Moving Forward on ART Scale-Up

Working Meeting on an International Action Plan on Scaling Up Access to HIV Care

Geneva · October 2002

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21 October 2002

To: Participants in WHO Working Meeting on an International Action Plan on Scaling up Access to HIV Care, 1-2 October 2002
From: Mark Harrington
Treatment Action Group (TAG)
Re: Moving Forward on ART Scale-Up
cc: People invited or involved but not present

This is a response to last week's draft "Meeting Summary" by WHO staff of the 1-2 October 2002 meeting on developing an International Action Plan (IPA) on scaling up access to ART and HIV care. Here I provide an interpretation of the meeting that differs in emphasis from that recorded in the "Meeting Summary" – as well as (to follow) my own notes from the meeting which provide the basis for my interpretation – and some suggestions on the best way to move forward.

The meeting was difficult and frustrating – as one might expect given the complexity of its topic and the scope of its goal. However I think it was in many ways a fruitful one, for the difficulties experienced may actually help to clarify the way forward. For example country representatives were clear that they needed immediate technical assistance in planning and implementing ART scale up programs. Rich country donor representatives were clear that they needed better information and clearer evidence in order to obtain more support for ART scale up. Community based NGO advocates were clear that affected communities needed to be an integral part of developing the international framework as well as working at country level.

I am agnostic as to whether the new entity is called an Alliance, a Coalition, or a Partnership (my thesaurus says they're all synonyms anyway). However, while I agree with most of points 1-6 which the "Meeting Summary" describes as "important decisions reached by consensus", I am not clear that there was consensus about #2, "Given the need to conduct international consultation around an international plan of action, it is unrealistic to expect that such a plan could be finalized in time for a launch prior to 1 December 2002". I was concerned towards the end of the meeting when it was suggested that we not only skip December 1, but that the meeting of the Alliance and the announcement of the International Plan of Action would not take place until June and July 2003, respectively.

This will be seen as an enormous and unacceptable loss of momentum towards achieving the goal of treating three million people by 2005 (3M/05) which was announced at Barcelona. Certainly WHO needs to do something more than simply announce a new Alliance (or Coalition) on December 1, and tell everyone that they will simply have to wait seven months for any more details to emerge.

Instead, WHO and the Alliance could provide a clear roadmap for the way forward by:

• Issuing a powerful advocacy document – A Call to Action – on 1 December 2002, which lays out the resource needs for scale up to 3M/05;
• Announcing the time-line for WHO to conduct consultations, broaden the Alliance, and develop the elements in the IPA, including:
  • A country toolkit
  • A framework for international technical assistance
  • A database or resource center where the latest epidemiology, evidence, program and planning information will be accessible to countries, donors and NGOs
• Providing countries with immediate technical assistance; and
• Assuring that all these elements come together into a credible International Plan of Action within the first half of 2003.

Here are my more detailed suggestions on the way forward, enlivened with some remarks from the meeting.

I need a clear roadmap describing what the Alliance is all about. Who? Why? How? Tools are important and will help countries develop plans. We're willing to support this, but we need good evidence.

—Eugene McCray (CDC)

What should the partnership look like? It should look new and necessary, effective and efficient.

—David Stanton (USAID)

1. A Global Access Alliance is needed, but its role needs clarification, and it needs to deliver. There was support for creating a Global AIDS Alliance, but stakeholders from different sectors were not always clear about what the Alliance could, should or would offer. Thus the support, in the end, was broad but in some cases tepid.

A strong message on ART scale-up is needed by 1 December 2002. The UNGASS commitments paved the way for the goal, announced at Barcelona, to treat three million people within three years. We now need a message to mobilize the international community by World AIDS Day. We need to identify the main challenges developing countries have to face at the local level in scale up, and we need to propose steps the international community can do to help.

—Serge Tomasi (Coopération Française)

2. Simply announcing a new Global Access Alliance on December 1 is not a powerful message. Despite the scale of the tasks at hand most people felt it would be good to have something concrete by December 1. Simply announcing an Alliance, as was proposed at the end of the meeting, will not be perceived by most people as a significant or concrete accomplishment. WHO and the Alliance will be judged by what they deliver, not by what they say they will accomplish.

We need a short action plan. It needs to include a recommended deadline for countries to commit to national treatment plans, a call for resource mobilization from donors, clear messages about what we are going to produce, and the point that treatment is critical to prevention – without a clear treatment plan all our development goals will not be achieved.

—Zackie Achmat (TAC)

A strategic advocacy document is needed, along with the more clearly articulated framework for international action and country tool-kit.

—Mark Harrington (TAG), for Group Three

We need a plan of action – quickly – for the international community. What will we as an international community do to help countries scale up?

—Vincent Habiyambere (WHO), for Group One

3. A powerful advocacy document – a Call to Action – is needed quickly. While it would not be feasible to release a complete country tool-kit or a comprehensive framework for international technical assistance by 1 December 2002, it would be possible to create a powerful advocacy document – a Call to Action – by that date which would lay out the tasks at hand describing the scope of the need, the existing evidence base, the needed financial, technical and human resources, and the plans of WHO and the Alliance to create the framework and the toolkit within the next few months, and describe the steps which needed to be taken by developing countries and by donors in order to achieve the goal. An advocacy document is needed by 1 December 2002 because key donors such as the US government have not yet finished planning their budgets for 2003 and 2004; such a document could help leverage significant new resources for ART scale up. Without those resources the 3M/05 goal will not be met.

We felt there was a need for two documents – first, a strategic document to get buy-in from the international community such as donors and those in a position to reduce prices of antiretrovirals. This would document existing country experiences such as Brazil, Uganda, etc. It would define the necessary commitment by an international partnership to technical assistance. Second, an implementation plan or plans appropriate for medium and low resource settings.

