The Regional Administrative Court (TAR) for Lazio, with a ruling published on 14 February 2023, had annulled the interministerial decree on medicinal plants and botanical ingredients, in the part in which the application in Italy of the Consolidated Drug Act to the cultivation of Cannabis Sativa L. for the purpose of using its leaves, inflorescences, shoots. (1)
The Italian government – I am not satisfied with the poor performance of having once again hindered the free movement of goods in the single market and damaged a virtuous supply chain, based on a crop with no equal in terms of CO2 capture performance in the atmosphere – but insists, with a appeal presented by the State Attorney’s Office on 6 September 2023 to the Council of State. An in-depth look.
1) ‘Officinal Decree’, the appeal to the TAR
Four associations sector (Federcanapa, Canapa Sativa Italia, Sardinia Cannabis, HRD-Ong Resilienza Italia), three agricultural companies and three processing and distribution companies had appealed to the Lazio TAR for the annulment of the decree of 21 January 2022 – adopted by the Ministry of agriculture, in concert with those of the ecological transition and health – containing ‘List of cultivated medicinal plant species as well as collection and initial processing criteria for spontaneous medicinal plant species‘.
The valuable ‘officinal decree’ it had in fact been corrupted by a provision in clear conflict with European law, as already reported on this site (2,3). Where it was indicated that ‘the cultivation of cannabis plants for the production of leaves and inflorescences or active substances for medicinal use is regulated by the decree of the President of the Republic of 9 October 1990, n. 309, which prohibits its cultivation without the required authorization from the Ministry of Health‘ (officinal decree, article 1, paragraph 4).
2) Cannabis Sativa L., EU rules
Cannabis Sativa L. is qualified – in Common Market Organization Regulation (EU) No 1308/2013, and in subsequent acts – as ‘agricultural product’ and ‘industrial plant’. Without any distinction between the parts of the hemp plant that can be used in the production chain. To qualify as an industrial plant, hemp only needs to meet two conditions:
– come from varieties registered in the Common Catalog of varieties of agricultural plant species (directive 2002/53/EC, article 17),
– have a THC level less than or equal to 0,3%.
3) Industrial hemp, Italian legislation
Italian law 242/2016 containing ‘Provisions for the promotion of the cultivation and agro-industrial supply chain of hemp’ in turn apply to ‘hemp cultivations of the permitted varieties registered in the Common Catalog of Varieties of Agricultural Plant Species, pursuant to Article 17 of Directive 2002/53/ EC (…), which do not fall within the scope of application of the consolidated law on the regulation of narcotics and psychotropic substances‘ (art. 1, paragraph 2).
‘From the examination of these rules‘ – noted TAR Lazio in the ruling of 12 February 2023 – ‘no distinction can be made between the freely cultivated parts of the hemp plant, pursuant to the aforementioned law n. 242/2016, which can be used for the purposes established by the law itself. The international and community sector regulations clarify, in fact, that the discretionary criterion for establishing the free cultivation of hemp lies in the type of plant, considered in its entirety.
4) Court of Justice of the European Union, case law
Court of Justice of the European Union, as the TAR recalled, intervened on a matter similar to that in question, ‘concerning the conformity with European Union law of a national (French) regulation which prohibited the marketing of CBD (cannabidiol) extracted from the cannabis sativa plant in its entirety and not only from its fibers and seeds‘. The EU Court of Justice – as we have seen (4) – has clarified that:
– national rules capable of restricting the free movement of goods in the single market must be justified by concrete needs for the protection of public health (TFEU, Treaty for the Functioning of the European Union, article 36). In particular,
– ‘the decision to ban marketing (…) can only be adopted if the alleged real risk to public health is sufficiently demonstrated on the basis of the most recent scientific data available (…). In such a context, the risk assessment that the Member State must carry out has as its object the estimate of the degree of probability of harmful effects on human health deriving from the use of banned products and the severity of such potential effects.,
– ‘in exercising their discretion in matters of public health protection, Member States must respect the principle of proportionality. The means they choose must therefore be limited to what is actually necessary to guarantee the protection of public health, and must be proportionate to the objective thus pursued, which could not have been achieved with less restrictive measures‘. (5)
5) French Council of State, the previous one
The Conseil d’État French – as we have seen (6) – has examined the issue in depth, clarifying that Council Directive 2002/53/EC on the common catalog of varieties of agricultural plant species provides:
– that Member States ensure that ‘seed of varieties permitted in accordance with the provisions of this Directive or with the principles corresponding to those of this Directive is not subject to any marketing restrictions‘, as well as
– ‘the conditions under which Member States may be authorized by the European Commission to prohibit the use of a variety or, if there are good reasons to believe that it presents a risk in particular to human health, to prescribe conditions for the use of products resulting from the cultivation of a variety listed in the common catalog of varieties (article 16, paragraph 1,2).
