Welcome to the first issue of 2025 of our Healthcare Sector Update series. In this issue, we examine a selection of topics and trends impacting our clients during the course of the coming year.
First up, Kate Moloney and Aislinn O’Shea explore the challenges of calculating general damages in medical negligence cases involving multiple injuries. They examine recent case law, assess different approaches, and provide key insights into this complex area.
Some of our featured articles include:
• Shaping the Future of Irish Nursing Homes - What’s Ahead in 2025?
• Speak Up at Trial to Protect Your Appeal
• Batteries Regulation in MedTech
• Prescription Medicines and the GDPR
• The Government’s View of Aged Care in Ireland
Should you wish to discuss these topics or any other issues impacting your organisation, please reach out to a member of our Healthcare Sector team.
Key Contacts
Robert Dickson Partner, Healthcare Sector Lead rdickson@mhc.ie
Catherine Allen Partner, Head of Public, Regulatory & Investigations callen@mhc.ie
Contact our Healthcare Sector team
Calculating Damages for Multiple Injuries Under the Personal Injuries Guidelines
Aislinn
O’Shea Senior Associate, Medical Law
+353 86 851 7573
aoshea@mhc.ie
The Personal Injuries Guidelines set out ranges of monetary sums or damages for compensating certain categories of injury. The process of determining the level of compensation is usually simple where just one injury is sustained. However, many cases can involve multiple injuries. This is particularly true in medical negligence claims. The cornerstone of the Guidelines is to ensure plaintiffs are ‘fairly and justly compensated’ by an award which is ‘proportionate and just’.
Computing the ‘uplift’
When assessing multiple injuries, it is necessary to identify the “dominant injury” and its suitable level of damages under the Guidelines. Once the dominant injury is determined, the other “nondominant” injuries are considered. The Court will then apply an “uplift” to the value of the dominant injury to reflect the impact of the other injuries sustained by the claimant.
Recent High Court and Court of Appeal judgments have illustrated that this is not a settled science.
Mr Justice Coffey in a case entitled Lipinski v Whelan quantified damages for the dominant injury. The judge then applied a further cumulative uplift regarding other injuries sustained, without providing a breakdown of the level of damages allowed for each of the non-dominant injuries.
In a separate case, McHugh v Ferol, an overall discount was applied to the total value of the nondominant injuries to reflect the temporal overlap of the injuries.
Kate Moloney Associate, Medical Law
+353 86 601 2836
kmoloney@mhc.ie
In this instance, the Court did provide a breakdown of the level of damages allowed for each of the nondominant injuries. More recently, in O’Sullivan v Ryan, varied discounts were applied from the outset to the level of damages for each of the non-dominant injuries to reflect that some injuries shared the same temporal period, while the effects of others lasted beyond it.
Other matters to bear in mind when computing damages for multiple injuries
‘Reality check’
The Court of Appeal in Zaganczyk v John Pettit Wexford Unlimited Company emphasised that there should be a comparison of the overall award to other individual categories set out in the Personal Injuries Guidelines. If the total award exceeds the value of an award for a more serious injury, that should act as a “reality check” and trigger a recalculation to ensure the award is proportionate. The Court of Appeal reduced the total general damages from €90,000 to €60,000 for a post-traumatic stress disorder (PTSD) dominant injury. It noted that severe neck injuries, which may require spinal fusion and involve significant permanent disability, are valued between €70,000 and €100,000 under the Personal Injuries Guidelines, and this acted as a reality check.
Where the cumulative effect of the injuries is worse than an individual injury
In Keogh v Byrne, the High Court emphasised that applying an uplift is secondary to the trial judge’s duty to “fairly and justly” compensate the plaintiff for all injuries. The award must remain “just and proportionate.” This requires the judge to step back from assessing individual injuries and their assigned values to holistically evaluate the cumulative impact on the plaintiff. In certain cases, the combined effect of multiple injuries may be more severe than the sum of each injury alone. The example provided is where a plaintiff suffers injuries to both eyes resulting in total blindness.
Comparison of different methods of computing damages for multiple injuries
From these judgments, it is apparent that there is not one simple formula that can be used for the calculation of damages of multiple injuries. Generally, the dominant injury is identified, and an uplift is applied for the non-dominant injuries. The Courts have used different methods when calculating an uplift:
• By making a deduction from the damages that are tallied for the non-dominant injuries, or
• By making an initial deduction to each of the non-dominant injuries
In these scenarios, the deductions can be expressed as a percentage or by a specified sum. Available to download here is a helpful quick reference guide, which provides a comparison of some of the methods used by the Courts.
Conclusion
Although different methods of adjustment exist, the Courts have noted that they hold little practical significance, as long as the final award of general damages is calibrated to ensure overall fairness and proportionality in compensating a person who has sustained multiple injuries. There may be additional methods employed by the Courts, particularly in cases where multiple dominant injuries exist, and it is difficult to determine which is the most significant — a common scenario in medical negligence claims. In addition, the Guidelines do not cover all complex injuries, such as damage to organs or vessels, frequently encountered in treatment for underlying medical conditions or injuries. It remains to be seen how the Courts will address multiple injuries in future medical negligence cases, and we await further developments with interest.
For more information and expert advice on defending claims, contact a member of our Medical Law team.
Shaping the Future of Irish Nursing Homes
Key 2024 trends and what’s ahead in 2025
Eimear Lyons Partner, Corporate +353
86 804 7749
elyons@mhc.ie
While the seeds of change were sewn in the Irish nursing home sector in 2024, it is hoped that 2025 will see the most significant changes for the last number of years. In this article, we will reflect on the market shifts that came to define the sector in 2024. These trends have shaped key policy developments that now form the foundation of legislative reforms in the sector. However, these reforms also bring new responsibilities and obligations for providers.
