THE ABILITY to develop new effective drugs quickly is essential to respond to the health needs of the population. And the road that leads to this goal necessarily passes through a profitable public-private collaboration: the current Covid 19 pandemic reminded us of this, with the fundamental impetus given to the development of new mRna vaccines arrived from the warp speed program of the American administration, and the nearly 20 billion dollars it has poured into companies active in the development of Covid vaccines. We therefore need funding, of course, but also certain rules, transparency, and the ability to enhance the findings of public research, to make it sustainable and transform it into therapies that are effectively available for patients. This is what was discussed today in Rome on the occasion of the presentation of the second edition of the White Paper “Biomedical research and the public-private relationship”, created by the Fadoi Foundation and the IRCCS Polyclinic San Matteo Foundation in Pavia and promoted by the Roche Foundation.
90% of clinical research supported by the private sector
In Italy – the experts present at the event agree – there is still a lot to do to promote public-private collaboration in biomedical research, and maximize the opportunities in economic and health terms for citizens. First of all, on the financing front. Our country dedicates 1.4% of GDP to research, compared to an EU average of 2.7%, and an international indication that sets the minimum optimal level at 3%. Furthermore, 90% of clinical research is still supported by private companies, while we know that clinical trials represent an opportunity for savings for public hospitals: only drugs made available free of charge by manufacturers in the context of trials are obtained 2 , € 2 savings for each euro paid by the sponsor.
Reformulate public-private collaboration
“The emergency management has highlighted the importance of a strategic vision in terms of public health, where public-private collaboration can make a difference and make our country more competitive”, observes the Scientific Director of Fadoi. Gualberto Gussoni, which together with Sergio Scaccabarozzi of the Scientific Direction of the Irccs Polyclinic S. Matteo di Pavia Foundation oversaw the creation of the White Book. “The public-private relationship – adds Gussoni – is not to be understood only at a financial level, but also as a cultural contamination and objectives, which in biomedical research must find a synthesis, because the ultimate goal of research must in any case be that of health of the individual and the community “.
To do so, it will be necessary to definitively overcome the approaches of the past that have produced many of the frailties experienced in dealing with the pandemic. He is convinced of it Luca Pani, Full Professor of Pharmacology at the University of Modena and Reggio Emilia, according to which “in Italy the research and clinical development of drugs and vaccines should receive an important boost through the implementation of public-private partnerships, which are based on a clear definition and distinction of roles. Italy can, for example, count on a mine of health data that needs to be exploited also through transparent collaboration between public and private sectors, in the interest of research and health for the country “.
The new EU regulation on clinical trials
The perfect opportunity, on the other hand, is about to arrive. In fact, next year the new EU regulation on clinical trials of medicinal products for human use should come into force, which will establish certain and uniform rules throughout the Union, regarding non-profit research by universities and public health companies, and for profit research by companies. pharmaceuticals, and collaborative research. Which will allow, for example, the transfer of data for registration and industrial purposes, guaranteeing coverage of the costs incurred by the National Health Service. A challenge that could represent a driving force for Italian clinical research, and in front of which our country must be ready, accelerating the enactment of the implementing decrees of the reform, still absent, as too often happens, a few months after entry in force of the regulation.
“The new European regulation places the entire world of research, from researchers to competent institutions and the world of industry, in front of a completely renewed scenario for which it is essential to reformulate and modernize the research system both at European level and in individual countries members, ”he recalls Carmine Pinto, President of the Federation of Italian Cooperative Oncology Groups and author of one of the contributions contained in the White Paper. “Also for Italy, therefore, the new Regulation represents an important challenge and an opportunity for the relaunch of research, and in this perspective it becomes essential to proceed with regulatory, structural and organizational changes. The opportunity of the Regulation should, among other things, create the conditions to overcome the dichotomy between research sponsored by pharmaceutical companies and ‘non-profit’ research – concludes Pinto – moving towards research that is as collaborative as possible and enhancing the overall medical and scientific skills present. in our country, in the primary interest of patients “.
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