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The UK Cannabis Industry Needs New PR Strategies

By Kajal Shah
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The cannabis marketplace is an ever changing one. The opportunities being generated in the UK space are immense. Yet despite the countless benefits cannabis can bring to the economy, patient care and supporting health and wellness for consumers, an image problem continues to persist.

Despite its expansive growth, there is still a lot of uncertainty and misinformation. Having worked with several cannabis businesses in recent years, I firmly believe there are a myriad of ways in which the industry can benefit from PR support. A strong PR strategy can not only drive media coverage, but help to reach customers, shorten sale cycles, bolster brand reputation and drive change within political and regulatory circles.

Whether you are a flourishing cannabis brand, a start-up or ancillary cannabis business, PR can help you stand out from the competition and become a credible voice in this competitive market.

Here are some key ways in which cannabis businesses can profit from PR:

Campaigning for progress

Each category of the cannabis sector faces its own reputational challenges. Medical cannabis is perhaps the most significant of these, yet it still goes largely misunderstood by the general public. This, along with regulatory restrictions and a lack of education in the clinical community means cannabis stigma continues to exist.

For the thousands of patients suffering with the likes of multiple sclerosis and epilepsy, still struggling to access this fully legal drug, this is a tragic, pressing issue. There are several families and individuals across the UK who campaign for medical cannabis access to be improved, by leveraging their story via the press and lobbying Parliament. Some of these high-profile families have been supported through strategic communications at The PHA Group, most notably Hannah Deacon, the mother who successfully campaigned for the first NHS cannabis license for her son, as well as the parents of toddler Charlie Hughes, who are currently seeking Judicial Review against NICE.

Both cases offer strong proof of the powerful role PR can play in supporting those in need of medical cannabis. Through speaking to media and generating coverage of the stories of both families, the complex issue of medical cannabis access has been thrust into the public eye, this in turn putting fresh pressure on the Government to address this through much-needed change. For cannabis leaders and professionals looking to invest in PR, it is critical that your PR partner understands the key issues, culture and complexities of the industry to create credible stories and campaigns to gain cut through in the media.

Reputation enhancement

CBD is the most established sector of the UK cannabis industry, having become firmly attached to the lifestyle scene in recent years with its broad spectrum of health and wellness products. With approximately 7.3 million people in the UK using CBD products each year through a market already worth an estimated £300 million, the industry is predicted to grow at a rapid rate, with experts claiming this figure will more than triple in the next five years.

Just some of the many hemp-derived CBD products on the market today.

Despite its impressive growth, the industry has faced its own stumbling blocks. Until this year, CBD had been in a period of regulatory uncertainty and the industry faced understandable criticism when high profile cannabis probes found over half of the most popular CBD oils did not contain the amount of CBD promised on the label. This did nothing to help the already precarious public perception of CBD in the UK, meaning firms have had to work extremely hard to heal their reputations and ensure their brands are deemed trustworthy by consumers going forward.

With hundreds of brands claiming to be the best option, establishing credibility and becoming a trusted voice is key. Educating your audience by positioning company experts will help to keep your audience up to speed on the most current information and allow your brand to achieve an authoritative voice within the cannabis space.

Amplifying awareness 

Driving awareness drives revenue. It doesn’t matter if your story and products are revolutionary if nobody knows they exist! PR can help build a narrative which conveys the purpose of your business, along with its vision and products, whilst promoting key insights to keep your company relevant. The power of public relations in this regard is very similar to that of positive word-of-mouth.

Strategic brand building

UKflagCannabis companies can’t advertise like mainstream companies, so they must tread carefully in the marketing of their products. However, there are great possibilities within PR. Through case studies and careful product placement, PRs can work carefully with CBD companies to raise awareness of the benefits of their products and solidify their brand image, without risking trouble with the ASA. With CBD brands and manufacturers springing up left and right, there are opportunities aplenty for PR firms to lend support, whether that’s from a consumer perspective, across food and drink, beauty or general wellness, or from a strategic business view.

Stories sell. It’s vital for a brand that wants to develop a sustainable, long-term plan to build a story which resonates with its audience. Strategic PR can therefore increase brand value and coupled with a digital marketing and social media strategy, boost engagement and elevate the profile of the business.

