On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.

Throughout the day our speakers shared their perspectives on a range of legal, regulatory, and business trends, including the evolving regulatory frameworks in the EU and UK; information exchange in ongoing collaboration; investigations and whistleblowing; key ESG topics, and the complexity of options to acquire in pharma deals.

We have set out some of the discussion from the sessions below.

European Life Sciences – The Changing Landscape for Pharma and Biotech

Grant Castle, Head of Covington’s European Life Sciences Regulatory Practice, Peter Bogaert, Marie Doyle-Rossie and Anna Wawrzyniak kicked off with a discussion about the Changing Landscape for Pharma and Biotech.

The UK and EU both aim to deliver access to innovative and transformative medicines and foster international competitiveness in the life sciences industry. Despite the practical challenges faced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in recent years, it has emerged as an ambitious regulator and is establishing innovative regulatory frameworks, including an international reliance scheme (see our update here), point of care manufacturing regulations, and the relaunch of the Innovative Licensing and Access Pathway (ILAP).

The EU is also pursuing a wave of legislative reform, including wide ranging revisions to the EU’s pharmaceutical legislation, the EU’s supplementary protection certificates (SPC) rules, and proposals for a compulsory licensing scheme.

There can sometimes be a tension between the UK’s and EU’s aims and the practical impacts of regulatory reform, especially in the early stages of implementation.

The EU HTA Regulation

This tension was evident in Adem Koyuncu’s and Raj Gathani’s overview of the EU HTA Regulation: Practical and Legal Points for 2025 & Beyond. From this year, the EU HTAR will introduce a Joint Clinical Assessment (JCA), a form of health technology assessment focused on relative clinical effectiveness against one or more selected comparators, for new medicines subject to an application for an EU centralised marketing authorisation. JCAs are designed to facilitate market access for medicines by supporting Member State evaluation of medicines for pricing and reimbursement.

Adem and Raj discussed how JCAs are likely to be resource-intensive for companies with compressed timelines. Further, it is not clear if the EU has enough assessors or resources; the Annual Work Programme 2025 predicts that 25 JCAs will be initiated, but only 10 joint scientific consultations (JSCs), which enable companies to obtain scientific advice on the data requirements for each JCA process, will be offered.

It remains unclear what impact the JCA process will have on Member States, who must give JCAs “due consideration”, and whether the company can challenge an unfavourable JCA.

Companion Diagnostics under the IVDR

A more established regulatory framework that poses ongoing challenges for the EU’s aim to deliver innovative and personalised medicine, and compete for a share of commercial clinical trials, is the EU’s In-vitro Diagnostic Medical Devices Regulation (IVDR).

In Sarah Cowlishaw and Roderick Dirkzwager’s talk on Companion Diagnostic Development, Sarah outlined how, since the introduction of the IVDR in 2022, companion diagnostic (CDx) devices have been subject to higher pre-market regulatory requirements, such as increased Notified Body involvement and drug authority consultation.

Roderick observed how the lack of alignment between the IVDR and Clinical Trial Regulation can create unique regulatory challenges (and delays) for the use of CDx devices in EU drug clinical trials. A recent report by IQVIA for EFPIA and Vaccines Europe suggests that since 2018 the IVDR may have contributed to a 22% reduction in oncology trials and a 42% reduction in neurology trials in the EEA.

Sarah and Roderick concluded by exploring how parallel requirements under pre- and post- market drug and device regulations raise unique challenges for CDx device collaborations, such as which partner is responsible for regulatory compliance of CDx performance studies.

Efforts Clauses

In life sciences collaborations, commercial partners may negotiate the delegation of responsibility by using “efforts clauses” to qualify their obligations.

Jonathan Gimblett and Monique O’Donoghue, from our International Arbitration and Disputes practice, presented on this topic: Efforts Clauses in Life Sciences Contracts. They explained how the interpretation of efforts clauses, from “commercially reasonable efforts” to “best efforts” (“endeavours” for those in the UK), varies by jurisdiction.

Uncertainty in interpreting efforts obligations and the risk of dispute can be reduced by expressly stating in the contract the steps the obligor should take to achieve the relevant objective, and by considering factors such as cost and time expenditure. Comparative standards for effort (e.g., similarly situated pharma companies) can also reduce uncertainty, and, in the event of a dispute, may enable an expert to comment on industry standards.

