Prof Trevor M Jones CBE FMedSci, Chairman, EUMCA, charts the priorities for research and development, production and distribution of medical cannabis-based treatments in Europe today
The considerable expansion of the availability of medicinal cannabis products throughout most of Europe in recent years is a positive move to bring health and wellbeing benefits in several therapeutic areas to a wider population. Whilst many of these products are supplied from reputable manufacturers, the rapid growth in their use has been accompanied by sourcing from a wide variety of suppliers; many of which have no background in the requirements related to providing safe and effective medicines.
As with other items of commerce, patients (and their carers) have a right to expect that the products that they purchase (or are prescribed) are manufactured in high-quality establishments, that the ingredients are accurately listed on the label, that these ingredients are present in the products at the doses/concentrations listed over the shelf life of the product and that any therapeutic claims made for the product are correct and based on sound scientific research.
Regrettably, there have been several recent reports of poor-quality products being sold directly to the consumer. In addition, the popular press/advertisements abound with statements regarding the potential medicinal value of products that might be misleading and, potentially, delay patients from seeking appropriate, alternative treatments.
In the interest of patient safety and to safeguard the reputation of respectable companies operating in this field, it is important that the EU (and the wider world) takes steps to ensure that medicinal cannabis products conform with acknowledged scientific standards of quality, safety and efficacy and that any therapeutic claims made for the products are backed by sound data.
Medicinal cannabis products are either extracts from plants, specific cannabinoids isolated and highly purified from such extracts or chemically synthesised. Over many years, it has been an absolute requirement that licensed medicines are manufactured to defined standards of Good Manufacturing Practice (GMP). The EU should agree on the GMP requirements for medicinal cannabis products and initiate an inspection regimen to ensure compliance. Further, the analytical methodology used to identify and measure the ingredients of medicinal cannabis products, and their stability, vary considerably. The EU should agree on which validated analytical methods must be used by manufacturers and create pharmacopoeial monographs for specified ingredients. Member States should introduce formal monitoring procedures to examine the quality of products available from all sources.
Safety and efficacy
Whilst cannabis extracts have been used for centuries for a very wide range of physical and neurological conditions, only recently has the scientific basis for their potential started to be elucidated. In a few conditions, as a result of clinical trials, this has resulted in formal regulatory approval of some products with a medicinal claim. There are thousands of anecdotal studies in many different therapeutic areas; usually in a small number of subjects using poorly defined products, variable doses and methods of administration, which “suggest” possible efficacy, but what is required are clinical studies with sufficient numbers of subjects, defined product characteristics, agreed clinical endpoints to demonstrate adequate safety and efficacy in specific disease states. Whilst it could be said to be the responsibility of individual companies to perform such studies, given the widespread use of medicinal cannabis products and their potential medicinal value, the EU should establish a priority list of the conditions most likely to be successfully treated and, importantly, create multi- centre clinical networks to conduct the studies to agreed protocols and accepted standards of Good Clinical Practice (GCP). These networks could include existing clinics with expertise in medicinal cannabis prescribing.
We know that many of the constituents of medicinal cannabis products, especially the principal cannabinoids, are not well absorbed into the body after oral administration (i.e., they have low/poor “bioavailability”. In consequence, some products simply cannot deliver an adequate therapeutic dose for whatever condition is to be treated. Formulation technologies exist that can improve bioavailability. Currently, there is a paucity of data on the bioavailability of most medical cannabis products. The EU should define the methodology that should be used for such studies and consider requiring manufacturers to provide such data for their products.
It is unacceptable that patients (and their carers) continue to be burdened, confused and even misled by loosely worded “suggestions” in advertisements/ product labels as to the possible therapeutic value of the wide range of medicinal cannabis products available from both pharmacies and general stores. The EU should establish a working party to draw up guidelines and/or agree on the extent of any such therapeutic claims and, through the individual Member States, conduct regular reviews to ensure (legal) compliance.
The actions proposed above might be enacted through an established centre of authority, such as the European Medicines Agency (e.g., as a special unit dedicated solely to Medicinal Cannabis) or, in view of the somewhat unique issues involved, the creation of a specific unit focused only on Medicinal Cannabis.
To achieve these goals, in addition to a central EU approach, it will be important that national government healthcare policies are created that advocate the ethical prescription of pharmaceutical- grade medicinal cannabis, and advance patient access to treatments, including appropriate reimbursement schemes.