Press release no. 26/2016 of 6 April 2016

Self-cultivation of cannabis for therapeutic purposes permissible by way of exception

Today, the Federal Administrative Court (BVerwG, Bundesverwaltungsgericht) in Leipzig obliged the Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) to grant to the seriously ill claimant an exemption permit allowing him the self-cultivation of cannabis on the grounds that the narcotic is required for his medical care and no other equally effective and affordable therapeutic alternative is available to him.


The 52-year-old claimant has suffered from multiple sclerosis since 1985. He has been treating the symptoms of his disease by regular use of cannabis since about 1987. He was last acquitted of a charge of unlawful possession and cultivation of narcotics in January 2005. The criminal court found his actions to be justified because no alternative therapy was available to him. The Federal Institute for Drugs and Medical Devices, by notice dated 6 December 2007 and objection notice of 10 August 2010, had rejected the claimant's application filed in May 2000 for an exemption permit allowing him to cultivate cannabis for medical self-supply. The Administrative Court (Verwaltungsgericht) overturned these decisions and obliged the defendant to issue a new decision on the claimant's application taking into consideration the court's legal opinion. The court dismissed any further going complaints. The appeals on points of fact and law lodged by the claimant and the defendant to the Higher Administrative Court (Oberverwaltungsgericht) were unsuccessful.


The Federal Administrative Court dismissed the defendant's appeal on points of law. Following the claimant's appeal on points of law, the Federal Administrative Court amended the judgments of the previous instances and obliged the defendant to grant the claimant the permit he had applied for. According to section 3 (2) of the Narcotic Drugs Act (BtMG, Betäubungsmittelgesetz), the Federal Institute for Drugs and Medical Devices may issue a permit for the cultivation of cannabis only in exceptional circumstances for scientific or other public interest purposes. In this exceptional case, the treatment of the seriously ill claimant with home-grown cannabis is in the public interest because, according to the binding findings of the Court of Appeal, the ingestion of cannabis leads to a considerable relief of his symptoms, and there is currently no equally effective and affordable drug available to him. The purchase of so-called medicinal cannabis from a pharmacy (which also requires a permit) is unsuitable as an alternative treatment for cost reasons. His health insurance has repeatedly refused to pay the costs. He is not able to finance the costs from his incapacity pension. Under the given circumstances, the claimant cannot reasonably be expected to initiate new legal proceedings against his health insurance company for assumption of costs before the social court. None of the grounds for refusal under section 5 BtMG prevents the granting of a permit. According to the binding factual findings of the Court of Appeal the security and control of the narcotics traffic is sufficiently guaranteed. The safeguards installed by the claimant in his apartment provide sufficient protection against unauthorized removal of the narcotics. There is also no indication of any improper use by him. Furthermore, as a result of years of self-therapy the claimant now has extensive experience in terms of the efficacy and dosage of the cannabis variety he grows. Moreover, both the cultivation and the therapy are under medical supervision. Permission may also not be withheld under the international Single Convention on Narcotic Drugs of 1961. Under these conditions, the granting of the exemption permit is legally mandatory because of the respect of physical integrity required by article 2 (2) first sentence of the Basic Law (GG, Grundgesetz), which means the discretion available to the authorities is effectively reduced to one possible sound decision (Ermessensreduzierung auf Null). The authority of the Federal Institute for Drugs and Medical Devices to grant the permit with additional stipulations remains unaffected.


BVerwG 3 C 10.14 - judgment of 6 April 2016


Judgment of 6 April 2016 -
BVerwG 3 C 10.14ECLI:DE:BVerwG:2016:060416U3C10.14.0


Please note that the official language of proceedings brought before the Federal Administrative Court of Germany, including its rulings, is German. This translation is based on an edited version of the original ruling. It is provided for the reader’s convenience and information only. Please note that only the German version is authoritative. Page numbers in citations have been retained from the original and may not match the pagination in the English version of the cited text. Numbers of paragraphs that have completely been omitted in the edited version will not be shown.
When citing this ruling it is recommended to indicate the court, the date of the ruling, the case number and the paragraph: BVerwG, judgment of 6 April 2016 - 3 C 10.14 - para. 16.

