‘Early Access’ Scheme Unveiled for Innovative Medicines - European Medical Journal

‘Early Access’ Scheme Unveiled for Innovative Medicines

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Innovations

People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

The Early Access to Medicines scheme would enable safe and promising drugs to be “fast tracked” into the NHS before they have even been granted a licence for use.

The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

Experts will carry out a rapid analysis of the treatment before labelling it a “promising innovative medicine”.

The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.

The MHRA has estimated that initially one or two medicines a year might qualify under the scheme.

“Making Britain the best place in the world for science, research and development is a central part of our long-term economic plan,” said Health Secretary Jeremy Hunt.

“This ground-breaking scheme will provide cutting edge medicines earlier, give hope to patients and their families and save lives. And as part of our strategy for life sciences it will create more jobs and opportunities for people, helping secure a better future for our country.”

Through the scheme, pharmaceutical companies will be able to gain experience of how their medicines are being used in the NHS. The hope is that such companies will then invest more in the UK due to increased confidence that they can introduce drugs more quickly.

Once a drug has been fully licensed for use, it will come out of the Early Access to Medicines scheme and be assessed by the National Institute for Health and Care Excellence (NICE) in the usual way.

Dr Harpal Kumar, chief executive of Cancer Research UK, welcomed the scheme.

“Time is of the essence for many cancer patients, particularly those with more advanced disease. It can mean the difference between life and death,” he said.

“Therefore this scheme, which has at its heart the potential to bring promising new medicines to patients faster, is to be warmly welcomed.

“The scheme should also make it more attractive for life sciences companies to conduct their development activities in the UK, which will bring a multitude of benefits to the population.”

Copyright Press Association 2014

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