Key Contacts: Ronan Dunne – Partner |  Marie Kinsella – Partner

Welcome to this update from the Philip Lee Healthcare, Pharmaceutical and Life Science group in respect of the first quarter of 2024. Please get in touch if you would like to know more about what we have covered.

Contact details for our team members can be found at the end of this publication which covers:

  1. General Regulatory – EU
  2. General Regulatory – Ireland
  3. Global Insights
  4. Competition Law
  5. Data Protection
  6. Healthcare

1. Revision of the Existing European Medicines Agency Fee System (here).

Regulation (EU) 2024/568 was published in the Official Journal of the European Union on 14 February 2024.

The regulation revises the existing EMA fee system. It establishes a transition from a flat-rate to a cost-based EMA fee system, ensures the sustainability of the European regulatory network formed by the EMA and national competent authorities, provides a sound financial basis to support their operations, simplifies the existing legislation, and merges the content of the two current regulations for pharmacovigilance and non-pharmacovigilance fees into one single legal instrument.

Regulation (EU) 2024/568 entered into force on 15 February 2024 and will apply from 1 January 2025.

2. European Parliament and European Commission reach provisional agreement to ban all intentional uses of toxic mercury (here).

On 8 February 2024, the European Parliament and the European commission reached an agreement to prohibit the last intentional remaining uses of mercury in the EU including dental amalgam.

Dental amalgam is currently the largest remaining intentional use of mercury in the EU, but the Commission considers that there are now viable and safer alternatives that do not contain mercury.

3. European Commission proposes amendments to Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation including roll-out of EUDAMED (here).

On 23 January 2024, the European Commission proposed an amendment to the Medical Devices Regulation (the MDR) and the In Vitro Diagnostic Medical Devices Regulation (the IVDR). The changes proposed were to:

  • Further extend the transitional period for certain IVDs to comply with the requirements of the IVDR. High-risk (Class D) Devices having until December 2027 to comply, devices with high individual and moderate public health risk (IVDR class C devices) having until December 2028 to comply, lower risk devices (class B and A sterile devices) having until December 2029 to comply;
  • Speed up the launch of the European Database on Medical Devices (EUDAMED) which will contain information about all medical devices and IVDRs placed on the EU market.
  • Impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs.

On 21 February 2024, the Council of the European Union endorsed the Commission’s proposal to implement the above amendments to the MDR and the IVDR.

4. EFPIA Shows Concerns Over the Negotiations of the Text of the EHDS (here).

On 26 February 2024, the European Federation of Pharmaceutical Industries and Associations (EFPIA) expressed concerns about the ongoing negotiations regarding the text of the regulation establishing a European Health Data Space (EHDS). EFPIA had already shared concerns regarding the regulation in the preceding months (which we covered in our Q4 2023 newsletter).

It highlighted the rush shown by the European legislators to finalise the regulation before the upcoming European elections taking place in June. EFPIA urged legislators to take the necessary time to finalise the regulation to ensure the quality and robustness of the legal instrument forming the basis of EHDS creation.

Among its concerns, EFPIA presented the worry shared within the European health care ecosystem that the EHDS lacks the required level of legal certainty and consistency with the existing regulatory frameworks.

5. IMDRF SaMD Working Group Opens Public Consultation on Considerations for Device and Risk Characterisation for Medical Device Software (here and here).

On 2 February 2024, the Software as a Medical Device (SaMD) Working Group of the International Medical Device Regulators Forum (IMDRF) published a document titled “Medical Device Software: Considerations for Device and Risk Characterisation.” The guidance will apply to the subset of software that meets the definition of a medical device, as defined by the IMDRF.

The purpose of the guidance is to promote and inform clear accurate characterizations of medical device software and introduce a general strategy for characterizing software-specific risks that leverages the key features of a comprehensive medical device software characterization.

The IMDRF guidance is referred to in the EU Medical Device Coordination Group guidance and in the ongoing consultation on medical devices in the UK, and so the guidance, once finalised, is likely to have implications for the EU and UK approach to characterisation of medical device software.

6. Landmark Assisted Human Reproduction Legislation to commence Committee Stage in Dáil Éireann (here).

The Health (Assisted Human Reproduction) Bill 2022 has commenced Committee Stage in the Houses of the Oireachtas. The legislation will address retrospective surrogacy arrangements with the insertion of a range of new sections. 

This legislation will, for the first time in Ireland, introduce regulation on a wide range of assisted human reproduction practices undertaken in this jurisdiction, including gamete and embryo donation for assisted human reproduction and research; domestic altruistic surrogacy; pre-implantation genetic testing of embryos; posthumous assisted human reproduction; and embryo and stem cell research.

7. Doctors and patients are suffering mental harm as a result of Ireland’s slow and expensive litigation process, according to the Medical Protection Society (here).

A new Medical Protection Society (MPS) report states that a clinical negligence claim in Ireland takes an average of 1,462 days to resolve, 14 per cent longer than in South Africa (1,279 days) and 56 per cent longer than in Hong Kong (940 days), the UK (939 days) and Singapore (938 days).

