This is one of the most regulated sectors in the world and one in which the different branches of law—public and private law—intertwine. Due to this unique convergence, a highly specialized sectoral advisory service covering all legal areas is required to provide agile solutions with added value.
Our lawyers have extensive experience in offering comprehensive and multidisciplinary advice to companies in the (i) pharmaceutical, (ii) medical devices, (iii) biotech, (iv) healthtech, (v) consumer healthcare, and (vi) phytosanitary and agrochemical sectors; as well as to (vii) investment funds; (viii) hospitals (private and public), foundations and institutes dedicated to research; and (ix) healthcare companies.
We accompany our clients in all stages of a product’s lifecycle (e.g., medicine, special medicine, medical devices and cosmetics), applying the multidisciplinary approach required: commercial, contractual M&A, administrative and regulatory law, competition law, intellectual and industrial property, IT, data protection, labor and compliance:
- Research stage: clinical study agreements; product research license agreements (in & out); pre-litigation and litigation issues concerning patents, trademarks, business secrets, know-how and unfair competition; and designing regulatory structures.
- Manufacture and distribution stage: manufacturing and supply agreements, quality agreements, pharmacovigilance agreements, agreements with QPs (both from a regulatory and labor perspective), and transport and logistics agreements.
- Marketing stage: proceedings for obtaining marketing authorizations, special proceedings for authorization of medicines, license agreements, co-promotion agreements, post-authorization studies, financing regimes and pricing, designing marketing strategies depending on the product type and category and the restrictions linked to the product category (sales of chemist stores and hospitals), and public tenders.
- Promotion stage: implementing and validating discount policies from a regulatory and a competition law perspective, reviewing and validating promotional material and actions (including medical checks); advising on the applicable regulations, as well as on adapting to the different ethics codes applicable depending on the product type; interacting with health professionals; and designing and implementing compliance policies.
INNOVATION AND DIGITAL HEALTH
- M&A: We advise sector companies and investment funds on negotiating and implementing all types of commercial and corporate transactions, including joint ventures, M&A and corporate restructuring.
- Litigation: We handle civil and administrative proceedings against competitors, as well as against public administrations, ministries, agencies, deontological commissions or other relevant authorities.