The European Medical Cannabis Association (EUMCA) is calling for the reduction of the lower THC limit in cannabis extracts from 1% to 0.2% to fall in line with the German Narcotic Law.
Sita Schubert, Secretary General of the European Medicinal Cannabis Association (EUMCA), the Brussels-based industry body which advocates for European evidence-based policy to improve patient access to high-quality cannabis treatment, has welcomed the newly published German monograph on Standardised Cannabis Extract, however, it is now calling for an amendment to reduce the lower THC limit in medicinal cannabis treatments from 1% to 0.2%.
The EUMCA says failure to make this amendment will deny patients, particularly younger patients, access to their existing treatments. In this instance, it is the physician, not the policymaker, who should be making the decision on the appropriate course of treatment and formulation for their patient.
Schubert said: “Reducing the lower THC limit is imperative, and failure to make this amendment will deny patients, particularly younger patients, access to treatment.”
Reducing the THC limit in cannabis extracts
The German Monograph on Standardised Cannabis Extract (Cannabis extractum normatum), compiled by the Drug Commission’s Committee on Pharmaceutical Biology in cooperation with the Federal Institute for Drugs and Medical Devices (BfArM), was published on the 1 June 2020.
Schubert commented: “The European Medical Cannabis Association (EUMCA), and the medicinal cannabis manufactures and suppliers that we represent, welcome the monograph on the standardised cannabis extract. This monograph is important since it allows us to take a step closer to harmonised standards in the preparation of medicinal cannabis. Importantly, such quality standards will facilitate the production of high-quality medicinal cannabis products and further strengthen patient confidence in the already outstanding quality of products from our members.
“However, it is also important to offer the patient and the treating physician a wide range of products, so that the pharmacist can produce an individual prescription, prescribed by the physician, and tailored to the needs of each patient.
“For example, the monograph as it stands is not sufficiently restrictive in that it proposes a THC limit of at least 1 % instead of adopting the legal lower limit (German Narcotic Law) of 0.2% THC. Depending on the clinical status of the patient, treatments of young patients, in particular, might require low THC levels, especially if these levels are already established in their treatment plan. For severe and palliative pain treatment, doctors request high THC levels. To meet all these patients’ needs, and since products containing less than 0.2% THC are currently available, the manufacturer should be able to continue to provide these formulations. This would allow doctors to continue to treat their patients, giving them the right to continue with their established and successful treatment. The limitations in the current version of the monograph would deprive patients of this right. We note that the monograph for Cannabis Flowers (Flos) does not limit CBD or THC levels.
“We recommend that the abovementioned lower limit of 1% in the current monograph be adjusted to the existing narcotic legal minimum of 0.2% THC and the limit of THC shall be according to the doctor’s need and less to formal regulation. We assume that the next publication of the monograph will be adjusted in accordance with the existing legal regulation of the German Narcotics Law.”