—Alex Coutinho (TASO), for Group Two

The real donors are the US government and Congress. There there is no buy-in that this is possible. What's in the countries? What's in the health care infrastructure? What types of health care structures exist that can support antiretroviral treatment?

—Mark Dybul (NIH)

4. As part of the Call to Action, WHO needs to clearly identify the scope of the resources – financial, technical and human – necessary to accomplish the 3M/05 goal. The resource calculation should be based on the best available epidemiology, country and donor capacity assessment and programmatic budget estimates. In the long run – as was done with The Global Plan to Stop TB – WHO could simply add up the sum totals of each country's AIDS treatment plan, but since very few countries have created true national scale-up plans – and some of those which have, such as Malawi, have been forced to scale them back – WHO will necessarily have to make some educated guesses here.

What do we want from an Alliance? We know that we cannot do it alone. We don't have the technical know-how. We need to know how to help countries utilize these resources. Two types of country requests come in – first, how can we buy antiretrovirals? And second, how can we ensure that Global Fund monies are used synergistically with bilateral and World Bank programs?

—Debrework Zewdie (World Bank)

5. WHO is well on the way to creating a good framework for international technical assistance. Most participants felt that the documents presented provided a good start on creating materials which would be useful as part of a framework for international technical assistance.

Finalize the framework. Work on a draft tool-kit. Develop regional and country consensus. Make an inventory of capacity at country level and an inventory of possible alliance members. Do rapid assessments of the support needed at country level ... Understand the epidemiology – how many are in need? What are the political obstacles? ... We need a mechanism to coordinate countries and donors.

—Peter von Rooijen (STOP AIDS Now), for Group Two

6. The country tool-kit needs a lot of work. Most participants felt that the country toolkit was a good idea but needed a lot more work.

Many countries already went through a process to develop this... WHO should put together what exists and put resources in a common pot.

—Moustapha Guëye (UNDP)

The IPA needs to be based on current experience where ARV programs exist. There is a need for regional and sub-regional consultations in developing the IPA.

—Vincent Habiyambere (WHO), Group One

The audience is national AIDS program planners and partners.

—Jeff O'Malley (International HIV/AIDS Alliance, UK)

7. Countries need to be brought into the process now. Getting input, sharing experiences, and creating better communication among developing countries involved in scale-up activities, and those interested in starting to get involved, would be an essential part of developing a good International Plan of Action. This needed to include country and regional consultations as well as documentation of existing experiences and a way to field test elements of the technical package.

An International Plan of Action is needed. It must be responsive to country needs and it must be developed with regional and sub-regional input.

—Moustapha Guëye (UNDP)

We're interested in learning more about how to scale up, learning from experience, doing something concrete which adds value, is responsive to developing countries and the needs of the poor. This will require a consultation process with donors, developing countries, civil society and technical agencies.

—Alistair Robb (DFID, UK)

What experience is there to support donor input? Or what evidence is there to justify a leap of faith or build the boat while sailing it? Can experience gained from the treatment of 1,000 people be expanded to 10,000 or 100,000? The scale-up documents need to define the strengths and bottlenecks, and provide a blueprint for addressing them – e.g., how to scale up VCT? They need to support a country led process – empower and encourage countries to make bold proposals to the Global Fund and other donors. Define the minimal health care infrastructure required for scale up. Strengthen the links between improving prevention and linking it with improved care. Finally, regional consultations are required before finalizing the document.

—Alex Coutinho (TASO)

8. Donors need better information and want stronger evidence. Donors expressed concern that they did not know how poor countries could scale up ART on a nationwide scale. They want evidence that scale-up is feasible. Lacking that evidence, they are reluctant to commit to scale-up. This creates a catch-22 where lack of evidence impedes mobilization of the resources required to develop that evidence. WHO and the Alliance could play a key role by formulating clearer messages about what is known, what needs to be known, and how to build and evaluate models for nationwide scale up while strengthening the evidence base for how best to do so.

We want to be operational now ... We need a clear picture of how to define goals at a national level which would enable us to get to 3 million in 2005. We need discussions with donors and developing countries.

—Serge Tomasi (Coopération Française)

We would like to have clear objectives, to identify areas of possible technical support, and to know where donors could be helpful.

—Sybille Rehmet (GTZ)

We're proposing this gigantic new thing, which will take up a lot of money. The donors are the governments we represent... What do our governments need? They need a clear justification of why we think it's doable. Why do we think it's doable? Donors don't believe small pilot projects do it. It would be nice to have this by December 1.

—Mark Dybul (NIH)

9. WHO needs to create an accessible, flexible database documenting existing and planned ART programs for use by countries, donors, technical agencies, NGOs and advocates. No one has yet assembled in one place all the existing experience with ART use in developing countries or all the existing or planned ART scale-up programs (examples would be Brazil – established; Botswana – underway; Chile, Malawi, Thailand – planned). Nor is there an single obvious accessible and up-to-date place to determine current bilateral, multilateral, NGO and private sector donor aid flows, and other key elements of the evolving international response.

We need country/regional consultations, a mechanism to collaborate on these issues, an information exchange mechanism, the product of a group of partners. Concrete steps, construct a knowledge base, consult with program managers, [develop a] framework document.

Jos Perriëns (WHO)

There is a need for a clearinghouse/database to document and build on existing programs. Strengthen and articulate the evidence base and rationale for the claim that three million could be treated within three years.

