Biznes Fakty
Emtricitabine/Tenofovir disoproxil Mylan. There are problems with availability in pharmacies
There is an issue with the accessibility of a medication utilized for treating individuals infected with HIV in pharmacies – such a report was received on Kontakt24. This information has been corroborated by the Chief Pharmaceutical Inspectorate, which acknowledges that availability may be challenging for several months.
An internet user brought this issue to light by sharing information with Kontakt24. It pertains to the medication Emtricitabine/Tenofovir disoproxil Mylan, employed in the treatment of HIV infection. The user pointed out that the difficulty in obtaining the medication has persisted for about two to three months. She mentioned that the unavailability of the drug has compelled many individuals to halt their treatment.
GIF regarding „limited access” to the medication
The editorial team at Kontakt24 sought confirmation of these claims from the Chief Pharmaceutical Inspectorate (GIF). The response from GIF suggests that the challenges for patients may not be resolved promptly.
„The cause of the limited access to the medicinal product Emtricitabine/Tenofovir disoproxil Mylan is the temporary halt in its introduction to the market, which has been reported to the President of the Office for Registration of Medicinal Products by the responsible entity,” – as stated in the response from GIF. This responsible entity refers to the pharmaceutical company that manufactures the drug.
„We have been observing restricted access to the mentioned medicinal product since mid-February 2025 and we anticipate that this will persist until the conclusion of the temporary marketing suspension, which is expected to be at the end of October 2025,” the statement added.
According to GIF, a corresponding alternative is available in circulation – Emtricitabine + Tenofovir disoproxil Aurovitas.
„However, due to the shortages of the Emtricitabine/Tenofovir disoproxil Mylan product, its availability may currently be limited. The replenishment of stocks for the Emtricitabine + Tenofovir disoproxil Aurovitas product is expected to occur in March (the MAH is likely planning to deliver the product to Poland next week),” it was clarified.
„Furthermore, to enhance the general availability of medicinal products containing emtricitabinum + tenofovirum disoproxilum, the Minister of Health has granted, in accordance with art. 4 section 8 of the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686), consent for temporary marketing authorization of the medicinal product via so-called intervention import (medicinal products in foreign language packaging may become available on the market),” – reported GIF.
„The issue is the unavailability of the preparation in open pharmacies”
Dr. Błażej Rozpłochowski, MD, from the Department of Infectious Diseases at the Józef Struś Multi-Specialist Municipal Hospital in Poznań, clarifies that there are no issues with the availability of the drug for individuals living with HIV. The medication is supplied by the National AIDS Center to facilities that provide antiretroviral therapy.
– The challenge, however, lies in the absence of the preparation in open pharmacies – he adds.
This means that the medication is currently inaccessible to those who wish to initiate or continue HIV pre-exposure prophylaxis – PrEP. – The concept of PrEP is to avert infection at the moment the virus enters the body, preventing the onset of a long-term infection. It is estimated that over four thousand individuals in Poland utilize PrEP – the doctor explains.
As he pointed out in an interview with TVN24, „the lack of access to the medication may lead to a disruption in prevention efforts and contribute to a rise in the number of new HIV infections.”
Moreover, the Emtricitabine/Tenofovir disoproxil medication, when combined with a third drug, is also employed in HIV post-exposure prophylaxis (PEP). – The unavailability of the medication might result in insufficient protection following exposure to HIV infection – Dr. Błażej Rozpłochowski explains.
HIV infections in Poland
Since the first recorded case of HIV infection in Poland in 1985, nearly 33,000 infections have been documented, over 4,000 individuals have developed AIDS, and 1,496 patients have succumbed to the disease.
HIV is the human immunodeficiency virus. The infection can remain asymptomatic for many years, complicating diagnosis significantly. It may not manifest any symptoms for as long as 8-10 years, yet during this time, the virus continues to replicate and damage the immune system of the infected individual. It has the potential to cause acquired immunodeficiency syndrome – AIDS.
