Who pays? Financing for new HIV prevention technologies

With economic recession, shrinking health funds and competing priorities, it is likely that donors might put in the dollar where they perceive to get the most value. Although the research for new HIV prevention technologies has indeed made some progress, yet a formidable way lies ahead to find enough money to finish the research and to make ‘from discovery to delivery’ a reality for those in need of protecting themselves from HIV. This issue of health financing of new HIV prevention technologies was in spotlight at the closing day plenary of the International Microbicides Conference (M2012) in Sydney, Australia.

“Twelve years ago at first International Microbicides Conference in the year 2000, the first major international conference focused on microbicides for HIV prevention, I stood before a similar audience in Washington D.C. and said that, “because of the ferocious speed with which the HIV/AIDS epidemic has spread, we, as an international community, must expand our prevention options more urgently than ever”. That statement is still true. And even though the global response has come a long way since then, the need to invest in new HIV prevention methods remains urgent and necessary” said Dr Debrework Zewdie, Deputy General Manager and Head, Strategy, Investment and Impact Division, of the Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund). 

Dr Zewdie added: “Today, more than 30 years after the start of the AIDS epidemic, we have more tools to prevent the disease than ever before: male and female condoms, sterile injecting equipment, male circumcision, protocols for prevention of vertical transmission, post-exposure prophylaxis and – most recently – treatment as prevention. But are these all the tools we need and are they accessible to all in need?”

Also it is important to highlight the DELAY ‘from discovery to delivery’ – for example, after confirmatory studies that medical male circumcision (MMC) helps prevent HIV it took us more than six years before donors funded the MMC roll-out. Female condoms after being launched in India in early 2000s still remain out of reach of those women in most need.

“Female condoms are the only HIV prevention tool available today that women can initiate and control. But, among other things, the average cost of a female condom at 60 cents (about Rs 30) is 20 - 30 times that of a male condom – I am talking about commodity costs only, as estimated by UNFPA. This cost makes female condoms virtually inaccessible to women in low-income countries. Current use is mainly confined to female sex workers. And this when a recent review by Shattock and Rosenberg confirms that one of the highest-risk factors for acquiring HIV among women in sub-Saharan Africa is being in a stable long-term relationship where condom use is low” said Dr Zewdie.

Is it fair that most women at risk of HIV today still have no access to a tool they can control to protect themselves from the virus? That is the reality we have created with our choices over the last 30 years: choices about what to prioritize and where to invest money, time and effort. It is that reality that needs to be changed. 

Agreed Dr Dr Zewdie: “What brought me here at M2012 is an uncomfortable knowledge that, if today we do not have a more affordable and effective microbicide, at least part of the reason is that we did not make it enough of a priority. And it is the most vulnerable women who pay the price for our decisions.”

All is not that bad. HIV rates have come down in most countries. “Primary prevention of HIV is the preferred objective, both from a public health standpoint and from an individual one. In that respect, there is good news: HIV prevention is working. In 2010, UNAIDS reported a 19% percent decline in HIV incidence over the past ten years. The biggest epidemics in sub-Saharan Africa— in South Africa, Zambia, Zimbabwe, Nigeria and Ethiopia – have either stabilized or are showing signs of decline” said Dr Zewdie.

Added Dr Zewdie: “So we are starting to win some important battles; but not yet the war. We need to pay closer attention to concentrated epidemics in many other parts of the world. And millions need treatment but do not have it. For them, we must race to expand HIV testing and ART coverage – especially now that we know more about the preventive effects of the latter.

But for every one person started on ART today, UNAIDS tells us that there are two people who become newly infected. Unless we become better at primary prevention therefore, the epidemic will continue to advance. To drive HIV trends further down, we must increase access to effective prevention tools among people at risk.”

As sex-disaggregated epidemiological data became more widely available, it emerged that women, especially young women between the ages of 15-24 years, are disproportionately affected by the virus. Women are twice as likely as men to acquire HIV during unprotected sex. And in areas like sub-Saharan Africa, where the epidemic is driven by heterosexual sex, 60 percent of adult HIV infection is in women. Furthermore, women face important barriers in accessing prevention services, such as lower levels of income and education.

If we do not protect women effectively, then children are also at risk. UNAIDS reports that, in 2009, 370,000 children became newly infected with HIV globally while an estimated 42,000 to 60,000 pregnant women died because of HIV. The WHO - UNAIDS strategy to reduce new HIV infections in children includes prevention of new HIV infections in women. And the virtual elimination of paediatric HIV cannot be achieved without preventing HIV in women.

“This is where microbicides fill an important gap for women. When it comes to sexual transmission, many women do not have the social power necessary to insist on condom use and fidelity, or to abandon partnerships that put them at risk. As a user-initiated technology that does not require a partner's cooperation, microbicides would give women – but also men – who are unable to successfully negotiate condom use or mutual monogamy the one thing they have been denied for all these years: the power to protect themselves from HIV. In spite of the need to demonstrate higher levels of efficacy therefore, from a gender and human rights perspective, microbicides would have an extremely important role to play” said Dr Zewdie.

