Fundamental rights – Lawful revocation of the licence of a pharmacist convicted of adulterating cancer drugs (Bottrop pharmacist)
written and translated by Ali Tahir Sen
A pharmacist authorised to produce medicines for the treatment of cancer patients, who massively and thousands of times does not comply with the requirements of the medical prescription, thereby accepting an incalculable health risk for patients, some of whom are seriously ill, and abuses their trust for personal financial interests, is unreliable and unworthy in the sense of § 6 II BApO in conjunction with § 4 I 2 No. 2 No. 2 BApO.
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Until the end of November 2016, the plaintiff, a pharmacist in Bottrop, operated a pharmacy for which he held an official permit to produce cytostatics for the treatment of cancer patients according to a doctor’s order. On November 24th, 2016, an arrest warrant was issued against the plaintiff and the district government of Münster, as the licensing authority, was informed due to investigations on urgent suspicion of “at least 40,000 cases of manufacturing, placing on the market or otherwise dealing in medicinal products or active substances, the quality of which is not insignificantly reduced due to deviations from the recognised pharmaceutical rules, and commercial fraud to the detriment of health insurance funds and private patients”. On March 14, 2017, the suspension of the licence to practise as a pharmacist was ordered.
On July 6th, 2018, the plaintiff was sentenced to 12 years’ imprisonment for, inter alia, wilful violation of the German Medicines Act in a total of 14,537 cases in a row and for fraud in 59 cases, as well as a lifetime ban from the profession and the confiscation of an amount of 17 million euros in value was ordered (Grand Criminal Chamber of the Essen Regional Court, judgement of July 6th, 2018 – 305 Js 330/16 56 KLs 11/16). The Federal Supreme Court reduced the latter to 13,605,408 euros in the context of the plaintiff’s appeal (Decision of June 10, 2020 – 4 StR 503/19). A hearing appeal was rejected as unfounded, a constitutional complaint is pending. A decision was issued by the competent licensing authority on September 7th, 2020 and was received by the plaintiff on September 14th, 2020. According to clause 1, the plaintiff’s licence to practise medicine was revoked, according to clause 2, he had to surrender his licence to practise medicine, and according to clause 3, he was threatened with a penalty payment of €500 for failing to act within the deadline. In the opinion of the licensing authority, it follows from the numerous offences resulting from the plaintiff’s conviction that
his unworthiness and unreliability to exercise the profession of pharmacist […]. The revocation of the plaintiff’s licence to practise pharmacy was also not disproportionate in the light of the freedom of profession under Article 12 of the Constitution (Grundgesetz, GG). In particular, the life-long professional ban imposed in the criminal proceedings did not prevent the revocation of the licence.
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 15.
In a letter from a lawyer dated 08.09.2020, K informed the licensing authority that he had lodged a constitutional complaint and requested that the decision on the revocation of his licence to practise medicine be postponed until the Federal Constitutional Court had reached a decision. On October 14, 2020, he filed a complaint against the revocation. As grounds, he submits that the revocation cannot be issued on the basis of his criminal conviction, as this would have affected him in his
fundamental right to a fair trial under the rule of law as a manifestation of the function of [Article 2.2 sentence 2 of the Constitution] to secure freedom, since the criminal division [had insufficiently assessed the effects of his brain injury and] had not taken the expert evidence requested by him.
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 17.
These were “fundamental strands of justification” for his conviction and thus there were “weighty indications” from which the incorrectness of his conviction could be inferred and for which, as a result, the decision (revocation) had to be annulled. The defendant Land (North Rhine-Westphalia) applied for the action to be dismissed.
The following discussion does not address the admissibility of the action (under state law), but the court has local jurisdiction pursuant to section 52 no. 3 p. 2 and p. 5 of the Administrative Code (VwGO). Despite the fact that the plaintiff is in another administrative court district due to his imprisonment, it also has subject-matter jurisdiction, as he has not voluntarily given up his previous place of residence (section 83 1 VwGO in conjunction with section 17 I 1 General Administrative Court Act (GVG)).
