For months now there has been ongoing controversial debate about whether or not specimen-collecting kits for the detection of a SARS-CoV-2 infection or related antibodies may be furnished to members of the general public. The background to this discussion is that section 3 (4) of the German Medical Devices Dispensing Ordinance, "MDDO" prohibits the dispensing of in-vitro diagnostic kits to persons wForho do not belong to any specifically named specialist groups such as doctors or healthcare institutions. The German Federal Ministry of Health ("MoH") has now made it clear, both towards representatives of the specialist press as well as the authors themselves, that such sets are not subject to the prohibition on dispensing under section 3 (4) of the MDDO.
Background
Many patients whish to find out, quickly and reliably, about the presence, or not, of a possible SARS-CoV-2 infection or corresponding antibodies. So-called specimen-collecting kits for patients provide for a simple solution: with such sets patients receive at home all the utensils they need, so that they themselves can take the necessary throat swab or collect the required drop of blood. The specimens, taken according to the instructions for use, are then sent to a medical laboratory, which carries out a medical lab test to detect the presence of SARS-CoV-2 infection or related antibodies. Commonly not only the patients will be informed of the outcome of the test, but also, in the case of a positive test result, the health authorities, in accordance with the specifications of the German Infection Protection Act ("IPA"), [Infektionsschutzgesetz, "IfSG"].
In April 2020, the Federal Union of German Pharmacists' Associations ("FUGPA"), referring to section 3 (4) MPAV, advised pharmacies against dispensing rapid antibody tests to patients or carrying out such tests in the pharmacy (https://www.pharmazeutische-zeitung.de/schnelltests-in-apotheken-nicht-erlaubt-117215/). At the beginning of September, the FUGPA also confirmed this view with regard to specimen- collecting kits (https://www.abda.de/aktuelles-und-presse/pressemitteilungen/detail/apotheker-duerfen-an-laien-keine-corona-tests-abgeben-1/).
Legal assessment and comments of the German Federal Ministry of Health
According to section 3 (4) MDDO, in-vitro diagnostics intended for the direct or indirect detection of a pathogen, or of a disease named in section 24 sentence 1 of the IPA or an infection with the corresponding pathogen, i.e. also for the detection of SARS-CoV-2, may only be supplied to specific recipients, i.e. primarily medical professionals and healthcare facilities. Patients and other medical laypersons do not belong to the group of permissible recipients in section 3 (4) MDDO. Exceptions to this prohibition exist for HIV self-testing kits (in accordance with Annex 3 to the MDDO) and where the Robert Koch Institute explicitly permits such tests for reasons of public health (cf. section 3 (5) MDDO).
As regards the above-mentioned in-vitro diagnostic home-testing devices as such, the prohibition on dispensing them under section 3 (4) MPAV is clear: they may not be dispensed to laypersons. But what about the dispensing of products for the taking and storing of specimens which are to be sent to a medical test laboratory? The utensils contained in the specimen-collecting kits may qualify as medical devices, often Class I, according to Directive 93/42/EC, or as in-vitro diagnostic medical devices according to Directive 98/79/EC. An in-vitro diagnostic device will be deemed to be such, in particular if the utensils used by the patients are, at least partly, "specimen containers" in the sense of section 3 (4) sentence 2 of the German Medical Devices Act ("MDA"). They are defined there as "evacuated medical devices or others which are specially prepared by their manufacturer to receive specimens derived from the human body immediately after their removal and store them for the purpose of in-vitro diagnostic examination". The essential criterion here is immediacy. It is only fulfilled if the specimen-container itself is used to take the specimen, i.e. comes into contact with the human body when the specimen is taken (see Hill/Schmitt, WiKo, Chapter II 1/sec. 3 MPG, margin No. 37). This must be ascertained individually for each specimen-taking container. Where the above definition cannot be applied, the products being used for the taking or storing of human specimens will regularly be deemed to be medical devices (but not in-vitro diagnostic devices).
If a specimen-taking set is an in-vitro diagnostic device, the application scope of section 3 (4) MDDO will become relevant. However, mere specimen-collecting kits are not subject to the dispensing prohibition: section 3 (4) MDDO, according to its protective purpose, aims to prevent home testing by medically laypersons. This follows from the explanatory memorandum to the MDDO (BR-Drucksache 235/14, p. 31) and from the very fact that in-vitro diagnostics for self-testing to detect HIV infection (HIV self-tests) have been removed from the scope of the ban (cf. Annex 3 to the MDDO, BR-Drucksache 357/18). Products intended for home collection and/or storage of specimens to be sent to a medical laboratory for analysis are not covered by the ban. They may also be supplied to laypersons.
Uncertainties due to the controversial debate of recent months were cleared up by the Federal Ministry of Health last week vis-à-vis representatives of the specialized press (see e.g. https://www.deutsche-apotheker-zeitung.de/news/artikel/2020/09/01/neuer-antikoerpertest-fuer-zuhause-sorgt-fuer-verwirrung-bmg-positioniert-sich) and explicitly confirmed to the authors.
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