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TPP countries. Photo: CBCAfter ten years of debate, on November 5, 2015, international negotiators released the final text of the largest regional trade agreement in history—the Trans Pacific Partnership (TPP). This trade deal between the United States and 11 other Pacific Rim countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) links 40 percent of the world’s economy, dramatically reduces tariffs, and establishes high standards for labor, environmental, and intellectual property (IP) protections—including enhanced protections on pharmaceutical products.Why does TPP matter for global health?IP protections for health products can be a double-edged sword. They help to encourage innovation and spur the development of new drugs, tools, and other health technologies by temporarily providing exclusive rights to sell or market a product—allowing developers to recover expensive upfront investments in research and development (R&D). Without this promise of protection, companies might be skeptical to invest in new R&D for fear a competitor could steal their trade secret and sell a similar product, undercutting their profit. At the same time, many public health advocates believe that when IP protections are too strong, they impede access to affordable medicine. In this case, the health care costs of delaying introduction of affordable generic medication could outweigh the benefits of incentivizing innovation.When the 1994 World Trade Organization agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was negotiated, parties sought to strike a balance between promoting public health and encouraging health-related innovation. TRIPS set a global minimum of 20-year patent protection for pharmaceutical products, while at the same time affirming the rights of countries to take measures to protect public health and promote access to medicines for all. This included designating public health crises as national emergencies, in which countries can override IP protections, and allowing least-developed countries a 10-year on-ramp period to introduce patent protections.As TPP’s provisions were negotiated behind the scenes, many public health advocates feared that the agreement would go far beyond TRIPS standards and establish a new high-water mark for pharmaceutical patent and data protections that would become the minimum standard for future trade deals. Now that the official text has been released publicly, we can see the results of the negotiations.What’s in TPP?Below I break down IP protections in TPP, describe their potential impact on health technologies, and discuss how these provisions compare to the changes speculated.Patents for new uses of an existing productPhoto: PATH/Eric BeckerWhat would TPP do?“confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product.”This provision allows “evergreening” of existing pharmaceuticals, or the ability to re-patent an existing or slightly revised product for a new application.Why is this concerning? How did negotiations shake out?Under TRIPS, countries can choose to exclude new uses of existing products from patentability. TPP (and other trade deals negotiated after the 1994 TRIPS agreement) allows “evergreening” across all technologies and does not single out pharmaceuticals. While public health advocates feared TPP would include a new provision explicitly prohibiting countries from implementing an enhanced efficacy requirement for “evergreen”-type patents, it is not included in the final text and therefore efficacy requirements remain the individual decision of each party country.Patent term extensionsWhat would TPP do? “provide the means to…adjust the term of [a] patent to compensate for delays” in patent approval. This provision allows companies to petition for a patent extension if there has been “unreasonable delay” in processing an application for a patent. “Unreasonable delay” is defined to mean a delay of more than five years from initial filing or a delay of more than three years after a formal request for examination on patent delay. “with respect to a pharmaceutical product that is subject to a patent…make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.” This provision allows companies to petition for an extended patent term if a country unreasonably delays the marketing approval process. Why is this concerning? How did negotiations shake out?TRIPS does not specify what constitutes “unreasonable delay.” Advocates feared TPP would go beyond standards set by other trade agreements and lessen the time companies could claim an ureasonable delay for patent approval to four years from filing and two years from request for examination. Instead, TPP maintains the status quo at five years and three years respectively, with no definition of unreasonable delay in granting marketing access.Data exclusivity Photo: PATH/Patrick McKernWhat would TPP do?Provide five years data exclusivity for pharmaceutical products if “the submission of undisclosed test or other data concerning the safety and efficacy of the product” is required “as a condition for granting marketing approval.” This provision prevents generic manufacturers from using test or clinical trial data from a branded product to demonstrate safety or efficacy of the generic (and therefore be awarded marketing rights) for five year after a patent expires. Provide three years data protection “with respect to new clinical information submitted as required in support of a marketing approval of a previously approved pharmaceutical product