Search for:

In brief

A revision of EU pharmaceutical legislation by the European Commission will be published on 21 December. These revisions indicate the execution of the European Commission’s 2020 Pharmaceutical Strategy – a strategy that seeks to create a more resilient regulatory system in light of the COVID-19 pandemic.

The revised legislation’s objectives are to encourage access to affordable healthcare, spur pharmaceutical innovation and improve supply chain resistance. This improved regulatory framework will be more adaptable to technological and scientific progress and should reduce red tape. This legislation will also allow the EU to cement its influence in global medical regulation and its capability to deliver high-quality medical products globally.

Public consultation regarding the revision of the EU’s pharmaceutical legislation ran from 28 September 2021 to 21 December 2021. The public entities in the healthcare sector (businesses, authorities, providers) and stakeholders shared their views on the ‘Have Your Say’ European Commission portal. From the total pool of 478 public consultation responses, key concerns included making the regulatory system more future-proof, simple, transparent, accessible, coherent with other EU legislation and environmentally impactful. The consensus was that the revised pharmaceutical legislation should implement an incentive system and that the system should be in the interests of both public and global health.

A Council recommendation on cancer screening (set for 7 September) and the EU’s global health strategy (forecast for 6 November) are other projects in the pipeline for the European Commission.

The European Commission will need to consider how to implement such changes affordably. From a UK governmental perspective, the revised EU pharmaceutical legislation may push the UK government to assess whether to implement similar changes or, in fact, diverge from the EU’s regulatory agenda as the UK seeks to remain an attractive market in the medicinal space.

We will continue to monitor the progress and initiatives arising from the ongoing Pharmaceutical Strategy.

For further information on this article, please contact Els Janssens of our Brussels office or Julia Gillert of our London office.


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.


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.

Write A Comment