Unlocking the Secret of Global Health Victories

Websites

Bill and Melinda Gates Foundation: Neglected Infectious Diseases
The Gates Foundation supports research and development for global health initiatives, including for NTDs, HIV, malaria, and TB.

Centers for Disease Control and Prevention: Neglected Tropical Diseases
Information on NTDs from the U.S. Centers for Disease Control and Prevention. The CDC is focused on the seven NTDs that can be controlled or even eliminated by providing safe and effective medicines through mass drug administration.

GAVI Alliance
The GAVI Alliance partners with international organizations to increase access to immunization in poor countries.

Global Alliance for TB Drug Development
The TB Alliance works to discover and develop better, faster-acting, and affordable drugs to fight tuberculosis.

The Global Fund to Fight AIDS, Tuberculosis, and Malaria
The Global Fund builds support for the fight against AIDS, TB, and malaria, working with partners to support the most effective prevention and treatment.

Global Health Innovative Technology Fund
The GHIT Fund facilitates international partnerships that enable Japanese technology, innovations, and insights to play a more direct role in reducing disparities in health between the rich and the poor of the world.

National Institute of Allergy and Infectious Diseases, NIH: Neglected Tropical Diseases
Information about the NIAID research program devoted to understanding, preventing, and treating NTDs. Studies look at the microbes that cause NTDs, targets for potential new drugs and vaccines, and strategies for controlling the organisms that transmit NTD-causing agents to humans.

PLOS Neglected Tropical Diseases
Public Library of Science open-access articles on neglected tropical diseases.

The World Bank: Concessional Finance and Global Partnerships — Advanced Market Commitment
Information about advanced market commitments from the World Bank Group's unit responsible for mobilizing and managing concessional and grant financing.

World Health Organization: Neglected Tropical Diseases
The Department of Control of Neglected Tropical Diseases coordinates and supports policies and strategies to enhance global access to interventions for the prevention, control, elimination and eradication of NTDs including zoonotic diseases.

UNAIDS
UNAIDS, the Joint United Nations Programme on HIV/AIDS, aims to advance global progress in achieving country-set targets for universal access to HIV prevention, treatment, care, and support and to halt and reverse the spread of HIV.

UNICEF: Health
UNICEF, the United Nations Children's Fund, targets preventable diseases by funding innovation and partnerships, with a focus on child health.

United Nations Development Programme
The UNDP helps countries achieve poverty reduction and work on Millennium Development Goals, democratic governance, crisis prevention and recovery, and environment and energy for sustainable development.

Sponsors

Presented by

Speaker:
B.T. Slingsby, GHIT Fund
 
Moderator:
Ko-Yung Tung, Morrison & Foerster LLP
 
Panelist:
Kiyoshi Kurokawa, GHIT Fund; National Graduate Institute for Policy Studies, Japan; Health and Global Policy Institute, Japan

Highlights

• The GHIT Fund focuses on building public–private partnerships to bring Japanese pharmaceutical research and development to very poor populations.
• The WHO recognizes 17 neglected tropical diseases, which are parasitic, viral, or bacterial diseases that affect more than a billion people but receive scant R&D.
• Partnerships can drive progress by spreading risk (cost) and combining diverse expertise.

Introduction

Unlocking the Secret of Global Health Victories featured panelists with diverse experiences in the global health field, which is focused on solving population-level health crises that cross national borders. The Japan Society's president Motoatsu Sakurai framed the discussion by outlining its goals: to identify successes and setbacks in global health, to understand how to bring new vaccines and cures into the field, to explore how public–private partnerships work, and to recognize new opportunities.

B.T. Slingsby, CEO and executive director of the GHIT Fund, explained how the organization aims to impact global health. The GHIT Fund is a Japanese initiative focused on bringing breakthroughs in Japanese pharmaceutical research and development to very poor populations. Two of the four best-selling drugs in the U.S., aripiprazole (Abilify) and rosuvastatin (Crestor), were developed in Japan; but the Japanese drug industry is not heavily involved in global health programs and GHIT Fund aims to make it more so.

