Europe’s lawmakers are pushing to create a single “trial union” by merging 27 national systems and speeding up how new medicines are tested, with approval times set to fall to 75 days. But pharmaceutical companies warn the EU is still falling behind, demands approvals in weeks, not months.
The benchmark is China. At Europe’s Choice, the pharmaceutical industry’s annual conference last week, Pfizer’s Alexandre de Germay put the target bluntly: “We go down to 75, we should try to go to 30 days, because that’s what’s happening in China.” China now clears trials in about a month while Europe is far slower. Even the EU Biotech Act would not fully close the gap.
Speeding up trials is the concrete number one action of the Act. MEP Vytenis Andriukaitis (S&D/LTU), the report’s co-rapporteur and a former EU commissioner for health, put it plainly. “A central element is clinical trials. Today, Europe is too often slow, fragmented and unpredictable. This is bad for researchers, bad for companies, and above all, bad for patients.”
We go down to 75, we should try to go to 30 days, because that’s what’s happening in China. — Alexandre de Germay, Chief International Commercial Officer, Pfizer
Mr Andriukaitis and co-rapporteur MEP Wouter Beke (EPP/BEL) presented their joint draft report, 390 amendments, to a joint meeting of the public health (SANT) and industry (ITRE) committees on Monday. The facts are there, Mr Beke told the committees: a decade ago Europe ran 22 per cent of the world’s clinical trials; today it runs 12 per cent, while about 40 percent are now in China.
The race to go faster
The Act’s central promise is time. Approval time of 106 days would fall by nearly a third. For many, even that is not enough. Speaking for the Socialist MEP Dario Nardella (S&D/ITA), Mr Andriukaitis read a sharper line. “Reducing approval timelines from 106 days to 75 days is welcome, but given that the US, UK and China operate within a 30-day window, we should be more ambitious.”
The regulator is already moving. Emer Cooke, the European Medicine Agency’s director, told the same conference that national regulators and their ethics committees are piloting the approach before the law takes effect. “We’re already showing that we can do clinical trials in 70 days,” she said, calling regulatory capacity “a strategic asset.”
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From 27 systems towards one
To get there, the report rewires the machinery. A multinational trial must currently clear a patchwork of national procedures. The report builds a more central route, creating a Clinical Trials Expert Committee, chaired by the EMA, to assess them. MEP Beke said the committee would “harmonise and accelerate the approval procedure for clinical trials even more,” with “strong coordination of the EMA (…) while avoiding unnecessary delays by the member states.”
The boldest idea goes further. The report adds an optional EU-level route for rare disease, orphan and advanced therapy trials, run by the EMA, with a single binding ethics opinion that replaces every national ethics committee. MEP Stine Bosse (Renew/DEN), wants exactly that. Europe must move “from a group of trial nations to a trial union,” she said, with “a 28th regime, which will centralise ethics assessment across the union while respecting the red lines of the member states.”
Trials, not just numbers
MEP András Kulja (EPP/HUN)said the ambition should be trials “conducted across all member states,” not just more of them. Biotechnology, he added, “is not only about innovation. It’s about people.” MEP Peter Liese (EPP/DEU) flagged a warning case. The EMA, he said, “has just approved a medicine where the clinical trials only happened in China,” raising questions about ethical standards. The co-rapporteurs, he noted, have addressed the point.
The patent fight in the wings
One row will dominate the autumn, though it is not the trials story. It is the 12-month patent extension, the supplementary protection certificate (SPC), on which we reported last week. MEP Timo Wölken (S&D/DEU), the Legal Affairs opinion rapporteur, said he had “deleted the dangerous proposals regarding the SPC.” MEP Ville Niinistö (Greens-EFA/FIN), wants it rejected. “The objective is not simply more biotechnology,” he said. “It’s better biotechnology.”
The Commission defended it as conditional, not a giveaway. “It’s not a gift,” its representative said. “It comes with very strict conditions in terms of where you conduct your clinical research and where you manufacture.” Mr Beke called the extension “an important piece of the puzzle to keep the industry here in Europe”, but left the fight for later. Mr Andriukaitis urged a “balanced approach” to “all incentives”, not only the SPC.
Why it matters
The procedure sits on top of a competitiveness alarm. On 26 June, the European Life Sciences Coalition, with Invest Europe, told EU leaders the EU draws just seven per cent of global life-sciences venture capital, against 63 per cent for the US and 14 per cent for China. It urged them to “eliminate fragmentation that slows clinical trials” through the Biotech Act.
MEP Beke framed the stakes bluntly. He noted 66 of 67 biotech IPOs happened in the United States, and that the sector was worth 38 billion euros in EU GDP in 2022 and supported more than 913,000 jobs.
As trials and capital leave, dependency follows. He stressed: “Europe needs this, not for the sake of the industry, but we need the industry for the sake of our patients.”
Industry made the same case. At the event, EFPIA president Stefan Oelrich said the Biotech Act “points in the right direction, but EU-level ambition will fall short if national systems remain anchored in the past”, because there is “no true single market for medicines”.
What happens next
The Biotech Act began as a Commission proposal on 16 December 2025, the first of two planned acts. The committees’ deadline for amendments is 7 July. After the summer, Mr Beke said the rapporteurs will return with “a new set of compromise amendments” as the starting point for negotiation, with the Irish presidency, he added, “an engaged partner” in the Council.
Mr Andriukaitis’s test still stands. The Act, he said, “will determine whether Europe leads or follows in the next decade of therapeutic innovation”.
