MSF calls on Global Fund Board to make urgent changes to prevent drug shortages and quality issues
NEW YORK/GENEVA, NOVEMBER 14, 2018—People in countries that are losing donor support from the Global Fund to Fight AIDS, Tuberculosis and Malaria are facing dangerous HIV and TB treatment interruptions and have been treated with drugs of unknown quality, said the medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) today at the start of the Global Fund board meeting.
MSF called on the Board to make urgent changes to Global Fund policies and practices for countries transitioning away from donor support. Current policies force many countries to pay much higher prices for medicines, and increase the risk of critical drug shortages and alarming drug quality issues, MSF said.
“The current pace of Global Fund country transitions, hastened by underfunding from donors, is creating a ticking time bomb where people’s HIV and TB treatment is jeopardized by unknown drug quality and drugs simply not being there,” said Dr. Els Torreele, executive director of MSF’s Access Campaign. “Allowing countries to fall off a cliff without mitigating the risks for people who need treatment could reverse nearly two decades of progress against two of the world’s deadliest infectious diseases.”
Beyond the countries that are about to transition from Global Fund support, even lower income countries are being called upon by the Global Fund to start paying for key medicines and diagnostics–often without assessing procurement challenges or financial capacity, and often in the absence of the robust risk mitigation planning needed to safeguard people’s access to treatment.
Over the last 16 years, the Global Fund’s central purchasing of HIV and TB treatment medicines and diagnostics has helped secure affordable prices through high-volume orders and by attracting multiple competing suppliers. Crucially, the Global Fund has also been instrumental in ensuring people’s access to quality treatment by requiring all drugs purchased with its funding to have quality approval from either the World Health Organization Prequalification of Medicines Program or a stringent drug regulatory authority.
The Global Drug Facility (GDF), which helps countries procure TB drugs, has documented a number of problems related to the Global Fund’s policies. In the past 18 months, 15 countries in Asia, Africa and the Eastern Europe, and Central Asia region have experienced shortages of TB drugs. Additionally, 29 countries in these regions along with Latin America have purchased TB drugs of unknown quality, and 21 countries have purchased TB drugs and tests at prices that far exceed what they would have paid through Global Fund support.
MSF has witnessed similar problems in countries where we work, including shortages of TB drugs in Armenia due to pharmaceutical corporations not registering their products in the country; shortages of pediatric HIV drugs in India due to a lack of quality-assured suppliers; and an unstable supply of HIV drugs in Guinea due to Global Fund co-financing expectations that exceed the capacity of national systems.
"We worry about more drug stock-outs in the future that could lead to treatment interruptions or treatment failure,” said Dr. Greg Elder, medical coordinator of MSF’s Access Campaign. “We’re calling on the Global Fund to look before it leaps and find solutions by working with countries and other players, because people’s lives are on the line. The number of drug stock-outs is an alarming sign that countries’ transition from Global Fund support is being handled in a rushed manner.”
In order to avoid drug shortages and quality issues, MSF calls on the Global Fund Board and Secretariat to urgently carry out risk and readiness assessments for countries expected to increase their co-financing of medicines and diagnostics, as well as countries currently undergoing transition. Transitioning and co-financing countries should also be offered flexibility to continue accessing drugs through the GDF or pooled procurement mechanisms to obtain quality medicines at affordable prices.
Transitioning countries with growing economic capacity also have a critical role to play in preventing drug shortages and quality issues, including by adapting laws to enable access to global markets and reinforcing national quality assurance standards.
“Ultimately, it’s the Global Fund’s donors that need to provide adequate funding so that its efforts to fight HIV and TB won’t be curtailed, including by continuing to enable the use of quality affordable drugs and tests needed to keep people alive and healthy,” Torreele said. “Hundreds of thousands of people have already been affected by TB drug stock-outs and quality issues. Now, HIV programs in many additional countries face similar risks. Unless action is taken by multiple actors to address these risks, this will grow to millions of people affected.”