A unique opportunity to join forces; supporting the HTA regulation

Over the next nine weeks we will be hosting a series of blogs exploring some of the issues highlighted in the EFPIA Manifesto in view of the upcoming EU elections. Following last week’s vote in the European Parliament on the proposed Health Technology Assessment (HTA) Regulation, we are focusing on Improving patient access in Europe by setting up a European Clinical Assessment System that accelerates the process through harmonisation of clinical data requirements and removal of duplicative assessments.

I have been a keen follower of European legislation for over 20 years and I count myself as part of the 70% of European citizens that want more to be done on healthcare at an EU level. It’s one of the reasons why the proposed HTA Regulation feels like a potential positive tipping point for the EU’s health policy agenda.

Last week, MEPs gave the rapporteur Ms Cabezon a strong mandate, across political groups, to negotiate with Member States. To-date, the loudest message we hear from some Member States, in the context of HTA, is ‘watch out for subsidiarity’. Can the clinical needs of citizens across Europe be so different from country to country? Do their elected MEPs and representative governments really have such fundamentally different views on the clinical impact of a new technology or medicine?

The proposed HTA regulation is not, or at least should not be complicated. The Commission is suggesting that Member States get together and pool clinical expertise to review and analyse medicinal products. So far so good. Right? This means: defining, together which evidence they expect from innovator companies and agreeing together whether the evidence submitted is strong or not, conclusive or not, and whether anything more is needed, all this via joint clinical assessments.

There is a danger that we let the politics of subsidiarity subvert better decision making on new treatments for patients. Member States have underlined their concern that clinical assessment reports may not meet their needs, or be of sufficient quality. This objection seems difficult to understand in the context of how the regulation defines the process.

There is no such thing as ‘an unqualified European group’ creating European clinical assessment reports. The reports will be written jointly by Member States for Member States. How can one object to the use of reports that one has been part of developing? Moreover, the European Parliament has clarified procedural steps to help address the concerns of Member States, such as qualified majority voting. Under these circumstances, it is difficult to see why Member States would need to complement joint reports with additional national data. Or worse, duplicate pan-European assessments at a national level.

It may be that the quality of the reports or their suitability are not the real heart of the issue.

Subsidiarity concerns may be related to the perception that joint clinical assessments lie at the top of a perceived slippery slope to losing control of a country’s ability to decide on prices. It is true that clinical assessments feed directly into pricing mechanisms, however pricing is, and should continue to be, a national competence. It is inextricably linked to a country’s economic conditions and the organization of its healthcare system. The European Parliament has attempted to allay fears, making it very clear, that both appraisal, and pricing and reimbursement are distinct from any clinical assessment that can, and should be conducted jointly.

Put simply, if you take a statin in Sweden or Bulgaria the impact on your cholesterol will be similar. The cost of care for the heart attack that it prevents would be significantly different. Clinical assessments you can do across Europe, cost effectiveness has to be done country by country.

Together with many partners from across the healthcare community, we hope that those Member States that have raised objections can see that their concerns addressed including an appropriate transition period and that the Council will endorse the approach proposed by both the Commission and the European Parliament. We have, perhaps a unique opportunity to join forces to ensure there is one strong scientific basis for national HTA decisions based on the right evidence to answer the research questions at hand. The system will only work if Member States use the joint clinical assessment reports they produce. Delays, inconsistencies and duplication should not be an option: not for patients, not for healthcare systems and not for the research-based industry.

Nathalie Moll

Nathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director...
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