13th March 2008
The British In Vitro Diagnostic Association (BIVDA) broadly supports sentiments behind a report published this week by Sense About Science called Making Sense of Testing. However as the industry association for the in vitro diagnostic sector, BIVDA feels that tests legally sold in the UK are well regulated under EU law with the exception of those developed and used in-house by the NHS which are considered exempt from the laws applied to commercial manufacturers.
BIVDA also calls for the greater awareness in the public of the existing regulations for self-tests and that policing by Government should be tighter for kits that do not carry a CE Mark but can be bought via the internet.
BIVDA is concerned about the growth of the unregulated sector of direct to consumer (DTC) testing services, where consumers send samples by post to allow the service to carry out the desired tests. These services are currently unregulated and may cause unnecessary distress and unreliable results. Despite lobbying the MHRA on this, so far there are no plans to regulate DTC testing services. BIVDA is therefore in the process of producing a code of self-regulation for industry although clearly this will only cover ethical suppliers - "the cowboys who bring our industry into disrepute can legally continue their activities" said Ms Williams.
The Association was also concerned that the report makes all testing appear unreliable and could reduce confidence in laboratory medicine among the public. "The tone of the report appears to be returning to curing sick people and away from the Government's agenda of prevention /early intervention" said Doris-Ann Williams, BIVDA's Director General . "This angle was very surprising and unexpected".
However BIVDA supports the message of ‘Making Sense of Testing’ that diagnostic tests have a key role to play in prevention, detection and treatment of disease. It is therefore vital that all publicly available tests continue to be strictly regulated and that patients are made aware that tests must be considered within the broader diagnostics context of clinical experience, research, symptoms and discussion with a healthcare professional.
Director-General of BIVDA, Doris-Ann Williams, said:
“Our members are committed to ensuring the highest standards in their products. Diagnostics are a valuable tool when used in the right circumstances but we remain concerned about the availability of illegal self-test kits, which can be purchased , via the internet. These tests may not be reliable or meet the standards set by the EU directive and leglslated in the UK under the Consumer Protection Act."
“We look forward to further discussions with the Royal College of Pathologists, the Association for Clinical Biochemistry, key stakeholders and the DH to ensure that diagnostic tests continue to deliver for patients, practitioners and the public.”
Contact BIVDA:
Nick Carter – 0207 340 6224
Jonathan Lomax – 0207 340 6214
Sophie Fry – 0207 340 6215
NOTES FOR EDITORS:
- The British In Vitro Diagnostics Association (BIVDA) is the national trade association for companies with major involvement and interest in the In Vitro Diagnostics (IVD) industry. BIVDA represents both manufacturers and distributors who are active in the UK.
- These comments come in response to the report published on 11 March 2008: Making Sense of Testing (http://www.senseaboutscience.org.uk/index.php/site/project/232/)
|