Monday, January 21, 2008

World Medical Association warning to ophthalmologists on cash for tissues

The world’s leading body of physicians has lent its weight against the sale of corneal tissue, according to Paul McGinn, writing in the February edition of EuroTimes.

In its “Statement on Human Tissue for Transplantation,”the World Medical Association has warned ophthalmic surgeons and all other physicians who transplant tissue to oppose transplants where a donor’s family receives cash for donated tissue.

“Financial incentives such as direct payments for donating tissue for transplantation are to be rejected – in the same way that they are in connection with organ transplants. All other steps, such as the procurement, testing, processing, conservation, storage and allocation of tissue transplants, should likewise not be commercialised,” reads the statement, which the association adopted at its annual meeting in Copenhagen last October.

The adoption of the statement follows by seven years a similarly worded association statement that banned physicians from transplanting organ purchased from donors or their families.

Although the statement of itself does not legally bind a physician to follow it, physician regulatory bodies throughout the European Union often rely on such statements in deciding whether physicians have acted unethically. Some statements, notably the association’s Declaration of Helsinki – which sets ethical parameters for clinical trials – have been adopted by a number of physician regulatory bodies into their own codes of ethical conduct and as such, can carry the force of law.

According to the Statement on Human Tissue for Transplantation, physicians involved in harvesting, processing and transplanting tissue must balance the rights of the tissue recipients with the rights of the families of the deceased donors, the statement adds.

“Physicians are fundamentally obliged to treat patients according to the best of their knowledge and expertise. However, this obligation must not be taken to the point where, for example, the human tissue necessary for therapy is procured in an unethical or illegal manner,” the statement reads.

“Tissue must always be procured with due consideration for human rights and the principles of medical ethics. To secure the provision of tissue for transplantation, physicians should inform potential donors and/or their family members about the possibility of tissue donation. In the event of combined organ and tissue donation, information should be provided, and consent obtained, in one step,” the statement adds.

In addition to its ban on the sale of tissue, the new statement also bans the use of corneal tissue donations from prisoners, the nomination of specific recipients for donated corneal tissue, and the coercion of potential donors or their families.

“The voluntariness of tissue donation must be ensured. The informed and non-coerced consent of the donor or his/her family members is required for any use of human tissue for transplantation. Free and informed decision-making is a process requiring the exchange and understanding of information and the absence of coercion,” the statement reads.

In addition, the statement also specifies that:

1. Risk of disease and infection “must be minimized through appropriate testing that does not merely comply with sufficient standards, but additionally reflects the respective, nationally implemented state of medical science and technology”;

2. If there is any delay in diagnosing an infectious disease or malignancy in the donor, “an alert should immediately be reported to all tissue recipients in order to institute the appropriate precautionary steps”;

3. Physicians and all other personnel involved in removing, storing, processing and transplanting tissue must take all necessary steps to avoid contamination;

4. Physicians should allocation tissue only according to the medical indication, urgency and prospects of success of the transplant.

5. All experimental and clinical studies involving tissue must be conducted in accordance with the Association’s Declaration of Helsinki. In addition, scientists and physicians should continuously inform the public about developments in tissue medicine and its therapeutic options.

6. Physicians and their national and specialty medical associations should lobby their respective state agencies and governments to ensure they regulate the international exchange of tissue for transplantation according to appropriate standards.

7. Any information about tissue donors that is stored or maintained by national transplant organizations or tissue banks should be provided only if the living donor or family of the deceased donor provides free and informed consent to such release.

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For more information about the new statements from the World Medical Association, visit www.wma.net. For more stories from EuroTimes, visit www.escrs.org

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