This is even more evident when we look at higher risk settings, like sex work or sexual violence settings. Recently, UNAIDS estimated that in Democratic Republic of Congo, HIV prevalence among women who have suffered sexual violence in areas of armed conflict is as high as 25.6 per cent, compared with the 1.8 per cent prevalence among women in the general population. “A shocking disparity! We must ensure that any new prevention technology is universally available and accessible to the most marginalized and to people facing the highest risks” said Dr Zewdie.

Dr Zewdie shared that an interesting study published by Steve Paul et al in 2010 in ‘Nature Reviews: Drug Discovery’ looks at the cost of bringing a drug from development to market. The study estimates that the average cost of developing a new drug is USD 1.8 Billion with an additional USD 870 million in out of pocket costs. By the end of 2010, just over USD 1.8 Billion had been invested into microbicides research. These numbers speak to my earlier points about how much we have made microbicides a priority. 30 years into the epidemic, we are still about USD 800 million short of an average investment effort, in spite of the great need that women – especially – have for this tool.

In 2010, total global investment in microbicide research and development was USD 247 million, a five percent increase over 2009, which is a good sign in the current global financing environment. It is also positive that these funds cover a wide range of research activities including investigations into basic mechanisms of mucosal transmission, relevant behavioral and social factors, infrastructure and policy and advocacy.

“But in their 2011 report, the Resource Tracking Working Group for HIV Vaccines and Microbicides caution us not to derive a false sense of security about future funding from these 2010 numbers. Important research is still needed for new prevention technologies and for microbicides in particular, including pre-clinical research and large-scale follow-on clinical trials and implementation research. Given the relatively small number of donors, we must be concerned about future funding, particularly when we are so close to market and ready to capitalize on promising research results. This is not the time to lose momentum” said Dr Zewdie.

About 93 percent of the USD 247 million in research funds contributed in 2010 have come from public-sector donors – predominantly the US, European governments and the European Commission. The philanthropic sector accounts for an additional six percent of the research funds through 2010. The reality is that most of the funding continues to be provided by governments and philanthropic donors in upper-income countries to invest in research and development most needed by lower-income countries. “Most of us have heard of the “10/90” research gap - which is that only ten percent of global medical research investment is dedicated to health problems in low income countries, which bear ninety percent of the global health burden” said Dr Zewdie.

Earlier investments in male circumcision research were made predominately by the United States and by the Bill and Melinda Gates Foundation. The large funding spike in 2010 was because of an eight-fold increase in contributions by the Gates Foundation towards operational research in male circumcision. It is interesting how relatively small the investments have been for such a powerful prevention method. Now that cost-effectiveness and potential impact have been demonstrated and male circumcision is WHO and UNAIDS-recommended, increasingly diverse funding sources are appearing.

“Last December (at the Africa AIDS Conference) UNAIDS and PEPFAR launched The Joint Strategic Action Framework to Accelerate the Scale-Up of Voluntary Medical Male Circumcision for HIV Prevention in Eastern and Southern Africa 2012 – 2016. This action plan will invest USD 1.5 billion to accelerate the roll-out and expansion of medical male circumcision services in 14 priority countries over the next five years. Successful implementation would prevent an estimated 3.4 million new HIV infections and realize net savings of USD 16.5 billion in averted treatment and care costs by 2025” said Dr Zewdie.

The Global Fund is also scaling up investments in circumcision. The five year strategy for 2012-2016 is focused on encouraging countries to request new funding and/or to reprogramme grants they already hold to invest in the highest impact activities with the greatest value for money.

“In spite of definitive evidence of the preventive effects of circumcision being widely acknowledged in 2006, it took until 2012 for donors to begin to mobilize funding at the necessary scale. With microbicides, because of the long pharmaceutical product development and licensing cycle, we have the benefit of advance notice. We already know that we are close to a safe and effective product. Should we not use this knowledge to our advantage, and gain time by preparing for large scale financing and integration of microbicides into prevention programs?” asked Dr Zewdie.

Access has been one of the most difficult challenges to deal with when it comes to health technologies roll-out especially for the most in need populations. “In the past, new health technologies have rarely become widely available in developing countries until more than a decade after their approval in the US and Europe – an unacceptable delay that we have to anticipate and prevent – for microbicides, a life-saving technology developed primarily with public funds” said Dr Zewdie.

Sharing a personal experience, Dr Zewdie said: “I paid for my two daughters to be vaccinated against Human Papilloma Virus to reduce their lifetime risk of cervical cancer by 70 percent. It was not cheap, but fortunately I could afford it, and did not need to think twice about protecting my daughters’ health. Every mother deserves to have access to new prevention technologies for her own health and the health of her daughters. And every woman, regardless of the economic or social conditions she finds herself in, has the right to be healthy. Microbicides are very much about giving women their right to health. And the responsibility is ours to make sure they are not shortchanged.”

As a parting note from CNS, we believe that ‘access’ to health technologies especially for those most in need is under-estimated in terms of the challenge it presents and also cross-sectoral response it mandates. Also serious work on access to existing HIV prevention options should be continued with equal thrust as the research progresses ahead for newer options for HIV prevention.