ÖAustria, you’re better off, one might think with a view to quick corona tests. In the pharmacies of the neighboring country, the customer has the choice: Either they have the smear done there, for example because they need a negative certificate for the hairdresser. This is free of charge for those with statutory health insurance, otherwise it costs 24.90 euros. Or the customer can buy a self-test at home for 14.90 euros. No unpleasant nose picking or throat picks are necessary for this “spit test”, but it should be used early in the morning on an empty stomach, when the viral load is highest.
In Germany, this type of self-examination is still a few weeks away. The pharmaceutical company Roche wants to bring its first product to market in mid-February, and 30 more tests are waiting for so-called special approvals at the Federal Institute for Drugs and Medical Devices (BFarm). This could be done from the beginning of March.
The political and legal path to self-testing has been mapped out since Tuesday. A draft of the Federal Ministry of Health for the “expansion of the national test strategy” became known, according to which the federal government wants to greatly expand the capacities for corona tests – “in time for the gradual lifting of the contact restrictions (‘winter lockdown’)”, as the paper says .
On the one hand, there is the assumption of costs for professionally applied rapid antigen tests “for all citizens” from March 1st. On the other hand, the next Corona cabinet should approve the inclusion of “layman rapid tests” in the test ordinance on the basis of the recommendations.
One procedure has already been concluded
As it is said, the house of Jens Spahn (CDU) is currently negotiating with the manufacturers about the purchase of minimum quantities for the German market. It is important to “secure budgetary law”, says the draft as a request to Finance Minister Olaf Scholz (SPD). On the one hand, the self-applications are to be used in schools and day-care centers as part of the test strategy of the federal states. On the other hand, the federal government wants to offer it to everyone as “low-threshold access” as part of its national test strategy. A personal contribution of one euro per test is considered.
The market introduction of home or lay tests is actually uniformly regulated in the EU. Medical devices need a CE mark in order to be marketed in Europe. They receive this from “Notified Bodies”, in Germany from the TÜV. One of the three responsible local test centers is TÜV Süd. It says there that such self-user tests are currently being tested. You don’t want to say how many manufacturers are involved.
Just this much: a procedure has already been concluded. In addition to a lot of data, for example, clinical studies are also required to show that laypeople can use the test correctly and evaluate it themselves. “We currently do not see any bottlenecks in terms of test procedures for self-user tests,” said Tüv Süd, with over 900 medical device specialists worldwide. With the first registration, however, there are “small delays” when checking the production facilities due to local travel restrictions. Because the companies often have production partners or plants abroad.
How safe are self-tests?
However, special approvals by the BFarm are also possible. These usually take place more quickly, but are spatially limited to Germany and temporally to the pandemic phase. In addition, they are tied to many requirements, such as proof that an application has been submitted to a notified body or at least sought. The product must also have a CE mark for professional use, for example in test centers. A positive evaluation by the Paul Ehrlich Institute is also required.
It is particularly important to the BFarm and the superordinate Ministry of Health that the test really works at home. That the instructions for use are understandable and that the application is simple: for example from the sputum or with a smear from the front of the nose or throat. “The thing has to be really foolproof, otherwise it will do more harm than good,” says one participant. In Austria, one trusts the manufacturer’s information on usability without being checked by a qualified body. “That weighs in with a false sense of security.” In fact, the tests in Austria do not have a CE mark either, otherwise they would also be approved in Germany.
No government review
Miriam Schuh, attorney for health issues at Reusch Law Consultants, speaks of “window dressing” when it comes to the usability and safety of these tests in Austria. “In Austria, the federal government, through the competent authority (BASG), is not responsible for checking self-tests for self-application,” she says. There the manufacturers only have to sign a declaration of self-commitment, according to which the tests are safe.
“But you don’t have to submit a single document to prove that, there is no test,” she says. In terms of liability law, this is a catastrophe. “Because the fact is that the self-use tests don’t even exist yet, that won’t come until the beginning of March at the earliest,” she says. In Austria, the tests are also designed for professional users and are simply given to laypeople via the “crutch” of the declaration of self-commitment, she warns. For the layman, this is an impenetrable constellation in the event of damage. People are slower in Germany, but think they are more thorough.