A wealth of opportunities

The legal cannabis industry is gaining traction and is one to watch. In relation to medical cannabis, the industry has called for change to improve patient access and pressure has been exerted on the government and regulatory bodies to normalise cannabis as an effective treatment for a myriad of health conditions In parallel, the CBD sector is only set to grow and in recent years, there has been increasing interest and investment into hemp, a versatile variety of the cannabis plant hailed as the next big thing in sustainability.

Cannabis is a commonplace yet spectacularly complex plant. It therefore needs a PR strategy which can uncover key angles and opportunities across a multitude of avenues to position brands within the space for success and growth.

Whilst there is still much to learn and navigate in cannabis, PR has an important role to play in changing attitudes as the industry continues to expand and evolve. I am excited to see where it goes next.

The Changing Landscape of CBD in the UK

By Mike Barnes
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Reports estimate that up to 8 million people in the UK use CBD for its variety of wellness benefits. The market is currently worth £300 million, a figure which is expected to more than triple in the next five years.

Sales of CBD already outstrip those of Vitamin C at £301 million vs £119 million and given that almost 90 percent of users in the UK purchase CBD online, new investments into omnichannel and e-commerce capabilities are likely to lead to even more growth.

Yet, for all this excitement, the truth is the UK’s CBD industry is facing a bit of a roadblock.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Until this year, CBD has been in a period of regulatory uncertainty and the industry faced understandable criticism when high profile cannabis probes found that over half of the most popular CBD oils did not contain the amount of CBD promised on the label. On February 13, 2020, the Food Standards Agency (FSA) unveiled new plans to better regulate the industry and announced a deadline of March 31, 2021 for the submission of a valid application for novel food licence for businesses selling food and food supplements containing CBD in the UK. Contained in the announcement was a warning to all CBD companies that failure to comply may result in products being taken off the shelves.

Consumers are also advised by the FSA to “think carefully” about taking CBD, and not to consume more than 70mg a day, making the UK the first country in the world to set recommended limits for CBD consumption, despite no scientific basis for the 70mg recommended limit.

Whilst it is undeniable that the CBD market requires some form of regulation and standards need to be raised for CBD products, to ensure consumers are receiving safe, legal and quality products, this will be a complex and costly process. CBD companies, particularly smaller CBD brands, will need to ensure they have the necessary infrastructure, expertise and resources to meet this deadline.

The deadline is fast approaching, and no extension has been granted despite of the difficulties caused by COVID-19. This will put all businesses under pressure, as the process for applying for Novel Food status requires supplying a large amount of data from rigorous testing. For larger players, this will likely be nothing more than a costly inconvenience, but for smaller, nascent businesses, these costs may put their longevity at risk. There are hundreds of CBD start-ups which have done great work to future-proof their businesses and create safe, high-quality products. Now, instead of preserving costs to try and stay afloat during the pandemic, these businesses must put a significant amount of precious resource and funds into finalising their applications in time.

Improving end user confidence in CBD products and understanding the process from seed to shelf is crucially important in this developing industry, however, I firmly believe these regulations are suffocating the market. I fear that on April 1, 2021, many smaller firms who haven’t managed to achieve Novel Food status yet have a superior product, will suddenly find themselves unable to legally trade.

On the other hand, there is the argument that the FSA ruling may increase the importation of CBD products from firms based outside of Europe. So far, the large cannabis firms in North America, which have the budget and expertise to meet FSA standards, have held back on importing CBD products to the UK. This may well have to do with the slightly dubious legal status CBD has so far had in the UK, so it will be interesting to see whether this changes in April next year and which players will enter the market. The CBD market will continue to grow and diversify but it will be essential that this leads to increasing consumer choice rather than confusion.

In my opinion, the only way the UK will be able to fully harness the potential of CBD is to create an independent, self-sufficient industry that not only helps consumers but contributes to the wider economy through jobs, skills and investment. The pandemic has done well to put a spotlight on the huge access issues cannabis patients face in the UK, bolstering the case to ‘onshore’ the industry.

