The National Commission of Markets and Competition (CNMC) has expressed this Friday its rejection of self-diagnostic products, such as pregnancy or Covid-19 tests, are exclusively for sale in pharmaciesTherefore, it has issued a recommendation to reverse the situation. He argues that this exclusivity does not occur in other European countries. It also advocates justifying the new requirements for a prior operating license and specifying the requirements for granting them.
The General Council of COF is not going to enter, for the moment, to assess this recommendation, as it has stated to this medium. However, regarding the position of the CNMC, Luis Maria de Palaciopresident of the Spanish Pharmacists Business Federation (FEFE), has shown his indignation and discomfort to this medium: “The Commission has some very incoherent and irresponsible positions Regarding this sector, if we consider the silence it kept when pharmacists asked to do the first covid tests or now when we ask for the use of the infrastructure and human capital of our pharmacies. However, it is now looking at these products, which are regulated the same as medicines.”
And he adds: “Before we were able to save more lives; now we can make primary care closer and more sustainable. But no, what is relevant is that the tests are in the promotion headlines of the large surfaces”.
This statement from the CNMC comes almost two months after have analyzed the regulatory project by which Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017, on diagnostic medical devices is incorporated into the Spanish legal system in vitro(IPN/CNMC/009/23). In other words, the Royal Decree Project regulating medical devices for diagnosis in vitro,who has been in public hearing from May 24 to June 13, 2023. It is will replace the Royal Decree 1662/2000, of September 29.
In the report that the CNMC published last May, it acknowledges that “diagnostic medical devices in vitro are one of the categorieswithin the market of sanitary products, has experienced greater growth, due to the exponential increase in demand caused by the health emergency of Covid-19″.