A licence to practise medicine must be revoked pursuant to § 6 II BApO if one of the prerequisites pursuant to § 4 I 2 No. 2 BApO has subsequently ceased to apply. According to Section 4 I 2 No. 2 BApO, it is necessary that the applicant (or the addressee of the revocation of the licence) has not been guilty of any conduct which would render him unworthy or unreliable to practise the profession of pharmacist. Both unworthiness and unreliability are indeterminate legal concepts for which the authority has no discretionary power of assessment and which are subject to full judicial review within the framework of the legal protection guarantee of Article 19 IV 1 GG.
The indeterminate legal concept of unworthiness can be concretised by the duties of a pharmacist according to § 1 BApO. According to § 1 BApO, the pharmacist is called upon to properly supply the population with medicinal products intended for human use and veterinary medicinal products (Arzneimittel) and to serve the health of the individual and the entire nation. With regard to the constitutionally guaranteed protection of the freedom of profession according to Art. 12 I GG and the principle of proportionality, the following reasons must be given for unworthiness and thus the revocation of the licence to practise pharmacy
rather, serious conduct which, when all the circumstances are considered, permanently destroys the trust between pharmacist and patient which is indispensable for the proper fulfilment of duties [required].
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 41.
This misconduct need not be directly in relation to the patient, it is sufficient if
it leads to a loss of reputation and confidence which makes the person concerned appear unacceptable for his profession, [for which] all circumstances of the misconduct(s) are to be taken into account, such as the nature, gravity and duration of the misconduct, the sentence imposed and the underlying penalty assessment considerations [as well as] whether, at the relevant time of assessment of the conclusion of the administrative proceedings, there are indications which lead to the fact that professional unworthiness cannot be assumed or can no longer be assumed
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 43 ff.
For the specific case, the VG Gelsenkirchen states that the plaintiff
has shown serious misconduct which is incompatible with the professional profile and the general requirements of the personality of the pharmacist. […]
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 51.
In the view of the VG Gelsenkirchen, this already results from the 59 cases of the plaintiff’s fraud by monthly, false settlements towards health insurance funds. In this regard, it states:
Correct billing of pharmaceutical services to the statutory health insurance funds is one of the pharmacist’s self-evident professional duties. The endangerment of the financial basis of public as well as private cost units through fraudulent billing on a large scale over many years and damage amounting to millions of euros represents a serious professional misconduct even without a direct treatment-relevant connection. The reliability of the billing system is an indispensable condition for the functioning of medical as well as pharmaceutical care for the population, which serves to safeguard a particularly important general interest […].
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 53.
According to the VG Gelsenkirchen, this applies all the more to the violations of the Medicines Act by manufacturing and placing the defective medicines on the market.
A pharmacist who – like the plaintiff – with a licence to produce cytostatics for the treatment of cancer patients massively and repeatedly fails to comply with the requirements of the medical prescription in several thousand cases and thereby accepts incalculable health risks for patients, some of whom are seriously ill, and ruthlessly abuses their trust in order to satisfy his personal financial interests, violates the core area of his professional duties to an extremely high degree […] The nature, scope and duration of these 14. 537 acts for which the plaintiff is responsible according to the findings of the Regional Court leading to the final conviction make him appear unworthy of exercising the profession of pharmacist, particularly in view of the medically incalculable consequences for the patients affected by the medicinal products produced in this way. In view of the extraordinary number of acts committed in the core area of the plaintiff’s professional activity and the high profits in the multi-digit millions achieved over a period of almost five years due to the fraudulent settlements towards the (public) cost units, the public’s trust in the profession of all pharmacists would be permanently shaken if such conduct remained without consequences for the continuation of the plaintiff’s licence to practise […].
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 58.
As a result, the VG Gelsenkirchen therefore finds that the plaintiff is unworthy, which would in principle already require revocation according to § 6 II BApO (“has” to revoke).
