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Welcome to the October 2019 edition of our newsletter.

The EMEA Healthcare Industry Group Newsletter is your regular digest of legal developments affecting the life science and healthcare industries across the region.

In this issue:


• General presumption of confidentiality of clinical study reports: Opinion of AG Hogan in Case C-175/18 P, PTC Therapeutics International Ltd v European Medicines Agency (EMA)
• Medical Device Regulations: publication of rules on designation of expert panels
• Orphan drug designation: the EU Court of Justice position

Europe – Brexit

• The Status of “retained EU law” Repeal of the European Communities Act
• Can no-deal Brexit stockpiled drugs be sold out of the UK?


• New draft decree on pricing of medicinal products
• Medical devices: designation of the first Italian notified body
• Functional equivalence between medical devices with different durations


• TİTCK announces updates and improvements for ÜTS

United Kingdom

• Expansion of the streamlined single submission pilot for clinical trials
• UK maintains its global edge for clinical trials ahead of Brexit
• Aspen offers to pay GBP 8 million compensation to NHS as part of settlement with UK Competition & Markets Authority
• MHRA enhances the quality of biological medicines
• All-Party Parliamentary Group Report: Recommendations for NICE’s upcoming methods review
• UK Focus: Cannabis-based Drug for Childhood Epilepsy Approved for Use in the UK



Julia joined Baker McKenzie's London office as a trainee in 2005, qualifying in 2007, with a secondment to the Singapore office, and has shaped her practice to focus exclusively on regulatory matters affecting the Healthcare & Life Sciences industry.


Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office. Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products. Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections. Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.