Biomedical Research in Developing Countries - UNICRI

INTRODUCTION
For several years, Italy has been very active in improving the health sector of developing
countries at various levels, the most important being health care and biomedical research.
In the health care sector, I would like to mention the Association “Alleanza degli Ospedali
Italiani nel Mondo” (Italian Hospitals in the World Alliance), which has been established a
few years ago, by a Ministry of Health initiative, with the participation of the Ministry for
Scientific Research and the Ministry for Foreign Affairs. The Association comprises over 20
Italian health centers working in developing countries, connected with 30 Italian health
centers working in Italy; their aim is to promote a medical consultancy service, through teleconsultation
and e-learning services for health personnel and, eventually, for the local
population, in order to ameliorate health care in developing countries.
With regard to Biomedical Research, there are currently many clinical trials for
pharmaceutical products in developing countries, sponsored by qualified Italian health
structures. For instance the AIDS vaccine trial of the National Institute of Health; the
research done by the “Istituti di Ricovero e Cura a Carattere Scientifico”, sponsored by the
National Institute for Infectious Diseases “Lazzaro Spallanzani”, which is centered on
tuberculosis, malaria and HIV/AIDS clinical trials in Africa, in collaboration with nongovernmental
organizations; several health initiatives funded by the Ministry of Foreign
Affairs.
Biomedical Research and its critical issues are always under the attention of Italian
researchers, the Italian Ministries promoting the research and AIFA Agenzia Italiana del
Farmaco (the Italian Medicines Agency), which has the duty to monitor and control the
clinical trials carried out in Italy and abroad.
At the national and international level, Biomedical Research is a complex and topical issue,
due to the continuous challenges that Science faces and necessarily requiring a deep reflection
on ethics of scientific discoveries.
In the last years, the number of clinical trials of pharmaceuticals products in high income
countries and, more recently, in developing countries and low and middle income countries
has grown in an exponential way. According to FDA data, clinical trials in developing
countries, have grown up from 9% in 2003 to 17,5% in 2007; in India, clinical trials have
grown from 96 in 2001 to 493 in 2007. The Associated Chambers of Commerce and Industry
of India (ASSOCHAM), foresees that the clinical trials business will grow from the present
150 million to 546 million of US dollars in 2010.
As evidenced by Dennis Normille in an analysis published in the magazine “Science” in
October 2008, there are several reasons for the growth of clinical trials in developing countries:
1) clinical trials that investigate the different reactions to drugs due to different
ethno-genetic factors;
2) clinical trials implemented in order to facilitate the setting-up of an industry or a
society in a country, where the creation of new drugs market is foreseable;
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