By GARY COHEN
Executive Vice President and President, Global Health and Development at BD (Becton, Dickinson and Company), Acting CEO of GBCHealth, and Board Director at the CDC Foundation and the U.S. Fund for UNICEF

One way to assess just how far a journey has progressed is to take a look back to the starting place. For many companies that today are deeply involved in helping address a wide range of unmet global health needs among resource-limited populations, the HIV & AIDS pandemic was where their journey began.

The origins of collaborative business engagement in the HIV & AIDS pandemic can in part be traced back to 1997, when meetings began between four large pharmaceutical companies, the Financial Times, and MTV Networks in what became known as the “Global Business Council.” Membership grew to over 20 companies, and meetings were held in Davos, Switzerland. The focus of these meetings was establishing best practices and getting member companies to commit to an AIDS strategy, both internally and externally. Sir Richard Sykes, then Chairman of Glaxo served as the first chair, and Bill Roedy, then Chairman and CEO of MTV Networks International, assumed the role of chair in 1999.

Advancements in anti-retroviral therapy (ART) in the 1990’s increasingly enabled HIV to be managed as a chronic disease rather than becoming a certain cause of death. But an enormous disparity emerged in access to ART among people living in developed versus developing countries. In particular, HIV prevalence rates were highest in southern Africa (representing approximately 75 percent of the global HIV burden at the time), yet access to ART in Africa was essentially non-existent at the turn of the millennium in 2000.

This enormous, life-and-death disparity prompted an unprecedented level of civil society activism. World leaders began to prioritize HIV & AIDS at the top of the global development agenda, prompted in part by an unprecedented meeting of the UN Security Council in January 2000 focused on the impact of AIDS in Africa. This meeting was led by then- U.S. Ambassador to the United Nations Richard Holbrooke. In 2001, Ambassador Tim Wirth (former U.S. Senator and the first President of the UN Foundation) and Peter Piot (first Executive Director of UNAIDS) suggested that Ambassador Richard Holbrooke assume the helm as president and CEO of the Global Business Council (which soon a after was renamed the Global Business Coalition on HIV/AIDS, or GBC). This proposal was encouraged by UN Secretary General Kofi Annan and former President of South Africa Nelson Mandela, who were among world leaders that recognized the importance of engaging the business sector in the battle against HIV & AIDS, particularly for the purpose of substantially expanding access to ART drugs, which at the time were priced too high to enable broad access in developing countries.

Holbrooke was well known for his diplomatic yet forceful personality. Having served as primary negotiator on behalf of the U.S. government for ending the war in Bosnia, Holbrooke was experienced in taking on big challenges. He also had private sector experience as a senior adviser to Lehman Brothers and vice chairman of private equity firm Perseus, L.L.C. Holbrooke moved quickly to establish GBC as the leading force engaging the business sector in the HIV & AIDS pandemic, expanding membership to over 225 companies.

Among GBC’s first private sector engagement initiatives was actively soliciting member companies to change their workforce policies in order to destigmatize HIV & AIDS and extend access to health services, including ART, for their employees, families, and communities. Companies such as Anglo American and Chevron, which employed very large workforces in sub-Saharan Africa, emerged as early leaders in this effort.

In this same time frame, a substantial movement was underway to raise massive levels of funding for the HIV & AIDS response, with particular focus on dramatically expanding access to HIV rapid tests for diagnosis, ART drugs for treatment, and contraceptives (condoms) for prevention. By 2003, two new funding mechanisms were established, the Global Fund to Fight HIV, TB and Malaria, a multi-lateral aid program headquartered in Geneva, and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), a bilateral aid program based in Washington, D.C.

A key area of focus for health for officials and policymakers was to substantially reduce the cost of ART drugs in order to support massively expanded access. The Clinton HIV/AIDS Initiative (CHAI for short, today the Clinton Health Access Initiative) was particularly instrumental in this effort. CHAI leaders understood that the most feasible way to achieve massive increases in access and manufacturing scale was to help companies establish sustainable business models with volume commitments that enabled a sufficient profit to be earned at drastically reduced prices. CHAI negotiated pricing and volume agreements with both branded and generic ART manufacturers. CHAI leaders also recognized that scale-up of sophisticated laboratory tests, particularly CD4 count and viral load, would be necessary to support efficacious initiation and monitoring of ART, and they engaged in negotiations with manufacturers of these diagnostic tests, similar to the approach taken with ART manufacturers. For example, BD (Becton, Dickinson and Company) entered into an access pricing agreement with CHAI that reduced the price of the company’s CD4 tests by up to 75 percent. This access price was extended to 55 developing and emerging countries. BD also worked collaboratively with CHAI and other partners to train over 8,000 laboratory technicians in these countries on proper procedures for conducting CD4 tests, contributing to substantial expansion in diagnostic testing capacity throughout the developing world, particularly in sub-Saharan Africa. This agreement was signed in January 2004.

