Key Contact: Ronan Dunne – Partner  |  Maire Kinsella – Partner

Welcome to the latest update from the Philip Lee Healthcare, Pharmaceuticals and Life Science group.

This update covers a range of topics:

General Regulatory – Ireland

1. Irish Government publishes Legislation Programme Spring 2022
2. Potential new EU law to help consumers take ‘collective action’ against firms
3. HPRA Provides updated guidance for submitting mock-ups for labels and leaflets

General Regulatory – EU

4. Heads of Medicines Agencies, European Commission and European Medicines Agency launched Accelerating Clinical Trials initiative (ACT EU) to transform how clinical are designed and conducted in the EU
5. The European Commission has launched a public consultation on the revision of REACH, the EU’s chemicals legislation
6. EU adopts updated proposals to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta
7. Regulation 2019/6, the Veterinary Regulation has come into force throughout the EU
8. European Commission adopts legislative proposal for a Corporate Sustainability and Due Diligence Directive

Global Insights

9. Takeda’s Exkivity receives MHRA conditional marketing authorisation
10. Novel therapeutic strategy shows promise against pancreatic cancer

Competition Law

11. New Competition Amendment Bill in Ireland
12. Commission issues draft guidelines on information exchange in dual distribution
13. The European Commission invites public consultation on new changes to guidance on horizontal agreements

Data Protection

14. Data Protection Act 2018 (Access Modification) (Health) Regulations 2022 enter into force
15. The UK adopts new International Data Transfer Agreement and Addendum for the transfer of data (“IDTA”)
16. Data Protection Commission imposes €17 million fine for data breaches on Meta Platforms Ireland Limited (formerly Facebook Ireland Limited)
17. Psychotherapy centre Vastaamo in receipt of fine imposed by the European Data Protection Board for data protection violations
18. The Finnish Motor Insurer’s Centre fined for collection of unnecessary patient information


19. Personal injury guidelines: The aftermath
20. Personal Injuries Resolution Board Bill 2022: A proposal to amend the Personal Injuries Assessment Board Act 2003-2019
21. Finally, the long Awaited: Assisted Decision-Making Capacity Act
22. Patient Safety (Notifiable Patient Safety Incidents) Bill 2019
23. The decision made in the Nervous Shock case of Warren Harford v Electricity Supply Board (2020) has been overturned by the Court of Appeal
24. English Supreme Court appeal: Puberty Blockers case

To read the full update see: Healthcare, Pharmaceuticals and Life Science Update.

For further information in relation to this article please contact Ronan Dunne or Marie Kinsella.​