Human Tissue: Ethical Issues
Safety and quality
13.44 The regulation of the safety and quality of human tissue for different uses, and of medicinal products or devices incorporating human tissue, is discussed in Chapter 12. There is, rightly, much concern stimulated by these issues. The regulatory regime is voluminous and complicated, originating as it does from different sources: local, national, European and international (paragraphs 12.2 - 12.5). Recently, attempts have been made to harmonise and standardise regulatory provisions (paragraphs 12.38 - 12.40). In the UK, if the protection offered by regulation fails, or is thought to have failed, and harm ensues, there are limited opportunities to pursue claims through the courts (paragraph 12.41 - 12.66).
13.45 One area of uncertainty is in the regulation of medical devices incorporating human tissue. The extent to which medical devices incorporating human tissue will be covered in proposed European legislation is not clear. It is undesirable that such devices should fall through a gap in the regulatory network and we believe that there should be comprehensive guidelines covering their manufacture and use. We recommend that the Department of Health should seek to ensure that the proposed European Directive on In Vitro Diagnostic Medical Devices, and other relevant guidelines covering medical devices, include medical devices incorporating human tissue (paragraphs 12.17 - 12.20).
13.46 We have highlighted the need for the coordination and regulation of tissue banks in order to maximise the efficiency of tissue supply, ensure that tissue is supplied to users on a cost-recovery rather than a profit-making basis and regulate the safety and quality of human tissue so that best standards of practice are maintained throughout different centres in the UK (paragraph 12.33). The increased use of donated tissue, and awareness of the need for strict safety precautions, is leading to increasingly stringent screening and selection of donors. Ethical issues arise in connection with the role of consent to questioning, the obligation to disclose information, record-keeping, confidentiality, counselling and the ability to trace donors. These issues will also have arisen in the review of tissue banking that is currently being carried out by the Department of Health. We recommend that, when the tissue banking review is completed, the Department of Health, in consultation with the appropriate professional bodies, should seek to take account of these concerns (paragraph 12.36).
13.47 There are currently inconsistencies in the arrangements for compensation of patients or healthy volunteers who suffer any injury in the course of research in the UK. Fortunately, such cases are rare. We recommend that the major bodies responsible for research funding, such as the Department of Health, the Medical Research Council, medical research charities, and pharmaceutical and biotechnology companies, should consider how arrangements could be standardised to provide fair and adequate compensation in such cases (paragraph 12.64).
13.48 Apart from injuries sustained during research activity, those seeking compensation for harm suffered as a direct or indirect consequence of the use of human tissue have to rely upon civil laws relating to medical malpractice and drug litigation. These procedures are complicated, lengthy, costly and widely regarded as unsatisfactory. We support those who seek a further review of this area of the law (paragraphs 12.65 - 12.66).