Mark Harrington (TAG), for Group Three

10. Countries need immediate technical assistance. While WHO and the Alliance are consulting with countries and donors and developing the framework and the toolkit, they need to ensure that countries which need immediate assistance in designing and implementing scale-up plans – for example those which have received awards from the Global Fund – get good technical support right away. These experiences and interactions will be key in figuring out how best to move forward. Without immediate assistance both for those with programs underway and those actively planning programs, the 3M/05 goal will not be met.

The way forward is very clear. Donors [need help] to bridge the gap between pilot and full scale-up. Countries want to address their pressing needs. The Alliance could help by providing several outputs – strong advocacy tools, a resource and information center, and direct country support and technical assistance.

Alex Coutinho (TASO)

11. If these steps are taken, the pieces will be in place to move from a Call to Action on 1 December 2002 to an International Plan of Action by 1 June 2003.

What we need is simple – How to do it; Who does what, when; Where; With what; and monitoring and evaluation. [The Alliance should say], "We identified these gaps and needs and are doing this to address them."

Debrework Zewdie (World Bank)

12. WHO's leadership will be key to accomplishing these tasks and forming a credible, effective Global Access Alliance. In addition WHO will need to assure that sufficient staff and resources are available to simultaneously gather and distribute evidence; assist, advise, and consult with countries; leverage donor resources for scale up; and develop a powerful International Plan of Action. To do this, WHO needs assistance from the other partners in the Alliance – but WHO will need to lead the way.

Working Meeting on an International Action Plan
on Scaling Up Access to HIV Care

1-2 October 2002 ·Geneva

At the XIV International AIDS Conference in Barcelona the World Health Organization (WHO) committed itself to working to ensure that three million people with HIV/AIDS in developing countries – an estimated half or less of those in need – were receiving antiretroviral therapy (ART) by the year 2005¹. Together with the International AIDS Society (IAS) and UNAIDS, WHO convened a series of meetings to discuss forming a Global Access Alliance involving all key stakeholders to work towards achieving this ambitious goal.

After Barcelona, WHO quickly set to work to get this alliance off the ground, convening a meeting in Geneva on 14-15 August at which it was decided that the nascent alliance should focus on developing 1) an International Plan of Action (IPA) for scaling-up access to ART and 2) a country tool-kit to provide countries with a blue-print for planning, budgeting, evaluating and implementing scaled-up ART programs.

Subsequently WHO organized a number of technical working to develop a draft IPA, an outline for a country tool-kit, and a suite of draft technical assistance packages or proposals including materials on human resource development and training, drug procurement and supply chain management, operational research, monitoring and evaluation, and quality assurance. WHO and IAS then convened a larger meeting in Geneva on 1-2 October 2002 involving more stakeholders from a broader range of sectors, including rich country donor agencies, Geneva-based and regional WHO and UN system staff and northern and southern NGOs. (A list of participants is attached.)

Tuesday 1 October 2002

Bernhard Schwartländer, director, HIV/AIDS Department, Family & Community Health (FCH) cluster, WHO, and Joep Lange, President, International AIDS Society (IAS) welcomed participants and introduced the agenda.

I. International Plan of Action for Access to Antiretroviral Therapy: A Draft Framework – Presentation & Discussion

Jos Perriëns, Care, Research & Evaluation (CRE) branch, HIV/AIDS Department (HAD), WHO, described recent activities leading to global commitment on scaling up access to ART. The Durban AIDS conference, the UN Millennium summit, the UNAIDS/WHO Accelerating Access Initiative, the Abuja conference, the UN General Assembly Special Session on AIDS (UNGASS), the formation of the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), the release of the WHO Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Guidelines for a Public Health Approach, the addition of twelve antiretroviral drugs to the WHO model list of essential medicines, continuing dramatic reductions in drug prices obtained through generic competition², and the announcement of the goal of having three million people with HIV/AIDS on antiretroviral therapy by the year 2005 created momentum leading towards a massive global effort to scale up access to ART.

WHO estimates that today, about 750,000 people worldwide are receiving ARV therapy, including about 230,000 in developing countries. Of that number, about 100,000 are in Brazil, leaving just 130,000 people on ARVs in developing countries where three million people died of AIDS last year. Just 50,000 people are estimated to be on ART in Africa – just one percent of those who could benefit from it. If multiplying the annual death rate by two gives a minimal estimate of the number who could benefit immediately from ART, six million people worldwide need it right now. WHO estimates that three million of them live within reach of a functioning health system³.

Since May 2000, over 80 countries have expressed interest in participating in the Accelerating Access Initiative, 39 have developed national plans to improve access to care, and 19 countries have made agreements with individual drug companies⁴. Countries as diverse as Botswana, Chile, Malawi, Nigeria and Thailand have expressed interest in scaling up ART programs in their countries. The Global Fund has already announced awards which will effectively double the number of people on ART in poor countries. UNAIDS and WHO planned to meet a group of 'like-minded donors' at the Hague on October 3 to discuss better coordination.

Perriëns said that the treatment of HIV today should not be more difficult than treatment of tuberculosis (TB) and that nurses could be trained to prescribe and monitor ART. He discussed different models of providing care, including public sector health systems where central clinics providing clinical care and evaluation are linked to diagnostic and monitoring services, and more diffuse private sector systems where clinical care, evaluation, monitoring and diagnosis may be separate. Currently two thirds of ARV treatment in developing countries takes place in the private sector (Brazil excepted). As has been shown with TB control, private sector care is harder to monitor and may require intensified efforts at quality assurance. He discussed different potential models for HIV care in urban and rural, resource poor and resource intermediate settings.

Perriëns said that treatment preparedness programs for affected communities, health care personnel, policymakers and others often fell off the agenda, and needed stronger support.

