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Michael Clancy

Partner

Sample Lawyer

"Incredibly responsive, he has an incredible understanding of the pharmaceutical industry."

Acritas, Thomson Reuters 2020

Overview

Michael Clancy is a competition lawyer who focuses on providing clients with actionable, commercially-minded advice and solutions, allowing clients to manage complex internal and external challenges and achieve their objectives.

Michael works with clients in a range of industries and has extensive experience in the life sciences sector, where he advises clients on the competition law issues arising throughout the lifespan of a product, including:

Collaborations / Licensing / M&A

With over 15 years of experience advising clients on R&D collaborations, licensing and M&A transactions, Michael helps clients successfully plan, complete and implement complex transactions and long-term collaborations, navigating required government approvals and issues ranging from pricing control/IRP management, trade, exclusivity and information exchange.

Pricing 

Michael routinely advises clients on the pricing of high-profile medicines and other products, working closely with clients’ legal and pricing teams to develop compliant pricing strategies that allow successful agreements with customers and payors, address threats from competitors, and minimize any implementation issues that might otherwise undermine commercial success. Michael also provides advice on internal and external pricing governance systems that allow clients to implement desired pricing strategies across different countries and regions.

Strategies v. Competitors

While it is normal and allowable for companies to prepare for and compete with new entrants to the market and other competitors, certain activities may violate the competition laws and trigger large fines.  Michael works closely with clients’ legal and business teams to develop proactive guidance allowing compliant and effective responses to competitive threats.

Supply and Distribution

While supply and distribution systems are an afterthought in many industries, failure to implement legally robust systems to manage parallel trade, resale pricing and other issues can trigger legal compliance risks and undermine commercial success.  Michael works closely with clients on their supply and distribution systems to proactively address such issues with constructive and compliant solutions.

Compliance Tools

Michael works with clients to develop effective compliance tools, tailored to the clients’ specific business, which allow in-house counsel to constructively advise and guide business teams on competition law issues that may impact commercial success or create legal compliance risks.

Investigation Defense & Complaints

While our objective is always to help our clients avoid legal issues and regulatory scrutiny, where legal challenges arise, Michael works with clients on proactive steps intended to quickly resolve the issue or investigation, and has assisted clients to successfully resolve complaints and investigations by the EU and national competition authorities and before national courts.  Michael also supports clients to take legal actions against competitors engaging in illegal activities.

Languages

English

Recommendations

  • Legal 500 for Healthcare and Life Sciences (‘Next Generation’ leading lawyer)

Education

  • Yale Law School, J.D., 2003
  • University of Dayton, B.A. in Mechanical Engineering, 2000

Publications

Articles on competition law issues arising in the life sciences and other sectors.

Bar Admissions

New York
Brussels

Expertise

Publications and insights

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    • 24/05/2022
    • Articles

    Belgium - Entry into Force of New Law Governing Veterinary Medicinal Products

    The Law of 5 May 2022 regarding veterinary medicinal products (the Law - see, attachment) entered into force on 21 May 2022, subject to limited exceptions in relation to the identification code on the immediate and outer packagings. The Law both complements and implements Regulation (EU) 2019/6 on veterinary medicinal products which started to apply on 28 January 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 10 January 2019; see also, Van Bael & Bellis Life Sciences News and Insights of 10 September 2021). The Law regulates a set of important issues, including clinical trials with veterinary medicinal products; product requirements such as packaging, labelling, and summary of product characteristics (SmPC); marketing authorisations; post marketing authorisation measures, including the requirement to collect data regarding the sales volumes and use of antimicrobial medicines; pharmacovigilance; the manufacturing, preparation, importation and exportation of veterinary medicinal products; wholesale and retail trade, including sales at a distance; parallel trade; veterinary medicinal products prepared in a pharmacy in accordance with a magistral or an officinal formula; inspection, supervision and criminal penalties; and administrative settlements. As a result of the Law, the Law of 25 March 1964 governing medicines will no longer apply to veterinary medicinal products and is for that reason made subject to a lot of modifications. The stated objective of the Law was to create two distinct sets of rules and to have veterinary products covered exclusively by the Law and its implementing Royal Decrees. However, the Law of 28 August 1991 regarding the exercising of the veterinary profession (the Veterinary Profession Law or VP Law) continues to apply and contains several rules that affect veterinary medicines. Additionally, the Law does not address a range of topics for which a separate set of rules was considered to be necessary, while there was no time left to complete the legislative process for that set (as noted, Regulation (EU) 2019/6 has already become applicable on 28 January 2022). This is why a separate statute, currently scheduled to be submitted as a bill to the federal Parliament in the fall of 2022, will regulate the following matters: " Additional indications on the SmPC of homeopathic veterinary medicines; " Additional obligations for wholesalers engaging in the parallel trade of veterinary medicines for reasons of public or animal health; " Authorisations for making preparations; " Substantive requirements for prescriptions; " Processing of personal data contained in inspection files; " Advertising for veterinary medicines; " Rights and obligations of veterinarians with regard to veterinary medicines (Articles 9 to 12 of the VP Law) - It is unclear whether the future law will also tackle Article 17, VP Law which covers pricing issues as well as benefits and reductions given for the benefit of veterinarians.