Slingsby pointed to the "relationship between the critical timing of health care [and] the individual's quality of life," contending that the "ability to participate in community and in society and to work is really related to health care." To illustrate, he told the story of an Egyptian man who despite recovering from lymphatic filaraisis lived with its debilitating effects for the rest of his life. This disease is classed as a neglected tropical disease (NTD), one of the 17 parasitic, viral, or bacterial diseases in this category. The World Health Organization (WHO) estimates that more than a billion people, in 149 countries, are infected with NTDs.

Infectious diseases—NTDs, malaria, HIV, and tuberculosis (TB)—afflict one in seven people. Three billion people are at risk of infection. However, both effective medications and investment in drug development are lacking: infectious diseases are targeted by less than 2% of the 1500 new drugs that become available in a decade. "That's because of a lack of a market mechanism," Slingsby said. The GHIT Fund exists to fill this gap. Companies find it difficult to profit from drug development for infectious diseases because most recipients are too poor to pay for expensive medications; the organization builds private–public partnerships through which to fund much-needed research and reduce the cost of drugs. Slingsby called the partnerships the GHIT Fund finances "global partnerships," in this case between a Japanese organization and an organization from another country; building such global partnerships between different countries and different sectors was a recurring theme throughout the event.

The GHIT Fund: partnerships for global health

After Slingsby's introduction Ko-Yung Tung, a senior partner at Morrison & Foerster LLP, moderated a panel discussion that explored global health projects and the changes that are needed to meet current challenges. Tung is a GHIT Fund board member who previously helped to set up the UN's Global Fund program as the general counsel at the World Bank. The panel included other members of the GHIT Fund Board of Directors: Kiyoshi Kurokawa, an academic at the National Graduate Institute for Policy Studies and chairman of the Health and Global Policy Institute in Japan; Peter Piot, director of the London School of Hygiene & Tropical Medicine; and Ann M. Veneman, the former executive director of UNICEF. It also featured GHIT Fund grant awardee Mel Spigelman, president and CEO of the Global Alliance for TB Drug Development.

Tung first asked Kiyoshi Kurokawa about the GHIT Fund and how each member—the Japanese government, five Japanese pharmaceutical companies, and the Bill & Melinda Gates Foundation—contributes to its efforts. Kurokawa discussed the changing face of global health management, which has previously been dominated by intergovernmental action and international organizations, such as the UN and the WHO, but is now more reliant on private–public partnerships, in part because of the high debt held by most developed nations.

Kurokawa also talked about why engagement in global health is important in our increasingly interconnected world, which highlights global disparities. Vaccines have made it possible for many people to live without fear of diseases such as poliomyelitis, but some in poor countries do not have access to these and other medications, and the distinction is glaring. As Slingsby mentioned, many drugs are discovered in Japan but they are rarely marketed globally by Japanese companies. The GHIT Fund is a new type of venture, distinguished by its scale and international partnerships; Kurokawa thinks that this model is "changing the mindset of the Japanese government and Japanese [corporations]" and hopes that the organization will help to "narrow the gap" between rich and poor nations, especially in disease burden.

Moderator:
Ko-Yung Tung, Morrison & Foerster LLP
 
Panelists:
Peter Piot, London School of Hygiene & Tropical Medicine, UK; GHIT Fund
Ann M. Veneman, formerly of UNICEF; GHIT Fund
Mel Spigelman, Global Alliance for TB Drug Development

Highlights

• A combination of science, politics, and activism brought HIV/AIDS to the world's attention.
• Tackling infectious diseases requires better medications, delivery systems, and education programs. We need to build sustainable health systems within countries, shifting the focus of aid from campaigns to solutions.
• Despite enormous need, drug development for infectious diseases is lacking. Profit motivation is low, but partnerships can encourage companies to invest in research.

