Memorandum submitted by the Alzheimer's
1. THE ALZHEIMER'S
1.1 The Alzheimer's Society is the leading
care and research charity for people with dementia and their carers.
It was founded in 1979 as the Alzheimer's Disease Society. It
provides information and education, support for carers, and quality
day and home care. It funds medical and scientific research and
campaigns for improved health and social services and greater
public understanding of dementia.
1.2 The Society has over 22,000 members
and operates through a partnership between some 250 branches and
support groups and the national organisation in England, Wales
and Northern Ireland. The Society brings together carers, family
members, health and social care professionals, researchers, scientists
and politicians through shared concern for people with dementia
and those who care for them.
1.3 Dementia is one of the most significant
health and social care challenges of the next century. There are
over 700,000 people with dementia in the UK. Dementia affects
one person in 20 aged over 65 and one person in five as they reach
80 years of age in the UK. As the population ages so the number
of people with dementia will grow. There are 17,000 people with
dementia aged under 65 years of age in the UK.
1.4 The use of genetic information raises
important public, social and moral issues and the Alzheimer's
Society welcomes the Committee's enquiry into the use of genetics
and insurance. The Society believes that the Government's decision
to allow insurers to take into account the results of genetic
tests will have adverse consequences for people with Alzheimer's
disease. It will increase social exclusion, fail to protect consumers
and contribute little to improving public health.
2. GENETICS AND
2.1 Alzheimer's is the most common form
of dementia. Alzheimer's is a multifactorial condition and the
importance of any individual risk factor will vary from person
to person. In the majority of cases of Alzheimer's we do not know
what causes it. Most people develop Alzheimer's later in life
and age is the most significant risk factor for Alzheimer's disease.
For most people, genes will play a role in determining whether
or not the disease develops. For people who develop Alzheimer's
in older age, there is a known genetic risk factor associated
with a protein apoliprotein E (ApoE). It is not deterministic
nor absolute and must act in conjunction with other risk factors
to produce the symptoms of the disease.
2.2 There are a very small number of families
who have an inherited form of Alzheimer's. Very few people will
inherit a gene that inevitably gives them Alzheimer's and which
in turn they will pass on to their children. It is this group
of people, who tend to develop Alzheimer's at a younger age, that
are likely to be subject to discrimination by the insurance industry
in the near future on the grounds of genetic testing.
2.3 Familial early onset Alzheimer's disease
(FAD) affects people under 65 years of age. Out of the 17,000
younger people with dementia in the UK, less than a third will
have Alzheimer's disease. Of these, approximately half will carry
one of the three identified gene mutations that can be detected
by current genetic screening. This means that less than 3,000
people show a Mendelian pattern of inheritance.
2.4 There are three genes associated with
familial early onset Alzheimer's named on the Association of British
Insurers' (ABI) matrix attached to the Code of Practice Genetic
Testingamyloid precursor protein (APP), presenilin-1 and
pre-senelin-2. However, out of the 47 reported Alzheimer's disease
mutations in presenilin-1 or presenlin-2, 35 have been found in
single kindreds or in single individual patients and in no other
unrelated families or patients. New patients or families are likely
to have negative results in a screen for known presenilin gene
defects even when they are harbouring a mutation in one of these
genes. Equally, mutations in genes relevant to Alzheimer's disease
might be non-pathogenic even when found in an affected family
member. Non-pathogenic mutations in the presenilin genes have
been reported. This means that great skill is required in interpreting
the results of genetic tests. The insurance industry has been
able to discriminate against individuals who have a positive test
for these genes.
2.5 The insurance industry has argued that
it would experience adverse consequences from being denied information
about an applicant's genetic test results. However, there is a
lack of evidence on both the numbers of people affected by genetic
predispositions and the level of risk that they currently represent
for an insurer. The Alzheimer's Society believes that the insurance
industry has failed to demonstrate the need to reject the moratorium
on using genetic test results proposed by the Human Genetics Advisory
Commission (HGAC) in 1997.
3. SOCIAL EXCLUSION
3.1 The Government's decision to allow insurers
to use genetic tests legitimises discrimination. People with Alzheimer's
disease and their carers already experience high levels of social
stigma. This action can only make an individual and their family
further excluded from society.
