In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods. The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.” Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. Continue Reading EU Court Overturns EU-wide Botanical Food Ban
Peter Bogaert
Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in local litigation in Belgium. Peter's practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.
Chambers Global notes that a client said: “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions." He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Peter's prominent regulatory pharmaceutical and environmental practice. Legal 500 EME noted that he is "a superb lawyer who is very pleasant to work with." Peter regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group and also served for fifteen years as Managing Partner of the firm’s Brussels office.
European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry
On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here). In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process.
Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series). Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.
We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.Continue Reading European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry
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: Access to Documents and Transparency of R&D Funding
The EU’s latest draft pharmaceutical legislation contains some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of research and development of medicinal products.
1. Draft Regulation – Further Clarity Regarding Public Access to Documents
Disclosure of documents in response to an…
Continue Reading EU Pharma Legislation Review Series: Access to Documents and Transparency of R&D FundingEU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”). At the same time, the measures are also aimed at promoting and incentivizing the development of new…
Continue Reading EU Pharma Legislation Review Series: AMR and Transferable Exclusivity VouchersEU Pharma Legislation Review Series: Pharmacy and Hospital Exemptions
The existing EU pharmaceutical legislation provides for a number of specific exemptions from the marketing authorisation requirement, including products supplied on a named patient or compassionate use bases; products compounded and dispensed in pharmacies (magistral and officinal formulations) and also for products necessary to respond to public health emergencies. Given…
Continue Reading EU Pharma Legislation Review Series: Pharmacy and Hospital ExemptionsEU Pharma Legislation Review Series: Paediatric Medicines
More Obligations for the Same Reward?
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU’s general pharmaceutical legislation. As expected, the Commission’s proposal represents a significant overhaul of the EU medicine rules. Not least the incorporation of the EU’s amended paediatric and orphan…
Continue Reading EU Pharma Legislation Review Series: Paediatric MedicinesEU Pharma Legislation Review Series: Orphan Medicines
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006.
As expected, the draft Regulation significantly shakes…
Continue Reading EU Pharma Legislation Review Series: Orphan MedicinesEU Pharma Legislation Review Series: The EU’s proposals to amend its pharmaceutical laws released today
This is the first in a series of Covington blogs about the EU’s proposals to amend the current pharmaceutical regulatory framework, which were released today (see here). It introduces some of the key aims and themes and invites readers to read more in-depth summaries as we release them. …
Continue Reading EU Pharma Legislation Review Series: The EU’s proposals to amend its pharmaceutical laws released todayEU Talking Life Sciences Audiocast: Episode 1 – Key Developments in the Pharma Sector: A Review of 2022 and Insights for 2023
Tune into the first episode of Covington’s Talking Life Sciences Audiocast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health…
Continue Reading EU Talking Life Sciences Audiocast: Episode 1 – Key Developments in the Pharma Sector: A Review of 2022 and Insights for 2023