HIV/AIDS: the road to global action

Tung next invited Peter Piot of the London School of Hygiene & Tropical Medicine to speak about his experiences in the field of HIV/AIDS. While acknowledging notable progress, Piot, who was the founding executive director of UNAIDS, emphasized that there is still much work to be done.

"AIDS has transformed how we look at health," Piot said. "Even the term global health is quite new." Indeed, AIDS was one of the first diseases to be thought of in such terms and to be discussed on a global stage. AIDS itself is a new disease, having first been identified only 35 years ago. However, the taboo surrounding it in the early years prevented the disease from garnering much serious discussion, and most gains have been made in the past decade.

Piot identified three mechanisms that together made these gains possible: science, politics, and activism. When the first drugs for HIV were developed in 1996, treatment cost $14 000 per person per year and remained out of reach for most patients, 75%–85% of whom live in Africa. At this point, Piot said, he "became obsessed [with] bringing down the price of the drugs." A combination of scientific innovation and negotiation with pharmaceutical companies, persuading them to cater to the poor yet vast market in developing nations, helped to achieve this goal. The drugs now cost $100 per person per year.

The development of these medications coincided with the founding of UNAIDS, headed by Piot. The organization focused on describing the prevalence of HIV/AIDS and looking for solutions. At first, Piot said, he was "naïve" in thinking that scientific breakthroughs would be enough to stop the disease, but he realized that success would require more than new drugs. Instead, the organization needed a political strategy, a "coalition of the willing" to advance its agenda.

"We're in this for the long haul, and that will require sustained political will, funding, and innovation."

As the AIDS epidemic gained prominence, spurred initially by the work of activists, political will converged on the topic. In 2001, the international trade agreement TRIPPS (Agreement on Trade Related Aspects of Intellectual Property Rights) was amended to allow countries to import generic brands of patented medications in public health emergencies. This change was partially responsible for the dramatic fall in the price of HIV drugs, because it opened the market to generic manufacturers in India and other emerging markets. One year earlier, the G8 summit had initiated a project that became the Global Fund to Fight AIDS, Tuberculosis and Malaria, and in 2003 the U.S. Congress provided $15 billion to create PEPFAR, the U.S. President's Emergency Plan for AIDS Relief, providing crucial funding to lower prices and deliver drugs.

Despite the international attention and hefty funding HIV/AIDS has received, "the end is not in sight," Piot concluded. "1.7 million people died last year: that's not success." There were 35.2 million people infected in 2012 and 2.3 million new infections. To change these figures, the main ingredients will be political determination, funding, and further scientific advances to improve treatment and prevention regimens.

A multidimensional approach

As he introduced the next speaker Ann M. Veneman, Tung echoed Piot's sentiment. Notwithstanding the title of the event, "I don't want to do a victory lap," he said. "We're far from it, so what do we do?" As former executive director of UNICEF and former U.S. Secretary of Agriculture, Veneman could speak about programs Tung called "truly global" in scope. He asked her to identify those that work, and to explain why.

Veneman's remarks highlighted the many features that must come together for health initiatives to succeed. She began by discussing the progress UNICEF has achieved in reducing child mortality by providing vaccines for preventable diseases such as poliomyelitis. Polio has been nearly eradicated globally and only survives in a few regions. Most of these regions are conflict zones where drug delivery is difficult. Indeed, conflict poses particular challenges for all international health initiatives and can lead to regression from earlier gains; polio, for instance, recently reemerged in Syria during its civil war.

Even without conflict, delivering drugs on a scale that can impact public health is daunting. Eradicating an infectious disease means distributing vaccines to every remote village. Transportation systems must be in place and routes must be navigable. Simply transporting vaccines is complicated by the need to keep them refrigerated.

