Coalition wants to overturn controversial cannabis regulations for pain patients

The Union and the SPD surprisingly included a change in health insurance benefits in the legislative package, according to which doctors should first prescribe finished cannabis medicines to pain patients before they can get individual prescriptions from the pharmacy. The law required a six-month treatment trial with the finished medicinal products.

The biggest beneficiary of this regulation was probably the pharmaceutical company Vertanical from Gräfelfing near Munich, which only received approval for its cannabis painkiller “Exilby” in Germany at the end of May. Other available cannabis painkillers are approved for very narrow indications.

At the end of August, SPIEGEL reported on documents that suggest that there was pressure from above when “Exilby” was approved. The responsible Federal Institute for Drugs and Medical Devices (BfArM) denied this.

Several changes planned

Next week, a law to reform emergency care will be debated in the Bundestag's Health Committee. The content of the reform does not have anything to do directly with the GKV Savings Act. But since this is already in force, the changes should be passed within the framework of this law, according to the Bundestag.

An overview of planned amendments, which SPIEGEL has received, shows that the coalition factions want to delete the six-month therapy trial in its current form.

A revised regulation should make it clear that the therapeutic trial is only prescribed for indications for which the medication is approved. Doctors speak of “in-label use”. The cannabis drug “Exilby” from Vertanical, for example, is approved for chronic, radiating pain in the lower back area.

The coalition also wants to abolish the mandatory minimum period of six months and leave the decision on how long to apply to the doctors. The “Ärzteblatt” first reported on the amendments.

Doubts about the benefits of the drug

SPIEGEL has documents that suggest that there were already doubts about the benefits of the active ingredient during the approval process for “Exilby” at the responsible Federal Institute for Drugs and Medical Devices (BfArM). A person familiar with the approval told SPIEGEL: "According to the technical assessment, the BfArM would not have granted approval without the instructions from the house management."

The BfArM explained that the approval was based on a “comprehensive scientific assessment of the documents submitted by the applicant.” Vertanical did not want to comment on the institute's internal assessments, but pointed out that "Exilby" had shown a "significant reduction in pain" in two studies.