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Article Germany: Medical Marijuana Act Enters into Force

(Mar. 13, 2017) On March 10, 2017, an amendment to the Narcotic Drugs Act entered into force in Germany that allows doctors to prescribe cannabis to seriously ill patients even if other treatment options are available.  No additional special permit will be required.  The costs of the treatment will be covered by the patient’s health insurance.  Self-cultivation of cannabis and recreational use will not be allowed.  (Gesetz zur Änderung betäubungsmittelrechtlicher und anderer Vorschriften [Act to Amend Narcotic Drugs Provisions and Other Related Provisions] (Amendment Act), Mar. 6, 2017, BUNDESGESETZBLATT [BGBl.] [FEDERAL LAW GAZETTE] I at 403, BGBl. website.)

Before the amendment, medical marijuana was only available to seriously ill patients with a special permit from the Federal Institute for Drugs and Medical Devices that was rarely granted.  (Gesetz über den Verkehr mit Betäubungsmitteln (Betäubungsmittelgesetz – BtMG) [Narcotic Drugs Act], July 28, 1981, BGBl. I at 358, as amended, § 3, para. 2, § 7, GERMAN LAWS ONLINE; Narcotic Drugs Act, Federal Ministry of Health website (unofficial English translation, current through Dec. 18, 2009).)  By April 5, 2016, there were only 647 patients in possession of such a special permit. (Betäubungsmittelrecht geändert. Cannabis für Schwerkranke auf Rezept [Narcotic Drugs Laws Amended. Cannabis Prescription for Seriously Ill Patients] (Feb. 10, 2017), Federal Government website.)

New Requirements for Receiving a Medical Marijuana Prescription

According to the amendment, doctors may, on a case-by-case basis, prescribe medical marijuana to seriously ill patients either if there is no generally accepted medical standard for the treatment of the disease or symptoms (Option a) or if alternative treatments are available but the physician comes to the conclusion that they should not be applied in this particular case after taking the risks and the condition of the patient into consideration (Option b).  In addition, for both options, there needs to be the likelihood that the treatment will have a noticeable positive effect on the illness or on certain symptoms.  (Amendment Act, art. 4 § 31.)

What constitutes a “serious illness” is not defined in the Narcotic Drugs Act.  The non-binding Regulation on Medicinal Products from the German Federal Joint Committee, composed of physicians, dentists, hospitals and health insurance funds, defines it as “an illness that is either life-threatening or that will affect the quality of life permanently because of the severity of the resulting health problems.”  The Federal Joint Committee is the supreme self-regulatory body in the health sector.  (Arzneimittelrichtlinie [AM-RL] [Regulation on Medicinal Products], Dec. 18, 2008, BUNDESANZEIGER AMTLICHER TEIL [BAnz AT] [FEDERAL GAZETTE, OFFICIAL PART], Mar. 31, 2009, no. 49a, § 12, ¶ 3, Federal Joint Committee website.)

Health Insurance Coverage

Under the old rules, the costs for medical marijuana treatment were not covered by health insurance.  According to the amendment, the treatment costs will generally be covered by the patient’s health insurance, and a refusal will only be possible in duly justified exceptional cases.  (Amendment Act, art. 4 § 31.)

Cultivation and Distribution

Pharmacies will carry out the distribution of medical marijuana to individual patients.  The Federal Institute for Drugs and Medical Devices (BfArM) will be in charge of controlling and coordinating the cultivation and distribution of the marijuana to the pharmacies.  A special cannabis agency will be set up within the BfArM.  The agency will also evaluate patient data in order to research the effects of medical marijuana.  Patient data will be anonymized and submitted by the treating physician.  The study will be published on the website of the Federal Institute for Drugs and Medical Devices.  The Federal Joint Committee will use the results from the study to determine which types of medical use of cannabis should be covered by the statutory health insurance.  (Id.)

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