The Association of the British Pharmaceutical Industry (ABPI) has highlighted how patients in the UK would miss out on ground-breaking clinical trials by voting to leave the EU.
Reformed EU clinical trial regulations are set to create a centralised gateway for clinical trial applications, but Brexit would see patients in the UK fall out of this new system leaving EU patients ahead in accessing the latest innovative clinical research.
The UK already has an enviable position as one of the go to destinations for clinical trials, but this legacy is now under threat, says ABPI CEO Mike Thompson.
Data published by the ABPI and Thomson Reuters in 2015 highlighted how patients in the UK are already in a good position within Europe for opportunities to take part in clinical research, accessing the latest medical innovation. The research showed that the UK is the top country in Europe for phase one clinical trials, second behind Germany for phase two clinical trials and third behind Germany and Spain for phase three clinical trials.
Alongside this legacy, the new European Union Clinical Trials Regulation, set to come into effect at the end of 2018, is also set to harmonise procedures for the assessment of applications for clinical trials, enhance collaboration between ethics committees, streamline safety-reporting procedures and increase transparency in trial outcomes.
This does not only impact patient access to clinical research, but would also negatively influence the economic growth of the NHS, which currently benefits through existing investment in research by the life sciences industry.
Commenting, Mike Thompson, ABPI Chief Executive said:
"A corner stone of maintaining the UK's status as a premier global destination for life sciences, clinical trials are vital to the process of drug discovery and innovation, delivering UK patients the opportunity to access medical innovation to fight cancer and HIV/AIDS, as well as the rarest forms of genetic diseases.
While the decision in this referendum is for the people of the UK and the industry is committed to investing in research and delivering new medicines for patients regardless of the outcome of the vote, the UK's continued membership of the EU is vital in maintaining UK patient access to clinical trials to continue to deliver positive patient outcomes.
We know the old Clinical Trials Directive did not function effectively– yet the new clinical trials system will cut the bureaucracy of the old Directive, and not only enable more much-need research, but will also underpin the EU as the home for clinical trials at global level. By voting to leave, UK trials could face delay, as companies would deprioritise Britain for a more collaborative and harmonised approach available inside the EU. This would be a backwards step for patients and for the NHS.
EU reform on clinical trials also provides a framework for collaboration across Europe and is just one real-world example of how Brussels is willing to listen to UK industry, to UK government and to the UK public to fix complex problems and cut red tape."
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The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies supplying around 90 per cent of all medicines used by the NHS, and are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.