OR WAIT null SECS
Is agenda blurring the line between alliances and assimilation?
Just in time for what is going to be a tumultuous year of argument in Europe over highly contentious medicines legislation, the research-based pharmaceutical industry has moved adroitly to recruit a wide swathe of stakeholders to its causes. Simply put, innovative drugmakers in Europe feel under threat from excessive regulation, hostility to intellectual property rights, and indifference to their economic equilibrium and global competitiveness—so much so that Bayer’s pharma boss announced in mid-January that his company would be shifting its focus to more sympathetic regions of the world in 2023.
The reasons for the anxieties have been repeatedly spelled out by their leaders and spokespeople over recent weeks. They depict a siloed policy environment that gives insufficient attention to industrial and scientific imperatives or a comprehensive approach to healthcare. Instead, they say, Europe’s innovative potential is sacrificed through a determination to keep down costs and to prioritize equality over quality in a bid to satisfy—or at least pacify—critics. The picture offered is gloomy: national authorities receive insufficient encouragement to modernize their infrastructure to support development and access to new medicines. Regulation lacks agility and offers resistance to novel market access mechanisms exploiting the new chances offered by real-world evidence. A new draft law on sharing health data risks wasting the opportunity for innovation because it lacks clarity and disdains trade secrets. An increased focus on onshoring and manufacturing older, generic medicines risks damage to future innovation. Meanwhile, Europe’s pharma industry complains it is already losing its place in global competition, leaving Europe’s citizens at risk of missing out on new drugs.
On the other side of the debate, national health ministers and their officials, the insurance organizations that pay for medicines, the consumer and civil society associations that represent patients, and citizens frequently accuse the industry of self-interest—often deploying language that verges on the lurid in their denunciations of the pursuit of profits over patients.
Into this standoff, enter the self-styled EU Health Coalition, with what it calls “a vision for European health, supported by a set of concrete recommendations and policy proposals designed to make it happen.” It urges “a Europe where health and care systems are without siloes,” with programs to strengthen “integrated care,” investment in human, intellectual, and innovation capital, and alertness to innovative health technologies and clinical practices. On data sharing, it urges a common approach and investment in digital infrastructure and skills.
The agenda overlaps in many places with the ambitions of the pharma industry. Because this coalition is an attempt to bridge the gap between the industry and its critics. It brings together “43 patient organizations, EU research-oriented medical societies, industry organizations, healthcare providers, regional and local health authorities, and other relevant stakeholders, who all share a common vision.” The list of partners is impressive, but equally prominent among the partners are the big beasts of the pharma industry lobbies in Europe—Big Pharma in the shape of the European Federation of Pharmaceutical Industries and Associations, the European Confederation of Pharmaceutical Entrepreneurs, and EuropaBio, among others.
The mixed membership of the coalition is reflected in the mixed content of the recommendations. It genuflects to reducing health inequalities and to unmet medical needs; it speaks of an approach centred on people and patients and on recognizing health as a “strategic pillar for Europe.” But while many of the buzzwords remain largely as token mentions in the text, the pro-industry concepts are more fully developed. The introduction explicitly envisions “modern services anchored in a value- and outcomes-based approach to health system organization, financing, and management”—a direct echo of policies long embraced by the industry, aimed at diverting the focus from the cost of individual therapies to the benefit they may bring to healthcare or society as a whole.
Line by line, the “vision’s” views on digital health, health systems integration, and access to innovation resonate with positions directly favorable to the industry’s urgings. Legitimate, no doubt. Maybe even laudable in its intention of seeking cooperation. But the exercise leaves an impression of artfully dodging the really difficult challenges of drug prices, of balancing patents with public interest, and of adequately containing the health risks intrinsic to innovation. This year will doubtless reveal many other stakeholders who will be ready to dissent from this easy compromise of a manifesto.
Reflector is Pharmaceutical Executive’s correspondent in Brussels.