La dichiarazione di Erice deriva da una Conferenza su "Comunicazione e Farmacovigilanza", tenutasi presso il Centro Ettore Majorana di Erice nel settembre 1997. Tale conferenza fa seguito ad una iniziativa precedente, conosciuta internazionalmente come "Verona Initiative", organizzata in collaborazione con il WHO Collaborating Centre for International Drug Monitoring di Uppsala e con il Council for International Organisations of Medical Sciences (CIOMS). Un breve "commentary" al riguardo è apparso su Lancet nel volume 348 del 5 ottobre 1996 a pag. 908.
Alla Conferenza hanno partecipato rappresentanti di tutte le categorie interessate, provenienti da tutto il mondo, e quindi da situazioni economiche, sociali e culturali anche molto diverse. Il risultato mostra come si sia potuti giungere ad una concordanza di principi ed idee.
Il testo della dichiarazione è stato fatto circolare presso società scientifiche, associazioni di categoria, bollettini di farmacovigilanza ed i Centri Nazionali partecipanti al "WHO Programme for International Drug Monitoring".

Su Lancet, nel volume 350 del 1997, a pag. 1041 e 1646, si possono leggere rispettivamente un editoriale ed un "commentary".

SOMMARIO

Monitoring, evaluating and communicating drug safety is a public-health activity with profound implications that depend on the integrity and collective responsibility of all parties – consumers, health professionals, researchers, academia, media, pharmaceutical industry, drug regulators, governments and international organisations – working together. High scientific, ethical and professional standards and a moral code should govern this activity. The inherent uncertainty of the risks and benefits of drugs needs to be acknowledged and explained. Decisions and actions that are based on this uncertainty should be informed by scientific and clinical considerations and should take into account social realities and circumstances.

Flaws in drug safety communication at all levels of society can lead to mistrust, misinformation and misguided actions resulting in harm and the creation of a climate where drug safety data may be hidden, withheld, or ignored.

Fact should be distinguished from speculation and hypothesis, and actions taken should reflect the needs of those affected and the care they require. These actions call for systems and legislation, nationally and internationally, that ensure full and open exchange of information, and standards of evaluation. These standards will ensure that risks and benefits can be assessed, explained and acted upon openly and in a spirit that promotes general confidence and trust.

The following statements set forth the basic requirements for this to happen, and were agreed upon by all participants from 34 countries at Erice:

1. Drug safety information must serve the health of the public. Such information should be ethically and effectively communicated in terms of both content and method. Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged, and information provided in ways that meet both general and individual needs.
2. Education in the appropriate use of drugs, including interpretation of safety information, is essential for the public at large, as well as for patients and health-care providers. Such education requires special commitment and resources. Drug information directed to the public in whatever form should be balanced with respect to risks and benefits.
3. All the evidence needed to assess and understand risks and benefits must be openly available. Constraints, on communication parties, which hinder their ability to meet this goal must be recognised and overcome.
4. Every country needs a system with independent expertise to ensure that safety information on all available drugs is adequately collected, impartially evaluated, and made accessible to all.

Adequate nonpartisan financing must be available to support the system. Exchange of data and evaluations among countries must be encouraged and supported.

5. A strong basis for drug safety monitoring has been laid over a long period, although sometimes in response to disasters. Innovation in this field now needs to ensure that emergent problems are promptly recognised and efficiently dealt with, and that information and solutions are effectively communicated.

These ideals are achievable and the participants at the conference dedicate/commit themselves accordingly. Details of what might be done to give effect to this declaration have been considered at the conference and form the substance of the conference report.