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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 EU 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.
- 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.
Memberships and Affiliations
- Brussels Pharma Law Group, founding member and program committee (1995-present)
- Regulatory Affairs Journal, member of the editorial board
Regulatory Update: Real World Evidence and What Might be on the Horizon
June 19, 2019, Life Sciences Counsel Seminar & Dinner
January 10, 2019, Covington Alert
On January 7, 2019, EU Regulation 2019/5 was published in the Official Journal of the European Union. The Regulation is part of a package that makes numerous significant amendments to the EU’s regime for veterinary medicines and medicated feed, and it also made some key changes to the EU financial penalties regime.
May 2018, Covington Alert
The Nagoya Protocol to the Convention on Biological Diversity entered into force on 12 October 2014. It imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the cosmetics, food, pharmaceutical and other life science sectors. It now has more than 100 contracting parties, including the European Union.
UK And EMA Could Work Together Informally After Brexit
March 15, 2018, The Pink Sheet
Bart Van Vooren and Peter Bogaert are quoted by The Pink Sheet in an article regarding the future relationship between the UK and the European Medicines Agency following Brexit. According to Van Vooren, the EU "considers that cherry-picking the benefits of the internal market on a sector-by-sector basis, combined with a request to be able to influence the rules, ...
January 31, 2018, Covington Alert
In the EU, a sponsor can obtain an “orphan designation” for a medicinal product pursuant to Regulation 141/2000. Adopted in December 1999, the regime aims to encourage investment in R&D for treatments for rare diseases. The most important incentive is the 10-year market exclusivity for designated products. Other incentives include protocol assistance and fee ...
October 10, 2017, EurActiv
Peter Bogaert is quoted in a EurActiv article regarding EU Commissioner for Health and Food Safety Vytenis Andruikaitis' remarks in support of drug innovation. "The incentives which are built in the pharmaceutical regime and especially the SPCs and the regulatory exclusivity aim to work as a stimulus to develop new products in order to basically continue the ...
May 15, 2017, Covington Alert
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 ...
April 26, 2017, Inside EU Life Sciences
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
DIA, IBC- Informa, IIR, and other organizers
2002-present
Mr. Bogaert is a regular speaker, session chair or program chair at conferences sponsored by these organizations.
December 7, 2016, Covington Alert
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 ...
November 23, 2016, Politico
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.”
The Impact of Brexit on the Pharmaceutical Industry and Regulatory Requirements
September 28, 2016, EU Pharmaceutical Regulatory Law
September 21, 2016, Covington Alert
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 ...
July 12, 2016, Inside Medical Devices
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...… Continue Reading
July 11, 2016, Covington Alert
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 ...
June 30, 2016, Covington Alert
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 ...
June 27, 2016, Covington Alert
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 ...
May 8, 2016, Financial Times
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 ...
April 1, 2016, Covington Alert
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 ...
Some policy and legal comments on the new EU
November 19, 2015, Partnerships in Clinical Trials 2015
Compassionate Use & Named Patient Use in the EU
November 13, 2015, Off-label Use in Europe
Clinical Trials - What to expect from the New Regulation?
August 26, 2015, Pharmaceutical Law Academy 2015
June 2015, Intellectual Property & Technology Journal
June 11, 2015
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 - ...
May 19, 2015, Informa Life Sciences’ 24th Annual EU Pharmaceutical Law Forum
The Global Threat of Counterfeiting in the Pharmaceutical Industry
February 10, 2015, World Pharma Licensing Congress Conference
January 27, 2015, Scrip Regulatory Affairs
December 12, 2014, Inside EU Life Sciences
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 ...
October 27, 2014
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 ...
October 27, 2014, Covington E-Alert
Medical Device Directives" and "Revision of the In Vitro Diagnostic Directive
October 1, 2014, Regulation of Medical Devices Conference
Clinical Trials - What to Expect From the New Regulation?
September 17, 2014, Pharmaceutical Law Academy 2014
EU Law and Life Sciences Webinar Series: Pricing & Rebate Strategies
June 17, 2014, Webinar
4/30/2014
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
December 19, 2013
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, ...
