Legalisation of Medicinal Cannabis in Macedonia

In February 2016, Macedonia legalised medicinal cannabis but the law is far from ideal. Drugreporter's Macedonian partner, Healthy Options Project Skopje – HOPS – carried out an analysis of the law. Read their key remarks and recommendations presented by Vlatko Dekov.

Yes, it’s true – in February 2016, Macedonia legalised medicinal cannabis. The law covers the production of cannabis by legal entities which then supply it to companies producing cannabis-based medicines in Macedonia. It was a surprise to everyone, considering the intolerance exhibited by our right-wing government towards illicit substances and marginalised communities. Still, the act confirmed the suspicion that literally anything can be expected from a government such as ours, regarding drug policies. As an example, just a few years ago, at the time of Bolivia’s request to the UN for the legalisation of coca leaves, Macedonia was one of four countries which withdrew objections to the proposal.

It should be said from the outset, that the law is far from ideal. Its adoption lacked transparency, and it was drafted without input from civil society. The law was never presented during the two debates organised around the issue, and  representatives from civil organisations working in this field were not invited to contribute. The draft law began moving through the parliamentary system immediately after being issued, thereby preventing any proper analysis or discussion. Nevertheless, Healthy Options Project Skopje – HOPS – carried out such an analysis, and we present our key remarks and recommendations below.

Inconsistent goals in the Law and its Amendments

The first comment relates to the fact that medicinal cannabis was legalised via amendments to the existing Law on Control of Opioid Drugs and Psychotropic Substances, as opposed to the adoption of a separate law, or amendments to the Medicines Law.  

The current Law on Control of Opioid Drugs and Psychotropic Substances aims to prevent the abuse of opioid drugs and psychotropic substances, as well as the illegal production of, and trade in, opioid drugs, psychotropic substances, and plants used to produce opioid drugs. On the other hand, the Amendments aim to regulate medicinal cannabis, not “cannabis cultivation for the production of opioid drugs,” as worded in the new chapter of the Amendments. We therefore believe that medicinal cannabis needs to be regulated by a separate law drafted to reflect the specifics of the cannabis plant and the numerous studies carried out on its effects, as well as legislation already developed in countries where medicinal cannabis has been regulated.  
The Amendments introduce the words “and/or cannabis" to the current provisions on poppy cultivation, production and sale. While this identifies the two substances as equal, it further introduces stricter conditions on cannabis cultivation in the additional chapter, i.e. a stricter regime for cannabis, compared to poppy cultivation and production.

Cannabis as medicine

In contrast to the regulation of other medicines, the Amendments (to the Law on Drugs) also stipulate which specialists will be allowed to prescribe this medicine. These are publicly-employed specialists in neurology, oncology and radiotherapy, and infectious diseases, working in hospitals. The stipulation/restriction of specialists allowed to prescribe cannabis treatment is an issue more properly covered by regulations on the registration and use of medicines, not this Law. If the aim is to use these Amendments to regulate medicinal cannabis, the specialist fields in which cannabis can be recommended cannot be limited; therefore the proposer – the Ministry of Health – needs to consider all the health conditions which are proven to be alleviated by the use of cannabis, and remove the provision artificially limiting cannabis prescription to a few specialist fields.

The Amendments also restrict the right to prescribe to specialists employed in public health institutions – a violation of the patient’s right to treatment and free choice of doctor (Article 5, Law on Protection of Patients’ Rights). Patients have the right to use the health services they have chosen in a public or private health institution, and the Law must provide access to medicine to all patients equally. In fact, private health institutions do provide public health care, and there is no legal justification for the exclusion of private health institutions from a law on treatment.   

Cannabis cultivation

The amendments purport to apply similar conditions to the cultivation and production of poppies and cannabis. Closer inspection, however, of the detailed requirements (e.g. the licencing procedure, and the security of the work-space) clearly reveals significantly stricter requirements (physical, spatial, human resources, financial) being imposed on cannabis producers.

The first difference is that physical entities are prohibited from cultivating cannabis, although they are allowed to cultivation poppies. Poppy cultivators who have obtained approval can report the sowing to the competent ministry up to fifteen days after the event, but cannabis cultivators must obtain permission from the Ministry of Health, with prior written approval from the Government, before starting sowing. Insisting on government approval in addition to the normal permission process makes the procedure more burdensome, and amounts to a stricter regime in the case of the sowing, cultivation and production of cannabis, without any stated justification.

