Select Committee on Science and Technology Appendices to the Minutes of Evidence


Memorandum submitted by GlaxoSmithKline

  As the UK's leading healthcare company with substantial investment in research laboratories, the ability to conduct genetic research effectively and to high ethical standards is central to GSK's aim of discovering new medicines to combat diseases with unmet needs. We therefore welcome this enquiry and hope that the enclosed submission will prove a valuable contribution to the Committee's debate.


  1.  GlaxoSmithKline (GSK), the UK company recently formed from the merger of Glaxo Wellcome plc and SmithKline Beecham plc, is a world leader in the research and development of innovative, life-enhancing pharmaceuticals. The ability to conduct genetic research effectively to high ethical standards is central to GSK's commitment to:

    —  Discover new medicines to combat diseases with unmet needs.

    —  Deliver medicines to those patients likely to derive the most benefit.

  The success of GSK's efforts and the resulting health benefits are inextricably tied to the willingness of individuals to participate in genetic research.

  2.  GSK is a UK based multinational company with substantial investment in UK research laboratories and operations facilities. Accordingly, the Committee's continued interest and deliberations regarding the impact of using genetic test results for life insurance on the research environment for genetics in the UK are of profound interest to GSK.

  3.  In this regard and the broader issues of genetic research in the UK, GSK is providing evidence to the House of Lords Science and Technology Select Committee Inquiry on genetic databases and providing input to the Human Genetics Commission (HGC) in response to a recently distributed discussion document.

  4.  This memorandum provides information specifically relates to the question:

    What effect could the use of test results by insurance companies have on research in the UK?

  The other two questions posed by the Committee relate to the assessment of actuarial evidence and the regulation of insurance services. These are areas where GSK does not have specific business interests or experience and, therefore, is not qualified to comment in detail. However, GSK welcomes an approach in which all relevant stakeholders, including consumer representatives, assess the scientific and actuarial reliability and predictive value of specific single gene genetic tests before they are used for insurance purposes.


  5.  GSK recognises that the potential use by insurance companies of genetic information has been the source of some public concern.

  6.  In October 2000, the Genetics and Insurance Committee (GAIC) announced that the reliability and relevance of genetic tests for Huntingdon's Disease are sufficient for insurance companies to use the results when assessing applications for life insurance. This type of test for a single gene disorder detects the presence or absence of a mutation or mutations in one or both copies of a single gene, which leads to disease. Thus, there is often a strong causal relationship between the presence of the mutation and the manifestation of the disease. There are currently few, if any, effective interventions that alter the progression of many of these diseases. This gives rise to a number of ethical, legal and social considerations associated with diagnostic (symptomatic) and predictive (asymptomatic) genetic tests for single gene diseases. These issues include the:

    —  Potential for unlawful discrimination.

    —  Healthcare implications and psychological impact on patients and family members.

    —  Need for pre- and post- test genetic counselling.

  7.  Given the public concern already expressed related to genetic test results and insurance, the use of certain single gene test results by insurance companies could be perceived negatively and reduce the willingness of subjects to participate in GSK genetic research initiatives. This is despite the fact that it is made clear to potential participants in the informed consent process that:

    —  The results of genetic studies sponsored by GSK are for research purposes only and not for clinical diagnosis or use by unconnected third parties.

    —  GSK's human genetic research (as is increasingly the case for genetic research in general) is focused on understanding patients' responses to medicines (pharmacogenetics) and the genetic basis of common diseases such as asthma, heart disease and diabetes (disease susceptibility). For common diseases, unlike single gene disorders, alternative forms (alleles) of multiple genes interact with each other and environmental factors to cause disease. The presence of a version of a single gene associated with a common disease is not thought to be sufficient, by itself, to cause the disease.

    —  GSK employs multiple processes and security procedures designed to protect research subjects' privacy and confidentiality. For example, patients' personally identifiable information are not transferred to GSK (only a code number is used to identify the data) and data security and access restrictions are implemented to prevent unauthorised access. Additionally, no research results are returned to participants (unless legally required).

  8.  To prevent the use of genetic test results for single gene disorders by insurance companies from reducing subject participation in genetic research, it is important to increase public understanding of modern genetic science and the procedures in place to protect individual participant confidentiality in research. These initiatives could include:

    —  Encouraging the media to present a balanced view of modern genetic science and its applications.

    —  Raising awareness and understanding of modern genetic science amongst physicians and healthcare providers and the potential of modern genetic science to deliver significant healthcare benefits.

    —  Introducing modern genetics into school curricula with less historical emphasis on single gene genetics.

  These initiatives would help potential participants in research make a balanced judgement regarding their involvement and enable the potential benefits and risks of different genetic-based applications to be fully appreciated (figure).

  9.  It is important that educational initiatives present a balanced view of modern genetic science and its applications. For example, in the future, the ability to predict more accurately patients' responses to medicines may have medical insurance implications. The magnitude of such implications remain to be determined but are likely to be less than those associated with single gene tests and life insurance.


  10.  The UK is well positioned to assume a leadership role in creating an environment in which genetic research can flourish in a manner that advances the interests of the public and healthcare communities. It is important that the UK maximises this opportunity to ensure that the UK population can reap the benefits of genetic research and the UK can attract further investment into the science and life science sectors in an increasingly competitive global environment.

  11.  To this end, it is important that legitimate uses of single gene genetic testing information for insurance purposes are communicated effectively to the UK population. These communications should include the rigour of the validation and approval process that includes all relevant stakeholders and the potential benefits to those individuals who have a family history of a single gene disorder but have not inherited the mutated gene. It would also be helpful if such communications are placed in the broader context of modern genetic science and research. This would help differentiate the use of specific single gene genetic test results for insurance purposes from the use of genetic research data to help discover new medicines for common diseases and deliver medicines to those patients likely to derive most benefit.

January 2001

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