There needs to be an independent review of the UK’s Human Tissue Act 2004 to determine whether it is stifling cancer research, a new report recommends.

The report by science policy think-tank Newton’s Apple looks at ways in which research findings in oncology can be translated into real benefits for patients. It also recommends incentives encouraging industry to work towards the development of personalised medicine and matching diagnostic tests; and prioritisation of funding for the development of decision-making tools that could help general practitioners to diagnose cancers.

The regulation arising from the Human Tissue Act 2004, which deals with the removal, storage and use of human tissue, was implemented by the Human Tissue Authority in 2006. As Newton’s Apple points out, the aim was to support researchers by boosting public confidence in research using human tissue. The Act makes consent the fundamental principle underlying the lawful storage and use of body parts, organs and tissue from the living and the dead.

However, some academic and industry-based researchers see the human tissue regulation as a hinderance, citing the additional and substantial costs involved in meeting the new requirements and becoming a licensed tissue bank, notes the report, Delivering Innovative Cancer Diagnostics and Treatments for Patients.

“Both academia and industry-based research teams recognise that good research governance is crucial but feel that the bureaucracy and cost involved is absorbing too much of the time and investment in research,” Newton’s Apple comments. The think-tank has received reports from one leading UK university that up to £51,000 a year is being diverted from research funds to comply with the regulations.

Proposed changes to the Human Tissue Act in the UK government’s draft Human Tissue and Embryos Bill – such as a much-criticised plan to form a new Regulatory Authority for Tissue and Embryology (RATE) by combining the Human Fertilisation and Embryology Authority with the Human Tissue Authority – were stripped out of the controversial legislation when it was formally introduced as the Human Fertilisation and Embryology Bill in November 2007.

“Both the human tissue regulation and the authority that enforces it are in their infancy,” acknowledged Newton’s Apple director Gillian Pepper, adding that there are “bound to be teething problems and there will always be tension between regulators and those who simply dislike being bound up in red tape”.

Nonetheless, she said, the concerns highlighted in the report about bottlenecks to cancer research created by the regulation indicate “a serious need to investigate whether this is true and, if so, how the situation can be improved”.

The BioIndustry Association provided an unrestricted educational grant to enable printing of the report, while the stakeholder consultation event that informed the report was supported by AstraZeneca, the Association of the British Pharmaceutical Industry, the BioIndustry Association, Cancer Research UK, the Lymphoma Association, Merck, Sharp and Dohme and Pfizer