Italy invests approximately 1.4% of GDP in Research and Development as a whole compared to 2.07% of the European average. The share of this 1.4% traditionally dedicated to “health promotion and protection” corresponds to about 10%. These are some of the numbers contained in the White Paper “Biomedical research and the public-private relationship” presented today by the Fadoi Foundation and the Roche Foundation.
Numbers that must take into account how Italy is “a country that, more than others at a European level, has suffered in terms of growth and investments in recent decades”. In particular, the document states, “between 1999 and 2019 in Italy the Gross Domestic Product (GDP) grew by 7.9% against 30.2% in Germany, 32.4% in France and 43.6 % of Spain. In the same period, total investments in our country grew by 66%, compared to 118% in the euro area “.
Covid and vaccines
The pandemic, with the rush to vaccines and treatments based on monoclonals and antivirals, has taught us how important it is to bring the efforts of both the private and public to clinical research. But in Italy, clinical trials, which numbered 880 in 2008, drop to 672 in 2019. A minus 23% within which independent non-profit research is even more penalized, which in 2018 stood at 27.3% of the total number of trials, the following year contracted to 23.2%, so much so that today 90% of investments for clinical research are supported by private companies.
A disproportion that should worry us, because independent studies, conducted in a logic of collaboration between companies and the public, respond to less stringent needs than market needs and can lead to discoveries in areas that do not arouse interest in private investors.
Collaboration with the private sector
The second White Paper on clinical research, edited by the Fadoi Foundation, the federation of companies, says that in Italy a public-private collaboration in medical research is a necessity and that it is necessary to overcome bureaucracy and prejudices to enhance excellence and create value for the country. internal medicine scientists, and the IRCCS Policlinico San Matteo di Pavia Foundation.
The too long bureaucracy times were and are a factor that limits Italy’s participation in clinical trials. To say it are the numbers, because if in our country 4.6 every 10 thousand inhabitants take place every year, in Germany there are 5.6, in Spain and France 6, in Great Britain 6.8, in Holland 16.7, for not to mention the Danish record set at 25.5. “A gap where it is mainly the patients who lose out, because where research is done, there is even better care”, explains President Fadoi. Dario Manfellotto. “In fact – he stresses – in countries where clinical trials are carried out, innovative drugs usually arrive first and their knowledge spreads more rapidly among doctors who can then use them at their best”.
An advantage from the point of view of assistance, but also from an economic point of view, because as the editors of the White Paper remark, for every euro paid by the sponsor to the hospital or scientific institution for a clinical trial, savings are generated for the Health Service d 2, 2 euros thanks to the free supply of medicines. Not to mention the fact that, according to some studies, a more structured and organic regulatory framework could generate a growth of 30% in clinical trials, with an estimated economic advantage of over 700 million euros, deriving both from investments by companies and from savings. for the Ssn.
But if in general for the development of trials it is necessary to de-bureaucratise to shorten not only the approval times of Aifa and the Ethics Committees, but above all the delays that block the research centers and administrative and contractual aspects, on the level of non-profit research the relaunch “it passes from the unhinging of the principle of non-use for commercial purposes”, argue the editors of the White Paper. “If the principle is accepted that, when an indisputable advantage for the patient and for the community is documented, the non-profit group can transfer the results to a commercial entity that intends to use them for registration purposes, and this against a refund of all the costs incurred and an economic recognition for the innovative idea that led to the realization of the project, a virtuous circle would be triggered in which the public system would receive funding from private industry, such as to allow the public itself to reinvest in other successful independent research. “
“With Covid-19 we have understood the significant role that public support can play in accelerating and amplifying the development and availability of health technologies for citizens and patients”, says the scientific director of FADOI. Gualberto Gussoni, who, together with Sergio Scaccabarozzi of the Scientific Direction of the IRCCS Policlinico S. Matteo di Pavia Foundation, oversaw the creation of the White Book. “The public-private relationship – he added – 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 must in any case be that of the health of all. individual and community “. A goal that also requires overcoming prejudices and old legacies. Like those of those who see the devil oriented only to profit in companies and holy water in the public which, however, is impossible to draw from due to the slowness of the bureaucratic mechanisms.