The Association of the British Pharmaceutical Industry (ABPI) has issued a report that findsover half of the active products in the global industry research pipeline are personalized medicines, and the U.K. healthcare system is at risk of failing to adapt to this new challenge. The report highlights the emergence of specialized medicines as a key challenge for the U.K. pharmaceutical industry and says for the commercial environment in the U.K. to respond to this challenge, a fundamental shift in the Health Technology Assessment (HTA) approaches is needed.

But changes are occurring in the U.K. and in Europe, in the form of pioneering joint-working initiatives involving NHS and industry. The report also points to NICE’s Highly Specialized Technology (HST) program, which has the potential to make a big difference to how specialized medicines for very rare diseases are evaluated.

The report highlights further challenges, including rising drug development costs and difficulty with patient recruitment for clinical trials, saying about 80% of clinical trials do not meet patient recruitment timelines and, on average, last 30% to 42% longer than companies initially plan. To overcome this, the U.K. must improve trial performance by enabling faster patient enrollment, encouraging the use of electronic health records and streamlining the research governance process.

Stephen Whitehead, chief executive of the ABPI, said, “This report sheds new light on the challenges facing the U.K. pharmaceutical industry. Whilst companies are refocusing their pipelines toward specialized and stratified medicines, a gap is opening up between the commercial environment the industry currently operates in and the new R&D environment the industry is moving toward. If we don’t address this gap soon, patients will be unable to access the best treatments and the U.K. economy will suffer.” 

The Securing a Future for Innovative Medicines discussion paper was prepared for the ABPI by the Office of Health Economics (OHE). Professor Adrian Towse, director of the OHE, said, “Global pharmaceutical R&D is changing, and the U.K. needs to adapt to the new environment in order to retain its status as a leading location for biomedical R&D, both pre- and post-launch.  We must not forget that there already are examples of best practice where changes are occurring in the U.K. and at European level. Only when industry, academia and NHS work together and spread best practice will we better understand how changes in drug development will alter the relationship between the research and commercial elements of the pharmaceutical industry for the NHS.”