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Europa Industrie Onderzoek Productie Wetgeving

News: 13th European Industrial Hemp Association Conference 2016

The Voice of the Hemp Industry

On June 1st & 2nd 2016 EIHA (European Industrial Hemp Association) held its 13th Annual Conference. It is the leading event of the sector worldwide with hundreds of participants and contributors. With EIHA & Nova Institut spearheading its organisation, the event has established itself as the central locus of both networking and technical dissemination within the Hemp Sector. It was an opportunity for the Hemplab Institute to cement various contacts made during previous projects as well as expand into new and exciting possibilities.

Standardisation, GMP / GAP & Hemp Market Projections

The repetitive theme of this year’s event, echoed by concerns from participants and contributors alike, was that of Standardisation of practices particularly GMPs & GAPs. This marks an evolution from earlier market concerns centred primarily on agricultural legislation, financial viability and agricultural techniques & equipment. It is testimony to the maturing process the industry is undergoing, with an ever growing list of products and hemp applications. The next step of this process is producing ‘mainstream’ products – particularly in the food & pharmaceutical markets – which invariably implies highest consumer standards, validation and analytical precision.

CANNABINOID ECONOMY HEMP MARKET DEVELOPMENTS HEMPLAB INSTITUTE

EIHA 2016 Conference – HEMPLAB Institute

Another marker of maturity evident during this year’s event was the presentation and discussion of much more comprehensive and authoritative market data and projections of the industry – with aptly demarcated analyses of particular sub-categories of products such as ‘self-care CBD’ products or food supplements. Key market risks relate to the lack of uniform legislation (on a European level) – a concern which was identified by our 2015 report.

Hemp: A market for Analytical Laboratories

With the concept of ‘Standardisation’ on everyone’s mind, the discussion naturally progressed towards the existence of institutions and companies capable of carrying out such programmes and their analytical methodologies. Analytical equipment manufacturer Waters was present with a dedicated stand and the presence of North American laboratories (e.g. ProVerde) to share technical know-how, with which we had the chance to discuss in depth our mutual experiences. With analytical standards and methodologies still absent for cannabinoids across the world, it provides a major opportunity on commercial grounds, as well as scientific and policy requirements.

We look forward to the 14th edition of this informative event!

 

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Categorieën
Europa Gezondheid Medisch Onderzoek Productie Wetgeving

Medical v Recreational Cannabis: Initial Remarks – Part A.

Medical Cannabis: Debunking the Myth

A lot of air is being vented around the dichotomy of ‘Medical’ v ‘Recreational’ Cannabis. On the policy and public opinion level, this distinction is highly operative as countless legislative plans around the world are centered on it. However is there a sound scientific or medical basis that can support it?

The Plant & The Body: A Complex Interaction

In order to start the analysis of this question it is necessary to understand the plant & the human body holistically as a system of interaction. To the best of our current knowledge the Cannabis components active on the human body are Cannabinoids. These can, but do not necessarily carry with them psychotropic effects. Cannabinoids are particularly susceptible to interact in profound ways with the human body given a particularity of the latter. Humans have what has come to be known as the Endocannabinoid System (ECS). The ECS is a group of endogenous cannabinoid receptors located in the mammalian brain and across various parts of the nervous system – it plays an important regulatory role in pain, appetite, mood and others*. In short, the human body is naturally calibrated to recognize and utilize the chemical compounds produced in Cannabis. Even though true, this statement is in danger of producing the naïve conclusion that any/all cannabinoids in any form of intake are beneficial and free of negative side-effects – a conclusion that needs to be resisted. What is undeniable on the other hand is that cannabinoids have a strong effect on the human regulatory system (of which ECS is a major component).

Human Consumption

Cannabis Sativa L. (Cannabis / Hemp) has been used by humans for thousands of years. With that in mind it is virtually impossible to give a comprehensive list of methods of consumption, let alone the psycho-social and / or medical and self-care motivations that underlie it. However interesting pointers can be given in order to commence an analysis relevant to the 21st century.

A salient operative distinction is the presence (or absence) of a particular condition for which Cannabis is used. In the former case, from a usage point of view, it is appropriate to apply the label ‘medical use of cannabis’. Things, however, are never as simple as they seem initially – important considerations are needed to supplement this simplistic distinction.

Firstly, it needs to be separated from the question of the Efficacy of the Treatment. The latter needs to be independently and objectively determined through appropriate scientific and quantitative standards. However the degree of efficacy doesn’t alter the motivation or use as medical from a subjective point of view. Furthermore, a distinction needs to be made between curative & condition management approaches. Cures are not the only relevant medical category. Secondly, the presence of a clearly defined condition is sufficient for the ‘medical’ label but not necessary inasmuch as one’s subjective experience of an ailment might not be represented in medical orthodoxy. More importantly, in line with the mood, sleep and appetite regulatory virtues of cannabinoids, maintaining an overall quality of life through their consumption has strong arguments for the ‘medical’ label. Illuminating examples are stress/anxiety management and insomnia suppression – both liable to have a huge impact in a person’s quality of life and overall health.