Environmental, Social and Data Laws

In the opening panel, Grant Castle discussed how it is now, more than ever, important to look beyond pharma laws at environmental, social and data laws.

To that end, Grant, Mark Young and Paul Maynard provided an update on the EU’s NIS2 Directive: Complying with NIS2 and Update on National Laws. NIS2 imposes new security and governance requirements and short incident reporting windows. Companies will need to consider the intersection of NIS2 with existing rules related to data integrity and security under sector-specific rules.

Colleagues also presented on ESG – Key Topics for Life Sciences Companies. Cándido García Molyneux discussed the significant financial impact the EU’s new Urban Wastewater Treatment Directive (UWWTD) will have on producers of pharmaceutical (and cosmetic) products. The UWWTD requires producers to pay 80% of the cost (capital and operational) of quaternary treatment to remove micropollutants from wastewater.

Another emerging financial and compliance burden for pharmaceutical companies, considered by Bart Van Vooren, is the stacking of global and national access and benefit-sharing obligations, which require companies to disclose their use of non-human biological materials and digital sequence information, and pay “taxes” for using such information.

Seán Finan provided some practical examples of how pharmaceutical companies making green claims should take care to comply with both the general rules on green claims and greenwashing (the EU’s Greenwashing Directive and Green Claims Directive), and the specific rules on advertising and communicating for the pharmaceutical industry.

Options to Acquire

A multidisciplinary panel hosted by James Halstead on an innovative exit strategy, Options to Acquire, concluded the Symposium.

Under an option to acquire structure the pharma partner is granted a right to acquire the whole of a smaller target company or part of that company’s portfolio, typically alongside a funded collaboration. The parties pre-agree the exit terms (including price), locking-in the target’s asset(s) and determining the target’s strategic focus.

Winsome Cheung and Ben Land-Maycock discussed how this structure is best suited to early-stage single asset transactions where pricing can be more readily agreed.

It is often many months (indeed, years) before the option is exercised, which, as Inga Pietsch explained, requires deal terms to be flexible enough to accommodate an evolving asset and intellectual property portfolio. Bethan Lukey described how the time between the initial investment and the option being exercised can also create complexity for merger control.

Guy Dingley provided an overview of key tax considerations, including the treatment of the option fee, R&D tax relief and shareholder EIS relief.

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We would like to thank our industry connections for attending the Symposium, and look forward to hosting similar events in the future.

If you would like to discuss the latest European life sciences developments and what they may mean for your company’s operations, please feel free to reach out to our specialist UK and EU teams or the speakers.

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Photo of Grant Castle Grant Castle

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law…

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 21 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

Photo of Peter Bogaert Peter Bogaert

Peter Bogaert 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 EU Courts in Luxembourg and in local…

Peter Bogaert 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 EU Courts in Luxembourg and in local litigation in Belgium. Peter’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 Peter’s prominent regulatory pharmaceutical and environmental practice. Legal 500 EME noted that he is “a superb lawyer who is very pleasant to work with.” Peter regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group and also served for fifteen years as Managing Partner of the firm’s Brussels office.

Photo of Marie Doyle-Rossi Marie Doyle-Rossi

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics…

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics, biologics, combination products, digital health and personalized medicine.

Marie provides strategic, policy and regulatory advice on biologics, orphans, human tissue and cells, market and data exclusivity, clinical trials, pricing and reimbursement, product life-cycle management, data privacy and compliance issues.

She has developed considerable expertise in GxP, including adverse event reporting, quality systems and manufacturing, supply chains and recalls. She regularly counsels clients on “Brexit” related issues from both a UK, EU and Irish perspective.

Marie also advises on, and performs regulatory due diligence for, corporate/commercial transactions including acquisitions, public offerings and clinical trial agreements.

She is associate co-chair of Covington’s Food, Drug, and Device Rapid Response team during the COVID-19 pandemic.

