Essential medicines and health products

WHO prequalifies first generic hepatitis C medicine and first HIV self-test


In the lead-up to the Paris AIDS Conference and World Hepatitis Day, WHO has prequalified two priority products to tackle both HIV and hepatitis C. The first WHO-listed generic sofosbuvir could extend treatment for this major disease to many more patients. And the first WHO-prequalified HIV self-test will improve diagnosis in low-resourced health systems and in countries where stigma prevents people from getting tested.

Global public consultation on WHO prequalification of similar biotherapeutic products

In September this year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. To ensure clear understanding of the prequalification process for biosimilar products and guide manufacturers wishing to submit their products, WHO is seeking public comments on three key guidance documents.

WHO to develop Essential Diagnostics List

The 20th WHO Model List of Essential Medicines was published on 6 June this year, with a number of important new additions, including a recommendation by the Expert Committee on the Selection of Essential Medicines that WHO develop an Essential Diagnostics List (EDL). Based on that recommendation, WHO has begun to lay the ground for the preparation of the list, which will become an important contribution to Universal Health Coverage (UHC).

Regulatory preparedness key to addressing public health emergencies


The 2014-2016 Ebola crisis in West Africa highlighted major shortcomings in the world’s preparedness for serious epidemics and public health emergencies. It also showed that National Regulatory Authorities (NRAs) have a strong role to play, but they must have strong preparedness and response plans in place. To that end, WHO held an informal consultation in Geneva, on 17-19 May, on options to improve regulatory preparedness and how WHO can support the process.

20th Essential Medicines List (2017)


The 20th Essential Medicines List, published on 6 June 2017, marks the 40th anniversary of this flagship WHO tool to expand access to medicines. The updated list adds 30 medicines for adults and 25 for children, and specifies new uses for 9 already-listed products, bringing the total to 433 drugs deemed essential for addressing the most important public health needs globally. The 20th List also provides new advice on which antibiotics to use for common infections and which to preserve for the most serious syndromes, based on a thorough review of all essential antibiotics. The aim is to optimise antibiotic use and reduce antibiotic resistance without restricting access. Other important additions include medicines for HIV, hepatitis C, tuberculosis and cancer.

Fair pricing forum paves the way for expanded access to medicines

Access to medicines is a major challenge for all countries as medicines prices soar, particularly for innovative products. Public health spending is limited and when prices are too high, access will be rationed, denying patients urgently needed treatment. At the same time, some older medicines whose price has sunk too low are disappearing from markets, signalling that too low prices are not good for access either. A fair pricing system therefore would mitigate these challenges by making high-priced medicines more affordable and at the same time provide more incentive for manufacturers to remain interested in innovation and in manufacturing older medicines.

WHO to begin pilot prequalification of biosimilars for cancer treatment


In September, WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO Essential Medicines List: rituximab (used principally to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia), and trastuzumab (used to treat breast cancer).

WHO prequalifies first generic active ingredient for hepatitis C medicines

On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir. Sofosbuvir is an essential ingredient for new, highly effective medicines to treat hepatitis C called direct active antivirals (DAAs). The prequalified product’s manufacturer is Mylan Laboratories Ltd - INDIA.



WHO Medicines and Health Products Programme Strategic Framework 2016 - 2030

The new 2030 development agenda and increasing globalization of health products development and supply have generated a need—and an opportunity—for WHO to adjust and strengthen its work in this area at all three levels of the Organization. WHO needs to ensure that headquarters, regional and country offices function more organically to deliver on development targets, and that health systems strengthening activities result in tangible progress for people everywhere. This new long-term framework for 2016–2030 aims to provide a broad vision and strategic direction to focus and reinforce WHO’s ability to help Member States achieve universal access to safe and quality-assured health products and universal health coverage.

Ocean Road Cancer Institute, Dar es Salaam, Tanzania