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

Welcome to the latest update from the Philip Lee Healthcare, Pharmaceutical and Life Science group in respect of the second and third quarters of 2022.

This update covers a range of topics:

General Regulatory – Ireland

1. Autumn 2022 legislative programme published
2. Public consultation on draft Policy Framework for open disclosure in the Irish health and social care sector
3. Expanded role for HPRA as Ireland adopts new In Vitro Diagnostic Devices Regulation Enforcement Measures

General Regulatory – EU

4. New Vertical Block Exemption Regulation and Guidelines from the Commission
5. The introduction of ‘critical medicines lists’ under EU Regulation 2022/123 to increase transparency
6. In Vitro Diagnostic Medical Devices Regulation (the “IVDR”) came into effect in the EU on 26 May
7. Regulation proposed through a political agreement to address the serious cross-border threats to EU health policy
8. European Commission evaluates legislative framework around tobacco and introduces changes for heated tobacco products
9. The EMA publishes final revised guideline on developing new antibiotics
10. European Commission issues draft proposal for new regulation on blood, tissues and cells
11. European Commission releases revised guidelines on manufacturing sterile medicinal products
12. European Commission adopts European Care Strategy
13. European Commission issues communication to member states to prepare for COVID-19 outbreaks in autumn and winter

Global Insights

14. European Health Union: Start of delivery of vaccines in response to the monkeypox outbreak
15. Luxemburg – Competition authority makes recommendations for regulatory reform
16. Update on the EU-Switzerland mutual recognition agreement for In Vitro diagnostic medical devices
17. WTO reports on pharmaceutical dispute between Turkey and the EU
18. UK government announces infected blood victims to receive £100,000 interim compensation payment
19. European Court of Human Rights decision in euthanasia case

Competition Law

20. European Commission prohibits acquisition of GRAIL by Illumina
21. European Commission starts competition investigation against Vifor Pharmaceutical regarding disparaging statements made against Rival’s Medicine
22. Adaption of the Competition Amendment Act signals significant changes to Ireland’s merger control rules

Data Protection

23. European Parliament publishes briefing paper on European Health Data Space proposal

Healthcare

24. Commencement of the Assisted Decision-Making (Capacity) Act 2015
25. EMA begins rolling review of adapted Comirnaty vaccine
26. EMA recommends withdrawal of marketing authorisation for amfepramone medicines
27. EMA and the Heads of Medicines Agency (the “HMA”) issue statement on interchangeability of EU-approved biosimilars
28. European Commission proposes new approach on early cancer screening
29. High Court admits man to wardship despite diverging medical evidence from psychiatrists on his capacity
30. EMA press release recommends authorisation of first adapted COVID-19 booster vaccines in the EU
31. High Court rules that HSE counsellors are required to report child sexual abuse allegations made by adults
32. High Court refuses application by Medical Council to suspend doctor from register pending the outcome of fitness to practice inquiry
33. Final report of the high level task force to consider the mental health and addiction challenges of those who come into contact with the criminal justice sector

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

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