Author: Giacomo Bulleri Studi Legale Bulleri
The reform of Legislative Decree No. 70/2018 (so-called “Testo Unico officinali”)
Medicinal plants represent an extremely deep-rooted cultivation and culture in Italy. The term ‘officinal plants’, in fact, refers to the ‘officina’ or ‘opificina’, with the meaning of ‘laboratory’, where plants were subjected to various processes (e.g. drying, trituration, maceration, distillation, extraction of active ingredients, etc.) in order to make them usable for various purposes. From that the term ‘medicinal plants’ to indicate those plants that can be processed in a laboratory.
From an agronomic point of view, medicinal plants are a collection of very heterogeneous plant species such as medicinal, aromatic and perfume plants, but also algae, fungi and lichens.
The officinal plant sector had been clamouring for a long time for a radical reform in line with the advancement of technologies and the markets in which operators were forced to deal with the outdated Law No. 99 of 1931 based on a now obsolete model that identified the figure of the herbalist as the only person who could harvest and produce such plants.
This approach did not take into account the profound evolution of the sector and the EU agricultural market, which in recent decades had been witnessed profound innovation in both agricultural structures and machinery, but also in terms of environmental and biodiversity protection and energy saving.
These needs took concrete form in the long-awaited medicinal plants law (Consolidation Act on the cultivation, harvesting and first processing of medicinal plants) adopted by Legislative Decree No. 75/2018 (henceforth ‘T.U. Officinali’).
Legislative Decree No. 75/2018 profoundly innovates the matter by allowing the farmer to cultivate, harvest and first process medicinal plants.
It defines officinal plants, in Art. 1, c. 2, as “so-called medicinal, aromatic and perfume plants, as well as algae, macroscopic fungi and lichens intended for the same uses” as well as those “plant species that according with their properties and functional characteristics can be used, even after processing, in the categories of products for which this is permitted by the sector regulations, after verification of compliance with the required conformity requirements“
In essence, the T.U. defines officinal plants both on the basis of their belonging and their botanical and functional characteristics and with reference to their intended use, identifying, in essence, three sectors of application: medicinal, aromatic and perfume with whose sector regulations the Legislative Decree no. 75/2018 will have to interact and coordinate.
A subsequent interministerial decree (the Interministerial Decree of 22.01.2022) would then define the list of medicinal plants.
In that prospective, the farmer may, without the need for any prior authorisation, cultivate, harvest and carry out the first processing of medicinal plants, i.e. carry out the activities described in Article 1(4):
“The result of the activity of growing or harvesting individual species of medicinal plants can be used directly, or be subjected to first processing operations indispensable to production needs, consisting on the activities of washing, defoliation, sorting, assortment, hulling, drying, cutting and selection, pulverising dried herbs and obtaining essential oils from fresh plants directly on the farm, in the event that the latter activity needs to be carried out with freshly harvested plants and parts of plants. Any activity aimed at stabilising and preserving the product intended for the subsequent stages of the chain is also included in the first processing stage that is indispensable for production needs’.
The farmer, according to Article 2, paragraph 2, must take care of the cultivation and harvesting of medicinal plants for medicinal purposes or for the production of active substances “without the need for specific authorisation” in accordance with the GACP of Annex 7, point 7 of the GMP of European Union.
In any case, cultivation and processing of medicinal plants regulated by Presidential Decree 309/1990 on narcotic drugs are excluded from the scope of Legislative Decree No. 75/2018.
On the other hand, the T.U. officinali excludes the farmer from ‘sales to the final consumer and activities subsequent to first processing, which remain governed by specific sector regulations’ as well as ‘extemporaneous preparations for food use, in compliance with food legislation, which are intended for the individual customer, sold loose and not pre-packaged, and consisting of plants as they are, alone or in a mixture, dry or liquid plant extracts’.
These preparations are in fact reserved, in addition to pharmacists, to those who hold the title of herbalist obtained in accordance with the regulations in force.
