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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The competent authorities for enforcing the laws governing medicinal products are the Agency for Medicinal Products (AIFA) and the Ministry of Health, both of which are entrusted with a wide range of enforcement powers relevant to their own areas of competence, including:
- undertaking inspections and audits;
- suspending and revoking authorisations; and
- issuing interdictory or pecuniary penalties.
Inspections may be conducted through the police body specialised in health-related matters (NAS). Since 2017, the AIFA has a dedicated NAS unit. Regions and hospital units also have parallel enforcement powers concerning, for example, wholesale activities or pharmacies.
On January 19 2017 the AIFA signed a memorandum of understanding with the Anti-competition Authority in order to increase cooperation and enforcement in the pharmaceutical sector by facilitating the exchange of information and data – for example, with reference to suspected abusive behaviours in price and reimbursement negotiations or counterfeiting cases. Further, the authorities will cooperate in carrying out sector enquiries.
At the industry level, the self-governing industry association Farmindustria has enforcement and sanctioning powers over affiliated companies in relation to Ethics Code compliance.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
From a company perspective, it is good standard practice to implement an organisational model and ethics code, as well as standard operating procedures, in order to prevent employees from committing crimes. Under Legislative Decree 231/2001 regarding the administrative liability of companies for crimes committed by their employees, a company may be exempted from liability if it provides sufficient evidence that it adopted adequate measures to prevent the commission of crimes by its employees.
Farmindustria has provided guidelines on how to establish a proper organisational model in the pharmaceutical industry, especially with regard to sensitive areas, such as interactions with healthcare professionals and public institutions and rewarding mechanisms for agents operating in the field.
Healthcare organisations must abide by Legislative Decree 190/2012 and enforcing Decree 33/2013, which aim to ensure transparency among public bodies and prevent corruption and bribery by implementing a number of long-waited measures in Italy (eg, with regard to whistleblower protection). In particular, each public body (eg, public hospitals) must adopt specific prevention measures, including:
- the adoption of an anti-corruption plan;
- the appointment of a compliance officer; and
- the adoption of an employee code of conduct.
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