Delivery is also insufficient; education programs are needed both to ensure that drugs and other interventions are used correctly and to allay misinformation about their safety and effectiveness. Veneman pointed to efforts to combat malaria, which "illustrate the need for integrated approaches." Bed nets are one of the most important tools to reduce exposure to mosquitoes and have been a focus of aid efforts. However, the nets are only effective when used properly and when combined with other tools. We need to think about disease prevention in terms of creating a "whole preventative atmosphere," Veneman said, rather than homing in on one aspect or another.

Like Piot, Veneman related the importance of reducing the cost of health interventions. UNICEF also works in the field of HIV/AIDS, with a focus on reducing mother-to-child transmission and treating pediatric disease. These initiatives have been effective, and the organization has been able to use its clout as a large buyer of medications to negotiate prices with pharmaceutical companies. Sometimes, however, achieving the lowest possible cost for an intervention is not paramount; UNICEF and other organizations must decide whether to charge a small fee for some products. Veneman said there has been debate, for example, about whether to charge for bed nets, in the hope that doing so would increase their value to recipients and encourage proper use.

"You can't create sustainable results with campaigns. We need structural initiatives."

"You can't create sustainable results with campaigns ... we need to address the structural initiatives around global health," Veneman said. Such an approach shifts the focus from targeting specific diseases and aims to be more comprehensive. A primary goal, she said, is to "create workable, sustainable health systems" within countries; a major challenge is to figure out how to do so.

The Millennium Development Goals have created a useful framework, establishing "a commonality of purpose around poverty alleviation" that puts a world focus on global health. Veneman concluded by iterating the importance of new and continued funding from sources such as the Global Fund and the GAVI Alliance, as well as of advanced market commitments for new vaccines, in which donations subsidize the cost of vaccines still in development, helping to guarantee a market for new drugs. Returning to the theme of the event, she pointed to partnerships as "absolutely critical"; not surprisingly given her focus on multifaceted approaches, her list of essential partners is comprehensive, including governments, the private sector, civil society, international organizations, communities, and families.

Grants and partnerships: the way forward

The final panelist, Mel Spigelman of the Global Alliance for TB Drug Development, is a GHIT Fund grant awardee. Tung asked him to comment on TB and to explain how a GHIT Fund grant helped his organization. Although not classed as an NTD, TB is one of the many tropical diseases that are neglected "because they concern mostly the poor of the world and those who are unable to pay going rates for innovation and for new products," Spigelman said.

In 2011 there were 8.7 million new patients and 1.4 million deaths from TB; as Tung remarked, "these are staggering, jaw dropping figures." Astonishingly, Spigelman reported, 2 billion people worldwide are infected with the bacteria that cause TB. The disease is a major cause of child mortality and predominantly affects young adults. Yet, because pharmaceutical development is profit-driven, little research has been done in this area. The "highly ineffective" vaccine used in many countries, though not recommended for all children in the U.S., became available in 1921. A new diagnostic developed last year replaced one that was 80 years old.

The Global Alliance for TB Drug Development is working to change the status quo through partnerships. It has 25 projects, and one new drug that is in phase III clinical trials may be approved by next year. The model aims to be cost-effective. Partnerships are particularly important for spreading the cost (risk) of drug development—estimated at around $2 billion per product. The organization's partners include pharmaceutical companies, U.S. government agencies, and universities.

"What's fundamental to all PDPs (product development partnerships), is lowering the barrier for others to get involved," Spigelman said. Grants from the GHIT Fund provide a means to do so. Its combination of diverse players is a departure from the traditional bilateral partnership model; Spigelman described the fund as "a paradigm shift in how we can make progress ... [that is] forming a path for others to follow." He advocated for the creation of similar initiatives in other countries, particularly those with emerging markets and growing pharmaceutical industries.

Moderator:
Ko-Yung Tung, Morrison & Foerster LLP

Why Japan? Can others follow?