Whilst this would require a streamlining and simplification of the licensing laws around growing cannabis, the development of a UK-based industry would have endless benefits. Not only would medical cannabis patients see improved access to their medication, CBD firms would no longer have to ship oil in from the dominating wholesale nations such as Poland, Czechia and Italy, this in turn having huge economic benefits. The development of a UK industry should involve the creation of a new regulatory system specifically designed for cannabis products and preferably for a new regulatory body, similar to the Office of Medicinal Cannabis in the Netherlands, to oversee all cannabis regulation, licensing, importation and approvals. This would mean a move away from the current solution of forcing CBD products into the Novel Food category and subjecting them to inappropriate regulations which will soon begin to smother the market with unnecessary red tape.

People are increasingly turning to more natural health and wellness solutions, so as Britons become better informed about CBD products and as the market matures, demand will certainly increase. Yet with both Brexit and standardisation of cannabinoid regulations occurring in parallel, the future and scale of the CBD market is still to be determined. A huge UK market could potentially help push it in a positive direction, facilitating processes for CBD producers.

The cannabis industry is resilient and until this point, has managed to grow at an exponential rate despite regulatory uncertainty. As acceptance and demand continues to increase, so the case for an independent UK industry will strengthen and regulatory roadblocks finally overcome.

Marguerite Arnold

UK Non-Profit Launches Project TWENTY21 To Register 20K Cannabis Patients

By Marguerite Arnold
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Marguerite Arnold

In late June, as more than a thousand people descended on the South Bank Center to attend the largest cannabis conference held so far in the UK, another development was taking place away from the headlines.

Drug Science, a non-profit research group founded to reform drug policies based on scientific evidence rather than politics or even economic considerations, launched an ambitious trial project in the UK.

The goal? To get medical cannabis to 20,000 British patients suffering from a range of conditions that the drug is well known to help treat.

Who Is Drug Science?

Founded by Professor David Nutt, the former chief drug advisor to the British government who was fired in 2009 for stating that ecstasy and LSD were less harmful than alcohol, the group itself is clearly not afraid to tackle controversy. The Project TWENTY21 initiative is an ambitious if not desperately needed undertaking.

Targeted patient groups include those suffering from chronic pain, PTSD, MS, Tourette’s and addiction.

Several cannabis companies have already signed up to support the effort which also includes the United Patients Alliance ,and academic researchers.

According to Abby Hughes, Head of Outreach for UPA, “Whilst a change in UK law has given clinicians the green light to prescribe medical cannabis, the majority of patients are denied access, some even being criminalised, whilst corporations are profiting from the same plant.”

UKflagHughes also noted that the goal of the project is to begin to ground patient demand in research and hard data. “We hope that by having a dataset that proves the efficacy of medical cannabis, thousands of patients will be able to access legal, affordable medicine, which may improve their quality of life,” she said.

What Is The Scope of Project TWENTY21?

It is the first-of-its-kind project in the UK where, 9 months after the law changed to allow prescription of cannabinoids as well as the medical importation of the same, there are less than 20 (legal) patients in the country. And all of the successful candidates so far have fought for the right and still do.

While important in its own right, the concept if not forward motion on the same, is also poised to create similar trials all over Europe. This is especially true in countries (like France) where the issue of reform has not moved at all. Or even in Germany (with well over 50,000 patients two and a half years after similar reform was passed by the Bundestag) where problems with access and questions about medical efficacy still frustrate the close to a million Germans who cannot access the drug. Switzerland and Luxembourg may yet prove to be similiarly interesting.

Why Is This Timely?

There has been an increased call for the need for widespread and sustained population trials across Europe as the cannabis industry has really begun to establish itself since mid-2016. This is the only way to help forward medical understanding of cannabinoids at a level that leads to mainstream acceptance. And more importantly, medical and payer mainstream approvals. Until that happens, despite all the press releases, overall sales across the continent remain low.

One of the most important issues beyond this – the extraordinarily high pricing seen in Europe until late last year – has also played a role of course. Payers (see the German “statutory” health insurers) on the front lines of uncertain medical efficacy are still reluctant to pay for a drug, in any form, they do not understand, do not have evidence for, and are still highly suspicious of.

There has been an increased call for the need for widespread and sustained population trials across Europe With cannabis companies agreeing to provide product (in this case potentially from Australia), a research organization with national chops and brave leaders is likely to take the conversation far. And not just in the UK.

While Drug Science is of course not the only British entity planning canna trials and in part supported by the Canadian industry (see The Beckley Foundation for starters), Project 2021 is also certainly likely to be a study with both local as well as regional and global implications.

