Self-diagnosis HIV test now available in pharmacies without prescription

The public can now purchase self-diagnosis HIV tests from Spanish pharmacies since, following a proposal from the Minister for Health, Social Services and Equality, Dolors Montserrat, the Council of Ministers approved the Royal Decree in December that amends the legislation on healthcare products for "in vitro" diagnosis, removing the need for a prescription when selling self-diagnosis HIV products and enabling these products to be advertised for sale to the public.

To implement this new diagnosis method, a partnership agreement was signed in October 2017 between the Ministry of Health, Social Services and Equality and the General Council of Official Associations of Pharmacists to encourage the early diagnosis of HIV, one of the objectives of which is to undertake training and information actions for improved pharmaceutical action when dispensing healthcare products for the self-diagnosis of HIV.

In order for pharmaceutical professionals to have all the information they need to better dispense these products, the Ministry of Health, Social Services and Equality worked with the General Council of Official Associations of Pharmacists to produce a Guidebook on Pharmaceutical Action for the Dispensing of Healthcare Products for the Self-diagnosis of HIV.

This guidebook seeks to provide community pharmacists with the necessary knowledge regarding the HIV self-diagnosis test - what the test is and what it can detect, the possible results, what they mean, confirmation of the result at a clinical laboratory, where to go for more information and other tests, etc. - so they can answer questions from potential users regarding the dispensing of these products.

For more information on the HIV Self-diagnosis Test and other methods of prevention, the Ministry of Health, Social Services and Equality also provides the public with a multi-channel information and prevention service on HIV and AIDS, which is free and confidential, and managed by the Spanish Red Cross via 900 111 000 and the Red Cross HIV Info website.

Questions and answers for interested citizens

Furthermore, in order to facilitate the use of this healthcare product, the Ministry of Health, Social Services and Equality has published a document on its website containing frequently asked questions for those citizens wishing to use this test.

One in five people remains undiagnosed

In Spain, it is estimated that between 140,000 and 145,000 people currently live with the HIV infection, of which approximately one in five (18%) have not been diagnosed. Late diagnosis of the infection is one of the main obstacles to our response to this epidemic, given that increases the associated morbidity and mortality, and reduces any response to the treatment.

Under the Strategic Prevention and Control Plan for HIV and other Sexually Transmitted Diseases 2013-2016, extended to 2020, efforts are being made to foster the early diagnosis of HIV in order to reduce the proportion of people undiagnosed. Access to the test therefore needs to be improved, which includes the use of self-diagnosis products among other things.

In order to facilitate access to the test and bearing in mind that the prescription requirement for sale to the public of products for the self-diagnosis of HIV would pose a significant barrier to its use, the regulations have been amended to remove the need for a prescription when being dispensed. Similarly, in order to raise awareness about the existence of this test, it will now be possible to advertise these products for direct sale to the public.

Healthcare self-diagnosis products are only sold at pharmacies, meaning that this will be the exclusive channel for the sale of these items. However, by removing the prescription requirement, pharmacies will be able to make them available via the Internet.

Non official translation