Courtney Carson, MA

A close-up of packets of pills. (Photo: PATH/Christopher Nelson) In November 2015, United Nations (UN) Secretary-General Ban Ki-moon convened a High-Level Panel on Access to Medicinesto discuss and develop solutions to promote innovation and access to essential medicines, vaccines, diagnostics, and other health technologies needed to ensure health and well-being around the world. This panel comes on the heels of the UN General Assembly formally adopting the Sustainable Development Goals (SDGs)—goal three of which is to “ensure healthy lives and promote well-being for all at all ages”—and is designed to consider ways in which intellectual property (IP) protections, trade rules, and international human rights law might affect global access to medicine and the ability of the international community to achieve SDG three by 2030. The panel also comes at a time when the United States and the international community are considering one of the most ambitious trade agendas in the last several years. The Trans-Pacific Partnership (TPP), the largest regional trade agreement in history, linking 11 Pacific-rim countries that make up 40 percent of the world’s economy, was finalized in October 2015 and is currently under review by the US Congress. The agreement has stronger IP protections for pharmaceutical products than those included in previous regional and bilateral trade agreements—including twelve years of data protection for new biologics and the ability to evergreen certain pharmaceutical patents—which may impact timely access to generic medicines in TPP countries. The US is also in the process of negotiating the Trans-Atlantic Trade and Investment Partnership (TTIP), which would reduce tariffs and codify trade-related standards between the United States and the European Union. Details of this agreement have not yet been made public. (To read more about the potential impact of TPP on access to medicine, visit GHTC’s blog .) Though minimum standards for patents and IP protections have been included in trade agreements since 1995, when the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was approved by the World Trade Organization (WTO), certain actions have carved out exceptions to protect public health and support low- and middle-income countries. The Doha Declaration on TRIPS and Public Health formally clarified that TRIPS IP protections for pharmaceuticals should not prevent countries from protecting public health and promoting access to medicine. It also affirmed flexibilities for least developed countries (LDCs), as designated by the UN, to gradually enforce IP protections for pharmaceuticals, including provisions around compulsory licensing of generic medications, and established January 1, 2016, as the deadline for LDCs to implement enforcement of pharmaceutical patents. The US May 10th Agreement established congressional intent for TRIPS flexibilities, as expressed in the Doha Declaration, to be reflected in all US trade negotiations. With the on-ramp for LDCs to enforce pharmaceutical patents set to expire at the start of the new year, in November, the WTO committee on IP rights agreed to extend the provision allowing LDCs to avoid applying and enforcing IP rights on pharmaceutical products until 2033. In a June 2015 letter to the WTO, advocates argued that, “Many LDCs (at least 25 countries) have relied on the…pharmaceutical product [exemption] to declare patents unenforceable as well as to exempt pharmaceutical products from patent and test data obligations, thereby allowing them to import critical treatments such as medicines for their national HIV and AIDS treatment programs” at affordable prices. Because “the public health crisis in LDCs is a long-term challenge that will endure at least as long as these countries remain LDCs,” an extension of the on-ramp is critical to “provide suppliers, procurers and donors of affordable medicines in LDCs the clarity and certainty to confidently manufacture, export and import generic medicines.” Countries with strong pharmaceutical industries, like the United States, negotiated to make the extension time-bound to 2033 in lieu of the permanent extension sought by LDCs and their advocates. It is with this backdrop that the UN High-Level Panel on Access to Medicines begins its work. The UN Secretary-General has appointed members of the panel—with representatives from both developed and low- and middle-income countries. Further, a group of expert advisors—from civil society, the private sector, and academia—has been established to help guide the Panel’s work. Several documents including a Report on HIV and the Law are cited as background for the Panel’s work. After the first in-person meeting of the panel in December, the group opened a call for contributions by interested stakeholders “that address the misalignment between the rights of inventors, international human rights law, trade rules and public health where it impedes the innovation of and access to health technologies.” The panel will discuss these contributions at two public hearings in March, which will help to guide the development of their formal report to the Secretary-General, expected to be finalized in early June. To ensure that essential global health technologies get into the hands of populations in need, promoting access to medicines and global health tools is just as critical as supporting the research and development that drives these new innovations. GHTC will be closely monitoring the work of the High-Level Panel and looks forward to contributing to the public hearings in March.