covering a new indication, new formulation or new method of administration.”Why is this concerning? How did negotiations shake out? Data exclusivity, in effect, extends the life of a patent because, most often, generic manufacturers cannot afford to conduct their own duplicate clinical trials and tests. This means that generic manufacturers must wait until data exclusivity has expired before they can use branded data to justify the safety or efficacy of their product and introduce it into the market. Data exclusivity is not discussed in TRIPS, and while previous trade agreements have included data exclusivity for new pharmaceutical products, TPP is the first agreement to extend data exclusivity to new uses of existing products.Biologics What would TPP do? “provide effective market protection through…protection of undisclosed test or other data…for a period of at least eight years from the date of first marketing approval of that product.OR “provide effective market protection through… protection of undisclosed test or other data…for a period of at least five years” and “through other measures.” These provisions prevent generic manufacturers from using test or clinical trial data from a branded biologic to demonstrate safety or efficacy of the generic biosimilar for a defined period of time. Countries can choose whether to require a minimum of eight years data exclusivity or minimum of five years data exclusivity combined with additional, unspecified measures that acknowledge the upfront cost of investing in R&D for biologics. Why is this concerning? How did negotiations shake out? Biologics are a new class of pharmaceutical product that hold tremendous promise for hard-to-treat diseases and conditions. Since the technology is so new, it is uncertain how patent terms and data exclusivity will impact the scale-up and roll-out of this new class of drugs. Because this technology was unknown in 1994, biologics were not included in TRIPS. Each country party to TPP has established different IP protections on biologics—ranging from twelve years data exclusivity in the United States, to eight years in Japan, to five years in Australia, to no protection at all in Vietnam.Public health advocates were concerned that US pharmaceutical companies were behind the United States’ push for 12-year data exclusivity for biologics in TPP, mirroring provisions in the Affordable Care Act. Other nations, led by Australia, Chile, and Peru, strongly opposed a twelve-year term because  delaying the introduction of biosimilars could increase the cost of medicine and strain public health systems. After contentious negotiations that threatened to derail the entire trade deal, a compromise was reached: TPP countries can chose to provide a minimum of eight years of data protection for biologics or a minimum five years of protection combined with “other measures” of protection.  What’s next?While some IP elements in TPP remain concerning for public health advocates, negotiations did not expand IP protections for pharmaceuticals as much as many had feared. In addition, TPP includes language reaffirming commitment to the Declaration on TRIPS and Public Health stating: “The obligations of [the IP] Chapter do not and should not prevent a Party from taking measures to protect public health.” IP provisions “should be interpreted and implemented in a manner supportive of each Party’s right to protect public health and, in particular, to promote access to medicines for all.” “Each Party has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances  of extreme urgency.”Still, there is reason to closely monitor this trade agreement as it is considered for ratification in each of the twelve member states. High-level officials from the World Health Organization worry that TPP represents corporations influencing decision-making in health policy, and groups like Médecins Sans Frontières state that, “Although the text has improved over the initial demands, the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries.”On the other end of the spectrum, Senator Orrin Hatch (R-UT) who leads the Senate Finance Committee—key to passing TPP through Congress—is “concerned that, particularly with regard to intellectual property, the administration may not have gotten the best deal possible” and should return to the negotiating table. While TPP doesn’t change US law on biologics, he remains concerned unequal treatment abroad may prohibit US companies from recouping the costs of investment.President Obama signaled his intent to sign TPP when the Administration released the agreement’s text on November 5th. Per statute, there must be at least 60 days for public review and comment before the President can sign, and the Administration has pledged to extend the comment period to 90 days. Next the President will send legislation authorizing implementation of TPP to Congress, where members will have a maximum of 90 days to approve or disapprove of the trade deal, without amendment.Even if TPP is ratified, there will be a significant transition period before all regulations go into effect—it could take decades to implement some provisions in developing country signatories like Vietnam. In this way, the full impact of TPP on access to medicine will not be realized for years to come. It is important that the global health community continue to monitor this deal and push for trade agreements that appropriately balance protections for IP with protections to public health and access to medicine.IPCourtney Carson is GHTC’s senior policy and advocacy associate.

