APPENDIX 21
Memorandum submitted by the Department
of Health
1. This memorandum is provided by the Department
of Health on behalf of health and science ministers in reply to
the letter dated 11 January sent by Geoffrey Farrar, Clerk to
the House of Commons Science and Technology Committee, to the
Office of Science and Technology. This letter requested information
on the significant issues surrounding the use of genetic test
results by insurance companies.
2. The Government is aware of the sensitivity
of this issue and the widespread public concern that individuals
should not be disadvantaged by their genetic inheritance. The
Government is concerned to prevent unfair discrimination as a
result of genetic developments.
3. The Human Genetics Advisory Commission
(HGAC) produced a report entitled "The Implications of Genetic
Testing for Insurance" in November 1998. The HGAC report
recommended the establishment of a mechanism to evaluate the scientific
and actuarial evidence presented in support of the use of specific
genetic tests for insurance products. The HGAC also recommended
that a moratorium on use of genetic tests should be put in place
for at least two years.
4. The Government accepted the first recommendation
and has subsequently established the Genetics and Insurance Committee
(GAIC). GAIC has a remit to develop a procedure and criteria for
the assessment of genetic tests currently being used in insurance
risk assessment and to evaluate each test against the criteria
agreed.
5. The Government carefully considered the
recommendation to introduce a two-year moratorium. Since this
would have required the introduction of primary legislation, the
Government explored with the Association of British Insurers (ABI)
the possibility of a temporary moratorium on the use of tests
until they had been considered by GAIC. The ABI was not prepared
to accept this. The ABI did, however, agree that it should advise
its members not to use any tests which were not submitted to GAIC
by the end of December 2000, and that it would advise its members
to abide by GAIC's decisions, so that tests that were judged unreliable
by GAIC would be withdrawn. The Association also agreed to advise
its members to re-underwrite any individuals who may have been
disadvantaged by the disclosure of a test result for any such
conditions, since November 1998.
6. The current position is that family records
are used in medical assessments to establish whether individuals
have a genetic predisposition to a particular disease and, if
they do, this information is taken into account in establishing
premiums. In addition, most ABI members ask for the results of
the genetic tests for Huntington's Disease, early onset Alzheimer's
Disease (PSI and APP genes), hereditary breast/ovarian cancer
(BRCA1 and BRCA2 genes), myotonic dystrophy, familial adenomatous
polyposis, multiple endocrine neoplasia and hereditary motor and
sensory neuropathy if they have been taken by people seeking insurance.
7. By the end of December, the ABI had only
put forward tests for three conditions. We understand that the
ABI will not advise its members to cease using the tests relating
to all other conditions.
8. The result of the GAIC procedure is to
rule out the use of tests for which there is no actuarial basis,
while a deeper examination takes place of the wider social and
ethical issues involved in the use of all genetic tests. The HGC
is currently considering these issues.
(i) How does the current regulatory
system operate, and what future developments are planned?
GAIC was established in 1999. It is a multidisciplinary
committee including actuarial and genetic expertise and representatives
of relevant patient groups. GAIC has published evaluation criteria
covering the details of the genetic condition being tested for,
the accuracy and reliability of the tests used to detect it and
the relevance of the test results to decisions about insurance
underwriting. Over the next few months, GAIC will consider applications
relating to three conditions currently covered by the Association
of British Insurers' Code of Practice on Genetic Testing. These
are Huntington's Disease, the early-onset form of Alzheimer's
Disease and hereditary breast/ovarian cancer. The intention is
to complete the review of these applications by September 2001.
In the future, if another test should be proposed for use in insurance
risk assessment then assessment by GAIC would be required before
insurers could start to use results of the test.
The insurance industry, through the main trade
body the Association of British Insurers (ABI), has agreed to
abide by GAIC decisions. If GAIC decides that the evidence on
the reliability and relevance of a particular test is insufficient
to justify its use, the Association will advise its members to
cease to use results of that test and to retrospectively reassess
affected individual insurance premiums. The ABI Code of Practice
on Genetic Testing states that individuals should not be asked
to take a test before being offered insurance but, where individuals
have already been tested as part of their medical care, then insurance
companies can ask for that information.
Complementary to the work of GAIC is the work
of the Human Genetics Commission in looking at the wider social
and ethical issues related to the use of genetic test results
by insurers. The Commission was created in 1999 to provide the
Government with strategic advice on the big picture of human genetics.
The Human Genetics Commission has included the wider social and
ethical issues involved in the use of genetic data in insurance
in their ongoing public consultation on the storage, protection
and use of personal genetic data, "Whose hands on your genes?"