President Obama 2016 State of the Union address. Photo: White HouseGHTC has long championed US leadership in global health and innovation, and we were encouraged to see President Barack Obama highlight these themes in his State of the Union address.On combating the 2014 Ebola epidemic in West Africa, the president highlighted a coordinated domestic and international effort to leverage expertise, resources, and value-add of all partners—a strategy we support for advancing global health R&D. He stated: Fortunately, there’s a smarter approach, a patient and disciplined strategy that uses every element of our national power. It says America will always act, alone if necessary, to protect our people and our allies; but on issues of global concern, we will mobilize the world to work with us, and make sure other countries pull their own weight… That’s how we stopped the spread of Ebola in West Africa. Our military, our doctors, and our development workers set up the platform that allowed other countries to join us in stamping out that epidemic. The president also discussed US investments in global health and development as a core piece of American foreign policy and national security, nodding to the Global Health Security Agenda, which coordinates domestic and international efforts to prevent, detect, and respond to global disease epidemics. In addition, his message called for renewed commitment and funding for US efforts to end the epidemics of HIV and AIDS and malaria: Leadership means a wise application of military power, and rallying the world behind causes that are right. It means seeing our foreign assistance as part of our national security, not charity. When we help African countries feed their people and care for the sick, that prevents the next pandemic from reaching our shores. Right now, we are on track to end the scourge of HIV and AIDS, and we have the capacity to accomplish the same thing with malaria — something I’ll be pushing this Congress to fund this year. President Obama also highlighted the transformative power of medical research to end endemic and emerging health threats: For the loved ones we’ve all lost, for the family we can still save, let’s make America the country that cures cancer once and for all. Medical research is critical. GHTC is pleased to see President Obama echo themes we have long advocated: partnerships and innovation are key to advancing health at home, and around the world.To curb the spread of emerging disease epidemics, we will need domestic and international commitment to work together and develop new tools and technologies to monitor, track, diagnose, and treat infectious disease. To finally end the scourge of malaria and achieve an AIDS-free generation, we will need renewed commitment to develop innovative vaccines and treatments that move us beyond current interventions. To cure noncommunicable diseases and other health challenges that plague developed and lower-income countries, we need continued investment in research and development for health technologies.GHTC looks forward to working with the president and his administration to drive these issues forward in 2016.

Photo: PATH/Patrick McKernUpdate: The Global Health Technologies Coalition is excited to announce that the Global Health Innovation Act (H.R. 2241) passed the House of Representatives on December 18. Last month, Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) introduced a new piece of legislation—the Global Health Innovation Act (H.R. 2241)—that would strengthen global health research and development (R&D) programming at the US Agency for International Development (USAID).USAID plays an important role in advancing global health in low and middle-income countries and this legislation would ensure that the agency is taking appropriate steps to incorporate innovation for new global health technologies across its programming by requiring that the agency submit an annual report to Congress on the development and use of global health innovations in the agency’s programs, projects, and activities.The Global Health Innovation Act marks a key opportunity in advocacy for the need for innovation in global health. The GHTC dissects the bill below and highlights the key provisions.If passed, H.R. 2241 would: Make permanent and improve USAID’s annual report to Congress on health-related research and development activities. The act would require a comprehensive analysis of USAID’s activities to develop, advance, introduce, and scale up global health technologies. This allows policymakers and advocates to track and understand the full scope of health R&D activities taking place at USAID, identify best practices, and zero-in on gaps that may exist. Require USAID to articulate how it sets goals for health product development and measure progress toward these goals. The legislation would require USAID’s report to describe how it sets goals for health R&D in relation to its overall health objectives and mission, and how the agency measures progress towards these goals. This provides enhanced transparency into USAID’s decision-making and review processes. Require USAID to describe and demonstrate the impact of its investment in health innovations on global health outcomes. This includes analysis in the annual report of how the agency’s investments and activities in health innovation have advanced its goals to reduce the burden of HIV and AIDS, end preventable child and maternal deaths, and protect against infectious diseases. Such an impact analysis will help magnify the importance of investment in health R&D for achieving sustainable health solutions. Direct USAID to report on how it is working with partners, donors, and through public-private partnerships to leverage US investments to accelerate health innovation. This includes a description of the how the agency is working through partnerships to develop, introduce, and scale up affordable, available, and appropriate health products and close gaps in the health innovation development pipeline. This section of the report will acknowledge the diverse coalition of private sector, nonprofit, foundation, and academic institutions partnering with USAID on health innovations, and demonstrate the importance of a coordinated, cross-sector approach to health R&D. Encourage USAID to improve collaboration and coordination, both within USAID and between other US agencies, to fill critical R&D gaps. The act requires that USAID report on how it is coordinating R&D activities across its programs and how it is collaborating with other US agencies to support global health product development and ensure critical gaps are filled. This will help promote a whole-of-government approach to health R&D, which will better leverage investment, knowledge, and expertise. The legislation would make permanent and improve USAID annual report to Congress on its R&D activities. Credit: USAID The Global Health Innovation Act would not only ensure important information about USAID’s activities is made available to global health nongovernmental organizations, advocates, and policymakers in Congress, but it would also be an asset for USAID. In codifying the report on global health innovations, the bill will ensure that the agency continues to coordinate, streamline, and organize its use and development of global health technologies—a practice area that spans many departments and bureaus. It will also help the agency gauge performance, share best practices, and understand gaps in service to more efficiently and effectively serve its mission.The legislation draws upon the 21st Century Global Health Technology Act, legislation introduced in the 113th Congress, which sought to strengthen global health R&D programming at USAID by codifying programs supporting product development partnerships. The new legislation takes a more holistic approach, and directs USAID to analyze how it is using innovation to address global health challenges and the ways in which the agency can further accelerate the development and use of health technologies. It shifts away from endorsing specific programs and instead underscores the importance of USAID’s strong partnerships that leverage investments in R&D and advance global health innovation.Passing the Global Health Innovation Act will drive home the fact that health innovations are a critical piece of the global health agenda. GHTC and our members look forward to working with Congress to champion this important legislation.To read the full text of the Global Health Innovation Act, click here.

