Italian healthcare has a problem with conflicts of interest

Euros for Docs is a French association that deals with transparency in healthcare. For some years it has been collecting data at European level on payments by major pharmaceutical companies to individual doctors, private companies or public organisations such as universities. IrpiMedia has already reported how major pharmaceutical companies have made donations, covered travel expenses, paid for consultations and events to doctors, hospitals and research centres. A real pressure system that distributed more than €333 million in 2019 alone.

A deeper analysis of the Euros For Docs data on Italy, in collaboration with the magazine Scomodo, reveals two new elements. The first is the presence of numerous payments to various members of the Consiglio superiore di sanità and the former technical-scientific committee, now dissolved following the end of the Covid emergency. Although the payments are not illegal, our investigation suggests opaque management of conflicts of interest within the two bodies.

Sometimes, however, the line of legality was crossed, at least according to the magistrates. The second element, in fact, is the presence in the register of the names of some people who have ended up at the centre of corruption investigations, for donations of money by pharmaceutical companies to hospital managers and university professors.

Issues of incompatibility

The Consiglio superiore di sanità (CSS) is a ‘scientific-technical advisory body of the Ministry of Health’. It carries out scientific investigations and studies and gives opinions on various public health issues to advise the Ministry and suggest appropriate measures. It consists of thirty ex officio members – including managers of the Ministry and other health institutions, such as the Italian Medicines Agency – and thirty members chosen by the Ministry with a three-year term of office. These were last appointed in February 2022, when Roberto Speranza was the Minister of Health. Data from Euros For Docs shows that at least eight of the members chosen by the Ministry received payments from pharmaceutical companies until shortly before they were elected. Six of these eight received payments until 2019, i.e. three years before the formation of the last CSS. Three of them – Giuseppe Curigliano, Franco Locatelli and Marco Montorsi – however, were also part of the previous SCC, appointed in February 2019: this means that they received payments less than a month after their appointment, at best, or even while they were already members of the SCC. The amounts of the payments vary greatly from person to person. In some cases, the figures are relatively small: Anna Odone, a current member of the Css, for example, received around EUR 2,500 between 2018 and 2019, mainly in the form of reimbursement of business travel expenses. In other cases, however, the figures rise sharply. Luca Richeldi, a Css member and professor at the Università Cattolica del Sacro Cuore, received around EUR 134,000 between 2017 and 2019 from various pharmaceutical companies including Boehringer-ingelheim and Sanofi. Most of the payments concern fees for ‘consultancy services’. The president of the Css, Franco Locatelli, received EUR 24,000 between 2016 and 2019, also mainly for consulting services.

Providing paid services to pharmaceutical companies is legal, we reiterate. And yet, it raises serious questions about the management of possible conflicts of interest within the Css. According to what we have been assured by a current member of the SCC, whose anonymity we wish to preserve, upon appointment those who join the board must inform the ministry of their current and past collaborations with public or private entities in the sector, so that any conflicts of interest are clear from the outset. However, these documents are not published online. We have sent a FOIA request to the Ministry of Health to obtain them, without receiving a response. It is also unclear whether disclosure of a conflict of interest has ever led to the exclusion of a board member.

Online, however, are the ‘declarations of absence of conflict of interest’ of the Technical and Scientific Committee (STC), a body set up in February 2020 to deal with the Covid emergency and dissolved at the end of March last year. There is also overlap between the Cts and the SSC. Some current members of the Css, in fact, have also been members of the Cts, such as Sergio Abrignani, and the aforementioned Locatelli and Richeldi. Cross-referencing the payment data and the documentation available online, what emerges is an opaque management of conflicts of interest within the Cts. In his declaration of conflict of interest, dating back to 28 September 2020, Luca Richeldi indicates that he continues to do consultancy work for a number of pharmaceutical companies – including Boehringer-ingelheim, which made €76,521.78 in payments to him in 2017.

Conflicts of interest are, at least on paper, assessed for the impact they could potentially have on the decisions of Committee members. This is served by the Conflicts of Interest rating grid, which ranks the severity of possible conflicts of interest with a number from 1 to 3, from least to most serious.

At the first level, ‘unrestricted involvement in the activities of the CTC is allowed’, at the second level, ‘restrictions may apply’. The third level, on the other hand, is defined with one word: ‘incompatibility’. According to this table, providing consultancy services while being a member of the Cts corresponds to level 3, the maximum conflict. One cannot be an advisor to Big Pharma and an advisor to the Ministry of Health at the same time; the two roles are, quite simply, incompatible. Despite this, Richeldi continued to be a member of the Cts until Draghi took office, only to be called by Speranza to join the Css.

Richeldi is not the only one. Locatelli himself, president of the Css from 2019 and also coordinator of the Cts for a few weeks in the spring of 2021, has received payments for consulting services until 2019, according to Euros For Docs data, from several companies including Sanofi, Novartis and Gilead. In his declaration of interests to the Cts on 23 September 2020, he in fact indicated that he had worked as a consultant for pharmaceutical companies in a range of time ‘from 0 to 3 years previously’. This according to the Committee’s conflict of interest assessment grid corresponds to level 2. In theory, therefore, Locatelli could be restricted in his participation in the activities of the body of which he was coordinator.

In a later conflict of interest declaration, dated April 2021, Locatelli’s conflicts of interest become even more apparent. Indeed, he indicates that he ‘currently’ provides consultancy services to some companies. This, as already seen with Richeldi, represents the highest level of conflict, incompatibility. In addition, the current chairman of the SCC also states that he has held a patent since 2019 – which, according to the grid, also corresponds to the highest level of conflict. In addition, other potential minor conflicts are highlighted, which correspond to level 2 in the evaluation table, concerning his role as an investigator in some projects.

