The GDF: A New Perspective on TB Procurement

The Global Drug Facility (GDF) is a mechanism for saving lives. The GDF is an initiative to increase access to high quality tuberculosis (TB) drugs for DOTS implementation, a TB control strategy. Globally, TB is the leading curable cause of infectious death. The GDF is housed in WHO headquarters in Geneva and managed by a small team in the Stop TB partnership secretariat.

The GDF is not a traditional procurement mechanism. It has adopted a new perspective on TB drug procurement, by linking demand for drugs to supply and monitoring, outsourcing all services to partners on a competitive basis, using product packaging to simplify drug management and linking grants to TB programme performance. The GDF provides a unique package of services, including technical assistance in TB drug management and monitoring of TB drug use, as well as procurement of high-quality TB drugs at relatively low cost.

 By every measure the GDF is one of the most effective ways to support DOTS and save human lives at risk from TB.

We aim to:

• Save 25 million lives and prevent 50 million new TB cases by 2020
• Prevent new strains of drug-resistant TB emerging
• Make purchasing TB drugs more cost-effective
• Improve the quality of TB drugs globally

Why do we need a GDF?

The GDF is important because it tackles head on the main barrier to preventing and eliminating TB: infrequent and poor quality drug supplies to TB patients. A constant and reliable supply of high-quality drugs means that the WHO-recommended strategy for fighting TB, DOTS, can be expanded by governments. One element of the GDF mandate is to ensure that TB drugs meet WHO quality standards and are procured within strict regulations. Low quality drugs damage patient recovery and increase the likelihood of drug-resistant strains of TB. Taking out the work of ensuring an uninterrupted supply of quality drugs, frees up precious financial and human resources in poor countries.

How does the GDF work?

All governments as well as non-governmental organizations (NGOs) working with the respective national health ministry are able to apply for a GDF grant. Countries complete an application including information on TB drug needs, a description of a DOTS expansion plan and the national TB programme, country statistics on TB and plans for distribution of drugs. Once approved (on the basis of application materials), a GDF team travels to the country to meet with government officials and evaluate drug needs and distribution capacity. Following the country visit, the application is either officially approved and terms and conditions of the grant finalized or the application is rejected.

What is DOTS?

DOTS, or Directly Observed Treatment, Short-course, is a combination of regular TB drug dosage and clinical observation and visits. According to the WHO, using DOTS increases TB cure rates by 20-50%, reduces deaths by 10-30% and prevents the spread of multidrug-resistant TB (MDR-TB). As a system for combating TB, DOTS has been adopted by over 130 countries. Currently 69% of TB patients have access to DOTS. Together the global plan for DOTS expansion and the GDF have the potential to hep reverse this epidemic and improve global public health by catalyzing expanded TB control efforts.

It aims for:

• Sustained political commitment
• Quality-assured TB sputum microscopy
• Standardized short-course chemotherapy for all cases of TB under proper case-management conditions, including direct observation of treatment
• Uninterrupted supply of quality-assured drugs
• Recording and reporting system assessing every patient and overall programme performance

LITTLE-KNOWN DRUG PROGRAMME REACHES FOUR MILLION IN FOUR YEARS

Ask the average American what kind of threat tuberculosis (TB) poses to global health and you’re likely to be met with a puzzled expression and a response somewhere along the lines of, “Didn’t we get rid of it years ago?”

Most people don’t know that almost a third of the world’s population - roughly two billion people - are infected with TB. Although the disease remains dormant in most, millions of those infected – especially those with compromised immune systems resulting from HIV/AIDS – develop active TB and two million die each year. Most are adults in the prime of life who leave behind school-age children and a tremendous void in the community.

Yet behind these grim figures lies great hope thanks to a massive effort by the World Health Organization and the Stop TB Partnership to bring TB under control.

India’s success story

On the outskirts of New Delhi, India, a small shoe store sells more than footwear. During an average week, 20 TB patients drop by to receive their prescribed dose of TB medicine. The shop owner is also a volunteer health worker and is part of India’s massive effort to bring TB under control by making DOTS (Directly Observed Treatment, Short-course), a TB control strategy, easily available to anyone with the disease. To make this a reality, treatment must be brought to areas where people live and work. In the case of India, a shoe shop where 90 patients have already been successfully treated.

Getting an army of volunteers involved in community-based treatment centres has produced one of India’s greatest public health success stories with the country scaling up its national TB programme 40-fold in the last four and a half years.

Such progress is largely due to the Global TB drug Facility (GDF), a WHO-sponsored mechanism which provides an uninterrupted supply of TB drugs to countries like India, free of charge. Till date, the GDF has provided a remarkable four million patient treatments in four years. This ‘4in4’ achievement by the GDF is proof that with good coordination and an efficient mechanism, drug delivery can work in even the poorest countries.

Global intervention for global impact

Established in 2001, “to expand access to and availability of, high-quality TB drugs to facilitate DOTS expansion,” the GDF is now one of the most important initiatives of the Stop TB Partnership. It was created in response to difficulties experienced by countries in the 1990s in finding and funding stable TB drug supplies. This in turn hindered the expansion of the DOTS TB control strategy. Perhaps of even greater concern, is that patients develop resistance to TB drugs as a result of poor quality drugs and unreliable supply channels making the disease difficult and expensive to treat.

Four years later, a highly effective and streamlined workflow now makes the GDF unique. Firstly, the GDF operates a direct procurement system with several key advantages:

• Competitive prices of between US$ 14 -18 for a six month course of treatment for an average weight patient with the final price depending on the treatment regimen used and the packaging of the tablets
• High-quality products which meet WHO stringent standards
• Individual patient blister packs for easy administration
• Rapid drug delivery times
• Web-based tracking of orders
• In-country assistance on drug management, registration and supply issues

Secondly, the GDF developed an application process that is simple and quick. Both governments and non-governmental organizations (NGOs) in collaboration with the respective Ministry of Health are able to apply for GDF assistance. Countries complete an application including information on TB drug needs, a description of a DOTS expansion plan and the national TB programme, country statistics on TB and plans for distribution of drugs. Once approved (on the basis of application materials), a GDF team travels to the country to meet with government officials and evaluate drug needs and distribution capacity. Following the country visit, the application is either officially approved and terms and conditions of the grant finalized or the application is rejected.

By September 2004, the GDF had received 89 grant applications, approved 65 and supplied drugs to 51. Among the successful applicants were:

·         India - with the largest number of TB cases in the world - with 644 000 patients receiving GDF-sponsored TB drugs.

·         Democratic Republic of Congo - ranked in the top ten of high-burden TB countries - with approximately 220 000 patients receiving GDF-sponsored TB drugs.

·         Bangladesh - ranked as the country with the fifth highest rate of TB in the world - with 200 000 patients receiving GDF-sponsored TB drugs.

As a result of its success the GDF mechanism is being seen as a possible model for cheap and effective drug delivery in the fight against HIV/AIDS and malaria.

For further information on the GDF check out these online brochures:

• Introduction to GDF
• Direct procurement
• Patient kits
• Quality Assurance
• Sustaining the gains