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In this guest post, Jenny Howell—senior policy & advocacy associate at PATH working with the GHTC—writes about how the government shutdown and budget negotiations in Congress will impact global health research and development (R&D) programs across the federal government. She also provides an update on new legislation that would impact the President’s Emergency Plan for AIDS Relief (PEPFAR). It’s been a hectic few weeks in Washington. When House Majority Leader Eric Cantor (R-VA) canceled last week’s scheduled recess—and lawmakers from both chambers stayed to work over the weekend—we hoped that policymakers could successfully prevent a government shutdown. Because members of Congress have been unable to agree on long-term budget deals, funding for the government has been based on short-term continuing resolutions (CR)—stopgap budgets that fund the government for a few months at a time. The last short-term deal, passed in March, funded the government through the end of September, requiring Congress to pass a new CR by midnight on September 30 or face a federal shutdown. What the shutdown means in practical terms varies across the government--from Congress to agencies such as USAID, NIH, CDC, and FDA. The past week has been a Ping-Pong between competing House and Senate budget bills, with Republicans in the House insisting on a CR that is coupled with the defunding or delay of the Affordable Care Act. Senate leaders, on the other hand, pledged that they will only consider a “clean CR,” or a bill that doesn’t contain major policy changes but only deals with funding. What the shutdown means in practical terms varies across the government. Congress On the Hill, it’s up to lawmakers to determine which staffers serve essential functions and which staffers are non-essential. Therefore, staffing will vary greatly from office-to-office. USAID The US Agency for International Development (USAID) issued a guidance outlining a few possible scenarios, but indicated that the majority of its contracts and grants are not dependent on new appropriations and will continue operations. The agency has promised to contact partners who have grants or contracts that will be directly impacted by the government shutdown. While most ongoing programs should remain safe with existing funding, this also means USAID won’t be investing in any new R&D funding, contracts, or grants until a budget deal is reached. HHS The Department of Health and Human Services (HHS) has also released its contingency plan in the case of a shutdown. The National Institutes of Health (NIH) will continue caring for patients in current clinical centers. However, health research will be severely impacted as NIH will not accept new patients for clinical research. This is on top of an already exhausted post-sequestration budget that NIH Director Dr. Francis Collins has described as delaying innovation. The Centers for Disease Control and Prevention (CDC) will continue to operate its 24/7 operations center, as well as activities funded through mandatory spending like PEPFAR, the Global AIDS program, and the Vaccines for Children program. The shutdown does impact CDC’s ability to support the annual flu program and much of its ongoing disease surveillance and R&D activities. The Food and Drug Administration (FDA) will continue activities related to critical public health issues, but will cease the majority of lab research, routine inspections, monitoring, and notification programs. The FDA will continue the majority of its programs linked to user fees, including product approvals, but approval times may be delayed as a result of understaffing. Moving on PEPFAR Amidst the tension of the budget battle, members of Congress have seemingly found something they agree on. On September 24, Sens. Robert Menendez (D-NJ) and Bob Corker (R-TN) introduced The PEPFAR Stewardship and Oversight Act of 2013 (S 1545). A day later, Reps. Eliot Engel (D-NY), Ed Royce (R-CA), Barbara Lee (D-CA), and Ileana Ros-Lehtinen (R-FL) introduced a companion bill in the House (HR 3177) Most of the PEPFAR program can continue to operate as long as Congress appropriates funds. However, some components—mostly reporting requirements—could end without renewal. The bill introduced last week is by no means a full reauthorization and is extremely limited in scope, only extending the PEPFAR program as it relates to HIV and AIDS with no specific extension of tuberculosis (TB) or malaria programming or funding. PEPFAR currently supports a variety of global health R&D projects, including research on microbicides and vaccines for HIV and AIDS, TB, and malaria. Bill status The bill is already moving quickly and with the addition of a short manager’s amendment, it was approved by the Senate Committee on Foreign Relations by voice vote earlier this week. The manager’s amendment added reporting requirements to include reporting on co-infections and co-morbidities of HIV and AIDS, including TB, as well as country efforts to improve health work force issues. The government shutdown makes next steps for the bill uncertain, but the strong bipartisan support makes it likely that leadership in both chambers will fast track the bill and bring it up for consideration without additional amendments. Looking ahead We hope support for PEPFAR isn’t the only thing Congress can come to an agreement on this week. While uncertainty about the impact of the shutdown remains high, the quicker that lawmakers can reach an agreement the less severe the negative effects will be across our nation and around the world. Whatever the outcome, we’ll continue to track the progress and its potential impact on global health R&D.