Covington & Burling LLP | Peter W.L. Bogaert

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Peter W.L. Bogaert

Partner

Brussels +32 2 549 5243 pbogaert@cov.com Download V-card

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Peter Bogaert is a managing partner of the Brussels office, and 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 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 Mr. Bogaert's prominent regulatory pharmaceutical and environmental practice. Legal 500 EMEA (2011) noted that he is "a superb lawyer who is very pleasant to work with." Mr. Bogaert regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group.

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Active participation in the development of many pieces of legislation, including the Orphan Medicines Regulation, the 2004 revision of the EC pharmaceutical legislation, the Paediatrics Regulation, the Pharmaceutical Penalties Regulation and the Advanced Therapies Regulation.
Counsel to Pharmaceutical Research and Manufacturers of America (PhRMA) in Europe on various legislative and policy issues.
Successful defense of a pre-market approval in Olivieri v. Commission, the first legal challenge of an EC approval for a medicine. The claim was brought by a former investigator for the product and was dismissed by the EC Court of First Instance.
Advice on the interplay between regulatory procedures and patent rights and assistance in the management of the procedures.
Detailed advice on supplementary protection certificates and the EC paediatrics rules, including regulatory planning with regard to SPC extensions.
Life cycle management planning for various pharmaceutical companies.

Defence of the orphan drug status of various products in the EU.
Regulatory strategies for protecting core downstream use of functional ingredients in consumer products, with specific attention to the impact of a revised chemical classification for use in finished products.
Regulatory audits and gap analyses for life sciences companies, focusing among others on pharmacovigilance procedures and commercial practices.
Regulatory strategy throughout Europe for food ingredients that have significant health benefits.

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Brussels Pharma Law Group, founding member and program committee (1995-present)
Regulatory Affairs Journal, member of the editorial board

European Commission Proposes New Powers to Request Confidential Information From Companies and Trade Associations

On May 2, 2017, the European Commission published a legislative proposal for a Regulation on a Single Market Information Tool. If adopted, the proposed Regulation would empower the Commission to request information from companies and trade associations, from a wide variety of industrial, technological and services sectors, if the Commission finds that serious difficulties in applying European Union (“EU”) law may undermine an important Union policy objective. Companies and trade associations failing to provide the requested information would be subject to significant fines.

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

Global Enforcement of the Nagoya Protocol in Life Sciences Industries

In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to unawareness of the regime and uncertainty over its requirements.

ECJ ruling on document access rattles chemical, pesticide industries

Peter Bogaert is quoted in a Politico article regarding the broader impact of a decision by the European Court of Justice in favor of disclosing confidential safety tests by pesticide companies. According to Bogaert, “There is a very serious concern about the dangerous broadening of the definition of what constitutes an emission into the environment.”

Highest EU Court Rules on Ban to Market Cosmetics Tested on Animals

On September 21, 2016, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-592/14 European Federation for Cosmetic Ingredients v UK Secretary of State for Business. The Court has ruled that animal tests performed outside the European Union (EU) to comply with non-EU rules should not be used for the product safety assessment to gain access to the EU internal market for cosmetics.

Impact of Brexit on EU Medical Devices Regulation and Structures

The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest.

Impact of Brexit on Food and Drink Regulations

Last week, the UK voted to leave the European Union in an advisory referendum. The impact of Brexit on food and drink regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest. But we have set out key considerations on this below based on two proposed models being discussed.

Impact of Brexit on Pharmaceutical Regulations and Structures

Last week, the UK voted in an advisory referendum to leave the European Union. The next steps are not yet clear, but the referendum may have significant implications for the pharmaceutical industry in the UK and for international companies operating in the UK. Its impact will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest.

UK would lose two pharma bodies in event of Brexit, lawyers warn

Peter Bogaert and Grant Castle are quoted in a Financial Times article regarding the effect Brexit would have on the UK pharma industry. According to Bogaert, commenting on the important relationship between the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency, “Brexit would be a loss for both sides.” Castle adds that ...

EU Enforcement of the Nagoya Protocol on Use of Genetic Resources

Strict EU rules enforce compliance with the principles on access and benefit sharing under the Nagoya Protocol. The rules affect all companies doing research on genetic resources, such as plants, bacteria and viruses, and related traditional knowledge. They in particular are relevant for the pharmaceutical, medical devices, cosmetics, biocides and foods industries, as well as plant and animal breeders. Compliance needs to be documented as from the beginning of the research. This alert provides a brief overview of the rules and their practical impact.