Photo of Anna Wawrzyniak Anna Wawrzyniak

Anna Wawrzyniak is a senior scientific and regulatory advisor in the Life Sciences team. As a non-lawyer with a Ph.D. in biomedical sciences, Anna provides detailed scientific and regulatory advice to the firm’s pharmaceutical, food and feed clients. She draws on her technical…

Anna Wawrzyniak is a senior scientific and regulatory advisor in the Life Sciences team. As a non-lawyer with a Ph.D. in biomedical sciences, Anna provides detailed scientific and regulatory advice to the firm’s pharmaceutical, food and feed clients. She draws on her technical and regulatory expertise to help clients in strategic planning and in navigating regulatory proceedings, especially in areas where a deep understanding of the underlying science is important. In particular, she advises pharmaceutical clients on regulatory issues relating to product classification, biologics, advanced therapies, orphans, paediatrics, market and data exclusivities.

Anna has deep expertise in the following areas:

  • The development and approval of medicinal products;
  • Strategies for obtaining and maintaining regulatory exclusivities, including orphan market exclusivities, regulatory data exclusivities (new active substance status) and paediatric incentives;
  • Support to high stake litigation on regulatory aspects;
  • PRIME, accelerated approvals, conditional and exceptional marketing authorisations;
  • Advanced therapies, biologic and substances of human origin;
  • Borderline classification;
  • Regulatory due diligence;
  • Novel foods and food supplements; and
  • Feed.
Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem is a life sciences industry advisor with more than 25 years of professional experience. He has a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. Adem also provides strategic advice. He knows the life sciences sector also from…

Adem is a life sciences industry advisor with more than 25 years of professional experience. He has a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. Adem also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “Adem Koyuncu is one of the most intelligent lawyers I know.” (Legal 500 2023)
  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • “Great professional and human competence, good team player.” (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “He is an excellent dispute resolution lawyer and advises at the highest level, including, in particular, strategic advice.” (Legal 500 2023)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.” (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

Photo of Raj Gathani Raj Gathani

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals…

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals and patients, pricing controls and reimbursement strategies particularly in the UK and the Republic of Ireland.

Healthcare, its structure and delivery are specialist practice areas for Raj, particularly having operated healthcare and pharmacy businesses for eight years prior to joining the firm. This experience enables Raj to provide in-depth advice to healthcare clients –particularly those in the digital health space – as well as other life sciences companies whose work engages medical practice, dispensing and health-services rules.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Sarah regularly advises on:

  • obligations under the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, including associated transition issues, and UK-specific considerations caused by Brexit;
  • medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • borderline classification determinations for software medical devices;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah is also Graduate Recruitment Partner for Covington’s London office.

Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Roderick is also a member of Covington’s Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

Photo of Jonathan Gimblett Jonathan Gimblett

Jonathan Gimblett joined the firm in 2004 following a successful career in the British Diplomatic Service. His practice combines international and antitrust law, drawing on his experience of 15 years in government. Jonathan’s international practice focuses principally on investor-state arbitration and public international…

Jonathan Gimblett joined the firm in 2004 following a successful career in the British Diplomatic Service. His practice combines international and antitrust law, drawing on his experience of 15 years in government. Jonathan’s international practice focuses principally on investor-state arbitration and public international law disputes, on which he advises both states and corporate clients. He also represents clients in U.S. federal court litigation relating to international law issues, including the application of the Foreign Sovereign Immunity Act (“FSIA”). His antitrust practice embraces litigation, counseling of corporate clients, and regulatory matters.

Photo of Mark Young Mark Young

Mark Young is an experienced tech regulatory lawyer and a vice-chair of Covington’s Data Privacy and Cybersecurity Practice Group. He advises major global companies on their most challenging data privacy compliance matters and investigations. Mark also leads on EMEA cybersecurity matters at the…

Mark Young is an experienced tech regulatory lawyer and a vice-chair of Covington’s Data Privacy and Cybersecurity Practice Group. He advises major global companies on their most challenging data privacy compliance matters and investigations. Mark also leads on EMEA cybersecurity matters at the firm. In these contexts, he has worked closely with some of the world’s leading technology and life sciences companies and other multinationals.

