EU joint health technology assessment—what hope for a breakthrough in 2020?

Hopes that the year-long stalemate on the European Commission’s proposed Regulation on health technology assessment (HTA) would be resolved before the end of 2019 have been confounded. The Finnish Presidency of the EU Council is drawing to a close with limited progress to report. What are the prospects for a breakthrough in 2020?

Continued opposition from several Member States

In December 2018, the Health Ministers of Germany, France, Spain, Poland, the Czech Republic and Bulgaria submitted written objections to the European Commission and European Council regarding the Commission’s proposal for joint HTA. In particular, they opposed mandatory use of joint HTA and prohibition of national assessments, simple majority voting on decisions and the prominent role of the European Commission in decision making.

According to Josef Hecken, the Chairman of the Gemeinsamer Bundesausschuss (G-BA; Joint Federal Committee), Member States now fall into three groups with regard to their stance on mandatory use of joint HTAs:

• In favour of mandatory joint HTA: Belgium, Croatia, Cyprus, Estonia, Greece, Ireland, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovakia, Slovenia
• Opposed to mandatory joint HTA: Bulgaria, Czech Republic, Denmark, France, Germany, Poland, Spain and Sweden
• Neutral: Austria, Finland, Hungary, Italy, Latvia

European Parliament is broadly supportive of the proposal

Flora Giorgio, who heads the team on HTA at the European Commission, has commented that the European Parliament broadly supports the Commission’s approach but recognises a need for greater flexibility. German MEP Tiemo W?lken, the rapporteur for the HTA file in the European Parliament, has expressed the view that “Germany and France are blocking the proposal for subsidiarity concerns, but we should act now as the EUnetHTA is coming to an end” (in 2021).

W?lken has also warned that “Member States should know that there are red lines that will not be crossed. A mandatory adoption of the evaluation, for example, is essential to ensure the new Regulation is worthwhile.” Furthermore, the European Parliament does not want the long-term continuation of a project-based approach such as EUnetHTA.

Finnish Presidency made limited progress

Despite its best efforts—including holding at least seven meetings on the subject—the Finnish Presidency was unable to achieve a breakthrough on joint HTA. In a progress report, it noted the following developments:

• Most countries favour taking the Franco-German suggestion of a step-wise approach to joint clinical assessment (JCA)—starting with around 10 technologies per year and increasing the number every 2-3 years until full capacity is reached.
• Several countries believe JCA should be compulsory for many centrally authorised medicines.
• Many countries want the Coordination Group (composed of representatives from national HTA authorities and bodies) to play a larger role in conducting and approving JCAs, with the Commission being less influential. However, the Coordination Group has no legal personality and cannot impose obligations on third parties.
• Finland has proposed that reasoned scientific views should be annexed to joint clinical assessment reports and that the reports should be approved by consensus. However, some countries want the Commission to verify that correct procedure has been followed for each JCA.
• Some countries have concerns regarding the potential quality and timing of JCAs.
• The obligations on Member States as regards uptake of JCAs have been softened, but countries would still be required to consider JCAs in their national HTA processes.

Next steps are likely to prove challenging

Stella Kyriakides, the recently appointed EU Health Commissioner, is optimistic of progress in 2020. Speaking at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on 9th December 2019, she expressed the hope that “the Croatian Presidency [which begins on 1st January 2020] will take these negotiations up and go one step further.” Croatia is among the countries that supports mandatory use of JCA.

Kyriakides acknowledged that “more work is needed. We’re clearly on the right path, I’m fully committed to take the necessary actions during my mandate and I hope to come back with a proposal end of 2020 that we will be able to discuss in more concrete terms.” That timetable may prove challenging, given that Germany—apparently the arch-opponent of mandatory JCA—takes over the Presidency of the Council from Croatia in the second half of 2020.

Ortwin Schulte, Head of the Health Unit at the German Permanent Representation to the EU, recently disclosed that his country is working on a “trio presidency” with the two countries that will follow it, in 2021, namely Portugal and Slovenia. He expressed concern that the proposed health programme’s budget may not cover “all the new tasks we have, including formal HTA co-operation.” Given their apparently differing stances on mandatory JCA, it will be interesting to see how the three countries work together to advance the cause of joint HTA. The negotiations will have to resolve the following key issues:

• Legal status of JCAs
• Number of technologies to be subject to JCA and the criteria for their selection (e.g., indication based or ad hoc)
• Methodology to be used for JCAs
• Acceptable evidence for JCAs
• Clear distinction between assessment and appraisal of technologies
• Level of obligation on Member States to use JCAs and possibility of opting out
• Potential restrictions on additional national/regional HTA activity
• Dispute resolution process on both scientific and procedural issues (simple or qualified majority voting)
• Funding for the period 2021-2027

Industry concerns about the direction of travel

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has been supportive of joint HTA in principle. However, the federation has two main concerns about this process: (1) the Commission should oversee the procedural framework, including ensuring that manufacturers’ rights are respected; (2) JCAs should be used effectively at national level, with no duplication of work.

Jean-Christophe Tellier, the CEO of UCB and President of EFPIA, has warned that requiring manufacturers to participate in joint HTA without an equivalent obligation on Member States to support the process would “weaken the industry’s trust in Europe.”

Nathalie Moll, the Director General of EFPIA, has suggested that “it may be best to delay implementation of a permanent process for the joint production of clinical assessments until Member States and industry have established sufficient trust in the quality of own joint work and can formally commit to the undisputed use of jointly produced clinical assessments in national decision-making processes. Until such point of trust in the joint work can be reached, Member States, as well as companies should be formally entitled to decide their participation in the new system on a case-by-case basis. Ultimately, what we all want is a system that improves the availability of innovative technologies for patients. Delays, inconsistencies and duplications should not be an option.”

The outlook for joint HTA will ultimately depend on whether its advocates—the European Commission, the European Parliament, the pharmaceutical industry and around half of EU Member States—can overcome dogged resistance from a handful of powerful countries led by Germany and France. Will an irresistible force shift an immovable object? Watch this space.