Financial pressures
In recent years, the escalating cost of care for nursing homes was the dominant theme in the sector and several facilities closed. It has been reported that operational costs surged 36% since 2017. In addition, providers are now facing further financial pressure with the increase in the national minimum wage to €13.50 from 1 January 2025. Providers also need to contend with the new statutory sick pay entitlements. While Fair Deal rate increases offer some relief, many nursing homes continue to struggle with increased costs.
Enhanced and expanded regulation
As we discussed previously, the Government legislated actively throughout 2024. The Health Information and Quality Authority (HIQA) was expanded considerably with the introduction of the Health (Miscellaneous Provisions) (No. 2) Act 2024.
Among other changes, this Act extended greater power to HIQA to inspect, gather and investigate information related to suspected breaches of the Health Act 2007 by providers. It also empowers HIQA to issue compliance notices to providers, directing them to cease breaches of the Health Act 2007 or face liability for a criminal offence. Towards the end of 2024, the Health Act 2007 (Care and Welfare of Residents in Designated Centres for Older People) Regulations 2013 were amended with the addition of further regulations. Among other things, these regulations copper-fastened fundamental rights of residents on issues such as visitation and the facilitation of communication with family members.
Looking to 2025, we can expect further shape to be put on the Department of Health’s Design Guide for Long-Term Residential Care Settings for Older People. As we discussed previously, the Design Guide is at draft stage pending further updates to reflect changes from the public consultation held last year. The Design Guide will provide HIQA with the ability to assess the development plans of new residential care settings or adaptations to existing ones. HIQA is permitted to insist on recommendations for interior design, bedroom layout, communal areas, infection control and staff areas.
Cost of compliance
The financial blow for providers of compliance with the reforms is partially cushioned by the development of some initiatives in the sector. For example, the Resident Safety Improvement Scheme allowed providers to apply for a state grant in 2024 of up to €25,000 for permitted works contributing to resident safety. Skills development across staffing was identified by the Department of Health with the provision of new funding for a postgraduate course specific to nursing home care. Additionally, the Minister for Health announced in the 2025 Budget €1.223 billion to support the Fair Deal Scheme, an increase of 5.3% as compared to 2024. A further €10 million was provided to support compliance with certain Regulations.
Industry groups such as Nursing Homes Ireland (NHI) engaged heavily with the Irish Government to address the deficiencies in the Fair Deal Scheme. The “It’s Not Fair – Save our Nursing Homes” campaign further increased the pressure on the Government to assess whether the scheme, introduced in 2009, is still fit for purpose. While it is reported that there has been a 6.6% increase in the national average Fair Deal rate in 2024, up 1.1% on 2023, there is a still a lot of work to do to address the deficiencies in the scheme. The pricing model has not kept pace with rising operational costs. We await further developments in this regard.
Comment
2024 was no doubt a challenging year for the nursing home sector in Ireland due to several notable trends. Systemic issues, such as deficiencies in the Fair Deal Scheme, continue to hamper the sector. However, challenges like operating costs, local authority rates, and staff shortages are less entrenched and can be addressed through effective collaboration between the Government and the sector. The Government demonstrated an appetite last year to push through regulatory and legislative change and it is hoped that this trend will continue in 2025.
Reform and financial support, combined with an improving economic outlook driven by falling interest rates and inflation, are fuelling renewed confidence in the sector’s rebound in 2025. While consolidation stabilised in 2024, optimism is building for the year ahead, as growth is expected to be driven by increased investment, further consolidation, and the entry of new providers. For more information and expert advice on navigating expanded compliance obligation in this sector, contact a member of our Healthcare Sector team.
Speak Up at Trial to Protect Your Appeal Rights
Katie McAuliffe Senior Associate, Healthcare
+353 86 851 7573
kmcauliffe@mhc.ie
The Court of Appeal dismissed the appeal of patient Caitriona Crumlish against a High Court decision in favour of Letterkenny University Hospital (the Hospital).1 Mrs Crumlish alleged the Hospital failed to diagnose her breast cancer causing a five month delay in diagnosis. The Court of Appeal decision provides helpful insights for legal practitioners on when to make procedural complaints during a trial and on the Court’s consideration of expert evidence.
The High Court decision
The High Court claim 2 arose out of an alleged failure on the part of the Hospital to detect and diagnose Mrs Crumlish’s breast cancer when she attended a symptomatic breast clinic in May 2017. She was advised the lumps were cysts. Mrs Crumlish was not diagnosed until five months later at her second visit to the clinic in October 2017. While the High Court accepted the cancer was present in May 2017, Mrs Crumlish did not prove her cancer was detectable at that time, so the Court found there was no delay in diagnosis.
Notably, the High Court found Professor Bundred, consultant surgeon retained as an expert witness for Mrs Crumlish, was biased. Professor Bundred estimated the size of the cancer in May 2017 by unjustifiably selecting a 45 day period for the cancer to double in size.
1. Caitriona Crumlish v HSE [2024] IECA 244
2. Catriona Crumlish v HSE, High Court, Record No. 2020/553P
3. Age-Dependent Growth Rate of Primary Cancers – Peer et all, 2003
Áine Hogan Senior Associate, Medical Law
+353 86 048 1933
ahogan@mhc.ie
This would mean the tumour size would neatly match the May 2017 lump size. He did this based on a paper 3 which estimated that a tumour doubles between 44 and 147 days, but he did not include this range.