One month prior, in December 2003, GBC CEO Holbrooke and then-U.S. Secretary of Health and Human Services (HHS) Tommy Thompson personally led a delegation of approximately 100 health and business leaders on a visit to four countries in sub-Saharan Africa for the purpose of in- depth and first-hand study of the HIV & AIDS pandemic. This delegation included a literal “who’s who” of health leaders such as JW Lee of the World Health Organization (WHO), Peter Piot of UNAIDS, Julie Gerberding of the U.S. Centers for Disease Control and Prevention (CDC), Elias Zerhouni and Anthony Fauci of the National Institutes of Health (NIH), Louis Sullivan, former U.S. Secretary of HHS, Sir Richard Feachem, newly appointed Executive Director of the Global Fund, and Randall Tobias, newly appointed as Ambassador of the U.S. Office of the Global AIDS Coordinator responsible for PEPFAR. The delegation also included business leaders from global companies such as Gilead, Pfizer, GalaxoSmithKline, and Bristol Myers Squibb, as well as leaders of non- government and faith-based organizations.

As a delegate on that trip representing BD, I can personally attest that the first-hand experience on the impact of HIV & AIDS was transformational. We visited Zambia, Rwanda, Kenya,* and Uganda, adhering to a very demanding and rigorous schedule. We engaged personally with patients in health facilities and in their homes, spoke with leaders of new programs established to expand ART, and met with government officials responsible for planning the scale-up of ART for their populations.

One particular experience stood out. In Uganda, we met with a woman living with AIDS named Margaret Achieng. Margaret’s husband had died from AIDS. Her son also died. She lived in a small home with no electricity, running water, or sewage access. There were more children than we could count on Margaret’s property, and they were all in her care, at least up until the point when AIDS made her too weak to walk. Then Margaret’s oldest daughter had to assume responsibility for the children. Margaret referred to this daughter as “her angel.”

Margaret had another angel, a young woman who, working for a U.S. government-funded program named TASO, traveled by motorbike to deliver free ART to people living with HIV & AIDS, bringing these drugs directly to their homes. This young woman accompanied us during our visit.

Four members of the delegation and two reporters visited with Margaret. Dr. Tony Fauci, who many consider to be the world’s leading physician-researcher on HIV & AIDS, was part of this small group. We listened to Margaret as she explained every detail of her therapy. She had a precise knowledge of her condition and treatment. She was aware of her CD4 count. In fact, Margaret was remarkably articulate about everything she discussed with us. We learned that she was university educated—a teacher before being disabled by AIDS.

Upon leaving Margaret’s simple home, Dr. Fauci told me that his “...paradigm of HIV treatment in Africa just fundamentally changed.” He continued to say, “My associates in the U.S. have told me that you can’t administer ART to patients in this type of setting because they won’t know the time of day to take their drugs. And then here’s Margaret, who knows more about her therapy than my average patient in Washington, D.C.” These comments typified the transformational experiences of all the delegates who joined this trip.

As a direct outcome of this trip and the influence of GBC and other private sector mobilization the efforts in 2003 and 2004, companies substantially scaled up their engagement in the HIV & AIDS response. By way of example, within two months following the trip, BD established a new HIV & AIDS function, charged with mobilizing the company’s HIV-related initiatives across business units and geographies. This new company function, soon after renamed BD Global Health, accomplished its mission by initiating public-private partnerships (PPPs) focused on specific health goals, such as establishing “Wellness Centres” to strengthen health workforces by addressing the testing and treatment needs of clinicians and their families. In 2007, BD, PEPFAR, and CDC initiated a new laboratory strengthening partnership focused on systems and skills necessary to improve diagnostic testing capabilities for HIV, TB, and other diseases such as diabetes. This partnership, now known as “Labs for Life,” enabled laboratories in sub-Saharan Africa and India to progress towards internationally recognized accreditation standards, supporting scale-up of national laboratory standards and systems in Ethiopia, Uganda, Kenya, Mozambique, and India. Peer-reviewed papers describing the measurable outcomes of this PPP were recently published in the Journal of Infectious Diseases.

