Danes probe cutting red tape in pharma package talks

Presented by EFPIA

By GIEDRĖ PESECKYTĖ

with CLAUDIA CHIAPPA, MARI ECCLES and RORY O’NEILL

PRESENTED BY

View in your browser or listen to audio

— The Danish Presidency of the Council of the EU is asking countries for “flexibilities” on the pharma legislation in talks with the European Parliament.

— WHO members have eschewed pharma lobbyists in favor of scientists and academics to advise on the pandemic agreement.

— Health experts in Gastein stress the importance of ensuring women’s participation in clinical trials.

Welcome to Wednesday’s Morning Health Care! For those of you at the European Health Forum Gastein who noticed Rory not participating in the dance session to conclude the discussion on prescribing arts for mental health, don’t be deceived. He warmly received the music, but had journalistic duties to attend to.

Get in touch: [email protected], [email protected], [email protected], [email protected]. Follow us on X: @MariEccles, @GPeseckyt, @chiappa_claudia and @rory_oneilll

DANES ASK COUNTRIES FOR ‘FLEXIBILITIES’ IN PHARMA TALKS: The Danish presidency of the Council of the EU will ask countries today for wiggle room on the Council’s position on the review of pharmaceutical legislation in three-way talks with the European Parliament and Commission.

The Danes have raised concerns that the Council’s mandate “will not provide the Presidency with a sufficient margin to complete negotiations with the European Parliament,” therefore it is asking to “explore flexibilities” on several issues. That’s according to a trilogue preparation document for countries’ permanent representatives meeting on Oct. 7 (initially posted online by the Council but then taken down).

Let’s simplify: The presidency wants countries to discuss whether it can seek trade-offs with Parliament to balance faster drug approvals with flexibility on environmental risk-assessment rules, to avoid extra administrative burdens for countries, it says. The Danes are also asking for a “certain degree of flexibility” on cross-border hospital exemption for advanced therapies and the duration a medicine may be prepared in advance by a pharmacy.

Other political issues: Trilogues will need to resolve differences between the Council’s and Parliament’s positions on governance of the European Medicines Agency drug approval timelines, pharmacy exemption, contraceptives and measures to tackle antimicrobial resistance — issues identified on technical meetings.

Will it complete this year? The Danes are still sounding confident, but this certainly has us raising an eyebrow.

How it works? Presidencies can seek “flexibilities” when they fear the Council’s position is too rigid to secure a deal. That request goes through the permreps, a Council official told Giedrė.

Countries’ moods: Some countries told Giedrė they’d be “somewhat” or “reasonably” flexible if needed. But another official warned the Council “believes very strongly in its mandate.”

Not so fast! The Danes aren’t yet sure whether tweaks are needed, since this is the first political trilogue after the Polish presidency’s “handshake” in mid-June. Seven technical meetings since then have covered less than a quarter of the legislation. “The Presidency sees the need to further explore the flexibilities of the Parliament and the Council at the political level before requesting an updated mandate,” according to the document.

Checking in: This was seconded by an official close to the Danish presidency: “Our first priority is to ensure that we have the Member States’ backing to our approach, so that we have the necessary support to close an agreement with the Parliament in December,” the official said, adding that “this remains our ambition and a priority for the Danish Presidency.”

Looking ahead: More political and technical clashes are expected. The Danes admit the current mandate doesn’t allow them to clinch a deal, but for now will try to maneuver within it.

Optimism boost from Parliament: The European People’s Party lawmaker Dolors Montserrat, in charge of negotiating the pharmaceutical directive for the European Parliament, believes that “the slight difference of view in regard to the few points in the agenda will be smoothly solved … before the end of the year.”

A word from Danes: The Danes are going into the first actual political trilogue “in a very constructive atmosphere,” the Danish permrep spokesperson told Giedrė.

TUNE IN: Join us this afternoon at POLITICO’s Competitive Europe Summit, where we’ll be discussing tariffs, the pharma package and much more. Tune in from 4.40 p.m. where Mari will be talking to EFPIA’s Director General Nathalie Moll, Emmanuel Cormier, head of regulatory science at the European Medicines Agency, Gloria Ghéquière, deputy head of cabinet for Belgian Health Minister Frank Vandenbroucke and Dean Summerfield, a senior vice president at the health data firm IQVIA where they’ll discuss Europe’s competitiveness problem. We’re also running a live blog.

MEANWHILE IN COPENHAGEN: Top industry executives are descending on the Danish capital city — home to pharma giant Novo Nordisk — today to press the EU’s political leadership to deliver on bold promises for a “competitive, strong, and secure” Europe, according to a near-final declaration obtained by Mathieu Pollet.

**A message from EFPIA: Cardiovascular disease remains Europe’s top killer, yet only 4% of recent clinical trials focus on it. Europe must act now to revert this trend.**

LOBBYISTS AND EXPERTS: World Health Organization members have eschewed pharma lobbyists in favor of scientists and academics to advise on the pandemic agreement, despite the EU’s nomination of industry reps.

Expertly curated: Officials circulated a list — obtained by Rory — of scientific experts who will be asked to advise on definitions ahead of next week’s negotiating session on the sharing of pathogen data and any resulting drugs, vaccines and diagnostics. The WHO told countries the list was “curated” from the names prepared by the country-appointed officials mediating the talks and those submitted by countries themselves. All 38 experts are already part of a WHO advisory group, committee or research center.

