Tag Archives: early access to medicines

Launching the Early Access for Innovative Medicines scheme

By George Freeman, MP for Mid Northfolk

First published in the Spectator

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Imagine this: you take a routine trip to the doctors. Except it doesn’t turn out to be routine at all. Instead, the doctor tells you that you only have months to live. Worse still, there is no certified cure. There is a potential drug that could save your life, but it’s stuck in a regulatory tangle, waiting for approval which takes years. It might come on the market in a decade. But by then, of course, it will be too late for you.

33 days to change medical history: sign our petition to enable medical innovation: http://chn.ge/1pqY6lS

Ludicrous, surely? Yet that has been the dilemma facing too many over recent years, unable to get access to the drugs that could save their lives. Decades more of enjoyment, time with the grandchildren, a whole chunk of life wiped out when a cure could be sitting there unused.

As was announced on Friday 15th 2014, this is going to change thanks to the Early Access to Innovative Medicines scheme I have helped design. It has the potential to revolutionise drug development and completes the vision set out in the UK Life Sciences Strategy launched by the Prime Minister in 2011 and the NHS Innovation Health and Wealth reforms. The core vision was that the UK would be a crucible of medical innovations that could help all of us live better for longer. It is the same philosophy that lies behind the Saatchi Bill, putting medical innovation front and centre of healthcare and helping find new cures that work for patients.

 Medicine is currently undergoing a seismic shift, from a 20th century model (something done to us by Government) to a 21st century model (something we increasingly take a responsibility for ourselves). Revolutions in genomics and data are driving a new generation of targeted and personalised medicines, and reshaping the landscape of drug design. The old traditional ‘blockbuster’ Big Pharma model of the post-war years is ceding to the world of ‘translational’ or ‘experimental’ medicine in which drugs are designed with, and around, patients, their data and tissues, in clinical research facilities and hospitals.

 This is part of a wider revolution of patient empowerment. Instead of sitting passively waiting for new medicines, today’s patients are increasingly impatient and want access to innovative treatments now. Patient charities and advocacy groups are becoming powerful players in the new landscape: funding research, lobbying for access and forming new companies. The Early Access Scheme fast-tracks the best new life-saving medicines to patients earlier while maintaining robust safety standards. It can only happen if the new drug is targeted at an area of unmet clinical need, there is powerful data and evidence to show the drug is safe and the patient taking the drug has provided informed consent.

 With the right safeguards in place, it soon becomes clear that the benefits of this new scheme are profound. Not only will this help save lives by providing patients with life-saving drugs quicker, it can help the UK be at the forefront of this new world of twenty-first century healthcare. We have the chance to cement a competitive advantage (over the USA and Europe especially) as the global location of choice for designing, testing and proving the new generation of personalised medicines. Under this Early Access scheme, UK patients will be able to trial the most innovative medicines before any others. With the NHS seal of approval, we can then help sell these drugs to the Qataris, Saudis and emerging-world rich all over the planet, investing the revenues back into the NHS to the benefit of us all.

Nothing in healthcare is without controversy. But with innovative medicines, as with the recent controversy over patient data, the arguments on both sides boil down to one single point: who wants to be better for longer? One thing’s for sure – I do. I think you do too. If any of us got that diagnosis, we’d want to know we had access to the latest drugs. Last week’s announcement – and the pioneering campaign of the Saatchi Bill – helps make sure we do.

33 days to change medical history: sign our petition to enable medical innovation: http://chn.ge/1pqY6lS