It is only
with the heart
that one can see rightly;
what is essential
is invisible to the eye
[ Antoine de Saint Exupery ]

The traditional branches of the law have been affected by developments in the life Sciences. There has been intense legislative activity in this sector which has given rise to new divisions of the law, such as Pharmaceutical Law.
The firm offers both judicial and extra-judicial assistance and consulting services in all matters relating to: research, production, marketing and use of drugs, medical devices, special foods and cosmetics.
The professional activity of the life Sciences Practice includes aspects of specific regulation and also general matters (from Business Law to IP Law to Employment Law to questions of civil liability, with particular reference to product liability) as they apply to the sector.
Consulting and extrajudicial activity covers all matters peculiar to the sector (license agreements, Marketing Authorization transfer, production, distribution, warehousing, co-promotion, co-marketing, clinical drug experimentation agreements, public administration supply agreements) and questions relating to the corporate and contractual aspects of acquisitions, asset transfers and joint ventures.
Judicial assistance and representation takes place before all courts which are competent in this complex matter (ordinary civil courts, specialized IP divisions, administrative courts, Eu courts, arbitration courts); in the field of criminal law the firm provides specific consulting to colleagues appointed to criminal defense.
The work of the life Sciences team aims to provide assistance and consulting services, both judicially and extra-judicially, in the following areas:

• Pharmaceutical Law
• Special legislation for medical devices, food supplements/special foods, cosmetics
• Health Law
• Protection of commercial and IP rights
• Risk management and the administrative liability of legal entities (Legislative Decree 231/2001)
• Employment Law
• litigation and arbitration

The partners of the team are:

• Francesco Setti - Partner
• Carlo A. Piria - Partner
• Francesca Libanori - Partner
• Alberto Mocchi - Partner

and the Associates are:

• Elena Cappellaro
• Teresa Candela
• Sarah Setti
• Anna Ranzani
• Francesca Belli

Pharmaceutical Law

The Pharmaceutical Law team has a sound knowledge of issues relating to the development, production, marketing, distribution and promotion of drugs (for both human and veterinary use).
The team regularly follows questions relating to Marketing Authorization procedures and regulations, both at pre-grant stage and in the subsequent stages of maintenance, modification and protection. The life Sciences team also provides assistance and consulting services in relation to pricing systems and classification for the purposes of drug supply and reimbursability.
The Pharmaceutical Law team offers its services to national and multinational firms, providing, from among its principal services, legal consulting in relation to:

• clinical experimentation,
• relations with regulatory authorities (Agenzia Italiana del Farmaco – AIFA, Department of Health),
• contractual matters (licenses, Marketing Authorization transfer, production, toll manufacturing, distribution, warehousing, co-promotion, co-marketing, joint ventures, asset transfers),
• participation in public calls for tender,
• advertising, competition/parallel importation issues,
• compliance and best practice (GMP, GDP and GCP)

The team led by Mr. Setti also provides consulting services in all questions relating to the corporate and contractual aspects of acquisitions and asset transfers in the pharmaceutical sector.

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Special legislation for medical devices, food supplements, cosmetics.

In relation to medical devices, food supplements and cosmetics the team offers its clients specific skills relating to:

• production,
• marketing (CE mark, regulatory activity, relations with the competent authorities),
• contractual issues,
• advertising,
• participation in calls for tender for public administration supply.

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Health Law

Its sound knowledge of the life Sciences sector means that the team also enjoys a vantage point on problems relating to the right to health from the perspective of possible product liability or liability arising from dangerous activity and violation of the Consumers’ Code.

Although these issues are not strictly peculiar to Pharmaceutical Law, they are of particular importance in this area.

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Protection of commercial and IP rights

Thanks to specific skills built up in the pharmaceutical sector, the life Sciences team also handles questions relating to the protection of commercial and IP rights (patents, certificates of complementary protection, data protection).

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Risk management and the administrative liability of legal entities(Legislative Decree 231/2001)

The life science team offers its clients consulting services on issues related to the administrative liability of legal entities (Legislative Decree 231/2001), issues which are important above all due to the evident public nature of relations (public calls for tender, relations with the Department of Health and with AIFA and the inspection bodies).

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Employment Law issues

Skills acquired in the field of Employment Law mean that the life Sciences team can offer sound advice in relation to a number of specific professional workers in the sector (pharmaceutical representatives, technical directors) and in matters pertaining to forms of collaboration with public sector employees (doctors, researchers).

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litigation and Arbitration

Studio Avvocati Associati Franzosi Dal Negro Setti offers its services for the protection of rights and interests before the ordinary courts, the administrative courts and the European Court of Justice, at every instance. The life Sciences team also offers assistance in arbitration proceedings and proceedings before independent authorities (AGCM - Competition and Market Authority), IAP (Self-Regulatory Advertising Institute), monitoring advertising self-regulation authorities and committees).

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International Affiliations

The firm is part of the European network Conference Bleue which has, since 1997, brought together the leading law firms in the pharmaceutical, health and medical sectors.
As a member of Conference Bleue, Studio Avvocati Associati Franzosi Dal Negro Setti can offer its clients a highly-specialized link with the legal systems of other Eu states The members of the life Sciences team regularly speak at seminars and publish articles in specialized reviews.

The members of the life Sciences team regularly speak at seminars and publish articles in specialized reviews.

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