The Commission has also been specifically asked
to consider the wider social and ethical aspects of genetic testing
and insurance, taking the wok of the Genetics and Insurance Committee
(GAIC) into consideration.
HGC will hold an information-gathering day on
genetics and insurance on 9 February 2001. The Commission will
hear presentations from all sides of the debate; particularly
academic insurance experts, the insurance industry, patient support
groups and clinical geneticists. The intention will be to allow
an informal discussion session with these and wider interests,
such as those responsible for data protection financial services
and consumer protection. In common with all full HGC meetings,
the meeting will be open to the public.
It is intended that a report from the information-gathering
day, together with relevant responses to the consultation, will
be discussed at the HCG's main meeting on 2 March. The Commission
will then discuss what additional work will be necessary on insurance
and what form their report and recommendation to Ministers on
this may take.
(ii) What is the Government's policy
toward the use of genetic test results for this purpose, and what
are the reasons underlying this policy?
The Government's policy in the short-term is
to prevent the use of genetic tests which are not clinically and
actuarially relevant while at the same time a major review of
the medical, social, ethical and financial implications of the
use of genetic tests is made by the HGC.
(iii) What scientific advice has the
Government based its decisions upon, and what measures have been
take to ensure its reliability?
The Government receives advice from both the
Human Genetics Commission and the Genetics and Insurance Committee.
Each has a responsibility to provide Ministers with advice under
their terms of reference. The roles of the two bodies are very
different, and their membership is intended to reflect these differences.
The role of the Human Genetics Commission in relation to insurance
is to advise the Government on its overall policy. In doing so,
it obviously has to take account of social and ethical issues.
The role of the Genetics and Insurance Committee is essentially
to decide the technical question of whether or not a test is a
reliable indicator of disease for actuarial purposes.
GAIC makes its decision on a specific genetic
test based on the following:
— the information included in the application;
— reviews of the application provided
by independent clinical geneticist and actuarial experts; and
— comments received from relevant patient
groups who are sent a copy of the application to review.
Full details of the basis on which GAIC makes
its decisions are included in the response form GAIC and are not
repeated here.
(iv) What is the Government's view
of insurers using results from diseases which are not single gene
defects, or where there are non-genetic influences (for example,
heart disease) when assessing risk?
At the moment, any genetic tests which insurers
have not submitted to GAIC for approval should not be used. None
of these tests have been submitted to GAIC. For most genetic polymorphisms
and multi-factorial conditions, the current level of understanding
of the relative importance of genetic and other factors for predisposition
to disease and excess insurance risk is likely to be insufficient
to make a case that the test is actuarially and clinically relevant.
Genetic tests that are not single gene defects or do not accurately
predict ill health (that are low penetrance or multi-factorial)
and those that are predictive of less serious conditions which
do not lead to serious ill health or disability should therefore
not be used by insurers in risk assessment at this time.
(v) What consideration has been given
to the potential effect on UK research of insurance companies
using genetic test results?
The Government is aware of the potential threat
to research if volunteers withhold consent due to concerns about
the possible effects of their participation on their subsequent
ability to gain insurance. Such use of research information by
insurers, if it occurred, could be considered to be an unfair
use of genetic data. The Government is very concerned that individuals
should not be unfairly disadvantaged by their voluntary participation
in research. The ABI's Code of Practice on Genetic Testing states
that only tests which have been assessed by GAIC may be used in
insurance risk assessment.
This concern is especially important in relation
to the proposed MRC/Wellcome database and agreement has been sought
with the ABI to include a specific reassurance on insurance in
the information given to participants on this project. The ABI
has informally indicated that any test carried out for research
purposes (including those for conditions assessed by GAIC) should
not be used by insurers. On this basis, there should be no threat
to potential volunteers.
(vi) What are the roles of the various
government departments in this area?
HGC is responsible to health and science ministers.
GAIC reports to health, science and treasury ministers. The secretariats
for both bodies are based in the Department of Health Genetics
Unit; the HGC Secretariat is a joint DH/OST body.
The role of the Department of Health in sponsoring
these bodies is part of the department's general responsibility
to contribute to improving and protecting the health and social
well-being of the people of England and in reducing inequalities.
The role of the Office of Science and Technology
in sponsoring these bodies is part of its general responsibilities
for trans-departmental scientific and technological issues and
for the Government's guidelines on scientific advice and policy
making.
The role of the Treasury in sponsoring GAIC
relates to its general responsibilities for financial services
issues in the UK and its objective of securing an efficient market
in financial services and banking with fair and effective supervision.
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