He then introduced the nine-page International Plan of Action for Access to Antiretroviral Therapy: A Draft Framework. The draft IPA includes an introduction, rationale, objectives and targets, principles, and sections on clinical aspects and basic scenarios for ARV treatment scale up, delivery models at country level, human resources management, drug and diagnostic test kit procurement, treatment preparedness, monitoring and financing.

Working Group Discussions and Reports Back on Draft IPA

Participants broke up into three working groups to discuss the draft IPA and report back with suggestions.

Vincent Habiyambere (WHO) presented the conclusions of Group One:

1. The draft IPA document is a framework outlining core elements of a scale-up program, but it's not an international plan of action. Change the title to make this clear; call it a "draft framework", not an "International Plan of Action".
2. We need a plan of action – quickly – for the international community. What will we as an international community do to help countries scale up?
3. The IPA needs to be based on current experience where ARV programs exist.
4. There is a need for regional and sub-regional consultations in developing the IPA.
5. Additional sections are needed in the draft framework document to focus on ARV resistance and surveillance, the impact of price/accessibility on first and second-line regimens, pediatric treatment, HIV testing, adherence strategies, and quality assurance for drugs. Our group felt that CD4 tests should be recommended but not required. Delivery scenarios such as Brazil, MSF, others should be addressed.

Alex Coutinho (TASO) reported for Group Two, which felt there was a need for two documents:

1. A strategic document to get buy-in from the international community such as donors and those in a position to reduce prices of antiretrovirals. This would document existing country experiences such as Brazil, Uganda, etc. It would define the necessary commitment by an international partnership to technical assistance.
2. An implementation plan or plans appropriate for medium and low resource settings.

Coutinho said his group asked whether the approach taken will be intensification of ARV access in a few countries, or expansion to all countries. What experience is there to support donor input? Or what evidence is there to justify a leap of faith or build the boat while sailing it? Can experience gained from the treatment of 1,000 people be expanded to 10,000 or 100,000? The scale-up documents need to define the strengths and bottlenecks, and provide a blueprint for addressing them – e.g., how to scale up voluntary testing and counseling (VCT)? They need to support a country led process – empower and encourage countries to make bold proposals to the Global Fund and other donors. Define the minimal health care infrastructure required for scale up. Strengthen the links between improving prevention and linking it with improved care. Finally, regional consultations are required before finalizing the document.

Mark Harrington (TAG) reported for Group Three:

1. The draft IPA is operational, not strategic. A strategic advocacy document is needed, along with the more clearly articulated framework for international action and country tool-kit.
2. There is a need for a clearinghouse/database to document and build on existing programs.
3. The document should clarify the role of ART within the continuum of care.
4. Key sections are missing on issues such as supply chain management and drug/diagnostics procurement.
5. Strengthen and articulate the evidence base and rationale for the claim that three million could be treated within three years.
6. Strengthen the language on the link between prevention, care and treatment.

Bernhard Schwartländer suggested that we may need three documents – a country toolkit, an implementation framework for international technical assistance, and a strategy document which would lay out a range of flexible solutions and give options without being prescriptive.

Julian Fleet (UNAIDS) observed that there was consensus that we need an action plan. Jean-Paul Moatti (ANRS) asked what was the timeline, and what kinds of country/regional input are needed.

Mark Harrington noted that several tensions were apparent:

1. There is no model of nationwide ART scale-up in a poor country – Brazil is a medium income country and the world's eight biggest economy;
2. Countries are holding back or are being actively discouraged (cf. Malawi) from asking for adequate support for full scale-up;
3. Donors are don't know how national scale-up can be done in a poor country. They are waiting for evidence from pilot projects. This creates a catch-22 – without evidence there will be no scale-up, and without scale-up there will be no evidence about how to do it;
4. The challenges are complex;
5. If several countries with big epidemics don't commit to scale-up, we will not achieve the target of having three million people on ART by 2005.

Serge Tomasi (Coopération Française) stated that a strong message on ART scale-up is needed by 1 December 2002. The UNGASS commitments paved the way for the goal, announced at Barcelona, to treat three million people within three years. We now need a message to mobilize the international community by World AIDS Day. We need to identify the main challenges developing countries have to face at the local level in scale up, and we need to propose steps the international community can do to help. Simply announcing a new alliance is not by itself a compelling message.

Alex Coutinho said it would be useful if key players – including some rich country donors and high-burden poor countries – endorsed the target.

After lunch it was determined to alter the agenda and plunge back into the discussion of goals and objectives. Jeff O'Malley (International HIV/AIDS Alliance) provided further background on how the materials presented in the morning had been generated. Originally the goal – articulated by Bernhard at the first pre-meeting on what became the WHO ARV Guidelines in April 2001 – of treating five million people by 2005. Later this was reduced to a more realistic three million and endorsed by WHO at Barcelona. At this time meetings were held to develop a Global Access Alliance – first proposed by IAS and STOP AIDS Now – to facilitate the steps needed to scale-up.

Moustapha Guëye (UNDP) said that an IPA was needed; the IPA must be responsive to country needs; and it must be developed with input from regional and sub-regional consultations.

Jos Perriëns replied that a meeting was planned for the end of October to bring in the thirty countries most interested in treatment access. (This meeting had originally been planned to brief countries on the WHO ARV guidelines.)

Mark Harrington suggested that rich country donor agency representatives should articulate exactly what they would like to see coming from WHO and from a Global Access Alliance.

