CBD reclassification: Administrative Court suspends decree again

Table of Contents

On September 11, 2024, the Lazio Regional Administrative Court suspended the decree on CBD issued by the Ministry of Health, which would have classified oral formulations containing cannabidiol (CBD) as narcotic substances. With the ruling, the judges accepted the appeal filed by the Italian Hemp Entrepreneurs Association (ICI) and set the next hearing for December 16, 2024.

The ICI welcomed the court's decision very positively, stating that the judging panel recognized the validity of their arguments and acknowledged the serious economic and social risks that implementing the decree could have caused to the sector.

Let's take a step back and review the legislative history of CBD.

On June 27, 2024, a new Decree was issued by the Ministry of Health, which included oral CBD-based compositions in Table B) relating to medicines and active substances attached to the Consolidated Law on Narcotics.

If the decree had come into effect, from August 5, 2024, such compositions would have been producible and saleable exclusively through pharmacies and entities authorized by the Ministry of Health, upon presentation of a non-repeatable medical prescription.

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CBD Reclassification: The Weak Points of the CBD Decree

The Lack of Scientific Evidence

As early as August 2023, the Ministry of Health had attempted to classify oral CBD products as medications with psychotropic effects.

However, this attempt was blocked by the Lazio Regional Administrative Court (TAR), which in October of the same year suspended Minister Schillaci's decree due to the lack of scientific evidence regarding the danger of CBD to public health.

With the final decision of the TAR still pending, the Ministry of Health has decided to force the issue with a new measure identical in content to the previous one.

What appears evident is that the Ministry's choice for the 2024 decree also lacks any scientific basis. Specifically: a) The decree briefly mentions the opinions of the Superior Health Council and the National Institute of Health, which were reportedly requested by the Ministry in this case.

However, the content of these scientific assessments is not reported in any way within the text of the decree and has not been made public by the authorities; b) Paradoxically, the decree cites the WHO (World Health Organization) recommendation 5.5, which in 2019 urged member countries not to include CBD in any table of substances with psychotropic effects - the exact opposite of what the Ministry of Health is about to do.

The Violation of European Law In addition to the absolute lack of scientific basis, the Ministry's decree is in clear conflict with the principles and rules of European Union law. Specifically:

a) Failure to notify TRIS (Technical Regulation Information System): Member countries are obliged to notify the European Union and other member states of any measure that potentially restricts the circulation of goods within the European Union, so that they can carry out their assessments.

In this case, it is evident that the decree, by granting exclusivity to pharmacies, restricts the circulation of goods within the European market and that Italy would therefore have been obliged to notify this decision.

However, the Ministry of Health has completely ignored this procedure and has not made any notification through TRIS.

b) Violation of Articles 34, 35, and 36 of the Treaty on the Functioning of the European Union: These articles prohibit member states from introducing quantitative restrictions on the import or export of goods from their country, as well as measures having equivalent effect, except when motivated by the need to safeguard public health. As mentioned earlier, the Ministry of Health's decree restricts the trade of CBD between Italy and other EU member states and, at the same time, as previously clarified by the TAR, is not justified by any evidence of risk to public health from the sale of CBD.

c) Conflict with the 'Kanavape' judgment of the European Court of Justice: In Case No. 633 of 2018, the European Court of Justice clarified that 'A Member State may not prohibit the marketing of cannabidiol (CBD) legally produced in another Member State when extracted from the Cannabis sativa plant in its entirety and not solely from its fibers and seeds' because 'the CBD in question does not appear to have any psychotropic effect or any harmful effect on human health'. Therefore, the decree in question, by restricting the marketing of CBD, openly violates what has been established by the judges of the European Court of Justice, whose decisions must always be respected by member states.

