Monthly Archives: February 2017

Are doctors ready to fight corruption?

If you are reading this blog post, chances are that you are working for a pharma or med-tech company. If so, you are probably spending a sizeable portion of your time ensuring that such company does not get involved in corruption (even more so, if your role specifically entails the duty of complying with the United States Foreign Corrupt Practices Act (FCPA), the United Kingdom Anti Bribery Act (ABA), or Italian 231 legislation).

The fight against corruption can often feel lonely and unrewarding. While the mission of instilling ethical principles into the company’s money-making activities may be inspiring, the day-to-day reality of compliance can, at times, feel disheartening.

Sometimes “compliance” seems at odds with “business”. Compliance people need to emphasize pessimistic worst-case scenarios, which at times appear to be completely opposed to the bright optimistic viewpoint of business people. Often compliance is confined to saying “NO”, when the sales people repeat, over and over, “BUT OUR COMPETITORS ARE DOING IT!”

Here are a few reasons why you should never, ever!, give up.

  • You are doing this for your company.

While you may be, in fact, stopping or delaying certain sales of your company, you are truly protecting the company from the horrendous sanctions that it could suffer under the FCPA, the ABA or 231 legislation. Anybody within your company should be grateful since you are ultimately saving the company’s existence. As a result, you are saving the jobs of the company’s employees.

  • You are helping your fellow citizens.

Corruption has a cost. Many entities, like Transparency International and its Italian chapter, have attempted to measure it. Certain sources estimate that corruption costs 20% of the total health expenses of a country. Eradicating corruption would thus mean a more efficient national health system, which would turn into more health services… and less taxes.

  • You are not alone.

Bribes can be offered by companies, but can also be requested by doctors. For a long time life sciences’ companies were interacting with doctors (who are public officials, under Italian law) who seemed to have a low sensitivity to corruption risks, as well as very little sympathy for compliance procedures of such companies. While companies in Italy had seriously started their anti-corruption battles about a decade ago, it seemed that doctors lagged behind.

This may now be changing as doctors are taking an active role in fighting corruption. In Italy, for instance, entities like Transparency International Italia and AGENAS have been working to involve doctors, too. On February 22, 2017 the medical societies Associazione Italiana Medici (AIM), Segretariato Italiano Giovani Medici (SIGM) and Segretariato Italiano Studenti in Medicina (SISM) have publicly endorsed the initiative “Cure Corruption”. Diabetologists (Associazione Medici Diabetologi (AMD) have also recently pointed to the close connection between sustainability of the health system and ethical interactions among its players (see the remarks by Maria Franca Mulas).

This is a very welcome development, as synergies between public administration, companies and doctors could really step up the fight against corruption and prompt a cultural change that will help the health system as a whole.

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Continuing Medical Education: New Rules under Italian Law (and How to Comply with Them)

A new regulation has been enacted in Italy, overhauling continuing medical education regulations. The new provisions will not only have an impact on healthcare professionals, who are subject to educational requirements, but also on pharmaceutical companies and medical devices manufacturers supporting educational events and congresses, as well as on third party providers and organizers. The new regulation has been adopted following consensus among regional authorities and the Ministry of Health on February 2, 2017.

The national commission for continuing medical education is entrusted with the task of determining the requirements and quality levels of educational events, as well as the minimum educational goals applicable nation-wide. The commission shall also adopt a manual for the certification of event organizers (so called CME providers). Regional authorities, on the other hand, must ensure a proper and adequate planning for medical education within their territories.

Furthermore, each professional shall develop and comply with an individualized educational plan (so called “dossier”), in order to ensure a coherent and complete education. Educational events attended abroad may also be recognized for purposes of medical education, in accordance with the criteria that will be established by the national commission.

As far as industry operators are concerned, the new regulation reiterates and strengthens the requirements of transparency and independence of educational providers from pharmaceutical/medical device companies. In particular:

  • CME providers must disclose any relationship between speakers/moderators and any private entity active in the healthcare industry;
  • CME providers must not have any direct or indirect interest in any pharmaceutical/medical device businesses or engage in any relationship with such businesses, other than the sponsorship pursuant to CME regulations;
  • CME providers must not organize any promotional events on specific products; a full segregation of activities between educational CME providers and other event organizers is therefore established;
  • The regulation further expands on the definition of conflict of interests and aims at better regulating all relationships and interests between the industry and educational providers;
  • More stringent provisions concerning advertisement and promotion during educational CME events are introduced, including restrictions for employees of the sponsor to attend educational classes and seminars.

While several provisions of the new regulation directly target CME providers, the industry should also be prepared to the new regulatory framework. Here is a list of what private operators should immediately think of:

  • Train your staff on the new regulations (both at your headquarters and on the field);
  • Check if internal company procedures needs to be updated;
  • Check if internal sponsorship documentation (including contracts) needs to be updated;
  • Review ECM providers with whom you usually work to ensure they comply with the new requirements and avoid conflicts of interests.