Eugene McCray (CDC) said, "We're here because we're interested in being part of this Alliance. I need a clear roadmap describing what the Alliance is all about. Who? Why? How? Tools are important and will help countries develop plans. We're willing to support this, but we need good evidence."⁵

Serge Tomasi (Coopération Française) said, "We supported the French Solidarity Treatment Initiative (FSTI), worked with UNAIDS to launch an international network and sponsored a satellite workshop in Barcelona on financing care. We want to be operational now. We have questions regarding the multiplication of multilateral institutions. We need a clear picture of how to define goals at a national level which would enable us to get to three million in 2005. We need discussions with donors and developing countries."⁶

Sybille Rehmet (GTZ, Germany) said, "We would like to have clear objectives, to identify areas of possible technical support, and to know where donors could be helpful."⁷

Debrework Zewdie (World Bank) said, "We wear two hats as a donor and within the UNAIDS partnership. What are we prepared to do? What do we want? The MAP [Multi-Country HIV/AIDS Program] has allocated $1.15 billion for prevention, care and treatment – including antiretrovirals. The MAP funds are 65% grant, 35% loan. We have committed over $600 million to twenty countries, and 27 are in the pipeline. In addition through the International Development Association (IDA) we programmed an additional $500 million in fiscal year 2002 which is all in grants. What do we want from an Alliance? We know that we cannot do it alone. We don't have the technical know-how. We need to know how to help countries utilize these resources. Two types of country requests come in – first, how can we buy antiretrovirals? And second, how can we ensure that Global Fund monies are used synergistically with bilateral and World Bank programs?"⁸

Alastair Robb (DFID, UK) said, "DFID's door is not shut. We're committed to taking forward our agenda focusing on poverty reduction and equity, seeking more effective international action, international coherence in support of national needs. But we're interested in learning more about how to scale up, learning from experience, doing something concrete which adds value, is responsive to developing countries and the needs of the poor. This will require a consultation process with donors, developing countries, civil society and technical agencies."⁹ Clare Short, the secretary of state for international development, was supportive of expanding HIV prevention and care if it proved to be a critical factor in reaching the millennium goals on poverty reduction.

David Stanton (USAID) said, "We had an unattended press conference in Barcelona [because everyone was busy watching or demonstrating at Tommy Thompson's simultaneous talk] where we announced our intent to introduce antiretrovirals in Ghana, Kenya and Rwanda¹⁰ working within existing publicly funded health care systems. We are committed to increasing access but need to find models to work within existing systems. Our efforts are taking place in parallel to the global [3M/05] targets. Regarding the robustness of the [projected] numbers – if setting [target] numbers helps, good. We may need to revisit them to some extent. Our philosophical approach to scale-up involves a number of principles. Partnership is key... Demand outstrips supply. We need clear guidelines for entry. Finally, at project level, we're going to be realistic. What do you need from us? We have technical and organizational skills – but we don't have the funds to take to scale. Include a call to action to my own government. Improve monitoring of patients on treatment. Address procurement via additional mechanisms yet to be invented. What should the partnership look like? It should look new and necessary, effective and efficient."

Mark Dybul (NIH) said, "We're interested in doing operational research, but we need antiretrovirals in the country or else the research will not be ethical. Our agencies won't be giving you $5 billion. The real donors are the US government and Congress. There there is no buy-in that this is possible. What's in the countries? What's in the health care infrastructure? What types of health care structures exist that can support antiretroviral treatment?"¹¹

II. Technical Presentations (I)

A. Country Toolkit

Jeff O'Malley (International HIV/AIDS Alliance) presented a draft "Took Kit for Planning & Implementing Scaled Up Access to ART", developed after a working meeting in Geneva on 27-29 August. Inspired by an HIV/AIDS NGO/CBO Support Toolkit comprising a printed web manual, web-based resource guide, and CD-ROM (http://www.aidsalliance.org/ngosupport) the proposal envisions "an electronic collection of resources about scaling up ART that has been collated by the Global Access Alliance". It would contain materials useful for planning and implementing ART programs, including a) rapid situation & response assessment, b) planning, c) implementation, and d) monitoring, evaluation & sharing learning. O'Malley said, "The audience is national AIDS program planners and partners. We're not talking about writing a how-to manual."

Moustapha Guëye (UNDP) said, "Many countries already went through a process to develop this. ANRS developed guidelines for Francophone countries to scale up. WHO should put together what exists and put resources in a common pot."

Srdan Matic (EURO) said, "A nice tool on the web? That's nice but that's not how it works. This reminds me of how we worked with [Arata] Kochi five years ago on STOP TB. I'm surprised that WHO were not prepared for this meeting – we've been doing global public health for sixty years!"

Eric van Praag (FHI) suggested using documentation from existing experiences to drive a toolkit.

Zackie Achmat (TAC) made a few points related to strategy. "I don't thank an International Plan of Action can be detailed. It needs:

1. A recommended date/deadline for countries to commit to national treatment plans;
2. Resource mobilization from donors, including Japan, other EU countries – a clear demand for resources from WHO;
3. Clear communication structure about the messages we need to get out; and
4. Treatment is critical to prevention – without a clear treatment plan all our development goals will not be achieved.

We need a short call to action."

Debrework Zewdie said, "The problem is not the countries, it's us. We need common goals and action plans."

Alex Coutinho said, "This process must add value. Technical assistance is a key output. Countries have their own experts and guidelines, but there is no experience yet in scaling up. No agency can do it on its own. We need a product that is clear and easy to understand. What is needed by December 1?"

Arata Kochi (WHO) asked, "What kind of technical approach are we going to take? All the programs to date including Brazil's have been based on individualized patient management. We may need to look at a different paradigm given the health care infrastructure in developing countries. Should we look at the TB model? The toolkit will differ depending on the approach you take, but it should include minimal standards."