In view of the above, the TU Officinali has profoundly innovated the matter by allowing, on one hand, the farmer to cultivate, harvest and carry out the initial processing (up to the preparation of essential oils) of officinal plants without a specific and prior authorisation and, on the other, reserving to the pharmacist and the herbalist the subsequent stages of the chain inherent the officinal preparations and the sale to the final consumer.
The only exclusion of operation of Legislative Decree No. 70/2018 (TU Officinali) are the narcotic substances regulated by the Presidential Decree 309/1990.
A subsequent interministerial decree was instead assigned of the task of drawing up a complete and updated list of the various medicinal plants. And it is precisely here that the problems arise with regard to what is being commented on.
- The Interministerial Decree of 22.01.2022 on the ‘List of cultivated officinal plant species and criteria for the collection and first processing of wild officinal plant species’.
After a long period of work by the Technical Table set up by the Officinal Consolidation Act, in January 2022 the State-Regions Conference had reached an agreement on the decree’s draft which, from the beginning, had aroused protests from the industrial hemp sector.
This Decree, in fact, in Article 1, c. 4, provided for an ad hoc provision for cannabis sativa L. (i.e. hemp coming from certified varieties registered in the Catalogue of Varieties of Agricultural Plant Species with low THC content governed by Law No. 242/2016) according to which:
“the cultivation of cannabis sativa L. of the varieties allowed for the production of seeds and seed derivatives is conducted according to Law No. 242 of 2 December 2016 that contains provisions for the promotion of the cultivation and agro-industrial chain of hemp. The cultivation of cannabis plants for the purpose of producing leaves and inflorescences or active substances for medicinal use is governed by Presidential Decree No 309 of 9 October 1990, which prohibits their cultivation without the prescribed authorization given by the Ministry of Health.”
This provision resulted in the list of medicinal plants into the insertion of a ‘double asterisk’ to hemp sativa which, in fact, limited the use of the cannabis sativa plant to its seeds and derivatives with the exclusion of the other parts of the plant.
To better understand the hemp issue, it is necessary to briefly summarise the legal framework and the interpretations provided by European and national judges.
III. The legal framework of hemp sativa L.
At the international level, the Single Convention on Narcotic Drugs of 1961 (the New York Convention, henceforth “SC”) establishes that “the term ‘cannabis’ means the flowering or fruiting tops of the cannabis plant (excluding seeds and leaves which are not joined to the apices) from which the resin has not been extracted, whatever is their application” (art. 1(b)); in such a case, seeds, leaves and inflorescences (from
which, precisely, the resin has not been extracted) do not contain a relevant quantity of the psychoactive principle and, therefore, are unsuitable to be qualified as narcotic drugs (so-called cannabis for industrial uses).
The term ‘narcotic’ is intended to refer to any substance, whether natural or synthetic, different from those referred to above, which, on account of its psychoactive effect, may not be cultivated, produced, marketed, except strictly for use in the medical and scientific fields, subject to a licence. (Article 1(j)).
Well, the SC (the New York Convention) established a system of international control only for narcotic substances, prohibiting their possession, use, trade, distribution, importation, exportation, manufacture and production except for exclusively medical and scientific purposes (according to their therapeutic value), and with a special licence. Cannabis for industrial uses, on the other hand, has no limits on its use placed by the Convention.
At EU level, the TFEU (Treaty on the Functioning of the European Union) includes hemp sativa L.among the agricultural products in Annex I.
Reg. (EC) No. 1307/2013 laying down rules on direct payments to farmers under support schemes under the Common Agricultural Policy (‘CAP’) for crops with a THC content below 0.3% from 1.01.2023 following the recent CAP reform.
Reg. (EC) No. 1308/2013 then establishes a specific common organisation of the market of hemp and flax.
Implementing Reg. No. 220/2015 finally includes hemp among ‘industrial plants’.
In any case, at European level, there is no distinction between the parts of the hemp sativa plant.
For an even more comprehensive overview, the Court of Justice of the European Union (henceforth ‘CJEU’) had also occasion to pronounce on the matter with two fundamental rulings:
- a) “Hammerstein” case
- b) “Kanavape” case
At national level, the matter is regulated, on one hand, by Presidential Decree 309/1990 (the so-called Narcotics Act) and, on the other, by Law No. 242/2016.
