Arthur Cox is a market leader in the provision of legal services to the Life Sciences industry, with a multi-disciplinary practice group successfully combining the very best of the firm’s corporate, commercial, transactional, regulatory, competition and intellectual property expertise to serve the pharmaceutical, biotechnology, medical devices, food and cosmetics industries in Ireland. Combining legal skill with solid industry knowledge, Arthur Cox represents many of Ireland and the world’s major pharmaceutical, medical devices and agri-business companies.
The Life Sciences team advises overseas and domestic clients on establishing operations in Ireland and on all aspects and stages of the life cycle of a product, from research and development through to manufacturing and marketing of finished products. Our extensive experience in this sector, allied with strong links with local and EU trade and regulatory associations, enables us to anticipate and identify potential issues in advance, thereby ensuring the smooth operation of our clients’ businesses. It is for this reason that we count many of the world’s leading pharmaceutical, medical device and biotech companies among our clients.
Please also visit our Life Sciences online resource, “BioBrief“, in the Updates section of the site, for the latest news and commentary on a range of issues relevant to life sciences industries operating in Ireland and abroad.
Arthur Cox Dawn Raid Response Unit
The regulation of business is growing internationally with the aim of ensuring the protection of consumers’ interests and a level playing field for businesses. However, the enforcement of regulation also brings challenges for businesses. Unannounced inspections, also known as “dawn raids”, are an important enforcement tool at the disposal of regulators, but can cause significant disruption to businesses. Understanding the purpose of unannounced inspections, how they are conducted and the extent of your rights and obligations during an inspection will help you better manage inspections and ensure your interests are protected. Learn more about the Dawn Raid Response Unit here.
Expertise – Pharmaceuticals, Medical Devices, Biotech AND DIGITAL HEALTH
The team advises on the full range of issues relevant to the Life Sciences industry including:
Our clients include many of the major multinational and domestic pharmaceutical, diagnostic and medical device companies, ranging from start-ups and university spin-outs to large multinationals and industry leaders. We provide broad based legal solutions and tax advice in relation to the negotiation and structuring of a variety of transactions including mergers, acquisitions, migrations, inversions, pre-sale spinouts or hive downs, business and product acquisitions and disposals, restructurings, reorganisations, cross-border mergers, distributions, joint ventures, corporate structures and related structural issues.
We have a proven track record in advising our clients in the sector on the negotiation and drafting of a wide-range of commercial agreements including contract and toll manufacturing, licensing, distribution, logistics, confidentiality, clinical trials, research and development collaborations, outsourcing, sourcing and supply, and other strategic alliance arrangements.
With our unrivaled knowledge of the industry, our Life Sciences Regulatory and Compliance team partners with market-leaders in the pharmaceutical, biotechnology, medical devices, food and cosmetics fields throughout the lifecycle of products, from development right through to marketing, providing specific advice on all regulatory and compliance issues. The team advises on clinical trials, product classification, marketing authorisation, CE marking, licensing, importation, manufacture and distribution, promotion and marketing practices, packaging and labelling, market access queries, pharmacovigilance, data protection and pricing and reimbursement.
We also draw on the strength of other relevant practice groups within the firm to provide comprehensive and strategic advice in contentious and non-contentious cases, in relation to managing risk, product safety issues and responding to inspections and other enforcement actions by competent authorities.
We also advise on specialist life sciences matters, including genetically modified organisms and derivate products, blood and tissue, biologics, biosimilars, combination products, the importation and use of embryonic stem cells in research, and other emerging areas such as the regulation of nanotechnology.
Many of our clients are navigating the challenges posed by the convergence of technologies in their products, with medical devices, medicinal products and software being increasingly combined, for example in medical software applications and remote medical technologies. Our Digital Health team regularly advises on the regulatory and data protection implications of such convergence.
We also have a comprehensive Food and Drink practice, advising on the manufacture, promotion and sale of consumables in Ireland. With our in-depth knowledge of the food industry, we work with our clients to address their regulatory concerns, advising on the labelling and advertising of food products and supplements, recall procedures, nutrition and health claims and restrictions on allergens and additives.
Product Liability and Product Safety
The Life Sciences team draws on the expertise of the firm’s Product Liability and Product Safety group in advising on non-contentious and contentious product liability and safety issues relevant to the pharmaceutical, medical device and related medical product sectors. Our advice encompasses general and sector-specific EU and national requirements.
