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. The Irish Pharmaceutical Healthcare Association (“IPHA”) and Minister for Health agree Framework Agreement on Pricing and Supply of Medicines 2021 – 2025
2. Medicines for Ireland (“MFI”) and Minister for Health agree Framework Agreement on Pricing and Supply of Medicines 2021 – 2025
3. IPHA has released a standardised model Clinical Trial Agreement (“mCTA”) for use in all interventional clinical trials in Ireland
4. Healthcare a key focus under the National Development Plan (“NDP”) 2021-2030 and under Budget 2022
5. New Intellectual Property List created as sub-division of the Irish High Court’s Commercial List
General Regulatory – EU
6. European Commission to Table Legislation to Ensure Continuity of Supply of Medicines to and from Northern Ireland
7. New EU Clinical Trial Regulation
8. Commission proposes extension to transitional period of the In Vitro Diagnostics Medical Devices Regulation 2017/746 (the “IVDR”)
9. European Commission Public Consultation on a Reform of EU Pharmaceutical Legislation
10. Publication of an Implementing Regulation of Good Distribution Practice for Veterinary Medicinal Products in accordance with Regulation (EU) 2019/6
11. Consultation outcome on cross border healthcare / Evaluation of patients’ rights
12. New EU Health Emergency Preparedness and Response Authority established (“HERA”)
13. Proposal for IP waiver for COVID-19 vaccines
14. EU Strategy on COVID-19 Therapeutics Strategy – 5 promising treatments identified by the Commission in the EU Strategy on COVID-19 Therapeutics
15. European Commission signs Contract for Supply of Monoclonal Antibody Treatment.
Global Insights
16. Molnupiravir pill from Merck: the first oral anti-viral Covid-19 drug seeks US approval
Competition Law
17. Competition and Consumer Protection Commission (CCPC) Publish 2020 Annual Report
18. Competition (Amendment) Bill 2021
19. European Commission scrutinising Illumina/Grail transaction
20. Imposition of fines by UK Competition and Markets Authority (CMA) for the placing of excessive prices on hydrocortisone tablets
Data Protection
21. Data Protection Commission (DPC) guidelines regarding return to in-person work / employers not allowed to inquire as to employees’ vaccination status
22. European Data Protection Board (EDPB) adopts guidelines on restrictions under Art 23 GDPR
23. EDPB adopts draft guidelines on GDPR provisions on international transfers (Chapter V) and territorial scope (Article 3)
To read the full update see: Healthcare, Pharmaceuticals and Life Sciences Update.