The report, entitled “The human and financial cost of clinical negligence claims”, says patients and doctors in Ireland are dragged through what can be a brutal process, for longer than necessary, and patients are having to wait longer to receive compensation.

MPS also says the slow litigation process in Ireland, which is largely due to a lack of mechanisms to facilitate early resolution, is resulting in high legal costs. The average legal cost for an Irish claim managed by MPS is €34,646 which is 26 per cent more expensive than in Singapore (€27,449), and 191 per cent more expensive than in the UK (€11,911).

8. Supreme Court judgment provides clarity in secondary victim claims made in a clinical negligence context (here).

On 11 January 2024, the UK Supreme Court had the opportunity to consider the law on negligently caused psychiatric illness to secondary victims in its judgment relating to three cases: Paul v. Wolverhamptom NHS TrustPolmear and another v. Royal Cornwall Hospitals NHS Trust and Purchase v. Ahmed.

In summary, these clinical negligence appeals related to failures to diagnose and treat the life-threatening conditions of the patients (the primary victims), resulting in the unexpected death of the primary victims. The close family members of the primary victims (the secondary victims), though not injured directly by the defendant hospitals/doctors, claimed that they had suffered psychiatric injuries through the witnessing of the deaths of the primary victims or the immediate aftermath.

In the first instance in each respective case, the defendant applied to strike out the claim on the ground that, as a matter of law, the claim for damages for psychiatric injury cannot succeed. The Court of Appeal dismissed all the claims but granted permission to the claimants to appeal to the UK Supreme Court.

By a majority of six-to-one, the UK Supreme Court dismissed the three appeals as well. In coming to its finding, the UK Supreme Court drew a distinction between secondary victims who sustained an illness as a result of an ‘accident’, namely witnessing a death or injury of a family member by an external traumatic event, and as a result of a ‘medical crisis’, namely the death or injury of a family member from illness or disease.

The UK Supreme Court also found that while doctors owe a duty of care to their patients, this does not “extend to protecting members of the patient’s close family from exposure to the traumatic experience of witnessing the death or manifestation of disease or injury in their relative”. This decision will have a significant impact on the ability of secondary victims in UK clinical negligence claims to recover for psychiatric injuries.

9. UK Advertising Regulator Upholds Complaints Against Advertising of Two Digital Health Apps (here).

On 21 February 2024, the UK Advertising Standards Authority (ASA) issued rulings against two digital health app developers, finding that each app was marketed as a medical device without the requisite conformity marking. The ASA is responsible for enforcing the UK Code of Non-Broadcast Advertising and Direct & Promotional Marketing (CAP Code), a self-regulatory code governing consumer advertising in the UK.

The ASA held that the advertising for the Impulse Brain Training app implied that the app could diagnose Attention Deficit Hyperactivity Disorder (ADHD). Similarly, the ASA found that the advertising for the Happyo app amounted to claims that it could diagnose and treat ADHD, as well as alleviate the symptoms of ADHD. As such, the respective claims were medical claims that presented each app as a medical device despite the apps not having the appropriate conformity marking. The ASA also held that the advertising for each app breached the CAP Code provision that advertisers must not discourage consumers from seeking essential treatment for a condition for which medical supervision should be sought.

10.Competition and Consumer Protection Commission approves merger of Lloyds Pharmacy and McCabes Pharmacy subject to commitments (here).

Lloyds Pharmacy currently operates 82 retail pharmacies across the State. McCabes Pharmacy comprises a portfolio of 31 retail pharmacies in Ireland, which are primarily located in the Dublin/Leinster region.

The Competition and Consumer Protection Commission (CCPC) cleared the purchase of McCabes Pharmacy by Lloyds Pharmacy following a Phase 2 investigation.

The CCPC was particularly concerned about the impact of the deal on the level of competition in the Lucan area of Dublin and how this could potentially impact customers. 

The deal was cleared subject to various commitments including a commitment to sell two of the pharmacies in the Lucan area to a third-party buyer, the identity of whom must be approved by the CCPC.

11. Pharmaceutical Sector Remains Key Area for EU Antitrust Enforcement (report – here).

The European Commission has published a report on competition law enforcement in the EU’s pharmaceutical sector during the 2018-2022 period. The report, released on 26 January, provides detailed insights into the actions taken by the Commission and national competition authorities (NCAs) to tackle claimed anti-competitive conduct and their approach to M&A transactions that raise competition concerns.

The Commission’s report shows that effective enforcement of EU competition rules in the pharmaceutical sector remains a matter of high priority for the Commission and NCAs. European competition authorities will continue to monitor and be pro-active in investigating potential anti-competitive situations as they continue to adapt to the sector’s continuous changes and evolutions. Pharmaceutical companies therefore need to remain alert to the impact of competition law developments on their operations and build effective compliance structures into their commercial strategies. Companies planning transactions should be prepared for rigorous scrutiny by the Commission, in particular in respect of the innovation-related aspects of transactions, and should consider potential competition issues at an early stage of their transaction planning (factoring in the increased risk of case referrals).

