Legal and Regulatory Issues

Abstract

The review of developments and key issues so admirably presented by Professor Daar raises concerns of appropriate legal and regulatory responses at three levels, namely governmental, clinical and social. Governmental approaches Developments in medical technology need not necessarily induce a legislative or regulatory response. Professor Daar notes that the field of xenotransplantation is moving very rapidly. This may caution governments against rushing to legislation that risks being overtaken by events, thus denying benefits to those whose interests governments claim to serve. Such a rush could, for instance, freeze governments into ill-considered positions, shaped perhaps by misguided stereotypes or imaginary horrors that are irrational and become increasingly indefensible. We have recently seen how moral panic over prospects of human cloning has resulted in demands for prohibitive laws that would endanger respect for values such as the right to freedom of therapeutic and academic enquiry, the right to reproductive choice and the right to benefit from scientific advances. Nevertheless, the concerns Professor Daar raises include risks to recipients of animal organs and cells, as well as to their companions and the public at large, that justify governmental scrutiny. The contrast is presented between the regulatory approach recommended in the United Kingdom by the Kennedy Report (1) and the advisory approach favoured by the United States Institute of Medicine (2). The regulatory approach depends on legislation that empowers a regulatory agency to approve or reject prospective xenotransplants. It protects potential recipients against their own and others' disregard of dangers arising from xenotransplantation, and it protects family members and others whom patients might expose to animal-derived infections, and the wider public. This approach may be criticized for being paternalistic, but people who in other regards are competent adults may feel that they have only an infantile understanding of the scientific implications of xenotransplantation, and appreciate informed regulation of this technology. This is particularly so if they see the technology as being promoted by commercial rather than therapeutic interests. The advisory approach favours informed, autonomous choice rather than governmental direction. An advisory council can often be legally constituted under existing governmental powers, but legislation may be required for payment of council members and administrators. If public health authorities or public clinics incorporate advisory council recommendations into their practices, principles of administrative law may apply. If their decisions affect patients' or staff members' legal rights or legitimate expectations, for instance to receive or render appropriate treatment, the persons concerned may be entitled to contradict advice and oppose recommendations before final decisions are made. Public authorities whose decisions affect others' legal interests cannot voluntarily surrender their duty of judgement to another agency like an advisory council. Though not directly legally binding, advisory council recommendations can have legal effects through the professional licensing of health care providers, and through private service contracts. Professional licensing authorities may consider disregard of such advice to constitute professional misconduct, and impose disciplinary sanctions such as the withdrawal or suspension of a licence. Similarly, it may be a written or implied term of a service contract that performance will follow such advice, and disregard may amount to breach of contract and justify its termination. Accordingly, advisory council recommendations on xenotransplantation can have serious but indirect legal consequences. Clinical approaches Professor Daar refers to the controversy over whether we are ready to embark on large-scale clinical trials of vascularized whole organs. …