For the last few years Health Action International (HAI) has been working on the issue of joint Health Technology Assessments (HTA). In short, HTA looks at added value of a new health technology, whether that be a medicine, medical device or diagnostic tool, when compared to ones already on the market. A debate over collaboration on joint Member State HTA at a European Union (EU) level has been dragging-on over the last few years. In principle, we support wider participation in joint HTAs because it will encourage transparency and the sharing of experience and resources across the continent. However, while harmonisation can be a means, it cannot be a goal in itself and flexibility should be shown on the grounds of national need.
A key part of our work on this issue is our membership of the EUnetHTA Stakeholder pool. We have been a member for several years now, and this year we continued to bring a much-needed civil society voice to the table, with a non-disease specific perspective on the implementation of joint HTA. We especially emphasised the need for the enforcement of stringent conflict of interest policies and how best to talk about HTA to patients.
Although 2019 has seen some small steps forward and many conversations around HTA, the proposed EU regulation that would bring it into force has progressed at an excruciatingly slow pace. The European Commission adopted the initiative at the end of January 2018, and Parliament followed suit in February this year. But the European Council is yet to act, and the initiative is about to reach the dubious milestone of having been on the desk of a third Council Presidency.
This inaction means that we haven’t yet been able to see whether our concerns with the original proposal have been addressed, namely that:
- Member states are allowed to participate in joint assessments at a pace that suits them and their resources;
- Flexibility to carry out additional assessments where necessary to meet a state’s specific public health needs is incorporated;
- A commitment is made to enforce conflict of interest policies; and,
- The high standards of assessments currently found across the EU are protected.
Once these concerns have been addressed, we believe that joint health technology assessments will be instrumental to a more transparent, affordable medicines system in the EU.
It’s widely speculated that the German Presidency—from July 2020—will be the end to the paralysis afflicting this important and innovative initiative. So we are eagerly awaiting the HTA developments that 2020 will, hopefully, bring.