By Sarah Steingrüber

In early July 2018, the new Italian government proposed a bill to adopt a so-called “Sunshine Act” in order to “[fight] corruption in the health system and maximise transparency in the relationships between companies […] and healthcare providers”. This piece of legislation calls for disclosure of all transfers of value over €10 between the pharmaceutical industry and healthcare providers. Italy currently relies on industry self-regulation as per the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code. Under this code, companies themselves are expected to disclose transfers of value on their websites or on a government-provided central platform. Should this new bill be adopted, Italy will join other leading European countries including France, Portugal, and Denmark, who also in the last decade have increased transparency in their healthcare systems through similar legislation.

Globally, adopting Sunshine Acts is in vogue as more and more research brings to light the influence that industry support can exercise on care providers’ objectivity towards patients’ best interests. For example, a 2016 study in the United States by ProPublica found that those care providers who had accepted industry payments were up to three times more likely to prescribe branded drugs compared to their peers.[1]

Sunshine Acts can act as deterrents to dissuade companies from overstepping their bounds and exercise undue influence over the behaviour of care providers, as well as reduce providers’ level of engagement with industry in ways that could compromise their judgement. Also, as the registers of transfers of value mandated through Sunshine Acts are made public, patients can consult the register to see if their care providers have conflicts of interest. Patients can make more informed decisions about the providers they seek care from, as well as the treatments they are offered.

Increasing transparency around the transfers of value between industry and healthcare providers helps to reduce corruption in health systems and better manage potential conflicts of interest. We spoke with Transparency International Italia Executive Director, Davide Del Monte, on the significance of this development in Italy.

Can you describe the relationship between the pharmaceutical industry and healthcare providers in Italy?

The last Report “Curiamo la corruzione” published by Transparency International Italia and other partner organisations, highlights how the relationship between pharmaceutical industry and healthcare sector presents a very high risk of corruption.

The analysis shows that the “public procurement for goods and services” represents the area perceived as most risky in the Italian healthcare sector.

A more specific problem regards the “undue prescription of drugs caused by opaque sponsorships” by the industry. This is, of course, a huge issue, because it really impacts the lives of the citizens who can only rely on the good faith of their doctor. In that way, this proposed Sunshine Act, which would provide full transparency about such sponsorships, can be really useful for identifying wrongdoing and illicit behaviours.

Do you think that patients in Italy are aware of the potential conflicts of interest that their care providers may have?

In Italy, the healthcare sector is perceived as the second most corrupt, only after the political sector. This means that patients are aware of the dangers, but they are “at the mercy” of the informative asymmetry. Again, the only tool that patients have is the full transparency and accountability of their doctors.

How has Italy faired with the EFPIA Code and industry self-regulation? Why do you think this piece of legislation is being proposed now?

Self-regulations and Codes, as per the EFPIA, are very important, but they are not sufficient. There is the need for coordinated activity from the government, and the Sunshine Act is a step in the right direction with the creation of a single website on which all the information will be easily accessible.

Does the proposed Act include any sanctions or penalties?

The actual version of the proposed Act includes economic sanctions for missing or incorrect information. It is difficult to evaluate if the sanctions are strong enough at the moment. But they are there, and this is a positive point.

What is Transparency International Italia doing to promote the Sunshine Act bill and ensure its success?

We will encourage any effort directed to a higher level of transparency in the healthcare sector. We have asked for a meeting with the competent Ministry in order to discuss the details of the Act because we are fully aware the “evil hides itself in the details”. We are sure that strong lobbying on this proposed Act will take place, so we will monitor that everything goes according to the maximum level of integrity and transparency. Transparency International Italia will act as a real watchdog should, by monitoring, proposing and supporting any idea that can lead to an improvement of the actual situation.

 

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[1] Jones R and C Ornstein, Matching Industry Payments to Medicare Prescribing Patterns: An Analysis, ProPublica, 2016.