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In a new opinion piece, Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) write about the need to sustain US investments in research and development for global health tools to prevent the spread of disease both in the United States and abroad. The International Federation of Pharmaceutical Manufacturers & Associations is calling for increased public-private sector engagement to accelerate progress toward the Millennium Development Goals. The group is also stressing that partnerships be central components of the post-2015 development agenda. Rep. Barbara Lee (D-CA) recently introduced a bill that aims to stop the spread of HIV around the world. The bill, called the Ending the HIV and AIDS Epidemic Act of 2013 (HR 3117), includes a focus on research to create new HIV and AIDS treatment and prevention tools. A new investment fund launched this week that will allow individuals and institutional investors the opportunity to finance the development of late-stage global health technologies. The HOOKVAC consortium has been awarded a grant from the European Commission to expand the Sabin Vaccine Institute Product Development Partnership’s work to develop and test a vaccine for human hookworm. Under the grant, the HOOKVAC consortium will begin the first clinical testing of the human hookworm vaccine in the West African nation of Gabon.

In this guest post, Dr. Judy Manning from the US Agency for International Development (USAID) and Dr. Zeda Rosenberg from the International Partnership for Microbicides (IPM) discuss the need for new and improved contraceptive options for women worldwide. The post was written to mark World Contraception Day. The picture could not be clearer: A woman's health and livelihood are threatened when modern family planning methods are out of her reach. On World Contraception Day (September 26), we are reminded that unintended pregnancy is a major contributor to maternal and infant death and disability around the world, and a recognized obstacle to global development. Forty percent of pregnancies worldwide are unintended, but that number is not so surprising when you consider that 222 million women have an unmet need for modern contraceptive methods. Access to such methods would enable women to plan and space their pregnancies, leading to improved health, educational, and economic outcomes for themselves and their families. New sexual and reproductive health innovations have the potential to revolutionize women's options by diversifying delivery forms, varying product duration, and targeting multiple health risks simultaneously. Photo: PATH. According to the Guttmacher Institute, 70 percent of the unmet need stems from method-related concerns. These include concerns about the safety and potential side effects of hormonal methods; appropriate options for women who have infrequent sex, or who are postpartum or breastfeeding; and opposition from their partners to specific approaches. Geography and access to health services are also barriers to modern contraception. Last year at the London Summit on Family Planning, the global community made an unprecedented pledge to reach 120 million more women with contraception by 2020. The upcoming International Conference on Family Planning in Ethiopia will map out additional steps required to make contraception available for all women. Efforts will focus on expanding access to existing methods as well as prioritizing the development of new innovative technologies. New sexual and reproductive health innovations have the potential to revolutionize women's options by diversifying delivery forms, varying product duration, and targeting multiple health risks simultaneously. Unfortunately, there is no magic bullet. When it comes to sexual and reproductive health, women face obstacles that are unique to their circumstances. But experience has taught us that if women have a range of affordable and appropriate products to pick from, they may use them more consistently, which in turn will allow them to better protect their health. We are excited about a number of cutting-edge technologies now in development. For instance, USAID is investing in the early-stage development of a biodegradable contraceptive implant that does not require removal. This product from FHI 360 could fill a critical gap in low-resource settings where women may not have access to trained health workers. Alongside contraceptive-only products, multipurpose prevention technologies (MPTs) can help address women's overlapping health needs in a single