Peter Bogaert

Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

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Exploring the EU Horizon for Pharma

The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the … Continue Reading

Lundbeck – The Details Of The European Commission’s Legal Analysis Of ‘Reverse Patent Settlement Agreements’ Revealed

This post is based on a Covington client briefing. The recently published landmark decision concerning the Lundbeck citalopram case revealed the details of the European Commission (“Commission”)’s competition law analysis regarding reverse patent settlement agreements. In the years 2002 and 2003, the Danish pharmaceutical company Lundbeck concluded six agreements with four companies (Merck KGaA/Generic UK … Continue Reading

Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection … Continue Reading

Innovation vs. Safety: The New Proposed Rules for Medical Devices in the European Union

Article originally published in the FDLI Update (January/February 2013) “Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.” This is how former European Union … Continue Reading

Judgment of the Court of Justice in AstraZeneca v Commission

Originally published as Covington E-Alert on December 10, 2012 On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including its challenge to the General … Continue Reading

Judgment of the Court of Justice in AstraZeneca v. Commission

Article originally published in Covington E-Alert, 10 December 2012 On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including its challenge to the General … Continue Reading

France – Prior Approval for Advertising for Medical Devices and IVDs

Originally published as Covington E-Alert on October 3, 2012 French Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products has been inserted into the Public Health Code (‘Code de la santé publique’ or CSP). It includes new advertising rules for medical devices (MDs) and in vitro … Continue Reading

New Medical Devices Regulations in the EU – Significant Changes But No Big Bang

Originally published as Covington E-Alert on September 26, 2012 Today the European Commission published its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices (IVD) will … Continue Reading

EU Financial Penalties for Centrally Approved Medicinal Products in Europe – How To Prepare?

Originally published as Covington E-Alert on September 17, 2012 Commission Regulation No. 658/20071 (the “Penalties Regulation”), as recently amended by Commission Regulation No. 488/2012,2 empowers the European Commission to impose financial penalties in relation to medicinal products approved through the centralised procedure. No financial penalties have yet been imposed, but the situation may change following … Continue Reading

What’s in a Name?

Article originally published in European Pharmaceutical Contractor, September  2012 Although at first sight the rules that govern the distinction between medical devices and medicines in the EU allow for a direct and systematic approach, borderline determinations are, in practice, often difficult and the rules lack logical rigour The European Commission is expected to publish proposals … Continue Reading

New Rules for Clinical Trials Proposed in Europe

Originally published as Covington E-Alert on August 1st, 2012 On 17 July, the European Commission released the long-awaited proposal for a Regulation on clinical trials on medicinal products for human use (the Proposal). The future regulation will replace the Clinical Trials Directive 2001/20/EC, the revision of which has been advocated by the pharmaceutical industry, academia, … Continue Reading

Cost Considerations Should Not Drive Off-Label Drug Use in the EU

Article originally published in Scrip Regulatory Affairs, June 2012 With off-label drug use in the EU moving into the regulatory spotlight, it is becoming clear just how limited member states are in their power to stimulate – or indeed allow – the practice. Off-label use of medicines always used to be somewhat in the shadows in … Continue Reading

The Advocate General’s Opinion in Astrazeneca v. Commission

Originally published as Covington E-Alert on May 17, 2012 On 15 May 2012, the Advocate General of the EU Court of Justice issued his opinion on the appeal of the General Court’s judgment in AstraZeneca v. Commission.1 The Advocate General largely agreed with the reasoning and holdings of the General Court, and recommended that the … Continue Reading

European Commission Adopts List of General Health Claims

Originally published as Covinton E-Alert on May 25, 2012 On 16 May 2012, the European Commission adopted the much delayed list of permitted general health claims (Permitted List) for foods after scrutiny of the list by the European Parliament and the Council ended on 27 April 2012. The Permitted List contains just 222 health claims … Continue Reading

Belgium – Regulatory Overview

Article originally published in the Life Sciences Handbook, 2012 1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)? Legislation The main legislative acts regulating medicinal products are the: „„ Medicines Law 1964. „„ Royal Decree of 14 December 2006 on … Continue Reading

Revision of the Rules on Pricing and Reimbursement of Medicines (The “Transparency Directive”) in the European Union

Originally published as Covington E-Alert on March 1st, 2012 Today the European Commission published its long awaited proposal for the revision of the so-called Transparency Directive. The Directive lays down procedural guarantees for the systems that regulate the pricing and reimbursement (“P&R”) of medicines in the thirty EU and EEA Member States. The revision aims … Continue Reading

Upcoming EU Requirements on Goods Treated with Biocidal Substances

Article originally published in EuroWatch on August 15, 2011 The Council of the European Union has adopted a position at First Reading on a proposal for a Regulation on Biocidal Products that would impose new requirements on goods treated with biocidal products (“Council First Reading”).1 The new rules would apply to a wide variety of … Continue Reading

Advertising of Medical Products and Summary of Product Characteristics (Smpc) before the European Court Of Justice

Originally published as Covington E-Alert on May 9, 2011 The EU Court of Justice just issued two long awaited rulings on the interpretation of the rules governing advertising of medicines in Europe. They address (i) the requirement that all advertising must comply with the prescribing information (SmPC) for the product and (ii) the distinction between … Continue Reading

Getting Ready For Reach: Substances Of Very High Concern

Originally published as Covington E-Alert in April 2011 THE REACH REGULATION AND SUBSTANCES OF VERY HIGH CONCERN The European Union’s Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH Regulation”) requires the European Chemicals Agency (“ECHA”) to identify so-called Substances of Very High Concern (“SVHCs”) and to list them in … Continue Reading

Biosimilar Regulation: Important Considerations and Global Developments

Article originally published in the Life Sciences Handbook Cross-border in 2011  During the past ten years, many stakeholders have expressed an interest in the availability of biologically derived medicines authorised on the basis of previously authorised biological refer­ence products, that is, on the basis of a truncated dossier that includes a robust showing of similarity … Continue Reading

Parallel Trade in Pharmaceutical Products in Europe: the European Court of Justice’s Ruling In Gsk v Commission

Originally published as Covington E-Alert on October 9, 2009 May a pharmaceutical company charge its wholesalers one price for products to be resold under the national healthcare reimbursement rules, and another, higher price for products to be resold in another EU member state? This was the question addressed by the European Court of Justice (ECJ) … Continue Reading

Medical Nanotechnology in Europe

 Article originally published in RAJ Pharma in July 2008 By 2015 nanotechnology-based medicines and medical devices are expected to flood the global market. Brian Kelly and Peter Bogaert discuss the regulatory and legal implications of medical nanotechnology in Europe. Nanotechnologies are the design, characterisation, production and application of structures, devices and systems by controlling shape and size … Continue Reading

Parallel Trade in Pharmaceutical Products in Europe: The European Court of Justice’s Ruling in Syfait v. GSK

Originally published as Covington Life Sciences Alert on June 1st, 2005 May a dominant pharmaceutical company refuse to supply in full the orders it receives from a wholesaler in an EU country in order to limit parallel trade in its products in the European Union? This was the question put to the European Court of … Continue Reading
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