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/Patrick McKern Update: The Global Health Technologies Coalition is excited to announce that the Global Health Innovation Act (H.R. 2241) passed the House of Representatives on December 18. Last month, Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) introduced a new piece of legislation—the Global Health Innovation Act (H.R. 2241)—that would strengthen global health research and development (R&D) programming at the US Agency for International Development (USAID). USAID plays an important role in advancing global health in low and middle-income countries and this legislation would ensure that the agency is taking appropriate steps to incorporate innovation for new global health technologies across its programming by requiring that the agency submit an annual report to Congress on the development and use of global health innovations in the agency’s programs, projects, and activities. The Global Health Innovation Act marks a key opportunity in advocacy for the need for innovation in global health. The GHTC dissects the bill below and highlights the key provisions. If passed, H.R. 2241 would: Make permanent and improve USAID’s annual report to Congress on health-related research and development activities. The act would require a comprehensive analysis of USAID’s activities to develop, advance, introduce, and scale up global health technologies. This allows policymakers and advocates to track and understand the full scope of health R&D activities taking place at USAID, identify best practices, and zero-in on gaps that may exist. Require USAID to articulate how it sets goals for health product development and measure progress toward these goals. The legislation would require USAID’s report to describe how it sets goals for health R&D in relation to its overall health objectives and mission, and how the agency measures progress towards these goals. This provides enhanced transparency into USAID’s decision-making and review processes. Require USAID to describe and demonstrate the impact of its investment in health innovations on global health outcomes. This includes analysis in the annual report of how the agency’s investments and activities in health innovation have advanced its goals to reduce the burden of HIV and AIDS, end preventable child and maternal deaths, and protect against infectious diseases. Such an impact analysis will help magnify the importance of investment in health R&D for achieving sustainable health solutions. Direct USAID to report on how it is working with partners, donors, and through public-private partnerships to leverage US investments to accelerate health innovation. This includes a description of the how the agency is working through partnerships to develop, introduce, and scale up affordable, available, and appropriate health products and close gaps in the health innovation development pipeline. This section of the report will acknowledge the diverse coalition of private sector, nonprofit, foundation, and academic institutions partnering with USAID on health innovations, and demonstrate the importance of a coordinated, cross-sector approach to health R&D. Encourage USAID to improve collaboration and coordination, both within USAID and between other US agencies, to fill critical R&D gaps. The act requires that USAID report on how it is coordinating R&D activities across its programs and how it is collaborating with other US agencies to support global health product development and ensure critical gaps are filled. This will help promote a whole-of-government approach to health R&D, which will better leverage investment, knowledge, and expertise. The legislation would make permanent and improve USAID annual report to Congress on its R&D activities. Credit: USAID The Global Health Innovation Act would not only ensure important information about USAID’s activities is made available to global health nongovernmental organizations, advocates, and policymakers in Congress, but it would also be an asset for USAID. In codifying the report on global health innovations, the bill will ensure that the agency continues to coordinate, streamline, and organize its use and development of global health technologies—a practice area that spans many departments and bureaus. It will also help the agency gauge performance, share best practices, and understand gaps in service to more efficiently and effectively serve its mission. The legislation draws upon the 21st Century Global Health Technology Act, legislation introduced in the 113th Congress, which sought to strengthen global health R&D programming at USAID by codifying programs supporting product development partnerships. The new legislation takes a more holistic approach, and directs USAID to analyze how it is using innovation to address global health challenges and the ways in which the agency can further accelerate the development and use of health technologies. It shifts away from endorsing specific programs and instead underscores the importance of USAID’s strong partnerships that leverage investments in R&D and advance global health innovation. Passing the Global Health Innovation Act will drive home the fact that health innovations are a critical piece of the global health agenda. GHTC and our members look forward to working with Congress to champion this important legislation. To read the full text of the Global Health Innovation Act, click here.