The Court decided that Mrs Crumlish did not prove that the lump detected in May 2017 was a cancer based on a 45 day tumour doubling time. It was more likely that the reporting radiologist’s report of the breast imaging in May 2017 was accurate and that a 12mm cyst caused the lump. As there was no delayed diagnosis, there was no need for the Court to determine whether Mrs Crumlish’s care at the Hospital was negligent or not.
We previously reported on and analysed the High Court decision here
The Court of Appeal decision
Mrs Crumlish appealed the case on 68 grounds, which was strongly criticised by the Court of Appeal. The Court directed Mrs Crumlish to distil down the grounds of appeal, resulting in seven grounds.
Notably, at the start of the trial Mrs Crumlish told the Court she was no longer relying on Professor Bundred’s expert evidence. In essence, she complained that:
• The Hospital’s defence of the claim was not properly or fairly conducted, and
• The judge had erred in her treatment of the expert evidence.
The Hospital’s defence of the claim was not properly or fairly conducted:
1. Mrs Crumlish claimed the Hospital’s real defence was that she developed an interval cancer and this was not pleaded by the Hospital.
2. A surgeon at the clinic gave opinion evidence on radiological issues which was outside of the area he was supposed to comment on.
3. The Hospital’s defence to the claim was not put to Mrs Crumlish on the stand.
4. The Hospital’s true defence was not disclosed until the end of the trial when a defence expert, Professor Crown, gave evidence on the interval cancer.
The Court dismissed these grounds and made some observations on how these types of procedural complaints ought to be dealt with at trial:
• The Court found it was clear that the Hospital asserted that there was no detectable cancer on the first occasion in May 2017. So, the Hospital’s case could not be described as anything other than a plea of interval cancer, though not expressly called that in the pleadings.
• The Court said the credibility of a witness was a matter for the trial judge and that a Court of Appeal would rarely find that a trial judge erred in their assessment of a witness’s credibility.
• Regarding points 2, 3 and 4 above, the Court said the proper remedy is to raise these issues during trial.
• It would have been possible to apply for an adjournment to allow the Hospital to amend its Defence. Mrs Crumlish could have sought her costs on the basis the Hospital didn’t properly plead its case. This was not done so Mrs Crumlish cannot complain that unfairness arose which requires a retrial
The judge erred in her treatment of the expert evidence:
The High Court judge dismissed the evidence of Mrs Crumlish’s expert Professor Bundred on tumour doubling time as being biased. On Appeal, Mrs Crumlish claimed the High Court ignored the other evidence from other experts on tumour doubling time. The trial judge had ruled that expert evidence from more than one expert in a particular field of expertise is inadmissible.
Usually, a party is only allowed to rely on one expert in a particular field of expertise to comment on a particular issue. Interestingly the Court of Appeal found that Mrs Crumlish was correct on this point and experts in different disciplines can comment on each other’s evidence as long as they are speaking on an issue within their own expertise. The Court of Appeal found the trial judge did consider all the relevant evidence in any event but preferred the Hospital’s evidence over that of Mrs Crumlish.
Key takeaways
• Procedural complaints should be raised during a trial and a remedy sought then, not afterwards, on appeal.
• If a witness gives evidence during trial that has not been pleaded, an adjournment should be sought to allow pleadings to be amended.
• The Court of Appeal will rarely challenge a High Court decision on the credibility of a witness, as the High Court judge has the benefit of hearing their evidence firsthand.
• If witnesses give evidence outside their particular field of expertise, and this is not objected to during trial, a judge may still consider this evidence.
• Grounds of appeal should be kept brief or the party appealing could be penalised when it comes to Court of Appeal costs.
Comment
The important takeaway from the Court of Appeal decision is to pick the right battles on trial conduct during the course of a trial, rather than waiting to appeal. Parties should be willing to seek a remedy from the trial judge in real time, by seeking a ruling or an adjournment or other direction to remedy a grievance. In addition, any evidence given by experts outside of their field of expertise should be objected to, or the Court will have to consider it. This may complicate matters when the trial judge is weighing this evidence against the evidence from the primary witness in that field of expertise. This Court of Appeal decision demonstrates the importance of taking action at trial. If parties fail to raise their concerns at trial, they risk losing their chance to address those issues on appeal.
For expert legal advice regarding the defence of negligence claims, contact a member of our Medical Law team.
Batteries Regulation in MedTech
Navigating the new compliance landscape
Jay Sattin Partner, Planning & Environment Law
+353 86 078 8295
jsattin@mhc.ie
The importance of batteries to medical technology cannot be overstated. Implantable medical devices are powered by batteries. Substantial volumes of other medical equipment also rely on batteries either as their main or back-up power source.
The EU Batteries Regulation aims to ensure that batteries on the EU market are sourced and manufactured in a sustainable manner. The Regulation sets out, amongst other things, rules on the sustainability, performance, safety, collection, recycling and second life of batteries.
It is important that manufacturers, importers, distributors, or any person placing batteries on the EU market or putting them into service are aware of their obligations under the Regulation. While the Regulation applies to all battery categories, this article focuses on its implications for producers of “portable batteries,” which are most commonly used in medical devices.
In-scope batteries
Broadly speaking, a battery includes nonrechargeable or rechargeable battery cells or packs of them, as well as batteries that have been re-used, repurposed or remanufactured. Portable batteries must be sealed, weigh 5kg or less, and not be a different category of battery covered by a separate provision of the Regulation.