3.2 A person excluded from obtaining affordable
insurance, particularly life assurance, may be unable to obtain
a mortgage, own their own property, or protect both themselves
and their family. This will lead to further marginalisation and
inequity, particularly for those who wish to take out additional
insurance for their health and welfare.
3.3 The ABI has argued that the provision
of a national health service mitigates against the necessity of
ensuring the opportunity for universal insurance cover. This fails
to recognise the inadequacy of provision of dementia care. Indeed,
much of what is deemed to be dementia care currently falls outside
the remit of "health". As a result, people with dementia
and their carers bear the majority of the costs of dementia care.
3.4 The decision to allow insurers to use
the results of genetic tests creates inequity. We now have a situation
in which two people with an identical genetic inheritance do not
have the same access to insurance. Compare, for example, one person
who takes out life and health insurance at a standard cost and
then requests a genetic test without incurring any financial penalty,
and another who undergoes a genetic test and then applies for
insurance cover. Both individuals have the same genetic make-up,
but only the latter individual is denied affordable insurance.
3.5 The ABI's claim that no-one is forced
to have a genetic test in order to obtain insurance may prove
to be an empty assurance. By default, in order to obtain insurance
at an affordable price, a person with a known family history of
a disease, may be forced to undergo genetic testing. Despite being
urged to do so by the Government, insurers have failed to demonstrate
that the needs of people excluded from purchasing affordable insurance
can be met.
4. PUBLIC HEALTH
4.1 The information on genetic testing circulated
by the ABI does little to promote public understanding. The way
in which Alzheimer's disease is listed on the ABI matrix is misleading.
It also creates confusion and alarm. While the list makes reference
to "familial adenomatous polyposis", "hereditary
motor and sensory neuropathy" and "hereditary breast/ovarian
cancer" (emphasis added), Alzheimer's disease is simply listed
as "Alzheimer's disease". No explanation is given that
the named genes are associated with a rare, familial type of early
onset Alzheimer's disease.
4.2 It is not Alzheimer's disease that is
under question, but familial early onset autosomal dominant Alzheimer's
disease and this is normally referred to in the literature as
FAD or early onset FAD. When the media reports this issue it frequently
fails to make it clear that the test relates only to those with
early onset Alzheimer's, affecting only 1 per cent of people with
Alzheimer's disease. As a result, the Society's Alzheimer's Helpline
is left to provide accurate information on genetics and insurance.
4.3 The Society has a great deal of experience
in dealing with members of the public concerned about risk or
perceived risk. The Alzheimer's Helpline deals frequently with
callers who are concerned about genetics and Alzheimer's disease
and plays a crucial role in informing the public and in providing
accurate information to the public.
4.4 A person with early onset Alzheimer's
disease wanting to take responsibility for their own health and
help to prevent the ill-health of others in the future will be
dissuaded from getting involved in genetic research and genetic
testing. Perceived fear of discrimination may deter a person from
taking a genetic test which could be of benefit in the early detection
of the disease and in therapeutic intervention. In addition, genetic
research may be impeded because of the unwillingness of individuals
to be involved in genetic testing. The participation of individual
families has been tremendously important in enhancing our understanding
of Alzheimer's disease to date. The Advisory Committee on Genetic
Testing (now part of the Human Genetics Commission) was set an
impractical task of monitoring the number of people who are dissuaded
from taking a genetic test. The Society remains unclear how the
level of deterrence will be monitored.
4.4 The Nuffield Council on Bioethics has
highlighted an additional concern which both the ABI and the Government
appear to have failed to address. The use of genetic information
for multiple purposes raises a number of issues about consent
and disclosure. The use of APOE illustrates the dilemmas that
may arise in the future as our genetic understanding grows. APOE
testing occurs as part of the diagnosis and treatment of heart
disease and is available in other countries such as the USA. APOE
is also a risk factor associated with Alzheimer's disease, although
it is of limited predictive value at the moment. This means that
a person may give their consent for one type of medical test and
have the result used for another purpose. It also highlights the
importance of obtaining as full a consent as possible.
5. CONSUMER PROTECTION
5.1 The voluntary nature of the ABI code
is insufficient to protect consumers. The Government's decision
to set up the Genetics and Insurance Committee does little to
reassure the public about the use/misuse of genetic information.
The insurance industry has failed to demonstrate that it:
(a) needs to collect information on pre-symptomatic
genetic test results;
(b) has competence in dealing with this type
of genetic information;
(c ) has the ability to regulate itself effectively.
