- prescribing, preparing, distributing, dispensing and using individually prepared medicinal products containing cannabis for medical use
Draft implementing decree amending Implementing Decree No 236/2015, laying down the conditions for prescribing, preparing, distributing, dispensing and using individually prepared medicinal products containing cannabis for medical use
The key point of the present amendment is to implement the relevant new authorising provisions contained in the amendment to the Act on Pharmaceuticals, which concern reporting by physicians who prescribe cannabis for medical use when providing health services in relation to reimbursement of cannabis treatment.
The draft implementing decree lays down the details of these reports, namely their structure, form, method and time interval.
The reports are based on anonymised data on the outcomes of treatment of individual patients.
The aim is to obtain real-life data and compare them with the results of registration trials. Data on the actual dosage, duration of treatment and compliance with the indication criteria are valuable for medical practice. It is expected that the registers to be kept will, in particular, refine clinical and pharmacoeconomic data, which will help ensure that the decision on permanent reimbursement of the medicinal products from health insurance is made with knowledge of real-life data. The worldwide lack of clinical data on cannabis treatment may become a hurdle to its further therapeutic use and limit reimbursement of the treatment from public funds.
keywords: cannabis, cannabis for medical use, anonymised data, clinical data, cannabis treatment results