Róisín Shortall (Dublin North West, Social Democrats)
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369. To ask the Minister for Health further to Parliamentary Question No. 740 of 17 November 2017, the principles which guide this funding with specific reference to intellectual property rights and return on public investment; the mechanisms of oversight, transparency and accountability in this regard; and if he will make a statement on the matter. [41878/18]

Róisín Shortall (Dublin North West, Social Democrats)
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370. To ask the Minister for Health if his attention has been drawn to a recently published document (details supplied); the extent to which public funding is contingent on these principles or ambitious to be contingent on these principles; his views on a move towards greater return for public investment in health research and investment; and if he will make a statement on the matter. [41880/18]

Róisín Shortall (Dublin North West, Social Democrats)
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371. To ask the Minister for Health if his attention has been drawn to the international call for a new requirement to be introduced according to which all beneficiaries of public funding for biomedical research and innovation for treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases shall commit to access, effectiveness, affordability and availability principles; if consideration has been given to the ways in which such a requirement might be implemented here; and if he will make a statement on the matter. [41882/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 369 to 371, inclusive, together.

I understand the paper referred to by the Deputy, 'Civil society's proposal for Horizon Europe (2021)' was submitted by a range of international organisations to the EU Commission for the next EU Research and Innovation Framework Programme (Horizon Europe) which will begin in 2021, and needs to be considered in that context.

In Ireland, Clinical trials involving medicines are regulated under EU legislation. The current legislation, the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, transposed EU Directive 2001/20/EC on clinical trials into Irish law. A new EU Clinical Trials Regulation, EU Regulation 536/2014, was adopted in May 2014 and is scheduled to be implemented in 2020. The new Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, across the EU.

The benefits of the new Clinical Trials Regulation will include:

- Harmonised electronic submission and assessment process for clinical trials conducted in multiple Member States.

- Improved collaboration, information-sharing and decision-making between and within Member States.

- Increased transparency, with information on the authorisation, conduct and results of each clinical trial carried out in the EU to be made publicly available.

At national level the Health Research Board (HRB) is the lead agency in Ireland supporting and funding health research. It is important to note that the HRB funds a great deal of research which is not directly aimed at the development of products. This includes most of its health services and population health research portfolio. Within the clinical trials space the HRB funds testing of medicinal products, medical devices as well as processes and therapies such as physical or psychotherapy without an associated product. It needs to be understood that great public benefit can arise from understanding how things can be done better outside of the development of products.

The HRB, in funding health research projects is committed to the highest standards and principles such as integrity, transparency, fairness and accountability; collaboration and co-operation and a focus on outcomes and impact. Examples of how they work to achieve these aims include the following:

- The HRB has been at the forefront of developing public and patient involvement (PPI) in research in Ireland. This aims to drive the relevance and improve the conduct of research.

- HRB allocation of research funding is made following international peer review to ensure that only those proposals of the highest quality are funded.

- Considerable investment has been made by the HRB, with funding from my Department, in developing a clinical research landscape in Ireland that can provide the supports and infrastructure to facilitate clinical trials of medicinal products, diagnostics and medical devices, such that they can be robustly evaluated to ensure their safety and efficacy.

- As part of its funding criteria, the HRB requires the registration of all regulated clinical trials and the publication of trial outcomes. Through its Open Publishing Platform (HRB Open Research), the HRB facilitates the publication of protocols and results. HRB Clinical Research Co-Ordination Ireland (HRB-CRCI) co-ordinates multi-site clinical trials activity in Ireland as well as collaborative and multi-disciplinary projects.

- The HRB terms and conditions for its funded research set out a number of clauses that cover oversight, accountability, transparency and protection of intellectual property of grant funding.

- The terms and conditions accepted by host institutions for HRB funding cover publication and broader public dissemination of results, and appropriate protection of Intellectual Property (IP) in line with the National Intellectual Property Protocol, "Inspiring Partnership - the National IP Protocol 2016: Policies and Resources to help industry make good use of public research in Ireland". This protocol encourages the use of non-exclusive licensing. Information on all HRB-funded awards is publicly available on its website.

The HRB monitor adherence to their terms and conditions of grants. They do this through annual and interim review and the collection of detailed evaluation data.