Tag: France

For all the foot-dragging, the French appear to be on track for what appears to be the largest, organized national trial in Europe.

It is hardly surprising, and for a number of reasons, that the French have finally stepped up to the plate on the medical cannabis discussion. After all, the WHO ruled that the drug was not a Schedule IV last December, right around the time that the European Commission voted that CBD is not a narcotic. This is now an unavoidable topic in every European capital.

However late they may be to this particular discussion, however, the French also seem to have learned a few lessons from neighbouring countries (including right next door in Germany) on how to proceed with this perennially sticky wicket.

As the Dutch government retreats in a fumbled recreational trial, and the German cultivation license holders have (yet) to produce at full speed, the French decided to take a different tact. Namely, they announced the launch of a national trial (much delayed) at the end of last year. There are to be 3,000 patients. And, here is the rub, participating companies must provide both product and vapes, for free.

Which Companies Will Be Participating?

There are six companies who have now been picked for selection in the French trial as announced in late January by the ANSM (the French agency of Medicines and Medical Devices). Their names will sound familiar to anyone who has paid attention to the global industry over the last few years. Like the German tender, several of the participants are from Canada (Aurora and Tilray/Aphria which are also both German bid winners). Australian firms Althea and Little Green Pharma were also chosen, along with the Israeli Panaxia and the UK based Emmac Life Sciences.

All of the product will be imported as the cultivation of cannabis is currently still illegal in France.

European Implications

With France now admitting that cannabis has medical efficacy, the second-largest economy in the EU has now signed up to moving forward on reform. Even if behind other places in Europe.

This also means that the next question is now, inevitably, in the room, and across Europe. When does recreational reform finally come here?

That topic is also on the table, inevitably, as COVID-19 restrictions begin to lift.

Be sure to book your tickets to the International Cannabis Business Conference this summer, when the conference returns to Berlin.

The Israelis are moving quickly to take advantage of the opening in the French medical cannabis market. Panaxia Pharmaceuticals has just announced a deal with Neuraxpharm, a leading European company specializing in disorders of the central nervous system. Their collaboration is intended to be a first step in establishing a manufacturing entity to commercial production and distribution of Panaxia’s cannabinoid medicinal products in France.

The model adopted for the collaboration is similar to those increasingly seen in Germany where foreign companies are partnering with established medical products providers in Europe to enter the market.

In the case of France, the companies are also clearly angling to be a medical provider for the national French medical trial, set to begin by the first quarter of March 2021. Indeed, as part of the first stages of their collaboration, Panaxia and Neuraxpharm are already planning on responding to the tender issued by the French government and medications agency ANSM, to regulate the country’s domestic cannabis market.

Panaxia is currently the only Israeli company with EU-GMP certification for the production of medical cannabis products.

The French Trial Is Looming – Will The German Mistakes Be Repeated?

While the French government is clearly copying the model of the German tender bid, it appears that some of the same mistakes will not be present here. Starting with not excluding Israeli firms.

However, given the same issues, not to mention tensions about legalization overall, which France now imports from other countries ringing it as well as the global marketplace, will this kind of alliance be the kind that inspires confidence in the market, if not effectively reaches patients beyond a 3,000 person trial now planned for spring?

The French trial, unlike the German one, expects participating companies to participate for free – rather than allowing companies to import products from another country and charging outrageous prices for the same before price controls had been set by the government, but insurance companies are still on the hook for payment.

Given Israel’s increasing global prominence in the medical market, this is a clear rebuke to Germany, where Canadian companies still dominate a market that is expanding and further requiring higher standards than those seen in other countries so far. And where repeated companies, no matter what country they hail from, have run into multiple and serial problems with quality control as well as a fully compliant supply chain.

The International Cannabis Business Conference is returning to Europe in 2021. Stay tuned!

The French government is officially looking for suppliers for its medical cannabis trial. Applications are due by November 24. Applicants may also submit questions until November 18.

What The French Are Looking For

The government is looking for GMP certified providers who can provide up to 3,000 French patients with different qualities of both raw and extracted products for free during the duration of the trial.

This includes not only the provision of the medicine itself but all costs related to import and distribution. It also includes, for floß cannabis, the requirement that the supplier provides a vaping device (per patient).

How Does This Differ From The German Bid?

The French appear to be looking for a larger cannabis producer who can bear the cost of not only medicine provision and distribution, but also of import (required) and additional equipment (vapes).

