Richard Barker writes about the challenges facing drug development
The Access to Medicine campaign is a unique one, created for patients by patients. This is a powerful voice, rarely heard - but one that I believe could have a real impact on how pharmaceutical companies, regulators, politicians and the general public view drug development.
As the Director of the Centre for the Advancement of Sustainable Medical Innovation (CASMI), I am delighted to be involved in this campaign. Opening up the discussion around the lack of availability of effective drugs for rare and life threatening diseases is a vital first step on the path towards accelerating new innovative drugs.
One of the key problems we’re facing today in overcoming the lack of drugs for rare or ‘orphan’ diseases is the challenge for industry in achieving a return on investment. Major drug companies have been cutting back on their research budgets because the R&D process has hit a wall of cost, time and failure rate. It’s a staggering figure worth repeating – to bring a new drug to market can cost up to £1 billion.
Obviously, the licensing of drugs is in place to protect the general public, and rightly so, but the development and approval processes must be streamlined. The benefit/risk tradeoff for patients who have been diagnosed with life threatening illnesses will be very different than for drugs to manage less serious conditions in the general population. Seriously ill patients are, quite understandably, more willing to try different combinations, or new drugs. Because these drugs may improve their quality of life, or even stop the progress of their disease, they’re willing to accept the risk of possible side effects. We need to involve them more fully in the decision-making.
This is a societal issue and all stakeholders must work together. We must be willing to rethink regulation, especially for rare and life-threatening diseases. The European Medicines Agency has an objective to pilot a new approach along these lines – which goes under different names: for example "adaptive licensing" and “progressive authorisation”. At CASMI we are in the process of working with companies, patient organisations and regulators to find pilots to push forward this concept and enable patients to access drugs more quickly.
I look forward to playing a part in this campaign and shall do all I can to drive this agenda forward.