Bart Van Vooren, Associate on behalf of Peter Bogaert, Managing Partner and Miranda Cole, Partner
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.
Miranda Cole is a partner in the EU Competition team, working from the Brussels and London offices. She practices all aspects of EC, international and UK competition law and policy, and has more than 18 years of experience in the field. Miranda’s competition law expertise encompasses merger control, compliance, abuse of dominance, vertical and horizontal issues under Article 101, advisory work and actions before the European courts in Luxembourg.
Her practice has a particular focus on advising companies active in the technology, communications and media, software and ecommerce, and aviation sectors. She advises clients on the competition issues raised by IP, data and technology interfaces, including access issues, standardization, remuneration and interoperability. She is increasingly advising clients regarding competition raised by algorithms and other implementations of AI, and connected devices and other Internet of Things applications.
Miranda was recently named among the Politico “2017 Women Who Shape Brussels” list, a group of “20 powerhouses driving debates and influencing policy in 2017.” Miranda is also on the Board of Editors of The Journal of Robotics, Artificial Intelligence & Law.
Bart Van Vooren has a broad European law practice advising innovative multinationals and start-ups on pharmaceuticals, food, and cosmetics.
He leads the practice on compliance with the Nagoya Protocol to the Convention on Biological Diversity (a set of rules to combat bio-piracy). In this area, Mr. Van Vooren has unique experience working for pharmaceutical, cosmetics, food, and biotech companies across four continents.
He has extensive experience in EU litigation, having handled more than 30 cases before the EU Court of Justice for trade associations, companies, and the Belgian government.
Finally, Mr. Van Vooren advises companies on complex issues of EU and public international law that are not typically familiar to practicing attorneys. Hence his significant role in clients’ Brexit preparedness work.
Even though the short term legal and regulatory urgencies continue to take over our lives, it is important not to lose sight of the long term impact.
For instance, the urgency and eagerness of public authorities allows companies to attain some of their legal and public policy goals that otherwise would have been unattainable.
Greater acceptance of initiatives in the field of public health at EU level: The degree to which the EU has been granted powers by the Member States with the Lisbon Treaty (and prior treaties) is clearly visible across the spectrum of measures the EU has taken so far in responding to the crisis. Article 168(1) TFEU states that Union action on public health shall “complement national policies” towards “the fight against the major health scourges.”
For instance, the Joint Procurement Instrument is a good example of this. It is “optional” for the member states to use it, and a specific procurement initiative will only have effect if at least 4 member states sign up. By contrast, the medical device and in vitro diagnostic medical device regulations are based on article 114 TFEU. This is the competence to approximate the member states’ laws to ensure the functioning of the internal market. This is a far ‘stronger’ EU competence than that granted in public health. For instance, on that basis the EU institutions have extended the MDR’s entry into force by one year.
Next, in international trade relations, the EU has exclusive competence to act. That was the legal basis for an EU-wide export ban on medical equipment to third countries. In summary, the EU has, or has not, been granted, that impacts its ability to respond “as one.” Based on the current treaties, the EU can act swiftly and coherently to regulate the exports of medical equipment to third countries, and can impose or delay regulatory requirements that devices must comply with to be placed on the market.
For instance, in the Netherlands there was an informal agreement to supply “own” (i.e. Dutch) clients first; and on 1 April 2020, Belgium adopted a blanket export ban with limited exceptions for supplies destined to other EU countries. Although Belgium changed its rules a week later, the initial reflex was unmistakable. The unified voice amongst the 27 in responding to Brexit was completely absent in responding to COVID-19. However, we expect that COVID-19 will spawn new initiatives to reform the EU and Member States, and perhaps even at an international level – see below.
This will certainly impact the Commission’s Pharmaceutical Strategy for Europe that was initially expected for Q4 of 2020. It looked like this could be further delayed but more recently there are signs it could even be accelerated.
As regards competition law, on 8 April 2020, the European Commission published its Communication on the “Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak”. The Commission stated that the current, exceptional circumstances “may trigger the need for undertakings to cooperate with each other in order to overcome or at least mitigate the effects of the crisis to the ultimate benefit of citizens” (para 3).
The purpose of the Framework is to: (i) explain the main criteria that the Commission will follow when assessing possible cooperation projects between undertakings aimed at addressing the shortage of essential products and services during the COVID-19 outbreak; (ii) describe the exceptional procedure that the Commission has set up to provide, where appropriate, ad hoc ‘comfort letters’ to undertakings in relation to specific cooperation projects. The Framework applies to forms of cooperation between undertakings aimed at ensuring the supply and adequate distribution of essential scarce medicinal products and medical equipment (presumably not only medical devices but also personal protective equipment), as well as related services, during the pandemic. Undertakings currently active in the health sector can benefit from it, but so can those active in other sectors that are retooling to focus on scarce products.
World Health Organization (WHO) may be reformed following the COVID-19 crisis.
First, The World Health Assembly (WHA) was scheduled for next month. It was initially cancelled, but now it is likely that there will be a virtual WHA entirely focused on COVID-19. On 15 April, the EU mission proposed that all WHO member states would “Work collaboratively at international level to develop, test and produce safe, effective, quality diagnostics, medicines and vaccines for the COVID-19 response, and to facilitate the equitable and affordable access of people to them, including through voluntarily pooling their intellectual property for all COVID-19-related medical interventions.”
Second, In April 2019, the WHA decided that: “WHO is ready to explore, in close dialogue and collaboration with all relevant partners, possible options, including codes of conduct, guidelines and best practices, and global multilateral mechanisms, for pathogen access and benefit sharing.” Even before the COVID-19 crisis, it was contemplating a new international regime that would have the following focus: “food safety, antimicrobial resistance, tuberculosis, HIV infection, malaria, and emerging high-threat pathogens like the Middle East respiratory syndrome coronavirus, and Zika, Ebola and Lassa viruses, as well as unknown future threats.” COVID-19 is likely to give a significant boost to these initiatives.
