This article is the first in our Changemakers series, looking at the players driving European policy.
Ask any pharma lobbyist: For all the talk of health policy being a national matter, it’s Brussels that holds major sway over drug prices. Intellectual property rights and incentives are a big factor, and some want the EU to play an even bigger role. A key piece of unfinished business from the outgoing European Commission is an effort to get EU countries to cooperate on so-called health technology assessment (HTA), the process by which policymakers decide how much money public health systems should pay for a new drug or treatment. Here are five key players to watch as policymakers restart the debate over the cost of cures.
Stella Kyriakides, commissioner-designate for Health
A breast cancer survivor and medical psychologist, Stella Kyriakides developed something of a “Mother Theresa” reputation in the Cypriot parliament, using a non-ideological style to win fans in both her center-right party and in the opposition. She’ll need that political finesse to polish off a complicated bit of leftovers: The Commission’s proposal for EU-level cooperation on HTA.
HTA refers to the process countries use to evaluate how much a new medicine is worth: How well it works; how many people might need it; and what other treatments might no longer be needed. DG SANTE wants countries to work together on the “how well it works” part, known as a clinical assessment. But critics of Kyriakides’ predecessor, Vytenis Andriukaitis, say he pushed too aggressively for a proposed requirement that countries only use the EU-level scientific assessment. Now the Council is at an impasse, with a powerful block of countries saying they’ll only accept a voluntary proposal.
Jens Spahn, federal minister of health, Germany
The fate of EU-level HTA is in Jens Spahn’s hands.
Germany leads a block of countries opposed to the Commission’s proposal. In a letter last year, they insisted that they’re not against working together to evaluate how well new medicines work, in principle. But they stressed that requiring capitals to rely only on this crowd-sourced scientific assessment takes things too far. Backers of the plan, for their part, contend that there’s no point in teaming up if every country goes its own way.
Spahn likely knows that the HTA file is bigger than just HTA. EU countries are already working together voluntarily on assessments on an experimental basis, and there’s a distinct fear in Brussels that if the HTA legislation withers, it’ll be the death knell for any significant pan-European work on health. Spahn will have a chance to play the hero if he brokers a compromise when Germany takes over the Council presidency in the second half of 2020.
Then again, he might already be gone at that point. An intra-party rival of Chancellor Angela Merkel, Spahn is champing at the bit for his next gig. Over just the past year, he’s thrown his hat in the ring to be both Christian Democratic Union leader and defense minister.
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Tiemo Wölken, MEP, Socialists and Democrats, Germany
Wölken is taking over the HTA file in Parliament, making him the top German counterpoint to Berlin’s opposition to EU-level cooperation. His frequent YouTube dispatches on subjects ranging from the burning Amazon rainforests to copyright reform earn tens of thousands of views, and he cites digitization and sustainability as his top priorities. But Wölken is quickly becoming one of the Parliament’s most influential players on drug pricing policy. At the end of the last Parliament, for example, he overcame objections from the lead rapporteur — and Big Pharma — to allow generic drugmakers to stockpile medicines that are still under patent extension — a provision that could help get cheaper copycats onto the EU market faster.
A lawyer by training, Wölken is starting his first full term in the Parliament after replacing another MEP in 2016. On HTA, however, his maneuvers in Berlin may be more important than those in Brussels: He’ll be working to persuade his Social Democratic counterparts in the Bundestag to drop their objections to the EU measure.
Bruno Bruins, minister for medical care, The Netherlands
While Brussels wrangles over how to regulate cooperation, capitals that want work to together are taking matters into their own hands. Bruins is at the forefront of these efforts, spearheading a new transatlantic collaboration to knock down drug prices, taking the fight to Big Pharma in the court of public opinion.
In October, Bruins plans to formally launch the International Horizon Scanning Initiative with Canada and a few other EU countries. “Horizon scanning” allows health systems to start planning early on how to pay for possibly pricey innovations that have yet to come to market. That, Bruins notes, allows negotiations between governments and drugmakers to start at an earlier stage, to avoid “inexplicably high prices.”
Bruins is also putting the drug pricing fight into the headlines. In August, he threatened to name and shame a specific company that increased its prices €150,000 per patient per year, if they don’t either explain the hike or roll it back. “The value of a human life is infinite, but the health care budget is not,” Bruins said.
Meindert Boysen, director of the Centre for Health Technology Evaluation, U.K. National Institute for Health and Care Excellence (NICE)
Think the U.K. won’t affect EU drug prices after Brexit? Think again. Deal or no deal, England’s NICE is likely to remain one of the most influential drugs gatekeepers in the world and one of the first stops for companies when they roll out new treatments — and Boysen is the man in charge of overhauling the agency’s HTA process.
Boysen used to work for the Pharma giant Eli Lilly, but he’s been with NICE since 2004, and took the helm of its HTA division in April 2018. Over the next few months, Boysen’s team will wrap up a review of new ways to quantify the value of medicines, such as whether a patient can return to work. His team will also need to navigate how to provide access to the first tumor agnostic drugs and single-use, highly expensive potential cures for inherited diseases. Expect their decisions to reverberate across the Channel.
Helen Collis contributed reporting.
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