Nuovo decreto del Ministro della Salute, Gaetano Schillaci, del 27 Giugno 2024
July 9, 2024 - Tullio Scrimali, Polo Clinico ed Universitario degli Erei

The new decree of the Minister of Health, Gaetano Schillaci, dated June 27, 2024

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The new decree of the Minister of Health, Gaetano Schillaci, dated June 27, 2024, concerning the compositions, for administration, for oral use, of cannabidiol obtained from cannabis extracts and new regulation of NegEnt Series

Minister Schillaci began last summer a legislative journey aimed at regulating cannabidiol as a substance with marked pharmacological activities and to be considered, therefore, in the same way as a drug. On that occasion, Schillaci had taken up the attempt, already implemented by Minister Speranza in 2020 (Speranza, 2020), to arrive at the regulation of cannabidiol as a pharmaceutical product to be registered as a drug and sold in pharmacies upon presentation of a non-repeatable prescription. Heavy bureaucratic formalities would have to be adopted for the preparation, even galenic, of compositions based on cannabidiol, which would have made it very difficult for CBD products to be available to patients. In that circumstance, protests from industrial cannabis stakeholders had prompted Speranza to issue a further decree that, contradicting the previous one, re-proposed the unregulated sale of all products based on cannabidiol, from the industrial variety cannabis sativa L., cultivated under the 2016 law.

About cannabidiol, there is, in popular culture and the more superficial and less attentive media, considerable confusion with the issue of so-called light cannabis, that is, industrial hemp from whose inflorescences cannabidiol is obtained, the use of which is currently unregulated. However, it is not, to date, formally prohibited. It is not useless, however, to recall that the parliamentary process is underway, which should be concluded in October, of the two amendments to the Security Decree that would prohibit not only any use for recreational purposes but also therapeutic to the derivatives of industrial cannabis and, even, any promotion of cannabis, even through simple images.
Minister Schillaci’s initiative last summer was conceptualized by most of the actors involved in the industrial hemp supply chain as a vulnus to the free sale of cannabidiol products derived from the industrial variety cannabis sativa L.

This was not the case since the Schillaci Decree of August 2023 specified that preparations, for oral use, based on cannabidiol must be considered drugs and, as such, regulated. It is well understood that the Schillaci Decree speaks of therapeutic cannabis and proposes a supportable axiom. If cannabidiol constitutes a drug (and there are the precedents of Sativex and Epidiolex, then preparations for oral use based on cannabidiol are drugs to be registered, and this is not because cannabidiol is narcotic, but precisely because it is therapeutic. In all advanced countries of the world, the state, through its agencies, registers drugs and ensures the product’s safety.

However, following an appeal filed by the Hemp Entrepreneurs Association, the Schillaci Decree of 2023 was suspended by the Lazio Regional Administrative Court, and a decision on the merits was set for September 2024.

Meanwhile, the Minister, as was to be expected, in the execution of the order of the Rome TAR judge, renewed the preliminary investigation, sending a new request for an opinion, both to the Istituto Superiore di Sanita’, with a note registered under number 99742 of 2023, and also to the Consiglio Superiore di Sanita’, with a note registered under number 37669 of 2024. Based on the findings obtained, it issued, on June 27, 2024, a new decree replacing the August 2024 decree, which was thus withdrawn, extinguishing the case pending before the Regional Administrative Court and which would have gone to decision, as mentioned, in September 2024 (Schillaci, 2024).
The consequences of the new Schillaci decree consist of the fact that all preparations for oral use based on pharmaceutical CBD, derived from Cannabis, as of August 05, 2024, will no longer be able to be freely marketed unless new interventions by the TAR or the ordinary Judiciary at the input of individual industrial hemp entrepreneurs or their Associations.

In our opinion, including cannabidiol for oral use in the Table of Medicines constituted an initiative that could no longer be procrastinated. However, it seems inappropriate and contrary to the scientific literature, the characterization of cannabidiol as a substance capable of producing addiction and, therefore, to be framed in Table B, which entails non-repeatable prescription and onerous bureaucratic burdens, for its preparation, even at galenic pharmacies.

The minister justifies his choice by the fact that Table B of Medicines already contains preparations derived from cannabis but refers, in this case, to preparations also containing THC. Since all the most authoritative scientific literature appears to agree that cannabidiol has no narcotic or additive effects, its placement in Table A, which includes drugs such as benzodiazepines that can be dispensed with a repeatable prescription, would be much more appropriate.

One of the main concerns regarding the use of CBD by ignorant people, including many of my patients, would be the alleged addiction this substance could cause. I must say, however, that with proper informational and psychoeducational work, I have been conducting treatments for months without ever recording any tendency to increase doses and no problems at treatment discontinuation!
From a Minister of Health, a physician, and a university professor, we would have expected a more informed and cautious approach. Indeed, numerous scientific studies have shown that cannabidiol is non-addictive and non-addictive. On the contrary, CBD has even been successfully used as a treatment for substance abuse, helping people free themselves from addictions to illegal drugs or improperly prescribed medications (Campo et al., 2021).

