A Happy New Year for European Pharma Policy?

The changing of the guard at the head of the European Union has not gone smoothly, but most of the pieces were in place before the end of 2019, and for anyone with an interest in health or patients or pharmaceuticals in Europe, 2020 could turn out to be a happy new year. But no promises.

The new European Commission swept-or, more accurately, trailed-belatedly into office at the beginning of December, behind its new boss, Ursula von der Leyen, herself a last-minute choice, and until only weeks ago Germany’s minister of defense. This at least relieved the new European Parliament of the burden of repeating its cumbersome approval process for the candidates for the top Commission jobs, and permitted it at last to turn to its own affairs for the first time since it was elected in May. The European Council, too, managed to appoint a new full-time president on schedule, with Belgium’s former prime minister Charles Michel taking over the organization of EU summits and strategy from Poland’s former prime minister Donald Tusk.

So much for the top management-which shouldn’t need adjusting now for another five years. What does it mean for health and for patients and for pharmaceuticals? For a start, it means the possibility of some consistent policymaking with a longer-term vision, instead of the haphazard and short-term responses that have characterized much of the EU’s approach to health until now. And within each of the principal EU institutions, there is some evidence of greater attention being paid to health issues.

The task ahead

The new Commission has identified health as an important policy area, and Stella Kyriakides, the new health commissioner, a Cypriot psychologist, has been tasked with implementing an ambitious agenda. Drug firm executives have been gratified to see that the first item is to “ensure Europe has the supply of affordable medicines to meet its needs,” and to “support the European pharmaceutical industry to ensure that it remains an innovator and world leader.”

Other main tasks include “effective implementation of the new regulatory framework on medical devices,” making the most of “the potential of e-health to provide high-quality healthcare” and the creation of a “European Health Data Space,” which is intended to promote health-data exchange and support research, covering “treatments, medicines, medical devices, and outcomes.” The health commissioner will also be in charge of setting up “Europe’s Beating Cancer Plan” to improve cancer prevention and care-and with a close link to the research mission on cancer envisioned for the EU’s seven-year, €80-billion Horizon Europe R&D program now under development.

“Europeans expect the peace of mind that comes with access to healthcare and protection against epidemics and diseases,” said Kyriakides. And she recognized that this requires, among other things, investment in new technologies.

The parliament, freed from seemingly endless debates over who was sufficiently qualified to become a member of the new Commission, has picked up its work on health matters energetically. The health committee- now 

one of the largest of the parliament’s dozen or so panels-has been engaged in developing a “strategic approach to pharmaceuticals in the environment,” in asserting its control over the management of the European Medicines Agency (EMA), and reviewing the EU’s legislation on blood, tissues, and cells. And late at night in the parliament’s last plenary session of 2019, MEPs sealed their approach to an optimistic resolution on “enabling the digital transformation of health and care.”

Meanwhile in the Council, work will resume in the light of a widely supported initiative to bring an integrated approach to health policy. Finland’s strenuous efforts in the second half of 2019, during its stint in the rotating presidency chair, led to the adoption of a strategy entitled “the economy of well-being.” Its chief architect described this as a plan which would, among other things, allow digitalization and new technologies to “create the ground for innovations and growing businesses, which will help to promote public health and the availability of new medicines.” At the beginning of this month, Croatia took over chairship of EU’s health council. As a small and new member state, it will be less ambitious than its predecessor, but it has, nonetheless, already identified “promoting lifelong healthcare” as one of the priorities it will pursue.

Over at the EMA itself, which moves into its new permanent home in Amsterdam this month, there is palpable relief that despite the immense Brexit-induced disruption of being abruptly uprooted from its London home, it has been possible to maintain something like business as usual on the agencies core activities. And there is a reasonable expectation that many of its other activities, suspended over the last two years as a result of strained resources, can gradually resume as staff numbers return to normal and the agency settles back into routine.

Challenging seas

But despite these favorable winds, the voyage into the future may not be entirely smooth sailing. A major strategic challenge was highlighted at the December meeting of the health council, by Margaritis Schinas, the commission vice president, whom von der Leyen has put in charge of “promoting our European way of life,” and who will be Kyriakides’ direct superior. The EU, he remarked, accounts for only 8% of the world’s population and only 20% of its GDP-but it currently accounts for 50% of the entire spending around the world on social security. This was a reality that the EU would have to take into consideration as it developed its strategy for continued access to health and social services, he indicated, underlining its significance for developing policies that maximized prevention.

The broad support for Finland’s efforts to create an integrated EU health policy have already been subjected to some conditionality over the details by many member countries’ governments, who have insisted on the immovable primacy of national sovereignty on health. The logjam persists in the Council over plans for closer cooperation among national and regional health technology assessment bodies. Drug shortages have shot to the top of the news agenda and the subject is now gaining priority as a policy issue-with the link frequently made, irrespective of the logic, with the ever-incendiary topic of drug prices.

Health ministers have given their backing to the concept of a new structure to seek solutions-and these range from simpler mechanisms such as improved sharing of information to elaborate discussions of repatriating active ingredient manufacture to Europe. All the time, a steady background drum beat of concern over balancing innovative medicine provision with healthcare budgets threatens to burst into a cacophony of outrage, with patients and health payers chorusing their disappointments. AIM, one of Europe’s most influential mutual insurance organizations, has recently intensified its attacks on industry practice, leveling accusations of “opacity” over “astronomical” drug prices at a meeting in the European Parliament in December.

The concerns over what are seen as unjustified drug prices are also leaking into competition policy-where the EU has much stronger powers than in health. As a minor reminder of the breadth of the EU’s continuing reach into healthcare, the European Commission-in its role as the EU’s competition authority-approved just before the holiday break the takeover by Danaher of the biopharma business of General Electric’s Healthcare Life Sciences division. Margrethe Vestager of Denmark, who is back in the new Commission in charge not only of competition policy but also of digital strategy, had expressed her concerns that the deal could lead to  reductions in competition and innovation, and increases in prices and product shortages.

Her anxiety was assuaged only by Danaher’s commitment to divest itself of some of its activities in molecular characterization, microcarriers, and chromatography resins and hardware in China, the US, France, and the UK. This will, she said, “preserve effective competition in the supply of inputs to the bioprocessing industry-to the benefit of patients.”

But her services have indicated that the Commission is prepared to deploy its formidable powers more widely, and specifically in relation to drug prices if there is suspicion of anticompetitive agreements or abuses of dominance related to pharmaceuticals.

Reflector is Pharmaceutical Executive’s correspondent in Brussels