14 October 2010 -- The BioIndustry Association (BIA) welcomes today’s announcement by the Minister for the Cabinet Office, Francis Maude MP, that a number of non-departmental government bodies (NDGBs) will cease to exist and/or have their functions transferred into one single regulator.
In particular, the BIA welcomes the transfer of functions of regulators including the Human Fertilisation and Embryology Agency (HFEA) and the Human Tissue Authority (HTA) in to one single regulator under the Department of Health. The BIA believes that this will cut bureaucracy and ensure efficiency and that this initiative is a step in the right direction towards streamlining the regulatory review processes and creating a more coherent and robust framework with clarity of responsibilities for research regulation and governance.
In its submission to The Academy of Medical Sciences Review of Regulation and Governance of Medical Research the BIA highlights the important role of the Medicines and Healthcare products Regulatory Agency (MHRA) in the area of clinical trials in the UK and Europe and that it would be appropriate for the MHRA to take on the regulatory functions of the HTA in respect of research and the human application sector as well as the HFEA licensing function relating to stem cell research along with the role of the Steering Committee for the UK Stem Cell Bank. Such a move would bring the UK in line with many EU countries, which compete with the UK to attract inward investments in life sciences.
The BIA also believes that the ethical and scientific/regulatory reviews should continue to be performed by separate and distinctive bodies and that the National Research Ethics Service (NRES) is well managed and is performing an efficient independent review of research through the NHS Research Ethics Committees (RECs).
Alan Morrison, Chair of the BIA’s Regulatory Affairs Advisory Committee, said:
“The creation of such a UK-wide research regulator should promote the competitiveness and attractiveness of the UK to companies looking to invest in R&D. A single regulator could also benefit smaller companies by providing a more efficient, transparent and predictable regime.
Additionally, it is important to have a true parallel approach to the regulatory and ethics approval process with appropriate allocation of responsibilities and good communication as is currently the case between MHRA and NRES.”
For further information, please contact Robert Winder, Communications Manager, 020 7565 7193; mobile 07825 942 934.
BioIndustry Association
Established in 1989, the BIA (BioIndustry Association) exists to encourage and promote a financially sound and thriving bioscience sector within the UK economy and concentrates its efforts on emerging enterprise and the related interests of companies with whom such enterprise trades.
With over 250 members, the BIA supports a wide range of sectors, majoring on the human health benefits of the technology and represents the interests of these innovative companies to a broad section of stakeholders from patient groups to politicians, advancing its members interests both within the UK and internationally to create a healthy UK bioscience sector which benefits society. For further information, please go to: www.bioindustry.org
The BIA events programme provides numerous opportunities for topical debate about emerging trends and key issues - plus excellent networking opportunities all year-round.
Up-Coming Events And Seminars:
The UK: A World-Leading Global Hub for Innovative Lifescience Research and Development Our Vision For a New Decade
25 October – London. Click here for more information.
Life Sciences Dinner – Scotland 27 October – Edinburgh. Click here for more information.
BIA Gala Dinner 2011 27 January – London. Click here for more information.
