Essential medicines and health products

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.

Global strategy for access to health technologies in developing countries under review


The global strategy on public health, innovation and intellectual property (GSPOA) and the related plan of action were adopted in 2009 and are intended to enable low- and middle-income countries to have greater and more sustainable access to the medical products they need – medicines, vaccines and other health technologies. Guided by the central concept of needs-driven essential health research and development, the GSPOA represents the first comprehensive framework and promise of long-term funding to support countries’ strategies for pharmaceutical innovation. The GSPOA went through an evaluation in 2016. The current review, based on the evaluation, aims to clarify the GSPOA’s feasibility as a model and identify areas for potential improvement.

WHO finds India’s vaccine regulatory authority compliant with international standards

A team of international experts convened by WHO recently found India’s National Regulatory Authority (NRA) to meet WHO standards for vaccine regulation. This effectively means that India is well equipped to produce and monitor safe, effective and quality vaccines, and will facilitate WHO prequalification of Indian manufacturers, which will allow them to supply vaccines through the international procurement system.

Snakebite gaining momentum – access to quality antivenoms a top priority

One of today’s most neglected health problems, snakebite-induced death and disability, impacts on the lives of thousands, mostly the rural poor, and contributes to multiple issues that challenge subsistence agriculture and the overall quality of life in many settings. WHO has for several years advocated for greater attention to the issue, including the need for a broader public health approach to tackling snakebite envenoming that focuses on prevention, education and management. In addition, WHO has developed a large body of guidelines, in particular on the quality manufacture of antivenoms.



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