This article is part of “Health Care 2024,” a survey-driven series of online debates in which POLITICO explores how the European Union can best tackle health policy.
There’s never been a stronger mandate for health in Brussels.
While EU voters painted a muddy picture in May when it comes to partisan politics, they sent one message loud and clear by sending policymakers pledging to confront cancer, climate, digitalization and other health-related matters to the European capital.
It’s a stark difference from a year ago, when we kicked off the Health Care 2024 Symposium. MEPs and industry experts were despondent over member countries’ resistance to working together on evaluating new medicines, implementing new rules on medical devices and fighting vaccine hesitancy. The nightmare scenario — the dissolution of the Commission department devoted specifically to health — seemed like a serious possibility.
On the contrary, DG SANTE is more powerful than ever before. It’s taking the lead on a top Commission priority — Europe’s Beating Cancer Plan — and taking over the high-profile issue of medical devices from DG Grow. Member countries, who have stymied so many EU-level efforts by clinging to their national authority on all matters health, are demanding Brussels respond to problems like drug shortages and high medicine prices.
Commission President Ursula von der Leyen (herself a medical doctor) issued Health Commissioner Stella Kyriakides a meaty mandate in her mission letter: ensuring access to medicines, reducing vaccine skepticism and advancing e-health.
Over the past year, POLITICO’s Health Care 2024 symposium set the stage for the debates that will consume the next five years. Experts and advocates weighed in on how the EU can keep health affordable; protect patient privacy in the digital age; persuade the public on vaccines; and best spend European health research money. Emerging debates likely to force their way onto the agenda — tackling obesity and cannabis policy — are also prompting difficult questions about the Brussels’ role in individual’s private lifestyle choices.
As we wrap our series of Symposiums, we wanted to ask experts one last question: What do they expect both in capitals and in Brussels in the year ahead? In a word, expect much of the discussion to be about costs.
Drug-pricing debate will heat up
Yannis Natsis is policy manager for universal access and affordable medicines at the European Public Health Alliance.
The debate over access to medicines — fueled by the wild price hikes that we’re seeing — will pick up even more. By now, it’s clear that this is a systemic problem that’s here to stay. The basic discussion centers on drug-price transparency — and how governments are trying to address the information asymmetry between industry and consumer. And we keep telling pharma that they’re fueling this debate with their aggressive pricing strategies.
At the European Commission, it’s very important that DG SANTE finally has a clear mandate on access for the first time ever. And the first line in the Health Commissioner’s mandate is about the supply of affordable medicines. That says it all. At the same time, given the competing interests within the commission, DG SANTE will have to stand its ground.
The biggest challenge is that powerful industries are banding together on the “innovation” principle. So it’s unclear whether the arguments for access and affordability will be taken seriously by the whole of the Commission. Ideally, the Commission should address these arguments in the context of its other compentences — trade, industrial policy, competition — that also affect pharmaceutical policy. What concerns me, however, is that the opposite will happen because pharma is fighting back with rhetoric about competitiveness and innovation.
Rare diseases will be front and center
Simone Boselli is director of public affairs at EURODIS.
The extraordinary crowdfunding campaigns for access to therapies for rare diseases, such as Zolgensma, were one of the biggest surprises this past year. They also highlight a problem to which Europeans have responded with great solidarity.
We now have an opportunity to craft a unified approach — from authorization to approval to reimbursement — at the European level to tackle rare disorders. There is strength in numbers, and there are a number of countries willing to partner with others to address availability, accessibility and affordability of therapies at the same time across the bloc.
To be sure, some might say health isn’t an EU competence. But it’s worth noting number of projects have been done without an EU competence, like the promotion of a joint defense. If countries want to voluntarily collaborate, they can do so. And they’re already applying this to the case of joint therapies assessment and negotiations, such as the Beneluxa and Valetta agreements.
Industry will seek compromises
Alexander Natz is secretary general of the European Confederation of Pharmaceutical Entrepreneurs.
When you look at the pipeline for cell and gene therapy over the next few years, there’s a lot still to come. We believe payers do see the potential of those types of therapies, which is a good thing. But we also need to be a good partner and understand their concerns about costs getting out of hand.
We need to help and take away the fear. This is not just about Zolgensma, but what’s to come. What I fear is that payers might say “no” simply because they see a huge number. To be honest with you, we will see that more often in the next couple of years. So the questions for us are: How can we hedge risk for the payers? How can we spread risk over the years?
Pharmaceutical entrepreneurs know what payers want, and they’re willing to compromise around that. So a lot of more discussions are needed rather than simply blaming individual companies for high prices. It’s important that we help payers, and that we’re having that discussion. It’s clear there isn’t an easy fix on how these therapies can be paid for very easily and quickly. But a lot of people, including those outside the non-medical community such as payers, see the value of advanced therapies.
Transparency will be key
Anna Prokupkova is advocacy and project manager of the Association of European Cancer Leagues.
The WHO Transparency Resolution this past May came as a surprise to many, given that the “T-word” has been taboo for most in the pharma sector. Despite the watered-down final text, we can’t underestimate its potential impact on the pharmaceutical market.
For one, it acknowledged we need to change the way that the pharmaceutical market functions. Even countries with large pharma sector spoke in favor of more transparency.
The resolution also made clear to pharmaceutical companies that they can no longer ignore the topic. It pushed them to shift their stance from insisting on confidentiality to at least admitting — with qualifications — that transparency is important. This is a big step toward having a constructive conversation.
Looking ahead, it’s important to agree on a definition of a fair price for medicines that’s both profitable enough to promote innovation while staying affordable and sustainable in the long term. We also need to elevate existing initiatives to share information about pricing, ideally with Commission support. Voluntary initiatives, such as the EURIPID joint action and joint procurement initiatives, could serve as platforms for governments to exchange information about pricing practices.
Finally, we should encourage EU countries to work with each other to boost transparency of public R&D spending and ensure that products resulting from publicly funded research are available at a fair and affordable price.
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