Today we publish a guest post by our colleague and friend Toma Barbarasa, attorney at law in Bucharest and food law expert. The article is related to Cannabis for medical use – not for food purposes – but we think it is interesting to monitor national developments in this area and in the use of CBD products. One of the focal points is how to supervise the cultivation and production of such products, without fostering illegal activities. Romania answer seems to be the institution of a Cannabis National Agency, under the Ministry of Health, that will be competent to purchase all the national production and distribute it to authorized legal persons.
In late November 2019, the Romanian Senate has adopted a draft law which envisages the legalization of Cannabis for medical use. The draft law is currently pending before the Chamber of Deputies which is the decisive body in this case.
The draft law is registered under no. 631/2019 before the Chamber of Deputies (the “Draft Law”) and establishes the legal framework for the medical use of Cannabis and its derivatives (such as preparations and substances containing Cannabis). The purpose of the Draft Law is to authorize the cultivation and marketing of Cannabis and Cannabis derived medicines in drug stores. The initiators of the Draft Law took into consideration the large number of patients with terminal diseases who cannot relieve their suffering, need access to alternative painkillers and who sometimes obtain Cannabis based substances from the black market.
Like in other EU Member States, the Draft Law proposes the creation of a Cannabis National Agency (the “Agency”) under the Ministry of Health. The Agency shall be responsible for authorizing and controlling any Cannabis related operations (such as growth and sale of Cannabis plants and related medicines) for medical purposes. The Draft Law envisages also the creation of a Single National Register which will provide useful information about the manufacturers and farmers of Cannabis for medical purposes.
Under the Draft Law, the Ministry of Health shall be competent to purchase all the national production of Cannabis and distribute it to authorized legal persons. The new piece of legislation stipulates that any Cannabis plants and derivatives may be used for medical purposes provided a medical prescription is issued to this end. Such medical prescription may be issued for outpatient treatment by specialist doctors or by veterinarians, as the case may be. The liability for assessing the necessity and legitimacy of Cannabis medical use as well as for its proper prescription shall be incumbent on the doctor who issues the prescription.
Under the Draft Law, the following Cannabis components may be used for medical purposes:
- Cannabis, Cannabis resin, extracts and tinctures;
- THC, its isomers and their stereochemical variants.
The permitted quantities of the main components are the following:
- THC – maximum 20%;
- CBD – to be determined by Order of the Ministry of Health.
The Draft Law was first introduced in July 2019 with the support of a large number of the members of Parliament and was expected thus to be adopted quickly and without any significant opposition. However, as the last months of 2019 have shown, the project was blocked by various negative endorsements and reports as well as by the opposition of the Ministry of Health who deemed there is no need for a cannabis law or creating a related agency.
Considering that Romanian drugs legislation is generally very strict but also ambiguous and subject to various interpretations when in comes to Cannabis, it remains to be seen whether the Draft Law shall be adopted and under what form. Although the Draft Law appears to be an effective solution for persons suffering from major diseases, a good part of the population and authorities still oppose such measures, considering it would only encourage Cannabis consumption for recreational purposes.