The VG Gelsenkirchen states with regard to the unreliability of the plaintiff:
[He has] over the substantial period of nearly five years knowingly massively breached his duties as a pharmacist with the licence granted by the local health authority for the manufacture and marketing of cancer medication individually prepared in accordance with a doctor’s prescription. This considerable misconduct over many years, which led to his legally binding conviction, prognostically indicates a clearly consolidated tendency in him that he would also in future not attach the necessary importance to his professional duties as a pharmacist for the patients, but also for the health of the population as a whole. […] According to the findings of the Regional Court, the plaintiff did not even begin to cooperate with the criminal court in coming to terms with his misconduct. To the end, he shows himself to be intransigent and denies his criminal responsibility. As already stated above, there is a risk that, due to the plaintiff’s misconduct, medicinal products with considerable non-effects have been used in disregard of the medical instructions, which have triggered health risks for the affected users. This is particularly the case if the medicinal products to be manufactured by the plaintiff were intended for the treatment of serious, life-threatening diseases such as in the context of cancer treatment. Dispensing medicinal products to these patients without the correct active ingredient content is highly reprehensible. By deliberately refraining from dosing the medicines with the actually prescribed active ingredient content, the plaintiff either deliberately disregarded this risk or simply did not want to recognise the risk of a deterioration in health. In the first case, this conduct reveals a careless and thoughtless attitude in handling these medicines, which justifies the prognosis that the plaintiff will continue to blatantly neglect his examination duties in the future. In the second case, it is to be feared that there will be further massive violations of professional duties due to a lack of expert knowledge and a misjudgement of situations and health risks.
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 64.
After establishing that the plaintiff was unworthy and unreliable, the VG Gelsenkirchen devoted itself to his objection that the revocation of his licence to practise medicine should not be based on his criminal offence, as this violated his fundamental rights.
In this regard, it states in principle that it is primarily the task of the criminal courts to determine whether criminal offences have been committed and guilt exists, and that the factual findings obtained in a final criminal judgement may, as a rule, form the basis of official and judicial assessment.
This applies as long as there are no weighty indications that the findings or the assessment of evidence in the criminal court decision are incorrect, i.e. the decision is not obviously incorrect.
The VG Gelsenkirchen denies an obvious incorrectness of the criminal conviction and states:
There are no significant indications for the incorrectness of the findings and the evaluation of evidence in the criminal court’s decision, neither from the plaintiff’s submission nor from the entire content of the criminal files that were taken into consideration. This applies in particular in consideration of his submissions in the constitutional complaint filed by him against his conviction. To the extent that the plaintiff argues here, with a legal opinion, that the Essen Regional Court should not have sentenced him by way of the legal institution of the non-authentic organisational offence, this does not essentially concern the determination of the facts of the case, but only its legal assessment – which is not relevant here and which, moreover, has been confirmed by the Federal Court of Justice. […] Finally, the plaintiff’s submission that the Regional Court of Essen violated his right to a fair hearing because it wrongly rejected his request to hear a neurological specialist as an expert in order to prove his – as he believes – lack of or impaired culpability does not cast doubt on the correctness of the legally binding findings. Furthermore, urgent reasons for the assumption that the plaintiff was not fully culpable when committing all of the offences with which he was charged are neither substantiated nor otherwise evident.
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 75.
Furthermore, the VG Gelsenkirchen states that § 4 I 1 No. 2 BAoP serves to avert danger, thus does not constitute a further punishment and does not presuppose criminal or culpable conduct. In the opinion of the Gelsenkirchen Administrative Court, “culpability” in the sense of § 4 I 1 No. 2 BAoP does not require full culpability in the criminal law sense.
Rather, the term ” culpable ” is to be understood in terms of regulatory law as meaning that the pharmacist must be able to be attributed the misconduct in the sense of an adequate causality
cf. with detailed reasons and further evidence Hessian Administrative Court, decision of 13 April 2022 – 7 A 2210/18.Z (on section 3 subsection 1 no. 2 BÄO, which is identical in content); cf. also the Federal Constitutional Court, chamber decision of 16 January 1991 – 1 BvR 1326/90. [Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 80.]
Finally, the VG Gelsenkirchen addresses the question whether the revocation of the licence to practise as a subjective professional licensing regulation violates higher-ranking law, the constitutionally guaranteed freedom of choice of profession.