5.2 The Society was particularly concerned
that, prior to an informal agreement between the ABI and GAIC
is December 2000, the ABI refused to wait until GAIC approved
a genetic test before permitting its use. This undermines the
confidence that a consumer affected by a genetic disorder could
have in the regulatory framework. The ABI's decision to allow
insurers to use tests that had not been approved by the GAIC endorsed
unfair discrimination. The Government's response to the Human
Genetics Advisory Committee (HGAC) report stated that approval
through the new evaluation mechanism should be a pre-requisite
for the use of the results of any test by the industry. This has
not happened. Indeed, the ABI has been allowed to continue with
its own voluntary code unimpeded and in clear disregard of the
5.3 The ABI code of practice states that
insurers must not offer lower than standard premiums (preferred
life policies) on the basis of genetic test results. This undertaking
runs counter to normal underwriting practice, where a lower premium
may be offered if the applicant presents a lower risk (for example,
a lower rate for non-smokers). However, insurers consider that
it is necessary in order to allay public concern that an uninsurable
genetic underclass may develop if the insurance industry were
to seek out the "good" genetic risks by offering them
cheaper insurance. The Society believes that this policy is unlikely
to be sustainable in the long term.
5.4 The insurance industry argues that they
need to collect personal medical information in order to predict
the actuarial implications of people knowing about their own genetic
make-up. The Society understands the importance of monitoring
the numbers of people affected by validated genetic tests. However,
why it has to be the insurance industry itself that collects this
information is not evident, particularly when the information
cannot be applied retrospectively, nor linked to family members.
Not only would members of the public be reassured by the independent
and anonymous collection of information on genetic testing, but
it would also serve to protect individuals known to be carrying
a genetic mutation.
5.5 The Alzheimer's Society has failed to
see evidence that the insurance industry is either able or committed
to promoting accurate information about genetics and insurance.
In particular it was only after complaints from the Alzheimer's
Society that a major breach of the ABI code of practice was rectified.
5.6 In March 2000, the Alzheimer's Society
carried out a small survey which indicated that the ABI's Code
of Practice was being breached by a significant proportion of
members of the ABI. Indeed, the ABI acknowledged that this `aspect
of the Genetic Testing Code of Practice [had] been breached by
some firms'. The Society found that insurers were breaking their
own rules on requesting information about genetic testing. Under
the ABI's own code of practice people should not be asked about
genetic testing when applying for life assurance on mortgages
up to £100,000. A random survey of standard insurance forms
showed that most of the UK's top insurers ask the applicant to
reveal results of all medical tests and investigations. Of nine
companies examined, only one, Allied Dunbar, made clear to customers
that they do not need to disclose results from any genetic tests
they may have had.
5.7 Paragraphs 30-31 of the Code of Practice
30 Insurers must make clear to applicants
before the application form is completed the special arrangements
for mortgage related life insurance (paragraph 31 refers).
31 Existing Genetic Test results need not
be disclosed in applications for life assurance up to a total
of £100,000 which are directly linked to a new mortgage for
the purchase of a house to be occupied by the applicant. This
is the standard for the life insurance industry (subject to review
in December 2001) which members may choose to exceed. If an applicant
chooses to disclose the result, it must be ignored unless it is
in the applicant's favour (eg by preventing a loading owing to
The Alzheimer's Society understands that the
Code of Practice identifies a standard which ABI member companies
must meet. Its principles apply to all ABI members and compliance
with the Code of Practice is a condition of ABI membership. Moreover,
paragraph 11 of the Code of Practice states that insurers' compliance
with the Code and details of how it has been achieved, must be
certified annually to the ABI by the insurance company's Chief
Executive. The ABI's failure to ensure compliance of its own members
on this issue casts doubts on the industry's ability to regulate
5.8 The Alzheimer's Society has been unable
to determine how the ABI monitors compliance. The Society requested
further information on the annual exercise on compliance in September
1999 but details were withheld.
6. THE GENETICS
6.1 The Alzheimer's Society understands
the desire to put in place a social framework for dealing with
genetic knowledge and the reasons for the establishment of the
Genetics and Insurance Committee (GAIC). However, the Society
believes that the establishment of such a mechanism is not only
at odds with practice in most other countries around the world,
serving to re-enforce discrimination on the grounds of genetic
inheritance, but ultimately unworkable, given the logical extension
of genetic tests for a large population.
