MEDICAL CANNABIS IN EUROPE - THE GMP STANDARDS GUIDE (EXTRACT)

Introduction

Prohibition Partners is excited to announce the launch of 'Medical Cannabis in Europe - The GMP Standards Guide', in association with Orion GMP Solutions.

If Europe wants to become global leaders in the cannabis industry, ensuring that it adheres to the highest manufacturing practices is essential. Our GMP Standards Guide is intended to be used as a resource by manufacturers, legislators and all involved in the European cannabis industry to educate on best practice and international legislation.

The report is due to be released in March 2018 but you can read a short extract here.


Background

Medical Cannabis has gained international credibility as a drug substance with potential to treat multiple health ailments. Few clinical trials have shown statistically relevant evidence for its place in Western Medicine for treatable disease states and their side effects, as shown in the National Academies of Sciences report on the Health Effects of Cannabis and Cannabinoids in January 2017. Despite insufficient evidence to definitively approve medical cannabis for specific disease states and their side effects, significant anecdotal evidence has supported its continued expansion in the international healthcare markets.  

 

Countries that adopt policies on medical cannabis must acknowledge the problem of insufficient scientific evidence for its use, while still recognising the anecdotal evidence. Cannabis agencies that take this into account must provide medical professionals and research scientists the ability to observe critical attributes of cannabis use, positive or negative. Clinical trials adhering to Good Clinical Practices and their corresponding clinical laboratory testing with Good Laboratory Practices are required to give medical professionals the evidence needed to support its use. However, the lack of understanding around how national medical cannabis programs are developed limits legislative progress for allowing clinical trials to take place, and prove/disprove the efficacy of cannabis in a clinical setting.

 

The United Nations conventions illustrate the international legislative framework for cannabis programs which have been successfully utilised by numerous countries for implementing cannabis policies and programs. The legislative and policy requirements established by those countries have varied, but they have all established national Cannabis Agencies. Understanding those policies, and how they relate to cannabis manufacturing standards are necessary and essential for countries wishing to develop robust programs.

 

There are many stakeholders that have interest in understanding these policies and standards, including:

  • EU and Foreign entities importing/exporting to/from the EU
  • Medical Professionals and Health Organisations interested in protection of public health through EU Good Manufacturing Practices
  • Regulators and legislators developing or maintaining cannabis programs using EU Good Manufacturing Practices

Integrating the interests of all stakeholders in a framework of policies and standards is essential for the international community to ensure positive health outcomes for patients that can benefit from the use of medical cannabis. The international legislative framework is clear and there are examples of nations that have successfully deployed cannabis programs and agencies. Combining this with the anecdotal evidence of positive health outcomes from medical cannabis use, the international community has the tools to develop robust policies and programs that fit the needs of public health worldwide.


 

United Nations Conventions

The United Nations Single Convention on Narcotic Drugs ("SCND") of 1961 describes the framework from which countries have developed cannabis programs. This foundational document describes cannabis, its legal status, how it can be produced, scheduled, allowed for import/export, and the system of controls for its manufacture.

 

While the SCND establishes the framework for medical cannabis programs, it views the drug from the perspective of fighting against "illicit traffic," the "treatment and rehabilitation of drug addicts," "records on international traffickers," and the "simplification of international control machinery." This language, despite being crafted for control of narcotics, has laid the framework that all participating UN members have used for developing their Medical Cannabis Programs.

 

In addition to the SCND, the United Nations Convention against illicit traffic in narcotic drugs and psychotropic substances of 1988 ("CNDPS") further describes mechanisms for the legal and controlled international distribution of cannabis. While the UN has decidedly approached cannabis as an illicit narcotic drug, it has provided the "legislative and administrative measures in conformity with the fundamental provisions of their respective domestic legislative systems" which guide all respected national cannabis policies and agencies that currently allow the manufacture and distribution of cannabis for legitimate medical and scientific purposes.


 

How Medical Cannabis Programs are developed

The SCND outlines how countries may develop a National Cannabis Agency. Such agencies designate where cannabis may be cultivated, the licensing of manufacturers, the extent of land that may be used, the chain of custody, importing, exporting, and wholesale trading guidelines. The successful development such agencies has been shown in multiple countries, often being left under the control of health agencies.  

 

The SCND provides guidance for Cannabis Agencies, and requires for the: estimation of drug requirements for medical and scientific use; the statistics of production, consumption, import/export, and total land use; total quantities required for serving legitimate medical and scientific purposes;

Cannabis Agency provisions for manufacturing; limitation of quantities manufactured for export based on market needs; prevention of misuse and illicit trade; licensure of manufacturers and scope of control by the Cannabis Agency; controls for international trade and distribution; requirements for supervision and inspection of manufacture of cannabis products; and seizure and confiscation of products.


There are several examples of countries that have followed the SCND and CPS guidelines to develop robust programs, such as Canada, Germany, and the Netherlands. While the results of those programs are readily available to the public through national legislation, many gaps must be filled to describe and implement medical cannabis policies and programs within domestic legislative systems.

 

Cannabis Agencies and how Policies are developed

Canada, Germany, and the Netherlands have assigned responsibility of the "Cannabis Agency" duties to the Health Canada, and Federal Institute for Drugs and Medical Devices, and the Office of Medical Cannabis, respectively. These agencies provide examples of well-regulated government institutions that have complied with UN guidelines.

 

The results of these programs have yet to be realised, however, they provide the baseline of control and data capture that fulfill the needs of medical patients. Germany, for example, has allowed for physicians to prescribe the herbal drug product, pharmacists to dispense herbal drug preparations, and for patients to consume the product if there is potential for positive health outcomes. This controlled system will, over time, allow for the collection of pertinent data that is traceable to the drug product, and take the anecdotal evidence into a clinical setting that will prove/disprove the efficacy of those specific cannabis products to specific disease states and their side effects.

 

In order for such policies to be developed, domestic legislative systems must rely on established monographs for pharmaceutical preparations, herbal drugs, herbal drug preparations, herbal drug extracts, substances for pharmaceutical use, and dosage form. These documents provide the specifications from which standards can be made by consensus, and provide a streamlined system for developing cannabis legislation and policies.

 


Guide to be published March 2018. Please contact stephen@prohibitionpartners.com for more information.