Life Sciences

We review policies and procedures for optimizing the distribution of medicines, pricing policies and the establishment of discounts, and we assist in defending against commercial practices under the supervision of national and European regulatory authorities.

We provide both preventive and reactive advice on compliance from a regulatory and criminal perspective:

• We design and implement compliance policies to meet sector-specific and legal requirements.
• We design internal procedures for the approval of promotional materials, interactions with healthcare professionals and healthcare organizations, etc.
• We support the Compliance Officer of companies in the sector and participate in compliance committees as advisors.
• We advise and assist companies in the sector in internal investigations and assume the legal defense of any resulting criminal actions.

We have extensive experience advising companies in the sector on the drafting and negotiation of sector-specific contracts:

• Clinical research and clinical trial agreements: comprehensive support and assistance with all contracts required with healthcare centers, CROs, and investigators to carry out clinical trials, observational studies, and clinical research involving medical devices.
• Co-development, CDMO, licensing, distribution, manufacturing, co-marketing, and similar agreements.
• Collaboration, sponsorship, and service agreements with healthcare organizations and public institutions for healthcare projects.

We promote R&D and innovation in the biomedical and healthcare sector, including among others:

• Advising on the specific regulations applicable to research personnel and the incompatibility regimes in the public sector at both the national and regional levels.
• Participating in the drafting of agreements and specific arrangements for collaboration among the different stakeholders in the research system, technology transfer, and the affiliation of research personnel.
• Providing support regarding the handling of human biological samples for biomedical research purposes.

We advise companies in the sector in areas such as the following:

• We provide strategic consulting for the design and development of promotional campaigns and activities in the pharmaceutical and healthcare industries, including the development of digital platforms and the review of promotional materials for social media.
• We advise on the management and sponsorship of promotional content for medicines and medical technologies in accordance with the Farmaindustria Code of Good Practices, the MedTech Europe Code, and the Fenin Code of Ethics.
• We assist and defend the industry in sector-specific self-regulatory proceedings (Farmaindustria, Fenin, ANEFP, Autocontrol).

We advise pharmaceutical, healthcare, and other Life Sciences companies on all regulatory matters, including:

• Issues related to marketing authorisations for medicines (sunset clause, data exclusivity, suspensions, etc.), CE marking of medical devices, and other licences concerning manufacturing and distribution activities.
• Participation in procedures for inclusion and pricing, including negotiations with national authorities and regional governments on various funding arrangements such as risk-sharing agreements, price-cap agreements, etc., as well as advice on reference pricing, both in administrative and contentious proceedings.
• Management and response to crises caused by shortages, and advice on parallel trade.

We advise companies in the sector in areas such as the following:

• Participation in the drafting and review of informed consent forms for participation in studies, clinical trials, and the collection and use of samples, among others.
• Advice on digital projects for promotion and/or interaction with healthcare professionals.
• Preparation of Impact Assessments for complex medical technology projects, advice on the validation of solutions and medical devices, and support in defining AI management models.