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26 November 2002The upper house of Australia’s Federal parliament (the Senate) has passed a Bill, which has already successfully passed through the lower house (the House of Representatives), to ban all forms of human cloning. The Bill bans not only reproductive cloning, but also so-called “therapeutic cloning”, in which a cloned embryo is produced by somatic cell nuclear transfer, with the aim of obtaining embryonic stem cells that might be usable to treat diseases such as multiple sclerosis or Parkinson’s disease (see Stem cells and cloning page for further details). An amendment banning the import or export of any cloned embryos or cells derived from them was also passed. The law is to be reviewed after three years, and the import/export ban after 12 months. The House of Representatives has also passed a second Bill, the “Research Involving Embryos” Bill, that would enable the use of excess frozen embryos produced by in vitro fertilisation technology for the production of embryonic stem cells. The use of fresh IVF embryos would also be permitted from 2005, provided these embryos had been created primarily for the purpose of assisted reproduction rather than research. This Bill has been considerably more contentious than the cloning bill, and after extensive debate a vote by the Senate has been delayed.  

Note added 9/12/02: The Senate has now passed the Bill that allows the use of surplus IVF embryos for stem cell research. Several amendments were made, but none changes the substance of the Bill.

13 November 2002The rapid development of technology that enables genetic diagnosis to be carried out on a single cell from an embryo before implantation, to avoid the birth of a child affected by a serious single-gene disorder carried by its parent(s), has led to questions about the circumstances in which preimplantation genetic diagnosis (PGD) should be made available by the National Health Service. The situation is complicated because PGD requires the use of assisted reproduction technology (in vitro fertilisation) to create the embryo, but is not a treatment for infertility. The Department of Health has issued guidance that includes an explanation of PGD, the regulatory framework, the evidence for efficacy of PGD, current availability and provision in the NHS, and current activity and outcome data across the country. The document concludes that PGD “may be a legitimate approach to reproductive choice” but that requests should be considered on a case-by-case basis. Priority should be given where the risk of the genetic disorder being passed on to the child is greater than 10%, and where the couple requesting treatment have no living or no unaffected children. It is suggested that the number of IVF cycles funded should be limited to 2 or 3. A flow chart sets out the referral pathway and highlights the points at which decisions should be made about proceeding further. 

13 November 2002The reorganisation of the NHS following the policy outlined in Shifting the Balance of Power places the main responsibility for commissioning health services on the new primary care trusts (PCTs). This has created some uncertainty with regard to specialised services, such as genetics services, that had previously been commissioned on a broader geographical basis. It was decided recently that the Regional Specialised Services Commissioning Groups would continue to operate for a further year while longer-term arrangements are put in place for genetics commissioning. The Genetics Commissioning Advisory Group, which advises the Department of Health on the commissioning of genetics services, has recently published a paper designed to give guidance to PCTs on the scope of genetics services, and on current and future arrangements for commissioning them. The paper outlines the need for PCTs to be aware of the range of genetics-based services in their area, including antenatal and neonatal screening programmes as well as the services covered by the definition of genetics services published as part of the National Specialised Services Definitions Set. The paper also flags up areas in which pressures may develop for commissioners during the next 3-5 years, including the expansion of rapid prenatal diagnosis techniques, the development of new national neonatal and antenatal screening programmes, increased requirements for genetic counselling in new settings such as primary care, and developments in presymptomatic genetic testing for cancer susceptibility. It stresses the need for commissioners to work with their local genetics services to anticipate new demands on the service and plan for their introduction, and mentions plans by the Department of Health to provide education and training opportunities in genetics for commissioners. It leaves open, however, the question of exactly how genetics commissioning will be organised in the future. 

1 November 2002A new international initiative, somewhat reminiscent of the international consortium that achieved the sequencing of the human genome, has been established to develop a “haplotype map” of the genome. The theory behind the International HapMap Project is that, within the human genome, different genetic variants within a chromosomal region (haplotypes) tend not to be found in all possible combinations; rather, certain combinations occur together far more commonly than others. The idea is that differences between haplotypes may be associated with differing susceptibility to disease, so mapping the haplotype structure of the genome would be a useful first step towards identifying the genetic basis of common disease. A five-nation consortium has now pledged a total of US$100 million over three years to construct a haplotype map based on 200-400 genetic samples from each of four different populations: the Yorubas in Nigeria; the Japanese; the Han Chinese: and individuals in the US with northern or western European ancestry. Additional work will be needed to find out whether the common haplotypes identified in these populations are representative of those in other populations, or whether additional populations will need to be included in order to identify the full range of haplotypes. Plans for the project include measures to ensure that it is conducted according to high ethical standards and protects the interests of participants. The stored DNA samples will have no personal identifiers other than the population of origin.  