In Europe, there are other regional trials now in the offing (see Switzerland, Germany and France). Only Germany of course, has a patient population that is starting to be large enough to be effectively studied, and of course, the majority of these patients are still receiving dronabinol.

It is also clearly a steady state march, rather than a discussion that is likely to see significant boosts in patient numbers any time soon. Unless of course, there are other contributing factors.

Regardless, unlike the U.S. and even Canada, the strict medical focus of Europe (including the UK) is finally moving the conversation to the next level. Large, regional and/or national medical trials – and further for conditions the drug is well-known to treat but are so far considered “off-label” for most Europeans will be the watchword here for the next several years.

european union states

Why International Trade Agreements Are Shaping The Cannabis Industry

By Marguerite Arnold
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european union states

If you have wondered over the past several years, why the big Canadian companies (in particular) are following the global strategy they are, there is actually a fairly simple answer: Newly implementing trade agreements, particularly between Europe and North America.

More specifically, they are highly technical trade agreements that are also called Mutual Recognition Agreements, (or MRAs).

In fact, look at the schedule of the MRA agreements signed between the U.S. and individual EU countries over the last several years, and it also looks like a map of the countries that have not only legalized at least medical cannabis, but where the big Canadian companies (in particular) have begun to establish operations outside of their home country.

But what is going on is actually more than just CETA-related and also will affect cannabis firms south of the Canadian-U.S. border.

All of these swirling currents are also why the most recent MRA to come into full force in July this year, between the U.S. and Europe, is so interesting from the cannabis perspective. Even before federal reform in the U.S. If this sounds like a confusing disconnect, read on.

What Are MRAs?

MRAs are actually a form of highly specialized trade agreement that allow trading countries to be certain that the pharmaceuticals they purchase from abroad are equivalent to what is produced at home. This includes not only ingredients but processing procedures, production plant hygiene, testing, labeling and more.

When it comes to the  EU-US MRA agreement, this means that individual states of the EU can now recognize the American Food and Drug Administration (or FDA) as an effective federal regulator of American pharmaceutical production that is equal to the procedures in Europe. US GMP standards, in other words, will be recognized as equal to those of EU states.

This will now also, by definition, include GMP-certified medical cannabis formulations.

What is so intriguing, however, is how this development will actually place certain American (and Canadian) manufacturers in a first place position to import cannabis into Europe ahead of the rest of the American cannabis industry.

What Are Mutual Recognition Agreements All About?

One of the most important quality and consumer safety aspects of establishing a clean supply chain is tied up in the concept of GMPs (Good Manufacturing Practices). These are procedures, established by compliant producers of pharmaceuticals, to ensure seed (or source) to sale reliability of the medication they make. In the cannabis industry, particularly in the advent of Canadian-European transatlantic trade in cannabis, this has been the first high hurdle to accept and integrate on the Canadian side.

GMPIf European countries recognize a country’s GMP certifications are equivalent to its own, in other words, and cannabis is legal for export, a country can enter the international cannabis market without facing bans, in-country inspections and the like. In the interim, imported products still have to be batch tested until the agreements are fully accepted and operational.

Israel, for example, already had an MRA with the EU, and medical cannabis is legal in the country. However, Israel was prevented from selling cannabis abroad until a legislative change domestically, passed on Christmas Day.

That is why the MRA agreement between the US and EU with Canadian companies in the middle also put both Israeli and U.S. firms at an extreme disadvantage in comparison. Both in entering the market in the first place, and of course associated discussions, like the German tender bid. That is now changing- and as of this year.

A Specialized Map Of Global Medical Cannabis Exporters

Ironically, what the new US-EU MRA could also well do is create a channel for pharmaceutical cannabis from the United States to Europe (certainly on the hemp and CBD front) just as Israel is expected to enter the international cannabis export industry (later this summer or fall). It could well be also, particularly given the Trump Administration’s tendency to want to not only “put America first” if not pull off “a better deal” in general and about everything, that this is why President Trump offered the delay to Israel’s president Benjamin Netanyahu in the first place.

Regardless of the international individual developments and subtleties however, what is very clear that from the time the first bid stalled in Germany in the summer of 2017 until now, the U.S.-EU MRA has been in the room even if not named specifically as a driver.

