Spain’s warning on drug pricing deals

Presented by EFPIA

By CLAUDIA CHIAPPA

with DOMINIC GIANNINI

PRESENTED BY

View in your browser or listen to audio

Want to receive this newsletter straight to your inbox? Sign up here to receive the reporting and intel from the Gastein Health Forum.

— Europe must band together to tackle drug pricing pressures rather than being picked off one by one, Spain’s Health Secretary Javier Padilla Bernáldez tells Morning Health Care.

— Parliament’s environment committee will vote on its opinion for the Biotech Act.

— EU health ministers meet in Dublin.

Welcome to Thursday’s Morning Health Care! Kudos to all those who made it to the 6am hike ahead of another jam-packed day at the European Health Forum in Gastein. I won’t throw Claudia under the bus, but I, for one, proudly took the lie-in. For those who opted for the walk, at least their stride shouldn’t have been impacted by this news that air pollution can impact marathon times — thanks to the clear air of the Austrian Alps.

Get in touch: cchiappa@politico.eu, dgiannini@politico.eu. Follow us on X: @chiappa_claudia, @domgiannini_

LET’S COME TOGETHER: Spain’s Health Secretary Javier Padilla Bernáldez has called for Europe to band together in the face of U.S. drug pricing pressures rather than seeking bilateral agreements. As pressure mounts on Germany to strike a deal with the Trump administration, Padilla Bernáldez argues any such deal risks weakening the European market.

Right now: “When [most favored nation] emerged, there was a consensus that the main strength of the European Union was being more people with a higher degree of universal health coverage, and the weakness was having a fragmented market,” Padilla Bernáldez told Morning Health Care at the European Health Forum in Gastein, Austria. “If you go bilateral, you are losing this main strength.”

The context: Europe is grappling with how to respond to the Trump administration’s most-favored-nation drug pricing policy, which risks delaying the launch of new medicines in Europe. Companies fear launching in Europe will risk a lower matched price in the U.S., limiting profits in that lucrative market. 

Is the breakfast club no more? Countries initially seemed to be on the same page about the best way to respond to the pressure — as a team. Back in June, 11 countries, led by Sweden, first met to debate how to protect EU prices and agreed they were stronger when working together rather than pursuing individual deals. The Beneluxa group — a health care alliance uniting Belgium, the Netherlands, Luxembourg, Austria and Ireland — also urged Europe to protect its solidarity-based health systems and warned against “uncoordinated, individual national responses.” 

Sweden continues to lead discussions on drug pricing and reimbursement amid geopolitical pressure, within an EU alliance of authorities that carry out this work known as NCAPR. (The next meeting is Oct. 9.) But some may be breaking ranks.

Art of the deal: U.S. diplomats and pharma companies are eyeing deals with EU countries similar to the one Washington struck with the U.K., which will see the National Health Service pay more for medicines.

Germany has been in talks with U.S. officials over the price of its medicines, following the Section 301 investigation. It has not announced an agreement but is considering rewarding drugmakers with higher prices if they invest locally.

France this week announced a new deal with the pharmaceutical sector on drug pricing, to provide “more clarity and predictability to pharmaceutical companies.”  “France is making a clear choice to invest in the future,” the government said Tuesday. Health Minister Stéphanie Rist said access to medicines was at the heart of the policy, while Public Accounts Minister David Amiel said “the resources released throughout the life cycle of medicines must make it possible to finance innovation and the treatments of tomorrow.”

Bad idea? Padilla Bernáldez warned that countries are giving up Europe’s main strength, its potentially large market, by thinking that they will be treated “in a positive way by the bully government of the United States” — but “I don’t think it’s going to happen.”

No comment, but: The U.S. government didn’t respond to a request for comment, but when it announced its trade probe into Germany’s drug pricing policies, Health Secretary Robert F. Kennedy Jr. said the U.S. was “calling on Germany to pay its fair share for the innovative treatments its people use.”

We’ve seen this film before: “When we talk about procurement in Europe, there are always countries with big economies that think — and maybe that’s true — that they are … going to get a better price if they are going on their own,” Padilla Bernáldez said. “Maybe France and Germany think they are going to calm the United States by going on their own. It doesn’t work like that.”

Muddy deals: Yannis Natsis, head of the European Social Insurance Platform, representing payers, agreed that “going it alone is no solution.” “It remains unclear what French patients and taxpayers will get in return for accepting higher prices,” he said. “Even less clear is what pharmaceutical companies are committing to in return, beyond benefiting from those higher prices.”

Yes, but: Renew MEP Stine Bosse said the new French deal has “the right instinct.” But she warned that Europe should act as one in rewarding innovation and manufacturing. Her fear is that multiple sets of rules or bilateral deals will make the EU “more vulnerable” — “we become an even less predictable place for the companies we want to invest here.” Patients will pay the price, she said, and Europe’s competitiveness will suffer.  “Europe must act as one, or we will be picked off, one by one.”

It’s a common sentiment in Gastein: Valentina Strammiello from the European Patients’ Forum supported the European Commission coordinating a discussion that included patients’ voices, saying it was important that stakeholders were brought together to find a solution. “Otherwise, keeping working in isolation doesn’t lead to any solution,” she said. 