MIA: We also got hold of the list of names the EU suggested for inclusion. Notably, it included lobbyists from the pharmaceutical industry, including David Reddy, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). But his name didn’t make the final cut.

Why does this matter? The move annoyed some negotiators from developing countries and NGOs, who warned it risked blurring the lines between expert and lobbyist. They feared pharma reps would try and tilt the design of the system in their favor if they were granted an advisory role.

Not cool: One diplomat from the Group for Equity, the negotiating bloc for low- and middle-income countries, granted anonymity to discuss the sensitive negotiations candidly, said the nomination of Reddy was “not ok,” adding: “IFPMA is a relevant stakeholder, so they can’t be an expert.”

Bird’s eye view: But, according to the EU, it’s necessary to have an overview of all the elements involved in the process. A Commission spokesperson told Rory before the circulation of the final list, that its proposed experts included a “wide spectrum of stakeholders knowledgeable about the relevant areas, including pharma producers who would need to be involved in producing and developing medical countermeasures in a pandemic situation.” We’ve got back in touch with the Commission to ask their position on the list circulated by WHO but did not receive a response by the time of publication.

IFPMA weighs in: A spokesperson for the IFPMA told Rory the lack of an industry expert in the upcoming round of negotiations is “an oversight that should be addressed in future rounds. As an organization in official relations with the WHO, IFPMA remains able to inform negotiators in these final, technical steps so that it can be implemented in practice.”

UP TODAY: The EU’s negotiating team and the Danish presidency will update the Council’s working party on public health on the pandemic agreement today. The Commission will also brief country reps on the ongoing negotiations with EEA countries — Norway, Iceland and Liechtenstein — on medical countermeasures .

BRIDGING THE RESEARCH DIVIDE: Bridging the gender gap in health starts with research and women’s participation in clinical trials, panelists said Tuesday at the European Health Forum in Gastein.

“If I’m doing participatory research … I have to make sure that the people I want to reach and the people whose voices I want to hear are able to participate,” said Lisa Lehner, senior researcher and health programs director at the University of Vienna and NGO AmberMed. “We need women’s viewpoints in research, but we also need real community engagement.”

Industry’s role: Industry must ensure that the epidemiology of clinical studies reflects the populations, said Michael Zaiac, Daiichi-Sankyo’s head of oncology medical affairs in Europe and Canada. “We really try to select the clinical trial sites according to the epidemiology, we’re trying to offer patients choice,” he said. “Women are especially sensitive to this choice, whether I want to go to a center or want to have my examination, my trial visit, at home or at my GP.”

Beyond research: It’s not just about research — policy and funding are also key to help bridge the divide. “As policymakers, we need to engage quickly and immediately with researchers, and researchers have to do a lot to actually engage early with policy,” said Lehner. And similarly, funders need to engage early with policymakers and researchers.

And the EU? The EU’s investment in women’s health projects has been “fragmented” so far, said Ffion Storer Jones, senior advocacy officer at global health NGO Deutsche Stiftung Weltbevölkerung (DSW). The post-2027 multiannual financial framework (MFF) was also a “missed opportunity” to really put the EU’s money where its mouth is in terms of funding.

Time for action: While there has been “greater political attention to women’s health” in the EU, “words are only words without action,” she said.

MY VOICE, MY CHOICE TO MEET WITH COMMISSION: Organizers from the “My Voice, My Choice” European citizens’ initiative are meeting with the European Commission today as part of their campaign to expand access to abortion care in Europe.

ICYMI: The initiative, which wants the European Commission to establish a fund to help women who can’t access abortion care in their own country to travel to another with more liberal abortion laws, successfully gathered the 1 million signatures needed to be considered by the Commission earlier this year.

Next steps: Organizers will meet with European Commissioner Hadja Lahbib, and later host a press conference to share the outcomes of the meeting. In the meantime, Commission President Ursula von der Leyen has officially requested to set a date for a public hearing at the European Parliament, according to a draft agenda of the Conference of Presidents, seen by our colleague Max Griera Andreu.

LONG COVID FINDING: Children that have been infected with Covid-19 twice have more than double the risk of developing long Covid, according to a new study published today. The findings “highlight the need to promote vaccination in younger populations and support ongoing research to better understand [long Covid], identify high-risk subgroups, and improve prevention and care strategies,” researchers wrote.

The Financial Times looks at how to keep our gut healthy.

STAT News sat down with Eli Lilly’s head scientist to discuss its GLP-1 pill, Alzheimer’s strategy and more.

**A message from EFPIA: Only 4% of clinical trials in recent years addressed CVD, despite it being Europe’s top killer. Following improvements in past decades, innovation in CVD is now plateauing with a significant slowdown in the approval of new CVD treatments. Bringing one CVD medicine to market has been estimated to cost between €3.7-4.6 billion with some investment as much as €11 billion because of several drugs that fail in late-stage clinical trials. This is higher than in many other therapy areas. To revert this trend and increase investment in cardiovascular research, Europe must create the conditions where science and innovation thrive. Imagine what that could mean for millions of lives.**

The post Danes probe cutting red tape in pharma package talks appeared first on Politico.