Global Health and Diplomacy — Fall 2015
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Global Innovative Financing For The Next Decade
Philippe Douste-Blazy

As the global community finalizes its new development agenda this September, the question of how to finance 17 new sustainable development goals (SDGs) remains top of mind for many public policymakers. The United Nations estimates that these new goals for ending poverty, promoting economic growth, combating climate change, and bettering health for all could cost as much as USD $172.5 trillion over the next fifteen years. Clearly, if we are to reach ambitious targets, innovative approaches to financing are needed.

In the area of health and access to medicines, innovative financing has played a major role in ensuring better outcomes for people living in developing countries over the past decade. Global actors such as UNITAID, a novel financing mechanism that raises funding through a micro-levy on airline tickets, have contributed to the delivery of 350 million treatments for tuberculosis and malaria. UNITAID, the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR) have drastically changed the lives of millions of people living with HIV.

However, an estimated two billion people still do not have access to the health-products they need.1 Very few products in the current industry pipeline, specifically for non-communicable diseases, are designed for resourcelimited countries, and new medicines are often priceprohibitive for the ministry’s budgets. At the UN Third International Conference on Financing for Development held in Addis Ababa in July 2015, leaders supported “relevant initiatives…which incentivize innovation while expanding access in developing countries” and acknowledged “voluntary patent pooling and other business models, which can enhance access to technology and foster innovation.”

The UNITAID-founded Medicines Patent Pool (MPP) brokers public health licenses on HIV medicines and facilitates the development of fixed-dose combinations appropriate for distribution in high-prevalence countries. Founded in 2010, the MPP has now signed licensing agreements with six patent holders: AbbVie, Bristol-Myers Squibb, Gilead Sciences, the US National Institutes of Health, MSD, and ViiV Healthcare (a joint venture among GlaxoSmithKline, Pfizer, and Shionogi) covering twelve priority ARVs. Fourteen generic companies have now sublicensed from the MPP and the organisation is managing more than 50 medicine development projects.

By working with IP holders and sharing intellectual property, the MPP seeks to ensure rapid delivery of affordable treatments in developing countries through qualified generic manufacturers. This also enables the development of appropriate fixed dose combinations and children’s formulations vitally needed in countries of limited resource settings.

Partnership is a key concept of success. The MPP consults with a range of stakeholders—communities of people living with HIV, governments, international organizations, IP holders, and generic manufacturers—to prioritise the medicines it negotiates and to enact the principles it establishes in MPP agreements.

PUBLIC HEALTH ORIENTED VOLUNTARY LICENSES

MPP’s voluntary licences and access agreements are designed specifically to improve public health outcomes and are significantly different than bilateral business originator-to-generic deals.

First, these agreements are broad in geographical scope, enabling the manufacture of generic medicines and their sale in countries where 87 to 93 percent of people with HIV in the developing world live. This includes all 34 low income countries and, depending on the licence, between 55 percent and 80 percent of middle income countries which represents a significant increase over licences prior to the establishment of the MPP.

Second they incorporate a series of unique public healthoriented conditions including:

• Options for technology transfer

• Waivers for data exclusivity

• The right of MPP generic sublicenses to oppose patents and respond to compulsory licenses

• Minimal restrictions on the manufacture and sale of active pharmaceutical ingredients (API) by and among licensees

• Transparency - all agreements published in their entirety on the MPP website must provide declarations of the patent status of the product

RESULTS: ACCESS, SPEED AND INNOVATION

Access

The MPP has focused on the key regimens that the World Health Organization (WHO) recommends as preferred treatment for people living with HIV:

• Regimens containing tenovofir disoproxil fumarate (TDF)—licensed in 2011 from Gilead Science—are now the preferred first-line treatment for adults and children

• Atazanavir (ATV)—licensed from BMS—is recommended for second-line treatment

• Abacavir (ABC)—licensed from ViiV Healthcare—is part of the preferred first-line treatment for children up to the age of ten

• Paediatric formulations of lopinavir and ritonavir—licensed from AbbVie in December 2014—are now the WHO-preferred option for children less than three years of age

The MPP seeks to spur competition among low cost manufacturers to bring down prices on existing HIV medicines, and earlier licences are already making an impact. For example, the first MPP licence for tenofovir disoproxil fumarate (TDF), the preferred first-line treatment for adults and children, has generated USD$79 million in savings for the international community, equivalent to one year of treatment for 625,000 people. Lower royalties for TDF and TDF combinations, as well as the ability of generic manufacturers to sell in more countries, have allowed governments and international agencies to buy the drugs at lower prices and thus stretch their treatment dollars. MPP licensees have supplied more than 2.18 billion tablets of TDF treatments to 117 countries.