David Foy Associate, Planning & Environment Law
+353 86 167 3086
dfoy@mhc.ie
The Regulation also applies to certain types of ‘battery management systems’, which control certain functions within a battery.
Producers
The Regulation uses the term ‘producers’ to describe persons who have obligations under the regime. The term ‘producer’ includes:
• Manufacturers
• Importers
• Resellers, and
• Distance sellers
Many of the obligations become applicable at the point the batteries are first placed or put into service on the EU market. This extends to producers of medical devices that incorporate batteries. However, if a producer places batteryoperated medical devices on the market without the batteries being incorporated into the device at the time it is placed on the market, they may not have obligations under the Regulation. Instead, the obligations would apply to the battery producer that separately places the required battery on the market. If, on the other hand, a producer of a medical device incorporates a third-party’s battery into the device, the producer of the medical device may have obligations under the Regulation.
Obligations on producers
The primary obligation under the Regulation is that batteries placed on the market or put into service shall not present a risk to:
• Human health
• Safety of persons
• Property, or
• The environment
However, the Regulation provides more specific obligations regarding ‘sustainability and safety requirements’ and ‘labelling and information requirements’. We summarise some of these requirements for portable batteries that may be of interest to producers of medical technology.
1. Restrictions on substances
The use of certain substances in the production of batteries is restricted. The Regulation provides that batteries shall not contain more than 0.0005% mercury, 0.002% cadmium, and 0.01% lead, measured by weight. Further restricted substances are set out in Annex XVII of Regulation 1907/2006 and in Article 4(2)(a) of Directive 2000/53/EC. This restriction is in effect.
2. Performance and durability requirements
Portable batteries for general use, excluding button cells, must meet minimum values for the electrochemical performance and durability. These parameters are set out in Annex III of the Regulation. The minimum values will be set out in a delegated act to be adopted by the Commission by no later than 18 August 2027.
The parameters to which the minimum values will apply include things such as rated capacity, resistance to unplanned escape of material, and the capacity a battery can deliver under specific conditions.
This obligation will apply from 18 August 2028. However, this date could potentially be pushed by the Commission in a delegating act.
3. Removability and replaceability of portable batteries
Portable batteries incorporated into products must be readily removable and replaceable by the enduser at any time during the lifetime of the product. This only applies to entire batteries and not to individual cells or other parts included in portable batteries.
A portable battery is considered “readily removable by the end-user” if it can be removed from a product using commercially available tools. Specialised tools are not required, unless they are provided free of charge with the product. However, there is an exemption for appliances including “professional medical imaging and radiotherapy devices” and “in vitro diagnostic medical devices”.
Although this requirement is in effect, the Commission will ultimately publish guidelines so that there is a harmonised approach on its application throughout all Member States.
4. Labelling and marking of batteries
Batteries must bear a label containing the general information set out in Part A of Annex VI. This information includes things such as details on the manufacturer, date of production, and battery information. This obligation will apply from 18 August 2026. However, this date could potentially be pushed out by the Commission in a delegating act. In addition, all batteries must bear the “crossedout wheelie bin” symbol from 18 August 2025. This indicates that batteries are to be disposed of in a separate waste stream to regular waste.
5. CE marking
The Regulation establishes a framework for conformity assessment procedures for batteries. Battery manufacturers are required to prepare a declaration of conformity in electronic format since 18 August 2024.
This document must be provided in the language(s) specified by each Member State where the batteries are being marketed. By drawing up the declaration of conformity, the manufacturer assumes responsibility for the compliance of the battery with the requirements laid down in the Regulation. It is not sufficient to simply add the Regulation to an existing declaration of conformity.
Conforming batteries must be visibly, legibly, and indelibly marked with the CE marking before the battery is placed on the market. If it is not practically possible for the marking to be on the battery, then the marking must be on any packaging and documents accompanying the battery. The general rules on how to affix the CE marking to a product, including portable batteries, are available in the Commission’s Blue Guide on the implementation of EU Product Rules 2022
6. Management of waste and producer responsibility
Producers of portable batteries must ensure that all waste portable batteries are collected separately from other waste. This requires producers to:
• Establish a waste portable battery take-back and collection system
• Collect, free of charge, the waste portable batteries collected at collection points, and
• Ensure that the waste portable batteries collected are subject to treatment in a permitted facility by a waste management operator
Producers of portable batteries must attain, and maintain on an ongoing basis, at least the following collection targets for waste portable batteries:
• 45% by 31 December 2023
• 63% by 31 December 2027, and
• 73% by 31 December 2030
7. Due diligence and risk management
Producers having a net annual turnover of €40 million or more have additional obligations under the Regulation. These producers are referred to as “economic operators”. Economic operators must implement battery due diligence policies from 18 August 2025. These policies must be third-party verified. The Commission is to publish guidelines on the requirements of due diligence policies by 18 February 2025.
Comment
In addition to the provisions already in force, the many other provisions of the Regulation will come into force on a gradual, phased basis over the next 12 years or so. The European Commission and Member States will implement secondary legislation to give full effect to the Regulation.
Specific obligations for manufacturers, importers and distributors of batteries are set out in Articles 38, 41, and 42 of the Regulation. Broadly speaking, they are required to ensure compliance with the other provisions of the Regulation.
For more information on the impact of the Regulation on your operations, contact a member of our ESG or Environment teams.
First Commencement Order Made for the Charities (Amendment) Act 2024
Alice Murphy Partner,
Charities & Not-for-Profit
+353 87 635 4500
alicemurphy@mhc.ie
The long-awaited Charities (Amendment) Act 2024, (Amendment Act 2024), was enacted on 10 July 2024. Since then, the charity sector has been waiting for news of “commencement”.