In conclusion, cannabidiol is non-addictive and can be used in a safe and responsible manner as part of medical treatment for general well-being or for the treatment of mental distress without any risk of creating addiction (Scrimali, 2023).

Herbal Neurocare and the author of this article have set themselves, since the founding in 2021 of the Company, and since its initial production and commercial operations, the goal of operating within a framework of legality and adherence to national and European regulations regarding therapeutic cannabidiol products, not derived from industrial cannabis, but from pharmaceutical grade production, intended for Companies engaged in the production of Medical Devices and Plant Medicines, with a scientific and ethical and not empirical and commercial approach to the use of cannabidiol for human and pet health. So, Minister Schillaci’s new decree did not find us unprepared.

NegEnt Series products will continue to be regularly marketed via the Internet, in our shopping, on Amazon and Goestro platforms, and soon, even in Pharmacies and Parapharmacies as they do not fall under the June 27, 2024, Schillaci decree, nor under the possible new scenarios, if the use of all derivatives of the cannabis L., industrial variety, were prohibited. Herbal Neurocare’s products use pharmaceutical-grade cannabidiol, not industrial cannabis.

We, therefore, wish to distinguish, with strength, our image and our mission from all those who today propose, with therapeutic purposes but with trivial language that is not at all scientific, products based on cannabidiol extracted from industrial cannabis sativa, without any control regarding the safety of the products obtained and the monitoring of any adverse effects. Herbal Neuro care’s activities, productive and commercial, are, instead, regulated according to the following synoptic framework:

  • Compositions based on cannabidiol from pharmaceutical cannabis (not industrial, therefore) and not for oral use:
    • NegEnt Mouth Drops (Cosmecetic EC)
    • NegEnt Spray – Panic Stopper (Medical Device CE)
    • NegEnt Spray – Skin and Mucous Membranes (Medical Device CE)
    • NegEnt Spray – Muscles and Mucosae (Medical Device CE)
  • Cannabidiol-based, pharmaceutical-grade compositions for oral use, but using CBD obtained from citrus and lichen:
    • NegEnt Elixir (Nutraceutical)
    • NegEnt Akeso (CE Medical Device).

Herbal Neurocare’s mission remains the development of the use of cannabidiol, of pharmaceutical grade, both from cannabis. This option could create the entire production chain in Sicily and from citrus and lichens, prepared in Northern Europe, for the therapy of psychic and psychosomatic distress and the improvement of wellness through the regulation of its products as cosmeceuticals, nutraceuticals, medical devices, and herbal medicines.

This mission is placed within the appropriate regulatory frameworks, Italian and European, and is, therefore, not afraid of the new trends of strict regulation expected in the coming months in Italy.

References:

Babalonis, S., Malcolm, R.J., Michelle R. Lofwall, M.R et (Al. 2017). Oral cannabidiol does not produce a signal for abuse liability in frequent marijuana smokers. Drug and Alcohol Dependence, Volume 172, March 1, 2017, Pages 9–13.

Campo, A., Fogaca, M. V., Sonego, A. B., Guimaraes, F. S., & Takahashi, R. N. (2021). Cannabidiol as a Potential Treatment for Addiction: A Systematic Review of the Evidence. Frontiers in Psychiatry, 12, 1197.

Morgan, C. J., Das, R. K., Joye, A., Curran, H. V., & Kamboj, S. K. (2013). Cannabidiol reduces cigarette consumption in tobacco smokers: preliminary findings. Addictive Behaviors, 38(9), 2433-2436.

Schillaci, G. (2024). Inclusion in the table of medicines, section B, of compositions for oral administration of cannabidiol obtained from cannabis extracts. Official Gazette, General Series No.157 of 06-07-2024.

Scrimali, T, (2023). Safety and Tolerability of NegEnt, a New Botanical Product Based on Liposomal Cannabidiol: A Case Series Report. 2023-06-26, DOI10.36648/ipctn.8.01.08
Scrimali, T. (2023 b). Cannabidiol regulation in Italy after the Schillaci Decree of 07 August 2023: Herbal Neurocare’s position for the production and sale of NegEnt. Herbal Neurocare blog, October 10, 2023.

Speranza, R. (2020). Update of the tables containing the indication of narcotic and psychotropic substances, referred to in Presidential Decree No 309 of October 9, 1990, as amended and supplemented. Inclusion in the table of medicines, section B, of compositions for oral administration of cannabidiol obtained from extracts of Cannabis. Official Gazette, General Series No.255 of 15-10-2020).