APPENDIX 18
Memorandum submitted by the Association
of the British Pharmaceutical Industry
INTRODUCTION
1. The Association of the British Pharmaceutical
Industry (ABPI) represents the majority of the companies in Britain
engaged in the research, development, manufacturing and supply
of prescription medicines. The ABPI brings together companies
producing such medicines, whether branded or generic, many smaller
organisations involved in pharmaceutical and biopharmaceutical
research and development, and those with an interest in the pharmaceutical
industry operating in the UK. ABPI member companies manufacture
and supply more than 80 per cent of the medicines prescribed through
the NHS and are major exporters to countries all over the world.
2. Six out of the world's top 25 medicines
were discovered and developed in British laboratories. As a result,
patients in the UK benefit from the early introduction of new
medicines here.
3. The industry's long history of pharmaceutical
innovation is supported by intensive research activity. The vast
majority of medicines research carried out in the UK is funded
by the pharmaceutical industry and most of the major global pharmaceutical
companies have established research and manufacturing bases in
this country. As a result, the industry is an important employer,
with around 60,000 people employed directly and many more in feeder
industries. The industry invested £2.7 billion in research
and development in 1999—more than £7 million every
day.
4. Genetic research has become an essential
tool of the pharmaceutical industry in its search for new diagnostic
and therapeutic approaches to the development of innovative medicines.
The majority of pharmaceutical companies are engaged both in genetics
research, enabling them to develop new targets for medicines discovery
and pharmacogenetics research—the attempts to study the
relationship between patients' DNA and their responses to medicines.
5. For both types of research to be carried
out, clinical trials involving patients are essential. Any issue
that would inhibit patients' willingness to participate in such
studies would be a matter of concern both to the industry and
to those academic researchers involved in the ongoing, early stage
studies of genes which could alter the risk of developing common
diseases.
Q: What effect could the use of test results
by insurance companies have on research in the UK?
6. The major concern of the pharmaceutical
industry in this area is based on the knowledge that there appears
to be at present a rather poor understanding by the general public
and the insurance companies of what is involved in the broad field
of genetic research and of what is meant by "genetic testing".
7. Genotyping analysis is likely to play
a key role in the clinical studies; and issues that might impair
recruitment of subjects for clinical trials could adversely impact
upon our ability to develop new medicines for important diseases.
8. There is a danger that the use of test
results by insurance companies could deter subjects from participating
in clinical trials. It would be a matter of concern if a subject
preparing to enter a clinical trial in which a genotyping analysis
is to be performed, could refuse to consent if he/she perceived
that insurance companies could potentially have access to test
results, or even the knowledge that a particular test had been
performed.
9. The industry is aware that there is an
automatic assumption in the minds of patients and the media that
all genetic research is concerned with testing for predisposition
to serious disease. In fact, genetic research which is not for
diagnosis in humans covers a range of activities. Such research
might include studies into common, less serious diseases and how
patients respond to medicines. We suggest that the social, legal,
and ethical issues associated with research of this type are generally
far lower than those associated with diagnostic testing for serious
disease.
10. Many companies engaged in this research
are careful to ensure that all genetic data remain completely
confidential and that research subject's privacy is protected.
Because such research data is not diagnostic data, companies carrying
out such research do not currently pass such data back to subjects
who have donated samples of DNA analysis. If, in the future, medicines
are developed with an associated genetic test for suitability
for that drug, it is acknowledged that those test data will be
"diagnostic" and will of course be given by the patient's
doctor to the patient. In most circumstances, these results would
not be of importance for insurance purposes, though some might.
It is possible that the results would benefit the patient seeking
insurance.
11. Subjects involved in donating DNA samples
for genetic research should not be confused with patients undergoing
diagnostic tests for possible genetic disease. More education
is required to ensure that both the general public and insurance
companies fully understand the difference. Thus, if insurance
companies are to ask people if they have ever undergone a genetic
test it is quite possible that a subject who had merely donated
a DNA sample for a research study might give an inappropriate
answer, and/or that the insurance company might misconstrue the
response. It would therefore be a matter of concern if the company
subsequently denied, or provided/offered limited insurance cover
to the individual on the basis of this misunderstanding.
12. The risk of insurance being denied if
insurance companies are allowed to ask if the subject "has
ever undergone a genetic test" is therefore likely to hinder
research in the UK by making subjects reluctant to take part in
genetic research studies.
Q: To your knowledge, what scientific evidence
have those involved in the area (Government, insurers, regulatory
bodies etc) based their decisions upon, and how reliable is it?
Q: How effective do you feel the current
regulatory system is?
13. The Association does not feel that it
has been involved closely enough in the assessment of the current
regulatory system for the use of genetic tests for insurance purposes
to be in a position to comment on the reliability of the scientific
evidence being used to inform current decision making. We also
feel that it would not be appropriate to comment on the effectiveness
of the current regulatory system.
14. We are pleased, however, that these
issues, and the more broader aspects of the use of genetic information,
are being addressed by the Government's Genetics and Insurance
Committee, the Human Genetics Commission, the Inquiry of the House
of Lords Select Committee on Science and Technology in Human Genetic
Databases, and by this present inquiry by the House of Commons
Science and Technology Committee.
15. We do feel, however, that a body such
as the Human Genetics Commission, which is beginning to play an
important role in informing the public and media on the applications
of genetic research, could be more active in explaining the differences
between the use of specific genetic testing and genetic research
in general.
January 2001
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