New quiet initiative to improve drug access in middle-income countries, change country classification system

Catherine Saez
Feb. 25, 2015, 8:24 p.m.

This week a confidential high-level expert meeting was convened in Geneva to start work on a potential change in the country classification used by global health actors to remedy the growing problem of access to medicines in middle-income countries.

The first meeting of a new initiative spearheaded by the Global Fund for AIDS, Tuberculosis and Malaria, according to some sources, and named the Equitable Access Initiative (EAI) took place on 23 February.

The meeting, which was not advertised and about which no public information appeared to be available, had tight rules of communication for participants. Yet it gathered high-level actors, such as Pascal Lamy, honorary president of Notre Europe, a Paris-based think-thank, and former director of the World Trade Organization, acting as co-chair, according to sources. The other co-chair was Donald Kaberuka, president of the African Development Bank Group.

According to sources, convening organisations of the EAI were the World Health Organization, the Global Fund, UNITAID, the United Nations Population Fund, and UNAIDS.

The issue of access to medicines in middle-income countries has been underlined by many as acute. Global agencies, such as the Global Fund or Gavi, the Vaccine Alliance, provide support to developing countries up to a certain economic threshold, after which countries are considered to graduate and left to fend for themselves.

Critics of the system have said that although the gross national income (GNI) per capita of those countries pushes them beyond the eligibility threshold, most of their population still suffers from lack of access to medicines. For example, in 2015, 25 countries will be graduating from Gavi support, such as Angola, Bolivia, Cuba, Ghana, Nicaragua, Nigeria, and Vietnam.

According to a source, the EAI is replacing earlier efforts by the Global Fund to address the issue by establishing a commission on tiered pricing, under which countries with higher average incomes must pay higher prices for medical products. This drew strong reactions from many, including civil society and public health advocates (IPW, Public Health, 7 April 2014). The 2014 initiative planned to create a “blue-ribbon Task Force of leading multidisciplinary experts, which will develop a framework for multiple pricing…,” according Global Fund Executive Director Mark Dybul’s report to the 30th Board Meeting [pdf] of the Fund in 2013.

According to several sources, the tiered-pricing approach has been abandoned.

The EAI is an attempt to remedy the problems that occur today with the country classification system used by various health funding agencies when allocating their resources, the source told Intellectual Property Watch.

The current classification is based on the World Bank classification of countries (low income, lower middle income, upper middle income, and high income), which was developed in the late 1980s and was never meant for making decisions on funding for health, the source said.

“It is not a complex issue to fix, and looking at the classification system has been long overdue,” added the source. “However, the bigger issue is the fact that insufficient resources are allocated for health at the national and the international level.”

Addressing equitable access also requires addressing the fact that health commodities are too expensive, and new patented products cause access issues. For example, the new hepatitis C medicines are affecting access not only in developing or least developed countries but also high income countries. This has become a truly global access problem, the source said.

A Gavi spokesperson told Intellectual Property Watch: “Gavi welcomes a discussion on how to best support countries who have experienced rapid economic growth, but may not have had time for concurrent growth in financial and programmatic capacity to address the health needs of its populations.

“Gavi’s funding model is based on the concept of transition – moving from the start of vaccine support, which Gavi co-finances together with eligible country governments, through to a gradual increase in countries’ contributions to vaccines which helps them prepare for when Gavi support ends,” the spokesperson said. “Recognising that this transition may be challenging for some countries, Gavi is undertaking a comprehensive analysis of sustainability risks and assessing options for strengthening the transition process towards sustainable outcomes.”

“Gavi welcomes the Equitable Access Initiative and is pleased to contribute its experience with a transition-based support model as well as its ongoing work on strengthening transition planning and market shaping for sustainable vaccine prices.”

Expert Panel to Reconvene in One Year

According to several sources, yesterday’s first meeting of the Expert Panel of the Equitable Access Initiative is the start of the process. A technical working group is expected to start working on proposals on country classification and the expert panel is expected to meet again to consider those proposals in a year’s time.

Agencies participating in the meeting were Gavi, the Global Fund (including Dybul), WHO (including Director General Margaret Chan), UN Population Fund, World Bank, UNAIDS, UNICEF, the UN Development Programme, and UNITAID, according to sources. About 70 participants attended the meeting, they said. Participants included senior officials from developing countries and public health advocates.

The conclusions of the working groups are expected in November or December with a final report on a new health classification framework in place by February 2016, according to a source. However, whether those agencies will use the new framework and how, remains a guessing game, said the source.

The source said that the EAI appears to be a more donor-driven initiative on how limited resources are spent. This, according to the source, potentially limits the opportunity to discuss other tangible issues such as longer term sustainable funding for global humanitarian assistance, or how middle-income countries can benefit beyond just direct financial aid.

The process is still unclear, the source added, saying, “This needs to be transparently elucidated in the near future.”

According to several sources, a request was made to make the initiative more transparent, in particular that some documents be available for publication. According to a source, this seems to have been agreed in the meeting.

Metrics

According to yet another source, views were divided on which metrics should be used. Some participants suggested a new metric with a number of disparate variables, including infection rates, health outcomes, infrastructure, and natural resources.

Others “strongly defended” GNI per capita, “particularly as a measure of ability of pay and financial need, while acknowledging the World Bank thresholds were problematic.” They said GNI was a statistic available for most countries, and simple enough so that policymakers could understand what it means, the source said.

However, according to the source, metrics could have multiple and unforeseen uses, and some metrics can prove hard to manage, host and maintain. He cited as example the UNDP Human Development Index or the World Intellectual Property Index which are complex, labour intensive and expensive to manage.

The source suggested that “using as a starting reference, a group of 7 to 12 large, higher income developed countries, and determine the level of income that they consider to be the threshold for determining poverty, or for qualifying for various subsidies, such as the Medicaid threshold in the United States.” Then countries could be classified according to whether or not some fraction of their population was living below some fraction of the relevant poverty rate established in a high income country.

The Global Fund and WHO had not answered requests for comments by press time.


Source: Intellectual Property Watch