10 October 2012 -- The BioIndustry Association (BIA) has called on the UK government to introduce a workable and funded Early Access to Medicines Scheme to enable patients to receive innovative new therapies as soon as possible, which will make the UK the most attractive early launch market in Europe.
The BIA welcomed the proposal to introduce an Early Access to Medicines Scheme in the UK, which was outlined in the Strategy for UK Life Sciences. In a detailed submission responding to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the scheme, the BIA raises four key areas that require consideration to make the scheme attractive and workable:
• Scope and candidate product qualification criteria
The BIA asks that the determining factor for eligibility should be the treatment in an area of unmet medical need.
• Stage of development
The BIA wants a flexible approach which does not restrict the Early Access to Medicines Scheme to the end of phase III trials, which we believe may offer limited incentives for innovative drug developers in the UK.
• The regulatory application process and fees
The BIA wants this process to be as streamlined and cost effective as possible.
• Reimbursement and wider economic considerations
The BIA believes that central ring-fenced funding for the Early Access to Medicines Scheme is vital to make the scheme successful and attractive in a global market.
Steve Bates, BIA Chief Executive officer, said:
"A funded early access to medicines scheme that makes it quicker and easier for new medicines to reach patients can secure the UK's position as the country for innovative therapies to be launched.
"We are pleased that the UK government committed to this consultation in its Strategy for UK Life Sciences. Our submission provides the practical details needed to make early access a workable and useful scheme."
The BIA is represented on the MHRA's Expert Group on Innovation in Healthcare Regulation and believes this will represent an important forum for discussing the responses to the consultation on the proposed Early Access to medicines scheme and for proposing the next steps. The BIA values the positive engagement with the MHRA and government and sees this as benefiting UK medical research, bioscience companies and ultimately UK patients.
For further information, please contact Robert Winder, Head of Communications, email@example.com, 020 7630 2191; mobile 07825 942 934.
BIA consultation response
The BIA response to the MHRA consultation on the government's proposal to introduce an Early Access to Medicines Scheme in the UK has been informed by extensive discussions with its membership and from the BIA-led sector-wide workshop held on 7 September. This workshop, which included representatives from the MHRA, government departments, patient groups, industry, academia and medical research charities, helped to achieve clarity on a number of aspects of the current proposal and acted as a forum to discuss a number of the issues.
The executive summary of the consultation response is available on the BIA website (http://bit.ly/biaregconsult). The full consultation response is available to BIA members on the BIA website (http://bit.ly/biaregconsult) or to the media by request from Rob Winder.
Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to www.bioindustry.org