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Article and Insights
Home Support Providers Act Signed into Law
The Health (Amendment) (Home Support Providers) Act 2026 establishes a statutory registration and inspection framework for home support providers.
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Article and Insights
Sanofi Pasteur SA: An Important ECJ Ruling on Defective Products
Defective Products: the ECJ confirms its position on dual liability, time limits and access to justice.
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Article and Insights
Government Approves Health Bill on Home Support Providers
The government has approved the publication of the Health (Amendment) (Home Support Providers) Bill 2025
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Article and Insights
Data and AI in Medicines Regulation: EMA and HMA Work Plan
The European Medicines Authority and the Heads of Medicines Agencies have published a three-year work plan detailing their vision for optimising Da...
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Article and Insights
Update: Transposition of Revised Product Liability Regime by 2026
The Revised Product Liability Directive came into force six months ago and must be transposed into Irish law by 9 December 2026.
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Article and Insights
The Innovation Race in Pharma and Healthcare Sectors
In the pursuit of next-generation therapies, several trends are emerging in the pharma and healthcare sectors.
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Article and Insights
High Court Confirms Scope of Duty of Care owed by Screening Service Providers
The High Court affirms there is no duty of care owned by screening services to relatives of those who participate in a screening programme.
Consultant
Margaret Muldowney
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Article and Insights
The Importance of ESG for Employers within the Life Sciences Sector
Employers not complying with their ESG obligations face regulatory, capital, and talent retention challenges. Our survey shows that only 17% of Iri...
Consultant
Alicia Compton
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Article and Insights
To Refer or Not to Refer? High Court Provides Further Guidance on Solicitor Referrals to Medical Specialists
High Court considers expert medical evidence where the plaintiff was referred to that expert by her solicitor and not her GP.
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Article and Insights
Reality Bites as Industry Forces Postponement of MDR Implementation
European Parliament votes to extend MDR transition periods to avoid supply shortages of medical devices while NSAI joins the IVDR club.
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Article and Insights
High Court Expresses Strong Disapproval of Solicitor Referrals to Medical Specialists
Mr Justice Twomey expresses strong disapproval of referrals to medical experts made by solicitors in personal injury claims and reiterates the appr...
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Article and Insights
Video: Brexit and Immigration Series – UK and Irish Nationals and the Common Travel Area
Karen Hennessy and Richard Smith from our Employments & Benefits team and Vincent Chung from Dixcart Legal discuss how UK and Irish nationals will ...
Senior Associate
Richard Smith
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Article and Insights
Stamp Duty Battle: Abbvie Wins Appeal Against €587m Irish Stamp Duty
A recent decision of the Tax Appeals Commission will peak the interests of Pharma, Healthcare and MedTech companies considering M&A transactions in...
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Article and Insights
Russia Issues Decree Providing For 0% Compensation for the Unauthorised Use of Certain IP Rights Emanating From “Unfriendly Countries”
Russia has issued a decree providing for 0% compensation for the unauthorised use by way of compulsory licence of certain IP rights owned by citize...
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Article and Insights
Regulatory Flexibility – Key Measures to Support Availability of Medicines and Medical Devices During COVID-19
The COVID-19 pandemic has propelled the healthcare and life sciences industries into uncharted territory. We explore the flexibility of regulators ...
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Article and Insights
New Government Legislation Programme: Industry & Sector Breakdown Summer 2022
The Summer legislation programme has been published by the government. The programme includes 34 bills for prioritisation.
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Article and Insights
New Government Legislation Programme Spring Session 2019 Published
No-deal Brexit legislation to dominate Oireachtas schedule over coming months
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Article and Insights
Medical Devices Regulation – Applicable from Today
Amidst much anticipation, the Medical Devices Regulation becomes fully applicable across the EU from today, 26 May 2021. These Regulations represen...
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Article and Insights
MDR Countdown – 1 Month. European Commission Updates its Rolling Plan
With the Medical Devices Regulation (MDR) set to become fully applicable next month the European Commission has published an update to its Implemen...
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Article and Insights
Medical & In Vitro Diagnostic Devices and the AI Act: Proposed Regulatory Requirements
Artificial Intelligence (AI) is becoming an increasingly pervasive general-purpose technology, with AI elements in everything from our phones to ne...
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Article and Insights
IVDR Crunch Time – Where does Ireland Stand?
The In Vitro Diagnostic Medical Device Regulation, (EU) 2017/746, is fully applicable as of Thursday 26 May 2022. Together with a summary of the ke...
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Article and Insights
IPHA’s Revised Self-Care Advertising Code
Effective from 1 March 2021, the revised IPHA Code introduces new rules for advertising non-prescription medicines, traditional herbal medicinal pr...
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Article and Insights
Implementation of EU Medical Device Regulation May Face Delay
The European Commission has announced that it is working on a proposal to postpone the date of application of the Medical Device Regulation (MDR) w...