Statutory Instrument 10 of 2025 was published on Friday 24 January 2025, notifying us that as of today (27 January 2025) there will be a partial commencement of the Amendment Act 2024.
This means that specific listed sections (only) of the Amendment Act 2024 come into force on 27 January. This is the first Commencement Order that has been made since the Amendment Act 2024 was enacted and is therefore a very noteworthy development.
We explain what sections are now in force and what changes they usher in. It is important to note that the rest of the Amendment Act 2024 (a majority of sections) remain uncommenced and the charity sector will have to wait for subsequent Commencement Orders to bring further sections of the Amendment Act 2024 into law.
What sections are being commenced on 27 January 2025?
As stated, this is a partial commencement only, with just 12 sections being commenced. We consider below the sections that commence today.
This commences sections 1 and 2 of the Amendment Act 2024 which are technical sections only setting out the name and commencement details for the Amendment Act 2024.
Section 3 – New or amended definitions
Section 3 amends certain provisions of section 2 of the Charities Act 2009 (2009 Act) which is the Interpretation section. Notable amendments to the definitions include:
• The updating of the definition of a charity trustee to exclude a company secretary/ person who performs the functions of a secretary to the charity trustees. This is a very positive change for secretaries, who were previously considered to be charity trustees. Note that this change may mean that charities may need to update their registers of charity trustees. Note also that the updated definition includes a new concept of a shadow director or any person in accordance with whose directions or instructions the board of the charity are accustomed to act.
• The introduction of a new definition of a “member of the charitable organisation”. This is a new development for charities that are not companies. Their members are those with the power to appoint, nominate or vote for the appointment of a person as a charity trustee of that organisation.
It is very important for charities to take the time to look carefully at their governing document to identify precisely who is considered to be a member within the meaning of the Amendment Act 2024. There will be new obligations and requirements relating to these members and the engagement by a charitable organisation with its members.
• The updating of the definition of connected persons
Section 5 – Disclosure of information by the Charities Regulator to other regulators or listed bodies
Section 5 amends section 28 of the 2009 Act which relates to the disclosure of information by the Charities Regulator to certain other bodies where it suspects an offence has been committed by a charity trustee or charitable organisation. The change made by the Amendment Act 2024 is that the offence in question must now be an offence other than an offence under the 2009 Act. There is also a new right for the Charities Regulator to provide to the other bodies (which includes An Garda Síochána and the Revenue Commissioners), any information that the Charities Regulator has obtained during the performance of its functions.
Section 6 – Administrative cooperation between Charities Regulator and other relevant bodies
Section 6 amends section 33 of the 2009 Act which deals with administrative cooperation between the Charities Regulator and other relevant bodies. The amendments provide a new definition of what a relevant body is. The definition now includes a body, or holder of an office, who carries out functions relating to the oversight or monitoring of charitable organisations where the body or office is prescribed by order of the Minister.
Section 20 – Direction to a charity or a charity trustee to provide Charities Regulator with information
Section 20 amends section 53 of the 2009 Act which deals with the power of the Charities Regulator to require a charity or charity trustee to provide it with information. The amendments to this section mean that the Charities Regulator can now specify the manner and the time period within which the information has to be furnished. Further new subsections now allow the Charities Regulator to request the Ministers for Education or for Further and Higher Education, Research, Innovation and Science to provide the Charities Regulator with information relating to a charity which is an education body. There are also new subsections which now provide that both the charity and the charity trustee are guilty of an offence if they fail to comply with a direction from the Charities Regulator.
Section 31 – Protection of charities, applications to the High Court
Section 31 amends section 74 of the 2009 Act dealing with applications to the High Court which are made by the Charities Regulator. These include applications on the grounds that offences are being committed, that property is being misapplied or that there is other misconduct or mismanagement in relation to the affairs of a charity. In addition to these grounds, the amendment provides that a High Court order may now be applied for by the Charities Regulator where there is no “effective management or oversight of the activities of the charitable organisation by the charity trustees”.
In addition, the amendment now provides for an exclusion from liability for persons appointed by the High Court to act as a charity trustee, with exceptions related to the bad faith, negligence or misconduct of that person and it expands the
orders that the High Court may make to include an order directing the dissolution of a charity (although this does not apply to education bodies).
Section 33 – Appeals by the Charity Appeals Tribunal
Section 33 amends section 77 of the 2009 Act. It previously prescribed a period of not more than 21 days for bringing an appeal to a determination of the Charity Appeals Tribunal. The amendment provides that appeals can now be brought to the Tribunal after 21 days if the Tribunal “for good and sufficient reason” determines.
Section 36 – Exclusion of liability for certain charity trustees
Section 36 introduces a new section 90A. The new section now excludes from personal liability in civil proceedings certain board members of certain education bodies, (specifically recognised schools and management committees of education support centres) in respect of anything done in pursuance of the 2009 Act, provided that they are acting in good faith. This provision reflects the indemnity provided under the Education Act 1998 to recognised schools and management committees of education support centres.
Section 37 – Repeal of restrictions on the sale of Mass cards
Section 37 repeals section 99 of the 2009 Act which previously set out restrictions on the sale of Mass cards and offences for breach of those restrictions.
Section 39 – Amendments to the Charities Act 1961
Section 39 makes a short suite of amendments and repeals to the Charities Act 1961, an older piece of legislation which predominantly deals with charitable trusts and property.