The end of the panel discussion featured questions from the moderator and the audience. After hearing about the lack of profit motivation in drug development for infectious diseases, Tung asked Kurokawa to explain why the Japanese government is interested in tropical diseases and why Japanese pharmaceutical companies joined a project like the GHIT Fund. Kurokawa talked about the value in making Japan more globally connected and said that partnerships are strengthening the Japanese pharmaceutical industry. With its Official Development Assistance (ODA) program, Japan is seeking to increase its assistance to developing nations. Piot also commented that the fund is "a unique opportunity to unleash the formidable potential of Japanese innovation and discovery for the benefit of the whole world." Although Japan has given billions to international aid efforts, this is a new means to harness the "innovation Japan is famous for," Piot said.

When asked whether this model can be replicated in other countries, Veneman answered that the organization reflects a global trend toward using aid to make lasting changes in poor nations rather than providing welfare. Many organizations no longer focus on "just aid and projects" but instead are looking to create "solutions, sustainability ... and economic opportunity." Meanwhile, the private sector is more focused on products that are profitable as well as beneficial to society. Together, public and private sectors are building projects that, while not identical to the GHIT Fund, aspire to the same goals.

Spigelman said that any type of partnership should be win-win. It can be difficult to create bilateral partnerships from scratch, but with a framework in place, with companies "already invested," with government backing, and with a focus on global health, it is easier to settle on common goals. He also pointed out "Japanese pharmas are poised for expansion around the world ... [and seeking] to grow into true global pharmaceutical companies." Reaching a global market means operating in Asia and Africa where TB and other infectious diseases are rife, and this situation has created "the makings of a win-win proposition for everybody." Slingsby remarked that although drug development partnerships are common, funding partnerships are less so. Japan is the second most generous contributor to foreign aid but only the fourteenth-highest investor in research and development. The GHIT Fund "puts them on the stage," and provides others with "access to innovation" from Japan.

Audience Q&A

One audience member pointed out that brands like Coca-Cola are everywhere, and refrigerated beer can be transported quickly and efficiently to remote areas. Why is the same not true of drugs? Veneman replied that drug-delivery partnerships, taking advantage of commercial systems that are already in place, are pending. However, the problem is two-fold because drug administration requires trained health care workers. Piot remarked that it would be helpful to develop drugs that are more user-friendly, do not need to be refrigerated, or can be taken less often. "That may make a bigger difference than a brand new vaccine," he said. Slingsby reported that partnerships with beverage companies are in development for transporting vaccines.

The GHIT Fund is focused on the discovery and development of new drugs, but the organization considers delivery and access when it decides which projects to fund. Spigelman said that funders are not responsible for making sure that every aspect that is involved in bringing a drug to patients is in place: "that's the benefit ... of partnerships." The projects that the GHIT Fund supports are late-stage technologies that will be ready for market quickly.

In their final remarks, the panelists outlined key takeaways from the discussion. Kurokawa recommended that Japan engage more globally; despite its advanced technologies, it is "behind in vision, human network, and mindset," he said. Piot emphasized the need for innovation and leadership, especially to develop new drugs: "we simply don't have the tools to end most of these diseases." Veneman agreed, but added that collaboration is also essential. She and Spigelman also pointed to the future, noting that eliminating infectious diseases is not a panacea for global health because the emerging big diseases are non-communicable. "Global health ... will be the diseases that we consider, quote, routine: diabetes, cancer, heart disease. Those will be neglected global diseases in ten years," Spigelman said. And we will need partnerships to solve them.

How do organizations find success in developing medicines that do not lead to easy commercial success? How can partnerships help?

What have we learned from past successes that make the difference between a breakthrough diagnostic or treatment and a trip back to the drawing board?

How can we build sustainable health systems in poor countries?

How can we transition aid efforts from campaigns to solutions?

Who is missing from the table in the efforts to push back against HIV, TB, malaria, and neglected tropical diseases?

Why should those outside the global health and NGO sectors join this effort?

Which kinds of medications should be the focus of drug development for infectious diseases? Should we improve the usability of existing drugs or develop new ones?

How can we improve medication delivery systems to remote areas?