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Article and Insights
High Court Guidance on “Non-Identification” Orders in Civil Proceedings Including Medical Negligence Claims
A recent decision of the High Court illustrates the use of non-identification orders under the Civil Law (Miscellaneous Provisions) Act 2008
Consultant
Margaret Muldowney
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Article and Insights
Guidance Published on Appropriate Surveillance under Article 120 of the MDR
The Medical Device Coordination Group has published guidance on the activities to be performed by notified bodies as part of their ongoing surveill...
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Article and Insights
Government Publishes Spring Legislation Programme for Spring 2021
The legislative programme for the forthcoming spring Oireachtas session has been published by the Government Chief Whip, Jack Chambers TD.
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Article and Insights
European Commission Proposes a Unitary SPC and/or a Unified Procedure for Granting National SPCs
The European Commission has proposed a unified procedure for granting Supplementary Protection Certificates in the EU. It seeks to address ineffici...
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Article and Insights
Emergency Measures to Halt the Spread of Covid-19
Government passes emergency COVID-19 Legislation
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Article and Insights
ECJ issues Decision on SPCs for Medical Devices
ECJ rules on the availability of SPC protection for medical devices incorporating a pharmaceutical drug
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Article and Insights
Cutting Costs in Personal Injuries Litigation
New legislative changes aimed at cost savings in personal injuries to commence
Consultant
Margaret Muldowney
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Article and Insights
Court of Appeal Upholds Invalidity of a Combination Product SPC Applying the CJEU Test
The Court of Appeal has upheld a finding by the High Court that Merck Sharp & Dohme's Inegy SPC was invalid on the grounds that it breached Regulat...
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Article and Insights
Compulsory Licences on the Horizon for Drugs and Equipment?
As concerns grow globally about the availability of certain drugs and equipment in the midst of the COVID-19 pandemic will we see other governments...
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Article and Insights
Clinical Trials Regulation to Take Effect from 31 January 2022
The European Commission has announced that the long-awaited Clinical Trials Regulation (EU) No 536/2014 will take effect from 31 January 2022.
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A Stricter Regime is Beckoning for Manufacturers of Popular Beauty Devices
The European Commission has proposed reclassifying certain beauty and brain stimulation devices without an intended medical purpose under the Medic...
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Article and Insights
A Further Update on the Unified Patent Court
The requisite number of Member States have now joined the protocol on a European Unified Patent Court. In this brief article we discuss the next st...
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Article and Insights
Third Strike for Warner-Lambert’s Lyrica® patent
The lengthy Lyrica® patent dispute between Warner-Lambert and Mylan and Actavis is over. Last week the UK Supreme Court unanimously dismissed Warne...
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Article and Insights
Court Dismisses Judicial Review of Marketing Authorisation Grant for Falling Outside Time Limits – A Cautionary Note to Pharmaceutical Manufacturers
In an appeal challenging the marketing authorisation of a generic drug, the Court of Appeal applied the time limits within which to bring judicial ...
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Article and Insights
Is Change on the Horizon for the Disclosure Regime Under Order 39, Rule 46 RSC?
In a recent decision, the Court of Appeal (CoA) considered the interpretation and application of Order 39, Rule 46 of the Rules of the Superior Cou...
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Ireland’s M&A activity skyrockets following challenging 2020
Deal value in the first six months of 2021 is more than eight times H1 2020 figure.
Managing Partner
Stephen Keogh
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Article and Insights
What Regulatory Challenges are Facing the Life Sciences Sector?
Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the line with Silicon Republic.
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Article and Insights
The European Unified Patent Court – is it Finally within Reach?
The German Federal Constitutional Court has rejected the latest constitutional challenge to the German Parliamentary Bill ratifying the European Un...
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Article and Insights
IPHA’s Revised Code of Practice for the Pharmaceutical Industry
Taking effect on 1 March 2021, the IPHA have revised their Code of Practice for the Pharmaceutical Industry
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Article and Insights
Improved Access to Affordable Medicines – EU Proposes Radical Action
EU Commission releases its Pharmaceutical Strategy for Europe, marking the first step in its proposed overhaul of the pharma regulatory framework.
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Article and Insights
Low Rate of Notified Body Designations under MDR and IVDR Causes Bottleneck Concerns for the European MedTech Industry
Continuing our series of publications, in this briefing we explore which EU Notified Bodies have been designated under the new Medical Devices and ...
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Article and Insights
Brexit Omnibus Bill Published
Bill to prepare Ireland for no deal withdrawal by the UK working its way through legislative process
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Article and Insights
Long Awaited Periodic Payment Orders Legislation Now Commenced
Periodic Payment Orders for Catastrophic Injuries Now Commenced
Consultant
Margaret Muldowney
