The Italian Medicines Agency (AIFA) was founded in 2004 under the management of Nello Martini and grew enriching its regulatory mandate with complementary activities such as funding independent research and providing information/education for professionals.
One of the biggest damage caused by the abrupt interruption of that season in 2008, as a consequence of the enquiry by the Public Prosecutor Guariniello (now ended with nothing after 7 years), was the rupture, now irreparable, of an experience which was particularly innovative in Italy and in the international panorama.
Many have already spoken, with their specific competences,1 in favour of the clinical research carried out by AIFA over those years. In this article, once again on the basis of a direct experience, I would like to try answering some questions about the responsibilities of Health Institutions on information, on the ground of the activity carried out by Martini’s AIFA, which I took part to (see box).
Is drug information opportune and necessary when provided by national drug Agencies?
The answer is yes, because it is of common interest that professionals and the public are guaranteed transparent information, independent by the producers and provided by whom has the data, and possibly reinforced by accessible education instruments.
Could the information originated by an Institution also be “critical”?
Yes and no. It must be rigorously based on the available scientific evidences and able to integrate them with all the other relevant data (for example prices, consumes, the expense, the ongoing promotional activities) to give an intelligent and understandably reading. But obviously it cannot criticize the public health institutions of whom it represents the point of view.
It is not about conflict of interests, as it is often said, but more about the coherence of the system: the same Agency cannot decide that a medicine is reimbursable and at the same time criticizes its benefits; if the decision is wrong, more than publicly criticizing it, it is better to amend it.
Institutional information, therefore, can be alternative to the commercial one and complementary to others independently produced by other actors, such as those affiliated to the International Society of Drug Bulletins (ISDB, for example Focus Farmacovigilanza) or some consumer associations. Actually, ideally speaking, the public would have interest in actively promoting critical voices (as the French State has done with Revue Prescrire, funding it in its first years until it reached self-sustainment), but surely the public sector cannot abdicate its duty of information, especially in such a relevant sector for health such as medicines.
If it is not “independent” and it is not “critical”, how could drug information by a Healthcare System Institution be qualified?
I would like to propose the term “responsible”, which seems appropriate, referring both to “accountability” and to being prepared to take in account all the consequences, positive and negative, that can originate from the dissemination of any information, in the interest of the public. An example, also confirmed by recent polemics, could be the information about vaccines, which has to be complete, honest and true, but in its communication must take into account the possible effect on the coverage, and therefore on public health.
Keeping this into account does not mean affecting the transparency, which would be censure, but projecting the dissemination of any “sensible” data in a communicative way (by definition a double-way process) so that return messages could also be heard. And adapting the information as an ongoing process on this basis.
All this had been done, with the few instruments available then, under Martini’s management. I can assert it because I was then involved professionally: just to cite a small example, I remember a participating exercise about prescription notes opened for discussion via e-mail to general practitioners.
The fruits of this experience were completely nullified by the following direction, which drastically downsized the research grants, now intermittent, abandoned education completely and reduced information to few marginal activities, often in the form of “campaigns” of publicity nature. As a consequence, the whole AIFA activity has acquired an “opacity” which seems to be the direct heritage of how its management was changed. The absolution of Nello Martini finally brings justice, but it does not shed light on this page of Italian Healthcare history, even though all the citizens should rightfully feel damaged for how things went.
INFORMATION AND EDUCATION BY MARTINI’S AIFA
Below are listed some of the main activities for education and information conducted by AIFA – and before by the General Directorate of Medicines of the Health Ministry – both under the management of Nello Martini.
- Bollettino di informazione sui farmaci (BIF - drug information bulletin): renovated in its contents and graphics, the old BIF had been transformed from the previous bureaucratic news report to a scientific journal. Sent to 300,000 practitioners and 60,000 pharmacists (published by Pensiero Scientifico, 2000-2009). http://www.agenziafarmaco.gov.it/it/content/bollettino-di-informazione-s...
- ReAzioni: bimonthly journal of Pharmacovigilance, distributed to more than 20,000 health professionals. Sixty-four issues were published by Zadig between 2007 and 2009. http://agenziadelfarmaco.gov.it/it/content/rea-online
- Clinical Evidence edizione italiana: Italian edition by the Italian Cochrane Centre of the compendium of the best scientific evidences on healthcare interventions effectiveness; it was distributed to 300,000 general practitioners, specialists, university professors. It reached it sixth edition (published by Zadig 2002-2008). http://aifa.clinev.it/
- Guida all’uso dei Farmaci nei bambini (Guide for the use of medicines in children): distributed in 600,000 copies, only edition (Laboratory for Mother and Child Health, Mario Negri Institute)
- Prontuario farmaceutico nazionale (National pharmaceutical handbook): published in two editions (2004-2005) by Masson in more than 300,000 copies
- Farmaci in gravidanza (Drugs and pregnancy): edited in 2007 (only edition, Laboratory for Mother and Child Health, Mario Negri Institute) in 285,000 copies
Online distance learning
- ECCE-Medici: Online distance learning programme based on Clinical Evidence for practitioners and developed with the Italian Cochrane Centre. It had more than 40,000 participants engaged in more than one million courses and dispensed more than one million CME credits (publisher Zadig 2005/2008)
- ECCE-InFAD: Online distance learning for nurses developed with IPASVI federation, it had more than 100,000 participants engaged in more than 4 million courses and dispensed more than 3.5 million CME credits (publisher Zadig 2006/2008)
- BiFAD: Online distance learning for practitioners based on the BIF (Bulletin of information on drugs), it had more than 3,000 participants engaged in more than 8,000 courses (published by Pensiero Scientifico 2006-2008)
- ECM CCM: Online distance learning for practitioners and nurses on prevention topics by the Centre for Diseases Prevention and Management (CCM) of the Ministry of Health. It had more than 10,000 participants engaged in more than 56,000 courses (Publisher Zadig, 2010).