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    • 16/05/2022
    • Articles

    Belgium - In Enforcement Priority Note for 2022, Pharmaceutical Industry is Again Target of Belgian Competition Authority

    The Belgian Competition Authority (BCA) has just published its enforcement priority note for 2022 (see, attachments). In keeping with its list of priorities in previous years and in tandem with the approach taken by fellow competition authorities, including the Dutch "Autoriteit Consument & Markt", the BCA will continue to have the pharmaceutical industry in the crosshairs and makes it clear that its vigilance and efforts apply to the entire value chain. As if to remind stakeholders that it means business, the BCA refers to recent enforcement action against pharmaceutical wholesalers (see, Van Bael & Bellis Life Sciences News and Insights of 18 February 2022). While this “hybrid” settlement case resulted in a fine of EUR 29.8 million for pharmaceutical wholesaler Pharma Belgium-Belmedis, the BCA continues to pursue proceedings against another wholesaler, CERP, which refused to settle. The BCA is also understood to handle cases involving excessive pricing and access to the hospital market. Of broader interest than the pharmaceutical industry is the BCA’s announcement that its budget will benefit from an increase of EUR 1.4 million (20%). The additional funds are earmarked for staff expansion, IT, knowledge management, and enforcement tools such as e-discovery and whistle blowers.

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    • 04/05/2022
    • Articles

    European Commission Launches European Health Data Space

    On 3 May 2022, the European Commission (the Commission) launched the European Health Data Space (EHDS), the European Union’s first sector-specific set of rules pursuant to its 2020 European data strategy. The EHDS, as expressed in the proposed Regulation on the European Health Data Space (COM(2022) 197 final) and in an associated Commission Communication (COM(2022) 196 final), has two principal components: • primary use of electronic health data, i.e., rules to improve access to and control by natural persons over their personal electronic health data in healthcare; and • secondary use of electronic health data, i.e., rules to broaden the use of health data for the benefit of society at large in areas as diverse as research, innovation, policy-making, patient safety, personalised medicine, statistics and regulatory activities. Under the primary use of electronic health data individuals will have easy and free of charge access to their own health data for purposes of data management and sharing the data with healthcare professionals (HCP) in and across Member States in the language of the HCP. Files such as ePrescriptions, images, and laboratory results will be created and accepted in a common European format and will be stored and transferred in a safe environment. The rights of the individuals will be guaranteed by a new digital health authority in each Member State and each such authority will participate in [email protected], a central platform for digital health that will support and facilitate the exchange of electronic health data between Member State contact points for digital health. The secondary use of electronic health data will boost the access to and utilisation of health data for research and other purposes of benefit to society. Access will be subject to a permit to be delivered by a newly created health data access body which will ensure that the data is used only for defined purposes in a close and secure environment. The identity of individuals will not be revealed, and specific types of data usage will be prohibited. Examples include taking decisions to exclude individuals or groups of natural persons from insurance coverage and engaging in advertising activities that target HCPs, health organisations or individuals. The health data access bodies will be connected to [email protected], a new European facility that creates a link between national contact points and the central platform specifically for the secondary use of electronic health data. The principal documents that embody the EHDS are attached and include the proposed Regulation, the Commission Communication, a Commission press release and a set of questions and answers.

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