Early diagnosis of HIV- On 30 December last year, the BOE published the Royal Decree 1083/2017. This is a regulation which amends the Royal Decree 1662/2000, of 29 September on in vitro diagnostic medical devices. This change regulates the sale to the public of self-testing medical devices for the detection of the human immunodeficiency virus (HIV) in pharmacies.
This new Royal Decree will be implemented in pharmacies thanks to an agreement signed by Elena Andradas, Director General of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality, and Jesús Aguilar, President of the General Council of Pharmacists. And with this agreement, one of the objectives set by the Strategic Plan for the Prevention and Control of HIV and Other Sexually Transmitted Infections 2013-2016.
How does the Royal Decree affect early diagnosis of HIV?
Until now, Spanish legislation on in-vitro diagnostic medical devices obliged pharmacies to sell these products only if the patient had a doctor's prescription. Therefore, in order to obtain an HIV diagnosis, a visit to a doctor was a prerequisite. And while it is true that various associations and patient groups offered these tests as a service to the community, they did so outside the legal framework.
Thanks to the new Royal Decree 1083/2017, In addition, it facilitates the public's access to these products for self-testing in pharmacies. And, as Jesús Aguilar says, “it takes advantage of the wide coverage and professionalism of the pharmacy network to promote early detection of HIV”. In other words, it will be possible to buy in pharmacies, where there are also professionals with a technical profile, capable of offering pharmaceutical advice people who want to take the test.
Apart from the interest for the pharmaceutical sector, this new regulation has a positive impact on the population as a whole. On the one hand, it significantly reduces the number of visits to primary care centres for HIV testing. This represents a direct saving for the Social Security coffers.
And on the other hand, a direct improvement for patients and groups at risk of infection. Today, a large number of people in Spain are infected with HIV and do not know it. If we take into account two factors, one increased likelihood of infection and a high rate of late diagnosis, The conclusion can be drawn that the model prior to the approval of Royal Decree 1083/2017 was conducive to:
- Higher morbidity and mortality rate
- Decreased response to treatment
Early diagnosis of HIV: a new pharmacy service for the community
From GTF, we value the initiative very positively. We believe that it brings a benefit to society as a whole, as it will allow easier access to devices for self-testing. And in a few years, if this legal initiative has worked, it will result in a reduction in the rate of HIV infection and a decrease in late diagnosis, and all this without renouncing the advice of a health professional - in this case, the pharmacist - to get tested!
Do you need more information on how this new Royal Decree affects you? Do you want to market a new HIV self-testing device and don't know where to start? Do you want to get advice from an expert? expert in regulatory affairs for CE Marking of Medical Devices? Consult the Technical Pharmaceutical Cabinet M. Camps. Our proposal: solutions!