Across the EU, giving patients access to innovative health technologies is a shared goal.
With 7000 new medicines currently being developed, new treatments like gene and cell therapies or combination therapies for patients ﬁghting cancer will play a central role in addressing Europe’s healthcare challenges.
However, continued collaboration on how we introduce these new technologies into our healthcare systems will be key, including on health technology assessment (HTA).
Through the European Federation of Pharmaceutical Industries and Associations (EFPIA), our industry has been supporting European cooperation on HTA since the beginning, including the proposed HTA Regulation, put forward in January 2018.
The Regulation would ensure effective harmonisation of clinical data requirements and removal of duplicative assessments, and I believe it would lead to faster patient access to new treatments, a more predictable system for companies and better, more harmonised, European quality standards.
To realise these ambitions, a European-wide system needs to fully integrate with national processes, rather than adding a supplementary hurdle which would effectively mean delays for patients.
But, as President of EFPIA and CEO of a European-based pharmaceutical company, I, and my peers, have strong concerns that EU Member States will opt for a compromise that will inevitably lead to an inefﬁcient system of joint clinical assessments used in HTA processes.
Europe needs to speak with a coherent voice on clinical evidence in the best interests of patients and our healthcare systems.
Unless the Regulation includes a clear role for the European Commission and ensures effective use of joint assessments it will create duplication and fail to address the current fragmentation across EU Member States in the assessment of clinical evidence.
Such an outcome, after almost 20 years of EU-funded cooperation, would fail to serve patients and miss an important opportunity for creating real efﬁciency.
"To realise these ambitions, a European-wide system needs to fully integrate with national processes, rather than adding a supplementary hurdle which would effectively mean delays for patients"
At a time when science is radically changing our idea of what treatment is, a well-functioning European capacity for joint assessments has never been more critical.
The future legislative framework can only realise its ambitions if the Commission, as guardian of the treaties, has a clear oversight on the procedural framework, including ensuring that the rights of manufacturers are respected and the Regulation provides for effective use of joint clinical assessments and critically, non-duplication at a national level.
An unpredictable system where Member States decide on a case by case basis if and how they commit themselves to use jointly conducted clinical-scientiﬁc assessments will not facilitate faster access for patients, but will delay it further.
At the same time, I hear that companies would be forced to engage: I can tell you this will weaken the industry’s trust in Europe.
Ultimately, what we all want is a system that improves the availability of innovative technologies for patients.
Through the HTA regulation, the Commission has outlined a route to achieve just that. Delays, inconsistencies and duplications should not be an option. Considering the lack of reciprocity and until everyone trusts a future system, it might be better to pause and reﬂect on other solutions.
This ThoughtLeader is sponsored by EFPIA