Alex Coutinho said, "The treatment strategy will depend on the settings. As a Global Access Alliance, what goes into the plan of action? Players, processes and products – a plan for mobilizing."

"Do we need another advocacy document?" asked Zackie Achmat. "It would call for political will, resource mobilization, communication of goals and messages, and establish the link between treatment and prevention. Left alone those targets will not be reached."

The working groups were asked to convene again to design a structure for the plan of action and identify key players. I was in group three. Moses Kamya (Academic Alliance, Kampala) said, "In Uganda we developed a plan to scale up. What is a good enough structure to provide ART? In Uganda we're thinking of training health care workers in clusters."

Jos Perriëns cited a program in Malawi which used one regimen, no back-up regimen, no labwork, and got good results, low mortality rate, etc. Joep Lange contrasted this with Mumbai, India, where, he said, due to unregulated polytherapy with a jumble of drug regimens, just six to eight percent of people on therapy had an undetectable viral load after one year.

David Stanton suggested a structure which 1) built at country level to build national political commitment, 2) developed a workable plan at country level to present to multiple donors to enable them to get on board, and 3) developed a series of sections including necessary technical support.

Mark Harrington suggested that Group Three recommend:

1. An advocacy document calling for donor and country commitment;
2. An epidemiology and evidence document showing the need and the knowledge;
3. A country toolkit for planning, budgeting and implementing national programs;
4. A framework for international collaboration to support country programs, including technical support elements

Zackie Achmat said, "I'm frustrated because we're going around in circles. At country level we know we need a treatment plan. We know we need government commitment. I would also like support from UNAIDS and others on legal support, treatment preparedness, etc. We don't want to undermine access and equity."

Which countries would attend the late October WHO meeting? According to Jos, Central African Republic, China, India, Senegal, South Africa, Uganda. "We will explain what we are doing, ask what they need and join and become our advocates subregionally. Our team is too small to do health preparedness. All we know is the date and the countries coming. We committed to a meeting on scale up. We are late on that."

"I'm hearing a resistance to identifying roles, responsibilities and actions," said Julian Fleet. "How can we be helpful?"

"Let's take Mark's latest outline structure," said Eric van Praag.

The full group reconvened.

Mario Antonio de Avila Vitoria (Brazil MOH) gave the report from Group One, which suggested:

1. A sub-regional consultation in October or early November to collect experiences on current practices involving the public and private sectors and NGOs. WHO would define the major questions and define the structure and report for those meetings. They should define actions required at global, regional and country levels. In an annex put standards for ART and monitoring programs.
2. A global meeting to finalize the framework for global action to be launched by December 1. Our group felt we do not need a plan, but a more comprehensive framework.

Debrework Zewdie said, "We need to have a document that's hard to disagree with. Do we really need something on December 1?"

Bernhard Schwartländer said, "We should do something, but be flexible."

Mario de Avila Vitoria suggested using December 1 as the day to start the process.

Debrework Zewdie said, "We need to learn from [what happened when WHO announced] the three million in 2005 goal. People expected something to happen immediately. I don't want to put out something empty. People will hold us accountable."

Peter van Rooijen (STOP AIDS Now) reported for Group Two. "We had a long discussion of players, process and product. Who are 'we' and what do 'we' have to 'offer' countries? Finalize the framework. Work on a draft tool-kit. Develop regional and country consensus. Make an inventory of capacity at country level and an inventory of possible alliance members. Do rapid assessments of the support needed at country level, the status of capacity. Understand the epidemiology – how many are in need? What are the political obstacles? A lot of it is there. We need a mechanism to coordinate countries and donors. We talked about the IAVI model. How do you pick the countries where you start? It needs clear institutional and clear personal leadership. Finally, the mechanism should also handle issues for the international plan of action."

Group Three's report called for:

1. An advocacy document calling for political commitment from the international community. This document would come out on 1 December 2002 with
2. A background document with epidemiology (documenting the need) and evidence (documenting that ART works in resource poor settings) in more detail using existing data from WHO, UNAIDS and elsewhere. The epidemiology would focus on what we need now, the evidence section on what we know now and what we need to know.
3. A country toolkit (document 3)/framework for planning, budgeting and implementing a national treatment plan.
4. A framework for international collaboration to support countries including technical sections. This framework could make up the rationale for a Global Access Alliance.

Debrework Zewdie said, "What we need is simple:

• How to do it
• Who does what, when
• Where
• With what
• Monitoring and evaluation

"We identified these gaps and needs and are doing this to address them."

Jos Perriëns said, "We need country/regional consultations, a mechanism to collaborate on these issues, an information exchange mechanism, the product of a group of partners. Concrete steps, construct a knowledge base, consult with program managers, framework document."

"This [the draft IPA] is a very weak document," said Debrework definitively.

The meeting broke for the evening. The group mingled briefly at a reception in the hallway outside, then scattered around Geneva in separate small groups for dinner.

Wednesday 2 October 2002

"All has changed again," said Bernhard Schwartländer at the start of the second day. "That's the sign of a good meeting. We will make a more concrete proposal today, after some additional technical presentations."

III. Technical Presentations (II)

B. Procurement

Jonathan Quick of the WHO Essential Drugs & Medicines (EDM) Department gave a detailed presentation with overheads and handouts on procurement and supply management.

He was on the procurement and supply task force for the Global Fund. The Fund board will decide on the recommendations next Thursday. He showed how many more people would access ART due to the first round of GFATM awards.

In response to questions Quick clarified several features of the WHO pre-qualification process.

