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Europe’s share of global commercial clinical drug trials almost halved over the past decade as pharmaceutical companies turned to the US and China to take advantage of their simpler regulatory regimes, according to industry representatives.
The proportion of commercial trials being carried out in the European Economic Area dropped to 12 per cent of world studies in 2023 from 22 per cent in 2013, according to a report to be published on Tuesday by the European Federation of Pharmaceutical Industries and Associations lobby group and by data provider IQVIA.
The number of clinical trials across the world increased by 38 per cent over the same period, according to the report. China has doubled the number of commercial trials it conducts since 2018 and now accounts for 18 per cent of the global total, the report said. North America saw its share slip from 26 per cent to 23 per cent over the same period but the US remains the leader in such testing.
The report argued that drugmakers were deterred by the length of timelines in the EEA, which because of its complex regulatory framework tend to be significantly longer than in other regions for vetting compliance, setting up trial sites and recruiting patients.
“European clinical trials are hampered by a slow and fragmented research ecosystem, and current initiatives . . . are insufficient to stop and reverse a decade of decline.” said EFPIA director-general Nathalie Moll.
Spain was an outlier, overtaking Germany as the country running the most clinical trials in Europe, with industry investment climbing from €479mn to €834mn in the decade up to 2022. Over the period, the country invested in new research sites and simplified procedures.
Clinical trials are scientific studies carried out to confirm the effects and safety of new medicines. For people with rare illnesses, they can at times be the only treatment option.
The decline in Europe has meant 60,000 fewer patients being enrolled in clinical trials involving an EEA country in 2023 compared with 2018, according to the report. The figure for EEA-only trials dropped by 20,000.
The fall was seen across a range of medical fields, from oncology and neurology to immunisation, paediatrics and cell and gene therapy.
Separate data from the World Health Organization shows that in 2021, the number of clinical trials in the Western Pacific region — which includes China — had risen to some 25,000 compared with 7,400 a decade earlier. Europe conducted around 17,800 in the same year compared with 10,300 in 2011.
Mario Draghi raised the issue in his September report on European Union competitiveness. The former European Central Bank chief pushed for the bloc to harmonise regulation and streamline the management of multi-country trials in order to attract more clinical research.
Moll said: “For Europe to be competitive, it needs to function as a unified region, not as individual member states, and be supported by policies to attract global research investment.”
Healthcare is the competence of national authorities in the EU, meaning health regulation often varies across the 27 member states.
The European Commission’s Clinical Trials Regulation — which came into effect in January 2022 — established a single portal through which sponsors could authorise trials rather than sending individual applications to each member state.
A spokesperson said that looking at “ways to further improve the functioning of the rules for clinical trials in the EU and thereby re-power clinical research” would be a “high priority” for the next commission, which is expected to take over by the end of the year.