Mark has been recognized for several years in Chambers UK as “a trusted adviser – practical, results-oriented and an expert in the field;” “fast, thorough and responsive;” “extremely pragmatic in advice on risk;” “provides thoughtful, strategic guidance and is a pleasure to work with;” and has “great insight into the regulators.” According to the most recent edition (2024), “He’s extremely technologically sophisticated and advises on true issues of first impression, particularly in the field of AI.”

Drawing on over 15 years of experience, Mark specializes in:

  • Advising on potential exposure under GDPR and international data privacy laws in relation to innovative products and services that involve cutting-edge technology, e.g., AI, biometric data, and connected devices.
  • Providing practical guidance on novel uses of personal data, responding to individuals exercising rights, and data transfers, including advising on Binding Corporate Rules (BCRs) and compliance challenges following Brexit and Schrems II.
  • Helping clients respond to investigations by data protection regulators in the UK, EU and globally, and advising on potential follow-on litigation risks.
  • Counseling ad networks (demand and supply side), retailers, and other adtech companies on data privacy compliance relating to programmatic advertising, and providing strategic advice on complaints and claims in a range of jurisdictions.
  • Advising life sciences companies on industry-specific data privacy issues, including:
    • clinical trials and pharmacovigilance;
    • digital health products and services; and
    • engagement with healthcare professionals and marketing programs.
  • International conflict of law issues relating to white collar investigations and data privacy compliance (collecting data from employees and others, international transfers, etc.).
  • Advising various clients on the EU NIS2 Directive and UK NIS regulations and other cybersecurity-related regulations, particularly (i) cloud computing service providers, online marketplaces, social media networks, and other digital infrastructure and service providers, and (ii) medical device and pharma companies, and other manufacturers.
  • Helping a broad range of organizations prepare for and respond to cybersecurity incidents, including personal data breaches, IP and trade secret theft, ransomware, insider threats, supply chain incidents, and state-sponsored attacks. Mark’s incident response expertise includes:
    • supervising technical investigations and providing updates to company boards and leaders;
    • advising on PR and related legal risks following an incident;
    • engaging with law enforcement and government agencies; and
    • advising on notification obligations and other legal risks, and representing clients before regulators around the world.
  • Advising clients on risks and potential liabilities in relation to corporate transactions, especially involving companies that process significant volumes of personal data (e.g., in the adtech, digital identity/anti-fraud, and social network sectors.)
  • Providing strategic advice and advocacy on a range of UK and EU technology law reform issues including data privacy, cybersecurity, ecommerce, eID and trust services, and software-related proposals.
  • Representing clients in connection with references to the Court of Justice of the EU.
Photo of Paul Maynard Paul Maynard

Paul Maynard is special counsel in the technology regulatory group in the London office. He focuses on advising clients on all aspects of UK and European privacy and cybersecurity law relating to complex and innovative technologies such as adtech, cloud computing and online…

Paul Maynard is special counsel in the technology regulatory group in the London office. He focuses on advising clients on all aspects of UK and European privacy and cybersecurity law relating to complex and innovative technologies such as adtech, cloud computing and online platforms. He also advises clients on how to respond to law enforcement demands, particularly where such demands are made across borders.

Paul advises emerging and established companies in various sectors, including online retail, software and education technology. His practice covers advice on new legislative proposals, for example on e-privacy and cross-border law enforcement access to data; advice on existing but rapidly-changing rules, such the GDPR and cross-border data transfer rules; and on regulatory investigations in cases of alleged non-compliance, including in relation to online advertising and cybersecurity.

Photo of Cándido García Molyneux Cándido García Molyneux

Cándido García Molyneux provides clients with regulatory, policy and strategic advice on EU environmental and product safety legislation. He helps clients influence EU legislation and guidance and comply with requirements in an efficient manner, representing them before the EU Courts and institutions.

Cándido…

Cándido García Molyneux provides clients with regulatory, policy and strategic advice on EU environmental and product safety legislation. He helps clients influence EU legislation and guidance and comply with requirements in an efficient manner, representing them before the EU Courts and institutions.

Cándido co-chairs the firm’s Environmental Practice Group.

Cándido has a deep knowledge of EU requirements on chemicals, circular economy and waste management, climate change, energy efficiency, renewable energies as well as their interrelationship with specific product categories and industries, such as electronics, cosmetics, healthcare products, and more general consumer products.