The Violation of European Law

In addition to the absolute lack of scientific basis, the Ministry's decree is in clear conflict with the principles and rules of European Union law. Specifically:

a) Failure to notify TRIS (Technical Regulation Information System): Member countries are obliged to notify the European Union and other member states of any measure that potentially restricts the circulation of goods within the European Union, so that they can carry out their assessments. In this case, it is evident that the decree, by granting exclusivity to pharmacies, restricts the circulation of goods within the European market and that Italy would therefore have been obliged to notify this decision. However, the Ministry of Health has completely ignored this procedure and has not made any notification through TRIS.

b) Violation of Articles 34, 35, and 36 of the Treaty on the Functioning of the European Union: These articles prohibit member states from introducing quantitative restrictions on the import or export of goods from their country, as well as measures having equivalent effect, except when motivated by the need to safeguard public health. As mentioned earlier, the Ministry of Health's decree restricts the trade of CBD between Italy and other EU member states and, at the same time, as previously clarified by the TAR, is not justified by any evidence of risk to public health from the sale of CBD.

c) Conflict with the 'Kanavape' judgment of the European Court of Justice: In Case No. 633 of 2018, the European Court of Justice clarified that 'A Member State may not prohibit the marketing of cannabidiol (CBD) legally produced in another Member State when extracted from the Cannabis sativa plant in its entirety and not solely from its fibers and seeds' because 'the CBD in question does not appear to have any psychotropic effect or any harmful effect on human health'. Therefore, the decree in question, by restricting the marketing of CBD, openly violates what has been established by the judges of the European Court of Justice, whose decisions must always be respected by member states.

CBD Reclassification: Industry Associations' Appeals and EU Condemnation

In light of the undeniable weaknesses of the Decree of June 27, 2024, numerous associations are already taking action to protect the interests of the Italian hemp sector and are prepared to appeal to the Administrative Court (TAR) with the aim of annulling this measure.

What gives hope is that the same Court had previously suspended the 2023 Decree, which contained the same content and contradictions as this latest one.

Moreover, the blatant violations of European law by the Decree and the illegitimate restriction on European Union trade put Italy and the Government at risk of infringement procedures and consequent financial penalties from European Institutions.

Once again, it seems that yet another defeat (along with global embarrassment) is on the horizon for this Government in its grotesque war against hemp and CBD.

CBD reclassification: On what legal basis should CBD be included in Table B?

It's important to clarify that it wouldn't be CBD in general that would be included in Table B of the consolidated law on narcotics. The decree would only affect compositions for oral administration containing CBD extracted from Cannabis.

But would it be correct to include CBD in this table?

The Table of Medicines, specifically section B of Presidential Decree No. 309/1990, includes medicinal products of plant origin based on cannabis, substances and plant preparations, including extracts and tinctures.

According to Article 13 of Presidential Decree No. 309/90, the following should be included in Section B of the Table of Medicines:

Medicines containing substances in current therapeutic use for which concrete risks of inducing physical or psychological dependence of lesser intensity and severity than those produced by medicines listed in section A have been ascertained;
Medicines containing barbiturates with antiepileptic action and those containing short-acting barbiturates;
Medicines containing benzodiazepines, pyrazolopyrimidine derivatives, and their analogues with anxiolytic or psychostimulant action that may give rise to the risk of abuse and generate drug dependence.

It's evident that CBD doesn't correspond to the definitions provided in the last two points. One can therefore assume that the reasons for wanting to include it in Section B of the Table of Medicines are to be found in the definition of the first point.

And yet...

The October 24, 2023 ruling had already highlighted gaps in the reasoning of the ministerial decree, specifically the lack of clarity on the concrete risks of CBD inducing physical or psychological dependence.

There are CBD-based medicines on the market, such as Epidiolex, for example, used for drug-resistant epilepsy in children. CBD is therefore an active substance recognized for certain beneficial effects, which, however, has no psychoactive effect and does not create physical or psychological dependence.

According to the 1971 United Nations Convention on Psychotropic Substances, CBD is not considered a narcotic. The WHO has specified that CBD is not a psychoactive substance, does not create physical or psychological dependence, and is not associated with potential abuse. The WHO has also explicitly recommended excluding CBD compositions with THC below 0.2% from the Narcotics Convention.

Generally, substances considered narcotic are those that pose risks of physical and psychological dependence. There are no scientific studies confirming such dangers related to CBD, as indicated in the World Health Organization (WHO) report.

All these elements had contributed to the decision to suspend the decree, with the cancellation of the inclusion of cannabidiol for oral use in Section B of the Table of Medicines of Presidential Decree No. 309 of 1990.

