INTRODUCTION

The use of human cells and tissue for therapeutic purposes in medicine covers a broad spectrum. A differentiated examination is necessary in order to do justice to the different requirements of the various sectors of tissue medicine.

The use of so-called "tissue transplants", such as corneas, bone, blood vessels and cardiac valves, is an established treatment method in medicine. Tissues are removed, conserved, stored and then implanted in patients after varying periods of time. In principle, they should therefore be treated in the same way as organs that are used for transplantation (cf. WMA Statement on Human Organ and Tissue Donation and Transplantation, Edinburgh 2000).

In contrast, so-called "advanced therapies", such as tissue engineering and other techniques of regenerative medicine, involve the use of human tissue as starting material for manufacturing a processed end product. Even though established therapeutic options already exist, it can be expected that the therapeutic importance of these methods may continue to increase, and that there may be many developments in this field in the future. In view of the further processing of the tissue involved, the frequently industrial nature of the manufacturing organizations and the possibility of tissue being pooled, different regulations are necessary for this sector of tissue medicine than for tissue transplantation.

The WMA limits this Statement to tissue in the sense of tissue transplants, and gives the following Recommendations for this sector of tissue medicine:

1. 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. Tissue must always be procured with due consideration for human rights and the principles of medical ethics.
   
   
2. 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.
   
   
3. 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. Because prisoners and other individuals in custody are not in a position to give consent freely and can be subject to coercion, their tissues must not be used for transplantation except for members of their immediate family.
   
   
4. Financial incentives such as direct payments for donating tissue for transplantation are to be rejected - in the same what 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.
   
   
5. If both organs and tissue can be removed from a potential donor for transplantation, organ donation must be given priority over tissue donation.
   
   
6. Posthumous donation of tissue to a specific recipient (directed donation beyond the immediate family) is to be avoided. Living directed donation requires both:
   
   1. proof of direct personal ties between donor and recipient (e.g. blood relations, spouses), and
   2. exclusion of potentially coercive material interests.
      
      
7. For posthumous tissue donation, the WMA calls for the determination of death to be conducted in accordance with its Declaration of Sydney on the Determination of Death.
   
   
8. The risk of diseases (e.g. infections, malignant tumors) being transmitted by transplanted tissue 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.
   
   
9. In the case of a delayed diagnosis for infectious disease or malignancy of the donor, an alert should immediately be reported to all tissue recipients in order to institute the appropriate precautionary steps
   
   
10. Contamination must be avoided when removing, storing, processing and transplanting tissue.
    
    
11. Unethical allocation formulas for tissue transplants are to be rejected. Allocation should be based on the medical indication, urgency and prospects of success.
    
    
12. Experimental and clinical studies, as well as open discussions on ethical and moral principles in society, are important for establishing new therapeutic methods. All experimental and clinical studies are to be conducted in accordance with the WMA Declaration of Helsinki. Scientists and physicians should continuously inform the public about developments in tissue medicine and its therapeutic options.
    
    
13. International exchange of tissue for transplantation should be properly regulated according to agreed upon standards.
    
    
14. Information on tissue donors should be stored and maintained by national transplant organizations and should be provided only if the living donor or family of the deceased donor provides free and informed consent.