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Everyone, it seems, agrees that health technology assessment in Europe needs improvement. What everyone does not agree on is how that should be done—and the ambiguity has just become more evident.
The European Union has at last agreed on how HTA should be coordinated among Europe's multiple HTA agencies, bringing to an end a three-year process of discussion. The agreement—taking the shape of a formal regulation—was greeted as a triumph by some influential voices.
The EU Council, representing the EU's member states, announced with something approaching euphoria that it had received the green light. A statement claimed that thanks to the new rules, "innovative, safe and effective health technologies will be more quickly available for patients," and "producers of medicines and medical devices will benefit because submission procedures will be simplified."
According to Janez Poklukar, the Slovenian minister for health and currently president of the EU's health ministers, the adoption of this law "is another demonstration of how EU countries, when acting together, can achieve very practical results for their citizens. This new law will benefit patients, producers of health technologies and our health systems."
"Great news: green light on HTA," tweeted Tiemo Wölken, the prominent German socialist MEP who had shepherded the discussions in the European Parliament.
And the news went down well in the powerful European consumers organization, BEUC, too. This agreement "will help improve consumer access to the medicines they need and help cut unnecessary costs in member state health budgets,” said its health spokesperson. “At a time when health ministries face ever trickier decisions about which treatments and medicines to reimburse, this new set of rules should help consumers get the most effective treatments reimbursed by social security systems," she added.
But as this column pointed out back in June, when the EU was in the closing stages of this long negotiation over a text, the new regulation was looking like only a very limited legislative framework. And very limited is what has emerged in the final agreement. It retains a similar shape to the initial 2018 proposal, but it is devoid of most of its substance. Member states will—as was intended—cooperate on joint clinical assessments and joint scientific consultations, and companies will have an opportunity for a single submission that could in principle eliminate the need for multiple local submissions. But—contrary to the plan put forward in 2018 (which enjoyed some support from the research-based industry)—member states will write their own rules for the conduct their assessments and consultations. And even more contentiously, if they reach a joint decision on a product at EU level, they are under no obligation to follow it at national level.
From the outset, key member states were opposed to any EU rule on HTA that would tell them what to do at national level. And in the final text now adopted, the council has given no ground on its flat rejection of what had been proposed as an obligation to apply joint clinical assessment reports in their national HTA procedures. They have instead conceded only that member states will "give due consideration" to them, without impact on their rights to draw their own conclusions.
So even if there has been some support for the agreement among those who do not use HTA—council, parliament and consumers—there has been a conspicuous absence of rejoicing from the constituency which pre-eminently does use HTA: the pharmaceutical industry. Its views on such a compromise were made clear months ago, when its main lobby in Europe, EFPIA, said it "risks introducing an unpredictable system", and called dit a "missed opportunity" that will be felt in "unnecessary administrative and regulatory barriers to patients' access to new medicines introduced in Europe." It had earlier warned that this softly-softly approach to coordination of HTA was "misguided" and could "only lead to an unsatisfactory result." Removal of all obligations on member states to make use of any joint clinical assessments emerging from the system is to deprive it of any value to companies seeking a more efficient system, EFPIA argued. Its silence since the deal was agreed this week is eloquent. It is difficult to resist the conclusion that, as this column suggested, the road to closer collaboration remains full of obstacles, because of persistent national reticences over handing over too much power to the EU. And the losers will be patients just as much as companies.