In a nutshell, as the Lazio TAR explained, ‘the Conseil d’État, ruling on the legitimacy of the national prohibition measure, underlines, first of all, that such a restrictive measure must
– be justified in light of the public health objective pursued e
– be proportionate to the health risks associated with the prohibited substances. Noting, in this regard, that the aforementioned risks depend on the quantities of THC actually ingested depending on the products consumed and the consumption patterns, so as to conclude that, based on the state of scientific data, the consumption of the leaves and flowers of cannabis varieties with a THC content lower than 0,3% does not create risks for public health sufficient to justify a general and absolute ban on their marketing‘. (1)
6) Risk management and principles of good administration
‘The considerations expressed by the highest body of French administrative justice are equally valid for the resolution of today’s dispute’, explained the Lazio TAR – ‘to the extent that, in the exercise of discretionary power, each member state is called upon, by virtue of the subjection to the constraints deriving from the community law, to apply – within the framework of agricultural policy of supranational importance – the correct balance between the interest in the protection of public health and the Euro-unitary principles of proportionality and precaution in the adoption of restrictive measures on free movement of agricultural products.
Public administration is called upon in its risk management activity to protect opposing interests with different degrees according to a dynamic perspective, without a priori solutions, excluded ab origine by the lack of scientific certainty.
In choosing the best risk management technique, administrative activity must be based on respect for the principles of proportionality, adequacy and reasonableness, which permeate administrative action as general principles.‘ (art. 1 of law n.241/1990).
7) Principles of precaution and free movement of goods
‘The precautionary principle is summarized at European level in the adoption by the public administration of proportionate, non-discriminatory, transparent and coherent actions, as they are aimed at achieving a correct balance in the balancing of the opposing interests at stake‘. (1)
In the present case the Lazio TAR deduced that ‘limiting the industrialization and marketing of hemp to fibers and seeds only would be in conflict with Articles 34 and 36 of the TFEU, which must be interpreted as precluding national legislation prohibiting the marketing of cannabidiol (CBD) legally produced, if it is extracted from the cannabis sativa plant in its entirety and not only from its fibers and seeds, unless such legislation is suitable to guarantee the achievement of the objective of protecting public health and does not exceed what is necessary to its achievement.
In other words, the national legislation of each Member State may limit the use of parts of the plant only if such limitation is strictly indispensable to protect the right to public health, provided that this does not exceed what is necessary to achieve it. Otherwise, the national legislation would determine an undue quantitative restriction, which would be in open and manifest contrast with the principle of free movement of goods enshrined at European level‘. (1)
8) TAR Lazio, the decision
‘No evidence regarding the need to protect the right to health, also from the perspective of the precautionary principle, was provided by the defendant administrations, who limited themselves to invoking such principles without however providing any concrete data or scientific element with respect to the case in question..
The ‘officinal decree’ moreover it isa purely administrative act (…) and, as such, must be accompanied by suitable motivation that adequately takes into account the reasons of public interest underlying the adoption of the act’.
The administration must therefore adequately explain the higher requirements for health protection and precaution, providing scientific data that give effective evidence of the existence of a risk deriving from the cultivation of hemp plants in their entirety (i.e. seeds, seed derivatives, leaves and inflorescences from which the resin has been extracted)’.