Fast forwarding from the prior decade to today, companies have expanded upon their engagement in HIV & AIDS to help address unmet needs in other areas such as maternal, newborn, and child health, non-communicable and neglected tropical diseases, and emerging epidemics such as Ebola and Zika. Initiatives such as Merck for Mothers and Helping Babies Breathe (which includes Johnson & Johnson and other partners) demonstrate substantial levels of investment and commitment from the business sector. Traditional methodologies utilized by the private sector to positively impact global health such as philanthropy and corporate social responsibility are being supplemented by newer “social innovation” methods such as shared value creation (initiatives specifically intended to achieve both positive social and commercial outcomes) and blended finance (combining public, foundation, and private capital to increase investment and share risk in bringing global health initiatives to scale).

There is also a substantial increase in innovation activities among inventors, academic institutions, start-up companies, and larger corporations for the purpose of addressing global health needs, catalyzed by initiatives such as Saving Lives at Birth: A Grand Challenge for Development. Saving Lives at Birth is a competition for groundbreaking innovations that can leapfrog existing products and conventional approaches to address deaths among mothers and newborns, almost all of which occur in low- and middle-income countries, especially in sub-Saharan Africa and South Asia where access to quality care is the most limited. To date, this competition has awarded “seed grants” and “transition to scale grants” in five rounds, from 2011 to 2015. The funding partners for Saving Lives at Birth are USAID, the Norwegian Ministry of Foreign A airs, the Bill & Melinda Gates Foundation, Grand Challenges Canada, UK aid, and KOICA (Korea International Cooperation Agency). The World Bank is an affiliate.

All of these activities can, in some way, trace their origin back to the business engagement in the HIV & AIDS response, to a time when most companies were just beginning to understand the broader role they could—and were expected— to fulfill in addressing the leading infectious disease of our time. Between then and now, companies have substantially advanced the breadth and depth of their engagement in global health, and barriers to private sector involvement that existed in prior decades, such as reluctance among some public sector agencies and leaders to partner with the private sector, have diminished. This progress better prepares all sectors to work together to address unmet health needs among high burden, low resource populations in the coming years, such as those articulated in Sustainable Development Goal number 3, including the “90-90-90” targets for diagnosis, treatment, and viral suppression of HIV & AIDS.

*Due to a report of a terrorist threat in Nairobi only a few members of the delegation traveled to Kenya.  This threat was later determined to be unsubstantiated.

By: AARON OXLEY
Executive Director, RESULTS UK

The discovery of penicillin changed the world. In 1928, Alexander Fleming revolutionized the way we see microbial infections by discovering the first antibiotic, a feat that ultimately awarded him the Nobel Prize in Physiology or Medicine in 1945. Penicillin has saved more than 200 million lives since its introduction in 1942.

But almost as soon as antibiotics were developed, resistance began to develop too. Now more than 70 years on, over-prescription, unnecessary agricultural use, and complicated treatment regimens are allowing organisms to survive exposure to the drugs designed to kill them. These resistant organisms spread, with drug resistant infections claiming over 50,000 lives a year in Europe and the US alone.1 Globally, we are seeing rates of so-called “superbugs” such as methicillin resistant.

Staphylococcus aureus (MRSA) skyrocket, with increased mortality rates and costly price tags. It is not just antibiotic resistance that is an issue as viruses such as HIV or parasitic infections such as malaria are becoming drug resistant, too. This highlights a technical but important distinction: antibiotic resistance is just a part of the broader problem of antimicrobial resistance (AMR).

Nowhere is this more important than in the progress humanity has made on eliminating infectious diseases. Diseases once thought to no longer exist in the developed world, such as TB and malaria, have the potential for a devastating return.

2016 has seen unprecedented and desperately needed international attention to AMR. Earlier this year there was the ground-breaking publications of the Review on Antimicrobial Resistance,2 led by Lord O’Neill, a UK Treasury Minister and former Goldman Sachs Chief Economist. Established by former UK Prime Minister David Cameron, the AMR Review’s mandate was to analyse and propose solutions to the rise of antimicrobial resistance.

The report concludes there is an almost inconceivable human burden and economic cost facing the world. It warns of an estimated 10 million AMR deaths every year by 2050, resulting in a reduction of 2-3.5 percent of in global GDP.3 Not only could the global economy be reduced by up to $100 trillion USD over the next 35 years, but without action standard operations and medical procedures may be deemed too dangerous to conduct due to the threat of an untreatable infection.

The world’s deadliest infectious disease becomes drug resistant.

We do not need to look far into the future to understand the consequences of ignoring this issue, because it is already here in the form of tuberculosis (TB)—one of the world’s oldest diseases and also the deadliest. TB has claimed more lives throughout history and claims more lives each year than any other infectious disease,4 and it is well along the path of becoming resistant to antibiotics. TB was placed firmly at the centre of the O’Neill review;

“Tackling TB and DR-TB must be at the heart of any global action against Antimicrobial Resistance. The burden of TB is too great and the need for new treatment too urgent.”