product. For example, women in areas with high rates of HIV often have the greatest unmet need for family planning, creating a double burden of risk. With support from USAID and other funders, IPM is developing a 60-day MPT ring to offer dual protection against HIV and unintended pregnancy that women could use discreetly. The self-initiated ring is being designed to provide sustained release of an antiretroviral (ARV) drug called dapivirine along with the contraceptive hormone levonorgestrel. USAID and other funders also recognize that, in many regions of the world, sexually transmitted infections (STIs) such as herpes simplex virus, human papillomavirus, and bacterial vaginosis are of greater public health concern than HIV. As a result, USAID is supporting CONRAD (in partnership with PATH) to develop an MPT that combines the new one-size-fits-most SILCS diaphragm with tenofovir gel—the first ARV drug shown to help prevent both HIV and herpes (a confirmatory trial of tenofovir's effectiveness is under way). This could provide women with a non-hormonal product that could be used "on demand," appealing to women who would like a product that is used at the time of sex. MPTs could result in significant health gains for women by broadly addressing their sexual and reproductive health needs, and reducing rates of maternal and newborn death associated with both unintended pregnancy as well as STIs. In fact, there is reason to believe that MPTs may have another added benefit: Combining two or more products into one may make protection more appealing and acceptable to women, and therefore increase its use. To fully realize the immense promise of up-and-coming innovations, we need continued investment in the development pipeline and in full access to the final products. No single product will address every woman's sexual and reproductive health needs, so it will take a portfolio of methods to ensure that women have options to choose from that are appropriate for their individual circumstances. New tools are not developed overnight—they take time, effort, and dedicated resources. But it is an investment that will help make modern contraception a reality for the 222 million women whose lives, health, and development depend on it. Originally posted by the Policy Innovations blog, a publication of Carnegie Council.

In this guest post, Rachel Wilson—senior director of Policy and Advocacy at PATH—writes about a new report focused on health innovations for women and children worldwide. The report was released this week at the United Nations General Assembly in New York. This post originally appeared on the PATH blog. This week, PATH, along with partners including the Norwegian Ministry of Foreign Affairs, the MDG Health Alliance, and the United Nations Foundation, is releasing a report called Breakthrough Innovations That Can Save Women and Children Now. The publication introduces ten innovations—from products to systems approaches—that could have immediate impact in saving lives. Each is low-cost, effective, and sustainable. If we made a majority of these innovations widely available now, they could save more than 1.2 million women, newborns, and children by the end of 2015. Pair them with other interventions currently available and in development, and we have the power to save millions more lives. Blessing Kingsley holds her four-day-old daughter, Great. Photo: PATH/Evelyn Hockstein. Three ways to save moms and babies For example, magnesium sulfate is the most effective drug to prevent and treat life-threatening pregnancy complications caused by high blood pressure. Simplifying dosing and improving modes of administration would give more poor women access to this lifesaving drug. Similarly, ROTAVAC® is a new vaccine that protects children from the leading cause of deadly diarrhea. If widely available, the vaccine could save thousands of children each year—at the cost of only US$1 a dose. And a program called Helping Babies Breathe uses innovative teaching tools to train health care workers and birth attendants how to resuscitate infants. In Tanzania, the initiative has reduced newborn mortality by as much as 47 percent. Help us get the message out But bright ideas and innovative technologies alone won’t save lives. This week, PATH’s leaders are at the UN General Assembly along with other key global health innovators and policymakers. We’re committed to gathering support so we can deliver solutions to the world’s women and children—and at the same time deliver on the promise of the Millennium Development Goals. At PATH, we’re transforming health through innovations like these. We can achieve a lasting impact only with the support of world leaders—and to get that, we need your support. Help us send the message that we can save women and children with innovations available right now. Join the conversation with @PATHadvocacy and @PATHtweets on Twitter and follow PATH on Facebook as we engage in the #innovations2015 conversation this week. More information See our report, Breakthrough Innovations That Can Save Women and Children Now. Learn more from the UN about the Millennium Development Goals.