Chambers Europe and Legal 500 EMEA Recognise Covington in 20 Areas

BRUSSELS, June 11, 2015 — Covington has received 20 leading practice group rankings in the 2015 editions of Chambers Europe and Legal 500 EMEA. The legal guides have recognised the firm’s expertise in the following areas: CHAMBERS EUROPE Europe-wide - Regulatory - Agro/Food Europe-wide - Regulatory - Environment Europe-wide - Regulatory - ...

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 ...

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 ...

Covington Adds Premier EU Competition Practitioner Andrea Zulli

Brussels, 27 October, 2014 — Covington & Burling is pleased to announce that Andrea Zulli is joining the firm’s EU competition group. Mr. Zulli was previously head of the Italian antitrust and competition group at a leading international practice. Mr. Zulli will be resident in the firm’s Brussels office, and will play an important role in the firm’s EU ...

Covington Strengthens EU Competition Practice with Johan Ysewyn and Peter Camesasca

Brussels, 30 April, 2014 — Covington & Burling is pleased to announce that Johan Ysewyn and Peter Camesasca are joining the firm's Brussels office as partners, where they will play substantial roles in the firm’s global antitrust and competition practice. The additions of Mr. Ysewyn and Dr. Camesasca will strengthen the firm’s existing EU competition team in ...

Covington Boosts European Life Sciences Group

Brussels, 19 December, 2013 — Covington & Burling is pleased to announce that Adem Koyuncu is joining its life sciences practice as a partner, along with associate Sabine Stute. Dr. Koyuncu and Ms. Stute will be resident in the firm’s Brussels office, and will focus on issues involving the law of the European Union and, in particular, of Germany. Dr. Koyuncu, ...

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...… ...

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 ...

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 ...

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 ...

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 ...

Covington’s Peter Bogaert Named ‘2012 Lawyer of the Year’

BRUSSELS, 24 May, 2012 — Best Lawyers in Belgium has named Covington & Burling partner Peter Bogaert as the 2012 Brussels “Lawyer of the Year” in the regulatory category for his “abilities, professionalism and integrity.” Best Lawyers recognises one lawyer in each practice area and region. Mr. Bogaert has a broad European life sciences practice. He has detailed ...

Covington Boosts Cross-Atlantic Government Affairs with Jean De Ruyt

BRUSSELS, 17 January, 2012 — Covington & Burling LLP is pleased to announce that Jean De Ruyt has joined the firm’s government affairs group as a senior European policy advisor in Brussels. Ambassador Jean De Ruyt is among the most experienced diplomats in Europe. Most recently, he served as the Permanent Representative of Belgium to the European Union and was ...

Covington Practice Groups and Lawyers Named to PLC Rankings

WASHINGTON, DC, February 15, 2011 — For the seventh time, Practical Law Company has awarded Covington & Burling LLP its worldwide first place ranking in the Life Sciences Regulatory Super League category. PLC also singled out Covington’s Antitrust/Competition, Corporate, and Insurance practices, along with lawyers from each group, in its practice-specific ...

Chambers Europe and Legal 500 EMEA Recognise Covington in 12 Practices

BRUSSELS, July 1, 2010 — Covington & Burling LLP has received a dozen practice nods in the 2010 editions of Chambers Europe and Legal 500 EMEA. The legal guides have recognised the firm’s expertise in the following areas: CHAMBERS EUROPE Competition/European Law - Belgium (including individual rankings for Georg Berrisch, David Hull and Lars Kjølbye) ...

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Chambers Global, Life Sciences (2013-2017)
Chambers Europe, Life Sciences (2009-2017) and Environment - EU Regulatory (2016-2017)
JUVE, Life Sciences and Brussels (2015-2016)
Legal 500 EMEA, EU Regulatory - Food, Pharmaceuticals, Medical Devices & Biotech, Healthcare & Life Sciences (2010-2017), and Chemicals (REACH) (2017)
LMG Life Sciences Europe, Life Sciences Star - Regulatory (Belgium and European Union) (2014)
PLC Which Lawyer?, Life Sciences - Regulatory, Belgium and EU (2001-2012)
Best Lawyers in Belgium, Regulatory (Pharmaceutical) (2009-2015)
Best Lawyers in Belgium, Regulatory "Lawyer of the Year" (2012)
Who's Who Legal, Life Sciences (2011)
Legal Experts EMEA (2010)
Global Counsel, “One of the top ten life sciences lawyers in the world” (2001-2002)

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Education

University of Oxford, B.A., 1984

Katholieke Universiteit Leuven, Lic. Jur., 1982

Katholieke Universiteit Leuven, Bac. Phil., 1980

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