Medical cannabis policy and research in Europe

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HEQ speaks to Medicinal Cannabis Europe about the European medical cannabis landscape.

The European medical cannabis area is evolving and more and more EU Member States are increasingly positive about the clinical benefits of cannabis and its derivatives. Medicinal Cannabis Europe was introduced in 2018 with the aim of guaranteeing patients fair and equal access to medical cannabis products and creating a harmonized political framework at EU level.

Medicinal Cannabis Europe’s Secretary General Stuart Lambie and Deputy Secretary Quentin Galland speak to HEQ ​​about medical cannabis policy, research and education in Europe.

What role does Medicinal Cannabis Europe play in the European cannabis landscape? What are your main goals?

SL: We are a multi-stakeholder non-profit organization based in Brussels. We represent the entire medical cannabis value chain, from patient communities to companies involved in the manufacture of cannabis-based medicines. We work actively with policy makers in Brussels, both with members of the European Parliament and with the regulators of the European Commission. Our aim is to make safe, regulated cannabis-based cannabis-based medicinal products available to European citizens in all Member States. attract European funding for research and innovation in medical cannabis applications and products; and we also want to play an educational role so that we can remove the stigma associated with medicinal cannabis. We want to educate the public and policy makers about the therapeutic benefits of medicinal cannabis and the clear distinction between the ancient, stigmatized recreational use of cannabis and its use as medicine.

At the end of 2020, the Court of Justice of the European Union ruled within a few weeks that CBD is not a narcotic, and the UN Narcotics Commission voted to reclassify cannabis from Appendix IV, where it is next to drugs like heroin, into a less harmful category. Are these positive steps an indication of a possible turnaround for cannabis policy?

SL: In general, it’s a very positive development: to a certain extent, it opens the door for European regulators to tackle the problem of cannabis as a medical device rather than a narcotic. However, it will take time for national governments across Europe to adjust their own regulatory picture in response to these changes.

CBD is relatively easy for regulators to talk about as it carries this wellness label and, unlike THC, has few to no psychotropic effects. But at some point, CBD alone won’t be enough. When we talk about medical cannabis, we mean more than just CBD – and we usually mean more than THC and CBD too. This plant contains hundreds of components, many of which have potential medicinal uses. and there needs to be a broader focus and clear definition of what we mean by medical cannabis. We need this definition to set the process of regulation and standardization in motion.

Where do you see the future of cannabis research? Are there certain areas or aspects that you would like further investigation into?

SL: We need to invest in research and innovation at a European level in order to create an evidence base for the effectiveness of treatments from the cannabis plant, regardless of whether they contain CBD, THC or other cannabinoids. This research base would also help expand the scope of cannabis-based medicines, as well as the scope and breadth of purposes for which medicinal cannabis can be used.

Currently, the lack of research and innovation in medical cannabis is hindering the development of regulatory solutions. Hence, there is a clear need to facilitate this research: we have received confirmation that the European Commission will welcome applications for funding of medical cannabis research through the Horizon Research Funding Program. The regulators have told us that they are in a difficult position as some provisions of the Herbal Medicines Directive, for example, require at least 30 years of scientific evidence. and we don’t have that for medical cannabis because cannabis wasn’t legal in Europe for the first 15 of those 30 years.

Cannabis has seen very little real research over the years, and because of its illegality, we’re essentially starting from scratch. What is important now is to define very clear research goals – there are all kinds of diseases that could be alleviated by using cannabis or cannabinoids, but for which no official research is currently available. Much of the research that has been done on cannabis has focused on older users who used cannabis for recreational purposes – and that research is then viewed as the gold standard for evaluating the effects of cannabis on certain conditions, even though this group of patients weren’t once patient; They were consumers. Their cannabis use had nothing to do with any specific disease or condition, and the compounds they received were not standardized for specific therapeutic effects. This has led to the creation of a database that we need to study carefully and question whether it is really thorough and useful for medical cannabis research.

From a European point of view, a start would have to be made from the beginning, taking into account standardized compounds and cannabinoids that are manufactured on the basis of Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP). As the research at European level is realistic, all conditions are never dealt with at the same time: it is carried out sequentially, if possible, but starts with small steps. Carrying out a multi-million dollar research project examining the effects of various characteristics of the cannabis plant on one or two conditions in clinical trials over a period of at least four years will already be cause for determining whether there is any evidence that Confirm that cannabis can be effective under certain conditions. We have to start here.

What changes would you like to see in drug policy in Europe? Should the EU take a more standardized approach to setting and enforcing medical cannabis policy?

SL: From a medical cannabis perspective, the existing systems that regulate drug registration are unsuitable for something like medical cannabis. With that in mind, either these systems need to be adapted to include medical cannabis – once we have a clear definition of what we actually mean by medical cannabis – or there needs to be a separate and special system that allows for the registration of what we could be drugs of the new generation.

FG: When we talk to medical cannabis stakeholders, as patients, they want things to accelerate – they really want access to medical cannabis to be made available more or less immediately. However, we need to look at the applicable procedures, processes and laws, whether we like them or not. Although it is currently small, the medical cannabis sector has the potential to change or facilitate change in the broader healthcare sector that has been spearheaded by the pharmaceutical industry for quite some time. The Herbal Medicines Directive leaves some room for maneuver in the medical cannabis market, but manufacturers still have to meet a number of criteria before they can make their product available on the European market. In the meantime, we’re working with policy makers to establish a workable definition of medical cannabis. However, this becomes difficult because cannabis contains so many compounds. It may be better to tackle the links individually than work towards a single definition that encompasses all medicinal cannabis.

Alongside this, it is equally important to raise awareness within the policy-making space of patients’ need for access to medicinal cannabis, as it has worked for them and some studies confirm it. There is still some stigma attached to patients who use medicinal cannabis. They are still being prosecuted in some regions. By engaging with policy makers, we can develop an awareness of what medical cannabis means to differentiate ourselves from the recreational and adult cannabis realms. Our aim is to create a stakeholder group within the European Parliament to discuss with policy makers the key issues related to medical cannabis across Europe and what needs to be addressed at European level to facilitate patient access. and at the same time enable the development of a truly European cannabis industry – otherwise foreign companies will enter the European market with their own product and lose this opportunity.

Stuart Lambie
Secretary General
Quentin Galland
Deputy Secretary General
Medical cannabis Europe
www.medicinalcannabiseurope.org

This article is from issue 16 of Health Europe. click Here to get your free subscription today.

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