Another importantCannabinoid table JP-01 parameter to consider is which cannabinoids, or combination thereof, achieves the desired effects in an individual user, whether or not directly related to a specified treatment. There exists a general combinatory classification of cannabinoids and particular effects (see Table). However self-reported effects and outcomes are relevant given the uniqueness of each individual ECS. Furthermore, there is a strong a case to be made for ‘holistic’ effects of the plant as a combination of dozens of cannabinoids, terpenes and other micro-elements.

A major dichotomy within the cannabinoids is effected between the psychotropic and non-psychotropic elements. The best representatives of each group respectively are THC and CBD. However it is wrong to presume that psychoactive cannabinoids are automatically associated with recreational or non-medical uses. Research shows that both these cannabinoids have major medical applications that range from mental conditions to cancer and multiple sclerosis. THC rich cannabis can therefore have medical applications in all its forms and methods of consumption. In conclusion it is misguided to naively conclude that the psychotropic effects of Cannabis are devoid of medical virtues.

Quality, Transparency and Ethical Responsibility

Transparency and accountability are the marks of any and all ethically sourced products. It is undoubtedly true that products marketed as ‘medical’ share a much heavier degree of responsibility however the principle is valid for all products destined to human consumption. In that respect there exist quality standards which can effect the Medical v Recreational distinction. Complete product characterization and ‘free of harmful exogenous substances’ are necessary conditions for the achievement of the desired medical effects as well as the protection of the user from potential harms (that could be caused from exogenous substances). If therefore a ‘Medical Cannabis’ legislation is adopted, it is necessary that the products available to consumers be of the accepted consumer, ethical and safety standards. As such, standardization and testing is necessary for a wide application of such a program, e.g. on a national level.

Concluding Remarks

In conclusion it is important to say a few words on the semantics of the ‘Medical’ v ‘Recreational’ distinction. The very setting of the debate implies the mutual exclusion of each term involved. However this is, at the very least, a hasty assumption. The term ‘recreational’ has been further hi-jacked by the political debate and necessarily associated with pejorative connotations – with negative implications and stereotypes flourishing liberally. The point is not to defend one or the other use (or any use), rather illuminate the assumptions and premises of the argument and its modes of presentation.

Cannabinoids are chemically relevant to the human body in ways which our scientific culture has come to label medical or medicinal. This is the base-fact of the plant as a relation to the human body, regardless of particular uses and regional legislation. From there on, particular uses of the plant can be for explicitly medical or non-medical purposes – however the modality through which cannabinoids interact with the body can always be viewed from the medical point of view. It is therefore a logical conclusion that appropriate use of cannabinoids, in light of the right evidence and research, can have medically positive outcomes.

This concludes the end of Part A. of this presentation. In the second part (Part B.), policy implications will be explored and related with actual examples and developments on the European level in Part C.

*Non-Exhaustive list / Internet Sources

 

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Categorieën
Europa Medisch Onderzoek Wetgeving

Medical v Recreational Cannabis: Some European Examples – Part C.

Introduction

The following is meant as a short overview of current state of affairs with regards to Cannabis and / or Drug Policies in three European countries. It is intended as a short supplement to Part A. and Part B.

Portugal

Portugal, since 2001, has ambitiously decriminalised all drug usage and possession, based on the assumption that it is a Public Health issue rather than a Criminal one. This approach does not make an explicit distinction, in the case of cannabis, with regards to medical or recreational use and is centred on a usage and harms reduction approach. In the words of Dr. João Goulão, Director-General of The General-Directorate for Intervention on Addictive Behaviours and Dependencies (SICAD) in Lisbon:

“It’s difficult to measure the impact of decriminalization as an independent variable; the evolution of the indicators has to be seen as a result of the development of all those responses. Considering different indicators of changing drug use patterns and demographics, some effects of decriminalization have included:

Portugal’s case is generally accepted, including by the French report discussed, as a relative success with promising aspects to implement more generally. Given that it is not cannabis specific, it is difficult to assess its impact, particularly in terms of Harms Reduction. Although a bold and commendable policy decision, it fails to address distribution side of things, particularly in the case of large-scale organised crime. The existence of such organisations can divert significant police resources and have spill-over effects into unrelated criminal activities, with drug distribution often being a major source of income. This also makes a case for the notion that no matter the amount of prevention, drug usage as whole is not an issue that can be tackled in isolation. It is extremely unlikely that demand for cannabis will evaporate instantaneously. It is therefore necessary to address the issue and distribution resulting from that demand.

For a detailed overview of all European countries’ drug policies and harm-reduction initiatives visit EMCDDA.

Germany

German Health Minister Hermann Gröhe has recently announced the country’s plans to make Medical Cannabis available to seriously ill patients by 2017. The law is rather an amendment on previously existing Medical Cannabis policies, relaxing conditions giving patients access to the plant.  Due to Germany’s federal makeup, there are various degrees of tolerance of cannabis not explicitly destined to medical use, with notable examples like Bremen and Berlin which are spearheading progressive policies.