Permission for self-cultivation of cannabis for therapeutic purposes  

Headnotes

1. Self-cultivation of cannabis for therapeutic purposes is in the public interest within the meaning of section 3 (2) of the Narcotic Drugs Act (BtMG, Betäubungsmittelgesetz) if the applicant suffers from a severe disease and there is no equally effective and affordable drug available to him to treat his disease.

2. If no compelling grounds for refusal according to section 5 of the Narcotic Drugs Act exist in such a case, it is legally mandatory to make use of the discretion provided under section 3 (2) of the Narcotic Drugs Act by granting permission on the grounds of the protection of physical integrity required by article 2 (2) first sentence of the Basic Law.

  • Sources of law
    Narcotic Drugs Act BtMG, Betäubungsmittelgesetz section 3 (2), section 5 (1) and (2), section 6 (2), section 9 (2), section 15
    Basic Law for the Federal Republic of Germany GG, Grundgesetz article 2 (2) first sentence
    Social Code Book V SGB V, Sozialgesetzbuch V section 2 (1a)

Summary of the facts

The parties dispute whether the claimant can or must be granted a licence allowing him the self-cultivation of cannabis to be used in the treatment of his multiple sclerosis disease.

The 52 year old claimant has been suffering from severe multiple sclerosis since 1985. Because of his disease, he has been in early retirement since 1999. He receives a monthly incapacity pension of approximately EUR 890. He has been treating the symptoms of his disease by regular use of self-cultivated cannabis since 1987. His complaint before the social courts against his health insurance to provide him with a THC containing drug as aid in kind, or alternatively to assume the costs, had remained unsuccessful.

In May 2000 he applied at the Federal Institute for Drugs and Medical Devices (Bundesamt für Arzneimittel und Medizinprodukte) for an exceptional permit under section 3 (2) of the Narcotic Drugs Act (BtMG, Betäubungsmittelgesetz) allowing him to cultivate cannabis for the treatment of his illness. In December 2007 the application was rejected by the Federal Institute for Drugs and Medical Devices citing compelling grounds for refusal according to section 5 (1) BtmG. The Federal Institute argued that self-cultivation of cannabis was not necessary for the medical care of the claimant since there was a therapeutic alternative on the basis of standardised cannabis extracts. Furthermore, the permission would contravene the purpose of the Narcotic Drugs Act aimed at precluding drug addiction as far as possible. According to the Federal Institute for Drugs and Medical Devices, the security of the trade in narcotic drugs was not guaranteed since the cultivation by an individual could not ensure consistent quality of the cannabis. Furthermore, the claimant had neither proved that he had suitable rooms and safeguards in place for the cultivation, drying and storage of cannabis nor did he possess the required expertise. The Federal Institute for Drugs and Medical Devices rejected the objection (Widerspruch) lodged by the claimant, adding that the granting of a permit would also contravene the Single Convention on Narcotic Drugs. Even assuming that no compelling grounds for refusal existed and that the granting of permission was therefore at the discretion of the authorities, the Federal Institute for Drugs and Medical Devices said that such a permission was no option because an alternative therapy with cannabis-containing drugs was available to the claimant.

The aim of the action by the claimant was to oblige the defendant to allow him the cultivation of cannabis in his apartment and to use it for his treatment. The Administrative Court had overturned the contested decisions, and obliged the defendant to issue a new decision on the application for a permission taking account of the court’s legal opinion. The Higher Administrative Court rejected the appeal on points of fact and law (Berufung) lodged by the defendant as well as the cross-appeal filed by the claimant.

The Federal Administrative Court dismissed the defendant’s appeal on points of law (Revision) and decided in favour of the claimant’s appeal on points of law.

Reasons (abridged)

10 The defendant’s appeal on points of law is without merit; the claimant’s appeal on points of law is well-founded. The Higher Administrative Court had found without violation of federal law (section 137 (1) no. 1 of the Code of Administrative Court Procedure (VwGO, Verwaltungsgerichtsordnung)) that the permit requested by the claimant for self-cultivation of cannabis for therapeutic purposes was in the public interest within the meaning of section 3 (2) BtMG (1.), and that no compelling grounds for refusal within the meaning of section 5 (1) BtMG precluded the granting of a permit (2.). Furthermore, the Higher Administrative Court had rightly found that the permission may not be withheld according to section 5 (2) BtMG in conjunction with the Single Convention on Narcotic Drugs because of the lack of a cannabis agency (3.). The contested judgment does however violate federal law insofar as it obliges the defendant only to issue a new decision on the application for a permit. Since discretion was reduced to only one possible sound decision (Ermessensreduzierung auf Null) the claimant is entitled to a permit (4.). This means that the appeal must be fully upheld and the rulings of the previous instances must be amended (section 144 (3) first sentence no. 1 VwGO).

