Euro Roundup: Drug and device industries lobby EU to shape response to US tariff blitz

Medicine and medical device industry groups have told the EU how they would like the region to respond to tariffs the Trump administration has imposed on imports into the US. The talks took place before 9 April, when US President Donald Trump paused the higher tariffs on the EU for 90 days.

A delegation from Medicines for Europe, a group that represents generic and biosimilar companies, met with European Commission President Ursula von der Leyen to discuss how the Commission can support their industry. While medicines were excluded from the initial set of global tariffs, drugmakers have begun preparing for duties.

Medicines for Europe called tariffs “regressive and counterproductive,” adding that they “would disrupt global supply chains, cause shortages of critical and essential medicines, and undermine patient access.”

The group has crafted a five-step plan, starting with urging the Commission to continue diplomatic efforts to prevent tariffs on EU medicines and active pharmaceutical ingredients. Medicines for Europe sees avoiding tariffs as key to preventing shortages and “very real harm to patients.”

To bolster competitiveness, Medicines for Europe wants the EU to review “complex and burdensome legislation that undermine pharmaceutical activities ... like the Urban Wastewater Treatment Directive and restrictions on substances required for manufacturing.” The group is also calling for the EU to accelerate the Critical Medicines Act and adopt the pharma legislation.

EFPIA, the European trade group for branded drugmakers, sent its own message to von der Leyen. The trade group surveyed its members last week, revealing that as much as 85% of capital investments and up to 50% of R&D expenditure in the EU are at risk. The survey found that more than €100 billion ($110 million) is at risk.

Companies are assessing whether to invest the money in the EU for a range of reasons. EFPIA said the “uncertainty created by the threat of tariffs” is one factor, explaining that “there is little incentive to invest in the EU and significant drivers to relocate to the US.” The trade group wants the Commission to make the EU competitive, bolster intellectual property, and adopt a world-leading regulatory framework.

Unlike medicines, medical devices were included in the Trump administration’s initial tariff blitz. US industry groups are pushing for exemptions for medical devices. In parallel, MedTech Europe is lobbying the Commission to inform the EU’s response to the tariffs.

In response to a consultation on the EU's response to US tariffs on steel and aluminum products last month, MedTech Europe said it expressed “high concerns to see several codes for finished medical devices, along with nearly a hundred codes related to inputs for medical technologies (such as raw materials, spare parts, and components), included in the list of products subject to potential EU countermeasures.” The group wants the EU to exempt devices, diagnostics and their essential inputs from retaliatory tariffs.

Medicines for Europe, EFPIA, MedTech Europe

EMA updates good manufacturing and distribution practice Q&A guidance

The European Medicines Agency (EMA) has updated guidance on good manufacturing and distribution practices (GMP/GDP), adding questions and answers on the basic requirements for active substances used as starting materials.

EMA added two questions about third-party audit reports. In its first response, the agency clarified that manufacturers “may contract with third parties to undertake relevant audits.” The law supports the use of third parties because manufacturers may lack the expertise or resources to conduct their own audits.

The second response covers the content of the written final assessments of third-party audit reports. EMA said the qualified person is ultimately responsible for ensuring audit reports are “properly evaluated when the audit is performed by a third party.” The written final assessment text should provide a “comprehensible summary” of the evaluation and be readily shared with authorities.

EMA said assessments should include “all expected elements of the auditing process and audit report(s) identified before, during, and after the audit.” EMA emphasized certain elements that need to be covered.

“This includes verification of contractual arrangements, scope and appropriate duration of audit, adequate competence of auditors considering the scope of the audit, planned audit frequency, and CAPAs whether adequate and how these are to be followed up,” EMA said. “Any conflicts of interest identified should be discussed.”

EMA Q&A

EU committee finds water directive’s PFAS definition covers some drugs

An EU committee has found that “many pharmaceuticals” fall under the definition of per- and polyfluorinated alkyl substances (PFAS) proposed for the implementation of the Water Framework Directive.

The directive requires the European Commission to set standards for substances that pose significant risks to the aquatic environment; the Commission proposed a standard in response. The European Parliament suggested changes, leading to the creation of a draft dossier with six options. The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was asked to review the dossier.

In a scientific opinion, SCHEER said the compounds covered by the definition of a PFAS total may present “important regulatory implications for the pharmaceutical industry.” The PFAS criteria in the standards dossier “implies that many pharmaceuticals and pesticides will fall under the definition,” SCHEER said.

SCHEER cited a 2022 analysis by US researchers that found the most inclusive PFAS definitions included “several top prescribed pharmaceuticals, e.g. Prozac and Lipitor.” The analysis looked at 360 drugs. SCHEER said the dossier definition would capture 107 of the drugs. “PFAS total,” an approach pushed by Parliament, would cover the remaining fluorine-containing pharmaceuticals.

SCHEER Opinion

EPC adopts framework on production and quality control of cell therapies

The European Pharmacopoeia Commission (EPC) has adopted a general chapter on cell-based preparations for human use, establishing a new production and quality control framework.

Building on the work of the Cell Therapy Products Working Party, EPC plans to publish the text in the European Pharmacopoeia in October and bring the framework into force in April 2026. The European Directorate for the Quality of Medicines and HealthCare (EDQM) called the general chapter a “significant addition” to the Pharmacopoeia that provides flexibility to the rapidly evolving field.

“While not legally binding, the chapter provides an extensive set of general requirements common to all cell-based preparations, together with four detailed sections outlining specific requirements for human hematopoietic stem cells, human chondrocytes, human limbal stem cells and human mesenchymal stromal cells,” EDQM said.

EDQM Notice

Notified bodies explain impact of down-classification of COVID-19 tests

Notified body group Team-NB has outlined how the recent down-classification of COVID-19 tests will affect manufacturers.

In January, an expert panel ruled that the SARS-CoV-2 virus no longer poses a life-threatening risk with a significant mortality rate for the general European population. The conclusion led the Medical Device Coordination Group to update its guidance on the rules for classifying in vitro diagnostics. Team-NB shared notified bodies’ interpretation of the new guidance.

“COVID tests will now have a different risk classification as opposed to the aforementioned Class D, ruling these Class B or Class C, depending on the intended purpose. This also means that specific Class D requirements for these devices are not applicable anymore,” Team-NB said. “Common Specifications are not mandatory anymore but are still considered to be state of the art.”

Press Release

Euro Roundup: Drug and device industries lobby EU to shape response to US tariff blitz

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