The section amends section 34(2) of the Charities Act 1961, which relates to the making of an application to the Charities Regulator for permission to dispose of land belonging to a charity to another charity for less than market value, where the charity trustees do not otherwise have a power to dispose. Previously, the Charities Regulator only had power to make such orders where the charity acquiring the land had a charitable purpose that was different to the charity disposing of the land. This amendment now extends the scope of the power of the Charities Regulator, enabling them to approve the disposition of charity land for less than market value to any other charity, whether or not their charitable purpose is different or the same as the charity disposing of the property.
In addition, the section makes three repeals to the Charities Act 1961. The first of these repeals section 29(4) relating to the making of Cy-Pres orders of less than €5,000. The second repeal will be of interest to charities who have legal proceedings in being as it repeals section 53 which was a requirement to give notice of the issuing of legal proceedings to the Charities Regulator. The third and final repeal is of section 54 which had previously allowed deeds of a charity to be deposited for security in a repository provided by the Charities Regulator.
Section 40 - Amendment of Taxes Consolidation Act 1997
Section 40 amends Section 851A(8) of the Taxes Consolidation Act 1997. The section provides the circumstances in which a Revenue officer may disclose information in relation to a charity.
Previously this included information authorised by a Revenue Commissioner, and which related to the name of a charity, its objectives, its governing documents and its principal officers.
The section 39 amendment introduces a new disclosure. A Revenue office may now disclose information if required by the Charities Regulator. This applies when the information is needed for the Regulator to perform its functions under the 2009 Act. However, such information may only be used for this specific purpose or related functions.
Recap on the structure of the Amendment Act 2024
The 2009 Act has been the principal piece of legislation for charities for almost a decade. The Amendment Act 2024 does not replace the 2009 Act. Instead, it makes a wide-ranging set of amendments, insertions and repeals of the 2009 Act. 35 separate sections of the 2009 Act are affected by changes introduced by the Amendment Act 2024. 12 of these sections have now been commenced.
The structure of the Amendment Act 2024 requires cross-referencing both the 2009 Act and the Amendment Act 2024. This is essential to gain a full understanding of the new laws in effect. This is the case with all “amending Acts” but it can cause difficulty for readers. We have prepared an “informal consolidation” that combines the 2009 Act with all the changes introduced by the Amendment Act 2024. This brings the full set of applicable laws together in one place. If you would like to receive a copy of this document, please contact a member of our Charity and Not-for-Profit team.
Next steps
Charity trustees and their senior management now need to familiarise themselves with the Amendment Act 2024 and whether or how they will impact their charity.
Should you require any advice on the provisions of the Amendment Act 2024’s recent commencement, please get in touch with a member of our Charity Law and Not-for-Profit team.
Prescription Medicines and the GDPR
Brian Johnston Partner, Data & Technology
+353 86 776 1771
bjohnston@mhc.ie
Background
A pharmacy (Lindenapotheke) had been marketing products on Amazon. These products could only be sold by pharmacies, but did not require a prescription. Lindenapotheke’s competitor, DR, sought an injunction prohibiting this practice on the basis it was an unfair commercial practice. DR argued that Lindenapotheke had infringed the GDPR by processing customers’ health data without their consent.
Two questions were ultimately referred to the Court of Justice of the European Union (CJEU) 1 :
1. Do orders for non-prescription medicines amount to ‘health data’ under Article 9 GDPR, and
2. Can competitors bring legal proceedings for GDPR infringements?
Question 1 – what constitutes ‘health data’?
The CJEU confirmed that where the data on purchases of medicinal products allow conclusions to be drawn as to the health status of an identified or identifiable person, it must be regarded as data concerning health. The CJEU referred to previous judgments, including Lindqvist 2, OT 3 and Bundeskartellamt.4 It confirmed that the concept of ‘data concerning health’ must be interpreted broadly.
Chloe Wilkinson Associate, Data & Technology
+353 86 078 7983
cwilkinson@mhc.ie
This approach aligns with the GDPR’s objective to ensure a high level of protection for individuals. On this basis, the CJEU said there was no basis to distinguish between prescription and nonprescription medicinal products.
The CJEU found that data entered on online platforms when ordering pharmacy-only medicinal products is health data where “a link” can be established between:
• The product
• Its therapeutic indications or use, and
• A natural identified or identifiable person
The CJEU made clear that absolute certainty was not required. Article 9(1) would apply where there was a certain degree of probability that the medicinal products are intended for those customers. The CJEU also reiterated that Article 9 is triggered irrespective of whether the information is accurate or falls within the controller’s stated aims.
The CJEU confirmed that a link could also arise even where the products are intended for someone other than the customer. This applies if it is possible to identify the individual and draw conclusions as to the state of their health. An example given is where the customer refers in the order to a family member.
1. Case C-21/23 Lindenapotheke, (4 October 2024) please see here
2. Case C-101/01, Lindqvist, (6 November 2003) please see here
3. Case C-184/20, OT, (1 August 2022), please see here
4. Case C-252/21, Bundeskartellamt (4 July 2023), please see here
On this basis, the CJEU concluded that customer information processed when ordering medicinal products online “such as their name, the delivery address and the details required for individualising the medicinal products, constitutes data concerning health, within the meaning of those provisions, even where the sale of those medicinal products does not require a prescription”.5
Question 2 – can competitors bring legal proceedings for GDPR infringements?
The CJEU stated that the GDPR does not prevent national laws from allowing this to occur. The CJEU noted that these types of actions are particularly effective in protecting data subjects. This is because they can help prevent a large number of infringements.
