BIVDA Response to Human Genetics Commission Consultation Document – The Supply of Genetic Tests Direct to The Public
The British In Vitro Diagnostics Association (BIVDA) was established in 1992 as the national trade association for the In Vitro Diagnostics (IVD) industry and is based in offices in central London. The BIVDA membership now represents the interest of more than 90% of the industry including both manufacturers and distributors with a total membership of 110 companies. The UK IVD market was £380 million in 2001.
On joining BIVDA member companies agree to follow a code of conduct related to their products and sales activities. As some diagnostic testing is moving outside of the hospital pathology laboratory to embrace point of care and self testing BIVDA are investigating the introduction of codes of practice related to this area and also to the supply of genetic tests.
However it must be recognised that genetic testing is not new and is not always ’bad news’. The regulatory control through CE marking of all diagnostic tests being introduced through the IVD Medical Device Directive in December 2003 will police genetic tests as well as the established procedures. The Government has two agencies already established to safeguard patients; the Medical Devices Agency (MDA) and the Patient Safety Agency. The MDA will be responsible for ensuring that any tests sold after December 2003 comply with the legislation and are performing correctly. The power of the MDA will increase when it merges with the Medicines Control Agency from 1st April 2003.
There are already self-test devices available via the internet where the ‘worried well’ can obtain potentially misleading information such as a test for Alzheimers Disease. BIVDA hope that the introduction of the requirement for tests to be CE marked in combination with education of the public to look for this mark before purchase, (as they already do for other consumer items such as electrical goods), will remove the cause for concern relating to any tests, genetic or otherwise. There are many tests which have a ‘genetic’ basis and others which give the same predictive value of disease e.g blood cholesterol and heart disease. Isolating genetic testing is highly questionable.
Just as some diagnostic tests are sold direct to the public and others intended solely for clinicians, the same distinction must be recognised for genetic tests. This misconception can be exploited negatively and the HGC can and should play a leading role in public education.
BIVDA also recommend that the results of any diagnostic tests should not be taken in isolation but used as a basis for discussion with a doctor or healthcare professional.
In conclusion, BIVDA members invest heavily in the development of state-of the-art technology and have long been frustrated by its slow uptake in the NHS. There is evidence to suggest that uptake is 20 years behind the United States. In some circumstances clear evidence demonstrates the major benefits of the new technologies but we still see little energy put into adopting a wider perspective of cost-benefit and in particular decision making which includes evidence, based on downstream costs or improved patient outcomes all of which could be improved by exploiting the technologies developing as a result of information from the Human Genome Project. The Government knows there must be particular emphasis on improving diagnosis and therefore treatment if any of its targets are to be met. As the general public demand more knowledge and control of their own health, then inevitably the demand for private testing will increase and genetic tests will be included in this. But with the provision of information, education and indeed adequate counseling where appropriate (for serious monogenic disorders) this should benefit the health of the nation. |