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CQC oversight would be negative for preclinical CROs, says Human Tissue Authority

19-Nov-2012

UK Government proposals to hand oversight of tissue handling to a non-specialist body would have a negative impact on the preclinical services sector says the Human Tissue Authority.

The HTA – which was set up in 2005 to police the use of human tissues in research following the discovery that some UK hospitals had been storing samples illegally – is one of a number organisations facing possible abolition under a Department of Health (DoH) review .

The proposal is to transfer HTA activities – including its licensing of contract research organisations (CRO) that use human tissue in drug research - to the Care Quality Commission, a body established in 2009 to regulate and inspect health services and social services in England.

HTA spokeswoman Jo deBank told Outsourcing-pharma.com that: “Transfer to a non-specialist regulator would have a negative impact,” explaining that overseeing the use of tissues in drug research, as well as the HTA’s other regulatory activities, requires specialist expertise.

The organisation’s position is supported by - among others - the doctors union the British Medical Association (BMA), research charities the Academy of Medical Sciences and the Wellcome Trust and patient group Genetic Alliance UK.

Government consultation on the proposals was completed in September but – according to deBank – a final decision has not been taken.

Preclinical oversight

The HTA’s oversight activities cover more than 800 organisations tissues and are based on various sector-specific compliance monitoring guidelines. In the field of preclinical the focus is on oversight and storage of materials.

UK preclinical contract research organisation (CRO) Precos is one example of a firm whose activites are impacted by this oversight.

In August the organisation announced that it was expanding its range of patient-derived tumour xenograft models after being granted a license HTA.  

At the time Precos said that: “The HTA licence will also allow PRECOS to collect patient material in addition to tumour tissue, such as blood samples, normal tissue and other bodily fluids which can be used for biomarker assessment and more specific requirements such as assessment of circulating tumour cells.

Direct access allows supply of samples to be tightly controlled and delivered with a specific protocol and timeframe and under the appropriate ethical review and consent."

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