There are good reasons to believe that the evaluation grid used by the Css is not too different from that of the Cts, despite the fact that the Consiglio superiore di sanità did not respond to our request for access to the document. First of all, because the areas of competence of the two bodies are very close – they both deal with public health – so much so that in March 2021 the former minister Speranza, in a press conference announcing the imminent end of the Cts and the Covid state of emergency, said that ‘the government as a whole will still be able to count on two fundamental structures that remain standing, the Higher Health Council and the Higher Institute of Health’.

In addition, according to what we have been told by one of the SCC members, when they are appointed, they must disclose ‘any direct or indirect collaborative relationships they have had with private individuals, in any way remunerated, over the past three years’, i.e. something not very different from what must be indicated in the SCC’s declarations of interest. This communication, the Css member reports, is followed by a commitment ‘to refrain from taking part in discussions and deliberations on matters for which there is a conflict of interest, even potential, of any kind’.

We also asked the source whether in this person’s experience it had ever happened that she or a colleague of the SCC had abstained from a discussion because of potential interests. We were told that, at least in her section, this has never occurred.

The picture that emerges is undoubtedly opaque. The lack of transparency prevents an accurate assessment of whether the law is being applied or not. Indeed, it is unclear whether declarations of actual potential conflicts of interest, even serious ones, are followed by particular measures or abstentions on certain topics.

If, on the one hand, the Cts in its period of operation has in any case made certain information public and accessible – both the declarations of interest of its members and all the minutes of its meetings – the SCC, on the other hand, is much less transparent. What is certain, from the Euros For Docs data, is that in 2019 some of its members received payments from pharmaceutical companies – for consultancy services or expense reimbursements – up to a few weeks before they were appointed, if not even while they were in office. And it is also confirmed by the Cts’ declarations of interest that some current CSS members have continued to provide consultancy services for pharmaceutical companies until at least 2020 or 2021. The data and documents currently available do not allow us to know whether these payments and consultancy services continued thereafter.

With what money

The second major theme that emerges from the Euros For Docs database concerns a series of arrests and proceedings that have taken place over the past few years. On 3 October 2018, Franco Aversa, a haematology expert and full professor at the University of Parma with more than 200 publications to his credit, was arrested. According to the accusations, he was at the head of an organisation of doctors, managers and entrepreneurs that secured favours for some pharmaceutical companies – such as negative or positive reports for a certain drug – in exchange for sponsoring conferences or actual payments. The investigation has ruled out the possibility of health risks for patients, but the dialogues coming out of the interceptions, reported by various newspapers, are very clear.

“There are companies that have contributed substantially and others that have not even responded, so it’s clear that I have to make a list of the good guys and the bad guys,” Aversa is reported to have said. “I’ll say it frankly… these new products that you guys have to launch, they will practically never get in here!”

The same day, in the same Nas operation, called Conquibus, Paola Gagliardini was also arrested. She is the managing director of Csc srl, a congress organisation company in Perugia. For the investigators, she was in charge of setting up the events sponsored by pharmaceutical companies thanks to favours obtained from Aversa.

These names reappear in the Euros For Docs database. According to the data, Aversa received almost EUR 19,000 between 2017 and 2018. They are mainly payments for consulting services and come from companies such as Astellas, Gilead, Novartis and Janssen. For Gagliardini’s company, on the other hand, the figures are much higher. Between 2016 and 2019 (although it only received one payment in 2019), Csc received almost EUR 320,000. The pharmaceutical companies that have given out the most money are Gilead, Novartis and Pfizer. Most of the payments are registered, predictably, as event sponsorships.

In July last year, Aversa plea-bargained a fine of EUR 80,000. The charges were bribery, attempted bribery, undue inducement, fraud and forgery. According to press reports, Paola Gagliardini was also close to reaching a settlement, but there were problems in settling the compensation, so her position has been disqualified. She will therefore face a separate trial.

These are only the two main defendants, but at the beginning of the investigation there were a total of 33 people indicted in the Conquibus investigation, together with various pharmaceutical companies including Celgene and Gilead, against whom a dismissal was eventually ordered. Some of these names, all initially involved in the Conquibus investigation, turn up in the Euros For Docs data. The figures involved vary widely: from those who received around EUR 38,000 between 2016 and 2019 for consultancy services, to those who were paid EUR 2,500 more or less in the same time frame by pharmaceutical companies in the form of reimbursements for travel expenses. Of the 33 people initially investigated, 15 were remanded in custody, 10 were acquitted, four took plea bargains and two were sentenced by summary proceedings. Pending trial, the payments made by the pharmaceutical companies are to be considered entirely legitimate.

In conclusion, the management of potential conflicts of interest within the CSS and the Cts, together with the legal proceedings of the past months, show the need for greater transparency in the economic relations between large pharmaceutical companies and health organisations, companies and professionals. A need that was also recognised by the previous Parliament, which definitively passed a law in June 2022 ‘on the transparency of relations between manufacturing companies, health professionals and health organisations’.

The pivotal element consists in the creation of a public register of payments made by pharmaceutical companies, accessible from the website of the Ministry of Health. The timeframe for implementation is very clear: ‘within six months from the date of entry into force of this law’, reads the fifth article. At the moment, six months have just passed and the register is not available on the Ministry of Health website.