– Presidential Decree 309/1990, similarly to the objectives which inspire the New York Convention (Prevention, Treatment and Rehabilitation of Drug Dependence), deals with the classification of narcotic or psychotropic substances and their regulation, providing for appropriate administrative sanctions in the event of non-compliance with the prescriptions contained therein.
As for the classification of these substances, Presidential Decree 309/1990 divides them, grouping them into five tables. In particular, for what is of interest here, Table II qualifies as narcotic drugs: (i) Cannabis (leaves and inflorescences); (ii) Cannabis (oil); Cannabis (resin).
As regards the relevant regulations, Article 17 of the Narcotics Act states that ‘anyone wishing to cultivate, produce, manufacture, use, import, export, receive for transit, trade in any capacity, or in any case possess for trade narcotic or psychotropic substances included in the schedules […] must obtain authorisation from the Ministry of Health’, but that their use must be considered limited to medical use, for those medicines that are composed of active narcotic substances, and for therapeutic purposes for human or veterinary use‘.
Consequently, the performance of the aforesaid activities in the absence of the prior ministerial authorisation constitutes a conduct that is criminally relevant under Article 73 of Presidential Decree No. 309/1990 and, as such, punishable.
It should be noted that, without prejudice to the provisions of the aforementioned Article 17, Articles 26 and 27 of the Narcotics Act identify areas in which the cultivation of hemp is permitted without the need to obtain prior authorisation from the Ministry and without incurring, therefore, into the imposition of criminal penalties:
– art. 26 states, in fact, that ‘it is forbidden in the territory of the State to cultivate the plants included in Tables I and II referred to in Article 14, with the exception of hemp cultivated exclusively for the production of fibres or for other industrial uses, other than those referred to in Article 27, permitted by European Union regulations’;
– Article 27 of the Narcotics Act, in turn, states that the ministerial authorisation ‘is valid not only for cultivation, but also for harvesting, possession and sale of the products obtained, to be carried out exclusively to companies holding authorisations for the manufacture and use of narcotic substances’.
According to the aforementioned legislation, therefore, authorisation must be requested from the Ministry of Health only in cases where cultivation is aimed at the subsequent use of the cannabis plant in the medical field, or in the pharmaceutical field (and, therefore, as a narcotic), while it is not necessary for cultivation aimed at producing fibres or for other industrial uses (other than medical/pharmaceutical) permitted by European legislation.
– Law no. 242/2016, on the other hand, is a ‘supply chain’ law aimed at supporting and promoting the agro-industrial hemp supply chain, which has liberalised the cultivation of certified varieties (for which Presidential Decree 309/1990 does not apply) and the process aimed at the uses peremptorily listed in Article 2, c.2, other than those referred to in Presidential Decree 309/1990 for which the authorisation of the Ministry of Health continues to be required, namely:
1) foodstuffs and cosmetics produced exclusively in compliance with the disciplines of the respective sectors;
2) semi-finished products, such as fibre, hemp, powders, wood chips, oils or fuels, to supply industries and craft activities in various sectors, including the energy sector;
3) material intended for the practice of green manure;
4) organic material intended for bio-engineering works or products useful for bio-construction;
5) material intended for phyto-purification for the reclamation of polluted sites;
6) crops dedicated to educational and demonstration activities as well as research activities made by public or private institutes;
7) cultivations intended for horticolture.
Law No. 242/2016 is a framework law that defines the perimeter of the matter of industrial hemp that is not regulated by the narcotics legislation according to the distinction that originates from the SC between cannabis-stupefacient (legal only for medical-scientific purposes and for which authorisation from the Ministry is required for cultivation and processing) and industrial hemp (an agricultural product not subject to the narcotics legislation).
This distinction is also confirmed by the recent UNCTAD document named “Commodities at a glance. Special issue on industrial hemp”, UN, 2022 where the need for the so-called whole plant approach is repeatedly expressed, i.e. the lawfulness of the use of the whole hemp plant for industrial applications,.
