To guarantee innovative, safe and effective treatments for patients, it is necessary to combine the health needs of patients with the economic sustainability of new therapies. This was recalled by the director of the Italian Medicines Agency, Guido Rasi, speaking at the international meeting taking place yesterday in Rome, organized by the Istituto Superiore di Sanità and Aifa, during which the leading international experts discuss the effectiveness of research and its rules. "We are at an early stage. In practice it is a think tank – explained Rasi – that needs to work to reconcile different, opposing needs. Starting with that of the sick so that they can have access to innovative treatments". This also means having the possibility of developing innovative medicines for what is not yet cured. Then there is "the need of the third party payer, the National Health Service, to obtain new drugs at affordable prices". And the third need "is that of pharmaceutical companies to bridge the gap between the constant increase between investments and research and the constant decrease in returns in terms of effective and profitable drugs", says Rasi. This means that "just like scientists and clinicians, we must review the rules to try to reconcile apparently opposing needs".
However, it is not necessarily a matter of «changing the rules. We must – Rasi specifies – rather evaluate whether there are new methodologies that are more useful for achieving the goal. It is the problem of a system that has reached the end of its creative drive in classical pharmacology. Furthermore, molecular medicine opens up new opportunities. The difficulty of bringing these innovations to clinical practice is a question that needs to be debated». The analysis by Enrico Garaci, president of the Istituto Superiore di Sanità, is similar, starting from the observation that there are fewer and fewer new drugs registered, to the point that in some sectors there has been a complete lack of innovations for several years, as in the case of antibiotics. And this despite the increased investment in biomedical research. “There is a gap between biomedical knowledge production and bedside applications. A problem on which it is necessary to start a debate at the highest levels», explains Garaci, also underlining the question of the costs of the trials. "They're getting taller and taller. It is estimated that $1.7 billion is required between discovery and market launch of a therapy. And this greatly affects the possible future sustainability of innovation».
DoctorNews – 13 April 2010 – Year 8, Number 64