11 The legal basis for the contested permit is section 3 (2) BtMG in the version promulgated on 1 March 1994 (Federal Law Gazette (BGBl., Bundesgesetzblatt) I p. 358) as last amended by article 1 of the Ordinance of 11 November 2015 (BGBl. I p. 1992). According to this section, the Federal Institute for Drugs and Medical Devices may issue a permit for the cultivation of the narcotics specified in annex I of the Act only in exceptional circumstances for scientific or other purposes in the public interest. Cannabis (marihuana, plants and plant parts belonging to the cannabis family) is not part of the marketable narcotics listed in annex I to section 1 (1) BtMG. (...)

12 1. The granting of the cultivation permit applied for is in the public interest within the meaning of section 3 (2) BtMG.

13 The established jurisprudence of the Senate clarifies that a permit under section 3 (2) BtMG may also be granted in exceptional cases for the treatment of a seriously ill patient with cannabis. The required public interest exists provided the illness can be cured or, at least, alleviated by the treatment with the narcotic and there are no equally effective therapeutic alternatives available to the person concerned (Federal Administrative Court (BVerwG, Bundesverwaltungsgericht), judgment of 19 May 2005 - 3 C 17.04 - Rulings of the Federal Administrative Court (BVerwGE, Entscheidungen des Bundesverwaltungsgerichts) 123, 352 <354 et seqq.>). These preconditions that apply both to the permit for self-cultivation of cannabis and the permission for its purchase (cf. BVerwG, judgment of 19 May 2005, see above, p. 360) are fulfilled here.

14 a) The claimant suffers from a serious and incurable disease in the form of secondary chronic multiple sclerosis leading to diverse and severe health impairments. According to the binding findings of the courts below regarding the facts of the case (section 137 (2) VwGO) the use of cannabis results in a major improvement of his subjective well-being (...). This substantiates the existence of a therapeutic benefit that justifies the assumption of a public interest in the use of cannabis for medical purposes (BVerwG, judgment of 19 May 2005 - 3 C 17.04 - BVerwGE 123, 352 <354 et seqq.>).

15 b) The claimant has no other equally effective therapeutic alternative available to treat his symptoms.

16 aa) According to the findings of the Higher Administrative Court which are binding for appeal proceedings on points of law (section 137 (2) VwGO) the authorised drug "Sativex" is no therapeutic alternative for the claimant on the grounds that it does not offer the same efficacy as the cannabis grown by him. (...)

17 Likewise, the prescription drug "Dronabinol" represents no therapeutic alternative for the claimant because of its lack of comparable therapeutic efficacy. (...)

18 bb) Medicinal cannabis is not affordable for the claimant and therefore does not represent for him an alternative that would eliminate the public interest in the self-cultivation of cannabis (BVerwG, judgment of 19 May 2005 - 3 C 17.04 - BVerwGE 123, 352 <359>).

19 (1) Medicinal cannabis (pharmaceutical-grade dried cannabis flowers) is not authorised as a medicinal product in Germany and may also not be prescribed (section 13 (1) third sentence BtMG). In case an exceptional permit is granted under section 3 (2) BtMG it is possible in individual cases to import medicinal cannabis to Germany and sell it to patients in pharmacies. According to the findings of the court of appeal, the purchase of medicinal cannabis from a pharmacy in the required dose of approximately 100g of "cannabis flos Bedrocan" would cause the claimant monthly costs of at least EUR 400, if not EUR 1,600. Given a monthly incapacity pension of approximately EUR 890 he is unable to bear these costs. By contrast, his monthly expenses for self-cultivation of cannabis are limited to approximately EUR 110.

20 (2) The claimant is not obliged to explore the possibility of cost reimbursement by his health insurance. The latter has repeatedly refused to pay the costs for his supply with medicinal cannabis (...). In case such a rejection is based on a potentially false legal opinion, the party concerned can be principally expected to initiate legal proceedings before the social courts. But the Higher Administrative Court found without error of law that the claimant cannot reasonably be expected under the given circumstances to initiate new legal proceedings before the social courts.

