On 6 October 2025, the World Health Organization (WHO) announced the prequalification of lenacapavir, a breakthrough long-acting injectable medicine for HIV prevention. The news was rapidly spread across general and specialized media. But a key question remains unaddressed: what does WHO prequalification really add for a medicine already approved by some of the world’s most stringent regulators, including in the United States and Europe?

The WHO Prequalification was created in 1987, to guide UN agencies and health programmes on the procurement of vaccines manufactured in countries with weak regulatory systems. After 2000, it expanded to other health products. Its impact was transformative. For example, it enabled the global upscale of vaccination programmes (with now over 2 billion vaccine doses annually through UNICEF) and of HIV antiretroviral therapy in low- and middle-income countries (LMICs).

Lenacapavir, however, is a different story. It had already passed stringent regulatory assessments particularly by the US FDA and European Medicine Agency (EMA). The added value of WHO prequalification would be clear if the WHO-prequalified product was a different version of Lenacapavir, for instance, from a production site in a less-regulated country. But based on public information, it is the same product authorized in the European Union and United States of America: same formulation, same manufacturing sites, no new inspection required. According to EMA  documentation (see here and here) it will simply be marketed with a different brand name for export markets.

The introduction of a new brand for WHO prequalification suggests a shift in purpose—from facilitating access to aligning with commercial or regulatory interests. Gilead Sciences now markets Yeytuo® in Europe, Yeztugo® in the USA, and Lenacapavir-Gilead® for “other countries” – all for HIV prevention; and Sunlenca®, for multidrug-resistant HIV-1. They are all exactly the same product. This regulatory segmentation coupled with brand segmentation does not come without consequences. First, it strengthens ‘niches’ where prices depend on the therapeutic indication and on the market strategy. Second, it might hamper global access. In case of shortages, the production of brands for high-price markets might get priority, while the regulatory segmentation would prevent the import of, let’s say, Yeytuo®  or Yetzugo® toward a low-income country—even though the medicines are technically identical.

According to a 2017 WHO report, an average of 10 percent of medicines in low-resource settings are substandard or falsified. Yet there is still no WHO PQ system for antibiotics, despite the global urgency of antimicrobial resistance, nor for other products that are critical for public health, including most medicines for noncommunicable diseases, pain relief, mental health, and many pediatric medicines.

All over the world, market failures and weak regulatory oversight continue to limit access to quality-assured products, putting lives in danger. Sure, regulatory procedures are complex, and WHO prequalification’s reliance on EMA or FDA requires a solid legal basis and expert reflection. Yet, prequalifying medicines approved by regulators that WHO itself recognizes as reference authorities risks diverting scarce resources from its core mandate—support access to affordable, quality-assured medicines where oversight is (still) weakest. Lenacapavir is hugely important, but it appears it’s time for a reflection on whether WHO’s efforts are really best spent on “re-labelling” quality-assured medicines, instead of addressing unmet needs.

Authors thank Cécile Macé for her kind contribution in the preparation of this blog