New rules regarding the medicinal cannabis pilot programme
On 1 January 2019, new rules regarding the medicinal cannabis pilot programme came into force. The changes concern export of the cannabis bulk, the permitted use of pesticides, and a special reimbursement system. In this article, we review the most significant changes, and we highlight what your company has to be aware of if you want your cannabis product included in the pilot programme.
The most significant changes
The new rules aim to optimize the medicinal cannabis pilot programme for the benefit of the patients as well as the involved companies.
The rules are a result of the amended Act on the medicinal cannabis pilot programme and several new executive orders. In particular, the changes concern five main points, which we will elaborate on below.
1. Export of the cannabis bulk
Prior to 1 January 2019, Danish companies could only export cannabis primary products. However, as requested by the Danish cannabis producers who wanted to export cannabis cultivated in Denmark, it is now also legal to export cannabis bulk made from cannabis grown in Denmark.
Just as for the export of cannabis primary products, the cannabis producers wanting to export cannabis bulk have to comply with the international rules within the area, including the UN Single Convention of 30 March 1961 on the control of Narcotic Drugs.
To help companies comply with these rules, the Danish Ministry of Health has issued a new executive order on the cultivation, production and distribution of cannabis bulk and the production of cannabis primary production stipulating the conditions for the exportation of cannabis bulk to foreign countries - read here
2. Use of pesticides
The rule stipulating cultivation of cannabis primary products without the use of pesticides has been abolished. Instead, the Danish Minister for Health can now determine more specific rules on the requirements for an imported cannabis product cultivated without the use of pesticides.
This amendment is primarily due to the fact that at present, there are not enough cannabis products available to the patients enrolled in the pilot programme. For this reason, the amendment will only apply for a period until a sufficient range of products is available to the patients enrolled in the pilot programme. It is expected that the range of products will be sufficient after 15 months. The volume of the range of products will be evaluated after 12 months.
3. Contract-based production
Prior to 1 January 2019, contract-based activities with cannabis primary products or cannabis secondary products were not possible as the legislator found it necessary to closely supervise the activities and to have the possibility for an effective control.
The Act on the medicinal cannabis pilot programme has now been amended, so that contract-based production of cannabis products is possible. Also this amendment is due to the present limited range of products for patients in the pilot programme. It is expected that more flexible possibilities for the organization of the production and the processing of the cannabis products will result in a widening of the range of products.
The specific rules on contract-based activities with cannabis primary and secondary products have been laid down in the executive order on import of cannabis primary products and production of cannabis secondary products - read here
To a large extent, the rules correspond to the rules on ordinary medicines pursuant to the executive order on production and import of medicines and secondary products - read here
However, it is not possible for cannabis primary products and cannabis secondary products to contract-base all activities for companies or persons outside Denmark which is otherwise possible for ordinary medicines.
4. The reimbursement system
The Danish Ministry of Health has considered it inexpedient that cannabis end products in the pilot programme are included in the ordinary reimbursement system. This is partly due to the impossibility of assessing the ratio between the price and the value of the treatment in relation to cannabis products, which constitutes a violation of the principles for the determination of the reimbursement.
Instead, the new rules establish a special reimbursement system for cannabis products included in the reimbursement system. The reimbursement system has a retroactive effect so that the cannabis end products bought in 2018 are included in the system.
Two new executive orders have been issued in connection with the establishment of the reimbursement system. The first executive order provides rules for the establishment of a Central Reimbursement Register for cannabis products and the rules on the information to be registered in the Reimbursement Register - read here
The second executive order regulates reimbursements in relation to cannabis products outside the hospital service and bought in other EU/EEA countries - read here
The interest in the pilot programme on medicinal cannabis and the parallel development programme has appeared to be greater than previously thought and has resulted in an increasing administrative burden for the Danish Medicines Agency.
Consequently, a legal basis for charging fees for the activities of the Danish Medicines Agency has been included in the amendments of the Act pursuant to the Act on the medicinal cannabis pilot programme. This legal basis for fees corresponds to the legal basis for fees of the Danish Medicines Agency in relation to ordinary medicines.
General information on the pilot programme - what do you need to be aware of?
If you are a company and you wish to have your product admitted to the pilot programme it is important to be aware of the following:
- Preparatory steps
Before you apply for the relevant licences to produce and/or handle cannabis products, it is important to prepare the company - including the productions facilities - for inspection by the Danish Medicines Agency. The Danish Medicines Agency is entitled to carry out an inspection as soon as a company has submitted an application.
- The development scheme
A development scheme running in parallel with the pilot programme makes it possible for a company to apply for a cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use. It is thus a scheme according to which the companies can "practice" production of medicinal cannabis in an isolated test environment, which also means that the cannabis products included in the scheme must not be put on the market. It is not compulsory for a company to be admitted to the development scheme before applying for admittance to the pilot programme. However, the company can obtain valuable experience with the cultivation of cannabis prior to applying for admittance of the product to the pilot programme.
- Different types of licences
You always have to apply for several licences prior to the admission of the cannabis product to the pilot programme. It should also be mentioned that there are different types of licences depending on whether you wish to import cannabis products into Denmark or produce cannabis products here in Denmark. In addition to the import and production licence, you also have to apply for admittance of the cannabis product to the pilot programme.
- Remember a licence pursuant to the Act on euphoriant substances
If you carry out activities with cannabis in Denmark it is also a requirement that you apply for permission to carry on activities with euphoriant substances. This applies regardless of whether you carry out activities with cannabis under the pilot programme or the development scheme.
- Report to medicinpriser.dk
When a cannabis product has been admitted to the cannabis pilot programme, information on the price and the package size must be registered on medicinpriser.dk. Not until then is the product ready for prescription.
Advertisement of cannabis products included in the development scheme and the pilot programme is prohibited. The reason is that the cannabis end product is produced specifically for the individual patient on the basis of the prescription from the doctor.
Do you want to learn more?
If your company wishes to apply for admittance of a cannabis product to the cannabis pilot programme you should make sure that you have the sufficient overview of the legal regulation including the required licences.
Plesner has experience within this area. If you want more information, please contact us.