The 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
EU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast
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
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EU Pharma Legislation Review Series: New Classification Mechanism for Borderline Cases
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 CasesEU Pharma Revision Series: Pharmacovigilance
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
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EU Pharma Legislation Review Series: Data Protection Aspects
On April 26, 2023, the European Commission proposed the long awaited reform of the EU’s pharmaceutical regulations (see here to view our previous blogs on the subject). This blog post discusses the data protection aspects of the proposals, which relate to the data processing activities of the European Medicines Agency
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EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations
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
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EU Pharma Legislation Review Series: National MA Procedures Including the Mutual Recognition Procedure and Decentralized Procedure
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 ProcedureEU Pharma Legislation Review Series: Decentralized Manufacturing
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 ManufacturingEU Pharma Legislation Review Series: Supply Security and Shortages Control
As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages. In particular, there are new obligations
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EU Pharma Legislation Review Series: Bolar Exemption under Patent Rights
The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the
Continue Reading EU Pharma Legislation Review Series: Bolar Exemption under Patent Rights