UK Gov’t Offers a ‘Review’ Amid Clamor Over Declining Clinical Research

The UK government has decided the decline in commercial clinical trials needs a response—and its response is to set up a "review" of the "landscape." The announcement came late this month, after repeated alarms being issued by the UK-based pharmaceutical industry—exposing yet more concerns over the downsides for the economy of the country's departure from the European Union.

The director of research policy at the Association of the British Pharmaceutical Industry (ABPI), Jennifer Harris, PhD, greeted the announcement with a mixture of relief and urgency. “Addressing the worrying decline of industry-sponsored clinical research in the NHS is critical if we are to deliver the UK’s ambitions for the life sciences sector and to support NHS recovery," she said. She is looking to see "system wide reform" that she says is needed to rebuild the UK's global competitiveness and to support NHS patients. She considers the setting up of the review as a recognition of the need to act decisively to reverse "this negative trend." Government-quoted figures confirm the severity of the decline. "Our life sciences sector has reported a 44% fall in recruitment of patients to commercial clinical trials between 2017 and 2021—so it is vital that we act to rebuild competitiveness," said George Freeman, minister for state at the new Department for Science, Innovation, and Technology. The ABPI's own figures underline the trends: the number of industry clinical trials initiated in the UK per year fell by 41% between 2017 and 2021, exacerbated by the effects of the pandemic.

The Department's Office for Life Sciences says that the review will be conducted by former health minister Lord James O’Shaughnessy, now a consultant. According to the government announcement, "the review will offer recommendations on how commercial clinical trials can help the life sciences sector unlock UK growth and investment opportunities and advise on how to resolve key challenges in conducting commercial clinical trials in the UK." The aim is to build on the government’s March 2021 10-year vision for clinical trials, and the UK's recovery, resilience, and growth program that the health system and industry work together to deliver the vision. The ABPI has said it will "work closely" with Lord O’Shaughnessy "to provide practical solutions."

But the announcement is stronger on rhetoric than on specifics. Current Health Minister Will Quince spoke of "harnessing the same spirit of innovation that delivered the COVID-19 vaccine and working hand in hand with the NHS, industry, and healthcare experts to get cutting-edge medicines to patients faster." Quince claims the review will identify "new ways to conduct commercial clinical trials that will speed up diagnosis, enhance treatment, and enable the NHS to deliver world-class care, as well as cementing our position as a life sciences super power." With striking optimism, and despite its own figures, the government announcement says that the UK "continues to lead the way in ground-breaking research."

The UK initiative comes as the drug industry in Europe is pushing hard for the creation of a more congenial climate for innovation in the forthcoming revision of the EU's 20-year-old EU pharmaceutical legislation. The industry's lobby in Brussels has been energetically pushing the message that European research is in peril from foreign competition, and demanding more favorable terms for research as the price for maintaining investigation in Europe. Since Brexit, the interests of the UK and of the EU have inevitably diverged, with a strong sense of competition between them in their campaigns to attract clinical trials. The harsh reality for both of them is that the major threat to their future is not one another, but the growing prominence of the US in drug innovation, and the rising capacity of China and other Asian nations.