Life Sciences and Healthcare

The life sciences and healthcare industries are heavily regulated and are subject to European, state and regional legislation and powers. Our team offers advice on procedures for obtaining and amending the necessary authorizations, on matters relating to pricing and reimbursement for medication and medical devices by the national health system, inspection and penalty proceedings (in the administrative and judicial review jurisdictions), as well as on promotion and advertising, quality control, labeling and packaging.

Commercial relationships in the life sciences and healthcare industries have very particular features, giving rise to the widespread use of certain types of contracts. We provide ongoing advice on best practices in the negotiation and drafting of licensing, joint marketing, joint promotion, clinical trial, distribution and manufacturing agreements, as well as agreements for research consortia, outsourcing of services and joint ventures.

We provide advice to pharmaceutical companies and manufacturers of medical devices on public tenders, review procedures, discount agreements, spin-off of public research centers or risk-sharing agreements. Our services in this area also include advice to hospitals on aid, subsidies, hospital finance and other related matters.

One of the key elements for research-oriented sectors such as life sciences and healthcare is the obtainment of adequate trademark and patent protection and the management (contentious or otherwise) of all aspects of industrial and intellectual property. Since our multidisciplinary team boasts not only lawyers but also biochemists and engineers, we can provide ongoing advice on patent infringement and invalidity proceedings, technology transfer, obtainment of strategic patents at international level and submission of challenges to patent applications, freedom to operate (FTO) reports, protection of plant varieties and regulatory compliance, as well as advertising and labeling.

We offer comprehensive advice on domestic and international taxation to national and multinational companies in the life sciences and healthcare sectors. Our tax team has broad expertise in mergers and acquisitions, tax credits deriving from the performance of R&D&I activities, transfer pricing, tax inspections and judicial review proceedings, as well as sector-specific matters (tax treatment of medical conferences, compensation in kind for sales teams, promotional expenses, excise taxes—alcohols—, customs, etc.).

Drawing on the experience and know-how of our corporate/commercial and tax law practices, we advise on contractual issues that are atypical of the life sciences and healthcare industry and constitute special transactions, mainly joint ventures with corporate vehicles, mergers, spin-offs and restructuring processes of business groups, venture capital investments at all phases and in all rounds of financing, special financial transactions or public offers of securities.

Antitrust law is one of the areas that sees the largest number of decisions by national and EU authorities affecting or influencing contractual relationships between manufacturers, wholesalers and other operators in the life sciences and healthcare market. Our services include advice on procedures for notification of concentrations to the antitrust authorities, ongoing advice prior to the signature of vertical and horizontal agreements, requests for information on investigation processes and advice on dawn raids by the competent authorities, design of programs for regulatory compliance, advice on leniency programs, and representation and defense of clients in judicial and administrative proceedings relating to anti-competitive practices.

Through the litigation & arbitration and administrative law practices, Garrigues provides advice on the defense and resolution of liability claims deriving from medicinal products and medical devices (through conciliation, mediation, arbitration and court proceedings), on the submission of safety objections by the regulatory authorities, and on the enforcement of corrective measures such as product withdrawals, additional product safety instructions or temporary restrictions on use.