Healthcare
Legislative and Regulatory Developments
IRISH LEGISLATION PASSED SINCE THE AUTUMN HORIZON TRACKER
Assisted Decision-Making (Capacity) (Amendment) Act 2022
Date signed into law: 17 December 2022
This act makes a number of amendments to the Assisted Decision-Making (Capacity) Act 2015 and will provide for the 2015 act's commencement as well as introducing key measures for compliance with the United Nations Convention on the Rights of Persons with Disabilities. The 2015 act, when commenced, will replace the current Wards of Court system in Ireland with a tiered range of decision supports, including decision making assistants, co-decision makers, and decision making representatives. In a recent press release, the government announced that the previous wardship system will be discontinued on 26 April 2023 and the new Decision Support Service will become operational.
Latest stage: A number of sections have been commenced by SI 46/2023.
BILLS
Health (Amendment) Bill 2023
Date published: 10 March 2023
The purpose of this bill is to amend the Health Act 1970, and revoke the Health (Acute In-Patient Charges) Regulations 2021, removing the acute public in-patient charge of EUR 80 per day, up to a maximum of EUR 800 in a year, for patients in public hospitals.
Latest stage: Completed Dáil Éireann, First Stage.
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: Currently before Dáil Éireann, Third Stage.
Regulated Professions (Health and Social Care) (Amendment) Bill 2022
Date published: 16 August 2022
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: Currently before Dáil Éireann, Third Stage.
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.
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: Heads of Bill approved on 25 July 2019. Committee agreed to waive pre-legislative scrutiny.
EU DRAFT LEGISLATION
Proposal for a Regulation regarding the Transitional Provisions for Medical Devices and In-Vitro Diagnostic Devices
Procedure reference: 2023/0005/COD
Date published: 10 January 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.
Latest stage: 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, the Commission published its proposed amendment to the MDR and IVDR on 6 January 2023 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.