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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
European health ministers are meeting later this week to review what has been, and what can be, done to strengthen future defenses to counter the COVID pandemic.
On Wednesday, December 2nd, European health ministers will meet to review what has been done so far to counter the COVID pandemic, and what can be done to strengthen European health defenses for the future. It's a huge agenda—and in amongst the many components of the European Union bid to find common ground among its 27 member states on the way ahead, one less conspicuous and apparently incidental item may give a clue to how good the chances are of finding agreement on the big picture improvements that are necessary.
That secondary item is health technology assessment, and the discussion among ministers will turn on the proposal now three years old for coordinating evaluations at EU level, instead of conducting as many as 50 distinct regional and national evaluations among the member states on every new medicine. The logic behind the plan is obvious: avoiding duplication, saving time and resources, and arriving at the best decisions by pooling expertise from across the continent. But ever since the proposal emerged, other factors have intervened—and notably the reluctance of some countries to abandon their own approach and submit to a judgment reached by a committee.
It the objections came from some of the EU's smaller countries (many of which favor a common approach, because they don't all have the resources to comfortably operate their own independent systems) the problem might be bulldozed out of the way. But Germany, France and Poland are among the chief opponents of the plan, firmly opposed to surrendering any national sovereignty on questions relating to which medicines they decide to reimburse. That trio constitutes a significant chunk of European policy weight, and there are plenty of other doubters too. As a result, countless meetings of diplomats and officials through 2018, 2019 and 2020 have shuffled around the paragraphs and provisions relating to which products to evaluate, who should offer opinions, what evidence to require, what processes to follow and a hundred other elements—but fruitlessly, since the key questions remain unanswered about who decides, and what happens when a decision is made.
In simple terms, the arguments come down to whether member states are obliged to be involved in the evaluations, and whether they have to accept judgements once they are agreed. The latest compromise text, on the table for ministers next week, doesn't answer those questions—or at least, it wraps the answers around with so many conditions and reservations and opt-outs and opt-ins that it pleases no-one. Not the member states who want a binding system, not the member states who want a voluntary system, and not the industry, which wants clarity above all else. From the outset, research-based drug firms have said they are happy with the principle of a streamlined system only if it delivers predictable, high quality evaluations, and replaces the current confusion of parallel systems. But if it is going to be just another HTA system on top of all the others, it will increase the workload without any boost to efficiency and will simply add another layer of barriers to launching an innovative medicine across Europe.
The prospects for agreement do not look good. And while COVID is still raging, and multi-billion dollar recovery plans and vaccine purchase agreements are under discussion, and Europe is openly considering repatriating pharmaceutical production from the Far East to member states, and major new joint cancer programs are in prospect, and a string of other initiatives have been proposed in what is being termed "a new beginning" for European health policy and even a European Health Union, it may seem disproportionate to worry over the fate of relatively minor initiative on clinical assessments. But if the EU is unable to agree on such relatively minor issues as this, when the arguments in favor are indisputably powerful, then what are the chances of the EU managing to reach common positions on so many so much more weighty items on its health agenda? Perhaps the Z December will provide some answers.