Tag Archives: ANAC

Corruption in Healthcare: What ANAC’s New Catalogue Means for Life Sciences Compliance

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Corruption in Healthcare. Corruption is a concrete, evolving compliance risk for life
sciences companies, not just a hypothetical risk. In my experience sitting on supervisory boards under Legislative Decree 231/2001 on corporate criminal liability, the risks in this space have grown more sophisticated and harder to detect over the years.

The numbers explain why. Italy’s National Anti-Corruption Authority (ANAC) recently noted
that roughly 25% of all public procurement spending in Italy flows to the healthcare sector, and
that 8% of whistleblowing reports concern that same sector. Those two figures alone justify
heightened scrutiny.

ANAC has been paying attention accordingly. It has adopted the “Catalogue of Corruption Risks
and Prevention Measures in the Healthcare Sector” (Catalogo dei rischi corruttivi e delle misure
di prevenzione nel settore sanitario), approved by ANAC’s Board with Resolution No. 318 of 29
July 2026. The Catalogue is meant to support National Health Service entities in drafting the “corruption risks and transparency” sub-section of their Integrated Activity and Organization Plan (PIAO), and it is a document worth reading well beyond that immediate audience.

The idea behind it is straightforward: healthcare is complex, the stakes are high, and the web of
relationships within the system calls for extra scrutiny, especially when public health is on the
line.

What the Catalogue Covers. The Catalogue maps new risks and new prevention measures across a wide range of areas: healthcare system regulation, biomedical research, pharmaceutical and medical-device marketing and promotion, public procurement, product distribution and storage, financial resource management, human resource management, and the actual delivery of healthcare services, including relations with accredited providers, oversight and inspection activity, and private practice and waiting lists.

For life sciences companies, the marketing and promotion chapter is the most direct point of
relevance: it is the clearest line connecting the Catalogue’s healthcare-system focus back to
industry conduct rather than treating it as a purely public-sector document.


Why This Matters. Healthcare is a perfect storm for integrity risk: high-stakes decisions, significant economic interests, constant public-private interaction, and pronounced information asymmetries. That mix can easily breed mismanagement, conflicts of interest, and outright corruption. ANAC’s own conclusion is that preventing corruption in healthcare takes a model built on transparency and impartiality, digitalization, independent controls, accountability, and the capacity to monitor the most exposed processes on an ongoing basis.

A Basis to Stress Test the Risk Map. Both public entities and private companies active in healthcare should take note of these risks and move to adopt measures that prevent them. For life sciences companies operating a Legislative Decree 231/2001 compliance model, the Catalogue is more than a general awareness exercise: it is a ready-made checklist against which to stress-test the existing risk map, refine the questions asked of management, and confirm that prevention measures keep pace with how these risks.

Legality Rating by the Italian Antitrust Authority: Is It Useful?

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“Not only must we punish corrupt companies but also encourage healthy businesses“. The statement released by Mr. Raffaele Cantone, Chairman of the Italian Anti Corruption Authority, summarizes the rationale underpinning the so called “legality rating”, i.e. a score that the Italian Antitrust Authority assigns to companies who apply for it. In fact, Law no. 62/2012, converting Law Decree no. 29/2012, requires the Italian Antitrust Authority to assign a score ranging from one to three “stars”, to any applying company who complies with a series of legal requirements (inter alia, the absence of criminal sanctions or preventive/precautionary measures against key personnel of the company, no judgments pursuant to Legislative Decree No. 231/2001, no breaches in the field of health and safety at work, and no definitive tax assessments against the company).

The instrument, available to entities generating a turnover in excess of Euro two million per year, is completely optional, but continues to be widely utilized. A statement of the Antitrust Authority shows in fact that, in January 2015, the Authority  received respectively 14% more applications than in the previous month and the trend seems to continue.

So, companies line up as schoolboys in order to show that they are worth a certain number of “stars” in an effort to demonstrate the soundness of their compliance program: is it worth it? To respond, we have looked into the benefits of the legality rating to understand the actual relevance of a practice that is becoming widespread. Below is a summary of the alleged benefits.

  • A new Regulation, developed by the Italian Antitrust Authority in collaboration with the National Anti Corruption Authority, entered into force on November 14, 2012, sets forth that companies benefitting from a legality rating are enrolled in a register of virtuous firms. Such registration is supposed tofacilitate relations with banks or the granting of public funding as well as the possibility to participate in public tenders.
  • The first example of a public procurement process taking into account the legality rating refers to postal services. The procurement documentation (Decision of December 9, 2014, published in the Official Gazette no. 1 of the January 2, 2015) stated for the first time that “for the public procurement of large size, the contracting authorities can evaluate the opportunity to give an additional and proportionate score to companies that benefit from a legality rating issued by the Antitrust Authority pursuant to §. 5 ter of Law-Decree no. 1 of January 24, 2012, or that have equivalent certifications issued to foreign firms from other agencies or public authorities”. For the first time, legality rating actually mattered as it gave a chance to companies to score additional points in public tenders.Some have criticized the use of a legality rating in this context, given that section 83 of the Italian Public Procurement Code (Legislative Decree no. 163/2006) requires that contracting authorities assess bidding companies on the basis of objective requirements only. It has been in fact argued that making reference to a legality rating is too discretionary. However, the Antitrust Authority, in opinion no. 163/2013, seemingly admits the possibility of using discretionary requirements, such as “the curriculum of the company, possession of licenses or quality certifications, availability of business assets, the providing of services or similar work, and in general, skills and references” as “factors that can be weighedas criteria for admission to tenders”.

In conclusion, if public procurement tenders give some weight to the legality rating, then obtaining it may actually be a good idea.

The risk is, as with any type of certification, that it will become a merely formal requirement, which does not attest the actual compliance efforts or a corporation’s culture.