Key takeaways
The new Regulation aims to prevent the interests of those who work or collaborate from even appearing to override the main interest, which is the protection of public health, and this is in line with the recent decision of the European Court of Justice, which overturning a decision of the EMA not to approve a particular drug, in the presence of a possible conflict of interest, ruled that the European Agency itself "is obliged to be vigilant to prevent the experts it consults from having a conflict of interest."
The Regulations considers a range of relationships and/or activities that constitute "direct secondary interests," including potential secondary interests of relatives or friends of Italian Medicines Agency's employees, managers and collaborators; dependent, consulting or collaborative relationships with a "sensitive" entity; money transfers from private individuals in the pharmaceutical industry; extra-institutional teaching activities; participation in strategic, scientific and steering committees organized or financed by sensitive entities; corporate offices, and so on.
Among the various penalties, violation of the obligations under the new Regulations entails disciplinary proceedings against Italian Medicines Agency's employees, and suspension of activity from three months to one year for experts, consultants, collaborators and working group members not directly employed by the Italian Medicines Agency.