Conclusion
This case is another important ruling on Article 9 GDPR. It underlines the broad interpretation that will be applied to health data, and other special categories of data. The CJEU has reiterated that the controller’s stated purpose and the accuracy of information are not relevant as to whether Article 9 applies. The key issue is whether there is a link of sufficient certainty between the information and an individual. This link must allow conclusions to be drawn about the person’s health. The case is also noteworthy as it clarifies that competitors are not prevented from bringing legal proceedings for unfair commercial practices based on GDPR infringements. This could present a significant avenue to challenge the actions of those engaging in unfair practices which infringe the GDPR.
For more information and expert advice, please contact a member of our Data & Technology team.
5. Para, 94
The Government’s View of Aged Care in Ireland
Stephen Cowhey Partner, Real Estate
+353 86 776 1743
scowhey@mhc.ie
What you need to know
• Ireland’s ageing population means that time is running out to find an equitable solution to aged care
• The scale and differing needs mean that there is not one solution and approaches including home care, independent living units and nursing homes should come together as one system
• The need for nursing home beds remains high while the cost of operating those beds is at times unsustainable
• We consider the Programme for Government and its action plans for aged care, including a consideration of the NTPF system
Introduction
Against the backdrop of an ageing population, struggling nursing home operators, and ongoing legal challenges to the National Treatment Purchase Funds (NTPF) scheme, the Government has published its Programme for Government. One of the overarching goals of the Government concerning the aged care sector is to implement a national action plan that will, among other things, examine and enhance the mix of professional care options. It is envisaged that those options will include home care, community-based care, independent living options and long-term residential care facilities, such as nursing homes.
This signals the Government’s intention to utilise as many options as possible when it comes to elder care in Ireland, as opposed to relying on nursing homes as a sole solution.
To achieve this the Government acknowledges the need to explore additional funding for, and greater use of, alternatives to nursing home care such as home care. The Government has identified that it plans to:
• Design a statutory home care scheme to allow people to stay in their own home for as long as possible
• Increase home care hours, and
• Increase the housing adaptation grant
In addition, Independent Living Units, also referred to as ‘ILUs’, provide housing for the elderly who are capable of living independently, but who have health and social care needs and wish to avail of shared services. ILUs serve to keep many elderly living independently for longer and delay their admittance into a nursing home.
The net effect of the Government’s aged care national action plan could be that fewer elderly in Ireland are going into nursing homes. That would in turn mean that the median age of those requiring a bed in a nursing home in Ireland is set to increase.
Nursing homes
The Government has also committed to strengthening the nursing home sector in Ireland by:
1. Increasing funding for the Fair Deal Scheme and ensuring that the waiting list does not exceed four weeks
2. Building more public nursing home beds
3. Publishing the NTPF review of pricing systems in early 2025 and working towards an equitable funding model for the nursing home sector, and
4. Providing a career pathway for healthcare assistants
Nursing Homes Ireland, the sector’s national representative body, has commented that these express commitments by the Government are a step in the right direction.
Fair Deal Scheme
The Nursing Homes Support Scheme, commonly referred to as the Fair Deal Scheme, has been in place since 2009 as a system of financial support for people who require long-term residential care. The scheme allows participants to contribute what they can to the cost of their care, with the remaining cost being covered by the State.
Pricing systems for nursing home beds under the Fair Deal Scheme
We expect that our clients engaged in the nursing home sector will be particularly interested in the release of the NTPF review of pricing systems.
Approximately 80% of nursing home places funded under the Fair Deal Scheme are in private or voluntary nursing homes that are funded by the Irish State based on prices negotiated with the NTPF.
The last review of the pricing system was published by the NTPF in May 2019 – now over five years ago. Inflationary factors over the last number of years have been a huge concern for nursing home operators, while they have struggled to understand the basis for proposed NTPF rates.
Comment
It is encouraging that the Government is committed to working towards an “equitable funding model” for the nursing home sector. Observers have been noting for several years that the current funding levels for nursing homes are inadequate, with one 2023 report finding that 51% of nursing homes are unprofitable. There is also a marked disparity between the average public and private rate across Ireland, with the public rate being as much as €640 per bed higher than the private rate. This will be watched closely by all parties in the hope that a more transparent system will lead to more equitable decisions.
The acknowledgement of the need for additional supports and options for the elderly is important and these other options will form a greater part of our client’s business plans in the near future.
For more information, contact a member of our Healthcare or Real Estate teams.
Charities Regulator Consent for Property Transactions – When and How?
Oliver FitzGerald Partner, Real Estate
+353 86 027 8838
ofitzgerald@mhc.ie
The requirement to obtain the consent of the Charities Regulator to a property transfer can be a crucial milestone in a transaction. It can entirely dictate both how a transaction is structured and how, or even if, the transfer proceeds.
It is therefore vital that the question of whether Charities Regulator consent is required is properly analysed. If consent is required, it is equally vital that the consent application is properly compiled, submitted and managed.
We have extensive experience in the sale of charity property and our Real Estate team has specialist expertise in dealing with Charities Regulator consent applications. In this article, we share some of our insights and experience in considering these issues, including assessing if consent is needed and navigating the process if it is.
What is the Charities Regulator?
The Charities Regulatory Authority (the CRA), commonly known as the Charities Regulator, is the statutory body responsible for regulating charitable organisations in Ireland. The CRA has the power to consent to or not consent to the sale of charitable properties in certain situations.
Kate McDermott
Associate, Real Estate
+353 86 107 8233
katemcdermott@mhc.ie
CRA authorisation – when is it required?
