Spain set to authorise the sale of coronavirus self-diagnosis tests

File photograph.
File photograph. / SUR
  • The Ministry of Health will allow the sale of the tests, without a prescription, in pharmacies

Spain will, next week, approve the sale of Covid-19 self-diagnosis kits in pharmacies - without the need for a medical prescription.

It represents a radical change in the strategy of Ministry of Health which, until now, had refused to allow the distribution of these tests because it alleged that they gave a false sense of security, apart from the fact that it did not consider them entirely reliable, especially without health supervision.

Head of the department, Carolina Darias, has said that the authorisation for the sale in pharmacies will be for an "in vitro diagnostic" test, and it comes after a favourable report was presented last Friday and saw no basis to prevent the commercialisation of these products, which are already distributed in many European countries.

The head of national public health insisted that the decree, set to be approved next week, will eliminate the "barrier" of the "medical prescription" because in recent times experts at the Ministry of Health have changed their criteria and consider it "very important" to increase the "capacity for self-diagnosis", particularly so that "asymptomatic" patients can be located. Now that the virus mainly affects young people between 12 and 29 years old, the majority carry the disease with hardly any symptoms but could infect other people.

The decree will allow these tests to be advertised, so it is likely that in a matter of days they will appear on television screens across the country.

Since the start of the pandemic, the Health department was reluctant to allow the use of coronavirus tests by non-health personnel, arguing that the general public would not be able to interpret the results. In fact, in September of last year, a Royal Decree was published that regulated the manufacture, import, certification, marketing, distribution, advertising and use of "in vitro" diagnostic medical devices. This expressly established the requirement of a medical prescription for the acquisition of these tests.

The radical change in position comes after months of pressure and requests, both from the regions and the pharmaceutical sector, which has thousands of diagnostic tests in its warehouses that could only be released to the health professionals, unlike other European countries, such as Germany where these products have even been sold in supermarkets since last spring.

The draft decree says, "Facilitating access to these tests is key to increasing the diagnostic capacity and thus improving the early detection of suspected positive cases and achieving adequate management of the progression of Covid-19.”

The text also refers to the self-diagnostic tests for antibodies, which "although they are not useful for detecting an active infection, will also contribute to reducing the healthcare pressure of the National Health System.".

According to the draft, the mass use of these tests will also have a positive economic impact because it is expected they will "help effectively control the spread of the virus and therefore reduce mobility restrictions and allow the resumption of normal activities."