Collection of scientific experience for medicinal cannabis pilot programme

05 October 2017

Call for applications

One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

Background

As part of the special funding scheme for health and elderly care covering 2017 to 2020, a medicinal cannabis pilot programme will be established. The programme will run for a period of four years, starting on 1 January 2018.

The purpose of the pilot programme is to establish a safe framework for the use of medicinal cannabis in the healthcare system, so that patients may be treated with medicinal cannabis prescribed by a doctor in specific cases. It is expected that some of the patients who presently self-medicate with illegal products will be offered a legal alternative.

Since more knowledge in the area is needed, for example about the patient safety consequences of a medicinal cannabis programme, special funds are allocated to research projects that can improve the scientific basis and support the collection of scientific experience (at hospitals and in general and specialist practices) in selected areas.

As part of the pilot programme, healthcare guidelines will be prepared, including general guidance on the patient groups and possible therapeutic indications, which the Danish Medicines Agency assesses to be eligible for treatment with medicinal cannabis.

In the pilot period, an evaluation of the programme will be made with a view to making a political decision about a permanent medicinal cannabis scheme. The results of the collection of scientific experience will form part of the overall evaluation of the pilot programme.

In 2018, the Danish Parliament has allocated DKK 5 million for research projects.

Link to the proposal for the medicinal cannabis pilot programme (in Danish)

Contents of the application and information about the applicant

The collection of scientific experience can run from the beginning of April 2018 to 1 May 2020. By 1 May 2020, a report with the results of the collection of scientific experience should be sent in electronic format to the Danish Ministry of Health. Subsequently, the Danish Ministry of Health will invite applicants to present the results at a meeting so that they can be included in the overall evaluation of the pilot programme.

The application should describe the project and include the following information:

1. Purpose

A clear description of the purpose of the project and the relevance in relation to the overall objective of the pilot programme, which is to obtain more knowledge of the use of medicinal cannabis, including the patient safety consequences of a medicinal cannabis scheme.

The projects may be carried out as randomised clinical trials, case control studies, interaction studies, or studies elucidating the use of cannabis products compared with conventional treatment etc.

2. Method and relevance in relation to possible future scheme in Denmark

A detailed description of the applied scientific hypothesis, method, type of study, data sources and planned analyses, including a statistical analysis plan as well as a critical evaluation of strengths and weaknesses of the material and the method applied. In addition, a description of the applied method must be made in relation to previous studies and general state-of-the-art knowledge in the area.

The description should also cover the project’s relevance in relation to a possible future scheme in Denmark.

3. Regulatory and ethical requirements

The applicant must give an account of authorisations from relevant authorities as well as ethical aspects of the project.

4. Project organisation

A detailed timetable divided into work packages, staff and resources, including a budget.

It is of overall importance that the results are submitted by 1 May 2020 so that they can be included in the overall evaluation of the pilot programme.

You can apply for full or partial financing of a project. If you have applied for or received funds for the project from another funding scheme, it must appear from the application.

5. Qualifications of the project group

In addition to the project description, the application must include a description of the applicant’s qualifications and a description of any relevant research activities carried out previously by the applicant. Please attach a brief relevant CV for each project participant. The description should also include any collaborative partners of the project.

The applicant must give an account of previous and present relationships with the pharmaceutical industry, including the nature of such relationships, tasks, current medicinal products in use or being tested etc. The description should also include any collaborative partners of the project.

Application format

The application must state the applicant’s full name and contact details, be written in Danish and submitted as a PDF. The application should cover a maximum of seven standard pages and five pages of appendices (type size 10/typeface Times New Roman). The application must address the above five criteria:

  1. Purpose
  2. Method and relevance in relation to the future scheme in Denmark
  3. Regulatory and ethical requirements
  4. Project organisation
  5. Qualifications of the project group

Procedures for the assessment of applications

The Danish Medicines Agency sends applications received on time to Innovation Fund Denmark. Innovation Fund Denmark makes a peer review of the applications received. The applications deemed worthy of support by Innovation Fund Denmark will be prioritised by a reference group. The reference group will make a recommendation for the prioritisation to the Danish Medicines Agency. The Danish Medicines Agency will then make a recommendation to the Danish Ministry of Health, which will make a decision as to the distribution of the research funds.

Applicants will be informed of any grant or refusal by email no later than at the beginning of April 2018. A press release about the allocation of funds will be published on the websites of the Danish Ministry of Health and the Danish Medicines Agency.

It is expected that funds will be allocated to one or two projects.

Reference group

The Danish Medicines Agency will set up a reference group with members from relevant councils, organisations and associations with insight into matters related to medicinal cannabis.

Members of the reference group cannot apply for funds or be a participant in a project applying for funds.

Closing date for applications

Please send your application as a PDF to the Danish Medicines Agency by email to medicinskcannabis@dkma.dk no later than 2 January 2018. In the subject field, please type ”Application for funds for the collection of scientific experience”.

More information

For more information, please contact Eskild Colding-Jørgensen, Chief Medical Officer, or Karen Juul Jensen, Legal Adviser, on +45 44 88 95 95 or write to medicinskcannabis@dkma.dk

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