Our experience in the Life Sciences sector encompasses all contractual, contentious, and regulatory aspects of pharmaceuticals (including those of biotechnological drugs and biosimilars), medical devices, health and healthcare services (both digital and traditional), as well as cosmetics and food supplements.
Thanks to our Digital, Media & Technology leadership in Italy, we increasingly often advise on complex legal arising through technological developments applied to Life Sciences (for example, from wearables for diagnostics to those supporting disabled persons, to remote medical assistance mobile applications, 3D printers of medical devices and cellular tissues, as well as the growing role of biotechnology in the development of medicines).
Our Life Sciences practice group comprises lawyers (some focusing exclusively on Life Sciences and with multi-year experience in the industry) who are able to provide multidisciplinary and integrated legal assistance, ensuring a systematic and at the same time innovative, flexible and pragmatic approach to matters. This is also possible thanks to our lawyers’ knowledge of the Life Sciences sector’s driving factors and peculiarities, its business and operational models, and of the whole production and distribution cycles of pharmaceutical products and relevant services.
Our clients are well established multinationals as well as startups and also technology companies branching out into Life Sciences.
We also cooperate with universities and polytechnics, healthcare institutions, contract research organizations (CROs), as well as clusters and technology parks, incubators and accelerators.
By way of example, the main activities in which we are involved include advising on these types of legal matters:
- during start-up phases (business incorporation, university spin-offs, financing, etc.);
- in various stages of research and product development, from the drafting of contracts relating to clinical trials to the resolution of issues that may arise during a trial (e.g., free drug supply, compassionate use, etc.);
- in the regulatory, compliance and best-practices environments, with regard to the release to the market of pharmaceutical drugs and medical devices, including advice for the launch of wearables devices and for matters relating to the price and reimbursement of medicines, market access, and the interfacing with public authorities (including the Ministry of Health, AIFA – Italian Medicines Agency, and EMA – European Medicines Agency), and with other sector operators, as well as for measures restricting the marketing of products, referral procedures, inspections by regulatory authorities, etc.;
- in the drafting and negotiation of commercial agreements, such as joint venture agreements and technology transfers, marketing authorizations of medicines, contracts with CROs, development, exploitation, valuation, concession and intellectual property acquisition right agreements, as well production, supply, distribution and co-marketing of pharmaceutical products, “toll manufacturing arrangements”, etc.;
- in the protection of intellectual and industrial property, both in adversary and out-of-court legal proceedings;
- in matter of antitrust, both in the context of extraordinary transactions and of exploitation of intellectual property rights, with particular focus on all major antitrust and regulatory issues that have become particularly relevant in recent years (license and cooperation agreements between competitors, parallel imports, restrictions and unjustified regulatory barriers; etc.);
- in the marketing and advertising of medicines and medical devices or, in general, of products and services in the health and pharmaceutical sector, including in matters pertaining to regulatory issues
- in M&A transactions involving companies in the Life Sciences sector;
- in Private Equity and Venture Capital, both to investors and target businesses;
- in all matters relating to privacy, cybersecurity and use of big data, including the protection of personal data in clinical trials and the processing of genetic data, including through biobanks;
- in adversary legal proceedings, as it pertains to liability for defective products and medical malpractice, and for assistance in the performance of internal audit procedures in major Italian and foreign companies.