The UK’s medical cannabis industry has called on the government to implement changes in cannabis-related policy.
The industry is making the call in a bid to increase understanding of the benefits of medicinal cannabis and access for patients. The call pushes for changes to regulatory requirements more conducive to institutional investment in the sector.
UK industry leadership body, the Centre for Medicinal Cannabis (CMC) has produced a report, Decalogue – Ideas to Increase Patient Access and Clinical Understanding of Medicinal Cannabis, outlining ten new ideas to achieve this aim.
Steve Moore, strategic counsel at the Centre for Medicinal Cannabis commented: “The report makes a compelling case for using existing governmental approaches to innovation and research and development to accelerate clinical studies, therapeutic understanding and patient access.
“It also exposes the absence of a coherent public policy strategic framework to support this new industry and its consequences. The medicinal cannabis industry can become a vital component of Britain’s life sciences sector and our aspiration to become a global scientific superpower but this now requires a nurturing approach from the government instead of the current reactive one.”
Some suggestions include:
- New clinical trial mechanism whereby drawing on the seminally successful RECOVERY trial deployed during the COVID-19 pandemic to ensure medicines reach patients quickly
- Clinical pilot study in primary care to assess the effects of community prescribing
- Adoption of Patient Group Directions1 (PGDs) which would allow healthcare professionals providing palliative care another option for their patients
- Removal of current restrictions on unlicensed medical cannabis products from the UK help to build the nation as a hub of medical cannabis knowledge and innovation
- Licensing authority to be transferred from the Home Office to the Department of Health and Social Care (DHSC)/The Medicines and Healthcare products Regulatory Agency (MHRA) for cannabinoid medicines being developed in an already highly regulated clinical trials environment
- Immediate changes to the Proceeds of Crime Act to open up investment opportunities for the UK sector
The latter two points suggested in the report could help foster innovation and investment in the UK – aims that fit with the UK Government’s plans to nurture economic growth and its life sciences sector post-Brexit.
From Home Office to healthcare
As part of the UK Government’s “Build Back Better” plan for growth, it set out its “Life Sciences Vision” in July 2021. The plan aims to harness “innovation and technological advances” to “diagnose, treat, cure and prevent a much wider range of disease than is currently possible.”
The medical cannabis industry is rife with innovation and research into the plant is continuing to reveal the plant’s potential for treating a wide variety of diseases and conditions that have limited or no treatments available. However, this research and innovation is hampered by current policy.
Report contributor Dr Andy Yates, Pharmacy Lead at The Centre for Medicinal Cannabis, highlights that prior to the legalisation of medical cannabis in 2018, there was no push for clinical development and the requirement for clinical data in cannabis medicines. The Home Office had jurisdiction of ensuring that cannabis wasn’t being grown for illicit use, which Yates says seemed appropriate prior to this point.
Under current policy, companies researching cannabis need a Schedule 1 licence from the Home Office – making the clinical trial process much more costly.
The CMC report highlights that in 2021 the UK Government’s Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) made key recommendations that could see the licensing of certain aspects of the UK’s medicinal cannabis industry moved away from Home Office control to the Department of Health and Social Care or the regulator, the MHRA.
The report suggests this should be implemented in order to “speed development, reduce cost and red-tape and lead to increased R&D expenditure and innovation within the UK.”
Currently, securing a Schedule I license to work with cannabis can be a difficult time consuming, says Yates, whose company develops synthetic cannabinoids for cancer patients: “When you are developing a medicine you are on very tight timelines. Medicines have a shelf life and you are expected to run your clinical trials in the timeframe.
“We have been working with UK NHS hospitals who are scratching their heads as they may have access to diamorphine – which is heroin – ketamine and cocaine, which are all Schedule II, but they cannot hold licenses for synthetic cannabinoids.
“It would be good to move the cannabis licensing authority from the Home Office to the Department of Health and the MHRA as drug developers are already talking to is the MHRA. They completely and utterly understand the drug development processes. They know the complexity of it, the timelines of it, how tight the timings are once you get into the clinical trial and they already do a regulatory role.
“If you go to a place like Canada or Ireland, drug licensing for products that have medicinal use or may have medicinal use and are being used in clinical trials, are looked after by medical regulators.”
