What’s to Come for HTA Legislation and Collaboration?

Reflector

Reflector is Pharm Exec's Brussels correspondent.

Pharmaceutical Executive, Pharmaceutical Executive-05-01-2021, Volume 41, Issue 5

The progress and stumbling blocks in building a formal EU system.

Prospects for European collaboration on health technology assessment (HTA) have brightened a little as winter has given way to spring, and there is now a realistic possibility that the dozens of distinct HTA agencies across Europe will start to work more closely together in the coming years.

The positive signs include a decision to begin negotiations at the political level over the draft legislation that could bring new alignment among national procedures, and some upbeat talk among the technicians and officials who have been trialling voluntary collaboration over the last decade—despite the fact that they now face closedown of their activities as their current funding and mandate expire. But the brighter prospects are still no guarantee of a happy landing, since this proposed legislation has been notoriously defying attempts at agreement since it first appeared in early 2018.

Nevertheless, for Marcus Guardian, CEO of EUnetHTA, the soon-to-be-ended project that has brought 80 HTA agencies together to find common ground, expectations have “shifted to something a bit more concrete than we thought, and we are very much excited.” His guarded optimism is shared by Rui Santos Ivo of the Portuguese medicines agency, Infarmed, who, sitting alongside Guardian at EUnetHTA’s final annual conference in April, described the recent upgrade from technical to political talks as “perhaps the last step in building a formal EU system for HTA.” He said: “We are positive in moving forward.”

Tiemo Wölken, the MEP who is guiding the legislation through the European Parliament, told the same meeting: “We all want to now finally seal the deal”–even though he characterized it as “finalizing this fight.” Anna Eva Ampelas of the European Commission expressed confidence that “the benefits for more structured cooperation are now quite clear for everybody,” and although it has been “a bit of a rollercoaster over recent years, we remain very optimistic,” with momentum recently restored to the faltering process. Yann Le Cam, CEO of the European rare diseases group, Eurordis, said he, too, was “really hopeful that an agreement will be reached and that things are going to be adopted and implemented fast and well.”

The biggest single stumbling block is what use is to be made of the joint clinical assessments that the scheme envisioned: essentially, will national HTA bodies be obliged to use them, or can they just ignore them? The original proposal from the European Commission—heavily backed by the pharma industry—was compulsory use, to reduce duplication and incoherence. But big EU countries object to having their hands tied by an EU-level assessment on such a sensitive issue as national pricing and reimbursement, and as the 27 EU member states that make up the Council go into negotiations with the European Parliament, their proposed compromise is to argue that use should be purely voluntary.

This means that a clash is certain as Council and Parliament face off in this final stage of the legislation. Wölken was quite clear in stating the Parliament’s position: MEPs oppose the ‘hands-off’ approach of the member states and want some binding element in the final text. “If we want this to succeed, we need to make sure that the joint clinical assessment is indeed taken into account at national level,” he said. Ampelas also underlined the Commission’s ambition in the upcoming talks to make cooperation stronger, “to make it more formalized and more structured.” She acknowledged that in the Council, the preparatory discussions so far “have been more difficult,” and saluted the Parliament’s backing for mandatory use. Le Cam was even more trenchant: “The joint clinical assessment has to have legal status, and it has to be re-used by national authorities. If not, we are just creating a new monster.”

But there are signs a more emollient approach is being prepared as a way for everyone to climb down from the more extreme positions. The Commission has been underlining that the proposal is not just a matter of mandatory use of joint assessments, but should rather be seen as a much broader project ranging from building up national and regional HTA capabilities to joint horizon scanning of upcoming innovations, and from post-launch evidence generation to periodic reassessment. Le Cam, too, has recognized that there will be “a learning curve” once the legislation is in place.

A new degree of goodwill is probably necessary, so that in parallel to moving the political talks along toward a rapid resolution, there is also support from national and regional HTA agencies to continue–even without EU funding—the technical collaboration essential for the success of any new EU-wide HTA system that is brought into being.

Reflector is Pharm Exec’s correspondent in Brussels

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