21 It is unlikely that an action for the assumption of costs of the supply with medicinal cannabis would be successful. According to the established jurisprudence of the social courts, entitlement to benefits in kind under section 27 (1) first sentence in conjunction with second sentence no. 3, section 31 (1) first sentence of the Social Code Book V (SGB V, Sozialgesetzbuch V) or entitlement to reimbursement and assumption of costs under section 135 SGB V are ruled out on the grounds that medicinal cannabis is imported from a third country and not authorised as a medicinal product in Germany (Federal Social Court (BSG, Bundessozialgericht), judgments of 27 March 2007 - B 1 KR 30/06 R - juris para. 10 et seq. and of 3 July 2012 - B 1 KR 25/11 R - Rulings of the Federal Social Court (BSGE, Entscheidungen des Bundessozialgerichts) 111, 168 para. 12 et seq.; Higher Social Court Stuttgart (LSG, Landessozialgericht) Stuttgart,), judgment of 27 February 2015 - L 4 KR 3786/13 - juris para. 36). A claim on the basis of section 135 (1) SGB V is excluded given the absence of the required guideline recommendation by the Federal Joint Committee (Gemeinsamer Bundesausschuss) (BSG, judgment of 27 March 2007 - B 1 KR 30/06 R - juris para. 12; LSG Stuttgart, judgment of 27 February 2015 - L 4 KR 3786/13 - juris para. 40; LSG Berlin-Brandenburg, decision of 4 May 2015 - L 1 KR 221/15 B ER - juris para. 18). The present case does also not constitute an exceptional case where the health insurance would be obliged to cover the costs despite the absence of a guideline recommendation. The preconditions of a so-called rarity case (Seltenheitsfall) of a disease are not fulfilled. Such a case refers to a disease that occurs extremely rarely worldwide and therefore cannot be investigated systematically (BSG, judgment of 28 February 2008 - B 1 KR 16/07 R - BSGE 100, 103 para. 30 with further references.). This does not apply to multiple sclerosis (LSG Niedersachsen-Bremen, decision of 7 March 2011 - L 4 KR 48/11 B ER - juris para. 21; LSG Mainz, judgment of 20 August 2009 - L 5 KR 100/08 - juris para. 15). There are also no indications for an unlawful failure to update the guidelines of the Federal Joint Committee (case of so-called system failure (Systemversagen), BSG, judgment of 27 March 2007 - B 1 KR 30/06 R - juris para. 13 et seq.; LSG Stuttgart, judgment of 27 February 2015 - L 4 KR 3786/13 - juris para. 42; LSG Munich, decision of 26 November 2015 - L 4 KR 419/15 B ER - juris para. 30).