With the UK’s goal to be a Centre of Excellence for Innovation and Life Sciences, Yates highlights that pre-Brexit, the MHRA was a leading regulatory body in the European Medicines Agency (EMA). The innovation taking place in the cannabis industry would provide the opportunity for the body to re-cement itself as a global leader in both innovation and clinical trials.
“If this change was made and done well we would be a go-to worldwide Centre of Excellence to run cannabis clinical studies. And not just the clinical trials but the work in the lead-up to the trials – which is the manufacturing and the processing. Currently, all of that is under Schedule I,” adds Yates.
From farmer to pharma
Yates highlights that licenses are currently being granted by the Home Office for cultivators in the UK to grow, reproduce, extract and manufacture cannabis medicines, but that at no point in this process is there a link to the MHRA.
“One of the things that we are advocating at the CMC is that we need to be moving on from the world of unlicensed medicines to the point where we should be running studies with them,” says Yates.
“Clinical studies are needed. This way, it would be good for the industry and ultimately good for investors. At the moment, having a licence in the Home Office is seen as a golden ticket. However, there is not a lot of prescribing off-label products here in the UK – there is none on the NHS.
“If you look into other jurisdictions, the cannabis market is not as big as it should be because we’re lacking data and proof that it is more effective than opioids. This could help get us to a point in the UK, where, if you get your licence, you are also somewhat ingrained in promises to the MHRA to do something with the product you are producing.
“Companies would not need multi-millions of dollars to do randomised control trials, but to be working with the MHRA which has already stated it wants to become more innovative, more creative and have more use of real-world evidence.”
Yates added: “There is precedent for the industry with Canada because its cannabis industry is flourishing. At least within Europe and most of the wider world, making these changes would really make the UK the go-to place to make investments in cannabis medicines.
“With cannabis medicine, there are projections for how big the market can be. But those projections are based on the current status quo.
“My belief is if we do true research and show the true worth and value of cannabis medicines, then you can double or quadruple those numbers – because the numbers that we are looking at now are based on the fact that cannabis medicines will never get truly tested and evaluated.”
From restricted to liberated investment
Adult-use cannabis is still illegal in the UK, meaning any investments made into recreational markets in jurisdictions where cannabis is legal would be caught under the Proceeds of Crime Act 2002 (POCA).
Recently, the channel islands – the Bailiwick of Guernsey and the Bailiwick of Jersey – have recognised the restrictions of Proceeds of Crime laws when it comes to investment in cannabis. Subsequently, Jersey has made amendments to the Proceeds of Crime (Jersey) Law 1999 which now allows businesses on the island to have direct or indirect involvement with legal cannabis sectors overseas for the first time.
On Guernsey, the Guernsey Policy and Resources Committee also issued notice to clarify that conduct/investment related to cannabis will not be foul of its Drug Trafficking Law if it is legal in the jurisdiction where it took place.
CMC report contributor, Dylan Kennett, senior associate at DLA Piper, highlights that making amendments to the Proceeds of Crime Act is one of the major gating items to any type of business operating successfully in the UK – whether for a listing or for existing businesses that are looking to participate in the market.
“It is a fundamental piece of legislation that has multiple touch points for a lot of companies. We would hope that in due course, there is some type of amendment or clarification of the law around this,” Kennett commented.
“We have noted that both Channel Islands have looked at this issue because they had similar concerns about whether people within Guernsey or Jersey, holding shares or receiving dividends from companies that are operating legally in Canada, for example, as to whether that constitutes Proceeds of Crime.
“It looks as though both jurisdictions have either amended or clarified their relevant legislation. It is welcomed by them and it will probably help their market as well – we would like to see the UK do something similar.
“If the UK wants to distinguish itself as a place of R&D and innovation, this is one way that companies doing R&D and innovation can access the capital markets. It is a very capital-intensive industry in a lot of respects, so, without that access to capital markets, you are shutting off a lot of opportunities for domestic homegrown companies.
“We have seen companies that were based overseas looking to get exposure to the London capital markets, whether Canadian businesses or elsewhere that were looking for secondary listings, but because their proceeds are generated, potentially from a hybrid of partly medicinal, partly recreational, they are precluded from a listing over here as well. It most likely will have a chilling effect – we have definitely seen companies unable to list that are legal in what we think are probably gold plated jurisdictions.”
