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Agenzia Italiana del Farmaco - Italian Medicines Agency
Rome, ITALY
The role of the Italian Medicines Agency in
promoting independent research on drugs
How to integrate clinical research and regulatory decisions
MAIN LIMITATIONS OF THE DRUG
REGULATION PROCESS
a.
b.
c.
d.
e.
Insufficient information on long-term efficacy and
safety of therapies
Frequent use of surrogate end-points
Insufficient information on relative efficacy
Under-representation of special populations
Conflict of interest
A POSSIBLE ANSWER: PROMOTING
INDEPENDENT RESEARCH
a.
Long-term efficacy and safety of therapies
b.
Clinical end-points
c.
Comparative studies
d.
Patients of interest in current practice
e.
No conflict of interest
How to promote independent research on drugs
Art. 48, Law
326/2003
 Pharmaceutical companies are obliged to devote 5% of their promotional expenditure to a fund for independent
research
 This mechanism ensures around 35 million € per year
AIMS OF THE RESEARCH PROGRAM
OBJECTIVES OF THE FUND
• Reimbursement of orphan drugs and life saving
drugs not yet marketed
Promote clinical research on drugs in areas of interest
for the NHS, where commercial support is normally
insufficient
 AREA 1: Orphan drugs for rare diseases
and drugs for non-responders
• Clinical research on drugs
• Post marketing surveillance
• Independent drug information
 AREA 2: Comparison among drugs and
therapeutic strategies
 AREA 3: Strategies to improve the appropriateness
of drug use and pharmacoepidemiology studies
How to implement the research program
RESEARCH & DEVELOPMENT COMMITTEE
The role of the R&D Committee is to support AIFA in
 Identifying research areas for the call for proposals;
 Conducting the first phase of the selection process;
 Supervising the implementation of the projects
MEMBERS
Lucio Annunziato; Renato Bernardini; Sergio Bonini; Maria Del Zompo; Antonio Francavilla; Enrico
Garaci; Silvio Garattini (chairperson); Alessandro Liberati; Giampietro Rupolo; Gloria Saccani Jotti
Research & Development Unit - ricerca&[email protected]
Salvatore Caruso, Alessia Cirilli, Alessandra Correggia, Lucia Masiero, Luciano Sagliocca, Giuseppe Traversa