OVERVIEW OF THE LEGAL FRAMEWORK OF THE “CONVENTION UNIQUE” MODEL CONTRACT ON COMMERCIAL BIOMEDICAL RESEARCH IN HEALTH INSTITUTIONS INVOLVING THE HUMAN PERSON

Abstract

In June 2013, in order to increase its attractiveness as
a place for healthcare R&D, France has signed a legal
agreement with its “Industry and Health Technology”
sector aiming at simplifying and accelerating the start
of clinical studies by implementing a model contract
for companies and public healthcare institutions specifying all their rights and duties. This contract, called
“convention unique”, has first been provided for by the
ministerial direction n°DGOS/PF4/2014/195 in 2014,
before being revised and included in the Public Health
Code by the 26 January 2016 Act n°2016-41. It has
been latter modified by the 16 June 2016 Government Ordinance n°2016-800. Nowadays, this model contract
is mandatory for all healthcare institutions.