Key Points
- At a European Union level, we discuss the status of the EU Pharmaceutical Package published in 2023, as well as the Regulation on the European Health Data Space, which is now in force. The Competitiveness Compass, Proposal for a Critical Medicines Act, and Health Technology Assessment Regulation are also reviewed.
- We look at some recent developments in relation to medical devices.
- In Ireland, the Irish Government's commitment to a National Life Sciences Strategy is considered; reimbursement is once more in the spotlight; digital health records look set to be legislated for, and finally, we look at the position on prescription regulation in Ireland, looking at mail order supply and cross-border operating models.
2024 saw elections which led to a new European Commission and a new Irish Government. With these new administrations both in place, the last number of months have seen much activity in terms of EU and domestic life sciences policy, signposting that we are heading into a period of intense activity in the sector. On the legislation front, these elections put the progress of some reforms on pause, but these are expected to pick up pace once more. All of this activity is set against an unsettling backdrop of the potential introduction by the US administration of tariffs, drug pricing reform, and cuts to research funding. In this piece, we take stock of some of the areas in focus.
European Union
EU PHARMACEUTICAL STRATEGY
Progress remains to be made on the EU's Pharmaceutical Strategy, first published in April 2023 and the trilogue stage is now underway, with the Council of the EU adopting its mandate for negotiations in early June. See more in our briefing: EU Pharma Package - Trilogue Negotiations Commence.
HEALTH DATA
Political agreement was reached on the European Health Data Space Regulation ("the EHDS") in January of this year, with this coming into effect at the end of March. Parts of it will start to apply by March 2027, with some not applying until 2029, 2031 and 2035. This Regulation implements the European Commission's proposal in its 2020 communication "A European Strategy for Data" and creates the first sector-specific common data space in the form of the European Health Data Space. It is intended to specify and complement the rights laid down in the General Data Protection Regulation.
The Regulation aims to improve individuals' access to and control over their electronic health data ("EHD") within their electronic health record ("EHR"). The definition of "primary use" of EHD is broad and includes healthcare provision and assessment, and the provision of medicinal products and devices. The Regulation grants rights to immediate access to one's personal, priority-category EHD, such as patient summaries, electronic prescriptions and medical test results, and to cross-border data portability. The Regulation also establishes a governance framework for the "secondary use" of EHD in areas including research, innovation and policymaking, with implications for industry.
Given that there is a particularly technical element to the preparation phase, we can expect to see further guidance from the European Commission and Member States as to associated practical measures, by way of implementing acts and domestic regulations. We cover this more in our briefing: The European Health Data Space Regulation – What Digitalising EU Health Data Means for Industry.
COMPETITIVENESS COMPASS
The European Commission published the Competitiveness Compass in January 2025. Leveraging off the findings of the 2024 Draghi Report, the Compass (which is thematic and cross-sectoral in nature) aims to turn to action and to set out "a compass that will guide the work in the coming five years and lists priority actions to reignite economic dynamism in Europe".
THE CRITICAL MEDICINES ACT
The Act was published in March by way of legislative proposal: a Critical Medicines Act and EU Biotech Act were both identified as political priorities for the second von der Leyen Commission and the Compass publication underscores this. In particular, the EU's Biotech Act and Life Sciences Strategy are "Flagship Pillar 1" actions spanning this year and next. The first quarter of 2025 also saw the announcement of an EU Biotech and Biomanufacturing Hub. This is intended to support companies – particularly start-ups and SMEs - in bringing innovative products to the EU market and increasing their competitiveness. Whilst it was announced at the end of March 2025 that the EU's proposed Biotech Act will now be presented in 2026 and not 2025, the feedback process is underway and matters are progressing. These initiatives are all geared towards strengthening the EU's position in both the biotech and pharma sectors.
HEALTH TECHNOLOGY ASSESSMENT REGULATION
(EU) 2021/2282 on Health Technology Assessment Regulation (the "HTAR") entered into force in January 2022 and became applicable as of 12 January 2025. Since 2022, preparatory work has been ongoing for the commencement of joint health technology assessment work, as provided for by the HTAR. The HTAR provides for joint clinical assessments and joint scientific consultations using a common framework of procedures and methodologies across the EU. It will only cover the clinical aspects of the assessment, and will not make any economic assessment or conclusion on pricing and reimbursement. We cover this more in our briefing: Health Technology Assessment Regulation – Applies as of 12 January 2025.
EU LIFE SCIENCES STRATEGY
As announced in the Competitiveness Compass, a public consultation took place on the upcoming "Strategy for European Life Sciences", concluding in mid-April. The strategy is expected to be adopted later in 2025.
MEDICAL DEVICES
January saw an important obligation to notify supply issues commence, which we discuss more in our briefing: Medical Devices Regulations – obligation to notify supply issues commences on 10 January 2025.
We take a look at some recent EU developments in relation to medical devices in our briefing: EU Medical Devices – Current Developments.