In addition, Cándido has particular expertise on EU institutional and trade law, and the import of food products into the EU. Cándido also regularly advises clients on Spanish food and drug law.

Cándido is described by Chambers Europe as being “creative and frighteningly smart.” His clients note that “he has a very measured, considered, deliberative manner,” and that “he has superb analytical and writing skills.”

Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Bart has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.

During his previous professional career, Bart was a professor of EU law at the University of Copenhagen and published a couple of books with Oxford and Cambridge University Press. His academic swan song was the (now leading) textbook republished in 2020 by his former academic colleagues in 2nd edition: EU External Relations Law, available from Hart Publishing.

Photo of Seán Finan Seán Finan

Seán Finan is an associate in the Life Sciences team. His practice covers environmental, food and beverage and pharmaceutical regulation.

Seán has specific experience in a number of key areas for EU and UK clients in the technology, food and beverage, pharmaceutical, cosmetic…

Seán Finan is an associate in the Life Sciences team. His practice covers environmental, food and beverage and pharmaceutical regulation.

Seán has specific experience in a number of key areas for EU and UK clients in the technology, food and beverage, pharmaceutical, cosmetic and consumer goods industries, including:

  • Environmental and ESG compliance issues, including CSRD, CSDDD and green taxonomy issues; green public procurement issues; extended producer responsibility obligations, etc.;
  • Advertising claims, particularly environmental claims and greenwashing;
  • General food regulation; novel food regulation; genetically modified and “precision bred” products; and
  • Chemicals legislation (REACH, CLP, biocides, etc.).

Seán has represented clients in judicial review actions involving novel foods against multiple national regulators.

Seán is qualified in both England & Wales, and the Republic of Ireland.

Seán is a co lead of the firm’s Disability and Mental Health affinity group.

Photo of James Halstead James Halstead

James Halstead is a managing partner of Covington’s London office and a member of the Corporate Practice.

He is recognised by his clients for his expertise in handling complex transactions. His clients include international pharmaceutical and tech companies, as well as leading venture…

James Halstead is a managing partner of Covington’s London office and a member of the Corporate Practice.

He is recognised by his clients for his expertise in handling complex transactions. His clients include international pharmaceutical and tech companies, as well as leading venture and growth capital investment funds active in these sectors together with their portfolio companies. His practice is focused on transactions concerning the development of, and realization of value in, new technologies. He has substantive experience in sell and buy-side M&A transactions and regularly advises on fund raisings. James also advises on commercial transactions including technology transfers, intellectual property pipeline arrangements, licensing and joint ventures.

According to Chambers UK, “James Halstead is very adaptable and works on both the corporate equity side and life sciences licensing.” 

Photo of Winsome Cheung Winsome Cheung

Winsome Cheung assists life sciences and technology companies to develop and commercialise their intellectual property assets. She advises on their strategic licensing and partnering transactions, and intellectual property and commercial matters throughout the entire product lifecycle.

Winsome Cheung is a partner in Covington’s…

Winsome Cheung assists life sciences and technology companies to develop and commercialise their intellectual property assets. She advises on their strategic licensing and partnering transactions, and intellectual property and commercial matters throughout the entire product lifecycle.

Winsome Cheung is a partner in Covington’s life science transactions team.

She advises a broad range of clients in the life sciences and technology industries, from start-ups, venture capital investors to global pharmaceutical companies. As a former scientist, she combines her scientific understanding with her legal and commercial knowledge to help companies build value and monetise their intellectual property assets.

Winsome regularly advises on:

  • Complex partnering arrangements, including licensing, collaboration, co-development, co-promotion and other strategic arrangements.
  • Commercial agreements throughout the entire lifecycle of life sciences and technology assets, including CRO, clinical trial, manufacturing and distribution agreements.
  • Intellectual property and commercial matters in relation to corporate transactions and venture investments, including:
    • IP and commercial diligence;
    • Ancillary/transitional agreements; and
    • IP warranties, contingent consideration provisions of share purchase/asset purchase agreements.

