Euro Roundup: EFPIA pushes EU to simplify, speed up clinical trial framework under Biotech Act

EFPIA has included a call for the European Union to simplify, speed up and harmonize the framework for clinical trials in its feedback on the planned Biotech Act.

The European Commission is pitching the act as a way to “create an enabling environment to accelerate the transition of biotech products from laboratory to factory and to the market, while maintaining the highest safety standards.” In its call for evidence, the Commission said EU companies are not competitive enough and “face barriers and complexity” when trying to bring biotech products to market.

EFPIA, a trade group that represents large biopharma companies, outlined what it sees as the barriers in its feedback to the Commission. The trade group is calling for “coordinated and urgent action” across multiple areas, including the framework for clinical trials.

Industry ideas for how to improve the framework include the “pragmatic implementation of the Clinical Trials Regulation avoiding requirements beyond its scope” and “faster, harmonized and coordinated processes for multi-country trials, including ethics reviews, with the use of reliance mechanisms.”

EFPIA also wants the EU to allow parallel submissions of substantial modifications and align regulatory pathways across frameworks. Alignment across regulatory frameworks such as the medtech regulations and genetically modified organism legislation could “reduce duplication and complexity,” EFPIA said.

The trade group is pushing for the modernization of the EU regulatory ecosystem. The framework “must apply better regulation principles to truly function as [an] enabler of biopharmaceutical innovation,” EFPIA said. The reform of the pharma legislation is part of the process, and the trade group sees the Biotech Act as a route to further progress, including by shaping cell and gene therapy standards.

EFPIA dedicated most of its response to an aspect of the pharma reforms that it has criticized, namely changes to intellectual property protections. The trade group wants the EU to use the Biotech Act to set up a “best-in-class IP environment” that it believes is needed to attract investment that might otherwise go to China or the US.

Specific requests include the removal of the five-year cap on protection from Supplementary Protection Certificates, without pediatric extensions. Dropping the cap would “allow companies to more accurately recoup the patent time lost between developing a novel drug and its marketing authorization,” EFPIA said. The trade group also wants market exclusivity to factor in the time taken to secure reimbursement.

The feedback is one of 224 submissions to the call for evidence in the Biotech Act. Companies including AstraZeneca, Boehringer Ingelheim and Novo Nordisk echoed some of EFPIA’s points in their submissions to the Commission.

Press Release, EFPIA Response, More

UK raises drug repayment rates, prompting ABPI to warn of ‘terrible message’ to investors

The UK government has pushed ahead with plans to raise the repayment rates on sales of prescription medicines despite 80% of respondents to its consultation disagreeing with the proposals.

Companies that sell prescription drugs in the UK can join a voluntary scheme that uses rebates to cap the growth in spending on medicines. Drugmakers that choose not to participate in the scheme are covered by a statutory scheme that is intended to be broadly commercially equivalent to the voluntary program. The UK government proposed changes to the statutory scheme earlier this year.

After reviewing feedback, the government has decided to raise the statutory scheme headline payment percentage for newer medicines in 2025 to 23.4%. The figure is slightly lower than the rate proposed in the consultation but higher than the 15.5% rate that came into force at the start of 2025. The new rate will take effect on 1 July.

The government said the increase is needed because the growth of newer medicines sales was higher than expected in the fourth quarter. The growth led officials to set a 22.9% rate under the voluntary scheme, meaning the old statutory scheme rate was no longer commercially equivalent.

Most respondents rejected the government’s argument, with only 10% agreeing with the proposed rise in the headline rate. The decision to raise rates twice in one year, and the notice period given for the second raise, attracted criticism.

“Respondents argued that the change of rate mid-year, and the increased rate for the second part of 2025, with only 3 months’ notice is a sign of acute fiscal and regulatory uncertainty,” the government said. “Respondents claimed that this leads to the UK being deprioritized as an early launch market.”

Responding to the finalization of the rates, trade group ABPI focused on the uplifted rate that will apply to companies that made payments at the lower rate in the first half of the year. Those companies will pay 31.3% in the second half of the year to achieve an annual average of 23.4% over the whole of 2025. The trade group said the UK has doubled the rate that pharmaceutical companies must repay.

The new statutory rate is the latest in a series of flashpoints between the UK government and branded drugmakers. ABPI Chief Executive Richard Torbet said the “UK’s sky-high and unpredictable payment rates send a terrible message to international investors.” The UK is trying to attract investment to drive growth.

Consultation Response, ABPI Statement

MedTech Europe report identifies regulatory barriers to decarbonizing device supply chain

A report commissioned by MedTech Europe has found regulations are impeding actions that could cut greenhouse emissions from the medical device supply chain.

The EU is aiming to reduce emissions by 90% by 2040. Trade group MedTech Europe commissioned BCG to research how the medtech industry can contribute to the decarbonization of healthcare. The report found medtech companies can cost-effectively address 40% of their emissions. Beyond that, regulations and money are barriers.

BCG found 25% to 30% of potential emission reductions “face some element of regulatory and economic challenges before full implementation is possible.” A further 10% of emissions are “both expensive and require extensive regulatory changes before implementation.” The other 15% to 20% of emissions “have no regulatory consideration, but the technologies are still immature and very costly.”

The 10% emission reduction that BCG found is blocked by regulations includes the use of new materials including bioplastics and new production processes such as cullets in glass. A cullet is glass that is crushed ready for remelting into new products.

Press Release, Report

EMA’s safety committee finds Novo Nordisk’s GLP-1 drugs may raise risk of vision condition

EMA’s safety committee has linked Novo Nordisk’s Ozempic, Rybelsus and Wegovy to increased risk of an eye condition that may cause vision loss.

The diabetes and obesity drugs all contain GLP-1 receptor agonist semaglutide. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found non-arteritic anterior ischemic optic neuropathy is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people. EMA has recommended that the labels of medicines that contain semaglutide are updated to include the eye condition as a very rare side effect.

PRAC analyzed several large epidemiological studies, concluding that exposure to semaglutide in adults with type 2 diabetes is associated with an approximately two-fold increase in risk. The increased risk would add around one case of the eye condition per 10,000 person-years of treatment.

Press Release, More

Euro Roundup: EFPIA pushes EU to simplify, speed up clinical trial framework under Biotech Act

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