I. Introduction
In rulings dated 05.11.2020, Case No. 3 C 7.19 and 3 C 9.19, the Federal Administrative Court decided that pharmaceutical knowledge comparable to that taught in a pharmacy professional education is not required for a person responsible for the wholesale trade in medicinal products to exercise his or her duties pursuant to Section 52a AMG.
In both cases, the Düsseldorf district government, as the competent supervisory authority, was of the opinion that the appointment of a wholesale representative requires that the representative has the necessary basic scientific pharmaceutical knowledge.
One case involved the Düsseldorf branch of a wholesaler, which in 2014 had reported a trained wholesale and foreign trade merchant as a “responsible person”, who had been working as an operations manager since February 2015 and had already managed several other branches of the wholesaler. The applicant claimed that its responsible person was therefore very familiar with the circumstances and requirements of a pharmaceutical wholesale business due to professional activity and experience, which the supervisory authority did not share.
Also in the parallel proceedings of a pharmaceutical company, whose concrete activity of the responsible person does not include any drug testing and in whose concrete premises there is no storage, no decanting, no packaging or labelling of medicinal products, but rather the activity of the wholesale representative is essentially limited to logistical tasks and the comparison of measurement results, the district government had also refused to appoint the responsible person on the grounds that the required proof of expertise had not been provided due to a lack of pharmacy knowledge.
In both cases, the supervisory authority threatened to order the suspension of the wholesale trade licence.
Pleasingly clear, the Federal Administrative Court rejected the opinion of the Düsseldorf district government and ruled (lead sentence):
“Required for the activity of a responsible person within the meaning of Section 52 a (2) No. 3 AMG is expert knowledge in the handling of the medicinal products that are the subject of the wholesale authorisation. The knowledge can be gained through practical experience, in particular through activities under the guidance and supervision of a responsible person in his/her area of responsibility. Pharmaceutical knowledge comparable to that imparted in a pharmacy professional education is not required.”
This positive final decision in III. Instance is of decisive importance for all holders of a wholesale trade licence.
II. Grounds for the decision
The Federal Administrative Court first established (para. 14 et seq.) that the normative requirements for the qualification of the responsible person neither demand pharmaceutical education nor comparable pharmaceutical knowledge.
According to Section 52a (2) no. 3 AMG, the holder of a licence to wholesale medicinal products must designate a responsible person who possesses the expertise required to carry out the activity, although the Medicinal Products Act does not contain any further details on the type, scope or proof of the required knowledge.
The provisions of EU law also do not contain any content-related specifications on the required expertise. The legislator of the AMG did not take up the wish expressed in No. 2.2 of the GDP Guideline regarding a university degree in pharmacy for the responsible person appointed by the wholesaler, unlike in the provisions on the expertise of the competent person to be appointed for the granting of a manufacturing authorisation pursuant to Section 15 (1) sentence 1 AMG. In this regard, the Court of Appeal already correctly pointed out that these requirements from Section 15 AMG cannot be applied mutatis mutandis to the expertise of the person responsible for the wholesale trade.
This requirement cannot be read into the law by way of interpretation either, neither from the comparison to the regulations of the pharmaceutical consultant, nor in view of the regulations otherwise to be found in the Medicines or Pharmacies Act or the wishful thinking anchored in number 2.2 of the GDP Guideline. Rather, the reference in the explanatory memorandum of the Federal Government’s draft law (BT-Drucksache 15/2109, page 34) that the required qualification can be obtained through professional training and practical experience speaks for a deliberate refraining of the legislator from the requirement of pharmaceutical education or corresponding pharmaceutical knowledge.
The Federal Administrative Court then clearly worked out that it must therefore be determined on the basis of the concrete area of tasks and responsibility which expertise is required to perform the concrete activity. The reference point for this is the activity of the responsible person in the establishment covered by the wholesale trade permit.
In this regard, the Federal Administrative Court has further emphasized that the required expertise must be based on the medicinal products distributed in the establishment as well as the type and scope of the wholesale trade there and that this is obvious especially with regard to the necessary pharmaceutical knowledge. It is obvious that if, for example, medicinal products requiring refrigeration, blood products or other sensitive medicinal products for which special precautions and monitoring steps are required for reasons of medicinal product safety are traded in premises, certain pharmaceutical knowledge may also be required for this purpose.
The responsible person must therefore have the knowledge that enables him or her to carry out the responsibility assigned to him or her.
On the other hand, even if the responsible person is responsible for decisions that may require specific pharmaceutical knowledge, it is not necessary for the responsible person to be able to perform pharmaceutical-scientific risk analyses himself. In this case, the pharmaceutical questions arising in the wholesale trade of medicinal products are regularly – and at least in the specific cases of wholesale trade with finished medicinal products – predetermined by standardised procedures of the quality assurance system.
The responsible person is therefore primarily responsible for ensuring the implementation and maintenance of a quality assurance system as well as the coordination and documentation of the essential process steps. In practice, the main points of inspection are checking for damage and verifying the storage and transport documentation submitted by the sender, while the pharmaceutical manufacturer is responsible for answering product-related pharmaceutical questions.
For the activity of a responsible person within the meaning of Section 52a (2) No. 3 AMG, expert knowledge in handling the medicinal products that are the subject of the wholesale authorisation is therefore required. This knowledge can be gained through practical experience, in particular through activities under the guidance and supervision of a responsible person in his or her area of responsibility. Pharmaceutical knowledge comparable to that imparted in a pharmacy professional education is not required. However, pharmaceutical knowledge may be required insofar as it is necessary for the specific designated activities in the handling of certain medicinal products.
In the present cases, the factual findings in the appeal judgement were not sufficient for a final decision on the merits by the Federal Administrative Court, which is why both proceedings were referred back to the appellate instance.
