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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.

On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force.  The rules were introduced by the Social Security Financing Law for 2021 (LOI n° 2020-1576 du 14 décembre 2020 de financement de la sécurité sociale pour 2021 or “LFSS 2021”, available here).  The reform seeks to simplify existing rules, make early access and off-label use more predictable for all users, and ensure the sustainability of these programs for the public health insurance system.  In this blog, we present an overview of the new rules.

Continue Reading New Early Access and Off-Label Use Rules in France

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 same time, discovering and developing new products is more complex and requires a collaborative effort. This happens against the background of new rules on medical devices and the protection of personal data, which are, for instance, relevant in assessing clinical effectiveness and relying on real world evidence.

Three members of the Covington European Life Sciences team will be speaking on these topics at the EU Pharmaceutical Law Forum being held in Brussels on 16-18th May.
Continue Reading Exploring the EU Horizon for Pharma

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 in relation to food information whilst ensuring smooth functioning of the EU market.

The FIC Regulation governs all food information provided to the consumer through any commercial communication, including in particular labeling and websites. The Regulation affects all food business operators along the whole supply chain as it changes the existing provisions and introduces new ones:
Continue Reading Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

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

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

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

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

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

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