22 It is also not clear whether the claimant could claim assumption of the medicinal cannabis costs under section 2 (1a) SGB V. According to this provision, insured persons suffering from a life-threatening or regularly lethal or comparable disease, for which no generally accepted standard-of-care service is available, are entitled to a service deviating from section 2 (1) third sentence SGB V provided there is a more than remote prospect of cure or of a perceptible positive impact on the progression of the disease. Section 2 (1a) SGB V was introduced by the Act on Supply Structures of Statutory Health Insurance (GKV-VSG, GKV-Versorgungsstärkungsgesetz) of 22 December 2011 (BGBl. I p. 2983) with effect as of 1 January 2012; it takes up the decision of 6 December 2005 of the Federal Constitutional Court (BVerfG, Bundesverfassungsgericht) - 1 BvR 347/98 – (Rulings of the Federal Constitutional Court (BVerfGE, Sammlung der Entscheidungen des Bundesverfassungsgerichts) 115, 25). The precondition for an entitlement to benefits is the existence of a life-threatening or regularly lethal or comparable disease in an emergency-like situation. This may be the case if the concrete circumstances in an individual case make it likely that the progression of the disease will lead to a lethal outcome or the loss of an important sensory organ which cannot be compensated or a prominent bodily function within a short and foreseeable period (explanatory memorandum for the GKV-VSG, Bundestag printed paper (BT-Drs., Bundestagsdrucksache) 17/6906 p. 52 et seq.). The Higher Social Court of Bavaria had considered the possible existence of a case of loss of a prominent bodily function which is not compensable when the mobility of a multiple sclerosis patient with a severe walking impediment is threatened to further deteriorate (LSG Munich, decision of 19 June 2013 - L 5 KR 91/13 B ER - juris para. 24 et seq.). But these considerations constituted only a preliminary evaluation in the framework of an impact assessment during temporary order proceedings; and - as far as can be established - this case has remained a singular decision. By contrast, the Federal Social Court assumed that the legal requirements of a life-threatening or similarly severe disease within the meaning of the decision of 6 December 2005 of the Federal Constitutional Court were not fulfilled in the case of an existing secondary chronic multiple sclerosis despite the undeniable severity of the disease (BSG, judgment of 27 March 2007 - B 1 KR 17/06 R - juris para. 18 et seqq.; comparable to judgment of 8 November 2011 B 1 KR 19/10 R - BSGE 109, 211 para. 23; LSG Stuttgart, decision of 10 November 2014 - L 11 KR 3826/14 ER-B - juris para. 25). In its draft of an "Act amending the Law on Narcotic Drugs and other Regulations" of 7 January 2016 (Referentenentwurf eines Gesetzes zur Änderung betäubungsmittelrechtlicher und anderer Vorschriften) (…), the Federal Ministry of Health likewise assumes that insured persons are not entitled to the supply of medicinal cannabis under current legislation and that the envisaged amendment aims at creating the possibility of an assumption of costs by the statutory health insurance in strictly defined exceptional cases.

23 Finally, there exists no entitlement to benefits from other social service providers. (...)

24 Against this background, the claimant cannot reasonably be expected to initiate legal proceedings before the social courts. This is particularly true given the extraordinary long permission procedure extending over a period of more than 15 years. The claimant filed an application for a permit in May 2000. In parallel, he had brought an action to obtain a supply with Dronabinol before the Social Court as early as in February 2000. This action was unsuccessful in all instances. The administrative court proceedings by the defendant against the (first) refusal of 31 July 2000 came to an end before the Higher Administrative Court in mid-2006 after the defendant had reversed the decision with a view to the Senate judgment of 19 May 2005 - 3 C 17.04 - BVerwGE 123, 352). The legal action against the (second) refusal of 6 December 2007, which is contested here, has been pending since June 2009. (...)

26 2. No compelling grounds for refusal under section 5 (1) BtMG preclude the granting of a permit.

27 a) According to section 5 (1) no. 2 BtMG a permit must be refused if the designated responsible person (section 5 (1) no. 1 BtMG) does not have the required expertise or is incapable of permanently meeting the obligations incumbent on him. It is irrelevant that the claimant fails to meet the requirement of a completed scientific university education within the meaning of section 6 (1) no. 2 BtMG which precludes him from fulfilling the role of the designated responsible person himself (section 5 (1) no. 1 second half-sentence BtMG). There are no objections to the Higher Administrative Court’s findings that such expertise can also be proven by a physician who treats the claimant and fulfils the role of the designated responsible person. Section 6 (2) BtMG allows to deviate from the expertise requirements specified in subsection 1, if the security and control of the trade in narcotic drugs are guaranteed. It is therefore possible to adapt the expertise requirements to the specific trade in narcotic drugs applied for, if and in so far as this is necessary in the interest of the required medical care and compatible with the required security and control of the trade in narcotic drugs. This is the case here. According to the binding findings of the courts establishing the facts the required expert guidance and support of the claimant can be ensured by his general practitioner who has agreed to assume the obligations of a designated responsible person. Moreover, as a result of years of self-cultivation the claimant has extensive expertise with regard to the cannabis variety used by him and in particular comprehensive practical experience in terms of efficacy and dosage.

28 It can also not be argued that the person responsible under section 5 (1) no. 2 BtMG must be able to permanently fulfil the obligations incumbent upon him. According to section 5 (1) no. 1 BtMG he is responsible for the compliance of the trade in narcotic drugs applied for with the legislation governing narcotic drugs and the orders of the supervisory authorities. "Permanently" within the meaning of section 5 (1) no. 2 BtMG means the continuous assumption of this responsibility ensuring secure monitoring of the trade in narcotic drugs. Any further details of the responsible person’s obligations, in particular the frequency and the scope of the controls, depend on the kind of trade applied for. In case of a permission for the self-cultivation of cannabis for therapeutic purposes the physician appointed responsible person fulfils his control function by continuously attending the applicant and by controlling as frequently and thoroughly as is required in the individual case whether the applicant properly meets his obligations regarding the handling of narcotic drugs. According to the findings of the Higher Administrative Court there are no indications that the claimant’s general practitioner would be unprepared or unable to do this.