There are few companies that are in a position to meet this challenge – not only from a quality perspective, but also from a cost perspective. Even the biggest companies right now are suffering from cash flow issues.

And even though the German bid required that cannabis companies spend a great deal of money to apply for a bid that was delayed twice by legal challenges, they could at least create revenue for themselves by selling the drug in the country in the meantime.

France is indeed challenging the industry to step up – and like the German government before it only looking for “established” companies.

The question is, outside a big French pharma right now, who is willing to step into this role?

How Does This Differ From Other Countries Steps Into Legalization?

The French foray into medical acceptance actually appears to be unique. No other country has launched a national trial like this to begin its foray into normalization.

It is also clear that the French are determined to push the onus back onto the industry itself to help prove its efficacy – and further do so in a way that may help build “infrastructure” in the form of creating a distribution network with an established French company – but no more.

This is not a bienvenue, but rather a révolution à contrecœur (reluctant change of heart).

The Upside

Clearly, the focus from the beginning in France is a GMP only market where the government is not on the hook for paying for the cost of the trial – and further that any cannabis company outside the country willing to engage in the same must have either a standing or in process partnership negotiated with a French pharmaceutical company capable of fulfilling the technical requirements of narcotic distribution within France.

For the latest on the changing market picture in Europe, be sure to attend the International Cannabis Business Conference when it returns to the continent next year.

On October 25, the French National Assembly finally gave the green light to a national experiment with medical cannabis. This has been in the offing for some time. As of now, the French government is finally willing to give the cannabis discussion a two-year trial. The Medicines Agency has already signed off.

Cannabis will be able to be prescribed for patients with treatment-resistant conditions including epilepsy, nerve pain, side effects of chemotherapy and for diseases of the central nervous system, including uncontrolled muscle contractions.

That said, the French are skipping the idea of “prescription joints” and will make oils and other ingestible basics (including drinkables) available via French doctors and through French pharmacies.

Prescribing doctors will have to complete an online training course, the details of which have not been released.

Will France Challenge Germany As Europe’s Most Lucrative Market?

Comparisons between France and other countries when it comes to cannabis are at this point premature. However, the French are certainly approaching the issue in a way that so far, even Germany has not.

Doctor training and certification, for example, are not centrally managed, administered, or even made available (no matter how many people are trying to set this up). However, Germany will be a producer within the next two years, unlike current plans in France. Unless and until French cultivation happens, French patients will be caught in the same conundrum as everyone else in Europe.

The idea of getting a prescription is very nice, but actually obtaining one, plus the approvals of health insurance to remove the burden of payment, is much, much harder than many people think.

In the short term look for more foreign-based businesses to get established in France, and further to see products entering the country from all points of the globe, starting with Portugal, Spain, Greece, and Poland.

There is a silver lining of course. Now that the two most powerful, economically intact economies in Europe are in the cannabis basket, it will drive other kinds of reform.

The idea of getting patients into an established program and out of the unregulated market is the ultimate goal, of course, however, it is a goal that is so far unreachable in an environment where medical cannabis is still expensive and far too hard to obtain.

So yes, vive la cannabis! But this is hardly the great green wave revolution most in France, if not in other places, have hoped and fought for. This is not the vision of the “industry” that most have sacrificed and worked for.

France is one of the least progressive countries in Europe when it comes to cannabis policy. France is one of the few remaining countries in Europe that completely prohibits medical cannabis. However, that could be changing.

On Friday lawmakers in France voted to approve funding for a two-year medical cannabis research project. Per The Local:

Olivier Veran, a lawmaker from President Emmanuel Macron’s centrist party who proposed the budget inclusion, said the experiments could target some 3,000 sick people in France.

They will seek to determine whether cannabis derivatives can alleviate the symptoms of certain illnesses, and in which doses, he said.

Seventeen other European Union members have already authorised cannabis-based therapies, he added.

The list of health conditions that will reportedly be a part of the study will include epilepsy, chronic pain, cancer, and multiple sclerosis. The study will not involve inhaled-forms of cannabis. Rather, participants will consume cannabis-derived medical products via capsules and other oral dosing methods.

The medical cannabis experiments in France are certainly better than nothing, however, the study is limited in size compared to others that will be conducted on the European continent in the near future.

Earlier this month a medical cannabis study was announced in the UK which will involve 145,000 patients and will be narrowly focused on whether CBD is an effective treatment for Parkinson’s disease.

Still, the approval for medical cannabis research funding in France is significant and will hopefully lead to an increase in future research and help build momentum for medical cannabis reform in France.