Sir

Italian scientists must be grateful to Nature and to Alison Abbott for providing an international forum to debate an issue that many Italians consider ‘an internal affair’ to be handled in the usual byzantine way (Nature 388, 609–610; 1997). I would like to comment on two points concerning the future of biomedicine in Italy. The question of the future shape and responsibilities of the Higher Institute of Public Health (Istituto Superiore di Sanità, or ISS) is complex because, as Abbott points out, the institute is burdened by a number of regulatory duties. It is not opposed in principle to the transfer of these tasks to new ad hoc bodies, similar to the US Food and Drug Administration (FDA) or Environmental Protection Agency (EPA).

Our fear is, however, that the government may create new agencies, leaving all the technical work to be carried out by the ISS because it would be too difficult to find enough new experts and too costly to build and equip the infrastructure necessary to undertake all the controls exercised by an FDA or EPA.

What the government must do is to choose between two models: to create new agencies and provide them with the funds, expertise and infrastructure needed to carry out their duties independently or, alternatively, to restructure regulatory duties within the ISS in such a way that they become as separate as possible from research activities. A hybrid solution would help no one.

Biomedical research in most Western countries, contrary to what happens in Italy, is supervised by a body separate from the National Research Council. In the United States, federal biomedical research is carried out by the National Institutes of Health (NIH), which are directly responsible to the Department of Health and Human Services; health-related research in the United Kingdom and Scandinavia comes under the Medical Research Councils of those countries, and in France under INSERM.

Combining the ISS with Italy's network of 22 national clinical research institutes (Istituti di Ricovero e Cura a Carattere Scientifico), to act as a ‘national institute for biomedical and health research’, will not by itself take anything away from the national research council (CNR) as some fear. Funds for the new entity would continue to come from the Ministry of Health, and the CNR, which is funded by the Ministry of Research, would continue to have its own network (the Committee for Biology and Medicine and CNR Medical Institutes).

The relationship between the two networks needs to be resolved but, at least in principle, an ‘Italian NIH’ should carry out research directly relevant to the activities of the national health system, whereas the CNR could concentrate on more basic aspects.

What is needed above all is to avoid waste, duplication and the splitting of funds into too many channels that benefit only ‘clients’, not researchers.