Accelerating Access to Innovation and Saving Children’s Lives

“HIV/AIDS affects all of us, no matter where we live or who we are.   And we know it’s our responsibility, as part of our common humanity, to help get medicine to the people who need it.”

- President Obama, World AIDS Day, December 1, 2014

Increasing access to medicines has been a priority of the U.S. government’s response to the global HIV/AIDS epidemic for over a decade.  Since the start of President Obama’s Administration, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has achieved a four-fold increase and is now providing 7.7 million people with life-saving antiretroviral (ARV) treatment worldwide.  Despite this historic progress, the sobering reality is that 3 out of 5 people living with HIV/AIDS globally still do not have access to the treatment they need to live healthy and productive lives.  And only 1 in 4 of the 3.2 million children living with HIV/AIDS worldwide are today receiving treatment.  This World AIDS Day, OSTP and PEPFAR celebrated efforts that enable the fruits of science and technology to accelerate innovation and increase access to life-saving HIV treatment around the world.

A major barrier to achieving the President’s vision of an AIDS-free generation has been the lack of market incentives for companies to develop pediatric formulations of ARVs that are safe, affordable, and palatable.  As a result, child-friendly ARV co-formulations recommended by the World Health Organization (WHO) since 2013 are still not available in the market.  We must close this gap.

That’s why OSTP is proud to support PEPFAR’s “Global Pediatric Antiretroviral (ARV) Commitment-to-Action,” which aims to accelerate the development and supply of child-friendly ARV medicines in low- and middle-income countries. The Commitment-to-Action, which was launched in partnership with Pediatric HIV Treatment Initiative (a collaboration of UNITAID, the Clinton Health Access Initiative, Drugs for Neglected Diseases initiative and the Medicines Patent Pool), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, builds on the existing work of the U.S. government to address the unmet needs for HIV treatment in low- and middle-income countries and ensure that patients supported through PEPFAR have access to safe, effective, and quality manufactured antiretroviral drugs.  New U.S. Government commitments announced this week include a new $2 million contribution to help eliminate regulatory bottlenecks that hinder access to medicine and diagnostic tools in Africa through the Global Medicines Regulatory Harmonization Trust Fund at the World Bank, the African Medicines Regulatory Harmonization (AMRH) program, and the East African Community (EAC) Medicines Regulatory Harmonization programs.

In addition to U.S. Government efforts, the Commitment-to-Action will also mobilize and incentivize drug manufacturers and other product developers to develop and supply ARV medicines while ensuring affordability, access, and rapid uptake of ARV medicines in national programs.  For example, on December 1, 2014 the HIV Medicines Research Industry Forum – a group of U.S. originator pharmaceutical companies working to address unmet needs for innovations in HIV treatment – announced that it has responded to the Commitment-to-Action and pledged to help develop an operational framework to take it forward. In addition, the companies committed to accelerate the development of new, high-priority pediatric ARV co-formulations for first- and second-line treatment by 2017. Last week, the Medicines Patent Pool announced that it is entering into a license agreement with AbbVie on pediatric formulations for Lopinavir boosted with ritonavir (LPV/r), part of the WHO-preferred first-line regimes for children under the age of three. The license will help generic manufacturers, who supply 97 percent of PEPFAR’s drugs, make ARV co-formulations that include pediatric LPV/r.  Once these co-formulations are developed, the license will help make drugs available in more than 100 low- and middle-income countries that are home to more than 98 percent of children living with HIV.

The combined effect of these public and private sector efforts is greater than the sum of its parts.  Together, they will accelerate both innovation and access, bringing us one step closer to achieving the extraordinary: an AIDS-free generation. 

Tom Kalil is Deputy Director for Technology and Innovation at the White House Office of Science and Technology Policy.

Ambassador Deborah L. Birx, M.D. is U.S. Global AIDS Coordinator at the U.S. Department of State.

Colleen V. Chien is Senior Advisor to the CTO, Intellectual Property and Innovation at the White House Office of Science and Technology Policy.