What happens following the recent EU Commission consultation on the Medical Devices and In Vitro Diagnostic Medical Devices Regulations will likely be the most significant development on the horizon.
Ireland
NEW GOVERNMENT SETS OUT COMMITMENTS FOR LIFE SCIENCES
With the publication of the Programme for Government ("the Programme"), flowing from negotiations between the coalition partners returned following Ireland's recent General Election, we saw a likely roadmap ahead for the Irish life sciences and healthcare sector for the next five years.
Notably, there is a commitment to the development of a new National Life Sciences Strategy to ensure that the sector remains competitive and to ensure the Government develops a coherent and ambitious approach to future opportunities.
With a broad pledge of accessible, affordable and high-quality healthcare for all, the Programme states that the new Government will be committed to ensuring that patients can access new innovative medicines and new treatments "as quickly as possible." There are a number of assurances here which will be of interest to all stakeholders. These include a promise to increase the number of clinical trials; a commitment to a review of the drugs reimbursement process (as well as a stated aim to investigate new methods for earlier reimbursement of certain treatments, to include early access schemes for rare diseases); and an assurance of working towards a more co-ordinated approach at a European level.
PRICING AND REIMBURSEMENT
The agreement between the members of the Irish Pharmaceutical Healthcare Association, the Department of Health and the Health Service Executive for the supply and pricing of medicines concluded in 2020, is set to expire later this year. There is a standalone commitment in the Programme to implementation of the Mazars Review, published in February 2023 which contained recommendations to ensure the approval process is more effectively resourced in the Programme – these have since been worked through by an implementation group set up by the then Minister for Health and which have gone through several rounds of stakeholder consultation.
A NEW ERA FOR DIGITAL HEALTH IN IRELAND?
Aligned with the EU's EHDS, healthcare digital transformation is a policy strand for the new Irish Government. In addition, the HSE's 2024 Digital Health Strategic Implementation Roadmap cited the EHDS as a key driver for developing Ireland's digital health framework, aligning Ireland internationally to facilitate the joint policy and implementation effort that is required to deliver against the roadmap.
The Health Information Bill 2024
The Health Information Bill 2024, which had previously lapsed with the Dáil's dissolution for the general election in late 2024, is now progressing once more through the legislative procedure. This aims to establish the grounds for patient data sharing and Digital Health Records. While, unlike the EHDS, its focus is on primary use of health records only and not secondary use, the Health Information Bill will support Ireland's obligations in relation to the EHDS and represents an initial legislative step in preparing for this regime. HealthData@IE is the national implementing project which is currently collaborating with the Department of Health, Health Information and Quality Authority and Health Research Board, to create the infrastructure needed for the EHDS and the creation of Ireland's Health Data Access Body.
HSE Telehealth Roadmap
EHealth Ireland has recently published the HSE Telehealth Roadmap 2024-2027 (the "Telehealth Roadmap") to improve population health outcomes through facilitating increased accessibility to and quality of digital health supports and services. The Telehealth Roadmap identified three methods through which telehealth delivers virtual care to patients in Ireland, comprising remote consultations and care, remote health monitoring, and online supports and therapies.
Electronic Prescriptions
The introduction of electronic prescriptions in Ireland represents a significant development in the provision of digital health services. Although secure e-prescribing was introduced by the Irish Government as a temporary measure in response to the Covid pandemic, we are not aware of any plans to change this. While delivery of prescriptions to pharmacies electronically is a positive development, the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020 (as amended) (the "Regulations") remain relatively restrictive in their application. Accordingly, where online platforms are proposing to deliver local or cross-border telehealth services involving Ireland, the Regulations require careful consideration.
Given the rapid growth in online platforms offering one-stop-shop digital health services across multiple jurisdictions, and in line with e-prescribing restrictions, providers should be aware of the prohibition on mail order supply of prescription-only medicinal products in Ireland and should seek advice on how best to mitigate any risk of supplying medicines by mail order in contravention of the Irish Prescription Regulations.
What's Next?
The backdrop of a new US administration and the shifting trade and geopolitical ramifications cannot be ignored in the life sciences sector. However, the EU and Irish developments looked at in this piece are a clear indicator of the direction of travel on this side of the Atlantic, and there is a real focus in terms of a joined-up approach across the EU bloc when it comes to matters such as joint clinical assessment and health data. The proposed Strategy for European Life Sciences only serves to underscore this cohesive approach. Whilst the final texts of the EU's two legislative proposals under the Pharmaceutical Package are not yet settled, the legislation continues to be keenly monitored by the innovative pharmaceutical industry.
Locally, the promise of a National Life Sciences Strategy is a welcome step. It is worth noting that at this point in time, the position in terms of Ireland's participation in the Unified Patent Court remains unresolved. It seems as though both Ireland and the European Union look set to usher in a new digital health era. Pricing and market access, leading to faster access by patients to treatments, remain a priority area of interest for all stakeholders.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.
