In a decision published on August 8, 2023, the Higher Administrative Court of North Rhine-Westphalia (Oberverwaltungsgericht Nordrhein-Westfalen, OVG NRW) ruled that the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) does not have to allow a physician to import the anesthetic sodium pentobarbital from Switzerland to Germany to supply it to his patients for the purpose of suicide. Pentobarbital is usually used for assisted suicide to induce death by asphyxiation and suffocation.
Facts of the Case
The claimant, a specialist in neurology and psychiatry, runs a private practice in Hamburg and is head of Verein Sterbehilfe (Assisted Suicide Association). He applied to the BfArM for a permit to import, purchase, and supply the anesthetic sodium pentobarbital to his patients for the purpose of suicide. The drug is currently not available in German pharmacies and must be imported from Switzerland. (VG Köln paras. 4, 5.)
When the BfArM denied the application, the claimant sued the BfArM over the denial. The Cologne Administrative Court (Verwaltungsgericht Köln, VG Köln) rejected the application, and he appealed this decision to the OVG NRW. (OVG paras. 5, 6.)
The Higher Administrative Court’s Decision
The OVG NRW dismissed the physician’s appeal and upheld the decision of the lower court.
The court noted that section 3, paragraph 1 of the Narcotics Act (Betäubungsmittelgesetz, BtMG) requires authorization for the import, purchase, and distribution of sodium pentobarbital. (Para. 34.) The claimant had argued that the decision of the German Federal Constitutional Court (Bundesverfassungsgericht, BVerfG) of February 26, 2020, which declared the prohibition on the commercial promotion of suicide unconstitutional, should be used by the court for interpreting the grounds for refusing an authorization in accordance with section 5, paragraph 1, no. 6 of the BtMG. He stated that section 5 must be interpreted in conformity with the constitution and that an authorization must therefore not be restricted to extreme emergencies. The court, however, stated that he had failed to explain how this decision had a bearing on his particular case, in particular because the legal situation was completely different. (Para. 22.)
Furthermore, the judges held that the grounds for refusing an authorization under section 5, paragraph 1, no. 6 of the BtMG precluded granting the permit. According to this provision, permission must be denied if the request for distributing the drug is not compatible with the purposes of the Narcotics Act, which are to ensure necessary medical care and to prevent drug abuse and addiction. According to the concept of the law, physicians are not entitled to provide their patients with narcotics free of charge. (Paras. 27–29.)
The court stated that the intended importation from Switzerland is also not exempt from authorization according to section 4, paragraph 1, no. 4 (a) of the BtMG. This provision applies only to the importation of narcotics by physicians who provide cross-border services if the physicians carry the narcotics with them when crossing the border for the purpose of their medical activity. (Paras. 36–38.)
The claimant’s intention to distribute sodium pentobarbital to his patients is also not exempt from authorization. (Para. 50.) The distribution of narcotics by physicians to their patients is regulated in section 13, paragraph 1 of the BtMG. Physicians may only prescribe narcotics, administer them, or make them available to their patients for immediate consumption. The claimant, however, intends to transfer the narcotics to the patients to do with them as they please, which is not covered by section 13, the court explained. (Paras. 52–54.)
The patient may receive narcotics free of charge on the basis of a physician’s prescription. However, according to section 13, paragraph 2 of the BtMG, dispensing physician-prescribed narcotics to patients is reserved exclusively for pharmacies as a further control measure to prevent the abuse of narcotics, the OVG emphasized. (Para. 60.)
Background on Assisted Suicide in Germany
In Germany, suicide is not a punishable offense, meaning that aiding and abetting (assisted suicide) is not punishable either. Initially, this exemption from punishment was limited by section 217 of the German Criminal Code (Strafgesetzbuch, StGB) (“Commercial prohibition of assisted suicide”), which was passed in 2015. However, in 2020, the BVerfG held that this provision was unconstitutional. The court stated that the general right of personality encompasses a right to a self-determined death, which includes the freedom to take one’s own life as well as the right to seek and use voluntarily offered help to do so.
In February 2022, the OVG NRW had already rejected the lawsuits of three seriously ill people who had demanded access to a lethal dose of sodium pentobarbital. The court pointed out that it is the task of the legislator to determine the legal form of possible access to sodium pentobarbital for suicide and to develop an appropriate protection concept for this purpose. Until then, those willing to commit suicide need to consult with assisted-suicide associations or doctors who prescribe other lethal drugs, because acquiring a lethal dose of sodium pentobarbital with the help of a permit from the BfArM is currently not the only reasonable way for suicidal persons to carry out their desire to die. (OVG 2022, paras. 84; 98–101.)
Since the Federal Constitutional Court issued its 2020 decision, attempts have been made to regulate assisted suicide by law, but they have proved unsuccessful. On July 6, 2023, the majority of the Bundestag (lower house of the German parliament) rejected two bills aimed at regulating assisted suicide. Both bills intended to create conditions under which suicidal people could get access to lethal drugs. This was to be achieved, among other ways, by amending the Narcotics Act. Both drafts also provided for regulating the advertising of assisted suicide by amending the Law on the Advertising of Therapeutic Products (Heilmittelwerbegesetz, HWG).
One of the bills proposed adding a new provision to the criminal code that would make commercial assistance in suicide a criminal offense in principle, and would standardize the exceptions under which assistance would not be illegal — namely, if the person who wants to commit suicide has had at least two medical examinations and at least one counseling session. Opponents of the bill criticized the consideration of a new criminal law provision because it would create the risk of being declared unconstitutional and that years of uncertainty would follow.
The other bill essentially provided for a new law on assisted suicide. It was intended to standardize the right to assisted suicide and to provide assistance to suicidal persons. The individual German states were to ensure that state-approved counseling centers were established. With regard to this bill, there was particular concern about the lack of safeguards against the abuse of assisted suicide.
Prepared by Laura Schwarz, Law Library Intern, under the supervision of Jenny Gesley, Foreign Law Specialist
September 25, 2023
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