A violation of the freedom of choice of occupation of Art. 12 I 1 Var. 1 and S. 2 GG can be examined according to the following scheme:
- Opening of the scope of protection (Eröffnung des Schutzbereichs)
- Material scope of protection (Sachlicher Schutzbereich)
- Personal scope of protection (Persönlicher Schutzbereich)
- Encroachment on the scope of protection (Eingriff in den Schutzbereich)
- Constitutional justification of the intervention (Verfassungsrechtliche Rechtfertigung des Eingriffs)
- Limitability (barrier, Schranke)
- Proportionality – three-step theory (Drei-Stufen-Theorie, Schranken-Schranke)
The activity as a pharmacist is a permanent activity that serves to create or maintain a livelihood and is thus a profession within the meaning of Art. 12 I GG, so that in the case of restrictions on the choice of the profession of pharmacist, the material scope of application of the freedom to choose an occupation is opened. The plaintiff’s personal scope of protection is not problematic. An encroachment lies in the fact that according to § 6 II BApO the revocation has to take place, whereby the plaintiff himself is currently and at least indirectly affected by the revocation of the licence to practise.
Art. 12 I 1 GG is in principle an unconditional basic law, but according to the case law of the Federal Constitutional Court it is limited by law or on the basis of a law, in this case the BApO.
According to the three-step theory of the Federal Constitutional Court, a distinction must be made within the framework of proportionality whether there is an encroachment on the freedom to choose an occupation or the freedom to exercise an occupation. The three-step theory covers professional practice regulations in the first step, subjective professional choice regulations in the second step and objective professional choice regulations in the third step. The revocation of the licence to practise has, according to § 6 II i.V.m. § Section 4 I 1 No. 2 BAoP, the revocation of the licence to practise must take place for reasons that lie in the person of the person concerned, so that these are subjective professional choice regulations (level 2).
An interference is justified according to the second step of the three-step theory if the interference serves the protection of important community goods. The interference must thus pursue this legitimate purpose, be appropriate and necessary to serve the protection of important community goods and be proportionate.
In this regard, the VG Gelsenkirchen states:
The revocation of the plaintiff’s licence to practise medicine, which is at issue here, is suitable for the protection of the important common good of health care and the safeguarding of the financial stability and thus the functioning of the statutory health insurance. Moreover, it is necessary despite the life-long ban on practising medicine imposed on the plaintiff by the criminal court as a measure of betterment and security. [This] results from the different purpose of the criminal prohibition and the official measure of revocation of the licence to practise medicine, which was submitted for judicial assessment in these proceedings. The occupational ban under [§ 70 StGB] is an offence-related measure of betterment and security to prevent a repetition of the convicted offence; it can, if necessary, be limited in time and, moreover, under certain circumstances, also be subsequently suspended. In contrast, the revocation of a licence to practise as a pharmacist due to criminal offences that justify unreliability and/or unworthiness as a pharmacist is a person-related measure under professional law aimed at ensuring compliance with the duties of a pharmacist. These special preventive aspects of professional law, which apply to all offences and are aimed at averting dangers to an important common good […] are not covered by a professional ban under criminal law. In the case of the plaintiff, there are also no other milder but equally effective means than the revocation of his licence to practise medicine.
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 86 ff.
Regarding appropriateness, it states in accordance with the case law of the Federal Administrative Court (BVerwG):
The consequences for the plaintiff associated with the encroachment on the scope of protection are not even remotely disproportionate to the purpose pursued by this. Finally, the principle of proportionality is also taken into account by the fact that the (theoretical) possibility exists for those affected to apply for the reissue of the licence to practise medicine after the revocation procedure has been completed and, if necessary, to apply for the granting of a licence according to §§ 2 Para. 2, 11 BApO.
Administrative Court of Gelsenkirchen, Judgement of. 25.08.2022 – 18 K 3908/20 No. 93.
Item 1 of the administrative order is therefore lawful, so that the question does not arise as to whether item 2 (return of the licence to practise medicine) and item 3 (penalty payment) of the administrative order are (still) lawful. The VG Gelsenkirchen dismissed the action as unfounded in its judgement of 25.08.2022 (18 K 3908/20).
written and translated by Ali Tahir Sen
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