In-house Counsel and Private Practice Panel Discussion: Regulatory Frameworks
May 14, 2013, Informa Life Sciences’ 22nd Annual EU Pharmaceutical Law Forum
January/February 2013, FDLI Update
January 3, 2013, Inside EU Life Sciences
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
December 10, 2012, Inside EU Life Sciences
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...… ...
December 10, 2012, Inside EU Life Sciences
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 ...
December 10, 2012, Covington E-Alert
October 3, 2012, Inside EU Life Sciences
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
October 3, 2012, Covington E-Alert
September 26, 2012, Inside EU Life Sciences
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 ...
September 17, 2012, Inside EU Life Sciences
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 ...
September 17, 2012, Covington Advisory
What’s in a Name?
September 5, 2012, Inside EU Life Sciences
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 ...
August 1, 2012, Inside EU Life Sciences
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 ...
June 2012, Scrip Regulatory Affairs
May 24, 2012
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 ...
Regulatory Incentives for Innovation: A success?
March 27, 2012, DIA EuroMeeting
March 1, 2012, Covington E-Alert
1/17/2012
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 ...
August 15, 2011, EuroWatch
August 1, 2011, Covington E-Alert
May 9, 2011, Covington E-Alert
February 15, 2011
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 ...
February 10, 2011, Covington E-Alert
2011, Life Sciences Handbook 2011
November 2010, Regulatory Affairs Pharma
7/1/2010
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) ...
Overview of Approval Process for New Drugs and Devices. Clinical Research Issues. Product Development IP
June 2010, European Healthcare Compliance Certification Programme
Update on EU Pharmaceutical Law and Current Regulatory Developments
May 2010, 19th Annual EU Pharmaceutical Law Forum
Sector Inquiry in the Pharmaceutical Sector: the Way Forward for the Innovative Industry
April 2010, Sector Inquiry in the Pharmaceutical Sector: the Way Forward for the Innovative Industry
Data Exclusivity in the Partnering Context - What are the Opportunities and Challenges for Effective Protection?
April 2010, PLG Spring Meeting
Diagnostics - Regulatory and Legal Incentives for Development and What Can be Improved
March 2010, 22nd Annual DIA EuroMeeting
Counterfeit Medicines and Parallel Import
February 2010, SMi 4th Annual Conference on Pharmaceutical Parallel Trade
December 2, 2009, Covington Advisory
The Pharmaceutical Sector Inquiry of the European Commission and its Consequences for the Pharmaceutical Regulation
December 2009, Competition In Turkish Pharmaceutical Sector Symposium
Potential Borderline Issues in Health Claims such as Sports Nutrition and Beauty Products and Cosmeceuticals
December 2009, 2nd International Workshop on Nutrients and Food Supplements in Europe
October 9, 2009, Covington E-Alert
December 2008, Covington Advisory
2008, PLC Cross-border Life Sciences Handbook
August 2007, EURALex
December 14, 2006, Covington E-Alert
Chairing the Pharmaceutical Law Summer School
July 17, 2006, IBC - Informa, Imperial College London
Biologicals, Tissue Engineered Products and Orphan Medicines
May 16, 2006, The EU Pharmaceutical Law Forum, IBC - Informa, Brussels
Scientific Assessment and the Rule of Law, Current Trends in the Judicial Review of EC Regulatory Acts
2006, Academy of European Law, Brussels
2006, Revue Trimestrielle de Droit Européen, p. 1 - 212, No 1
December 2005, Regulatory Affairs Journal, Vol 16 No 12
December 2005, Regulatory Affairs Journal
June 2005, Covington E-Alert
2004/2005, Global Counsel Life Sciences Handbook
Registratie. Generieke aanvraag. Uitleg Generics-arrest en Novartis-arrest. In wezen gelijkwaardig
September 2004, Jurisprudentie Geneesmiddelenrecht, afl. 3
April 2004, Law & Business, Volume 1, Issues 1&2
March 1, 2003, Global Counsel Life Sciences Industry Report
March 2003, Global Counsel Life Sciences Industry Report
- Chambers Global, Life Sciences (2013-2018)
- Chambers Europe, Life Sciences (2009-2019) 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)