Prequalification – in vivo bioequivalence data required. First, companies wishing to be pre-qualified submit a dossier, which is reviewed by WHO. It must include analytic methods. A company is not considered for a site visit unless it presents in vivo bioequivalence data. Second, a site inspection is carried out by a team including a WHO person, someone from the host country, and someone from an international alliance of countries with "stringent" regulatory authorities (these latter include the EU, Japan, the US, though the last does not participate in these site inspections).

Fixed-dose combinations (FDC) must show "interchangeability". Regarding fixed-dose combinations (FDC) of drugs which may not have been tested together in vivo by the brand-name sponsors – e.g., combinations such as d4T/3TC/nevirapine – if there is clinical evidence for products being used in that combination, then that combination can be considered for an FDC. The FDC must show "interchangeability" with the pills when given separately.

Compulsory licensing. Currently the TRIPS Council is wrestling with the issue of whether countries lacking generic manufacturing capacity can issue a compulsory license and import drugs made elsewhere. WHO issued a policy statement recommending that they be allowed to do so¹². It's unclear whether the issue will be resolved anytime soon.

Julian Fleet emphasized the additional legal obstacles facing poor countries, such as the lack of enabling legislation which would allow them to implement the provisions allowed under the Doha Declaration, and the need for international agencies to provide them with assistance. Should the Alliance take this up?

C. Training

Joep Lange presented an overview of training programs sponsored by the IAS. He proposed an ambitious global "core curriculum" for basic training in HIV/AIDS biology and treatment. Michel Kazatchkine (ANRS) said the core curriculum should serve to "train the trainer". Subsequently countries could assist others in their region – as for example, health workers from Senegal are training those in Mali, and those from Côte d'Ivoire are helping those in Gabon.

Lange was asked if they have developed a nursing curriculum. They have not yet done so.

Many speakers emphasized the need for sustainability, local ownership, and ongoing training and support updates within training programs. Moses Kamya mentioned again the importance of training "clusters" of doctors, nurses, and outreach workers who work together.¹³

Charlie Gilks (WHO) pointed out that a core curriculum presented the danger of being static, while knowledge in the field is dynamic and ever-changing. Put the emphasis in the "continuing" in "continuing medical education" (CME).

Carlos Cordero (GNP+) pointed out that HIV-infected persons participating in care and treatment programs could be useful as adherence counselors and in sustaining treatment preparedness.

David Hoos said that the MTCT-Plus sites wanted to ensure their training programs occurred close to the time of implementation.

Michel Kazatchkine suggested that the alliance could help develop an inventory of existing training materials, develop a core curriculum linked with scale-up, including accreditation, and link this program with regional and sub-regional programs.

D. Human Resource Constraints

Norbert Dreesch (WHO) gave an excellent overview of how to go about identifying and dealing with human resource (HR) constraints at the operational level.

"Mobility and mortality." Currently less developed countries are suffering multiple HR losses as some staff migrate to the rich world or to countries with treatment programs (e.g., Botswana), while in hard-hit countries many health care workers are sick from or dying from AIDS. Dreesch and colleagues did a "patient flow analysis" using data inputs from the McKinsey Group's consultation for Botswana (presented at the August IPA meeting by Anil Soni). According to the analysis, Botswana would need 330 additional nurses (on top of their existing 4,416) to provide the planned amount of ART.¹⁴ Alternatively, a savings of 4.2 minutes per hour or 7% efficiency saving would reduce the number of needed new nurses to 21. A savings of six minutes per hour or 10% efficiency gain would eliminate the need for new staff. However to make such gains in efficiency, close attention to the entire health system patient and staff flow is required. The model did not input time savings gained from having fewer patients sick with AIDS-defining conditions or tuberculosis, although, by reducing TB and OIs among both patients and staff, ART would free up time and stabilize the drain on staff.

Several participants noted that their countries were currently losing health care staff to Botswana. Zackie Achmat noted that many countries undergoing "structural readjustment" to please western investors and agencies such as the IMF have public sector hiring freezes. Thus, South Africa for example cannot even hire staff who depart due to attrition¹⁵. Zackie pointed out that scale up of ART would vastly improve staff morale, that the alliance could do something to stem staff "brain drain" to western countries, and that there is substantial additional capacity in many countries in the private sector, which could be drawn upon during scale-up.

Alex Coutinho said that the Botswana model was more clinic-based, while in countries such as Uganda, where 90% of the population is rural, a community-based model would be needed. The CDC is working with TASO to develop a DOT-HAART pilot model in rural Ugandan communities.

Charlie Gilks pointed out that besides brain drain, many countries are suffering from chronic absenteeism among health workers who are sick with HIV infection.

Mark Harrington raised the issue of whether health care workers should be targeted among the initial wave of those treated in ART programs. This raises equity issues. On the other hand, what is the use of scaling up ART if those being trained to deliver it are sick and dying? Should the Alliance come out and say that sick HIV-infected health care workers should get ART in countries where the health care system is dispensing ART? Zackie Achmat mentioned the importance of providing ART for occupational (and non-occupational) exposure to HIV.

Michel Kazatchkine asked what else the alliance could do to address HR constraints. Norbert Dreesch suggested that the alliance recommend that countries carry out health systems reviews and respond appropriately. Guidelines for doing so could be included in the country toolkit.

E. Operational Research

Peter Hale (IAS) gave an impressively comprehensive review of potential questions to be addressed through operational research, and suggested priorities for the next year.

Who's already doing operations research? ANRS, CDC, DFID, MRC, NIH, USAID, others. It overlaps with monitoring and evaluation.

Charlie Gilks pointed out that some questions were best addressed by controlled clinical trials. Here an obstacle is that treatment would need to be provided after the study, yet sponsors are unwilling to guarantee access. What happens to study participants when the trial is over? Industry and governments need to work together to guarantee ongoing access. The lead-in time for controlled trials can be quite long, and thus results may not be in for several years.

