EU resolution’s medical cannabis definition too restrictive, experts say

While the European Parliament’s approval of a resolution to develop a European strategy for medical cannabis was well received by industry stakeholders, the business effects of the move may be less rosy for a rapidly evolving industry.

“This is a missed opportunity,” Guillaume Balas, a member of the European Parliament (MEP) from France, wrote on his website.

“This resolution marks an important step that responds to the patients’ request and of which we can be satisfied. It will now be necessary to go further during the next term of office.”

Much of resolution 2018/2775(RSP) focuses on research, medical education and health insurance coverage, but some of the components – Article 14 in particular – have created concern around “protecting the interest of some manufacturers,” Balas noted.

A look at Article 14

Article 14 lays the foundation for what the European Parliament is calling medical cannabis:

(Article 14) calls on the Commission to work with Member States to ensure that safe and controlled cannabis used for medicinal purposes can only be in the form of cannabis-derived products that have gone through clinical trials, regulatory assessment and approval.

This restrictive definition was proposed “to ensure that cannabis-based medicines which have undergone clinical trials are readily available to all EU doctors and patients, but access to medical cannabis not supported by clinical trials be decided on a national level,” United Kingdom MEP Catherine Bearder told Marijuana Business Daily. 

“Legalization of cannabis for whatever reason is a national issue and isn’t a legal competency of the EU,” said Bearder, whose Liberal Democrat party supports fully legalizing cannabis and introducing a properly regulated market in the U.K.

Each country is still responsible for passing specific legislation regarding legalization, and the resolution is not binding on member states, which means each country could opt for broader definitions than those proposed by this resolution.

But if the standard were to be adopted by Germany, for example, Sativex is the only current cannabis product that would be allowed.

Juan Fernández Ochoa, campaigns and communications officer of the International Drug Policy Consortium, told MJBizDaily that in his organization’s view, “reducing medical cannabis solely to products derived from cannabis – such as Marinol (or) Sativex – would be unduly restrictive.

“Yet, the motion represents a considerable step forward, with the potential to galvanize progress in those EU countries where there’s still an unjust dearth of therapeutic options.”

Amendments that would have allowed for more options failed narrowly – by roughly 20 votes, Balas told MJBizDaily. “(I) fought hard for this paragraph and other restrictive aspects of the resolution to be modified.”

Pharmaceutical companies lobbied for the limited definition, and other MEPs voted for it because they believed it would provide more protection for patients, he said.

“Article 14 seems intended to grant exclusive access to the European market to a limited number of products patented by pharmaceutical companies,” said Martin Jelsma, drugs and democracy program director at Netherlands-based Transnational Institute.

“While the resolution acknowledges the therapeutic effects of both the cannabis plant and the extracted cannabinoids, it basically calls to ban the medical use of herbal cannabis and natural plant-based products.”

What about CBD?

The resolution largely ignores the existing CBD market in Europe, which is not driven by prescriptions.

But it “reinforces the idea of only two categories of cannabis – illicit recreational use vs. licit medical use – without taking into account the category of hemp-derived products sold legally throughout Europe,” said Eveline Van Keymeulen, counsel and head of the life sciences regulatory practice for international law firm Allen & Overy.

“It’s important for the EU institutions and member states to also recognize the licit nonmedical use of hemp, in particular its CBD compound … and the CBD industry should further advocate for such use to be regulated within the existing EU regulatory frameworks for these products.”

Alfredo Pascual can be reached at [email protected]

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