The Shifting Kaleidoscope of EU Pharma Policy

Even without the COVID-19 pandemic, this year would have seen some intense discussion in Europe of fundamental questions about its pharmaceutical industry. Long-running battles over IP protection and prices were going to come to a head anyway, as four years’ reflection by the European Union on research incentives were scheduled to deliver new views on its legislation on orphan drugs and pediatric medicines. The European Commission also produced a volley of new initiatives from early 2020, aimed at squaring the circle of stimulating drug innovation without bankrupting healthcare systems. At the same time, a reworking of the EU’s long-term budget included a massive boost to Europe’s health program, while the gaps identified in Europe’s digital infrastructure led to an ambitious plan to create an “EU Health Data Space,” and Europe’s indifferent record on tackling cancer prompted not one but two large-scale parallel programs.

Then came COVID, exposing multiple weaknesses in Europe’s capacity to respond—and most particularly, the slender shape of Europe’s vaccine industry, which had been in gradual decline for years. As it threw billions of dollars at the many problems that the pandemic generated, the EU promoted and subsidized big investment in vaccine development among a handful of selected producers, tweaked its regulatory systems to fast-track promising candidates through the authorization procedures, and urged steps to repatriate drug manufacturing back to Europe after years of relocation to cheaper sites in Asia, and even the creation of European non-profit drug manufacturers.

Amid all of this, the EU released a consultation at mid-summer on an overarching “European Pharmaceutical Strategy”—with a promise for it to appear before the end of 2020, on an agenda stretching from manufacturing autonomy and access to affordable medicines to environmental sustainability, digitalization, unmet needs, and antimicrobial resistance. As Europe’s pharma executives struggled to make sense of all this in their replies to the consultation, European Commission President Ursula von der Leyen delivered a “State of the Union” address last month which included the ambition to create “a genuine European Health Union,” along with a strengthening of the European Medicines Agency (EMA).

For the principal European trade body, the European Federation of Pharmaceutical Associations and Industries (EFPIA), the plans for a shake-up of European rules on pharmaceuticals do not go far enough in support for innovation, and it issued a stern warning against “tampering” with incentives to ease patient access to treatments. Europe needs a research and manufacturing infrastructure “that delivers the next generation of vaccines and treatments,” says EFPIA, with clinical trial networks, biobanks, and data banks, a European health data space, public-private collaboration in speeding products to patients, and encouragement for innovative manufacturing, along with an IP framework and incentives to address unmet medical needs.

The focus of the reply from Medicines for Europe, the generic industry association, was very different: “sustainable economic, regulatory, and industrial off-patent medicines policies.” It urged “removing barriers that delay off-patent medicines market entry at loss of exclusivity,” with “harmonized rules such as the Bolar Directive and an EU ban on patent linkage.”

EUCOPE and EuropaBio want to see “more supportive measures…to drive future medicine development for rare diseases,” and “improved access to new treatments (ATMPs, orphan medicines),” with “streamlined regulatory processes.” The German BPI urges “mapping of existing procurement strategies in all member states,” while in an intriguing comparison, Medicines for Poland wants “support for the building of national production capacities,” citing as a model the EU’s Common Agricultural Policy. The principal concern of Romania’s ARPIM is action to overcome “long delays for pricing and reimbursement processes and late start of market access.” In the Netherlands, the manufacturers’ body, the VNO-NCW, calls for measures that will “ease the development process of treatments, in order to reduce both development time and cost.”

All these views are, in theory, to be put into the crucible where the EU will forge its new strategy. So too will views from the many stakeholders with different viewpoints, such as the European Public Health Alliance, whose submission speaks—not untypically—of “financial toxicity” in EU current arrangements for pharmaceutical provision, identifying “the excessive price of medicines” as one of the key barriers for patient access in Europe.

REFLECTOR is Pharm Exec’s correspondent in Brussels