Italian Ministry of Health and the Istituto Superiore Di Sanita: from vigilance to ownership?

Who owns disease surveillance data? If data are gathered via a research plan granted to a public research institute is this institute or those who finance the research the sole responsible party for data usage and implementation? Is the ‘sensitivity’ of some surveillance data an argument for depriving the investigators of the freedom to publish? Is an agreement awarding the sole granters the faculty of free use of those data scientifically and ethically acceptable? Finally, can the necessary, if not mandatory collaboration between two public health institutions confound their distinct responsibilities? The questions above are some major ones which arise from a recent agreement (Accordo di collaborazione, 2014, hereafter referred to as the ‘Accordo’) between the Italian Ministry of Health (MoH), namely its National Center for Disease Prevention and Control (the CCM) and the Istituto Superiore di Sanità (ISS), the scientific and technical body of the Italian Health Service. Through this agreement, the CCM, which has managerial and no research or technical personnel, grants to the ISS for the fiscal year 2015 more than 2.5 million Euros to perform disease surveillance activity in the national territory, in some fields also bound to international obligations. By statute, the ISS is a public research Institute under MoH vigilance. It was last year declared by the Italian Government to be in receivership and under budgetary controls. Despite this, the ISS retains full technical and scientific autonomy. Its independence is a good thing since it avoids political interferences on its statutory activities, while assuring provision of quality data and evidence-based support to MoH itself and other public health policy makers. The resources that CCM annually allocate to ISS applicants support research activities upon which MoH policies, regarding such critical health issues as human disease prevalence and risk factors, antibiotic-resistance trends, vaccination schedules, certification of technical devices, food safety, to quote only some of them, are implemented. Although qualified as ‘routine surveillance’, these projects are not simple gathering of numbers and documents but are true research activities with rigorous study design and methods of data collection, assessment and reporting. Arguably, these criteria are used when the CCM, through its reviewer panels, allocates resources to some proposals and not to others. Unfortunately, reading through the pages of the ‘Accordo’, it does appear that the ISS investigators are simple executors of ministerial ideas, not proponents of their own research plans. Bitterly enough, one of the articles of the Accordo (Nu 4) states that everything generated in the research, including the Authors’ reports and potentially patentable materials, is the ‘‘exclusive’’ property of CCM, meaning they do not belong to, or are not even shared with, those who really proposed and performed the studies. Still more, the CCM reserves to itself the right of publishing the data, or even ‘selling’ (?) them, without previous consent by the ISS researchers, with only ‘the indication’ of those who did the job. Clearly, acknowledgement is not enough for CCM! Without doubt, the words used in the above paragraphs of the ‘Accordo’ are not those of a scientific agreement between institutions collaborating on a peer basis to the benefit of public health. Rather, they sound akin to those typical of a Material Transfer Agreement, whereby, for instance, an industry allows a researcher to use a proprietary reagent or drug, under restricted conditions. Is this really what the ISS investigators deserve, not even sharingwithCCMthe responsibility andproperty of the data they produce? Italy remains a country with remarkably low infrastructural investments in, and dramatic shortage of money allocated to, research. Public Health research Correspondence to: Antonio Cassone, Center of Functional Genomics, Polo della genomica, genetica e biologia, University of Perugia, Perugia, Italy. Email: [email protected]