Minutes of the meeting held on 3 and 4 September 2002
Tue, 16 August 2005
1st meeting
NUFFIELD COUNCIL ON BIOETHICS
WORKING PARTY ON THE ETHICS OF PHARMACOGENETICS
Minutes of the Meeting held at the Charlotte Street Hotel, 15 Charlotte Street, London W1T 1RJ on 3 and 4 September 2002
PRESENT
Professor Peter Lipton (Chairman), Professor Haleh Afshar, Professor Martin Bobrow, Professor John Caldwell, Professor Klaus Lindpaintner, Professor Sir Michael Rawlins, Professor Nikolas Rose, Dr Nigel Starey, Professor Albert Weale
SECRETARIAT
Dr Sandy Thomas, Tor Lezemore, Harald Schmidt, Nicola Perrin, Natalie Bartle, Jai Shah
CHAIRMAN’S INTRODUCTION
1 The Chairman welcomed the members of the Working Party and thanked members for the contributions made during the informal discussion at the dinner on the preceding evening. The aim of the meeting would be to identify the focus, structure and substance of the Discussion Paper that the Working Party would eventually produce.
GUIDELINES FOR MEMBERS OF THE WORKING PARTY
2 The Chairman drew attention to the Guidelines for members of the Working Party. These gave further details about the planned method of working.
DRAFT TERMS OF REFERENCE
3 It was agreed that the focus of the study would be limited to issues arising out of genetic variation between individuals and the bearing of this variation on the development of medicines and the differential treatment of individuals. There would be some overlap with issues relating to the genetic basis for susceptibility to disease. The draft terms of reference were discussed and agreed after minor revisions.
BACKGROUND PAPER AND CONSIDERATION OF THE MAIN AREAS OF STUDY
4 There was discussion whether pharmacogenetics would raise new issues in addition to those already discussed in the context of genetic testing for susceptibility to rare diseases. Ethical issues would most likely arise in a clinical context. For example, in Phase I clinical trials healthy participants might be genotyped, raising issues about anonymisation of samples.
5 With regard to R&D, pharmacogenetics could be expected to result in increased selectivity with respect to individuals who might be eligible for participation in clinical trials. Pharmacogenetics may thus make it possible to develop a medicine for subgroup A in a population, but not necessarily for subgroup B. There was also a global dimension with respect to selectivity in that the application of pharmacogenetics would only be relevant to the development of medicines in developed countries.
6 It was noted that it was likely that the application of pharmacogenetics would pose questions about cost effectiveness in addition to those raised by medicines that were delivered without prior genetic testing. Ethical issues may be raised when medicines were not developed for specific groups of patients because it was uneconomic to do so. The USA, the EU, Japan, Australia and Singapore already had regulation for orphan medicines in place that aimed to address this issue. It was discussed whether these regulations were effective in providing incentives for the development of medicines for these diseases.
7 With regard to the question of whether there were examples of cases where variation between individuals with respect to their response to treatment correlated with geographical or racial differences, it was noted that the MDR1 polymorphism affected the efficacy of certain HIV medicines. The less responsive genotype had a higher prevalence in Africans than in Caucasians.
8 The role of pharmacogenetics in the provision of health care was discussed. The impact of the application of pharmacogenetics on both the expectations of patients and the doctor-patient relationship would need to be considered. An important issue would be whether data relevant for pharmacogenetic analysis would be stored, and if where and by what means. Consideration would also need to be given to who would have access to the data, and how pharmacogenetic-based tests would be made available.
9 The nature of pharmacogenetic tests and the status of genetic information in comparison to other forms of diagnostics such as X-rays were considered. A sample obtained for pharmacogenetic testing was primarily collected for the purpose of determining response to treatment, but it could, in principle, be open to other usages.
10 There was discussion about whether the Working Party would want to consider how regulatory authorities could and should respond to issues raised by pharmacogenetics. It was agreed that if the provision of healthcare was to be addressed, it was necessary to consider the relevant regulatory frameworks and underlying ethical premises. Regulatory bodies that had to consider whether or not to make available a treatment in the context of public or private health provision should also be included.
11 Storage of samples could occur in the context of treatment or in the context of R&D of new medicines. Either case would require consent of the donors. Current practice was discussed, as well as recent proposals for harmonised classification of samples used in clinical trials. A taxonomy presented in a discussion paper by EMEA distinguished five types of samples according to the different degrees of linkage between genetic and personal information.
12 There was discussion whether the application of pharmacogenetics would influence the development of new medicines in such a way that they would reach the market more quickly and more cheaply. Predictions would depend significantly on whether, for example, regulations would be changed and allow trials of smaller trial populations.
13 There was some debate about the issue of expected stratification of medicines and patient groups once pharmacogenetics would play a more significant role. The concept of differentiating between individuals by means of medical tests was already well established, for example in stratifying patients according to their estrogen receptor status. With regard to the development of specific medicines it was observed that it was unlikely that industry would attempt to pursue segments smaller than 20-30% of a previously homogeneous market.
PROVISIONAL TIMETABLE AND METHOD OF WORKING
14 Members considered the structure of the first draft of the Discussion Paper. The Introduction would be subdivided in a scientific section and a section that would address ethical issues. The next chapter would be on the scientific background of pharmacogenetics (Chapter 2).
15 Chapter 3 would provide a descriptive overview of the current regulatory frameworks as relevant for the development of pharmacogenetic-based medicines. It would also consider the provision of genetic tests. The following chapter would address the likely socio-economic implications of the application of pharmacogenetics for medical practice and health care (Chapter 4). Chapter 5 would consider ethical issues and aim to assess adequacy of current regulation.
16 It was agreed that for the next meeting a first draft paper according to this structure would be discussed. Members were allocated to particular areas suited to their specialist knowledge and would develop the respective chapters on the basis of an initial framework that the Secretariat would produce for this purpose.
17 The date of the next meeting, 25 November 2002 was confirmed by the members of the Working Party. A suitable date for the subsequent third meeting was discussed. This would be held in mid February 2003.
FACT FINDING MEETINGS
18 Members discussed whether they wished to undertake fact finding meetings. Legal experts would be consulted in writing. For an oral consultation individuals with expertise in regulation, economy and the patient perspective would be invited to the next meeting. The first fact finding meeting would be held on 25 November 2002 from 10am to 1 pm at the Offices of the Council.
ANY OTHER BUSINESS
19 A paper would be drafted by the Secretariat for the purpose of a public consultation. Members would revise the draft and, subject to approval of the Council, the consultation would be published in early November. The paper would set out the principal issues in accessible language and would be sent to relevant individuals and organisations. It would also be made available for comment on the Council's website.
20 A first draft of a press announcement was discussed. The draft would be revised by the Secretariat and circulated again to the Chairman for authorisation.
Last Updated Tue, 16 August 2005