Would it be appropriate to include CBD in this table?

The Table of Medicines, specifically section B of Presidential Decree No. 309/1990, includes cannabis-based medicinal products of plant origin, substances, and plant preparations, including extracts and tinctures.

According to Article 13 of Presidential Decree No. 309/90, the following should be included in Section B of the Table of Medicines:

Medicines containing substances in current therapeutic use for which concrete risks of inducing physical or psychological dependence of lesser intensity and severity than those produced by medicines listed in section A have been identified;
Medicines containing barbiturates with antiepileptic action and those containing short-acting barbiturates;
Medicines containing benzodiazepines, pyrazolopyrimidine derivatives, and their analogues with anxiolytic or psychostimulant action that may pose a risk of abuse and generate drug dependence.

It's clear that CBD doesn't fit the definitions provided in the last two points. Therefore, one might assume that the reasons for including it in Section B of the Table of Medicines stem from the definition in the first point.

However...

The October 24, 2023 ruling had already highlighted gaps in the ministerial decree's rationale, specifically the lack of clarity on the concrete risks of CBD inducing physical or psychological dependence.

There are CBD-based medicines on the market, such as Epidiolex, used for drug-resistant epilepsy in children. CBD is therefore an active substance recognized for certain beneficial effects, but it has no psychoactive effects and does not create physical or psychological dependence.

Moreover, according to the 1971 United Nations Convention on Psychotropic Substances, CBD is not considered a narcotic. The WHO has specified that CBD is not a psychoactive substance, does not create physical or psychological dependence, and is not associated with potential abuse. The WHO has also explicitly recommended excluding CBD compositions with THC below 0.2% from the Narcotics Convention.

Generally, substances considered narcotics are those that pose risks of physical and psychological dependence. There are no scientific studies confirming such risks related to CBD, as indicated in the World Health Organization (WHO) report.

All these elements contributed to the decision to suspend the decree, with the cancellation of the inclusion of oral cannabidiol in Section B of the Table of Medicines of Presidential Decree No. 309 of 1990.

The Lazio Regional Administrative Court on Reclassification

On September 11, 2024, the Lazio Regional Administrative Court again suspended the decree issued by the Ministry of Health in the summer of 2024.

On January 16, 2024, an important hearing had already taken place before the Administrative Court regarding the case brought by Imprenditori Italia Canapa, which aimed to annul the Decree of October 28, 2020. This decree proposed, just like the current one, to include oral compositions of cannabidiol CBD in Table B of prescription medicines, generating many fears and uncertainties in the sector.

During the January 16, 2024 hearing, the State Attorney's Office asked the Judges to postpone the final decision, allowing the Ministry of Health to obtain a scientific opinion from the Higher Institute of Health. The goal is to incorporate this opinion into the investigative documents to influence the Administrative Court's final decision.

The Lazio Regional Administrative Court accepted the Ministry of Health's request, postponing the decision on the case to September 24, 2024.

But in the meantime... surprise: a new decree and a new suspension by the Administrative Court.

The new hearing is set for December 16, 2024, and in the meantime, CBD remains legal and the sector protected.

CBD Reclassification: Considerations

Considering that CBD is not considered a narcotic and has no known effects leading to physical or psychological dependence, several doubts arise about the potential validity of the measure.

The Ministerial Decree (M.D.) would introduce rules that would limit CBD circulation and impose on sector operators requirements similar to those for known psychotropic substances.

However, these requirements would be disproportionate if applied to a substance like CBD. A substance that, according to scientific evidence and the World Health Organization (WHO) opinion, is not psychotropic, does not create physical dependence, and is not associated with potential abuse.

These restrictions seem to aim more at controlling CBD trade and subjecting it to Ministry of Health control rather than actually protecting public health.

The decree's provisions, including authorization and production limits, would indeed restrict the freedom of economic initiative for businesses in the hemp sector.

If unfortunately confirmed, the decree would force companies in the sector to reorganize their activities or, in the worst case, cease operations to avoid legal proceedings and sanctions whenever there's a risk of violating the law.

This limitation would also impact sectors like ours, such as cosmetics and the production of semi-finished products derived from Cannabis Sativa L., which can be used in various industries after further processing.

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