Photo: PATH/Gabe Bienczycki Preterm birth complications are the leading cause of death for children under five years of age. Survival rates, particularly for babies born extremely premature (three months early), can vary drastically from 10 percent in low-resource settings to 90 percent in high-resource settings. While many babies are born in low-resource settings, outside of hospitals, and without access to high-tech interventions, it is still possible to provide the basic care many preemies need to survive. For example, a number of low-cost innovations and interventions, such as breathing support and clean cord care, have the potential to slash newborn mortality. GHTC member, The Global Alliance to Prevent Prematurity and Stillbirth (GAPPS), in partnership with Project Concern International and the American College of Nurse Midwives, has received a five-year, US$9 million grant from the US Agency for International Development for the Every Preemie—SCALE initiative to identify lifesaving interventions for the prevention and treatment of preterm birth and low birthweight and to support the scale-up of these interventions in 23 countries across Asia and Africa. To learn more about GAPPS’ work on the Every Preemie—SCALE initiative, we’re joined by Dr. Jim Litch, director of the Perinatal Interventions Program at GAPPS. Q: Central to the Every Preemie—SCALE initiative is research to identify evidence-based solutions for the treatment and management of preterm birth and low birthweight. What’s been done so far and what key findings are emerging? A: Ideally, pregnant women should have access to prenatal care, which is particularly important for women at risk of preterm birth who need particular prevention services and care interventions. Far too often, however, prenatal care is out of reach for families, of poor quality, or does not include the special needs for preterm births and preterm newborn care. Preterm birth has only recently received attention from the global health community, and there are many emerging opportunities to learn from current efforts to expand maternal and newborn health programs to include preterm birth prevention and care content. Preterm babies have different needs than full-term babies, and recognizing this helps us develop tools and interventions across the continuum of care. Just this month, accurate growth curves for weight, length, and head circumference for healthy preterm babies born as a single birth were published to complement existing growth standards for full-term infants and provide new, accurate standards for fetal growth. Through Every Preemie, GAPPS is supporting implementation research with local partners in Bangladesh, Ethiopia, India, and Malawi. In Bangladesh, we are testing a simple method of estimating gestational age during pregnancy using a tape measure and weight scale. In Ethiopia, we are evaluating implementation of preterm birth services within multi-partner maternal and newborn health programs across the continuum from the community to district hospital level in different living contexts (settled, semi-settled and urban). In India we are preparing to assess the safe use of antenatal corticosteroids (ACS)—which have been shown to reduce preterm birth complications—among women in imminent preterm labor, including pre-referral first dose of ACS administered by auxiliary nurse midwives. And in Malawi we are investigating the effectiveness of a comprehensive community mobilization approach designed to better link communities to preterm-related health services from the household to the facility level. A recurring finding from the implementation and research communities is that context is critical. What works well in one setting may not work well in another. This is a lesson that returns to us time and again. Standardized outcomes and robust descriptions of the settings from which evidence is obtained create a greater burden on research, evaluation, and program resources. Q: Can you talk a bit about some of the technologies identified as potential solutions under Every Preemie? And what characteristics make a product or intervention realistically scalable in low-resource settings? A: Infant death and morbidity following preterm birth can be reduced through interventions provided to the mother before and during pregnancy, including the period around delivery, and to the preterm infant after birth. The most beneficial set of maternal interventions are those that could improve survival chances and health outcomes of preterm infants when preterm birth is inevitable. In August 2015, the first World Health Organization recommendations on the Interventions to Improve Preterm Birth Outcomes were issued. These recommendations provide important guidance on interventions and related technologies that could be provided during pregnancy, labor, and the newborn period with the aim of improving outcomes for preterm infants. Understanding the demand for services is of critical importance when working to realistically reach scale in low-resource settings. This includes a need to better understand the knowledge, attitudes, and perceptions of families around preterm birth and preterm newborns in individual communities and settings, as well as the demand created by care providers within existing maternal, newborn, and reproductive health service delivery systems. Now more than ever, improvement in preterm outcomes requires a truly integrated approach. Q: What role will advocacy—whether at the global, national, and local level—play in advancing the innovations and interventions identified through Every Preemie? A: Advocacy is fundamental at all levels for real, lasting change. Moving a community to success can be accelerated by advocacy. When professional organizations, parent groups, economists, and others all demonstrate the effects of quality prenatal and newborn care, governments will institute policies to provide not just for the wealthy but also for the most vulnerable. The best interventions, products, and services can have impact on preterm survival only when the required attention and ongoing needs are continuously met for these highly vulnerable developing fetuses and preterm newborns. Ultimately a chain of basic newborn care, combined with special basic care for preterm newborns (thermal care, adequate feeding, hygiene, and counseling) is essential for more sophisticated clinical interventions and products to be successful in saving lives and limiting morbidity. Doing basic care well, for all pregnant women and newborns, will go a long way in supporting preterm survival and the effectiveness of clinical interventions directed at preterm complications. The numbers support this approach. Infants born before 34 weeks gestation, for which more advanced clinical interventions target, comprise roughly 3 percent of all births and about 30 percent of all preterm births. Also, the majority of newborns who die as a result of intrapartum complications, birth asphyxia, and severe newborn infection (also among the leading causes on newborn mortality) are preterm. Success depends on the right care, in the right place, at the right time—every time.

