Firms awarded licenses for meicinal cannabis production

WQ.120/2021

WRITTEN QUESTION TO THE

MINISTER FOR ECONOMIC DEVELOPMENT, TOURISM, SPORT AND CULTURE BY THE CONNÉTABLE OF ST. MARTIN

QUESTION SUBMITTED ON MONDAY 15th MARCH 2021

ANSWER TO BE TABLED ON MONDAY 22nd MARCH 2021

Question

In relation to firms awarded licences for the production of medicinal cannabis in Jersey, will the Minister advise members –

1. whether inspections have been carried out on the facilities to ensure they are compliant with the European Union's Good Manufacturing Practice (G.M.P.) certification and its relevant regulations; and if not, why not;
2. what regulations, if any, are in place to prevent rogue cross-pollination of hemp and cannabis crops in the Island (for example, by adequate sealing of greenhouses);
3. what regulations, if any, are in place to ensure that the recirculation systems in such facilities are sufficiently robust to prevent any water run-off entering the Island's reservoirs; and
4. what measures, if any, are in place for monitoring the destruction of hemp and medicinal cannabis crops that are damaged (for example, by mould) so that they do not contain psychoactive cannabinoids such as T.H.C.; and how any such measures are to be enforced?

Answer

1. No GMP inspections have yet taken place. These will be undertaken by the UK medicines regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), under the terms of an MoU agreed with them in 2019. Until such time as licence holders have been GMP certified they are limited in the types of product they can produce, but cultivation is required in order to demonstrate certain requirements of a GMP inspection relating to equipment and process validation and quality management systems. GMP inspections by the MHRA will take place once a licence holder is ready for an inspection.
2. For clarification, hemp is an outdoor, non-psychoactive crop. Cannabis is an indoor psychoactive crop.

• There are no regulations in place to prevent cross-pollination of hemp/cannabis crops.

• Male pollen producing cannabis plants are not grown.

• Measures are taken to ensure that no male plants/flowers or pollen are present in commercial cannabis crops as they pollinate female flowers which then direct resource to seed production and away from resin production on the trichomes.

• Outdoor hemp crops grown for CBD production from the resin also benefit from not being pollinated, and a percentage of male plants are removed/rogued out although inevitably some are left/missed and pollination occurs.

• Outdoor hemp crops grown for seed and oil require pollination and males are left in place for maximum pollination and thus seed./oil production.

3. Where waste water is generated and requires disposal, there are options to discharge lawfully to:

• the environment, under the provisions Water Pollution (Jersey) Law, 2000

• either directly or indirectly to the foul sewer network under the provisions of the Drainage (Jersey) Law, 2005.

Both of these options are subject to regulatory oversight and application processes. Following due consideration of any application and subject to its approval, the regulatory authority may also include conditions on any permission, such as prescriptive limits or further treatment, for example.

4. All destructions of controlled substances must be documented in accordance with the provisions of the Misuse of Drugs (Jersey) Law 1978. Licence holders must have an authorised witness named on their licence for the purposes of overseeing any destructions. This is consistent with UK Home Office procedures. Compliance inspections will check records and stocks held in order to confirm adherence to legal requirements. Licence holders must have a procedure to govern the destruction of any controlled substances.