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TO REIMBURSE OR NOT TO REIMBURSE? A recent judgement on scientific evidence and appropriateness of care.

A judgment by the Italian Supreme Court published on April 10, 2015, determined that an alternative cure must be covered by the Italian National Health Service even in the absence of compelling scientific evidence as to its efficacy.

Health is protected by Italian law as a fundamental right of the individual, as well as a collective interest of the community, and dignity and freedom of the human being must always be respected. These general principles are enshrined in the Italian Constitution (section 32) and in section 1 of Legislative Decree no. 502/1992. Therefore, the right to health is framed as an absolute and fundamental right, a theoretical approach that – given the many restraints affecting patients’ access to care – may appear almost fictional.

Further, Italian legislation sets forth that the National Health Service must offer uniform essential levels of care and assistance, taking into account human dignity, equal access to care, quality and appropriateness of therapy, as well as economic factors. (These latter economic factors often appear most pressing, as patients affected by hepatitis C are currently learning!).

With regard to reimbursement, the Italian National Health Service must cover assistance services which show, for specific clinical or risk conditions, scientific evidence of a significant health benefit, from an individual and collective standpoint, compared to the resources employed. Such concept is often called “appropriateness” and is something with which doctors, hospitals, patients and authorities struggle daily. Nobody will deny that all the above mentioned factors are of primary importance, but balancing them can be difficult in practice.

The recent decision by the Italian Supreme Court (Corte di Cassazione, judgement no. 7279 of 2015) determined that a quadriplegic patient was entitled to free access to a non conventional therapy (so called “DIKUL” therapy), even in the absence of compelling scientific evidence as to its efficacy, when it was proven that the patient benefited from it through a sworn appraisal of a Court appointed expert. The Court pointed out that, while no compelling scientific evidence was offered, the efficacy of the therapy was in doubt, but not openly proven as not efficacious.

In its reasoning, the Court reiterated the higher hierarchy of the constitutional right to health over the discretional administrative decision of the hospital to administer a certain therapy. Further, the Court emphasized that the efficacy principle set forth in Italian law may be based on actual benefits to the patient brought by the DIKUL therapy: the mere absence of available scientific evidence in favor of the DIKUL therapy was not sufficient to deny its access to the patient. Only if there had been scientific evidence proving that the DIKUL therapy was inefficacious, then its reimbursement could have been denied.

We have already commented on the infamous Stamina case in this blog, a case where the well intentioned desire of Courts and Parliament to help otherwise helpless patients prompted the recourse to a therapy which completely lacked any scientific basis and breached many legal provisions actually aimed at protecting patients (e.g., GMP manufacturing requirements, informed consent of patients).

The recent Supreme Court decision confirms the sometimes difficult relationship between scientific evidence and access to a certain therapy, particularly in cases of patients affected by diseases for which there are limited therapy options.

Italian Corporate Criminal Liability 101: Basic Facts You Should Know

Are Companies Criminally Liable under Italian Law? Yes!

Legislative Decree no. 231/2001 (the “231 Decree”) has introduced in Italy the principle that companies are responsible for crimes committed by:

  • Individuals vested with powers of company’s representation, control, direction, or management;
  • Individuals subject to the authority or control by the above-mentioned individuals, including employees, consultants, non subordinate employees and whoever acts on behalf of the company.
  • As a result, a company may now be considered liable for crimes committed by individuals in the interest or to the benefit of the company (while crimes committed by individuals in their exclusive interest or in the exclusive interest of third parties do not trigger company’s liability). The company’s liability is separate and distinct from the liability of the individual who committed the crime.

Which Crimes Trigger Liability? Several (not just corruption!).

The 231 Decree lists a number of crimes for which companies may be liable, which include:

  • Corporate crimes;
  • Crimes against public administrations;
  • Crimes against the dignity of individuals;
  • Conspiracies and terrorism;
  • Crimes arising out of breach of laws protecting the environment and health and safety at work;
  • Crimes related to criminal associations;
  • Money laundering.

Which Sanctions Apply? Monetary and blacklisting sanctions.

If a company is found liable, the following sanctions may apply:

  • monetary sanctions up to a maximum amount of Euro 1,549,370.69 (and precautionary seizure of the price or profit arising from the crime),
  • blacklisting sanctions (applicable also as a precautionary measure), with duration between 3 to 24 months, which can consist of, inter alia, the prohibition to conduct the Business’ commercial activity, the prohibition to contract with the public administration, the prohibition to advertise goods or services, seizure, or the publication of the court’s decision (if a blacklisting sanction is applied).

Are There any Grounds of Exemption from Criminal Corporate Liability?  Yes!

A company is not liable pursuant to the 231 Decree if it proves that:

  1. The management has adopted and effectively implemented a so-called Organizational Model’ in order to prevent the commission of the criminal offences listed in the 231 Decree by subjects acting on behalf of the company;
  2. The company has established an internal body (‘Compliance Committee’) entrusted with the task of supervising the proper functioning and update of the Organizational Model, as well as the actual compliance by all those who must abide by it;
  3. Crimes were committed by individuals vested with management powers who have fraudulently avoided compliance with the Organizational Model;
  4. The Compliance Committee has not omitted to perform, or negligently performed its supervision duties.
  5. This explains why companies operating in Italy typically devote substantial resources in the setting up of an Organizational Model.

How to Set up an Organizational Model?  Risk assessment, gap analysis, preventive measures.

In order to prepare an Organizational Model the following process is usually followed:

  1. Examination of areas of risk: on the basis of the company’s Organizational Model and relevant job descriptions, the risk of commission of each crime set forth in the 231 Decree is assessed.
  2. Analysis of existing procedures: all existing procedures and ethical principles are reviewed in order to identify procedures that may reduce the risk of commission of the crimes.
  3. Possible implementation of new measures: should the analysis of existing procedures lead to conclude that some of the risks are not properly reduced, new procedures should be implemented.

The Organizational Model must be Effective A compliance program on paper will not help!

Once a company has adopted an Organizational Model by means of a resolution of the Board of Directors, the company must ensure that it is effectively implemented, that employees and other individuals acting on behalf of the company are duly trained on the model and that any breach of the Model is sanctioned.

In particular, the appointed Compliance Committee must actively supervise the effective functioning and adequacy of the Model on an ongoing basis and in independent fashion. The Compliance Committee is generally in charge of:

  • Monitoring the activity carried out within the company and the areas considered at risk;
  • Assessment of the actual implementation of, and compliance with the Organizational Model;
  • Cooperation and consultation with the management as regards the application of disciplinary sanctions to employees in the event of breach of the internal procedures provided by the Organizational Model.

The last event of our HEALTH INNOVATION ACADEMY is coming up!

On May 21, 2015 our HEALTH INNOVATION ACADEMY series will hold its last event. Join us to hear speakers on the topic of networks for innovation at Via Francesco Sforza 28, Milano (Aula Milani) followed by drinks.

As always, the event is organized in cooperation with the hospital IRCSS Cà Granda – Ospedale Maggiore Policlinico di Milano and with Politecnico di Milano – e-Health LAB – Informatica BioMedica e Sanità Digitale

To find out more about the May 21 program or about HEALTH INNOVATION ACADEMY’s past events, click here: