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Life Science & Healthcare

The life sciences & healthcare sector is developing rapidly, driven by scientific innovation and shaped by an ever-evolving regulatory landscape.

In this dynamic environment, operators require highly specialised tailored legal support, capable of addressing the complex challenges that continually emerge across its many sub-sectors.

Our Life Sciences & Healthcare Department delivers prompt, efficient, and effective assistance to leading players in the field. We offer both integrated legal advisory services and targeted support for specific transactions and issues, relevant to our clients’ operations.

 

Strategic expertise for a highly regulated industry and constantly evolving sector

Our team assists Italian and foreign clients operating in all areas of the life sciences & healthcare sector, including hospitals, pharmaceuticals, medical devices, research, biotechnology, veterinary medicine, and animal care.

Our professionals combine in-depth sectoral insight with specialist legal expertise, which enable us to provide comprehensive support in areas such as:

  • Hospitals, Clinics, Diagnostic Centres, Nursing Homes, and other Healthcare Facilities
  • Pharmaceutical Law and Medical Devices
  • Research and Development, Biotechnologies, Digital Health, and Artificial Intelligence Systems
  • Veterinary Medicine and Animal Care

 

 

Hospitals, Clinics, Diagnostic Centers, Nursing Homes and other Healthcare Facilities

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01

Industry specific M&A transactions (including cross-border deals), acquisitions, mergers, demergers, joint ventures, partnerships, and horizontal and vertical integration agreements between healthcare entities and other sectors (g. insurance).

02

Agreements for the supply of medical services and devices, partnerships between healthcare facilities and public/private operators, and contracts regarding biological materials.

03

Authorisation and accreditation of healthcare facilities with the National Health Service, opening and management of hospitals, Scientific Institutes for Research, Hospitalisation and Healthcare (IRCCSs), clinics, diagnostic centres, and veterinary facilities.

04

Tenders and procedures for the management of hospitals and healthcare facilities, including public-private partnerships (PPPs).

05

Construction and management of healthcare facilities and nursing homes (RSAs), including assistance to funding entities and investors active in the sector.

06

Securitisation transactions involving receivables from private healthcare facilities accredited by local healthcare authorities.

07

Litigation, arbitration and alternative dispute resolution (ADR) concerning medical device recalls, product liability, regulatory matters, and medical malpractice.

08

Compliance, investigations, and audits within the healthcare sector.

Pharmaceutical Law and Medical Devices

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01

Authorisations for pharmaceutical products and active pharmaceutical ingredients (APIs) for human and veterinary use (marketing, manufacturing, import, wholesale distribution, and storage), including orphan drug, registration of medical devices, food supplements, and cosmetics, and management of relations with regulatory authorities and notified bodies.

02

Supply, distribution, co-marketing, co-promotion, and sales concession agreements, quality agreements, contracts for observational studies, clinical trials and investigations, and agreements with scientific information providers (ISFs).

03

Public procurement procedures for drugs and medical devices and dispute resolution, including litigation related to mechanisms such as Payback.

04

Trademarks, patents, and Supplementary Protection Certificates (SPCs) in the pharmaceutical industry and clinical trials, pharmaceutical patent litigation, patent infringement disputes (g. dosage regimes), and protection of bioequivalents and biosimilars, production and marketing of active ingredients and substances within the pharmaceutical industry.

05

Regulatory compliance, including advertising rules for medicines, medical devices, supplements, and cosmetics, pharmacovigilance, quality control systems (GMP, GLP), and crisis response, including product recall procedures.

06

Digital health, clinical risk management, and digital health data management in the use of technologies and the introduction of advanced technologies and AI solutions in drug development, medical devices or within healthcare facilities.

07

Grants, research subsidies, donations, sponsorship of promotional events and scientific conferences, scientific advisors.

Research and Development, Biotechnologies, Digital Health and Artificial Intelligence Systems

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01

Research and development agreements, clinical studies, technology transfers, contracts with public entities and Contract Research Organisations (CROs), authorisation procedures for investigator-initiated and company-sponsored clinical trials, observational studies on drugs and medical devices, and research projects in advanced therapies.

02

Inventions by employees and researchers, and related relationships with universities, public research institutions, and Scientific Institutes for Research, Hospitalisation and Healthcare (IRCCSs).

03

Intellectual property rights related to medical trials and protocols, co-development, research & development agreements, intellectual property rights licensing, disputes over fair compensation and unfair competition; copyright issues concerning the promotion of scientific materials and interactions with the Italian Medicines Agency (AIFA).

04

Digital health, telemedicine, artificial intelligence systems, symptom checkers, integration systems, electronic medical records, digitisation processes, and data management infrastructures.

05

Cybersecurity, data protection, and privacy matters related to digital health initiatives (g. electronic health records, electronic appointment booking systems, chatbots, etc.), clinical research (observational and interventional), and healthcare assistance and prevention activities.

06

Management of data breaches and applying cybersecurity regulations to the pharmaceutical and healthcare sectors, including compliance with frameworks such as NIS2.

07

Data Processing Agreements and Joint Controllership Agreements, Service Level Agreements (SLAs), cybersecurity protocols, Data Transfer Agreements, Data Sharing Agreements, and Transfer Impact Assessments for cross-border data flows outside the EU.

Veterinary Medicine and Animal Care

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01

Industry-specific M&A transactions (also cross-border deals), including veterinary clinics and animal stores.

02

Supply, distribution, and sales contracts for animal products and services.

03

Opening and management of veterinary clinics, including the structuring of investments for such facilities.

04

Compliance of production sites and manufactured products with applicable regulations, investigations and audits.

05

Labelling of veterinary products to ensure compliance with applicable regulations.

06

Advertising of veterinary medicines and animal welfare products.

07

Compliance of commercial policies with antitrust laws and on unfair commercial practices.

Insights & Knowledge

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19.06.2025 EVENTS

Cosa cambia nel Diritto del Farmaco? L’EU Pharma Package e gli sviluppi antitrust

Giovedì, 19 giugno 2025dalle ore 16:00 alle ore 19:00Legance, Via Broletto 20 – Milano INTRODUZIONEPietro Merlino, Partner, Legance INTERVENTO DI APERTURAGiuseppe Franco FerrariProfessore Emerito di Diritto Costituzionale e co-autore del…

circleLife Science & HealthcarecircleEU, Antitrust and Regulation
08.04.2025 PUBLICATIONS

LSHC News // April 25

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11.12.2024 PUBLICATIONS

LSHC News // December 24

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03.09.2024 PUBLICATIONS

LSHC News // September 24

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04.04.2024 PUBLICATIONS

LSHC News // April 24

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Get in touch with our team

For any inquiries or requests, please do not hesitate to contact our team of professionals

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Lorenzo Gentiloni Silveri

Lorenzo Gentiloni Silveri

Partner

lgentiloni@legance.it

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Pietro Merlino

Pietro Merlino

Partner

pmerlino@legance.it

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Filippo Pacciani

Filippo Pacciani

Partner

fpacciani@legance.it

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Monica Riva

Monica Riva

Partner

mriva@legance.it

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Ada Esposito

Ada Esposito

Senior Counsel

aesposito@legance.it

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