For example, the FDA confirmed the capability of Poland and Slovenia to carry out GMP inspections in February of 2019.  It was only last fall that Aurora pulled off its licensing news in the former (on the same day licensing reform was announced by the government). Denmark was recognized in November of last year during the first year of its “medical cannabis pilot progam.” Greece was recognized in March 2018. Italy, Malta, Spain and the UK came online in November of 2017.

Overlay this timetable with a map of cannabis reform (and beyond that, cannabis production) and the logic starts to look very clear.

The upshot, in other words, is that while cannabis still may be “stigmatized” if not still “illegal” in many parts of the world, more generalized, newly negotiated and implementing, specialized global trade agreements between the US, Europe and Canada in particular have been driving the development of certain segments of the cannabis industry globally and since about 2013.

The Biggest News?

As of this year, as a result, expect at least from the GMP-certified front at least, that such international trade will also include medical cannabis from the U.S.

Want an example of the same? First on that list if not early in the game will now undoubtedly be Canadian-based Canopy Growth, with Acreage on board, headquartered in New York.

British Barristers Take On Cannabis “Novel Food” Regulation In Brussels

By Marguerite Arnold
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The first thing to understand about the significance of the British barristers now challenging the EU’s classification of hemp extracts as a novel food is that this is like jumping into the middle of an action adventure by coming in at the second act. In other words, you miss the introduction and the first couple of car chases.

That said, this action movie also features a cannabis-flavored plot. Those used to the maddening hair splitting now going on just about everywhere as the industry gains legitimacy, in other words, are familiar with the larger story line.

Here are the “CBD Cliff’s Notes.”

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

It is highly significant that a major British cannabis trade organization, the Cannabis Trades Association, hired a leading law firm in London to go sue the EU over its recent decision to lump all CBD extracts into the same “novel” distinction. Up until now, only CBD sourced from cannabis had fallen prey to this strange regulation. Thus, the lawsuit. No Brexit themes involved. Yet. Although that too will play a role in all of this.

What Is This Really About?

If those in the CBD business are honest with themselves, the real reason for this segmented part of the cannabis industry to even exist in the first place is the race, desire and need to actually be allowed to operate in relative regulatory peace. No matter what the battles are on the THC front. CBD has been seen as a result, pretty much since the beginning of the new age of legalization, as the “safer” political and market entry choice by those in regions such as U.S. southern states and the burgeoning, can’t-wait-to-be-off-to-the-races, market in Europe. See the new federal hemp legalization bill in the United States as Exhibit A.

However, in Europe this has run into more than a few problems since the Swiss put “low THC” or “Cannabis Lite” on the map more locally. Starting with the whole discussion about licensing in general. And then, even more confusingly, about what to actually classify the plant. Especially when it is used in food and cosmetics as opposed to “medicine.”

Specifically, where does the cannabis plant in general, let alone its individual components, really fall when it comes to regulated human consumption?

european union states
Member states of the European Union

For the time being- read last year when the industry in Spain was facing police busts over CBD cookies on the shelves at health stores- the conventional industry wisdom was that this whole furore was “just” over the use of concentrates, tinctures and other products made from cannabis-sourced CBD. However, given the noise that Austria managed to make over Christmas about the entire “licensing” issue (namely who has the right to produce, sell and package even CBD as a cannabinoid no matter where it is sourced), the EU also moved all CBD products and tinctures- even those made from good old hemp- into the novel food category.

This means in effect, that even CBD extracts produced from the hemp plant (which is actually the majority of such product in Europe) must now be regulated as a “novel food” too. Even though in poor old hemp’s case, it is certainly the case that health food nuts have been consuming the same in Europe long before (and certainly after) standing EU “novel food” regulations were put into place back in the late 90’s.

Thus, the lawsuit, launched from a country unsure of whether it will even be in the EU post-May (either the month or the current PM).

According to the EU at least for now, CBD itself is a “novel food” no matter from where it is sourced. And that, according to not only science but food history is an absolute fallacy.consumer safety, from factory to pharmacy or farm to table, is never far from the discussion

Likely Outcomes

Those who were hoping that CBD would remain unregulated in the EU should think again. It is highly likely that what will happen is that CBD production licensing is in the cards and just about everywhere. Think GMPs but with a consumer-food twist.

