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


Memorandum submitted by the Association of the British Pharmaceutical Industry


  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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