EURORDIS calls to adopt the European Commission’s proposal for a future European cooperation on Health Technology Assessment.

EURORDIS-Rare Diseases Europe, an alliance of 779 rare disease patient organisations from 69 countries, calls on the European Parliament and Member States to adopt the European Commission’s (EC) proposal, published today, for a future European cooperation on Health Technology Assessment (HTA).

• Only a permanent structure can guarantee long-term cooperation and organise sharing of scientific expertise
  and methods across all EU HTA agencies.
• Joint HTA reports represent a major progress towards high quality, transparent and timely information
  necessary for the subsequent coverage/ reimbursement decisions made on a national level.
• With this proposal, patients will be better equipped to understand the scientific rational behind the assessment
  of the added value of health technologies, everywhere in the EU and for the first time in all Member States.
• In 2018, 24 years after the first EU project on HTA, it is time to create a more efficient process, with no
  replication in 28 Member States of the assessment of the added value when diseases and patients are the same
  across the EU.
• This is particularly needed when diseases are rare or technologies complex.

The EC proposal calls for the mandatory uptake of joint HTA assessments. EURORDIS welcomes this as the only
guarantee that the future cooperation will achieve its goals (no duplication, high quality assessment, timely
production of the reports).

When a joint report will be formally adopted at the European level, with the possibility for each Member State to comment before its final adoption, national authorities should not re-assess the clinical domains already assessed (efficacy, safety, relative effectiveness).

Currently, agencies use different methods and sources of data for HTA assessments, and do not have the resources to assess all new technologies or obsolete ones. Every year, more than one hundred innovative pharmaceuticals are authorised, and high numbers of invasive medical devices or in vitro diagnostic tools are proposed, and complex surgery need to be validated.

There is no reason why 28 Member States should conduct their assessment separately; this unnecessary duplication of efforts introduces disparities in the quality of the assessment and in the timing of the decisionmaking. With at least 20 Member States having limited capacities, optimising them and pooling of their resources, makes sense.

The legislative proposal will enable HTA agencies to share and transfer the highest scientific standards, applying common methods and guidelines, build mutual trust and share expertise and know-how. It will focus on clinical aspects, while costs and economic ones will remain a national-level responsibility.

Assessing new health technologies jointly is the only way to move away from the current status quo. For this, clear procedures by which all agencies can contribute with enough due time to comment on the joint work need to be in place. No Member State should feel a joint report to be imposed to them, all scientific contributions should be considered.

The new scientific secretariat hosted by the European Commission will ensure independent and efficient work. It will support Member States, with a stepwise approach, in the initial joint assessments.

As well as mandatory uptake of joint assessments, EURORDIS welcomes the activities envisaged for this future cooperation: from joint scientific consultations (early dialogues) to horizon scanning, development of guidelinesand methodologies, evidence generation and research activities on a voluntary basis.