Also pro-EU: Nathalie Moll, head of pharma lobby EFPIA, said that Europe risks losing out “as a whole” if countries put policies in place to attract manufacturing to their country. “The problem in Europe is … that there isn’t enough Europe. And here we need to be smart as a region in how we consider competitiveness and what tools we put in place to attract the investment, and not fragment ourselves even further than we are today.”

What now? Ministers had asked the Commission to conduct an impact assessment of Trump’s policies at their last meeting, which Health Commissioner Olivér Várhelyi handed back to member states in August — although it found it was too early to assess the impact on Europe. The ball is now in the Council’s court.

Rolling coverage: EFPIA’s Moll said it was “really important” the impact of MFN on Europe is “monitored very closely, so that we can respond to it in the right way,” adding there needs to be “continuous assessment.” Europe also had to look at solutions it could implement quickly, and this should include scrapping clawbacks and cost containment measures, she added.

POLITICAL ADVERTISEMENT

• Sponsor: European Federation of Pharmaceutical Industries and Associations (EFPIA)
• The political advertisement is linked to the EU Biotech Act

More information about political advertising here.

TIME TO VOTE: The environment committee is set to vote on its opinion on the Biotech Act today. Socialists and Democrats MEP Nicolás González Casares, who wrote the draft opinion, has called to scrap or limit the proposal to extend some biotech patents. This is only an opinion since the health and industry committees lead on the proposal.

Talking about the Biotech Act: Padilla Bernáldez has used his appearance at Gastein to defend Spain’s proposal to create a “European Coordinated Market Access Toolbox” to help drugs reach the market earlier. Countries could work together to estimate demand and coordinate negotiations with companies or launch collaborative procurement.

But: Companies could have commitments such as ensuring supply continuity, maintaining European manufacturing capacity, submitting national pricing and reimbursement applications on time, and ensuring equitable launch and access. 

Reciprocal commitments: Moll at EFPIA said there also needed to be reciprocal commitments on the part of states. “One of the commitments has to be to increase the value that is given to innovative medicines, so there needs to be a recognition that these products bring value beyond the value to the patient, but also to the economy and in the socio-economic context,” she told Morning Health Care.

Speed up access: Moll has another proposal — an agreement to make medicines available on the market while national pricing and reimbursement negotiations are ongoing, meaning patients would have faster access to drugs. Companies would set an initial price before discussions would start, and if negotiations stalled, patients would be able to keep using the medicine through a non-reimbursed route. Moll admitted the idea was in its early phases and hadn’t been brought to governments.

WELCOME: Ireland’s Health Minister Jennifer Carroll MacNeill will chair an informal meeting of EU health ministers in Dublin today, which will also include the EU health commissioner, the World Health Organization’s Europe director and the head of the European Medicines Agency.

Smile: Ministers were shown around Dublin’s National Institute for Bioprocessing Research and Training on Wednesday afternoon, and today’s meeting will kick off with a family photo. 

On the agenda: They’ll hold closed-door discussions on innovation and improving patient outcomes; integrating care across the EU and strengthening medical ecosystems; and, of course, discuss global pressures and collective action. 

Sneak peek: The Irish Council of the EU presidency wants to lean into Europe’s commitment to universal access to health for the whole population, rather than people’s ability to pay. “There’s huge strength in that,” Muiris O’Connor, assistant secretary at the Department of Health, told Gastein via videolink. “We retain a core belief in science, and we purchase medicines and medical products at national scale right across the European Union. So I really think we have to remember just what is really strong about us and shore up the vulnerabilities.” A press conference is scheduled for 3.30 p.m. 

SANT, ENVI VOTE ON UCPM PROPOSAL: Lawmakers in the public health and environment committees will vote today on an EU proposal for a union civil protection mechanism, or UCPM, for health emergency preparedness and response.

What’s this about? In the next multiannual financial framework proposal, the Commission wants to expand the civil protection mechanism — created to strengthen cooperation for disasters — to include health emergency preparedness and response. The proposed budget for this was €11 billion, though it’s unspecified how much will go to the civil protection department DG ECHO versus the health preparedness authority DG HERA.

Behind the report: The health and environment committees are leading on this file. Their compromise proposes increasing the budget to over €12 billion and allocating funds across sectors: 40% for civil protection, 40% for health emergencies, and 20% for flexibility.

Some of the changes: The committee draft proposes a new focus on climate-risk assessment, scenario planning and stress testing; emphasizes a One Health approach and measures to build public risk awareness and community preparedness; calls for action to fight disinformation; and expands support for resilient health care systems and workforces, cross-border medical teams, patient evacuation and stockpiling of medical countermeasures.

Smooth sailing: Lawmakers are expecting a “straightforward” vote, after reaching a “balanced agreement” supported by EPP, S&D, ECR, Renew, Greens and The Left, said S&D’s Leire Pajín, a co-author with ECR’s Aurelijus Veryga.

The FT looks at how Australia is battling a black market for cigarettes after a decade of tax rises.

Patients switching to Novo’s Wegovy pill from shots lose more weight, Reuters reports.

Want to receive this newsletter straight to your inbox? Sign up here to receive the reporting and intel from the Gastein Health Forum.