Regulatory proposals now being considered for faster access to medicines which meet major unmet medical needs present an opportunity for small life sciences companies to advance to becoming mid-sized firms, MPs have been told.
Last December, Prime Minister David Cameron announced that, as part of the Life Sciences Strategy, the Medicines and Healthcare products Regulatory Agency (MHRA) would be consulting on a scheme for earlier access to medicines, ahead of a planned 12-week public consultation on the issue early this year.
The proposals under consideration include the possibility for such products to obtain limited approval at the end of Phase II under an "adaptive licensing" scheme, and this would be good for both patients and industry, newly-appointed Life Sciences Champion Professor Sir John Bell told a meeting of the All-Party Parliamentary Group on Life Sciences recently.
For companies which want to grow, it would provide them with an opportunity to explore a product's effectiveness and also generate some income, said Sir John, who reminded MPs that major biopharmaceutical players such as Amgen and Genentech began with just one product.
All the leading biopharmaceutical communities worldwide started off by offering significant tax benefits, and with the new incentives now being offered by the UK, it is getting to be as attractive as anywhere in the world for companies in the sector, said Sir John, who is Regius Professor of Medicine at Oxford University and a former president of the Academy of Medical Sciences. However, he also pointed to 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 said.
"It's not UCL versus Cambridge - it's the UK versus the rest of the world," he said.
Asked by Pharma Times about the faster access proposals, the MHRA said that the Life Sciences Strategy includes a commitment for the Agency to consult on a scheme to make some new medicines available to patients before they are 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," said the Agency.
The Strategy also contains a commitment for MHRA to consider broader opportunities for regulatory change, it adds, and notes the growing debate "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 Agency told Pharma Times.
* "Adaptive licensing" was recently defined in an article in Nature as an approach "based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data-gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions," says the article, by Hans-Georg Eichler, senior medical officer at the European Medicines Agency (EMA), and others.