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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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    • 25/10/2021
    • Articles

    European Commission Carries Out Dawn Raid at Belgian Premises of Animal Health Firm

    The European Commission (the Commission) announced this morning that it is carrying out unannounced inspections at the Belgian premises of a firm active in the animal health sector (see, attachment). The firm is suspected of having engaged in conduct in breach of Article 102, Treaty on the Functioning of the European Union, which prohibits the abuse of a dominant position on the relevant market. However, the Commission did not offer any details regarding the practices under review. The inspections follow on the heels of a speech on the subject of cartel enforcement which Commissioner Margrethe Vestager, responsible for competition policy, delivered last Friday in Rome. In that talk, the Commissioner not only referred to the high-profile inspections which the Commission had already carried out earlier in October 2021 in the wood pulp sector. She made it also clear that more would follow: “And that’s just the start of a series of raids that we’re planning for the months to come – you’ll understand if I don’t say exactly when or where they’re going to happen”. The Commissioner thus issued a strong warning to the business community that the Commission had emerged from the Covid-19 pandemic and that the Commission’s “work on collecting evidence [would be] gathering pace”. Commissioner Vestager also explained that, given the decrease in the number of leniency applications, the Commission is investing in alternative ways of detecting cartels. In leniency applications, members of a cartel take the initiative to contact a competition authority, confess their participation in the cartel and help the competition law enforcers to dismantle and sanction the cartel. The alternative detecting methods contemplated by Commissioner Vestager include (i) the development of an electronic tool for use by whistle blowers; (ii) the increased reliance on intelligence analysts and data scientists; (iii) informal discussions with industry members (“people on the ground”); and (iv) the sharing of ex officio leads with fellow competition authorities and other law enforcement agencies.

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    • 19/10/2021
    • Articles

    European Commission Updates Q&A on EU Clinical Trials Regulation

    On 18 October 2021, the European Commission published in Volume 10 (“Clinical trials guidelines”) of EudraLex an updated version of its Q&A document on the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014 – the CTR). The updated Q&A document replaces the previous version issued in July 2021. The document: • provides additional guidance on the content and way of submission of the protocol synopsis as referenced in Annex I, point D.24 of the CTR (see, updated answer to question 5.8); • clarifies how sponsors should determine and report the anticipated submission date of the annual safety report (see, answer to new question 7.39); • clarifies that “[i]nformation regarding the [good manufacturing practice] compliance of the active pharmaceutical ingredients is not required by the CTR (and can therefore not be required by the Member States Concerned)” (see, updated answer to question 8.4); and • is accompanied by an updated Annex II (“Language requirements for part I documents”). The CTR will enter into force on 31 January 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021, 9 August 2021 and 11 October 2021). It provides for a three-year transitional period during which clinical trials will be gradually transitioned into the CTR system. By 1 February 2025, all clinical trials will be governed by the CTR, regardless of their submission date.

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    • 14/10/2021
    • Articles

    European Commission Proposes to Delay Application of Regulation on In Vitro Diagnostic Medical Devices

    The European Commission (the Commission) published today a proposal for a Regulation delaying the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) by three to five years, depending on the risk involved in the devices concerned (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices – the Proposal; see, attached copy). The IVDR was set to take effect on 26 May 2022. Referring to the extraordinary circumstances created by the COVID-19 pandemic and the resulting delay in the designation and work of notified bodies under the IVDR, the Proposal stresses that immediate action is necessary to avert a “significant disruption in the supply of in vitro diagnostic medical devices on the market both for health institutions and for the public” (p. 2). To date, only six notified bodies have been designated under the IVDR. Moreover, these six notified bodies are established in only three countries (France, Germany and the Netherlands). Extending the existing transitional period for devices covered by a valid certificate issued under the current in vitro diagnostic medical devices Directive (Directive 98/79/EC) by one year, the Proposal provides that these devices can continue to be placed on the market or put into service until 26 May 2025. Furthermore, the Proposal introduces tailored transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under the IVDR. For these devices, the length of the transitional period will depend on the risk class of the device concerned. Lower risk devices such as class B and class A sterile devices will benefit from a transition period until 26 May 2027, whereas higher risk devices (class D and class C devices) will only have a transition period until, respectively, 26 May 2025 and 26 May 2026. The Proposal responds to a widespread call for delayed application of the IVDR. This call is not new though. As early as in April 2020, the European trade association for the medical devices sector, MedTech Europe, warned that “even before the COVID-19 pandemic, very little progress had been achieved yet, to get the new IVDR regulatory system ready” and that “since the present COVID-19 outbreak, the IVDR implementation progress has come to a total halt” (see, Van Bael & Bellis Life Sciences News and Insights of 24 April 2020).

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