Photo: PATH/Eric Becker A new study suggests that the use of anti-parasitic drugs and insecticides in cattle can reduce human cases of Trypanosomiasis (sleeping sickness) by as much as 90 percent. Sleeping sickness is caused by parasites and transmitted by tsetse flies, and while cattle are not susceptible to human sleeping sickness, they do carry the parasite. The study, conducted in rural Uganda, involved injecting 500,000 cattle with two anti-parasitic drugs and spraying their legs, which the tsetse flies bite, with an insecticide. The team estimates that the program saved US$15 to $60 million in health care costs and increased Uganda’s gross national product by $400 million. Researchers at the Washington University School of Medicine in St. Louis have identified antibodies—immune system proteins—that could protect against or treat multiple alphaviruses, including Chikungunya. The antibodies are known as “broadly neutralizing antibodies,” a term which normally refers to antibodies that target different strains of the same virus (i.e., HIV, Hepatitis C) rather than different viruses altogether. The team, led by Dr. Michael Diamond, director of the Division of Infectious Diseases and Vaccine Development at Washington University School of Medicine, evaluated 60 human and mouse antibodies for Chikungunya and identified 10 that are active against three or more alphaviruses. The two most potent antibodies were then used as a treatment for mice infected with Chikungunya as well as two other alphaviruses—O’nyong’nyong and Mayaro virus—and the team confirmed that the antibodies reduced the symptoms of the infections. The team is using their findings to develop more antibodies which will then be tested on animals. New research conducted by professors Drs. Bruce Freedman and Ron Harty of the University of Pennsylvania School of Veterinary Medicine could pave the way for treatments against Ebola, among other viruses. Viruses utilize their hosts’ cells to mature, reproduce, and spread and Freedman and Harty have developed a mutated gene that blocks the pathways that many viruses use to communicate. By blocking those pathways, the virus remains trapped, unable to leave the cell and infect other cells. The team will next test their approach in mice with the ultimate goal of developing an anti-viral medicine effective against any virus that uses those same pathways to communicate.

The Global Health Technologies Coalition (GHTC) is excited to announce that Global Health Council (GHC) has joined the coalition. GHC is the leading membership organization supporting and connecting advocates, implementers, and stakeholders around global health priorities worldwide. “At Global Health Council, we seek to be the collaborative voice of the global health community and engage with key decision-makers to improve health globally through increased investment and policies,” said Dr. Christine Sow, president and executive director of GHC. “We recognize that research and development for new health technologies is an important part of the equation for delivering improved health worldwide and look forward to collaborating with GHTC and its members to drive forward policy solutions and investments that help catalyze the development of urgently needed health technologies.” Founded in 1972 as the National Council of International Health, the Council sought to bring together global health practitioners, researchers, and organizations to collaborate and share information with the collective goal of improving health worldwide. In 1998, the organization changed its name to Global Health Council to better reflect the scope of its work and global membership. Today GHC is comprised of over 70 member organizations—including nongovernmental organizations, foundations, corporations, faith-based organizations, and academic institutions—operating in more than 150 countries, and hundreds of individual members. GHC regularly convenes stakeholders around key global health issues and actively engages key decision-makers to influence health policy. “GHC has a long and distinguished history of bringing together diverse actors in the global health community to debate and collaborate around shared priorities and concerns in global health and is respected by policymakers for its leadership in the community,” said Erin Will Morton, GHTC’s coalition director. “We look forward to forging deeper relationships among both of our memberships as we work to advance the diverse set of solutions required to improve health worldwide.” For more information about Global Health Council, visit www.globalhealth.org.