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3 December 2002In July 2002, the House of Commons Select Committee on Science and Technology issued a report that criticised several aspects of the current regulatory regime governing developments in human genetics and embryology. In its reply to the Committee’s assertion that the Human Fertilisation and Embryology Authority does not function efficiently, the Government says that it has approved the HFEA’s request to make a large increase in the licence fee charged to clinics carrying out assisted reproduction procedures, and that it is also substantially increasing funding for the HFEA’s other work, including the regulation of embryo research and public consultation. It expects these increases in resources to enable the HFEA to function more efficiently. In contrast, the Government does not see a need for a large increase in funding for the Human Genetics Commission, but says that it views sympathetically requests for ad hoc funding for specific large projects. Countering a suggestion by the Committee that the current overall regulatory regime is unnecessarily complex and fragmented, the Government says it is satisfied that the existing committees have distinct and complementary functions, and work well together.
In the area of legislation and regulation, the Government says that it is maintaining an active role in the international arena, participating, for example, in discussions in the United Nations on a ban on reproductive cloning, and with the Council of Europe on an additional protocol to the Convention on Human Rights and Biomedicine. On the home front, it promises that if a pending appeal to the House of Lords by the Pro-Life Alliance succeeds, it will enact primary legislation to bring the technique of therapeutic cloning (somatic cell nuclear replacement) within the regulatory remit of the Human Fertilisation and Embryology Authority.
10 December 2002On 5 December, the House of Lords debated the report published earlier this year by its Select Committee on Stem Cell Research. This Committee was established when Regulations permitting the use of embryonic stem cells for research on stem cell therapy were passed by parliament. The establishment of the Committee was a response to the assertion by some MPs and peers that there had been insufficient examination of the ethical and scientific issues. The Committee’s conclusion was that embryonic stem cell research should be permitted, subject to regulation by the Human Fertilisation and Embryology Authority. The Government, in its response to the Committee’s report, accepted almost all of its recommendations.
The deep divisions of opinion on this subject were again aired in the Lords’ latest debate. There was also criticism that the Committee was composed only of people who either supported the Regulations or were undecided, and that no members had been chosen from among those peers who voted against embryo research. In addition, the credentials of the HFEA to regulate research adequately were questioned, in view of recent criticism of its activities. Questions were also raised about the commercial benefits to be derived from stem cell lines, and the issues raised by patenting. Nevertheless, several peers spoke robustly in favour of the report, drawing attention to its broad evidence base and the advantages of the UK’s regulatory approach to this issue. In his remarks on behalf of the Government, Lord Hunt outlined the Government’s commitment to strengthening and supporting the HFEA, and pointed out the benefits of the establishment of the publicly owned National Stem Cell Bank, which should gradually reduce the need for further use of embryos. The Lords voted to accept the Committee’s report.
3 December 2002The NHS Information Authority is running a public consultation on a draft strategy for protecting patient confidentiality. Under the NHSIA’s proposals, patients would have a considerable degree of control over who had access to their medical records and for what purposes. It would be assumed that patients consented to make their information available to bona fide practitioners directly involved in their care, and this assumption of consent would be underpinned by a concerted campaign of public information to raise awareness about ways in which patient information are used and how confidentiality is protected. Information would be provided on a “need to know” basis, that is, a practitioner would see only that part(s) of the record that was relevant to their role in the patient’s care. Information used for purposes other than direct care would either need to be anonymised or consent sought, except where the use fell into categories covered by regulations under Section 60 of the Health and Social Care Act. Patients would be able to restrict access to any information they deemed particularly private or sensitive though there would be provision for overriding these wishes in an emergency where consent could not be sought. The proposed model makes provision for an “audit trail” that would record every use of a patient’s record; any use without consent would trigger the involvement of a “privacy officer” to check that the breach of confidentiality had been justified.
As well as the proposed confidentiality model, the consultation documents also include a draft “National Patient Information-Sharing Charter”, a draft code of practice for NHS staff, a report on a background survey of people’s views carried out by the NHSIA in collaboration with the Consumers’ Association, and a draft video script for public information. The draft code of practice for staff sets out the key principles and the legal background and then, in a series of Annexes, provides detailed coverage of such issues as the importance of maintaining accurate records, good practice in storing patient information, informing patients and providing patient choice. It also sets out a decision support tool for situations where practitioners need to decide whether to disclose confidential information.
The consultation documents can be viewed and responded to on-line, or copies of the pack may be ordered from the NHSIA on 08453 660066. The consultation ends on 31 January 2003.
13 December 2002A substantial amount of research effort is currently focused on attempts to identify genetic factors associated with variation in cancer susceptibility, and with variation in aspects of tumour biology, tumour progression and disease prognosis. Some of the genetic variants investigated have been constitutional ones (that is, present in all body cells) and some have been variants that are restricted to tumour cells and may be implicated in the mechanism of cancer development in a particular tumour type. Thunberg et al report that a constitutional polymorphism in the P2X7 receptor gene, which encodes a protein thought to have a role in regulating the balance between cell proliferation and cell death, may be associated with overall survival in patients with B-cell chronic lymphocytic leukaemia (CLL) [Thunberg, U. et al (2002) Lancet 360, 1935-1939]. They studied a total of 170 patients, of whom 21% carried at least one copy of the 1513C allele of the P2X27 gene, and 79% were homozygous for the more common 1513A allele. They report that heterozygous A/C patients survived longer (104 months) than homozygous A/A patients (72 months). They also investigated the relationship between constitutional PX27 genotype, the tumour genotype for mutations in the immunoglobulin heavy chain (VH), and survival, and found that among patients with mutated VH genes, there was an even greater survival difference (53 months) between those carrying the 1513C allele of the PX27 gene and those carrying the A allele.
Comment: Other studies cited by Thunberg et al and discussed in an accompanying commentary [Di Virgilio, FD and Wiley, JS (2002) Lancet 360, 1898-1899] have also investigated the relationship between P2X27 receptor function, polymorphisms, and CLL. The results have been variable and not all studies appear consistent with those reported by Thunberg et al. These authors point out that the same genetic variant could affect different aspects of tumour induction and progression in different ways, leading to a level of complexity in genotype/phenotype correlation that could be very difficult to unravel. It is also important, however, to keep in mind that the confidence intervals reported by Thunberg et al are broad and overlapping, and further studies on larger numbers of patients are needed to clarify this issue.