While indie producers might groan at the prospect of fees and licensing procedures, remember this is Europe. And consumer safety, from factory to pharmacy or farm to table, is never far from the discussion.

While this lawsuit, in other words, is likely to make the EU think more closely about regulating CBD in general, what is most likely to happen is that entire enchilada will be lumped under a regime to insure that high quality production, particularly of crops bound for consumption, is also extended to anything that ends up in either a food or cosmetic product.

CBD Producers Have To Keep Current On Regs

Given the current murkiness that exists, in other words at this point across Europe, in every country and for every CBD product, exports here from other places are still not a great idea.

There are labeling, licensing and of course, ultimately legislative issues that are all still in flux. And while the outcome of the lawsuit might eventually regulate and standardize things, the idea that a license-free CBD production industry is clearly now dead in the water.

First Cannabis Clinical Trials All Set In UK

By Marguerite Arnold
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Beckley Canopy Therapeutics, based in Oxford, England has raised ₤7.4 million for the purposes of cannabinoid research and drug development. The new company is a unique partnership established between Canopy Growth Corporation and the Beckley Foundation, a research institute which examines the utilization of psychotropic drugs for the treatment of physical and mental conditions.

Studies focusing on the use of cannabinoids for the treatment of opioid addiction and cancer pain will be conducted in Europe, the UK and the US.

Why Is This Significant?

Here is the first reason: the woman behind it all. Her name is Lady Amanda Feilding, Countess of Wemyss and March. Born into a landed gentry family at Beckley Park (a Tudor hunting lodge with three towers and three moats) she also has a long history of engaging and supporting scientific endeavours that use stigmatized drugs in the treatment of both intractable disease and mental illness via the use of scientific research.

In 1998, Amanda Feilding set up the Beckley Foundation, a charitable trust which initiates, directs and supports neuroscientific and clinical research into the effects of psychoactive substances. She has also co-authored over 50 scientific papers in peer-reviewed journals.

The so-called “hidden hand” behind the rebirth of psychedelic science, Fielding’s contribution to global drug policy reform has been widely acknowledged in international drug policy circles. She was named as one of the bravest men and women in the history of science in 2010 by the British Guardian.

And here is the second reason: The foundation is now partnered with Canopy Cannabis, one of the leading cannabis firms in the world, which is also working closely with Spanish opioid manufacturer Alcaliber.

In other words, this coalition is almost the mirror opposite of the approach taken by the American Sackler family, makers of Oxycontin, who have fought cannabinoids as an alternative or even transition drug in multiple state legalization campaigns. Meanwhile the death rates from overdoses have quadrupled since 1999. In 2016, opioid-related drug overdoses killed about 116 people a day (or about 42,249 for the year). It is estimated that about 11 million people in the U.S. are currently misusing or dependent on opioids.

Amanda Fielding
Image credit: Robert Funke

Beyond The Politics of The Opioid-Cannabinoid War

While opioids clearly have a role particularly in chronic pain treatment, the question now at the global scientific table is this: Are cannabinoids a substitute for longer term chronic pain management? It is a fiercely battled scientific debate that has frequently, particularly in the U.S., crossed over into political drug reform questions.

The unique partnership of Beckley and Canopy is well placed both scientifically and culturally to take on a discussion which has languished for too long in the grass of political debate and reform.

Even better, it is taking place in a country where English is the first language, but outside the U.S. and further, in a country where cannabis has now been legally reclassified as a Schedule II drug.

Do not expect, in other words, the same trials and tribulations that faced noted U.S.-based researcher Sue Sisley, to slow down research, trials or findings.

Why Is A Cultural and Scientific Reset Required?

For the past forty years, since the end of the 1970s, cannabis in particular, has been pushed into a strange scientific territory in part, because of the culture surrounding the drug. This in turn, along with the schedule I classification of cannabis, has led to not only a dearth of research, but a reluctance on the part of prescribing doctors to examine its efficacy.

In the present, this means that doctors are still (beyond insurers who demand medical evidence before approving payment) the biggest hurdles in every medical system where cannabis is becoming legal. See the debate in Canada, the UK and of course, Germany, where patients frequently report asking for a drug their doctors refuse to prescribe.

This is exactly the kind of high-placed, societally influential effort in other words, that might finally break the medical taboo at the most important remaining logjam– at the point of prescription and approval for patients.