Over the last few decades, TB has been quietly transforming into new strains of drug resistant TB (DR-TB).** DR-TB causes an astounding 500 deaths a day and cannot be cured with standard TB drugs.5 As the only airborne drug resistant infection, the AMR Review estimates that TB has the potential to cause a quarter of all AMR deaths by 2050, with an estimated 75 million people dying from the disease over the next 35 years.

The economic cost of DR-TB will be astounding, estimated at $16.7 trillion by 2050. This is equivalent to the annual economic output of the EU,7 with one person dying from the disease every 12 seconds.8 The bacterium that causes TB disease is a hardy organism that takes months of daily treatment before being eliminated from the body, even with the best drugs available. This picture gets even more dismal when looking at treating DR-TB. Treatment can take up to two years, 14,000 pills and include eight months of painful injections. The strong but sometimes ineffective drugs are toxic, so treatment has the risk of adverse effects such as deafness, blindness, and in extreme cases, psychosis. This, coupled with the length of treatment means people often have difficulty finishing the full course of antibiotics, leading to the development of further resistance.

We have arrived at this point because no new drugs have entered the standard TB treatment regimen in nearly 50 years. Getting TB treatment down to days or weeks instead of months, and removing the most toxic drugs from our regimens would dramatically arrest the creation of DR-TB.

This requires the development of new drugs which will be difficult due to a chronic lack of pharmaceutical investment into antimicrobials. There was less than 5 percent of venture capital investment in pharmaceutical R&D between 2003 and 2013 for antimicrobial development.

There are over 9 million new cases of TB each year with almost half a million of those being a form of DR-TB, these people predominantly live in lower- or lower-middle-income countries, and are often themselves the poorest people in those countries. Their ability to pay for expensive new treatments is limited, and has not provided the necessary motivation for private-sector investment in TB R&D to date.

Ultimately, there is no way we will beat TB without a new vaccine. The current TB vaccine (the BCG) is almost 100 years old and not effective against the most common forms of the disease.10 A more effective vaccine could bypass drugresistance and be as game-changing as a new drug regimen. We must pursue both approaches simultaneously.

We know what the solutions are.

The AMR Review offers ten recommendations for addressing AMR around the world, including the development of a new fund to support basic academic research into new drugs and a pooled fund to provide a commercial incentive for private sector organizations to invest in new antimicrobials. This pooled fund includes the introduction of a market entry prize for a new TB regimen and individual antibiotics.

Encouragingly, the AMR Review emphasizes how important it is to ensure global access to any future and existing products. No solution to drug development is complete without getting the drug to the people who need it, including in low- and middle-income countries. New TB tools are no exception. A number of non-profit initiatives are already devoted to the search for more effective TB treatments, such as the TB Alliance for new drugs, and Aeras who is in the process of developing a TB vaccine. The recommendations made by the AMR Review will ”supercharge” these existing efforts by providing an incentive for new funders to invest in the development of TB medicines.

Looking upstream, providing funds for organizations that provide high-quality treatment that helps prevent the emergence of drug resistance is a powerful complimentary investment. Organizations like The Global Fund to Fight AIDS, TB and Malaria, or the Stop TB Partnership’s Global Drug Facility all contribute to this vital work.

An opportunity we cannot miss If increasing drug-resistance continues on its current trajectory, we may return to an era where treating simple infections becomes practically impossible. This is, in some ways, already true for TB and the scale of the human and economic impact that TB creates, means we urgently need new tools right now.

There is already an international action plan to tackle AMR led by the WHO as well as a collaboration between the United Kingdom, the European Union, the United States and others. AMR is on the agenda of this year’s G20 in China with countries agreeing to coordinated international action. However, just as the microbes that increasingly threaten us all are global in nature, we need more than the G20’s leadership. We need a global response from all states and their governments.

On 21 September, 2016, a crucial high level meeting on AMR at the UN General Assembly will take place. This meeting provides a unique opportunity to make a step change in global levels of awareness of AMR among politicians, professionals and the public.

More than words and promises, G20 leaders and the global community must act quickly to implement the AMR Review’s recommendations. This means fully funding new mechanisms for incentivising the development of drugs, diagnostics, and vaccines needed to defeat AMR. Failure to fully fund these mechanisms is to invite a catastrophe that will strike indiscriminately in an incredibly costly yet entirely predictable way. We can, and must, prevent this.