Requirements for legal entities

The requirements for legal entities seeking an approval for cannabis cultivation are determined by the Law. The criteria prescribe that the legal entity must have the capacity to cultivate and also dry and store cannabis, i.e. production and processing. The legal entity shall employ at least four people, including a pharmacist and an agriculturalist majoring in agronomy, each of them being of three years' standing. Once again, the law in the case of poppy cultivation includes no such specific requirements.

Regarding security requirements, the Amendments prescribe atmospheric protection of the space where cannabis is being cultivated, although the reason behind this requirement is unclear. Furthermore, the space has to be divided with a four-metre-high fence, topped by three rows of barbed wire. An additional burden on legal entities, in terms of cannabis cultivation, is a requirement for 24-hour video surveillance over the entire space, and the employment of security staff. The technical and security requirements impose a financial barrier for many who might be interested in cannabis cultivation.

Punitive provisions – Criminalisation of Cannabis for Personal Use

The Amendments introduce punitive provisions, such as long prison sentences for offenders and people employed by the legal entities, which do not apply in the case of cultivators of poppies and other controlled substances regulated by the Law. Article 95-d prescribes 1-5 years' imprisonment for anyone employed by the legal entity who keeps, carries out or transports seeds, seedlings or cannabis leaves for personal use. For the first time, this provision criminalises cannabis for personal use. The current Criminal Code does not punish possession for personal use, and such a measure is harmful and violates the rights of people who use drugs.

In 2014, the WHO recommended that all countries should review their legislation and decriminalise drug use. These Amendments conflict with those recommendations.

HOPS’s Position

It was the state’s intention, with these Amendments, to regulate medicinal cannabis – but our analysis indicates that the provisions do not serve the desired aim; on the contrary, they favour financially powerful legal entities with a dominant market position. The sowing, cultivation and production requirements impose high costs, which influence the price of the final product. When medicines are made artificially expensive, they become unavailable for most citizens - a violation of their right to treatment. Despite a wealth of evidence of this plant’s effectiveness in many health conditions, the Amendments restrict cannabis use to the recommendation of specialists from just four fields of public health, which further limits patient access. The strict criteria for potential cultivators encourage illegal markets and uncontrolled quality in the production of cannabis extracts. The Amendments criminalise the personal use of cannabis, contrary to the constitutional principle of the rule of law and the development of international standards for the protection of human rights and promotion of health. Bearing in mind the medicinal value of cannabis, patients’ right to access all forms of treatment, and the positive experiences from many countries, HOPS believes that there should be a specific law regulating medicinal cannabis in Macedonia. The law should provide easy access to cheap medicine, including cannabis oil, in pharmacies or special stores; patients, however, who are unable to buy the medicine, or who wish to grow their own, should also have the opportunity to do so. Medicinal cannabis should be available in different forms (for smoking, vaporised delivery, in capsules, edibles, or in the form of cannabis oil).
In addition, cannabis for medical purpose should not be conditioned by conventional medical practice.

Recent news

In light of these observations, HOPS drafted eight amendments and submitted them to the Assembly. Unfortunately, the Parliamentary Parties, other than DOM (the Green Party, with only one MP) did not support these amendments.

The Law was adopted by the Assembly, and four cannabis products have already been launched. Two of them contain high concentrations of THC, and can only be purchased with a doctor’s prescription, and only for one health condition – cancer. The reaction from private citizens and NGOs has mainly stressed the products’ high prices, because they are not covered by prescription subsidies, and must therefore be purchased at full cost to patients. As an example, 240 ml cannabis oil with 600 mg of THC and 600 mg CBD costs 150 euro – unaffordable for most Macedonian citizens. It seems the Law is beneficial only for affluent citizens – and, of course, for the pharmaceutical company making the product.  

On the other hand, in reaction to the Law, several civil organisations and patients’ groups have mobilised together, and are now the principal monitors of the law’s implementation. The Green Alternative organisation even approached the Ministry of Health to organise cannabis training for Macedonian doctors, covering its characteristics, treatment etc., led by prominent experts from throughout the world.    

Finally, I would like to add that this is a great opportunity for Macedonia to become a successful example of medicinal cannabis in this part of Europe, but only time will tell whether this can be achieved. We, the civil activists, can only make sure that we vigilantly monitor the implementation of the law, reacting to each inconsistency and, of course, proposing the necessary improvements.   

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