12. The EU Data Act and Digital Health (here).

On 11 January 2024, the EU Data Act (Regulation (EU) 2023/2854) entered into force, putting into place new rules for the fair access to and use of data. This will have an impact on those in the digital health sector when it applies from 12 September 2025.

The Data Act is a key pillar of the EU Data Strategy. It will operate alongside the EU Data Governance Act and sectoral legislation to develop common European data spaces such as the European Health Data Space. The goal of the Data Act – and the wider EU Data Strategy – is to facilitate reliable and secure access to data, fostering its use in key economic sectors and areas of public interest.

Any connected Internet of Things (IoT) device or wearable that obtains, generates or collects data of the person using the wearable, or regarding their environment, will be under the scope of the Data Act.

Medical and health devices are expressly mentioned and most digital health stakeholders, such as manufacturers of software medical devices and wearables, as well as suppliers of related services, will be subject to the Data Act where the product or service is placed on the market in the EU.

13. Proposal for a Regulation on the European Health Data Space (here).

Following the meeting of the Permanent Representatives Committee on 22 March 2024, there was an endorsement of the final compromise text of the European Health Data Space regulation with a view to agreement. Delegations were informed that the Presidency sent a letter to the Chairs of the European Parliament Committees on Environment, Public Health and Food Safety (ENVI) and on Civil Liberties, Justice and Home Affairs (LIBE).

The European Health Data Space is a proposal to set up a health data ecosystem that empowers individuals and supports research, innovation and policy making. It aims to ensure secure access, exchange and reuse of health data across the EU. The proposed regulation will:

  • Support individuals to take control of their own health data,
  • Support the use of health data for better healthcare delivery, better research, innovation and policy making, and
  • Enable the EU to make full use of the potential offered by a safe and secure exchange, use and reuse of health data.

14. Mater Private hospital group fails in appeal over €6.6m shortfall in €53m paid by HSE to make facilities public during Covid​​​​​​​​​​​​​​​​​​​​​​​​​​​​ (here).

The Court of Appeal has dismissed an appeal over a dispute related to an alleged €6.6 million shortfall in some €53.7 million paid by the Health Service Executive (HSE) for the Mater private hospital group to make its facilities publicly available during the Covid-19 pandemic.

The Court of Appeal upheld a decision by the High Court that Oval Topco Ltd and its operating firms had to repay to the HSE €673,000 for interest on loans held by the private hospital company.

The court also ruled they were not entitled to some €830,600 for depreciation and dismissed the remainder of Oval Topco’s monetary claim.

Oval Topco, whose parent is Luxembourg firm Oval Healthcare Infrastructure Sarl, acquired the hospitals in the Mater group for €603 million in 2018. Oval Healthcare is in turn majority owned by InfraVia IV Invest Sarl and by Oval Co-Investment Fund SCSp.

15. HPRA statement – Ruling of Justice O’Brien against Anne Rossi in case involving the unauthorised supply of the medicinal product botulinum toxin (brand name Dysport) (here).

In the Circuit Court, Justice O’Brien found Anne Rossi guilty on four charges of keeping for supply and four charges of placing on the market the unauthorised medical product Dysport from her business premises on dates in 2014 and 2015, contrary to the Medicinal Product Regulations. Dysport contains Botulinum Toxin 3TypeA, commonly known as Botox, a prescription only drug.

Justice O’Brien dismissed an appeal brought against an earlier decision of the District Court and instead affirmed that decision. Ms Rossi was convicted on all charges, and fined €1,000 on each charge with six months to pay. The judge noted the agreement of costs totalling €5,170 which must be paid within eight months.

Commenting on the ruling, Dr Lorraine Nolan, Chief Executive, the HPRA, said:

As demonstrated by this case, to protect consumer health, the HPRA will diligently pursue those involved in the illegal supply and promotion of medicines including those medicines that contain botulinum toxin. Prosecutions are progressed where it is considered that the illegal activity poses significant risk to public health. Medicines that contain botulinum toxin are prescription-only medicines. It is illegal to supply these without a prescription.

The HPRA’s ongoing enforcement activities reflect a growing trend where certain individuals offering aesthetic services may be operating outside the law by providing prescription medicines without a prescription. In such cases, they aim to take commercial advantage of consumers. Their primary concern is financial gain – not the health of consumers availing of these services. The HPRA welcomes any information relating to the potential illegal supply, administration and advertising of prescription-only medicines.”

16. European Commission Communication on boosting biotechnology and biomanufacturing (here).

On 20 March 2024, the European Commission adopted a Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU.

The Communication aims to unlock the full benefits of biotechnologies and biomanufacturing, which the Commission believes are crucial for the competitiveness and modernisation of EU industry and offer high growth and productivity potential.

The Communication also summarises the current challenges and barriers for biotechnology and biomanufacturing and proposes actions to address these challenges in a timely manner, in line with the Communication on the Long-term competitiveness of the EU. It also explores ways to foster engagement and collaboration, including through international dialogue and cooperation.