15 November 2013 -- Following the publication today of the Report of the Expert Group on Innovation in the Regulation of Healthcare, by the Medicines and Healthcare Products Regulatory Agency (MHRA), the BioIndustry Association (BIA) urges government to implement a properly funded and reimbursed Earlier Access to medicines Scheme (EAS), which the expert group makes its number one recommendation.
Steve Bates, BIA Chief Executive Officer, said:
“I am pleased to see the expert group supports the idea of an early access to medicines scheme, for which we have long advocated. Now the government must make a funded scheme a reality.
“I am also pleased that the expert group wants the European Medicines Agency to launch a call for adaptive licensing at the earliest opportunity so that companies could put forward pilot products; and that the group proposes the idea of adopting a new breakthrough designation for new therapies both at a UK and EU level.
“In just a year since new rules were put in place for the development of treatments in the US, 32 drugs have been granted breakthrough designation by the US regulator, the Food and Drug Administration (FDA). This designation has rapidly sped up the process for drugs to become available for patients who need them. These have been for products where there is a desperate need for new drugs for example in multiple myeloma, cystic fibrosis, hepatitis C, acute heart failure and Duchenne muscular dystrophy. Two drugs with breakthrough designation status have already been approved by the FDA.
“If UK patients are to benefit from the most promising new drugs and UK biotech companies are to develop those therapies here rather than overseas we need a similar ‘breakthrough designation’ scheme here. As well as holding the potential to significantly accelerate such treatments to those patients who need them, breakthrough designation has had a positive effect on the companies developing the products and on the investment community’s perception of those companies.
“It is encouraging to see in this report broad support for fresh thinking on the regulation of new medicines. Speedily adopting the group’s recommendations is one simple way in which the government can make the UK an attractive global destination for innovative biotech and pharmaceutical companies to research and develop the treatments of the future to benefit UK patients.”
For further information, please contact Robert Winder, Head of Communications, rwinder@bioindustry.org, 020 7630 2191; mobile 07825 942 934.
Report of the Expert Group on Innovation in the Regulation of Healthcare
Further information on the report is available at www.mhra.gov.uk/NewsCentre/Pressreleases/CON336726 Recommendation 1 of the Expert Group: “The Expert Group is supportive of the Government launching an Early Access to Medicines Scheme as soon as possible and urged the Government to conclude discussions on the funding aspects of the scheme.”
BioIndustry Association
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
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