When speaking of 'pharmaceutical criminal law', the meaning or, rather, the scope of this expression is not always fully understood. Indeed, it would be more accurate to speak of criminal risks for pharmaceutical companies in order to cover all possible 'sensitive' areas - in criminal law - for a company operating in this sector. The concrete experience of recent years has shown that, even from the point of view of the investigating judge, this area has been and continues to be in the spotlight of investigators. It is undeniable that investigations into pharmaceutical companies are frequent, in some cases even insistent. After all, the pharmaceutical world is objectively at the centre of global media attention - perhaps as never before at this very difficult time in history. Under which profile can an investigation be launched? No easy answer can be given, but we will try to do so on the basis of what we have seen happening in practice.

First of all, the issue of relations with public officials, especially with doctors, is certainly a particularly sensitive issue. More specifically, the issue of sponsorships (of scientific events, lectures for learners, medical symposia, international conferences, etc.) is very sensitive, giving rise to an inevitable connection between the pharmaceutical company (the sponsor),the provider company (the event organiser) and the doctor(s) acting as key note speaker (and who are often public officials on other occasions - e.g. when approving or prescribing drugs),with an equally inevitable involvement of considerable sums of money to cover the costs of these events (in relation to which pharmaceutical companies do not always have complete visibility). It should be specified that these events are absolutely ordinary and fully lawful initiatives, which, in themselves, have nothing irregular about them.

However, practice shows that significant pitfalls can often lurk in the relationships between the actors mentioned above, especially when certain administrative, contractual, internal policy rules are violated in the organisation of the event. In fact, such violations are often interpreted ex post as evidence of ex ante illegal arrangements. In short, the 'guiding' rule must be utmost scrupulousness and rigour in complying with internal procedures (including codes of conduct) and the laws governing the sector, since even small deviations in this respect might take on highly problematic connotations in a potential subsequent pathological scenario. I am referring, quite clearly, to charges of bribery or other offences against the public administration, but also, for instance, to fraud against public bodies.

But that is just one example. Indeed, pharmaceutical companies, especially multinational ones, are constantly exposed to criminal risks of all kinds. Suffice to think of product liability, an issue that has been made more topical than ever by the coronavirus epidemic and the related problems linked not only to vaccine administration but also, for example, to the production and marketing of special protective health devices (such as protective masks). Or think of the thorny world of tenders, in which pharmaceutical companies are often involved. Not to mention all the cases in which pharmaceutical companies are involved in a criminal investigation as a potential victim or injured party.

It is crucial for pharmaceutical companies to have the most robust compliance system possible. Consequently, it will be essential for these companies not only to have a valid organisational and control model pursuant to Decree 231/2001, but also to have efficient and functioning procedures that are up-to-date and known to employees. In short, never before has the world of pharmaceutical companies seen the establishment of an efficient internal control system not as a 'cost', rather as an important investment to protect the company. Specifically, the ability of the company to have a fast and efficient internal audit system is of great importance - and this too is a fact taught by concrete experience; in other words, the ability to intervene promptly, when faced with reports of anomalous events, to conduct internal investigations (often involving external professionals),to identify the problem that has occurred and take remedial action. This can often make a difference, even in Court.

Avv Fabio Cagnola and Avv. Filippo Ferri per Forbes, Jan 2022

® All rights reserved