Medicine Access Changes Will Help Companies Develop, UK MPs Told
UK MPs have been told that regulatory proposals currently being considered for quicker entrance for medicines which meet key unmet medical needs provide an opportunity for small life science businesses to grow to middle-sized organisations.
In December 2011, the UK’s Prime Minister, David Cameron, announced that, as part of the Life Sciences Strategy, the MHRA (Medicines and Healthcare products Regulatory Agency) would be consulting on a scheme for earlier access to drugs, ahead of a planned 12-week public consultation on the issue early this year.
The schemes under consideration include for products to gain partial approval at the completion of Phase II under an “adaptive licensing” scheme, which according to Life Sciences Champion Professor Sir John Bell, would be beneficial for both patients and the pharmaceutical industry.
For corporations which wish to grow, it would allow them a chance to explore how successful a product’s is and generate initial income from the medicine, Sir John added, who reminded MPs that organisations who are now considered main biopharmaceutical players, for example Amgen and Genentech, initially started with just one product.
All of the leading biopharmaceutical communities internationally began by providing substantial tax benefits, and with the new motivations now being offered by the UK, it is starting to be as attractive as anywhere else globally for organisations in the pharmaceutical sector, noted Sir John.
However, he also stressed the need for firms to work better together – while there are many biotechnology companies in the Thames Valley, for example, and along the M11 corridor going up to Cambridge, they don’t act as a cluster, he commented. “It’s not UCL versus Cambridge – it’s the UK versus the rest of the world,” he added.
In response to the PharmaTimes questions about the faster access proposals, the Medicines and Healthcare products Regulatory Agency commented that the Life Sciences Strategy includes an obligation for the Agency to consult on a proposal to make selected new medicines available prior to being licensed. “MHRA would provide a scientific opinion on the benefits based on information made available by the company. It would be for NHS purchasers to decide whether to purchase these unlicensed medicines,” noted the Agency.
The Strategy also includes a commitment for MHRA to consider wider chances for regulatory change, it adds, and notes the increasing dispute “on what is being called ‘adaptive licensing’.”
“The MHRA will be working with the relevant regulatory, industry and academic interests to consider what adaptive licensing could comprise and whether there would be scope for further work to develop this concept,” the MHRA informed PharmaTimes.