Step by step towards self-testing: Due to the Covid-19 pandemic, which continues to impinge upon everyday life, the German Federal Ministry of Health (Bundesministerium für Gesundheit, “BMG”), after approving the distribution of point-of-care (PoC) rapid antigen tests to certain community facilities, is now also paving the way for the distribution of in-vitro diagnostics for self-testing purposes, intended for direct pathogen detection of the coronavirus SARS-CoV-2 to laypersons and, for the second time ever, is overturning the restriction for use by physicians only, which is provided for under infection control regulations.
The path to coronavirus (self-) testing for laypersons
In order to ensure effective protection against infection, Section 24 of the German Infection Prevention Act (Infektionsschutzgesetz, “IfSG”) stipulates in principle that diseases subject to infection prevention regulations or infections with a relevant pathogen (which includes SARS CoV-2) may only be diagnosed or treated by a medical doctor. To ensure that this requirement is met, Section 3 para. 4 of the German Medical Devices Dispensing Ordinance (Medizinprodukte-Agabeverordnung, “MPAV”) provides that in vitro diagnostics intended for the direct or indirect detection of a pathogen which is notifiable according to the IfSG may only be dispensed to physicians, public health authorities and other privileged recipients. This restriction is supplemented by Section 12, para. 1 sentence 1 no. 2 German Health Care Advertising Act (Heilmittelwerbegesetz, “HWG”), according to which such in-vitro diagnostics may not be advertised to laypersons. Exceptions to the dispensing prohibition under the MPAV for in-vitro diagnostic products arise from Annex 3 of the MPAV, which previously only covered self-testing kits for HIV, and to the extent that the Robert Koch Institute (RKI) allows for temporary exceptions whenever necessary for public health reasons (cf. Section 3 para. 5 MPAV). Under health care advertising law Section 12 para. 1 sentence 2 HWG refers to Annex 3 of the MPAV and thus establishes conformity between the restriction on sales and the restriction on advertising. This means that in-vitro diagnostics for the detection of an infectious disease for lay use may only be advertised to laypersons if the corresponding test may also be supplied to laypersons.
In the past, there was scepticism about the laboratory test kits already available for laypersons, i.e. those test kits with which the laypersons would take their samples themselves and then send the samples to a laboratory for testing. The BMG had to clarify that Section 3 para. 4 MPAV only prohibits the dispensation of so-called home testing kits, i.e. self-tests, to laypersons. However, laboratory test kits may be distributed to laypersons and the laboratory testing made possible by them for the detection of coronavirus infections may be provided (see also LG Hamburg (District Court of Hamburg), judgement of 17 November 2020, file reference: 416 HKO 144/20). However, the question of whether and how these laboratory test kits may also be advertised and thus brought to the attention of laypersons in the first place has not yet been conclusively clarified. This is because according to Section 12 para. 2 HWG, any form of advertising for "procedures", e.g. for the detection of pathogens that are notifiable according to the IfSG, which includes SARS-CoV-2, is basically prohibited towards any layperson. Since – due to the broad understanding of "advertising" – even the description of the field of application and possibly even just the name could be covered by this advertising restriction, distribution would be de facto excluded. The District Court of Hamburg therefore ruled that the pure product description of laboratory test kits – without advertising surplus – was not covered by Section 12 HWG (see also LG Hamburg, judgement of 17 November 2020, file reference: 416 HKO 144/20).
Thus, up to now, only laboratory test kits – and this only under restrictions – could be distributed to the general public.
Already in November 2020, a first relaxation occurred: the distribution of PoC rapid antigen tests for near-patient use in certain community facilities was made possible via the inclusion of Paragraph 4a in Section 3 MPAV and the amendment of Section 24 IfSG (see Drittes Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite (Third Act for the Protection of the Population in the Event of an Epidemic Situation of National Significance of 18 November 2020)). Since then, it has been possible to carry out the corresponding PoC rapid antigen tests in the community facilities covered by the amendment, such as care homes, schools, day-care centres, facilities for people with disabilities, but also in shelters for the homeless or prisons. According to the German Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung, “MPBetreibV”), the operators of the community facilities must ensure that the tests are carried out by persons who have the necessary training/knowledge and experience and have been instructed in the use of the PoC rapid antigen test. The regulation is limited to the duration of the epidemic situation of national significance pursuant to the IfSG.
However, in order to be able to control the incidence of infection in Germany at an early stage and on a permanent basis, the distribution of coronavirus self-test kits to laypersons has now also been provided for, since February of this year. With the Third Ordinance Amending the MPAV, of 1 February 2021, Annex 3 of the MPAV was supplemented – without any time limit – to now include "in vitro diagnostics for self-testing intended for direct pathogen detection of the SARS CoV-2 coronavirus". In principle, in-vitro diagnostics must be CE-certified according to Section 5 of the German Medical Devices Ordinance (Medizinprodukteverordnung, “MPV”) in conjunction with EU Directive 98/79/EC (“IVD Directive”) in order for the products to be marketable. For in-vitro diagnostic devices for self-testing, it is particularly necessary that the conformity assessment procedure is carried out with the involvement of a notified body (cf. Annex III No. 6 of the IVD Directive). Only those coronavirus self-tests will be able to obtain CE certification that can be demonstrably used safely by laypersons and reliably lead to a sample being taken and a result being obtained. Therefore, as with all in-vitro diagnostic devices for self-testing, the instructions for use will be of particular importance.