29 There are also no other concerns regarding the security and control of the trade in narcotic drugs required under section 6 (2) BtMG since the grounds for refusal specified under section 5 (1) no. 3 to 6 BtMG also fail to apply as shown below.

30 b) Without explicitly mentioning the ground for refusal under section 5 (1) no. 3 BtMG the contested judgment is clearly based on the assumption that no facts exist which raise doubts about the reliability (Zuverlässigkeit) of the claimant. Reliable (zuverlässig) within the meaning of section 5 (1) no. 3 BtMG is a person who provides the guarantee to fully and permanently meet the obligations incumbent upon them with regard to the implementation of the trade in narcotic drugs applied for. The Higher Administrative Court found no indications that the claimant would abuse the cannabis cultivated by him or supply it for illegal trade in narcotic drugs (…). No further considerations were required given that the contested decisions were not based on this ground for refusal and that the defendant, in the court proceedings, presented no facts that raised doubts about the reliability of the claimant’s compliance with the legislation governing narcotic drugs.

31 No such doubts arise in so far as the Higher Administrative Court considered in its statements regarding section 5 (1) no. 6 BtMG that the seriously ill claimant had meanwhile developed an addiction to narcotic drugs. Although the purpose of the Narcotics Act according to section 5 (1) no. 6 is to preclude, as far as possible, the development or maintenance of an addiction to narcotic drugs, the wording "as far as possible" shows that the existence of an addiction does not always preclude the granting of a permit. Where the public interest in securing the medical care of the population is of paramount importance in an individual case, the risk of a drug addiction of the person concerned must be accepted. This is the case here. For the appeal proceedings on points of law, it can be assumed that the claimant has, as concluded by the previous instance, a drug addiction rather than a mere cannabis tolerance as claimed by him. Since according to the findings of the court of appeal no alternative to the cannabis therapy is available to the seriously ill claimant, there exists a greater public interest in his treatment also in the event of a drug addiction. The claimant has been a cannabis user for many years, consuming considerable daily dosages of the narcotic (...). The supervision by a physician aims at avoiding overdosage and limiting the cannabis ingestion to the amount required. There are no indications of improper use by the claimant. In this sense an existing narcotic addiction is an undesirable side effect which is inevitable in order to achieve the therapeutic success. Hence this fact alone is insufficient to question the reliability of the claimant. No other facts giving rise to concerns that the claimant would fail to comply with narcotics regulations were found by the Higher Administrative Court.

32 Accordingly, the contested permission may also not be withheld under section 5 (1) no. 6 BtMG on the grounds that the kind and purpose of the trade for which the application was filed do not comply with the purpose of this Act.

33 c) The ground for refusal under section 5 (1) no. 4 BtMG does also not preclude the granting of a permit. It stipulates that a permit should be refused if suitable premises, installations and security measures are not available for the trade in narcotic drugs. According to section 15 first sentence BtMG narcotic drugs should be kept in a separate place and should be secured against unauthorised removal. The Higher Administrative Court found that the security measures taken by the claimant meet these requirements. His apartment has a triple-locked entrance door and security glazed windows equipped with six-point locks and anti-lift protection. The envisaged installation of a grille in front of the bathroom window will provide the necessary protection when the window is left in the tilted position. The cannabis harvested is stored in a safe, while the mother plant and cuttings grown are kept in a cupboard. With regard to the plants kept in the shower of the bathroom during the flowering phase the claimant offered to install a fingerprint lock to keep the access to this room under control. He will also take precautions for the rare event of his absence. He intends to install a CCTV camera with programmed motion detector and automatic notification via mobile phone. If required, the defendant may ensure the implementation of the security measures by way of an order in accordance with section 9 (2), section 15 second sentence BtMG.

