GDF Technical Review Committee

Getting it done by committee

GENEVA, SWITZERLAND - On the first morning of the 12th Technical Review Committee (TRC) meeting, nine of the world’s top tuberculosis (TB) specialists and two of its leading drug management experts met to perform an unusual task. The group that had reviewed almost 200 national TB control programmes (NTPs) around the world was about to begin one of the most difficult reviews yet - of itself.

The reason for meeting in Geneva was to examine applications to the GDF for grants of anti-TB drugs and to recommend the type of support that the GDF should give to each, and under what conditions. Since 2001, the members of the TRC had met 11 times for this same reason and during those meetings had approved 75 applications from 59 countries for GDF support.

But four years after the first TRC meeting, the context in which GDF supports programmes had changed significantly. Many programmes that initially struggled to expand DOTS (the internationally recommended strategy to control TB) had now reached near 100% DOTS coverage. NTPs that previously had poor access to a reliable source of good-quality anti-TB drugs now had access through the GDF. New donors and partners had emerged to help secure that access, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM).

During this time, NTPs had also faced new challenges, such as learning to manage a drug supply more effectively and safely, and developing national budgets and systems that can thrive independently of donor assistance.

The conditions that had originally brought the TRC together had changed. Therefore, before considering the future of GDF grant support for applicants, TRC members were asked to first discuss the role that the TRC would play in that future. Given this new environment, how should the GDF technical review process evolve to support the needs of NTPs?

A unique opportunity

When the TRC members convened for the first time in March 2001, the task before them was one that some now recall as ground-breaking. "People always sat on committees", says Dr Giorgio Roscigno, TRC member and Chief Executive Officer of the Foundation for Innovative New Diagnostics. "But deciding whether to send fundamental, life-saving drugs to countries - this was unique."

At the time, the global TB epidemic was progressing unchecked, and there was an urgent need for such lifesaving drugs. Moreover, many NTPs were finding it difficult to launch or expand DOTS - the strategy that had promised to halt TB but had yet to reach 25% of patients worldwide. The priority for the GDF - and therefore the TRC - was clear: to increase access to quality-assured anti-TB drugs and in doing so to help expand DOTS. As Dr Jacob Kumaresan, former Executive Secretary of the Stop TB Partnership, explains: "The TRC at the time had to make sure that any drugs that GDF provided would lead to a further expansion of DOTS."

To do so, TRC members sifted through applications from countries, searching for evidence that a shipment of GDF drugs would not only meet the immediate need for patient treatments but also support DOTS expansion.

The applications reflected the disturbing reality that had led to the TRC being established. Of the nine countries whose applications were considered at the first meeting, none had reached more than 50% DOTS coverage, while most had only a few pilot programmes. While all but two of the nine countries claimed serious drug shortages, only five met the baseline GDF requirements for drug supply. Only four countries provided a plan for introducing or expanding DOTS, and in most cases the degree of government commitment remained unclear.

The TRC was, however, reluctant to reject applications from countries with a major TB epidemic and where large numbers of people were dying of an easily curable disease. Indeed, the committee made specific programme recommendations that aimed to address immediate needs while strengthening the long-term capacity of programmes. Those programmes that had not supplied plans to expand DOTS were urged to do so and reapply later that year.

According to Dr Fabio Luelmo, TRC member since 2001: "When advising on whether the GDF should support a country, the TRC could say 'yes' or 'no'. But the TRC goes much further than that. When the country requests drugs, the TRC gives recommendations not only on how the drugs should be used but also on other matters to do with the organization of NTPs that might have an impact on the use of drugs and improve their effectiveness against the disease."

Such recommendations seem to have had an effect. Three of the four programmes that had been urged to develop DOTS expansion plans promptly did so, reapplied and all subsequently had their applications approved. "In many instances," says Dr Luelmo," a country was told, 'you will receive drugs if such and such is done.' And then these things were indeed done."

Sustaining the gains

Since the founding of the TRC, this process - which relies on standard criteria to assess applicants and on the expertise of members to make recommendations - has led to GDF support for 15 of the countries most heavily burdened by TB. In total, 60 countries have used GDF Grant and Direct Procurement services.

This success has meant that the TRC’s role is no longer simply to encourage DOTS expansion but also to monitor the progress of programmes towards sustainability and self-sufficiency. As TRC member Dr Jan Voskens points out: "We must make sure that the TB drug supply is sustainable and not dependent upon grants."

The GDF grant provides three years of support. However, the grant recipient’s programme is monitored each year and must receive a "green light" for support to continue. The TRC regularly assesses whether a programme applying for a second or third year of support has met GDF terms and conditions. This review encompasses the programme budget for anti-TB drugs, which is required for future financial self-sufficiency. "If one just gives support for two or three years without making sure that the government contribution is continued, then a country can be placed at risk," explains Dr Voskens.

At the most recent TRC meeting, it was this concern for sustainability that prompted the TRC to plan its approach to programmes that were nearing, or had already reached, the end of their first GDF grant. By 2006, almost one third of GDF programmes will have reached the end of the first-term grant. Although countries would be allowed to apply for a second grant (an additional three years of support), there were still questions about the terms and conditions for these secondterm grants.

The TRC agreed that secondterm grantees must provide the GDF with information on government budgets, and demonstrate they are maintaining or increasing their expenditure on anti-TB drugs.

This decision ensured that countries in great need can continue receiving anti-TB drugs from the GDF - so long as they show progress towards selfsufficiency.

But recognizing that countries may not always have the expertise or resources to make such progressive improvements, specifically as they relate to anti-TB drug procurement and management, the TRC discussed ways to ensure that no countries were left behind. Several TRC members, particularly those involved in drug management, have long recognized the need to strengthen the supply chain at country level. As TRC member Dr Jan Voskens puts it: "My priority has always been that if we provide drugs we must make sure that the drugs are properly used to prevent the emergence of drug resistance." To date, though, the TRC’s involvement in this field has been limited to making recommendations to programmes. Some TRC members have expressed concerns that for such recommendations to be fully carried out, programmes must have access to in-country technical support for drug management.

During the discussion at its August meeting, the TRC made a formal recommendation that the GDF should play a more vigorous role as a broker of technical assistance in drug management. The committee urged the Stop TB Partnership Coordinating Board to expand the GDF’s mandate accordingly, proposing that a subgroup of TRC members should assist in drafting a strategy on technical assistance. Development of the strategy is now under way with an aim to submit the proposal for Coordinating Board approval in 2006.

To find out more about the GDF strategy for national selfsufficiency, see the GDF Sustaining the gains document, available on the GDF web site or upon request by email (gdf@who.int).