Potential US tariffs add urgency to the EU’s pharma regulation debate, balancing industry calls for innovation against concerns over medicine shortages and patient care.
Threats from the Trump administration to impose significant tariffs on Europe an goods, potentially including pharmaceuticals, have cast a shadow of uncertainty over the transatlantic trade relationship.
This comes against a backdrop of already booming pharmaceutical exports from European Union member states to the United States, such as Ireland, whichThese external pressures add fresh urgency to ongoing debates within the EU about how to best regulate its own pharmaceutical sector, balancing industry competitiveness with patient welfare. “It’s vital that medicines remain as accessible as possible to the UK and global markets. Patients should not end up the casualties in a global trade war,” Alwyn Fortune, the policy lead for the Royal Pharmaceutical Society’s Medicines Shortages Advisory Group, London, England, told. “Supply chain vulnerabilities make it harder for patients to access treatment, causing frustration, anxiety, and, in some cases, harm to patient health.”Even before recent trade threats emerged, the European Federation of Pharmaceutical Industries and Associations advocated for substantial policy reforms to maintain Europe’s position as a hub for innovation, particularly against competition from the United States and China. Their requests fall into four main categories:The industry views robust IP rights as fundamental. “IP is the backbone of our innovation, so without it, we’re not innovating,” Roberta Savli, executive director for Public Affairs at the EFPIA, told. In the EU, pharmaceutical reforms introduced in 2023 included shortening the period in which new medicines are protected by data exclusivity. While there are possible extensions for drugs that meet special needs or involve public research, many in the industry worry that these changes could make Europe less attractive for developing innovative medicines, especially for rare diseases. The EU is also considering a patent package to create a unified system for supplementary protection certificates across most EU countries. This would make it easier and cheaper for companies to protect their inventions in Europe. However, the package also includes new rules for compulsory licensing, which would allow governments to override patent protections during emergencies. While this could improve access to medicines in a crisis, Savli said the industry is concerned that it would affect innovation and the rights of patent holders. On the global stage, the World Health Organization released on April 16 a pandemic agreement for consideration at the upcoming World Health Assembly in May that requires countries to share technology and know-how needed to produce vaccines and treatments during health emergencies. Some countries want these transfers to be mandatory if voluntary sharing fails, while pharmaceutical companies and some governments argue that this could undermine incentives for innovation, Savli explained.EFPIA is also calling for speeding up the European Medicines Agency processes. EMA approvals take roughly 4 months longer than in the United States or Japan. While the ongoing pharmaceutical legislation reform initially proposed faster, flexible pathways and shorter assessment times, there are fears that member states might resist these changes, Savli said. Also, achieving true harmonization for clinical trials across the EU remains a challenge due to differing national requirements, complicating vital research and delaying patient access to potentially breakthrough treatments, she explained.Savli highlighted conflicts between different policy areas. For instance, environmental goals under the Green Deal could lead to bans on substances essential for manufacturing medicines, potentially clashing with initiatives like the Critical Medicines Act aimed at boosting European production. “They should talk to each other. These decisions shouldn’t be taken in silo because this is not the way to work well,” Savli said. Proposed revisions to the wastewater treatment directive, which is a directive that is looking at cleaning up micro-pollutants in water, are also seen as unfairly targeting the pharmaceutical sector. “ is only asking two sectors, the cosmetic and the human pharmaceutical, to pay for the pollution caused by all other sectors.”Central to industry concerns is how innovation is rewarded, primarily through national pricing and reimbursement systems. EFPIA argues that, compared with the United States, European systems don’t sufficiently value innovation, leading to “rebates and drawbacks” that diminish competitiveness, Savli said. Complex national and even regional processes lead to significant delays in patient access after EMA approval. “On average, Europeans get access to medicines 18 months after the marketing authorization,” she said, with wide disparities between countries. Proposed solutions include better implementation of joint Health Technology Assessments, managed entry agreements, and equity-based tiered pricing.While the industry focuses on competitiveness and innovation, frontline physicians stress the immediate impact of system pressures on patient well-being. Tiago Villanueva, a family physician in Portugal and the president of the European Union of General Practitioners, highlighted medicine shortages as the primary concern arising from the current uncertainty.“Any issue with shortages of medicines may compromise the quality of patient care because you are forced to use medicines that may not be as effective,” Villanueva toldhighlighted that increasing regulatory divergence between the UK and EU is adding to supply chain problems. The ongoing review of EU pharmaceutical regulation will inevitably have implications for the UK.” Villanueva said shortages and high costs drive a worrying trend: Patients seeking medicines online. This “is not a risk. That’s already happening,” warned Villanueva. Patients turn to “very doubtful places” online, primarily due to the lack of availability of prescribed drugs like Ozempic or to look for newer, expensive weight loss medications not covered by national health systems. The danger is significant. “You cannot be sure that it’s going to be a trustworthy medicine. It could be counterfeit. It could be less effective. It could be actually something else.” Despite industry calls for faster drug approvals, Villanueva expressed confidence in the existing regulatory safeguards. “We should have full trust in our European medicines regulator,” he said, believing that expedited processes seen during the pandemic streamlined bureaucracy without compromising rigorous safety checks. While promoting innovation is crucial, he argued, it must be balanced with rigorous testing and ensuring access to safe, reliable medicines through a strong regulatory framework. “Above all, patient care and safety are the most important things.”Manuela Callari is a freelance science journalist specializing in human and planetary health. Her work has been published in The Medical Republic, Rare Disease Advisor, All material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
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