Euro Roundup: European Parliament passes Critical Medicines Act to strengthen drug supply

The European Parliament has voted overwhelmingly in favor of the Critical Medicines Act, teeing up negotiations with governments on a law intended to strengthen the supply of essential therapies.

Members of the European Parliament adopted proposals with 503 votes in favor, 57 against, and 108 abstentions. At a press conference after the vote, rapporteur and politician Tomislav Sokol said the proposals have two goals: strengthening local industry to reduce reliance on imports and ensuring equal access to medicines across the European Union.

The plans include creating a European Union mechanism for coordinating national stockpiles and contingency stocks of critical medicines. As a last resort, the Commission would have the power to decide on the redistribution of medicines from one national stockpile to one or more other countries.

Some politicians pushed back against the forced redistribution plan in debates last year, but the idea survived committee and Parliament votes to be included in the text that is advancing to the next stage. Sokol predicted the redistribution mechanism will be the most controversial topic in negotiations with the European Council, which is composed of the leaders of EU governments.

“What we have now unfortunately is that national stockpiling in some Member States, especially the big ones, directly contributes to shortages in smaller Member States. This is something that is completely unacceptable for us,” Sokol said. “I know that this will cause a lot of different opinions, especially in the Council, but we'll be very strong and adamant to fight for this.”

Sokol said the large majority secured in the vote gives the Parliament a strong mandate to defend its plan in the upcoming negotiations. Big pharma trade group EFPIA is pushing for negotiators to make changes to multiple parts of the proposals, including what it sees as the “extremely broad framing of ‘medicinal products of common interest’.”

Aspects of the Parliament’s proposals are informed by events in the US. Sokol said Europe has so far not recognized the importance of its pharma industry. President Donald Trump has, Sokol said, and has prioritized lowering drug prices and reshoring manufacturing. Sokol said the changes triggered by Trump are “definitely a big problem for Europe” because the continent could depend on the US for innovative medicines in 5 to 10 years.

Seeking to avoid that outcome, the Parliament has backed the creation of industrial “strategic projects” in the EU to create, modernize, and improve manufacturing capacity and changes to procurement rules. Going beyond the European Commission’s original proposal, the Parliament wants to give preferential treatment in public tenders to companies that make at least half their active pharmaceutical ingredients or finished products in the EU. Sokol said the step is one of the EU’s strongest responses to US actions.

EFPIA said “measures that favor procurement based on manufacturing location risk weakening global supply diversification, reducing flexibility in supply chains, and undermining Europe’s position as an export-oriented base for innovative medicines.”

Press Release, EFPIA Statement, More

Swissmedic shares advice to tackle frequent critical shortcomings in device reviews

The Swiss Agency for Therapeutic Products (Swissmedic) has found “frequent critical shortcomings” in notified body opinions (NBOps) about drugs with integral medical device components.

NBOPs are essential documentation for evaluating integral combination products. As a key document, NBOps should provide evidence of a robust, complete, and unambiguous assessment of the conformity of the medical device component, Swissmedic said. The agency’s review of 10 opinions found notified bodies are falling short of that standard.

The NBOps showed considerable variation, Swissmedic said, and recurrent content-related deficiencies and critical points were identified. Recurrent deficiencies include a lack of clarity about the scope of the NBOp, missing or incorrect codes and classifications, the use of superseded standards, and the absence of sufficient verification and validation data.

In response, Swissmedic published fundamental instructions on the key content and expected quality of NBOps for authorization assessments. Applicants are responsible for ensuring their NBOps plausibly prove the conformity of medical device components and as such must critically assess opinions before submission.

Swissmedic Notice

EMA updates signal management Q&A as new variations guidelines take effect

The European Medicines Agency (EMA) has updated questions and answers on signal management to reflect the new variations guidelines that took effect last week.

Guidelines the Commission published last year took effect in the EU on 15 January. The change and other developments led EMA to update its signal management Q&A, including by deleting a question about the requirements for monitoring EudraVigilance and updating information on the responsibilities of marketing authorization holders (MAHs).

The agency updated its answer to a question about what to do if the Pharmacovigilance Risk Assessment Committee recommends a variation, noting a change in the handling of variations made and submitted from 15 January onwards.

Other updates reflect changes to the monitoring of EudraVigilance. EMA said “all MAHs with medicinal products authorized in the [European Economic Area] shall monitor the data available in the EudraVigilance database and use it as an additional source of safety information to support their processes and enhance signals detected through other sources.”

Q&A

EMA answers more questions about opening procedures to non-EU authorities

EMA has expanded a question-and-answer document about the OPEN Framework that allows non-EU regulators to participate and contribute to its scientific assessments.

Five years after starting to pilot the framework, EMA has provided more information on the benefits, scope, and workflow of the model. EMA said the framework improves predictability for industry, ensures “more expedient regulatory decision timelines,” and supports more rapid responses to questions from applicants.

The framework applies to marketing authorization applications and post-authorization procedures. EMA is strongly encouraging applicants to involve as many OPEN partners as possible in filings submitted through the framework, specifically for lifecycle management procedures. Involving more partners can promote regulatory alignment, EMA said.

OPEN partners should follow EMA’s assessment timetable and comment on application evaluations like EU Member States. Specific rules apply to World Health Organization staff participating in the framework.

Q&A

Trade groups unite behind call to safeguard IP in the European Health Data Space

EFPIA, MedTech Europe, and other trade groups have endorsed a paper about safeguarding intellectual property and trade secrets in the European Health Data Space (EHDS).

The paper, which was written by the trade association DIGITALEUROPE, addresses the need for health data access bodies to take appropriate legal, organizational, and technical measures to protect IP, trade secrets, and regulatory data protection. DIGITALEUROPE said the lack of an implementing act means the risk of fragmentation is high.

To mitigate the risk, the trade association has called for implementation guidelines that encourage Member States to establish dedicated IP and trade secret task forces within health data access bodies. The guidelines should also enable health data holders to indicate the confidentiality level and access conditions for each dataset and its metadata, DIGITALEUROPE said.

“Investing resources in harmonized guidance on the key elements outlined above will be decisive for the overall success of this landmark law,” the trade association said. “A coherent and well-resourced approach will ensure that the EHDS becomes a trusted and harmonized framework, enabling data-driven research and innovation whilst preserving the incentives that make such innovation possible.”

DIGITALEUROPE Report

Euro Roundup: European Parliament passes Critical Medicines Act to strengthen drug supply

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