III. Relationships and Similarities between Law No. 242/2016 and Legislative Decree No. 75/2018
From the above analysis, various similarities emerge between the structure of Legislative Decree No. 75/2018 and Law No. 242/2016, which denote a lowest common denominator related to the underlying rationale and principles, which can be summarised as follows:
(a) Both are framework laws that outline, in a general way, the perimeter and scope of the specific matter regulated (medicinal plants the Legislative Decree and industrial hemp the Law 242/2016);
- b) Both are primary laws of strict European derivation as is evident from the assumptions and references contained therein;
- c) Both laws are agricultural laws addressed to the farmer (or rather to the agricultural entrepreneur referred to in Article 2051 of the Civil Code) who can legitimately cultivate, harvest and carry out the first processing of medicinal plants, including hemp;
- d) Both fall outside the scope of Presidential Decree 309/1990 on narcotic drugs;
- e) Both exclude prior authorisation for the farmer;
- f) Both must coordinate and connect with the specific sector regulations for the uses of medicinal plants and hemp;
- g) Both – as we shall see below – run into the same interpretative error with reference to a specific plant: cannabis sativa (!).
The Appeal to the TAR Lazio
On the basis of the foregoing, category associations of the industrial hemp sector challenged the Interministerial Decree in order to submit to the TAR Lazio (Regional Administrative Court) the evident contrasts of it with the international and EU regulations, where there is no distinction between the various parts of the cannabis sativa L. plant, in order to obtain the annulment of a part of Article 1, c. 4 according to which:
“The cultivation of cannabis sativa L. of the varieties permitted for the production of seeds and seed derivatives is conducted pursuant to Law No 242 of 2 December 2016 laying down provisions for the promotion of the cultivation and agro-industrial supply chain of hemp. The cultivation of cannabis plants for the purpose of producing leaves and inflorescences or active substances for medicinal use is governed by Presidential Decree No. 309 of 9 October 1990, which prohibits their cultivation without the prescribed authorisation by the Ministry of Health.”
Judgments No. 2613 and No. 2616/2023 of the Fifth Section of TAR Lazio.
The TAR Lazio carried out a reconstruction of the relative complex regulatory framework, on the basis of what was outlined in the appeal (and as reported above), noting that ‘From an examination of these rules, however, it is not possible to infer any distinction between the parts of the hemp plant that are freely cultivated, according to the cited Law No. 242/2016, which can be used for the purposes established by the same law. The international and EU sectoral discipline clarifies, in fact, that the discretional criterion for establishing the free cultivation of hemp lies in the type of plant, considered in its entirety’.
In essence, the distinction between cannabis-drugs governed by Presidential Decree 309/1990 and hemp-industrial governed by Law No. 242/2016 lies in the provenance from certified varieties registered in the Common Catalogue of Agricultural Plant Species, which is periodically updated according to their low THC content naturally present (0.3% from 1 January 2023).
The TAR Lazio also operates a jurisprudential reconstruction by recalling the CJEU’s sentence rendered in the so-called “Kanavape case” mentioned above and the recent sentence of the French Council of State no. 444887 of 29.12.2022, which analysed the issue in depth, clarifying that “art. 16 of Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of agricultural plant species provides, in point 1, that the Member States shall ensure that seeds of varieties accepted in accordance with the provisions of this Directive or with the principles corresponding to those of this Directive are not subject to any marketing restrictions and it specifies in point 2, the conditions under which the Member States may be authorised by the European Commission to prohibit the use of a variety or, if there are valid reasons for considering 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 Catalogue of Varieties’.
The French Conseil d’État therefore emphasises that the restricting measure of the market must be justified by the persued the public health objective and it must be proportionate to the health’s risks associated with the prohibited substances, which,
in the present case, depend exclusively on the quantities of THC actually ingested depending on the products consumed and the patterns of consumption, so as to conclude that, on the basis of the existing scientific data, the consumption of flowers and leaves with a content of THC less than 0.3% does not create risks to public health that can justify a general and absolute prohibition on their marketing.