We have unrivalled experience in large-scale, multi-party product liability litigation, including the largest such case ever to have come before the Irish Courts. Managing complex product liability litigation requires an overall strategy that is sensitive not only to the litigation environment and objectives but also to the commercial, regulatory and public relations concerns that inevitably accompany such situations.
We offer comprehensive and strategic advice, both at the pre-litigation stage and in non-contentious cases, in relation to risk management, product withdrawal and recall, crisis management strategies, specialist insurance advice and other related issues.
The life sciences team benefits from the firm’s leading Patent Litigation practice, which has acted in substantial trade mark, passing off and copyright actions, and represents clients in multinational patent infringement and revocation actions.
The life sciences team, along with the Tax group, advises the firm’s many international life science companies on corporate and intellectual property reorganisations, corporate finance, corporate migration and the Irish R&D tax credits system.
We offer practical advice and commercial solutions to statutory bodies, health insurers, healthcare organisations, hospitals and healthcare practitioners.
The Environment and Planning group assists the life sciences team in serving the needs of the group’s industrial and manufacturing client base, in particular the pharmachemical sector, from the establishment of a site or project through to its completion.
The life sciences team works closely with the Intellectual Property group in providing practical advice to our clients in relation to protecting and commercialising innovative intellectual property.
The life sciences team regularly works with our Employment group to provide employment advice to clients operating in the pharmaceutical, medical device, cosmetics and food industries in Ireland.
The life sciences team draws on the expertise of the EC and Competition group in advising on the increasingly challenging regulatory and commercial issues affecting the global life sciences industry.
The life sciences team, together with the Finance group, offers advice on inward investment, and corporate and product finance generally.
Experience – Pharmaceuticals, Medical Devices, Biotech and digital health
We have set out below some recent corporate, commercial and product liability experience. For more information on our experience in the other areas outlined above please click through to the relevant page.
- Advising Allergan plc on its proposed €150 billion merger with Pfizer Inc.
- Advising Actavis plc on its $66 billion White Knight acquisition of Allergan, including an $8.4 billion simultaneous ordinary and convertible share offering
- Advising Covidien plc on its $43 billion takeover of Medtronic plc
- Advising Mallinckrodt plc on its $5.6 billion acquisition of Questcor Pharmaceuticals
- Advising a global top 5 medical device business on a major investment in an Irish business
- Advising a global top 30 medical device company on the acquisition of an Irish business
- Advising on the corporate reorganisation of a global pharmaceutical company in advance of a multi-billion dollar spin-out and subsequent sale of a division
- Advising a multi-national pharmaceutical company on spin-out and IPO of nutritionals business
- Advising on large scale multi-national post acquisition integrations
- Advising a national screening service on the drafting and negotiation of a major contract in relation to testing services and a national screening programme
- Drafting toll manufacturing agreements for a global pharmaceutical company as part of a worldwide third party manufacturing project
- Drafting supply agreements and other sourcing agreements for global pharmaceutical and medical device companies
- Drafting terms and conditions of supply and purchase for local operations of global pharmaceutical companies
- Advising one of Ireland’s largest agri-business companies on its supply and contract manufacturing arrangements, both in Ireland and overseas
- Drafting and negotiating a major licensing and manufacturing agreement on behalf of a global medical devices company
- Drafting clinical trial agreements, agreements with research institutions, investigators and investigator initiated agreements
Product Liability and Product Safety
- Defence of large scale, complex litigation involving large cohorts of claimants in the areas of tobacco, pharmaceuticals, blood products, telecommunications – including the defence of the largest such type of case to have come before the Irish Courts
- Advising on a wide range of high value unitary product liability claims
- Advising in relation to the pork product dioxin issue
- Managing product withdrawals and consumer recalls across a wide range of sectors
- Advising leading pharmaceutical companies with regard to the advertising and marketing of medicinal products to the public and other regulatory issues
- Advising on judicial review of decisions of regulatory bodies such as HPRA and the EMA
- Advice on insurance disputes specific to product liability policies and related coverage
- Advising a wide range of businesses on product liability issues and products recalls
- Advising on the defence of claims relating to products including representing clients in a number of significant actions pursued in Ireland