34 d) There are no other reasons that preclude the guaranteed security and control of the trade in narcotic drugs (section 5 (1) no. 5 BtMG). It is true that the self-cultivation of cannabis does not offer a therapeutic security comparable to medicinal cannabis acquired in a pharmacy whose production and quality complies with pharmaceutical standards. Nevertheless, the required trade security may be considered assured in this exceptional case on the grounds that the claimant, as a result of years of self-cultivation, has extensive expertise and experience regarding the efficacy and dosage of the cannabis variety grown by him. In addition, the reproduction method, i.e. the cultivation of cuttings from a mother plant, and the maintenance of identical conditions are a relative guarantor for a constant THC of his cannabis plants. The risk of incorrect dosing is thus controllable. Furthermore, the self-cultivation and the use of cannabis is assisted and supervised by a physician.

35 3. According to section 5 (2) BtMG permission may be refused if it is in conflict with the implementation of international narcotics conventions or resolutions, orders or recommendations of intergovernmental narcotics control institutions. None of these grounds prevents the granting of a permit in the present case.

36 A decision in favour of the claimant is also not precluded by the Single Convention on Narcotic Drugs of 1961 as promulgated on 4 February 1977 (BGBl. II p. 111) which took effect in Germany by the approval acts (Zustimmungsgesetze) dated 4 September 1973 (BGBl. II p. 1353) and 18 December 1974 (BGBl. 1975 II p. 2). It is, however, questionable whether the reason is - as found by the Higher Administrative Court - the lack of applicability of the provisions regarding the establishment of a national cannabis agency. The International Narcotics Control Board (INCB), in its letter dated 30 July 2010 to the Federal Institute for Drugs and Medical Devices, expressly points out that the existing obligation to establish a government agency under article 28 (1) in conjunction with article 23 of the 1961 Convention also applies to cases of self-cultivation of cannabis for therapeutic purposes. The International Narcotics Control Board is responsible for ensuring the implementation of the Single Convention on Narcotic Drugs (cf. articles 5, 9, 14 of the 1961 Convention). Its interpretation of the convention carries weight. A final clarification regarding the applicability of article 23 and article 28 of the 1961 Convention is not required in this case. A permit may not be withheld on the grounds that it would contravene the implementation of the International Convention on Narcotic Drugs, even if the convention actually required the establishment of a cannabis agency. Section 5 (2) BtMG leaves the refusal of a permit to the discretion of the authorities. It is not the intention of the Single Convention to prevent the therapeutic use of narcotics (BVerwG, judgment of 19 May 2005 - 3 C 17.04 - BVerwGE 123, 352 <361 et seq.>). According to its preamble, the medical use of narcotics drugs is indispensible for the relief of pain and suffering and adequate provision must be made to ensure the availability of narcotic drugs for such purpose. In the light of these provisions, the discretionary decision under section 5 (2) BtMG must be made in favour of the claimant. His interest in the required medical supply of cannabis that is currently only available to him by self-cultivation outweighs possible concerns resulting from the absence of a cannabis agency. The defendant is not entitled to invoke this circumstance because it is responsible for the failure to embark on the path stipulated by the Single Convention that leads to a nationally controlled cultivation of cannabis for therapeutic purposes.

37 4. Under the given circumstances the absence of compelling grounds for refusal means that the permission for the self-cultivation of cannabis has to be granted by way of exception. The use of discretion under section 3 (2) BtMG makes it legally mandatory to grant a permission ((Ermessensreduzierung auf Null), cf. BVerwG, decision of 3 October 1988 - 1 B 114.88 (…)) because of the respect of physical integrity required by article 2 (2) first sentence of the Basic Law (GG, Grundgesetz). The seriously ill claimant depends on a cannabis therapy to alleviate his symptoms. For the time being, he is only able to ensure his treatment by self-cultivation. It is not within his power to create the legal framework conditions for a cost assumption of medicinal cannabis by the statutory health insurance or to influence the establishment of a cannabis agency. It would be disproportionate to deny the claimant the possibility of self-help by self-cultivation even if the required security and control of the trade in narcotic drugs, as shown above, are guaranteed (likewise Administrative Court Cologne, judgment of 8 July 2014 - 7 K 5217/12 - juris paras. 128, 155).

38 The authority of the defendant to grant the permit with additional stipulations in accordance with section 9 (2) BtMG remains unaffected provided these provisions do not contradict this ruling. (…)