Prior to her legal career, Winsome completed an undergraduate degree in Biochemistry and a PhD in Medicine. During her doctoral research, she discovered a novel virus-host cell interaction which led to major scientific publications, and explored commercialisation of this research.

Photo of Ben Land-Maycock Ben Land-Maycock

Ben Land-Maycock helps clients execute strategic transactions. He acts on a full scope of transactional matters including public and private mergers and acquisitions, venture capital and private equity investments, restructurings, and IPOs and equity capital markets transactions.

Ben regularly advises companies in the…

Ben Land-Maycock helps clients execute strategic transactions. He acts on a full scope of transactional matters including public and private mergers and acquisitions, venture capital and private equity investments, restructurings, and IPOs and equity capital markets transactions.

Ben regularly advises companies in the technology, life sciences, and energy sectors. He represents many private equity and venture capital (including corporate venture capital) investors on their investments and exits.

Ben also provides day-to-day company law advice for public and private companies.

Photo of Inga-Marlene Pietsch Inga-Marlene Pietsch

Inga-Marlene Pietsch is an intellectual property lawyer in Covington’s Life Sciences Transactions team assisting clients in protecting and enforcing their most valuable assets.  She works closely with other teams across the firm in particular the Corporate and Regulatory teams.

Inga has an extensive…

Inga-Marlene Pietsch is an intellectual property lawyer in Covington’s Life Sciences Transactions team assisting clients in protecting and enforcing their most valuable assets.  She works closely with other teams across the firm in particular the Corporate and Regulatory teams.

Inga has an extensive contentious and non-contentious IP practice advising companies from the Life Sciences and Technology sectors on complex IP issues with a particular focus on patents. Her previous experience in patent litigation gives Inga a unique perspective on IP issues that arise.

Inga’s clients include start-up companies as well as large corporations advising throughout the company life cycle.

Inga regularly advises clients on:

  • IP aspects in transactions
  • IP strategy and landscaping
  • Third party IP risk assessments
  • IP ownership and entitlement
  • IP validity assessments
  • Cross-border IP issues
  • Supplementary Protection Certificates

Inga also advises clients on managing and protecting their trade secrets and confidential information, assisting clients in auditing and identifying their trade secrets and putting procedures and processes in place to establish good trade secrets and confidential information handling practices.

Prior to her legal career Inga completed a Ph.D. in Organic Chemistry and worked for a custom synthesis start-up company.

Photo of Guy Dingley Guy Dingley

Guy Dingley is a partner in Covington’s London office, concentrating on taxation and employee benefits, with a particular emphasis on corporate taxation and value added tax, taxation of investment funds, global mobility, and the establishment of incentive arrangements.

Guy’s practice encompasses corporate and…

Guy Dingley is a partner in Covington’s London office, concentrating on taxation and employee benefits, with a particular emphasis on corporate taxation and value added tax, taxation of investment funds, global mobility, and the establishment of incentive arrangements.

Guy’s practice encompasses corporate and business acquisitions and disposals, mergers and reconstructions together with advice on the tax aspects of supply chain management and employee remuneration.

In the share incentive arena, Guy has advised clients on the establishment of a wide range of share incentive arrangements designed to suit their business objectives, and often with tax benefits.

Guy has extensive experience of structuring investments and acquisitions in over twenty five jurisdictions, including continental Europe, Australia, India, and China. His expertise covers a wide variety of industry sectors, but he has particular experience in the life sciences, telecommunications and media, branded goods and energy arenas.

Photo of Bethan Lukey Bethan Lukey

Bethan advises on all aspects of EU and UK competition law, with a focus on merger control and foreign investment review. She also regularly advises clients subject to antitrust investigations and the application of EU state aid and UK subsidy control legislation. Bethan’s…

Bethan advises on all aspects of EU and UK competition law, with a focus on merger control and foreign investment review. She also regularly advises clients subject to antitrust investigations and the application of EU state aid and UK subsidy control legislation. Bethan’s practice covers a broad range of sectors with a focus on healthcare and consumer goods.

Bethan has previously undertaken secondments in Brussels and Stockholm, as well as a client secondment to a leading UK news and entertainment public company.

Mark Mitchell

Mark Mitchell is a Trainee Solicitor who attended BPP University Law School.