In this section we bring together a number of pieces of legislation which are important in relation to the overall regulatory and legislative context in the Healthcare, Pharmaceuticals and Scientific Research sectors.
ACTS AWAITING COMMENCEMENT
Regulated Professions (Health and Social Care) (Amendment) Bill 2022
Date signed into law: 6 June 2023
This bill makes a number of amendments to the Health and Social Care Professionals Act 2005, the Medical Practitioners Act 2007, and the Regulated Professions (Health and Social Care) (Amendment) Act 2020. The technical amendments address issues relating to the Medical Council's complaints investigation process, as well as allowing holders of UK medical degrees to access medical intern training posts in Ireland, and other matters.
Latest stage: Some provisions were commenced upon enactment. A number of provisions await commencement.
Regulated Professions (Health and Social Care) (Amendment) Bill 2022
Date signed into law: 6 June 2023
This bill makes a number of amendments to the Health and Social Care Professionals Act 2005, the Medical Practitioners Act 2007, and the Regulated Professions (Health and Social Care) (Amendment) Act 2020. The technical amendments address issues relating to the Medical Council's complaints investigation process, as well as allowing holders of UK medical degrees to access medical intern training posts in Ireland, and other matters.
Latest stage: A number of sections await commencement.
BILLS
Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022
Date published: 20 December 2022
The purpose of this bill is to implement the recommendations of the Madden Report on Post-Mortem Practices and Procedures by regulating the removal, retention, storage, use and disposal of human tissue from deceased persons. It will also provide general conditions for the removal, donation and use of organs and tissues from deceased and living persons for the purposes of transplantation. The bill will also provide an opt-out system of consent for organ donation.
Latest stage: Committee Stage, Seanad Éireann.
IRISH PROPOSED LEGISLATION
Health (Amendment) (Licencing of Professional Home Support Providers) Bill
To enhance home support service through the licensing of both public and private providers.
Latest stage: Heads of bill in preparation. Listed for priority drafting in the Autumn Legislative Programme.
National Research Ethics Committees Bill
This bill provides for the creation of a National Research Ethics Committee model in Ireland that will encompass all human health research including clinical trials of medicinal products.
Latest stage: Revised Heads of bill in preparation.
Research and Innovation Bill
The bill provides for the establishment of a new statutory agency for the funding of research in Ireland, under the auspices of the Department of Further and Higher Education, Research, Innovation and Science. This will involve the amalgamation of the Irish Research Council (IRC) and Science Foundation Ireland (SFI) to form the provisionally-named "Research and Innovation Ireland". The new agency is a key part of Impact 2030: Ireland's Research and Innovation Strategy and will serve to streamline the funding of research across all disciplines as well as simplify the process for receiving state support. Professor Philip Nolan has already been appointed as CEO Designate of the new agency. The pre-legislative scrutiny of the bill has been completed by the relevant Joint Committee and its report has been published.
Latest Stage: Heads of bill have been approved. Pre-legislative scrutiny complete. Listed for priority publication in the Autumn Legislative Programme.
EU DRAFT LEGISLATION
Regulation regarding the Transitional Provisions for Medical Devices and In-Vitro Diagnostic Devices
Date published: 15 March 2023
Regulation 2017/745 on Medical Devices (“MDR”) and Regulation 2017/746 on In-Vitro Diagnostic Devices (“IVDR”) entered into force in May 2017. The regulations set out a framework for quality and safety standards for medical devices and in-vitro diagnostic devices, setting out obligations for manufacturers including the maintenance of quality management systems to ensure risk management processes, clinical evaluation, and incident reporting amongst others.
The end date for the transitional period under the MDR was established originally as 26 May 2024, with the dates under the IVDR staggered from 26 May 2026-26 May 2028 depending on the risk class of the device. Due to the risk of medical device shortages, this regulation amends the MDR and IVDR in order to extend the transition periods for certain classes of medical devices under the regulations, and to delete the ‘sell-off’ deadline in the relevant provisions.
Latest stage: Entered into force on 20 March 2023.
EU DRAFT REGULATIONS
Proposed reform of the EU pharmaceutical legislation
On 26 April 2023 the Commission adopted a proposal for a new directive and a new regulation which will revise and replace existing general pharmaceutical legislation:
Commission proposal for the Pharmaceutical Regulation
Commission proposal for the Pharmaceutical Directive
The main objectives of the proposed legislation is to create a single market for medicines in the EU to ensure better access; to reduce the administrative burden of authorisation times; to enhance availability of medicines; to make medicines more environmentally sustainable; and to address antimicrobial resistance. Under the proposed reforms companies will be given incentives to make their medicines available to patients in all EU countries, and market authorisation procedures for generic and biosimilar medicines will be simplified. The reforms also include a move away from the current "one-size-fits-all" regulatory protection system, proposing instead a minimum period of regulatory protection of 8 years that can be extended in certain circumstances:
- If the medicines are launched in all Member States;
- if they address unmet medical needs;
- if comparative clinical trials are conducted; and,
- if a new therapeutic indication is developed.
Latest stage: Both proposals are first reading in the Council
Matheson Insight: Pharmaceutical Legislation Reform Proposed by the EU
EU INITIATIVES
Proposal to change market authorisation in pharmaceuticals
The Commission has proposed a review of the existing framework for pharmaceutical regulation to streamline resources for regulatory authorities and marketing authorisation holders, and speed up the authorisation of variations. The purpose is to make the lifecycle management of medicines more efficient.
Latest stage: Act is being drafted. Commission adoption of the proposed act is due before the end of 2023.
Read More: Lexology GTDT - Healthcare Regulation 2024 (Ireland)