This is an extremely important question that is often not properly considered. Not all disposals of charity property require authorisation of the CRA. Many charities and solicitors assume that consent is always required when dealing with charitable property. This can result in transactions being delayed while making unnecessary applications for consent. The CRA has itself stressed that:
1. Charities should avoid making unnecessary applications, and
2. The CRA will be unable to approve certain transactions relating to charitable property where consent was not strictly required
The assessment as to whether CRA authorisation is required is a complex analysis that should be undertaken by legal advisers experienced in dealing with the CRA, and in particular, CRA consents for real estate transactions.
An in depth assessment of the charities governing documents will be required in addition to a review of the title deeds relating to the property. This could be as simple as reviewing the current title to the property and the governing documents but it could also require a very detailed historic analysis of the title.
So, consent is required –what now?
If authorisation of the CRA is required, then an application must be made to the CRA. Trustees have an obligation to act in the best interests of a charity and this will be a key consideration in the application process.
We consider below some of the key issues that commonly arise in these applications for consent.
Marketing & valuations
All charities are required by law to obtain a market value when disposing of their property, except in certain specific circumstances.
The CRA strongly recommend that charities list the charity property for sale on the open market. This may not always be possible. If it is not possible, the CRA say that the application will be subject to additional scrutiny and consequently will usually take longer to process.
When making an application, the applicant must lodge a valuation report that is dated within six months of the date the application was submitted to the CRA. Only “Red Book” or “Blue Book” valuation reports are acceptable. These are formal opinions of value and can be relied upon by the instructing party. Where the property was not listed for sale on the open market, two valuations may be required. As well as a valuation, it is recommended that all marketing materials relating to the sale of the property, together with anonymised details of viewing and bidding history form part of the application.
Check the Register of Charities & the Property Trustees
If individual trustees are the legal owners of the property, they are often also trustees of the charity on the Register of Charities.
A charity should ensure that it has updated the Register of Charities with all current charity trustees. If it has not been updated, this will be one of the first queries raised by the CRA and this could delay matters. Note that it is possible for the charity trustees and the property trustees to be different.
It’s important to also check before commencing the sale process that there are property owning trustees who are available to sign and that the title registration is up to date. If there are issues in this regard, it may not be possible to contract to sell the property.
Timelines & queries
The timeline to obtain CRA authorisation will depend on how complicated the transaction is. The CRA has advised that all applications should be made as early as possible and that any proposed completion date as defined in the Contract for Sale should be long after the application is submitted. In practice, most contracts will be specified to be subject to CRA consent and completion will not happen until consent is obtained.
The CRA has the right to raise queries regarding the documents submitted as part of the application. In addition, the CRA may require further evidence of the proposed use of any income derived from the sale. Failure to respond to these queries can cause delays in the application being reviewed.
The CRA has advised that applications can take a number of months to process and that the authorisation for the disposal of charity property is at the discretion of the CRA.
Charities should be aware that the CRA assessment and queries can be broad in nature. The CRA may carry out an in depth analysis of the charity and its plans for the future to assess if the transaction is for the charity’s benefit.
Application & signatories
The application is made via an online system. There are a number of documents which must be uploaded as part of the application. These documents will vary depending on the property, however at a minimum, the below documents will be required:
• The fully executed Contract for Sale
• The map of the property
• The valuation report
• The charity governing documents, and
• The application form signed by the trustees
The need to get the application form signed by various trustees and other potential signatories can delay matters as signatories may not be readily available. Legal advice will be needed to confirm who needs to sign.
It may also be helpful to submit letters explaining the transaction, if it is in any way complicated.
Conclusion
1. Start early
The consent process can be lengthy, so begin early. Get legal advisers involved at an early stage to assess if consent will be required and, if it is, to ensure everything is in order to make the application.
2. Check if consent is needed
Not all transfers of charity property require Charities Regulator consent. Consult legal advisers who specialise in Charities Regulator applications to avoid unnecessary applications.
3. Need to show market value was obtained
Ensure that the Charities Regulator requirements regarding proving market value are provided, if required. These will vary depending on the transaction but may include valuations, marketing efforts and bidding histories.
As the pre-eminent provider of legal services to the Charity and Not-for-Profit sector in Ireland, our Charity Law & Not-For Profit team and Real Estate team have niche expertise in this area and can help clients navigate this complicated process.
Healthcare
We have the largest healthcare team in Ireland whose expertise and experience ensure that we deliver targeted, high-quality, sector-specific advice.
Our team is drawn from specialists across the firm and is comprised of lawyers having backgrounds in industry, science, and medicine.
We advise a variety of organisations involved in the provision and development of healthcare services and other businesses which support the healthcare sector. We also act for established public and private hospitals and voluntary organisations and governmental and nongovernmental organisations.
Our dispute practice is unrivalled, and we have been involved in many of the leading Irish medical negligence cases.
We have specialist experience advising on healthcare transactions including acting for real estate investors, Irish and international investors, operators and for healthcare technology, pharma and MedTech companies.
Advising on procurement, contract law, data protection, compliance and regulatory matters is a core part of our service to healthcare clients.
About us
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Our legal services are grounded in deep expertise and informed by practical experience. We tailor our advice to our clients’ business and strategic objectives, giving them clear recommendations. This allows clients to make good, informed decisions and to anticipate and successfully navigate even the most complex matters. Our working style is versatile and collaborative, creating a shared perspective with clients so that legal solutions are developed together. Our service is award-winning and innovative. This approach is how we make a valuable and practical contribution to each client’s objectives.
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