Questions and answers for policymaking
The European Monitoring Centre for Drugs and Drug Addiction has just (3 December 2018) published a timely paper on the medical use of cannabis and cannabinoids.
The paper asks four key questions:
- What evidence is there that cannabis and cannabinoids have medical uses?
- What regulatory frameworks are relevant to the medical use of cannabis and cannabinoids?
- What approaches to allowing the medical use of cannabis and cannabinoids have countries used?
- What are the regulatory challenges in allowing the medical use of cannabis and cannabinoids?
The medical use of preparations derived from the Cannabis sativa plant has a long history. However, by the twentieth century, medical use of cannabis had largely declined, and its consumption for medical purposes was already very limited when in 1961 cannabis was included in the United Nations Single Convention on Narcotic Drugs and classified as a drug that had no medical uses. In the past 20 years, however, there has been a resurgence of patient interest in using cannabis and cannabinoids to treat a variety of conditions, including chronic pain, cancer pain, depression, anxiety disorders, sleep disturbances and neurological disorders, the symptoms of which are reportedly improved by using cannabis.
Increased patient interest in the medical use of cannabis has been accompanied by renewed scientific interest in the medical use of substances found in the cannabis plant, namely cannabinoids. This followed the discovery, in the early 1990s, of a cannabinoid system in the human brain and body that was implicated in the control of important biological functions, such as cognition, memory, pain, sleep and immune functioning. However, the classification of cannabis as a drug without medical uses made it difficult to conduct clinical research.
Most EU countries now allow, or are considering allowing, the medical use of cannabis or cannabinoids in some form. However, the approaches taken vary widely in terms of both the products allowed and the regulatory frameworks governing their provision.
Evidence of medical use
The regulation of cannabis and cannabinoids for medical purposes is a complex patchwork of approaches. At
international level, the UN drug control treaties, under which the medical use of cannabis is very strictly limited,
provide a backdrop to the regulatory frameworks for the medical use of cannabis and cannabinoids in all signatory countries. In addition, at EU level, the European Medicines Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines, and it coordinates a network of national regulatory authorities.
There are three ways for medicines to receive cross-national authorisation within Europe. One grants EU-wide
access, and the other two can lead to authorisation in more than one EU country. To date, there have been no
EU-wide marketing authorisations for cannabinoid containing medicines, although, for example, nabiximols
has received approval in several EU countries using the alternative procedures. Medicines may also be authorised at national level. In practice, currently many of the substances being used across Europe are sold as herbal medicines which aren’t required to prove their efficacy; instead, they are required only to show evidence of product quality and consistency to ensure that consumers receive standardised doses of herbal products that are free from contaminants and adulterants.
Country approaches to make cannabis available for medicinal use
Novel policy approaches to the medical use of cannabis in the United States and Canada have prompted other
countries, including some in Europe, to allow patients to use cannabis and cannabinoids for medical purposes.
The most common initial approach has been to use some form of special access scheme, typically by creating
a system that provides medical approval and oversight, limits medical use to a restricted set of medical conditions, and often restricts the cannabis preparations that patients can use. The decision to subsidise or reimburse patient costs, or expect them to pay full price, for the medicine or preparation will also have an impact on the extent of use.
Several European countries have established some form of exceptional/compassionate use programme or other special access scheme to allow access to cannabis preparations for the treatment of a narrow range of medical conditions. Countries that currently have such programmes include Croatia, Denmark, Finland, Norway, Poland and Sweden. Four European countries have an established access programme: Czechia, Germany, Italy and the Netherlands. Both Luxembourg and Portugal passed laws on the medical use of cannabis in 2018, but details on implementation were not available at the time of writing. As many readers will know, in September the Home Office launched a review to examine the medicinal and therapeutic benefits of cannabis and cannabis-based medicinal products.
Many EU countries now allow, or are considering allowing, the medical use of cannabis or cannabinoids in some form. However, the approaches taken to making these available are very variable, in terms of both the medicinal products and preparations allowed and the regulatory frameworks governing their provision. Consideration of these diverse approaches highlights a number of key issues including:
- What types of medicinal products or cannabis preparations should be allowed?
- What forms of cannabis preparations should be allowed?
- What routes of administration for cannabis preparations should be allowed?
- For which medical conditions should treatment with cannabis preparations or medicinal products be permitted?
- If cannabis preparations were to be made available, would they require a prescription?
- If cannabis is made available for medical use, how will governments address the possible reluctance of
- physicians to prescribe cannabis for ethical or medicolegal reasons?
- For any scheme proposed, how much of the cost will be met by patients?
- What type of quality standards should be applied?
- How might governments permit the manufacturing and distribution of cannabis for medical purposes?