Legal framework for organ donation and transplantation.

The laws pertaining to organ donation and transplantation are new, innovative, and rapidly evolving. Over the past 9 years, the field has become increasingly legislated and regulated, more formalized, and more organized. Heart transplant centers must be certified in order to receive Medicare funding. OPOs must comply with UNOS policies and procedures in order to receive reimbursement. Cyclosporine is available to many more patients as a result of government funding. Donated organs must be shared according to specific criteria designed to ration these valuable national resources equitably and efficiently. The field of transplantation faces many challenges in the future. Perhaps one of the most ominous is the threat of increased litigation. Transplantation is no longer considered experimental, and patients are increasingly aware of their rights. The sheer increase in numbers of procedures will afford opportunities for lawsuits. Living related donors have a right to safe, reasonable, and effective treatment, irrespective of their donor status. Recipients have the right to receive viable, functioning organs free of infections and diseases. The law has defined a duty to question and test potential donors to reduce the possibility of transmission of disease and infection. Recipients and live donors have the right to provide informed consent. The physician has the duty to inform the patient of all inherent risks. Recipients also have the right to expect that their transplant will be performed at a level of competency in keeping with the national standard. Despite all the legal, medical, technical, and ethical activity devoted to the field of transplantation, one perplexing problem persists--the shortage of donated organs. Many more patients are availing themselves of the therapeutic effects of transplantation. Unfortunately, organ donation has not experienced a corresponding increase. The Uniform Anatomical Gifts Act of 1968 failed at its mission to increase, substantially, the numbers of donated organs. Required request legislation has increased the numbers of donor families who are afforded the opportunity to donate. However, many patients die in hospitals under circumstances permitting organ donation, and their families are never approached. Perhaps the 1987 amendments to the UAGA, once accepted by more states, will afford greater flexibility and a corresponding increase in donorship. If the spirit of cooperation fails, transplant programs and OPOs may be forced to request meaningful sanctions for noncompliance.