Filenews 23 October 2021 - by Marilena Panagi
Again in public consultation the medicinal cannabis. Following the Attorney General's opinion that the Regulations passed by the Parliament in March 2019, which govern its production, are not compatible with the United Nations Single Convention on Narcotic Drugs, it was deemed necessary to prepare a new draft Regulations, which has already been done a few days ago. The revised text was officially made available to the competent bodies for comments and remarks.
According to the briefing of the Pharmaceutical Services of the Ministry of Health to all involved, who are invited to submit their comments by the beginning of November, "the Attorney General has indicated that the legal framework must clearly reflect the relevant provisions of the Single Convention" and points out that with the existing Regulations "there is a pervasive divergence". Therefore, he adds, "it was held for legislative and legal reasons that the Regulations should be rewritten and the existing Regulations should be repealed and replaced".
In essence, the revised draft Regulations include provisions which, according to the Pharmaceutical Services, provided, inter alia, that "licensed producers of medicinal cannabis have only the right to cultivate and deliver the harvest to the competent Authority and all activities relating to the receipt by the licensed producers, the import, export and marketing of cannabis shall be transferred to the competent Authority, that is, to the Minister of Health.
At the same time, and through the new draft Regulations, "certain responsibilities such as pharmacovigilance (i.e. monitoring the administration of medicinal cannabis and recording possible side effects) are transferred from the licensed producers to the Minister/Ministry of Health, who must also observe security measures for cannabis that comes into his possession as well as certain records relating generally to importation, the export, possession and storage of hemp which will be subject to inspection.'
In addition, "the procedures for importing and exporting cannabis have been diversified so that the initiative for these activities is given to licensed producers who are in a more favorable position than the state to have knowledge of the local and especially the international market".
However, as provided for in the draft Regulations, "the relevant licenses are issued in the name of the competent Authority which undertakes the delivery of the imported cannabis to the licensed producers and the receipt for export purposes".
The revised text, as explained by the Pharmaceutical Services, "generally follows the structure of the existing Regulations" and "the provisions that were not affected by the opinion of the Attorney General are maintained, as are the provisions relating to the establishment of the Advisory Committee and the Coordinating Committee".
The comments and remarks of all involved, competent bodies that have been informed accordingly, must be submitted to the Pharmaceutical Services by November 4, 2021.
It is recalled that based on the relevant decisions and the legislation in force, in Cyprus licenses for the production of medicinal cannabis are granted to three producers who, as described in the draft Regulations, have the right to:
- Cultivate, produce and possess medicinal cannabis, prepare, process, process and deliver to the competent Authority medicinal cannabis as well as "destroy" medicinal cannabis for the purpose of conducting scientific research on its medical use or the preparation of galenic preparations by pharmacies for medical use or for the production of pharmaceutical products.
At the same time, they are obliged, as provided for in the draft Regulations, to deliver to the competent Authority, namely the Ministry of Health, "the entire cannabis harvest at the latest within four months from the end of the harvest", after first carrying out a quality analysis in an independent laboratory".
As far as the Ministry of Health is concerned, as provided for in the draft Regulations, it has the responsibility to exercise control over:
- The cultivation of sufficient quantities of medicinal cannabis for the purpose of conducting scientific research on the medical use of cannabis or the preparation of galenic preparations by pharmacies for medical use or the production of pharmaceutical preparations
And it has the right to "import medicinal cannabis to meet the needs of patients in the Republic in cases where the licensed producer is unable to meet these needs due to problems in its production".
In addition, it may "import dry cannabis, seeds and cannabis plants which it supplies to licensed producers for the purpose of growing and producing medicinal cannabis."
However, it is obliged to "buy the entire harvest of medicinal cannabis from the licensed producers and to take full possession of it as soon as possible and not later than four months from the end of the harvest", provided that it "proceeds to a prior determination of the quantities to be purchased", but also to determine the price at which it will buy.
The two Committees remain as they are
The establishment and operation of the two competent Committees, namely the Advisory Committee and the Coordinating Committee, is not affected by the revision of the text of regulations. Specifically, and as provided by the existing legislation, the Advisory Committee, which is appointed by the Minister, consists of the Attorney General, the Accountant General, the Chief of Police, the Director of Pharmaceutical Services, the Director of Mental Health Services, the Director of the State Chemical Laboratory, the Department of Agriculture, the Governor of YKAN, the President of AAEK, a pharmacist, a doctor and a person who is a member of the OSAK.
The Advisory Committee "provides an advisory opinion to the competent authority regarding the cultivation, production, import, export, supply and prescription of cannabis, the information and training of health professionals, the information and training of pharmacists and the imposition of special obligations on doctors, pharmacists and other professionals".
The Coordinating Committee is appointed by the Council of Ministers and deals with the granting of production licenses.
Keeping a record of side effects and training of health professionals
As far as the pharmacovigilance sector is concerned, according to the draft Regulations, the Ministry of Health has the obligation to "take all necessary measures to encourage patients, doctors, pharmacists and other health professionals to report all suspected adverse reactions (side effects) related to the use of medicinal cannabis" and to "facilitate reporting by patients through the provision of alternative reference methods in addition to those of the network'.
It also has the obligation to "take all appropriate measures to collect accurate and verifiable data for the scientific evaluation of reports of suspected adverse reactions" and to "provide the public with timely and important information on adverse reaction issues related to cannabis use by publishing them on the portal and in the media".
