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Reflector is Pharm Exec's Brussels correpsondent.
The European Union is moving ahead, in its own slightly crabwise fashion, with its attempts to work out what healthcare budgets should be used for. Reflector reports.
The European Union is moving ahead, in its own slightly crabwise fashion, with its attempts to work out what healthcare budgets should be used for. The characteristic sideways gait results from the fact that this isn't strictly speaking an EU issue. The EU treaty preserves health-spending decisions as a matter for national governments, and they have long-defended this approach in custom and practice. But health services in Europe are, as in so many other parts of the world, at serious risk of imploding under their own weight in these budget-constrained times. In consequence, any close observer of EU machinations can perceive one new group breaking fresh ground by looking at how to make national health services more efficient and sustainable, while another group looking at health technology assessment is about to take on a new lease of life.
The EU has been flirting with health technology assessment (HTA) for some time now, but for a long while the relationship was conducted in the EU's usual hands-off "don't look at me while I'm doing this" approach to pharmaceuticals and money. It took a bold step in 2011, when it adopted the cross-border patients' rights directive — which was really a Trojan horse designed by the European Commission to penetrate the camp of national regulators, while masquerading as a simplification of rules for the benefit of citizens. Artfully concealed inside the longwinded rhetoric about equality of opportunity and individual rights were a handful of hardcore institutional innovations, and the chief interloper among those meticulously disguised fifth columnists was the first legal base for HTA. No imposition, of course. That would be unthinkable. But a carefully crafted provision for a voluntary network of national HTA bodies, conveniently covering all member states, plus Norway and Iceland, and supported by an EU-funded organization with the unpronounceable title of EUnetHTA.
After a couple of years probing carefully and discreetly at how individual member states make their judgements on new drugs or devices or medical procedures, the EU is now getting ready for the next stage. Not quite an ambush, but definitely a fastidiously prepared convergence of thinking about the idea of something more systematic. Still voluntary, of course. The EU is the EU. But there are unmistakeable indications of EU aspirations to shift to a higher gear. At the end of October, delicate manipulations of circumstance persuaded members of the HTA network to adopt — unanimously — a 'strategy for EU cooperation on HTA'.
What this amounts to is an acceptance by national authorities of a strategic vision for HTA — something unthinkable only a few years ago, but now less rebarbative as a concept because of the hard times that austerity has forced upon healthcare planners. And to serve the development of that strategic vision, EU officials have convinced national officials that they should identify priority areas to be addressed through the network.
It is all still carefully wrapped around with allusions to the treaty's ban on any interference with areas of national competence or any harmonization of national laws or regulations, and explicit opt-out clauses making clear that "individual member states are free to decide the level at which they are willing to participate in cooperation efforts." But it is a real advance towards developing a European approach, rather than leaving all these decisions to the whims, caprices and local priorities or vested interests of member states. If it is to be a single market for medicines, then there must be some common elements in deciding which products merit reimbursement across that market, the logic runs.
HTA, says the new strategy, is "a useful tool to help decision-makers achieve sustainable healthcare systems, in the best interest of European patients." The goal of this new degree of European cooperation is "to increase use, quality and efficiency of HTA production in Europe and to promote HTA in decision-making". Cooperation can "promote more consistent approaches to HTA as a health policy tool to support evidence-based, sustainable, equitable choices in healthcare and health technologies". And it can develop “shared know-how” among national bodies working together to produce and apply shared methodologies.
The shift that is being encouraged, away from national thinking and towards a European approach, is palpable — and mould-breaking. But if it is ambitious, there is nothing naïve about this EU bid to generate a more coherent policy towards drug reimbursement. Aware of the tensions between distinct national interests and cultures in Europe, the new strategy notes that "trust is a precondition for successful cooperation". It goes on to argue that "such trust can be achieved only through a true commitment of all actors and access to expertise". There are challenges in engaging in activities across national boundaries and in joint work, the strategy frankly acknowledges. However, "the benefits of such activities are expected to largely outweigh the challenges".
In the short term, the focus of EU cooperation is to be on the clinical domains of HTA, but already the strategy notes that in due course, economic, organizational or societal perspectives should also be further explored. For the longer term, it even dares to venture into that still-virgin territory of "stronger synergies and closer interaction between developers of health technologies, regulators, HTA bodies and decision makers", arguing that working together can ease patients’ timely access to innovative, effective technologies. It envisages parallel early dialogue and scientific advice with developers of technologies in the pre-marketing phase, and periodic exchange of information between regulatory and HTA bodies throughout the later phases — including such elements as emerge from pharmacovigilance, clinical trials, and post-marketing clinical follow up.
Overall, says the strategy, "the network aims at implementing a vision which reflects that methodologies and evidence used to assess technologies are often global and can and should be shared". It will promote reliance "on each other's work to perform national HTA reports", and cooperation "in defining evidence requirements". The fact that this strategy, far-reaching in its implications, has been endorsed by member states demonstrates how smartly the EU has moved in securing a new degree of joint work on a subject that is — institutionally and constitutionally — beyond the EU's reach. The victory, if victory it is, has been achieved by the European Commission, the permanent civil service of the EU. Among senior officials, it has long been evident that the disparate approaches to pricing and reimbursement across Europe — many of them operating on a very slender base of evidence — have negative consequences for industrial policy and for innovation. Since senior officials are in no position to ride roughshod over the provisions of the treaty (or over the resistance of member state governments), they have had to operate as subversives rather than demagogues, as seducers rather than ravishers. Commission officials have proved effective with this tactic, convincing member states to vote for the very thing member states have long sought to avoid: the abandonment of their right to do what they damn well please about paying for drugs.
When you are underwater, condemned to operate in the murk of the sea-bed with partners who will eat you as soon as look at you, it can sometimes pay off to approach things crabwise.