We won Case T-201/21 Covington & Van Vooren vs European Commission. But why did we litigate? Why did we ask to see how the member states voted on an EU implementing act? A short background story, worth a few minutes of your time if interested in the
Continue Reading The EU member states’ votes banning a product cannot be presumed confidential: Why we litigated Case T-201/21 Covington & VanVooren vs European Commission (and won)
On 19 June 2023, after almost 20 years of negotiations, the United Nations (“UN”) member states adopted a landmark treaty to ensure the conservation and sustainable use of marine Biodiversity of areas Beyond National Jurisdiction (the “BBNJ” treaty).
One of the cornerstones of the BBNJ treaty
Continue Reading Historic Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companies
On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations. The MHRA
Continue Reading Fast-Tracking Access to New Medicines – UK Announces New International Reliance RouteThe Voluntary scheme for branded medicines pricing and access (“VPAS”) is a voluntary agreement that regulates the price of the vast majority of branded medicines sold in the UK (including branded generics and biosimilars). VPAS is critical to the commercial interests of most innovative pharmaceutical companies operating in
Continue Reading Update on the VPAS Judicial Review brought by the British Generic Manufacturers Association
On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU. The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023. The Commission intends
Continue Reading EU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast
Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear. Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences
Continue Reading EU Pharma Legislation Review Series: New Classification Mechanism for Borderline Cases
The European Commission’s proposal to amend the current pharmaceutical regulatory framework includes a draft Directive on medicines for human use (the “Proposed Directive”) and a draft Regulation on the central authorisation and supervision of medicines (the “Proposed Regulation”, together the “Proposal”). In this blog, we provide an overview of the
Continue Reading EU Pharma Revision Series: Pharmacovigilance
Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there
Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations
The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.” As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition
Continue Reading EU Pharma Legislation Review Series: National MA Procedures Including the Mutual Recognition Procedure and Decentralized Procedure
The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products. In particular, the Proposal introduces new obligations for manufacturers and for national competent authorities overseeing
Continue Reading EU Pharma Legislation Review Series: Decentralized Manufacturing