This article is part of our special report Shedding light on medical cannabis.
A strong EU regulatory framework on medical cannabis is needed to provide investors with stability but also to give peace of mind to patients struggling with fragmented legislation among member states, socialist MEP Miriam Dalli has told EURACTIV.
From patients’ perspective, getting access to medical cannabis in the EU is not an easy feat, she pointed out in an interview held on the sidelines of the MedCann World Forum, which took place in her home country Malta from 19 to 21 November.
“We are speaking about medical, not recreational cannabis,” she said, adding that the therapeutical treatment with cannabis and cannabinoids seem still to be treated with too much of a precautionary attitude, as though patients were using them capriciously.
According to her, it is unacceptable that patients who regularly purchase medical cannabis in their home country should be in the situation where they are not allowed to take their medicine with them if travelling abroad within the EU, or even don’t have access to it.
“If we really have our patients’ well-being at heart, we need to make sure that they can access medical cannabis across the EU,” she said.
Dalli called for a strong regulatory framework within the EU, citing the case of Malta as a trendsetter in laying down robust rules and regulations in the medical cannabis sector that have ensured quality products for patients and a quality market for investors.
In April 2018, Malta enacted the Production of Cannabis for Medicinal and Research Purposes Act, which provided a regulatory framework allowing business entities to cultivate, import, process and produce cannabis intended for medical and research purposes in a controlled and supervised environment.
“Our Mediterranean island is working hard to keep up the momentum and reap the benefits of the latest advancements,” she said.
A number of other European countries are developing or have already put in place policies for granting patients easier access to medical marijuana after Germany led the way by passing a reform of the country’s drugs law in 2017.
Weeding out misconceptions
Dalli considered herself a ‘firm believer’ in simplifying matters and not complicating access to medicinal products that can have therapeutic effects.
“Processes that create a lot of obstacles and hurdles will not help patients and will let the black-market fester. It’s not what we want,” she said.
As more countries will seek to tap into a growing market, the EU framework should ensure high-quality products for the patients. “Effective legislation does not hinder quality and it does not hinder growth,” she added.
However, prescriptions of medical marijuana have not seen the expected boom so far in countries like the UK, where cannabis-based pharmaceuticals were re-classified as products that may be prescribed eight months ago.
Some medical doctors, in particular, seem reluctant to write prescriptions for medical cannabis because of a lack of clinical trials.
But according to Dalli, research alone should not be used as an excuse to restrict the use of medical cannabis when there is already enough evidence showing that the medication can help out a certain cohort of patients.
“This is a new area of science and professionals, maybe trained 10 or 20 years ago, were not used to prescribing cannabis,” she said, adding that education for professionals is key.
For the Maltese MEP, helping medical doctors understand the research, the dosing and the endocannabinoid system can set the ball rolling, but the general view of medical cannabis needs to be changed.
“This is not alternative medicine. Medical cannabis should be considered a mainstream drug. After all, it has been used for a very, very long time,” she pointed out.
In February 2019, the European Parliament adopted a resolution calling on the European Commission and national authorities to provide a legal definition of medical cannabis.
MEPs, in particular, intended to draw a clear distinction between medicines approved by the European Medicines Agency (EMA) or other regulatory agencies, medical cannabis not supported by clinical trials and other applications.
On the research side, they also asked the Commission to determine the priority area of analysis, as well as embark on more research activity to stimulate innovation with regard to projects related to the use of cannabis for medical purposes.
Dalli wants to avoid medical cannabis suffering from the same confusion that previously surrounded food supplements containing the cannabis compound cannabidiol (CBD), which the Commission eventually decided to regulate as novel foods in January.
The novel foods distinction is for products that haven’t been significantly consumed before 1997, but according to Dalli, this means CBD products need a time-consuming process to be registered as they need additional safety research.
“So far, few member states have enforced the European Commission’s novel foods policy and some associations are challenging the EU’s position,” she said.
She also recalled that the World Health Organisation has officially recommended that the cannabis compound cannabidiol (CBD) should not be classified as a controlled substance.
[Edited by Zoran Radosavljevic]