"We need to reconcile existing scientific evidence with available economic resources to obtain quality care and maximum health gains". Guido Rasi, general manager of Aifa, the Italian drug agency since the summer of 2008, speaking at the scientific meeting that took place in the Loggia on "Money and science" promoted by the University on the occasion of the inauguration of the 2nd level Master's degree in Osteoporosis and Metabolic Bone Diseases, did not in the least demonize the presence of economic "interests" in the research and production of drugs.
However, he strongly underlined that these interests must be "controlled" and guided in order to speed up the placing on the market of innovative products while maximizing the protection of the citizen's health and safety. And this is essentially the role of AIFA, a public body operating on behalf of the Ministry of Health, set up with the aim of regulating the pharmaceutical sector.
The agency has various responsibilities: it takes care of the authorization, registration and control of drugs, evaluating requests to put them on the market, to allow them to remain on the market, to re-enter those that have undergone changes in formula and dosage.
Furthermore, "Aifa was the first agency in Europe that included the promotion of independent research on drugs among its tasks. The need arises from the recognition, increasingly debated within the international scientific world, of the importance of independent research in areas in which, despite the presence of potentially very significant health repercussions, there is a lack of sufficient commercial interest".
Just think, for example, of rare diseases (those classified are over five thousand), in which the prevalence of the condition in the population is extremely low; or to drugs with expired patents; to long-term safety during chronic therapies; to patient populations typically excluded from clinical trials, such as children or the elderly with multiple conditions.
"In these situations – explains Prof. Rasi – independent clinical research can help develop new knowledge, which is indispensable both in current clinical practice and in regulatory decisions".
The research, which is aimed at all Italian researchers from public and non-profit institutions, is financed by a contribution equal to 5% of the promotional expenses incurred by pharmaceutical companies.