The TAR Lazio held that “the considerations expressed by the highest organ of French administrative justice are equally valid for the resolution of today’s contentious case, insofar as, in the exercise of its discretionary power, each Member State is called upon, by virtue of being subject to the constraints deriving from Community law to apply – in the context of agricultural policy of supranational importance – the correct balance between the interest in the protection of public health and the European Community principles of proportionality and precaution in the adoption of measures restricting the free movement of agricultural products”.
From these principles it follows that restricting the agro-industrial hemp production chain only to hemp seeds and fibres ‘would be contrary to Articles 34 and 36 TFEU’ whereby ‘national legislation may restrict the use of parts of the plant only if such restriction is strictly necessary to protect the right to public health, so long as it does not go beyond what is necessary to attain it. Otherwise, the national legislation would result in an undue quantitative restriction, which would be in open conflict with the principle of free movement of goods laid down at European level’.
On the basis of the foregoing, in acceptance of the grounds of the appeal, the TAR Lazio annulled the part of the interministerial decree challenged in part qua, inviting the Administrations to re-examine the measure adopted taking into account the scientific evidence underlying the need to protect health in compliance with the European Union principles of precaution and proportionality.
The current situation.
The recent decision of the TAR Lazio, together with the precedents of the French Conseil d’Etat and the Community case law of the CJEU, now provides a very clear picture of cannabis sativa as a medicinal plant.
Given that the plant of cannabis sativa L. obtained from certified varieties is not, in its entirety, a substance subject to the control of the legislation on narcotic drugs referred to in the SC and Presidential Decree 309/1990, it is possible to apply to that plant the discipline referred to in Legislative Decree no. 75/2018 appears evident.
On the contrary, the judicial affair involving the contested interministerial decree makes it possible to have clear and incontrovertible elements regarding the inclusion of the entire cannabis sativa plant among medicinal plants.
This means that the entire cannabis sativa L. plant may be cultivated, harvested and subjected to first processing by the farmer, lawfully and without prior authorization,
and he can carry out all those operations described in Article 1, c. 4 of Legislative Decree no. 75/2018.
In concrete terms, he can therefore carry out all those first processing activities that are indispensable to production needs (washing, defoliation, sorting, grading, hulling, drying, cutting and selection, pulverising dried herbs and obtaining essential oils from fresh plants), as well as any activity aimed at stabilising and preserving the product destined for the subsequent stages of the chain. And these activities can be carried out directly on the farm.
Obviously, the inclusion of hemp among the officinal plants does not translate into an unregulated liberalisation of the products that can be obtained since, as explained above, Legislative Decree no. 75/2018 as well as Law no. 242/2016 are ‘framework laws’ that must connect with the specific sector regulations.
So much so that it is the T.U. officinali itself that takes care to specify how the sale to the final consumer and the activities subsequent to the first processing remain governed by the specific sector regulations, as well as “extemporaneous preparations for food use, in compliance with food legislation, which are destinated to the individual customer, sold loose and not pre-packaged, and consisting of plants as they are, alone or in a mixture, dry or liquid extracts of plants”, which can only be performed by the pharmacist or herbalist in possession of the necessary professional requirements.
Thus, the real impact of the TAR Lazio rulings has to be found mainly in the agricultural sphere, allowing the farmer (or rather the agricultural entrepreneur) to cultivate, harvest and process the entire hemp sativa plant. Related to the products that can be obtained from it, however, reference must be made to the regulations, requirements and authorisations foreseen by the sector regulations in the food, cosmetic, herbal etc. fields.
What does change, in the writer’s opinion, is the status of the whole cannabis sativa plant, which assumes full dignity as an officinal plant without distinction between parts of the plant, which is not subject to the regulations set forth in the Consolidated Narcotics Act, which will obviously continue to be applied to cannabis from non-certified varieties and for medical use.
At the same time, interesting scenarios open up with regard to extracts and herbal preparations that may be made by pharmacists and herbalists.
