficking, adverse events after transplantation, and the need for analysis of global data on safety, quality, efficacy, epidemiology, and ethics of our work. They have asked the Director General to report back every 4 years on progress, so they clearly do not want the WHO's eye to stray from the ball. One might ask whether this resolution is unusual—do the governments of the world have the same concern over all other fields of clinical practice? The answer is that outside of communicable diseases, “transplantation” is exceptional for the attention paid to it, especially as it may be seen as a niche high technology clinical practice with no place in the world of HIV, polio eradication, oral rehydration, resistant tuberculosis, and other infectious diseases that kill large numbers of people. There is a second remarkable phrase in the resolution: “by encouraging health-care professionals to notify relevant authorities. . . . ” The governments of the world have acknowledged our critical role in understanding and identifying the clinical practices that blight our field. Member states are urged to seek our assistance in opposing financial gain from trafficking in human body parts. This may be one of only two or three instances in the history of the WHO in which governments have recognized the role of healthcare professionals in accomplishing the tasks that they establish for themselves. The Guiding Principles are revised from a previous version endorsed by the WHA in 1991. So, one might ask whether there is anything new? The answer to that question is both yes and no. The Guiding Principles (1) published on pages 229–233 include nine principles that have not changed significantly, together with the rationale for each of them and two new principles. For those among us who believe that organ donation can best be increased through the application of market principles and by cash for organs, there is a reaffirmation that your government does not accept that view and indeed opposes it. “Purchasing or offering to purchase. . . . should be banned.” Human trafficking and brokering are issues of interest not only to the WHO but also to the United Nations and other agencies of the United Nations involved in human trafficking. We can be clear that we are supported in opposing these heinous practices. The two new guiding principles are numbers 10 and 11. Principle 10 focuses on safety, quality, and efficacy, whereas principle 11 concentrates on the twin concepts of transparency of practice and protection of the privacy of individual donors and recipients. These principles place a new burden on governments to adjust their regulatory systems to encompass our field with greater effect than they have to date. This adopted resolution by the WHA is in concert with the principles of the Declaration of Istanbul on Organ Trafficking and Transplant Tourism (3). Just as the Istanbul Declaration is intended to influence practices of professionals and professional societies, the endorsement of the WHO Guiding Principles is intended to influence governments and Ministries of Health. This is a substantial step in a long journey in which your society has been proud to play a small part. The governments of the world and the WHO Secretariat have not discussed these weighty matters in isolation. The Transplantation Society has been a constant influence at each step of the way, from our first meeting between the Transplantation Society and the WHO Secretariat in 2003 in Chicago, through three global WHO consultations, in Madrid twice and in Geneva, and through many regional consultations, chairing, reporting, advising, discussing, and promoting our field. There is much work to be carried out in the years ahead if we are to bring the benefits of transplantation to all communities of the world, but this is an important step in that journey, and May 21, 2010 was an important day.

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