The MPP has negotiated novel approaches to increase the number of middle-income countries covered under its recent voluntary licences. Its agreement with ViiV Healthcare, provisions for differentiated royalties based on countries’ average income and market segmentation (public vs. private sector) enables many more countries to benefit from the licence while maintaining financial incentives for the company.

Speed

Historically, it has taken five to ten years to deliver generic versions of new, promising HIV medicines to developing countries. By licensing promising ARVs immediately after approval or those in-late stage development, the MPP aims to significantly slash this timeline. For example, MPP’s agreement with ViiV Healthcare for dolutegravir (DTG) early in 2014 was signed just two months after the medicine’s approval by the European Medicines Agency and eight months after the US Food and Drug Administration’s approval.

In July 2014, the MPP signed a licence agreement for tenofovir alafenamide (TAF), a promising new HIV medicine currently in phase III studies. TAF has the potential to play a large role in the international community’s efforts to scale up treatment and improve medical options for millions of people living with HIV. Once approved in the U.S., generic producers can also gear-up to manufacture TAF for distribution in 112 low- and middle-income countries. This creative model and others could be applied to other diseases that disproportionately affect poorer populations.

Innovation

In addition to its work on licensing existing ARVs, the MPP’s mandate includes a focus on speeding up the development of new fixed-dose combinations and betteradapted formulations specifically designed for paediatrics. The MPP is a partner in the UNITAID-backed Paediatric HIV Treatment Initiative (PHTI) to develop WHO-designated “missing” formulations that are necessary for appropriate HIV paediatric care.

The MPP’s current agreements with AbbVie, Bristol- Myers Squibb, Gilead Sciences, MSD and ViiV Healthcare on key paediatric formulations are the first step in pooling the relevant intellectual property necessary for PHTI’s development work. The PHTI, working in collaboration with a wide range of stakeholders, aims to deliver three new paediatric fixed-dose combinations by 2017.

A MODEL FOR INNOVATION AND ACCESS BEYOND HIV?

Since 2010, UNITAID’s investments in the MPP have yielded 2.6 times the invested amount. This yield is projected to increase twenty times between 2010 and 2028, with $1.18 - $1.4 billion saved from the procurement of cheaper generic HIV medicines. UNITAID also has tasked the MPP with reviewing the feasibility of expanding its mandate to include medicines for hepatitis C and tuberculosis. Globally, 130–150 million people suffer from chronic hepatitis C (HCV) infection and 500,000 die each year. Sixteen percent of the HIV-infected populations are co-infected with HCV. Tuberculosis, a UNITAID focus area, claimed more than 1.3 million lives in 2012 and is a major cause of death for people living with HIV/AIDS. These feasibility studies are outlined in the public domain of the MPP website and treatment expansion is undergoing a public consultation. By the end of 2015, there is a high probability that this new, integrated method of increasing capacity for innovation and access will be applied to other treatment areas.

In the post-2015 Sustainable Development Goals (SDGs) era, new equitable approaches to ensuring that cost is not a barrier to appropriate healthcare will drive new United Nations discussions. Nothing, in fact, is more unjust than two human beings suffering from the same illness—one living in the U.S. or Europe with access to the best sciences has to offer, while the other, in Africa or Asia, waits ten to 15 years for the best treatment. We cannot hope to reach the SDGs for health— calling for the implementation of universal health coverage for all by 2030 and an end to AIDS, malaria and TB—without a revised framework for leveling the playing field regarding access to quality medicines. Creating new approaches to finance these goals is of the utmost importance. GHD

REFERENCES

1. Access to Medicine Index, 2014
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