All EU-funded clinical trials must be fully reported, coalition of 18 health groups demands

Eighteen health groups from around Europe today called on the EU to ensure that the €100 billion Horizon Europe research and innovation programme will incorporate best practices in clinical trial transparency, demand that grantees do the same, and annually audit their compliance.

Titled 'Public Return on Public Investment', the civil society proposal for Horizon Europe states that:

"To avoid duplication and research waste, and accelerate medical progress, Horizon Europe should sign up to and fully implement WHO best practices in clinical trial transparency, and require grantee institutions to do the same. Horizon Europe should annually audit grantees’ compliance."

Signatories include Global Health Advocates, the European Public Health Alliance, Salud por Derecho, Health Action International, BUKO Pharma-Kampagne, and TranspariMED.

Horizon Europe is set to succeed the EU's current research funding flagship, Horizon 2020, in January 2021. The civil society proposal ruefully notes that Horizon 2020 so far has not delivered on its transparency pledges:

"Horizon 2020 formally signed up to WHO best practices, but to date has not published the stipulated audit reports."

In order to maximise the public return and societal impact of EU research, the group recommends the introduction of a set of Access Principles in Horizon Europe. In future, medical research funded by European taxpayers should be:

• Needs-driven

• Equitable

• Effective

• Accessible, available and affordable

• Efficient

• Geared to the public-interest driven ownership of results

• Transparent

Ensuring that all clinical trials are registered and fully reported is not only a question of transparency, but also of efficiency.

The proposal further notes that:

"The proposal for Horizon Europe is the first EU Research Framework Programme to include societal impact as a key impact pathway. This represents an opportunity to implement needs-driven policies which increase the public return on investment of EU-funded biomedical R&I. This will be key to reinforce EU citizens’ confidence and show that investments into health R&I result in accessible and affordable products and more effective and equitable health systems."

It adds that its proposal would align Horizon Europe

"more closely with the commitments of EU Member States in multilateral instruments to which the EU subscribes, such as WHO resolutions, and the Sustainable Development Goals, which call for 'access to safe, effective, quality and affordable essential medicines'."

The civil society proposal was published on 25 September 2018, on the occasion of the Austrian EU presidency's event on Health Research & Development in Vienna.