Life Sciences

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The Arthur Cox Life Sciences team is a multi-disciplinary practice group, successfully combining the very best of the firm’s 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 is a market leader in life sciences law in Ireland, representing many of Ireland and the World’s major pharmaceutical, medical devices and agri-business companies.

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

Regulation

We advise market-leaders in the pharmaceutical, biotechnology and medical devices fields. We guide our clients throughout product life cycles, from the pre-marketing stages of pre-clinical research and clinical trials, protection and manufacturing, through to the ultimate marketing of the product. We have advised on our clients’ legal obligations in respect of manufacturing, advertising, interaction with health-care professionals, patient information, labelling, pharmacovigilance, data protection, pricing and reimbursement. 

We also have a comprehensive food law practice, advising on the manufacture, promotion and sale 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, recall procedures, health claims and restrictions on allergens and additives. 

Our clients in the cosmetics industry benefit from our advices on product classification, 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; and other new and developing areas such as the regulation of nanotechnology.

Healthcare

We offer practical advice and commercial solutions to statutory bodies, health insurers, healthcare organisations, hospitals and healthcare practitioners. Click here to go to our Healthcare Group's profile.

Restructuring and Reorganisation

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, restructurings, reorganisations, distributions, joint ventures, corporate structures and related structural issues. Typically these reorganisations involve share or business and asset transfers, capital contributions and distributions.

Product Liability and Product Safety

The Life Sciences team draws on the experience 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 also advise a range of clients on compliance issues, including good manufacturing practice requirements

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 issues.

Commercial Contracts/Sourcing

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 manufacturing, licensing, distribution, confidentiality, supply, clinical trials, R&D, outsourcing, procurement and other strategic alliance arrangements. In particular the life sciences team offers a full service with respect to the outsourcing and sourcing of services and goods (on a local and cross-border basis) and work with other specialist groups in the firm, where necessary, to provide a seamless service to our life science clients.

Collaborative Research

The life sciences team regularly work 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.

Competition

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 Banking and Tax groups, offers advice on inward investment and corporate and product finance generally.

Regulation

  • Advising a large pharmaceutical company on the implications of changes to the law on the use of certain plastics in the packaging of active ingredients
  • Advising a hospital on the storage and transport of blood and tissue samples
  • Advising leading pharmaceutical companies with regard to the  advertising and marketing of medicinal products to the  public and other regulatory issues
  • Advising a global pharmaceutical company on donations policies, promotional practices and interaction with healthcare professionals
  • Advising on the registration and pricing of pharmaceutical products in Ireland
  • Drafting and negotiating a clinical trials agreement for a global pharmaceutical company and advising on the steps to obtaining regulatory approval, including liaising with the Irish Medicines Board and relevant Ethics Committee
  • Advising on the marketing and distribution of infant nutritional products in Ireland
  • Advising a market-leader medical devices company on the regulation and accreditation of medical devices in Ireland
  • Advising a cosmetics company on labelling requirements and product claim restrictions
  • Drafting quality agreements for medical devices and pharmaceutical companies for use in conjunction with services and manufacturing agreements
  • Advising an educational institution on the contained use, experimental release, marketing and labelling of genetically modified organisms
  • Advising a multi-national company on the establishment of operations in Ireland and the importation and distribution of food supplements in Ireland
  • Advising pharmaceutical company on regulatory obligations, under Irish regulations on advertising and promotion, and the equivalent IPHA code, in connection with the provision of free samples of a product to an out of hours GP service
  • Advising a pharmaceutical company on their relationships with wholesalers and community pharmacies, specifically provision of samples and “bulk” deals
  • Advising on all aspects of reimbursement of pharmaceutical products under the IPHA/HSE Agreement, including advice in relation to applications under the Hi-Tech Scheme

Healthcare

We advise major public and private hospitals and clinics. We advise insurance companies, brokers and the insured on healthcare related claims.

Restructuring and Reorganisation

  • Corporate reorganisation of a global pharmaceutical company in advance of a multi-billion dollar spin-out and subsequent sale of a division
  • Advising a leading manufacturer of medical devices on the spin-out of its Irish business
  • Product Liability and Product Safety
  • 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

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 the Irish Medicines Board
  • Advice on insurance disputes specific to product liability policies and related coverage

Commercial Contracts/Sourcing

  • Advising a statutory body 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 a global pharmaceutical company
  • Drafting terms and conditions of supply and purchase for a global pharmaceutical company
  • Advising one of Ireland’s largest agri-business companies on its supply and contract manufacturing arrangements, both in Ireland and overseas
  • TechBrief, Q3 2009
  • Betting and Gaming, Technology, Intellectual Property, Life Sciences, Media and Entertainment, Privacy and Data Protection
  • 30.09.2009 | Format: pdfhtml