‘The Administrations Respondents will therefore have to re-examine the measure adopted, taking into account the scientific evidence underlying the need to protect health in compliance with the Euro-unitary principles of precaution and proportionality. (1) The Lazio TAR therefore accepted the appeal of the associations and operators in the hemp industry, canceling the ‘officinal decree’ within the meaning and limits set out in the motivation.
9) State Attorney’s Office, appeal to the Council of State
The lawyer’s appeal of State to the Council of State – for the annulment of the sentence of the Lazio TAR illustrated in the previous paragraphs – already stands out in the first pages for an apodictic and unscientific statement, according to which the CBD ‘can be used for the production of narcotic substance‘ (6.1). In blatant ignorance of the scientific literature based on the indications of the WHO (World Health Organization), the decision of 2 December 2020 of the ‘United Nations Commission on Narcotic Drugs‘ and the one adopted the following day by the European Commission, which denies any ‘narcotic’ action of cannabidiol. (7)
The Advocate General Tito Varrone – after having accused the reasons for the Lazio TAR sentence of ‘superficiality’ – then turns to the administrative judge of legitimacy, arguing that ‘the cultivation of hemp in Italy is at the center of many debates, making it complex to understand what the limits of legality are in the context of its cultivation activities, especially following the recent openings and/or arrests of the jurisprudence, regarding the cultivation of hemp for personal use only‘ (6.4 appeal). Following, references to jurisprudence that are completely off topic with respect to the defects of the ‘officinal decree’ identified by TAR Lazio.
10) Concluding remarks
Credit must be given to the Lazio TAR for having recognized the superiority of European law, which in fact has a higher rank even than national constitutional laws, compared to an interministerial decree in clear conflict with it. It could not and cannot be otherwise, even at the Council of State in Italy, after the Court of Justice of the European Union provided official interpretation (binding for all institutions and administrations, including judicial ones, of the EU and its member states) on the legitimacy of cultivation and use of every part of the Cannabis Sativa L.
It is noted however – once again, unfortunately, as in the most recent ruling on a shameful circular from the Ministry of Health, which in defiance of EU rules made it possible to hide the nature of the preservative additive of the lysozyme used in Grana Padano PDO (8) – like the TAR Lazio has persisted in not condemning the central administrations to pay court costs for illegal acts that have caused serious damage to the community. Where instead strong signals would be needed, already here, to stigmatize the irresponsibility of all the public managers involved.
It is noted finally, the disinterest of the large agricultural confederations towards the serious damage that the ‘officinal decree’ has inflicted and threatened to inflict on a promising crop such as industrial hemp. A crop rooted in the peninsula since the Middle Ages, which saw Italy in second place after Russia in global production – until its eradication imposed by the Marshall Plan (to cede the European yarn market to ‘Made in USA’ cotton) – and is still an emblem of agroecology, circular economy and fight against climate change. (9)
Dario Dongo
Footnotes
(1) Regional Administrative Court (TAR) for Lazio, Fifth Section. Sentence 25.1.23, published on 14.2.23, in proceeding no. 02613/2023 Provisional Reg. Coll. https://tinyurl.com/4dj7fctx
(2) Dario Dongo. Medicinal plants and botanical ingredients, the decree scheme runs aground on hemp flowers and leaves. GIFT (Great Italian Food Trade).
(3) Dario Dongo. Officinal plants decree, possible misunderstandings about hemp. GIFT (Great Italian Food Trade).
(4) Dario Dongo. Natural CBD, the EU Court of Justice declares unjustified prohibitions illegitimate. New horizons. GIFT (Great Italian Food Trade).
(5) Court of Justice of the European Union. Judgment of 28 January 2010 in case C-333/08, points 89,90
(6) Dario Dongo. Hemp flowers and leaves, green light in France and Italy. GIFT (Great Italian Food Trade).
(7) Dario Dongo, Silvia Giordanengo. Cannabis Sativa, CBD. Green light from the UN and the European Commission. GIFT (Great Italian Food Trade).
(8) Dario Dongo. Grana Padano with lysozyme preservative, TAR confirmation. GIFT (Great Italian Food Trade).
(9) Dario Dongo. Industrial hemp and circular economy. GIFT (Great Italian Food Trade).
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
