Accumulation of scientific knowledge, funds (second allocation)

20 March 2018
Temabillede om medicinsk cannabis med tekst

Call for applications

Research projects are requested to be carried out in order to increase our knowledge about the use and effect of medicinal cannabis. This is to take place as part of the medicinal cannabis pilot programme. 

Background

As part of the ‘Agreement on special funds in the health and elderly care area for 2017-2020’, it was decided to implement a medicinal cannabis pilot programme from 1 January 2018. A sound framework for the use of medicinal cannabis in the healthcare services is thus established, making it possible for patients to be treated with medicinal cannabis prescribed by a doctor.

Contrary to new authorised medicines placed on the market, there is no possibility to carry out scientific research on the effect, etc. of medicinal cannabis treatment. For this reason, a DKK 5 million fund was allocated in 2018 for accumulation of scientific knowledge during the medicinal cannabis pilot programme. In October 2017, applicants were invited to apply for these funds by 2 January 2018.

In the ‘Agreement on special funds in the healthcare area for 2018-2021’, a further DKK 5 million was negotiated. The agreement stipulates that the funds are earmarked for projects intended to monitor the treatment of patients across therapeutic indications based on registry data and patient interviews. The purpose is to shed light on the patients’ treatment courses, consumption of cannabis products compared to conventional medicines, contacts with healthcare services, patient-experienced effect and quality, e.g. in relation to pain and everyday coping.

The Danish Medicines Agency has issued a healthcare guideline as part of the pilot programme. It includes the Agency’s general assessment of the patient groups and possible therapeutic indications it considers eligible for treatment with medicinal cannabis.

The programme will be evaluated during the pilot period to make a political decision on whether to introduce a permanent medicinal cannabis programme. The project results will be included in the overall evaluation of the pilot programme.

For further details about the medicinal cannabis pilot programme, please see ACT no. 1668 of 26/12/2017

Content of the application and details about the applicant

The projects can run from end-September 2018 to 1 May 2020. A report with the project results must be submitted to the Ministry of Health electronically by 1 May 2020 at the latest. On receipt of the report, the Ministry of Health will shortly after call a meeting to invite the applicant to present the results in order for them to be included in the overall evaluation of the pilot programme.

The application must include a description covering at least the following:

1. Purpose

A clear description of the project's purpose and relevance to the pilot programme's overall purpose of accumulating more knowledge of the use and effect of medicinal cannabis. 

The project is to monitor the treatment of patients across therapeutic indications based on registry data and patient interviews.

The purpose of the project is to shed light on the patients’ treatment with cannabis products of the pilot programme, e.g. the patients’ use of cannabis products compared to other medicines, contacts with healthcare services, patient-experienced effect and quality in relation to for example pain, improved quality of life and everyday coping (how the patient performs daily functions).  The project must be designed to ensure a systematic description of the patients’ positive as well as negative experiences.

Funds will be allocated with the aim of including a significant number of patients to ensure the quality of the analysis.

2. Method and relevance in relation to a possible implementation of a programme in Denmark

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

The description must also consider the project's relevance in relation to a possible future programme in Denmark.

3. Regulatory and ethical requirements

The applicant must account for authorisations from relevant authorities and ethical aspects of the project.

4. Organisation of the project

A clear time plan organised by work packages, manning and resources with corresponding budget.

It is vital that final reporting is done by 1 May 2020 for the results to be included in the overall evaluation of the pilot programme.

The project can apply for full or partial funding. If the project has applied for or has been granted funds from other sources, it must appear from the application. It will be considered favourably in the assessment of applications if co-funding from other sources has been granted.

The funds under this call for applications are not available to projects that have already been granted full or partial funding from the DKK 5 million allocated for accumulation of scientific knowledge during the medicinal cannabis pilot programme under the ‘Agreement for special funds in the health and elderly care area for 2017-2020’.

5. Qualifications of the member(s) of the project group

Besides the project description, the application must describe the qualifications of the applicant(s) and describe the relevant research completed previously by the applicant(s). A concise and relevant CV must be enclosed for each project participant. The description must also cover any collaboration partners in the project.

The applicant must account for any past and present relationships with the pharmaceutical industry and companies engaged in medicinal cannabis, including the nature thereof, tasks, medicines and medicinal cannabis currently in use or tested, etc. The description must also cover any collaboration partners in the project.

Application structure

The application must include the full name and contact details of the applicant, be written in Danish and submitted in PDF format. The application may span a maximum of seven standard pages with five accompanying pages of annexes (font size 10/Times New Roman). The application must clearly address the five criteria described above:

  1. Purpose
  2. Method and relevance in relation to a future programme in Denmark
  3. Regulatory and ethical requirements
  4. Organisation of the project
  5. Qualifications of the member(s) of the project group

Procedure for review of applications

The Danish Medicines Agency will forward all applications received in time to the Innovation Fund Denmark. The Innovation Fund Denmark then makes a research scientific evaluation of the applications received.  The applications that the Innovation Fund Denmark considers eligible for funding are then put in order of priority by a monitoring group. The monitoring group recommends an order of priority to the Danish Medicines Agency. The Danish Medicines Agency then sends a recommendation to the Ministry of Health, which decides on the allocation of research funds.

Grants or refusals will be communicated to applicants via email by end-September 2018 at the latest, and an announcement will be issued on the website of the Danish Medicines Agency.

Monitoring group

The Danish Medicines Agency sets up a monitoring group with participants from relevant councils, organisations and associations that have knowledge of the aspects of medicinal cannabis.

A member of the monitoring group cannot also be an applicant or a project participant in applications for appropriation of the funds.

Closing date for applications

The application must be sent electronically as a PDF file to the Danish Medicines Agency by email to medicinskcannabis@dkma.dk with the following in the subject field: ”Application for funding – accumulation of knowledge about the use and effect of medicinal cannabis”. The Danish Medicines Agency must receive the application no later than 22 May 2018.

Further information

Further information is available from Legal Adviser Randi Munk-Jakobsen or Chief Medical Officer Eskild Colding-Jørgensen, tel. +45 44889595 or e-mail: medicinskcannabis@dkma.dk.

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