Life Sciences

The Practice

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 & drink 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 agribusiness 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, which is kept up to date with the latest news and commentary on a range of issues relevant to life sciences industries operating in Ireland and abroad.

 

Expertise – Pharmaceuticals, Medical Devices, Biotech

The team advises on the full range of issues relevant to the life sciences industry including:

Corporate

Our clients include many of the major national and multinational 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 pre-sale spinouts or hive downs, business and product acquisitions and disposals, mergers and acquisitions, restructurings, reorganisations, cross-border mergers, distributions, joint ventures, corporate structures and related structural issues.

Commercial

We have a proven track record in advising our clients in this area 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.

Regulatory

We advise market-leaders in the pharmaceutical, biotechnology and medical devices fields on both EU and Irish regulatory obligations. We guide our clients throughout product life cycles, from the pre-marketing stages of pre-clinical research and clinical trials, good clinical practice guidelines, IP protection and manufacturing, through to the ultimate marketing of the product. We advise our clients on registration, product classification, licensing, good manufacturing practice, importation, good distribution practice, advertising and marketing of medicinal products and medical devices, interaction with health-care professionals and patient organisations, patient information, packaging and labelling, pharmacovigilance, data protection, pricing and reimbursement.

We also have a comprehensive Food & Drink practice, advising on the manufacture, promotion and sale of consumables in Ireland. With our in-depth knowledge of the food and drink 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.

Our clients in the cosmetics industry benefit from our advices on product classification, packaging and labelling, product claims and assistance on compliance issues.
We have also advised on specialist life sciences matters including the contained use, experimental release, marketing and labelling of genetically modified organisms and derivate products; the storage and transport of blood and tissue; regulation of biologics, biosimilars and combination products,  the importation and use of embryonic stem cells in research; and other new and developing areas such as the regulation of nanotechnology.

We are very aware of the challenges posed to our clients by the increasing convergence of technologies in their products, with medical devices, medicinal products and software being increasingly combined such as medical software applications and remote medical technologies, and we regularly advise on the regulatory and data protection implications of such convergence.

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.

Dispute Resolution

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.

Tax

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.

Healthcare

We offer practical advice and commercial solutions to statutory bodies, health insurers, healthcare organisations, hospitals and healthcare practitioners.

Environment and Planning

The Environmental 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.

Collaborative Research

The life sciences team regularly works with other specialists in the firm, in particular the Technology and Intellectual Property groups, in advising on collaborative research projects.

Intellectual Property

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.

Employment

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.

Competition and Regulated Markets

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.

Financing

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

Corporate

  • 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 numerous pharmaceutical companies on Irish mergers and acquisitions
  • Advising on large scale multi-national post acquisition integrations

Commercial

  • 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

Regulatory

  • Assisting clients establish regulatory pathways to market medical devices, medicinal products, combination products and diagnostic tools
  • Advising leading pharmaceutical and medical device companies on the EU and national rules on advertising and marketing of medicinal products and medical devices to the public and healthcare professionals, donations policies, promotional practices and interaction with healthcare professionals and patient organisations, including negotiating and drafting related agreements
  • Assisting in developing EU-wide and country-specific promotion and marketing policies and SOPs that take into account applicable EU Directives and the national laws of EU Member States, as well as professional and industry codes of conduct and ethics
  • Providing advice in relation to disclosure of payments to healthcare professionals and healthcare organisations and other related transparency requirements
  • Advising manufacturers, brokers and wholesalers of medicinal products on their registration requirements,the Falsified Medicines Directive and their obligations in relation to the licensing, importation and distribution of medicinal products
  • Advising a market-leading medical devices company on the regulation and accreditation of medical devices in Ireland, and on the packaging and labelling requirements
  • Advising on the implementation of EU standards of Good Clinical Practice (GCP), good marketing practice (GMP), good distribution practice (GDP) and on post marketing authorisation HPRA and EMA inspections
  • Assisting and advising on issues related to pharmacovigilance and post-marketing vigilance activities including adverse event reporting and product recalls
  • Advising on all aspects of reimbursement of medicinal products under the IPHA/HSE Agreements, including advice in relation to applications under the Hi-Tech Scheme
  • Advising a multi-national company on the importation and distribution of food supplements and on the regulation of nutrition and health claims in advertising and promotions materials
  • Advising a global pharmaceutical company in relation to the regulatory implications of its involvement in a disease awareness campaign launched in cooperation with a patient organisation
  • Advising a multi-national company on the packaging and labelling requirements for cosmetics
  • Assisting clients to meet requirements for approval of clinical trials by ethics committees and competent authorities
  • Advising sponsors of clinical trials in relation to the regulatory requirements of conducting a clinical trial in Ireland, and drafting and negotiating associated contracts with trial sites, investigators and clinical research organisations
  • Advising leading pharmaceutical companies on the drafting and roll-out of a Phase III clinical trial throughout a number of EU Member StatesAdvising a public research organisation on the contained use, experimental release, marketing and labelling of genetically modified organisms and on the importation and use of embryonic stem cells
  • Conducting due diligence in connection with commercial transactions in the pharmaceutical sector
  • Advising a healthcare products company in challenging and successfully lifting a suspension by EMA of a marketing authorization for a medicinal product for use in echocardiography.
  • Assisting a number of pharmaceutical companies in response to threatened revocation of their marketing authorization by the EMA on the basis of new safety data
  • Assisting various medical devices manufacturers in challenging the suspension of the CE Certificate of Conformity for their medical devices due to alleged non-compliance with the Essential Requirements provided in Annex I to the Medical Devices Directive
  • Undertaking a world-wide review of the promotional activities of a leading pharmaceutical and medical device manufacturer, including both interactions with healthcare professionals and consumers, publications and website content
  • Addressing data privacy, including issues relating to the export of trial data to the United States

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