6 November 2002The Cambridge Genetics Knowledge Park will be formally launched at an event to be held at Hinxton Hall Conference Centre, on the Wellcome Trust Genome Campus, on 7 November. The Cambridge Genetics Knowledge Park is one of six in England and Wales funded by the Genetics Challenge Fund established by the Department of Health and the Department of Trade and Industry. The Knowledge Park initiative in Cambridge is especially concerned with the ethical, legal and social implications of human genetics, providing national leadership in public health genetics and contributing to the development of policy for the application of genetics science in the health services. It will do this by ensuring greater collaboration between relevant organisations and developing appropriate networks that will encourage better working joint working, and stimulation of the transition of research into clinical and commercial practice and benefits.

21 November 2002Some commentators have predicted that pharmacogenetics – the use of genetic testing to determine the best drug for an individual patient – will be the first area in which genetic testing as part of mainstream medical practice will become a reality. The Nuffield Council on Bioethics has decided to take a closer look at some of the assumptions behind this prediction. As a first step, it has begun a consultation to seek views on a variety of issues under two main headings: economic and regulatory implications (including the economic impact on both drug companies and health services, the effect on the conduct of clinical trials, and the criteria for drug and test efficacy and safety); and ethical issues (including consent, privacy, confidentiality, equity of access to expensive treatments, and effects on different racial and ethnic groups). It points out that consideration of these questions must take into account the fact that a pharmacogenetic test would rarely provide a “yes” or “no” answer, but rather a probabilistic estimate of decreased or increased risk. The consultation closes on 19 February 2003 and the working party is expected to publish its report later next year.  

8 November 2002The members of the new Secretary’s Advisory Committee on Human Research Protections, to be appointed by the US Department of Health and Human Services, will be asked to consider “pregnant women, embryos and fetuses” among the groups whose interests are to be protected [see news report by Check, E. (2002) Nature 420, 3)]. Critics are concerned that this instruction reveals a political agenda to further impede embryo research by giving the embryo or fetus the status of a human subject and requiring research to achieve the impossible goal of preserving its welfare. A spokesman for the DHHS has denied that this is the aim of the instruction; rather, he says, it is intended to draw attention to the need to inform a woman who is or may be pregnant that participation in a research study may affect the development of her baby. Nevertheless, scientists are wary about the way in which the instruction may be interpreted by those appointed to the committee. 

14 November 2002Efforts to achieve agreement in the United Nations to ban human reproductive cloning have foundered, at least for the time being, because of disagreement about the scope of the ban (see reports in Nov 16 Lancet, p. 1574 and Nov 15 Science, p. 1316). A group of 37 nations spearheaded by the United States wants the ban to encompass so-called “therapeutic cloning” as well as reproductive cloning. However, 20 other countries, led by France and Germany, oppose this approach on the grounds that, as there is no international consensus about therapeutic cloning research (which is currently legal in several countries including the UK, Singapore and The Netherlands, and by private companies in the US), argument on this issue would delay or defeat the aim of banning reproductive cloning. Indeed, such a delay is exactly what has happened. The UN working group on cloning will not now make a decision until late 2003.  

29 November 2002In recent years, concern has grown about how individual privacy may be protected when medical information is used for research or health surveillance, and how the ideal of privacy can be reconciled with the value, to the whole of society, of knowledge gained from these activities. As concern has grown, so has confusion, with a plethora of legislation and guidance on the use of personal data in general, and health data in particular (see page on Human genetic databases and the protection of medical information for background information). In a report for the Nuffield Trust, William Lowrance seeks to explain the background, clarify the law, identify the relevant ethical issues and chart a way forward. The report, “Learning from Experience: Privacy and the Secondary Use of Data in Health Research” is based on an extensive literature survey, interviews with experts and practitioners in a variety of fields, and a series of workshops to explore key issues. The report describes the range of secondary uses for medical data, and the new technological advances that have increased the power with which such data may be stored, linked and retrieved. The relevant UK legislation (in particular, the Data Protection Act and Section 60 of the Health and Social Care Act) is explained and areas of continuing uncertainty are highlighted. Particular attention is paid to the meaning and practicality of different forms of consent for the use of data, and different options for full, partial or reversible anonymisation. The author advocates a common-sense approach, based on a clear respect for individual privacy and involving transparent systems for protecting it wherever possible, but recognising that society’s interest is not served by making medical research prohibitively difficult or expensive. Therefore, a less rigid approach may be needed to the concept of “consent”, perhaps accompanied by clearer exemptions for activities such as public health surveillance that are deemed to be essential to the public interest. Anonymisation should be the norm wherever possible. Finally, it is vital to rebuild and maintain public trust.