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 sector.
Note the changes under the Health (Amendment) Act 2023 described below in relation to inpatient charges. Another significant development is the commencement of the Assisted Decision-Making (Capacity) (Amendment) Act 2022. In June our Financial Institutions Group will partner with our Private Client practice area to address issues in this space regarding financial decision making and the obligations imposed on financial institutions in this regard. Again this will be accessible through our Matheson Knowledge Hub.
IRISH LEGISLATION PASSED SINCE THE SPRING HORIZON TRACKER
Regulated Professions (Health and Social Care) (Amendment) Act 2023
Date signed into law: 6 June 2023
This act makes a number of amendments to the Medical Practitioners Act 2007, the Health and Social Care Professionals Act 2005, and certain un-commenced sections of 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: Awaiting commencement.
Health (Amendment) Bill 2023
Date signed into law: 4 April 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: Whole act commenced on 17 April 2023.
ACTS COMMENCED SINCE THE SPRING 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: On 26 April 2023 the Assisted Decision-Making (Capacity) Act 2015 and the Assisted Decision-Making (Capacity)(Amendment) Act 2022 were commenced and the Decision Support Service came into operation.
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: 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
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 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
Read more: Matheson Insight: Pharmaceutical Legislation Reform Proposed by the EU