In addition, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, “BfArM”) may, in the interests of health protection, allow coronavirus self-testing kits to be placed on the market for a limited period of time without CE certification by means of a special approval under Section 11 of the German Medical Devices Act (Medizinproduktegesetz,”MPG”). In this procedure, too, it must be proven that the in-vitro diagnostic device fulfils the relevant safety and performance requirements, such as the applicable technical standards. According to publicly available information, the BfArM currently has about 30 applications, of which, according to the Federal Ministry of Health, the first three manufacturers received special approvals on 24 February 2021. A constantly updated list can be viewed on the BfArM website here. Dispensing is possible through drugstores, discounters or in retail stores. I.e. the Federal Ministry of Health did not follow the original demand of the Federal Union of German Pharmacists’ Associations (Bundesvereinigung Deutscher Apothekerverbände e.V., “ABDA”) to dispense coronavirus testing kits only through pharmacies (sources (in German here and here).
With the inclusion of the coronavirus self-test kits in Annex 3 of the MPAV, these tests may also be advertised to the public according to Section 12 para. 1 sentence 2 HWG. The advertising is restricted by the prohibition of misleading statements (Section 3 HWG, Section 5 German Unfair Advertising Act (Gesetz gegen den unlauteren Wettbewerb, UWG)), which is interpreted particularly strictly in the area of health-related advertising. According to this, advertising claims are only permissible if they correspond to established scientific knowledge (see Federal Court of Justice (Bundesgerichtshof, “BGH”), judgement of 6.February 2013 – file reference: I ZR 62/11 – Basic insulin and weight advantages). This leads to the fact that, in particular, claims about the performance and reliability of the coronavirus self-test kits are only permissible if they are substantiated by high-quality clinical studies. It should be noted that the advertising requirements for scientific proof usually go beyond the documentation to be provided in the CE certification procedure. With increasing competition among the various manufacturers of coronavirus self-test kits, the prohibition of misleading statements and its enforcement with the help of competition law will gain decisive importance. In particular, established manufacturers who have tested their self-test kits in high-quality clinical trials will be able to defend themselves against "free riders".
Even attacks on the instructions for use and the product packaging under competition law cannot be ruled out. The consequences of a court order range from a temporary halt to sales to the recall of products that have already been delivered; in addition, there may be claims made for information and damages. Manufacturers of coronavirus self-test kits are therefore well advised to check their essential marketing material for its conformity with health care advertising law before entering the market.
The introduction of coronavirus self-tests for laypersons also raises questions regarding possible liability in the event of (consequential) damages occurring. In principle, in the absence of an independent liability regulation in European Union law and the German MPG, liability of a manufacturer of in vitro diagnostic medical devices is provided for under the general rules of liability law, such as, in particular, the German Product Liability Act (Produkthaftungsgesetz, “ProdHaftG”), which is independent of fault and provides for so-called strict liability, or under the liability standards of Sections 823 et seq. of the German Civil Code (Buergerliches Gesetzbuch, “BGB”).
According to the ProdHaftG, the manufacturer or the persons who, according to Section 4 ProdHaftG, have established themselves as the manufacturer, e.g. by affixing their name or trademark, and whom the law therefore equates with the manufacturer, are liable for material damage and personal injury caused by the product, insofar as the product was already defective when it was placed on the market (cf. Section 3 ProdHaftG). In parallel, a liability of the manufacturer according to Sections 823 et seq. BGB is also conceivable, in particular insofar as the respective claimant can prove fault on the part of the manufacturer. If the layperson disregards the manufacturer's instructions for use or warnings when using the product, the obligation to pay compensation could be reduced under Section 6 ProdHaftG, Section 254 BGB due to contributory fault on the part of the injured party.
It is unlikely that vendors, such as pharmacies, could be targeted for possible liability under the ProdHaftG, but experts recommend informing them about the use of the test. For the (direct) seller of coronavirus self-tests, a claim may be made under the general warranty regulations of the law on sales according to Sections 433 et seq. BGB.
Furthermore, liability of a supplier of coronavirus self-tests is possible according to Section 4 para. 3 ProdHaftG, if the manufacturer of the product cannot be ascertained or the supplier cannot name the manufacturer or its upstream supplier within one month.
These general liability regulations are not affected by the current amendments to the German Medical Devices Dispensing Ordinance. In principle, the Federal Ministry of Health would be authorised, according to Section 5 para. 2 sentence 1 No. 4 lit. a IfSG, to issue exemptions from the provisions of the law on medical devices by ordinance (only) with regard to "the manufacture, labelling, authorisation, clinical testing, use, prescription and dispensing, import and export, transfer and liability". Conversely, exceptions to the safety requirements (e.g. Section 4 MPG) are not permitted. With regard to other laws, the explanatory memorandum to the draft law on the protection of the population in the event of an epidemic situation of national significance (BT-Drs. 19/18111, page 20) clarified as regards Section 5 para. 2 no. 4 lit. a IfSG: "General provisions, such as those of the Civil Code or the Product Liability Act, remain unaffected".
In the event that damages occur as a result of (the use of) a coronavirus self-test, claims could therefore be brought against the manufacturer if the other necessary conditions were met. Whether the coronavirus self-test may be placed on the market on the basis of a conformity assessment procedure involving a notified body or on the basis of a special authorisation by the BfArM will not be of distinctive relevance for the manufacturer of a coronavirus self-test with regard to a possible liability claim.
Authored by Joerg Schickert, Nicole Boeck, Tina Welter and Michael Penners.