Commenting on the announcement, Paul Catchpole, Director of Value and Access at the Association of the British Pharmaceutical Industry (ABPI), said:
“We welcome the consultation response to the Early Access to Medicines Scheme, and both the Department of Health and Medicines and Healthcare Products Regulatory Agency’s (MHRA) commitment to launch the scheme by April 2014. The ABPI has been actively engaged in this project throughout.
“The scheme will benefit patients, the NHS and the UK clinical research community, of which our industry is a part. Most importantly, it means that patients with some life-threatening or seriously debilitating conditions, without adequate treatment options, will be able to get faster access to important innovative medicines as these will be made available before launch, following an assessment by the MHRA.
“The introduction of the Promising Innovative Medicines (PIM) designation should help make the UK more attractive for investment and growth, with similar merits to the Food and Drug Administration’s (FDA) Breakthrough Therapy Designation in the US.
“The collection of additional data and evidence over the period the medicine is available before launch is very welcome. This has the potential to assist NICE and other health technology assessment bodies, in being able to recommend more medicines for use with greater certainty after they are launched and could, therefore, result in more timely routine access to licensed medicines for NHS patients.
“We note that the scheme is currently unfunded, which is an issue for some companies. This means companies have to bear the risk associated with the upfront investment that will be required to participate in the scheme. As part of our consultation response, we have called for a one year on joint review of the scheme so that we can appraise its first year and potentially review funding options.”
Pete Butterfield, Chair of the ABPI Smaller Companies Forum, said:
“This scheme provides an exciting opportunity for smaller companies. We have already seen a similar approach working well in the US through the FDA’s Breakthrough Therapy Designation. Companies use it to secure investment and increase the credibility of the medicines in the scheme, particularly in other countries. This new scheme provides a clear signal that the UK is a leading healthcare provider with an innovative approach to securing quick and safe access to medicines for patients who need them.”
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Notes to editors
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by Government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.