6.2 The Genetics and Insurance Committee
was set up to evaluate the scientific and actuarial evidence in
support of the use of genetic tests for insurance products. While
the Society welcomes the active involvement of patient groups
in the work of the Committee, we have expressed our concern on
a number of issues surrounding the process and procedure of the
6.3 In order to have an application to use
genetic test information, an insurance company needs to provide
"peer reviewed evidence of the clinical impact of the disease".
However, GAIC does not demand the same level of independent review
when it comes to actuarial relevance. This is surprising given
the lack of knowledge based in this area. Incidentally, there
is no lack of journals in which research/data could be published.
The Society believes that the same standards should apply to both
actuarial and clinical data.
6.4 Moreover, the need to ensure that the
actuarial evidence submitted to GAIC is of high enough quality
was highlighted by the referee for the application for use of
the test for Huntingdon's disease. Indeed, in its announcement
on the use of this test, GAIC stated that "although the Committee
was persuaded that its threshold for actuarial relevance was undoubtedly
met, it also found that there were imperfections in the methodology
used within the application and the precise results obtained."
The detailed referee's report reveals substantial flaws in the
6.5 Both of the disciplines of clinical
genetics and actuarial science are saturated in technical terms
and concepts that make it hard to understand. As a result, the
Society welcomes GAIC's attempts at including a section explaining
the practice of underwriting as well as a glossary. However, the
Society believes that further explanation is needed on why "an
additional mortality risk of at least +50 per cent or an additional
morbidity risk of at least +25 per cent" is judged to be
actuarially significant. Indeed, when the Society requested a
definition of "actuarial significance" from the Institute
of Actuaries it was unable to obtain one. In fact, the Society
was informed that "if an actuarist says it is significant
then it is."
6.6 GAIC has not made it clear how it intends
to monitor compliance of its rulings. The Society would like to
see further clarification on this area.
6.7 The Alzheimer's Society is also concerned
about a potential conflict of interest. The ABI Code of Practice
on Genetic Testing states that the ABI Genetics Adviser has declared
that seven tests are "relevant, reliable and valid at November
1998" (paragraph 4). In addition, the ABI Code of Practice
declares in Part 3 that one of the responsibilities of the Genetics
Adviser is "to inform the ABI of any new genetic tests whose
results could be valid for insurance purposes, so that the ABI
could consider applying to the GAIC for validation of the test
result". When the Minister announced the establishment of
the GAIC it was described as a new independent review body. No
expert, however reputable, can independently review their own
advice. The fact that the ABI Genetics Adviser is a member of
the GAIC and remains actively involved in its decision making
raises some concerns.
7.1 The Alzheimer's Society understands
the desire to put in place a social framework for dealing with
genetic knowledge. However, this is not an issue that is unique
to the UK. Although different social security and insurance systems
exist, many other countries have adopted a more cautious approach
which is more focused on consumer rights. Austria, Belgium, Denmark,
France, and Norway all have some form of legislation that prohibits
the use (and, in some countries, the collection or possession)
of genetic information by insurance companies.
7.2 The Alzheimer's Society believes that
the Government's decision to allow the insurance industry to discriminate
against individuals with a known genetic predisposition is both
premature and unjustifiable with our present genetic knowledge.
It also runs counter to the Government's expressed aims of reducing
social exclusion. If we do not want to build a society which is
based on inequality on the grounds of genetic inheritance, the
European Convention on Human Rights and Biomedicine should be
endorsed. It states that "any form of discrimination against
a person on grounds of his or her genetic inheritance is prohibited."
7.3 The insurance industry has argued that
it would experience adverse financial consequences from being
denied information about an applicant's genetic tests results.
The evidence for this claim is weak and is not upheld by previous
experience with HIV/AIDS. In addition, at least two UK insurance
companies have publicly announced that an individual does not
need to reveal any genetic test information when applying for
insurance cover. This position undermines the ABI's claim that
the industry would suffer adverse consequences. The insurance
industry has failed to demonstrate the need to reject the moratorium
on using genetic test results proposed by the HGAC. The Society
believes that the insurance industry should be required to demonstrate
that a denial of genetic information obtained from a pre-symptomatic
test would be actuarially significant in terms of adverse selection.
18 January 2001