Kennett highlights that the recent announcement that Germany will likely be legalising adult-use will also throw a wrench into the works.
“What does that mean for UK companies holding asset German assets that then go into the adult-use business?” he commented. “Or German companies that are looking for listings in London – are we saying another European jurisdiction isn’t necessarily welcomed on the UK capital markets?,” said Kennett.
“That is probably looking forward and that’s depending on how Germany reacts over the next period of time, but that will be an interesting one to watch as Europe continues towards liberalisation.”
Find out more from the report on how lessons from Covid-19 can help improve access to medical cannabis from our sister site Cannabis Health here.
To read the full report please visit: https://decalogue.info/
Cross-party group established for recreational cannabis in Europe
#LegaliseitEP is focusing on human rights-based cannabis policy – “it is a matter of freedom”.
The group, made up of MEPs from five different parties, has formed to facilitate discussions around amending policy for the personal use of cannabis in Europe.
As countries such as Malta, Germany and Luxembourg have announced progressive amendments to cannabis policy, the informal interest group is supporting human rights-based policies for the personal use of cannabis.
The group is made up of the MEPs Luke Flanagan of Ireland, The Left; Mikuláš Peksa of the Czech Republic, Greens; Monica Semedo of Luxembourg, Renew; Cyrus Engerer of Malta, S&D; and, Dorian Rookmaker of The Netherlands, ECR.
In an open letter to 705 members of the European Parliament, the group states that Member States should have the autonomy to create cannabis policy that reflects the needs and specificities of their society.
As well as encouraging the MEPs to join the group, the open letter also calls for more information sharing between Member States regarding recreational cannabis and for fact-based discussion on cannabis, which the group says has been subject to misinformation for a long time.
The letter states: “Due to outdated and unpredictable patchwork of legislation, citizens across the EU are often finding themselves being forced to turn to the black market or even worse, imprisoned for being in possession of small amounts of cannabis for personal use. This does not reflect the level of freedom we have come to expect from living in Europe.
“We cannot deny that with new legislation coming forward within EU Member States, we are likely to find ourselves facing repercussions at an EU level. As MEPs, we want to build on this momentum and create a cross-party interest group within the European Parliament, where we will share best practices, talk to experts, organise hearings and conferences, as well as debate the situation of personal use of cannabis within the Union.”
Monica Semendo, of Luxembourg’s Renew, stated: “I am in favour of the legalisation of cannabis and cannabis products because it is a matter of freedom.
“It’s a matter of one’s own choice. And if someone decides to consume cannabis, they should have access to a safe product.
“We have to focus on transparent information, education programmes and risk reduction, especially for young adults.”
Cyrus Engerer of Malta’s S&D, stated: “People should have the right to take autonomous informed decisions about their lives, including whether or not they use cannabis.
“Let’s talk basics. No one should go to jail over a joint. And now for some real talk – many people still are.
“Where I come from – Malta – we are the first European country to fully legalise cannabis use Germany, and Luxembourg will soon follow it. It’s time that we talk about cannabis and our personal freedoms and rights.”
Hear what the founding members of #LegaliseitEP have to say about why they’ve decided to launch a cross party @Europarl_EN interest group on #Cannabis & #CannabisLegalisation @lukeming @RookmakerDorien @MonicaSemedoLux @vonpecka @engerer pic.twitter.com/b20NDFOAmg
— Legalise It EP (@LegaliseIt_EP) July 14, 2022
Greenrise welcomes cannabis policy developments in Germany
The company is preparing for the potential legalisation of adult-use cannabis in Germany.
Greenrise Global Brands has welcomed recent developments in Germany as it awaits guidelines from the German Government in the coming months.
Germany’s “traffic light” coalition made plans to legalise recreational cannabis official in November 2021 with the publication of its agreement.
The coalition, which includes the Social Democratic Party of Germany (SPD), the Free Democratic Party (FDP) and The Greens, agreed to legalise the controlled distribution of cannabis to adults for “pleasure purposes”. With a focus on health-oriented cannabis policy, the development aims to move consumers away from the black market, control quality of products and ensure the protection of minors.
