The VDGH welcomes the fact that the draft ordinance extends Annex 3 (to Section 3 (4)) of the Medical Devices Dispensing Ordinance to include in-vitro diagnostics for self-testing for the detection of influenza viruses. The lay dispensing of combination tests that detect influenza viruses, among other things, is thus legally safeguarded.
The Second Ordinance amending the Medical Devices Dispensing Ordinance already made the free dispensing of tests for self-testing more permanent. This was objectively necessary in order to be able to prevent new infections regardless of whether an epidemic situation was identified. The continuation therefore also applies to tests for the detection of influenza viruses.
The use of self-administered tests to detect the SARS-CoV-2 coronavirus has proven to be an indispensable tool during the pandemic. Self-administered tests have not replaced medical diagnostics, but have usefully supplemented them. The differentiated use of laboratory diagnostic procedures in relation to different groups of people and settings was underpinned by the Coronavirus Testing Ordinance and the German government's testing strategy.
The simple and error-free handling of a coronavirus self-test as well as the layman-friendly presentation of the test result and its interpretation are prerequisites for a successful conformity assessment procedure. This has been proven hundreds of millions of times in practice over the past three years. In this respect, the VDGH agrees with the reasoning behind the regulation to the effect that there is no reason "that this should be any different for influenza A + B".
Technological developments enable efficient panel diagnostics
Technological developments, in particular miniaturization, have significantly advanced the development of panel diagnostics in recent years. This is a blessing for infection diagnostics, as it allows various pathogens (e.g. bacteria, viruses, parasites) to be detected uno actu and in a comparatively short time.
Since July 1, 2022, various diagnostic panels have been billable in the standardized evaluation scale (EBM) in contract medical care. Listed are the nucleic acid detection of one or more pathogens of acute respiratory infections (GOP 32851), the nucleic acid detection of one or more pathogens of sexually transmitted infections (GOP 32852) and the nucleic acid detection of one or more pathogens of acute gastrointestinal infections (GOP 32853).
Respiratory panels with swab tests are already available as CE-marked tests for self-testing. If these tests include options for detecting other pathogens listed in Section 7 IfSG (e.g. Legionella sp.), the tests would not be dispensed until the MPAV is amended again. Such a procedure does not appear to be appropriate.
Market access restrictions: Reversal of the rule/exception principle required
§ Section 3 (4) MPAV basically constitutes a market access restriction, as in vitro diagnostic medical devices for self-testing are generally freely marketable on the European market if they bear the CE conformity mark. Under European law, market access restrictions are permissible for certain overriding reasons (e.g. protection of the general public from the spread of infectious diseases). However, such restrictions must be kept to a minimum.
The market restriction in Section 3 (4) MPAV arises from the reference to Section 24 sentence 1 of the Infection Protection Act (IfSG), which establishes the doctor's proviso for the detection of certain pathogens and thus excludes the lay provision of corresponding tests. The relevant Section 7 IfSG lists almost sixty such pathogens. Annex 3 (to Section 3 (4)) of the MPAV contains only two exceptions to this far-reaching restriction on market access, namely in vitro diagnostics for self-testing that are intended for the detection of HIV infection and in vitro diagnostics for self-testing that are intended for the direct detection of the SARS-CoV-2 coronavirus. These two exceptions were established at different times and for very different reasons.
From the VDGH's point of view, the rule/exception principle should be reversed so that market access restrictions are kept to a minimum.
On the individual regulations
§ Section 3 (4) MPAV
To reverse the rule/exception principle described above, an amendment to Section 3 (4) MPAV is proposed as follows:
§ 3 para. 4 new:
"In vitro diagnostic medical devices intended for the direct or indirect detection of a pathogen specified in Section 7 of the Infection Protection Act may only be supplied to:
- Doctors
- Outpatient and inpatient healthcare facilities, wholesalers and pharmacies,
- Health authorities of the federal government, the federal states, the municipalities and municipal associations,
- Blood donation services, pharmaceutical companies,
- counseling and testing facilities for particularly vulnerable groups of people.
This does not apply to in vitro diagnostic medical devices for self-testing, unless they are intended for the detection of a pathogen listed in Annex 3."
Justification:
Sentence 1 should be amended, as the current wording refers to Section 24 sentence 1 IfSG. However, this does not mention either diseases or pathogens. In our opinion, sentence 1 should correctly refer to Section 7 IfSG.
Sentence 2 reverses the rule/exception principle. The dispensing of self-administered tests by laypersons is generally possible (free marketability). Exceptions to this are explicitly listed in a new Annex 3. These are the pathogens listed in Section 7 IfSG, for which the lay administration of tests is excluded for overriding reasons.
