Tag Archives: health care

Therapeutic cannabis in Italy: business opportunities

Italy’s only authorized medical cannabis facility is currently controlled by the military. However, the production site, located in the Florence area, cannot keep up with the increasing demand, creating shortages for patients and barriers to its prescription by physicians (whose patients are unlikely to be able to obtain the quantities needed).

As Colonel Modica of the Italian Military recognizedThe health ministry and the defense ministry are trying to fix the shortfall because there’s been a huge increase in cannabis prescriptions and the number of patients who need them”.

Meanwhile, pressed by the patients’ associations, the Italian Health Care Ministry Giulia Grillo announced not only the increase of import of therapeutic cannabis products from the Netherlands (to cover the short-term shortages), but also the start of a longer-term project, eventually leading to the creation of a public-private partnership for the production of cannabis. “An invitation to present expressions of interest will be published in order to increase the production of therapeutic cannabis“, Ministry said. Although underlining that an appropriate time frame will be needed in order to implement the project, the Ministry confirmed that the cannabis production activity is “of great interest for both the Defense and the Public Health Care” and crucial in order to satisfy the increasing needs of both domestic and foreign markets.

The increase in the domestic production of therapeutic cannabis, along with the overall demand for it, appears to be inevitable.

On the other hand, the boom of “light cannabis” products in Italy (i.e., containing THC in a percentage lower than 0.2 and, therefore, expressly declared legal in Italy starting from January 2017) seems to have encountered some obstacles lately.

The Advisory Board of the Italian Health Care Ministry (Consiglio Superiore di Sanità) issued a report last spring, recommending the adoption of measures aimed at prohibiting the sale of light cannabis products.

In addition to that, an internal note of the Ministry of Home Affairs, recently made public, promoted a zero-tolerance approach and a strict application of the relevant laws and regulations. Such steps have caused great uncertainty and concerns amongst those who have invested in what came to the media’s attention in 2017 as a State-backed business.

Hence, the latest developments relating to therapeutic cannabis in Italy indicate that new business opportunities for both exporters and producers of cannabis-based prescriptions are likely to be offered in the Italian market. Conversely, serious questions can be raised in connection to the light-cannabis boom, in view of the inconsistent approach recently taken by Italian authorities.

The Italian Constitutional Court Reaffirms Freedom of Doctors in Choosing Appropriate Care

On December 9, 2015 the Italian Ministry of Health had issued a much debated decree (also known as Decreto Appropriatezza). The decree listed a number of health services, with a particular focus on diagnostic tests, and limited the ability of a doctor within the National Health Service to prescribe them.

The aim of the decree was to limit the so-called “defensive medicine”, which plagues many health systems (see our previous post on medical malpractice and defensive medicine) and has been defined as follows:

“Defensive medicine in simple words is departing from normal medical practice as a safeguard from litigation. It occurs when a medical practitioner performs treatment or procedure to avoid exposure to malpractice litigation. Defensive medicine is damaging for its potential to poses health risks to the patient. Furthermore, it increases the healthcare costs. Not the least, defensive medicine also paves way for degradation of physician and patient relationship.”

The Ministry of Health intended to limit the ability of doctors to prescribe diagnostic tests to predetermined cases and conditions when they were deemed to be appropriate. Many doctors disliked the constraints (as well as the possible sanctions, subsequently lifted) denoted in the decree, which implied strong limitations to the “divine profession” and a fundamental distrust of doctors’ own judgment.

In a recent decision (Judgement no. 169 of 2017), the Italian Constitutional Court provides an interpretation of the decree that strongly favors freedom of physicians in their prescription activities. The Constitutional Court states that the decree can be regarded as being consistent with the Constitution only if it is interpreted as a mere recommendation to doctors, who must remain bound only by their personal judgment based on science and on their conscience. The judgment touches upon many other interesting principles, and an analysis of it can be found here.

In conclusion, the Court found that constraining doctors’ decisions would result in a breach of the constitutional right to personalized and effective health care. It also stated that decisions on appropriateness of health services cannot be based on political or economic rationales, but must always be filtered through the autonomous and responsible judgment of doctors.