Romania takes an important step in the legalization of medical Cannabis

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:

  1. Cannabis, Cannabis resin, extracts and tinctures;
  2. THC, its isomers and their stereochemical variants.

The permitted quantities of the main components are the following:

  1. THC – maximum 20%;
  2. 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.

Romania Suspends Unclear Food Waste Law

Today I receive and publish an interesting contribution about the recent “food waste” law recently entered into force in Romania, coming from Oana Constantinescu and Toma Barbărasă (respectively partner and attorney at law at Schoenherr si Asociatii SCA).

After France and Italy to my knowledge that is the most concrete attempt in EU to mitigate the problem by law: the path seems nonetheless paved of difficulties. Compared to the Italian legislation (already covered on this blog) a point of merit is the provision of sanctions; but the negligible amounts of the fines could foster the lack of application of the law.

It will be extremely useful to follow the developments of these bills and try to measure the impact of them in the mid-term, since doubts on their real effectiveness seems to remain.

A new law meant to fight food waste in Romania came into force in late May but is now inapplicable, as its provisions are unclear and application norms have yet to be published.

On 21 May 2017, Law 217/2016 on Food Waste Reduction entered into force (the “Law“). The Law aims to reduce food waste by imposing measures on all operators in the food industry.

The issues

In its current form, the Law has already raised concerns about its scope as well as the practical measures that operators need to take in order to comply with it.

For instance, it is not clear which entities must comply with the Law, as the Law stipulates that it applies to operators in the agri-food sector without defining who these are. This may raise more difficulties, since the Law only refers to enterprises (in terms of applicable sanctions), but does not define them.

In addition, the Law does not provide a definition for products that are close to expiry. This is important, since a clear distinction needs to be made between highly perishable products that can only stay a few days before becoming unsafe and products with a longer validity.

Another cause for concern is the lack of clear procedures, as food operators are given no guidelines or instructions on how to implement the measures in practice. Of course, each operator must assess its activity on a case-by-case basis and proceed depending on the products and its specific activity.

All of these issues are meant to be resolved through the application norms, which were supposed to be drafted by 21 May 2017, but have now been pushed back pending analysis.

In the beginning of June, the Ministry of Agriculture issued a statement saying that the legal mechanisms included in the normative act cannot be applied and that the enforcement of the law is postponed until further notice.

Outline of the measures imposed

Under the Law food operators must take the following effective measures:

  1. Accountability measures for the reduction of food waste in the entire agri-food chain, from the manufacturing stage to the marketing stage, and to the final consumer;
  2. Low-priced sale measures for products close to expiry;
  3. Transfer measures by donation or sponsorship for products close to expiry; such transfers shall be made to entities specifically registered in this respect;
  4. Measures for the direction of by-products not intended for human consumption under Regulation (EC) 1774/2002, under certain conditions, for the disposal of animal by-products;
  5. Measures for the direction of agri-food products unfit for human or animal consumption by transformation into compost;
  6. Measures for the direction of agri-food products unfit for human or animal consumption for their transformation into biogas;
  7. Measures for the direction of by-products left after going through the above stages to an authorised neutralising unit.

The Law gives food operators the opportunity to offer nearly expired products to associations, foundations and social enterprises. It also sets maximum amounts in this respect, namely 3 % + VAT of the purchase price (for food marketers) or of the production price (for food manufacturers or processors). In their turn, associations and foundations may market the offered products at maximum 25 % + VAT of the purchase price (in case they receive the products from food marketers) and at maximum 25 % + VAT of the production price (in case they receive the products from food manufacturers or processors).

Sanctions

Operators who fail to observe the above measures will face fines ranging from RON 1,000 to RON 10,000 (approx. EUR 220 to EUR 2,200). The fines depend on the size of the entity, i.e. big enterprises will face higher fines.

Conclusions

Although the Law officially came into force on 21 May 2017, its provisions are not clear enough to be applicable in practice. Moreover, the Ministry of Agriculture and Rural Development had the legal obligation to enact application norms for the Law before 21 May 2017. Although the norms were initially published on the Ministry’s website for public debate, they are now no longer available.

A serious issue that the Law may trigger is so-called parallel trade caused by the obligations imposed on operators. On the one hand, operators must donate or sell products close to expiry at a low price. On the other hand, associations and foundations that purchase these products at a low price may then market them at maximum 25 % + VAT of the purchase/production price. Since the Law sets a maximum value for the latter, there is a risk that the price may raise competition issues by becoming fixed, thus affecting operators on a free market.

Obviously the Law will have a major impact on all players in the agri-food sector. A deeper analysis of the impacts will be required before the issues (or at least some of them) can be resolved.

Oana Constantinescu and Toma Barbărasă (respectively partner and attorney at law at Schoenherr si Asociatii SCA)