The European Congress on

 Legal and Regulations in Cannabis

• Legal basis
  Based on the UN Single Convention of 1961 and the underlying Austrian laws (Narcotic Drugs Act, Health and Food Safety Act (GESG), Narcotic Drugs Ordinance,…), the Austrian Agency for Health and Food Safety produces cannabis for the manufacture of medicines.
• Infrastructure/Production
  AGES cannabis production takes place in greenhouses. This allows a very high product quality to be produced with relatively low energy input.
  AGES has over 3,000m² of glasshouse space with 72 autonomous compartments.
  All cultivation parameters like : Temperature, Humidity, Light regime, Shading, Darkening, Fertilisation, Irrigation are autonomously controlled for each compartment and monitored 24 hours a day.
  By precisely defining and monitoring the production parameters, AGES can guarantee a high degree of standardisation of the product.
  AGES has its own tissue culture laboratory where in vitro propagation of plants can be carried out, resulting in plant material that is free of pathogens. These plants are the healthy basis for high-quality flower production.
• Security
  Securing the production area and the production method have the highest priority and comply with national and international legal requirements.
  AGES has committed itself to a very high level of safety in the production of cannabis, in which numerous safety systems are used.
• Production quality – GACP standard
  The production of cannabis is carried out according to the GACP standards.
  All production, hygiene, safety and training requirements are described and documented in detailed standard operating procedures (SOP) and are regularly monitored. Internal and external audits guarantee compliance with the GACP standards.

Recent years has seen an increase in the medical use of cannabis. Progress in scientific research of the endocannabinoid system has led to a belief that cannabis possesses beneficial potentials in a variety of medical conditions. As the number of patients permitted to use cannabis for medical purposes in Israel grew, it was deemed necessary to regulate the field.

Israel is committed to uphold the provisions of the International Single Convention on Narcotic Drugs and of the Israeli Dangerous Drugs Ordinance, both of which define principals for regulation regime of cannabis. In 2016 an Israeli Government Resolution “Cannabis for Medical and Research Purposes” set the principles for the medicalization model, whose purpose is to support the use of cannabis for medical and research goals, in the same manner as with other narcotic medicines.

The Israeli Canoecopia was formulated, and it includes the “Medical Grade Cannabis – Clinical Guide”, which lays down a uniformly clear methodology for applying treatment for recognized indications with medical cannabis. It also includes the Israeli Good Practices (IMC-GxP) for each link of the supply chain, setting the appropriate standards in order to ensure high quality and reproducibility of medical cannabis products. Vocational training seminars, intended for physicians and others, are held regularly and address the proper ways in which to provide care using medical cannabis. Finally – Israel is one of the leading countries in R&D of cannabis with a significant number of active studies in all levels from plant science to clinical trials.

Placebo effects represent one of the most important confounding variables in the design and interpretation of clinical trials, thus their understanding is today a priority in biomedical research. In this talk, I will present some examples of how recent research and insights into the mechanisms of placebo effects provide some interesting information that may help better design and interpret clinical trials. This is particularly important for trials on cannabis, which is quite an unexplored field of clinical research. First, patients’ expectations have been found to be the main mediators of placebo effects, thus their assessment should be the rule in any clinical trial. Second, previous exposure to active treatments may lead to substantial placebo responses, thus the history of pre-trial pharmacological and non-pharmacological treatments should be assessed very carefully. Third, communication across the participants of a trial has been found to affect several outcome measures, thus communication across participants should be avoided. Fourth, today we can identify and create placebo responders and non-responders in the lab by using both learning procedures and genetics, which indicates that placebo effects can be manipulated. These four examples suggest that this new scientific knowledge may have profound implications for clinical trials, including cannabis trials, thus moving trial design from speculative to evidence-based.

Parallel with the reductionist approach to the development of conventional pharmaceuticals the same deconstruction is increasingly applied to cannabis medicines. This pattern results in a gross underestimation of the diversity of cannabis strains and their distinct pharmacological potential. Seemingly subtle differences in the plant’s constituents can greatly alters its efficacy in preclinical and clinical medicine. Compounding the complexity and diversity of cannabis medicines is the patient-to-patient differences in cannabinoid receptors, metabolic pathways, and the therapeutic targets of this remarkable herbal medicine.

Few would disagree with the need for clinical trials, and randomized controlled trials (RCTs) of cannabis to educate patients and practitioners alike to better meet our therapeutic challenges. This call for more research while disregarding clinical observations and case reports, and, sustaining the prohibition of cannabis is disingenuous in light of the illegal status of cannabis on the world stage for the past century. How can we truthfully say we are putting the cart before the horse after a thousand generations of cannabis use for pleasure and medicine with so little evidence of harm when compared to so many licit and illicit drugs.

After decades of looking at cannabis as a drug of harm, abuse and addiction it is time to revisit existing and future research in cannabis as a therapeutic plant. Fortunes continue to be spent looking for harm while tens of millions of people are self-treating with cannabis while seeking to meet their personal needs. It is long overdue to drop the social-political constructs that have interfered with the advancement of science and the treatment of our patients.

The main barrier to the widespread use of cannabis for medical purposes in the UK is the difficulty of ensuring approved preparations and a lack of robust clinical trial data that precludes reimbursement by the NHS for prescriptions. Indeed, past published research has failed to show benefit for patients with chronic pain and other conditions in randomised, controlled trials. In this talk, we explore the current regulatory framework; NICE guidance and conduct of previous and current trials; and speculate how the benefits that patients report can be captured by the use of better and more sensitive trial designs and patient outcomes.

• History of Canabidiol movement in Brazil: the mothers
• Legal Act for Specially Controlled Substances (Port. 344/98)
• Anti-Drug Policy Law 11343/06
• Law suits for growers and patients associations to produce CBD
• Mandatory court decisions oblige government to supply for patients: how much does that cost?
• Direct Importation of drugs by patients and families: how does it work?
• First registered drug in Brazil (Sativex/Mevatil);
• New ANVISA regulations for growth under discussion;
• Purposed laws on Brazilian Congress: what is being discussed on legislative house.