Dáil Éireann Debate, Tuesday - 17 November 2020
817. Deputy David Cullinane asked the Minister for Health the status and plans for advancing the National Research Ethics Committees Bill 2019; the legislative timeline; and if he will make a statement on the matter. [36871/20]
Amharc ar fhreagraThe General Scheme of the National Research Ethics Committees Bill was approved by the then government in July 2019. The purpose of the Bill is to legislatively enable the establishment of a national research ethics committee (REC) framework that will reform and modernise the existing REC framework. Th effect will be to enhance health research in Ireland and to make Ireland a more attractive location for international health research.
The General Scheme made clear that a twin track legislative approach involving the use of secondary legislation to establish National RECs in areas covered by EU Regulations would allow more immediate action to be taken in the important areas of clinical trials of medicinal products for human use and clinical investigations of medical devices.
Secondary legislation was possible in those areas because of the EU basis for action. It is relevant to mention that the EU Regulation on clinical trials of medicinal products for human use and the EU Regulation on the clinical investigations of medical devices are both scheduled to come into effect in 2011 so there was an urgency in taking legislative action in those areas.
The establishment of national RECs in other areas of health research requires primary legislation which is the focus of the Bill. Substantive work on the Bill will, as planned, take place when the secondary legislation is completed.
During the course of the preparation of the General Scheme there was engagement with the health research sector and the rationale for the twin track approach was understood and appreciated as the best way to proceed.
As per the General Scheme, the principles and policies that are set out in the secondary legislation in the areas of clinical trials and clinical investigations will be replicated in the Bill thereby providing a consistent and unified structure across the spectrum of health research.
It is also important that the legislation to provide for this type of wide-ranging structural reform needs to be supported by practical operational initiatives if real reform is to be realised on the ground.
In that regard, I can point to the establishment of the National Office for Research Ethics Committee in March of this year. In its first few weeks of existence, the Office was directly involved in setting up successfully a National REC to deal with Covid 19 research. It is now working to ensure that the actions necessary to make the clinical trials and clinical investigations National RECs successful will be in place in early 2021. Part of that process will see the National Office embark shortly on a public expressions of interest campaign to ensure a broadly based and diverse membership of the National RECs.
In providing for a system of national RECs, I want to also make the point that, as in other countries, there will continue to be an important role for local and institutional RECs that are the backbone of the current structure. I also want to pay tribute to the members of those RECs who selflessly give up their time and I hope that many of them will be interested in being involved in the new national RECs.