This year, five hearings are planned throughout to discuss the legislative process on the controlled supply of cannabis to adults for recreational purposes, with the first meeting being held in June, at the Federal Ministry of Health.
The Federal Government is anticipated to submit a draft law to Parliament (Bundestag) by the end of 2022.
Greenrise Global, which has a wholly-owned medical cannabis subsidiary, AMP Alternative Medical Products GmbH that imports EU-GMP medical cannabis from within the European Union and elsewhere and has well-established relationships with pharmacies and clinics across Germany, has welcomed the development.
Supporter of the health benefits of cannabis and a keystone shareholder and director of Greenrise, as well as co-founder of CannaCare Health, Frank Otto, commented: “The consultation process shows that Germany is no longer talking about whether to legalise adult-use, but how.
“We also believe that there will be a domino effect as European countries are watching very closely as Europe’s largest economy joins Canada and California in legalising cannabis for adult use.”
AMP Alternative Medical Products has reported that preliminary unaudited sales for first half year 2022 increased 14 per cent to €268,479 compared to sales of €236,399 during the first half year of 2021.
Greenrise acquired 51 per cent of CannaCare, which sells CBD wellness products through traditional retail channels in Germany and German-speaking markets in Europe, at the beginning of Q2. The company has reported that preliminary Q2 unaudited sales for CannaCare increased 187 per cent to €474,000 compared to Q1 2022 sales of €165,000.
Managing director of AMP and director of Greenrise, Dr Stefan Feuerstein, said: “The exceptional sales growth from CannaCare during the second quarter confirms our strategy of investing in CBD in addition to medical cannabis as we prepare for the potential legalisation of adult-use in Germany.
“We look forward to the government providing guidelines in the coming months, which will provide certainty on how and when to position our businesses.
“We expect pharmacies to play a significant role and are preparing our pharmacy customers for the possibility of selling adult-use products as well as soon as legislation is in effect. We also realigned our medical cannabis business by streamlining our medical sales team, offering more pharmaceutical cannabis products to doctors to prescribe and are preparing to import high-THC flowers from several European cultivators.”
CFO of CannaCare, Dr Tilman Spangenberg, commented: “Greenrise’s investment allowed CannaCare to launch its CBD products in three leading German drugstore chains, which dramatically increased sales in a very short period of time.
“We expect the full impact of this sales channel to unfold in the third as well as fourth quarter. Our priorities for the remainder of this year are to grow CannaCare’s sales and operating cash flow positive by introducing new sales channels and adding additional drugstore chains.”
Switzerland’s amendment on medical cannabis comes into force
The Swiss government announced in June that rules for medical cannabis will be simplified.
Today, 1 August 2022, Switzerland’s amendments to its Narcotics Act come into force, which will allow patients in the country easier access to medical cannabis.
Switzerland has now joined a number of countries across Europe that are enabling patient access to cannabis by removing its ban on the medicine.
Previously, Switzerland’s Federal Office of Public Health (FOPH) required exceptional approval for use of medical cannabis. This reduced patient access to cannabis as administrative processing was unable to keep up with the demand from potential patients.
The use of medical cannabis will now be subject to regular control measures. The defined limit of at least 1.0% total THC content remains unchanged.
Under the new amendments, medical prescriptions will no longer require an exceptional permit from the FOPH. Cannabis will be reallocated from Switzerland’s Narcotics List Ordinance list from List d, which is prohibited narcotics, to List a, which is all substances subject to control measures), along with preparations such as extracts, resins, oils and tinctures.
Dronabinol and THC will now also be included List a “provided there is an intended medical purpose”.
The new amendment enables doctors to make the decision on whether a patient requires a medical cannabis prescription, speeding up the process of accessing the medicine for patients.
The medicine will now enter Switzerland’s pharmaceutical system and controlled by the health authority SwissMedic, which will be taking over the role of the country’s Cannabis Agency for the cultivation of medical cannabis.
Under the amendments, there will be a two-stage authorisation procedure, which will require an establishment licence and an individual licence for the cultivation of medical cannabis.
SwissMedic has stated that the handling of cannabis for non-medical purposes continues to be generally prohibited and will continue to require an exemption from the FOPH.