With regards to medical cannabis and the 2017 amendment, there have been several critical voices, particularly when it comes to reimbursement and social security. Incorporated within the proposal is the clause that makes reimbursement available only to those patients that agree to participate in research programs. What those ‘research programs’ entail is not yet defined, however that requirement creates issues of social justice even in principle. Adding the mobility restriction of many patients this stands to be a very controversial issue.

Another issue of concern is production. With distribution ensured through the existing network of traditional pharmacies, Germany also intends meet its internal demand with domestic production. However initial estimates are skeptical of the country’s ability to develop appropriate facilities in time. In that case, Germany will be depended on imports. One can speculate as to the possible source of the product but it is hard to overlook Bedrocan form the Netherlands. Concerns from the Dutch experience pertaining to an over-centralisation of production are an interesting case-study for German politicians and decision-makers.

With an estimated 800.000 potential patients making use of the coming law, it is not an inconsequential change. It is very interesting to see how the implementation will be carried out, what measures are taken towards training the medical professionals to prescribe, monitor and get the better out of the plant, as well as the production and quality measures.

Combined with some relatively tolerant cannabis policies, this amendment to medical cannabis improves significantly the aggregated effect of the legislations, giving access to the plant to those that need it most while resisting the outright criminalisation of non-medical users. According to recent polls, the vast majority of Germans support the legalisation of medical cannabis, with a significant chunk of them favouring outright legalisation. It is therefore not unwarranted to expect further changes, whether regional or national, on cannabis legislation in Germany.

The Netherlands

The Netherlands are known worldwide for very a tolerant cannabis policy. With regards to medical cannabis, patients with prescriptions can buy purpose-grown cannabis from pharmacies since the spring of 2000. The product originates from Bedrocan, the grower designated by the Dutch Office of Medicinal Cannabis (part of the Ministry of Health) in order to ensure the necessary quality of the final product. Further Quality Control procedures and check-ups are performed along its production and distribution life-cycle.

However the Dutch notoriety for tolerant policies obfuscates various grey zones of the Dutch system. In particular, personal growing and cannabis growing in general is illegal (and attacked) in the Netherlands, which means that effectively coffee shops are breaking the law on a daily basis. This has created a monopoly – a monopoly which is significant on commercial terms, but even more so on ideological terms. The latter refers to the resulting conception of the plant as determined exclusively within the constraints of the coffee shop system (quality, use, method of delivery, personal and societal consequences etc.). This confusion, sustained by commercial interests, has created a chasm between perceived and actual cannabis and has fostered short-termism in plant manipulation and potency increase as opposed to sustainable scientific research & development.

Focusing on the explicitly medical side of things, a number of criticisms have been voiced by patients and patient organisations as well as NGO’s such as ENCOD (For a 2015 ENCOD-sponsored report click here). Criticisms tend to converge on the following points:

  1. Lack of strains and medical cannabis derivatives (edibles, oils, pills etc.)
  2. Overall quality of final product
  3. Lack of dedicated training for health professionals resulting in a reluctance towards prescribing cannabis

A highly centralised system, modeled on some aspects of the existing pharmaceutical industry, has created a very monolithic environment for medical cannabis users. With limits placed on the strains and products that can be labelled ‘medicinal’, the patient’s ability to find the right care for themselves is severely restricted. Furthermore, stringent decontamination methodology with gamma-ray irradiation over the final product, has a created a quality-compromised product. The main reason being, according to literature, the fact that gamma-rays destroy the terpenes of the plant, responsible for cannabis’ distinctive taste and smell. It is also believed, although scientific confirmation is still lacking, that terpenes can have a modulatory effect on the main cannabinoids – the entourage effect (Gamma-ray irradiation is an FDA approved technique for decontamination of food products, particularly ones destined for import / export).

With a relatively restrictive list of ‘recognised conditions’, one could easily argue this as a negative of the system on both medical and social justice / human rights grounds. Coupled with a reported reluctant health establishment to prescribe cannabis, serious concerns have been voiced over the ability to access the medicine. The latter is further aggravated by a repressive policy on personal growth. A February 2016 court ruling, in a highly publicised case, gave permission to a patient to grow his own cannabis for treating his HIV. This is however an individual result that applies only to that person which further points out the need for access to medicine.

Overall the Dutch system has the merits of not criminalising a whole section of its population who choose to use cannabis for whatever reason. However, reluctance to update and evolve the system, namely by integrating production into mainstream economic activity, the underground market hasn’t evaporated. This can partly be explained away by what is known as the ‘neighbour effect’ – meaning that neighbouring countries with repressive cannabis legislations drive that demand. However, there are important reasons to doubt that argument when the origins of coffee shop cannabis is considered. Furthermore, the Netherlands has a relatively sophisticated, albeit extremely rigid, medical cannabis infrastructure. However the aggregate of both policies stands to greatly benefit from a progressive amendment.

This concludes our short introductory articles on Medical v Recreational Cannabis. You can find Part A. and Part B. on their respective links.

More detailed presentations and argumentation of this work is available for interested parties. Please do not hesitate to contact us in this regard by clicking here.

 

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