From a different point of view, the aforementioned approach may have repercussions at the Community level on pending applications on novel food and while, at national level, on the adoption of the sector plan under discussion at which the supply chain table set up at MASAF will be able to follow the ‘whole plant approach’ stimulated at the international level also by UNCTAD.
And it could not have been otherwise given the references and the European Union assumptions on which Legislative Decree no. 75/2018 and Law no. 242/2016 are based.
Moreover, regarding the legal use of the entire hemp plant for officinal use, there had been warnings, first in November 2019 with the unitary resolution of the XIII Agriculture Commission that had committed the government to allow the use of the entire plant for the industrial uses of the law, and then with the Ministerial Decree of 27.07. 2020, published in the Official Gazette on 19.08.2020, with which the Ministry of Agriculture had mentioned ‘hemp sativa inflorescence’ intended for ‘extractive uses‘ among the medicinal plants, also establishing the maximum unit price applicable for the determination of the insurable values on the subsidised market and for the adhesion to the mutualisation funds in the year 2020.
This decree, which was later ‘withdrawn’ by a subsequent ministerial decree, had clearly opened a loophole in the legislation, since it is evident, for basic logical reasons as well as legal ones, that a Ministry cannot issue a decree with an illicit object, even narcotic one!
In fact, the haste with which the decree had been withdrawn was yet another demonstration of how the cannabis sativa issue was founded on a fundamental misunderstanding inherent the (undue) overlapping of the narcotics legislation, or rather on a restrictive interpretation of the legislation perpetrated and repeated like a mantra by the Ministry of Health according to which ‘flowers, leaves, oil and resins’ of cannabis would always be narcotic regardless of their use and of their origin from certified or non-certified varieties and even regardless of the THC content present as they are mentioned in table II annexed to Presidential Decree 309/90.
The issue, as demonstrated and explained by the CJEU and by the rulings handed down by the French Council of State and by the Italian TAR Lazio, have shown how the relationship between narcotics legislation and agricultural legislation must be assessed on different levels, given that industrial hemp, given the very low content of THC naturally present, has to be qualified as an agricultural product and an industrial plant insofar as it is not likely to adversely affect human health.
Moreover, returning to the subject of officinal plants, it should be noted how, on one hand, the narcotic substances referred to in Presidential Decree 309/1990 are certainly in any case excluded from the list of officinal plants and, on the other hand, it is the same sector legislation referred to in the T.U. officinali that, in the ‘notes to the premises’ contained in the same Legislative Decree no. 75/2018, has taken care to settle any hypothesis of contrast between norms by affirming the following principles:
“The legislative decrees referred to in paragraph 1 shall be adopted on the basis of the following principles and directive criteria:
(a) recognition and express repeal of provisions that have been tacitly or implicitly repealed, as well as those that do not have effective regulatory content or are otherwise obsolete;
- b) organisation of the provisions by homogeneous sectors or by subject-matter, according to the preceptive content of each one, also with the goal of simplifying the regulatory language;
(c) coordination of the provisions, making the necessary amendments to ensure the legal, logical and systematic consistency of the legislation and to adapt, update and simplify the regulatory language;
- d) resolution of any inconsistencies and antinomies, taking into account established case law’.
It is therefore clear that the purpose of the Interministerial Decree in the version reformed by the TAR Lazio is precisely to overcome the doubts, misunderstandings and antinomies that have long held back the industrial hemp sector.
It follows that sativa hemp will be allowed to be cultivated (as long as it comes from certified varieties with a THC content of less than 0.2%) and processed not only for the purposes listed in Article 2 of Law no. 242/2016 (foodstuffs, cosmetics, semi-finished products, material for bio-building, bioplastics, floriculture), but also as an officinal plant according to the provisions of Article 2, c. 4 of Legislative Decree no. 75/2018.
Therefore, not only the cultivation, but also the first processing of the entire hemp plant will be allowed, as an agricultural-type activity.
27.04.2023 Avv. Giacomo Bulleri
FOOTNOTES