Arata Kochi said that operational research was an essential part of the program.

Christopher Benn pointed out that the Global Fund would not fund basic biomedical research, but would fund operational research as part of a country project.

David Stanton said that operational research needs to be designed along with the program. It's useless if it's added on afterwards.

The Way Forward

Debrewerk Zewdie chaired the discussion. "This discussion is necessary. There is a need to formalize an alliance, determine where to go from here, come up with an action framework and a structure. What is the mechanism? What is the structure? What are the goals?"

Michel Kazatchkine came right out with the question on everybody's mind. He asked Mark Dybul, Gene McCray, David Stanton, and Debrework Zewdie if they (or their agencies) saw any point in having a Global Access Alliance.

"I don't know how to answer," replied David Stanton. "What is the value of something that hasn't been defined? What's its organization, structure, purpose?"

"Would an alliance bring added value?" asked Kazatchkine, citing the technical reports and discussion of the past two days.

"We're in a hypothetical realm," replied Stanton. "Sure, they're important – but what's on the table?"

Peter van Rooijen made a concrete proposal.

1. The mechanism. A Global Partnership or Alliance for Access.
2. The structure. An Interim Steering Committee (ISC) would shepherd the process for the next six to nine months and move the partnership ahead. The milestones would be the announcement of the alliance on 1 December 2002 and the development of an International Plan of Action – or some other concrete output % by 1 July 2003. The ISC would announce the alliance's existence on World AIDS Day, draw up a clear short- and long-term agenda, identify needed work products, hold regional and sub-regional consultations, solicit additional partners, hold a partner meeting in June 2003 and release its plan or options for continuation in July 2003.
3. The goal. Scaling up treatment access to those in need as soon as possible with the ultimate goal of universal access to ART for those in need and the medium-term target of assuring that three million people are on ART by 2005. The alliance would strengthen the link between prevention and treatment and highlight the need for unprecedented action.

Suggested composition of the ISC – IAS, UNAIDS, WHO, World Bank, one donor, one foundation, someone from the private sector, a PWA organization, three NGOs from developing countries. WHO would be the secretariat. The partnership would be open to any organization committed to the goal and willing to provide concrete input including NGOs, countries, private sector organizations, business, the pharmaceutical industry, etc.

Alex Coutinho asked, "What are the roles? The structure should serve the roles versus vice versa."

Peter von Rooijen said the agenda included the following items – 1) announce partnership; 2) complete framework; 3) complete draft toolkit (after country consultations); 4) develop inventory/assessment on size of epidemic, country needs, country capacity, partner capacity; 5) conduct rapid assessment of economic situation, political/legal obstacles, donor analysis, private provider capacity, assess insurance schemes; 6) advocacy – strategy paper & plan; 7) drug regimens – simple/robust vs. cost; 8) quality assurance for staff (accreditation), drugs (prequalification); 9) prevention-treatment link (strengthen); 10) HIV testing/VCT; 11) training; 12) operations research/models of care; 13) health care financing; 14) treatment preparedness; 15) monitoring & evaluation (M&aE); 16) drug procurement and supply chain management.

A host of objections broke out to the composition of the Interim Steering Committee. The Global Fund should be on it. A northern NGO should be on it. Regional and subregional organizations needed to be on it. AfriCASO should be on it. ECOWAS should be on it. A Francophone country should be on it. More developing countries should be on it. Why were no country members specified? Etc., etc.

Exercising her prerogative, the chair declared that the suggestions would be taken under advisement, but that for now the Interim Steering Committee would remain as proposed.

Was the partnership a new organization? Would it be perceived as competing with the Global Fund? It would not be an organization – though it would have a secretariat. It was not designed to compete, but rather to complement, the Global Fund.

The group then went through the sixteen components of the Alliance agenda and identified partners for each component:

Participants welcomed the concrete objectives, assignments, but many felt that the July 2003 delivery date was too far in the future. What was the justification for the additional delay of nine months?

"Let me see," said Mark Dybul, "We're proposing this gigantic new thing, which will take up a lot of money. The donors are the governments we represent. What's this Alliance going to do that's different from everyone else? All these things need to be done. What do our governments need? They need a clear justification of why we think it's doable. Why do we think it's doable? Donors don't believe small pilot projects do it. It would be nice to have this by December 1. Everyone understands that this is a humanitarian disaster. But how would this Alliance address those tough questions? To whom would it be accountable?"

Jonathan Quick said, "None of these things will happen without a group like this. It would help to maximize the synergy and eliminate duplication. It sounds like another public-private partnership (PPP). There are at least 80 PPPs in the health sector, most set up in the past five years. What can we learn from their experiences?"

Christopher Benn said this is different from the Global Fund, which is a funding agency, not a policy agency. The alliance would focus on policy, complementing the Fund's focus on funding.

Someone pointed out that UNAIDS and WHO are supposed to provide policy and technical input to funders and countries.

Alex Coutinho referred to the five blind men and the elephant, and said the way forward is very clear. Donors want to fund projects at minimal risk. To take an example from his country, was the CDC capable of bridging the gap between pilot and full scale-up? No. Countries want to address the pressing need. The Alliance could help by providing several outputs – strong advocacy tools, a resource and information center, and direct country support and technical assistance.

Finally, Bernhard Schwartländer thanked everyone for their participation, stating that the meeting had been outstanding and had achieved good closure. Participants would receive meeting notes in a week or so. Follow-up activities would commence immediately.

• View all footnotes
• Comment on IAP meeting Richard Stern, Director, Agua Buena Human Rights Association