Professor Paul Workman, Chief Executive at the ICR, has led a study showing a concerning lengthening in the time which the National Institute for Health and Care Excellence is taking to approve innovative drugs for use by the NHS, especially compared to conventional medicines.
The study, whose results have been published in the journal Drug Discovery Today, suggests that there has been a slow-down in the pace at which NICE is approving innovative drugs, from date of patent filing to date of release on the NHS. It has gone from 12.8 years between 2000 to 2008, up to 14 years between 2009 and 2016.
According to this recent study, innovative medicines take on average three years longer to get NICE approval than conventional drugs. One of the more poignant examples of this shocking delay was the 22 year journey of a drug called trabectedin, which can extend the lives of those with advanced soft tissue carcinoma.
This ICR study shows a disappointing delay to life-changing treatments to patients across the UK. Whilst the regulatory process does hold some 'fast-track' routes for innovative drugs, these routes are still not producing the treatments fast enough for use by patients today. Clinical trials and the overall process to get a drug to market can be a minefield of legal and regulatory hurdles and tick boxes leading to frustrating timescales. However, the balance comes from the lives saved through the proper regulation of medicines and ensuring that when patients take the medicine, it is going to help and not harm either them or others. It is a tough balance to strike, but the 22 year statistic suggests we should be doing much better than this.