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The World Health Organization (WHO) recently announced that at its upcoming Executive Board meeting in February, member states will discuss challenges and issues in implementing the Nagoya Protocol—a legal framework that governs the access to and benefits gained through the sharing of genetic resources, including human and animal DNA, plants, and pathogens. As these discussions heat up, GHTC is taking a brief look at what the Nagoya Protocol is, how it impacts global health research and development (R&D), and what’s next for the future of this framework.WHAT IS THE NAGOYA PROTOCOL?The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization‒or Nagoya Protocol for short‒is a legal framework that went into effect in 2014. It regulates the sharing of genetic resources, including human and animal DNA, cultures and specimens, plants, and pathogens that are used in the course of R&D.Origin and goalThis protocol supplements a United Nations treaty, endorsed over a decade earlier in 1992, called the Convention on Biological Diversity (CBD), which established a basic principle: That every country has sovereignty over the genetic resources found within its borders. Its broader goals were to support the conversation of biological diversity, ensure its sustainable use, and ensure the “fair and equitable sharing” of the benefits derived from the use of genetic resources.The Nagoya Protocol was established to advance that third and final goal by creating greater legal certainty and transparency for both the providers and users of genetic resources. The protocol establishes more predictable paths for gaining access to genetic resources and creates frameworks for tangible agreements that outline the benefits that a donor country will receive in exchange for providing access. It also requires that users comply with any national legislation or regulatory requirements in the provider country governing the collection, use, or storage of these resources.  How does it work in practice?When a researcher, company, or institution wants to access the genetic resources in a foreign country that is party to the protocol, it should start by obtaining a prior informed consent from the country where the materials are located and outline the goal of the planned research and use. Second, the party seeking access and the provider country should also negotiate and reach “mutually agreed terms” that set conditions for the use of the genetic material and define the benefits arising from their use, such as when commercial products results from such research. These benefits could be monetary, such as a lump-sum payment or a share of the profit, or non-monetary, such as transfer of knowledge, technology, or training. A healthy debate over the Nagoya ProtocolThe aim of the protocol is to stop piracy of genetic materials across borders. Sovereignty is at the heart of the matter. Health authorities in low- and middle-income countries are often concerned that providing genetic resources will not yield a tangible benefit to their country or that the genetic materials will be shared without their consent and result in health innovations that may ultimately be unaffordable to their population. Ensuring that there are access provisions in place is critical.On the other hand, the provisions of the Nagoya Protocol can have a negative impact on international research collaborations. From basic research through clinical trials, medical research is highly collaborative and routinely involves the sharing of organisms, cultures, and research findings across borders. Adhering to the protocol can place a heavy bureaucratic burden on researchers and their institutions or companies who must comply with its requirements, as well as the procedures or laws of individual countries, which can vary greatly. The process of obtaining prior-informed consent and reaching mutually agreed terms between users and countries can take several weeks or months, putting research temporarily on hold.CONSEQUENCES AND POTENTIAL IMPLICATIONS ON HEALTH R&DThese delays can have serious consequences to public health. For example, in late 2018, implementation of the Nagoya Protocol in several countries caused significant delays in sharing seasonal influenza strains. Given selecting the strains for each year’s seasonal flu vaccine is a time sensitive process and researchers need genetic material to make this determination, this resulted in a delayed seasonal vaccine rollout and lack of public health preparedness to address influenza.Many fear that the protocol could cause similar challenges in detecting and responding to emerging infectious diseases, including advancing medical products, given pathogens spread regardless of national borders and creating control measures requires partnerships and sample and data sharing between countries and research institutions. Long negotiations to obtain specimens for research potentially increase the risk of disease spreading in populations that have no immunity and can harm the global interest of protecting against emerging infectious diseases.WHAT’S NEXT FOR NAGOYA?Given the potential impacts that the Nagoya Protocol could have on the development of vaccines and other medical products, many stakeholders are calling for exemptions to the protocol and for alternative approaches for the sharing of genetic materials to be considered. In the aftermath of the of the swine and avian flu a decade ago, WHO developed an agreement called the Pandemic Influenza Preparedness Framework, which outlines a potential path forward to mitigate unforeseen health consequences related to the protocol. The agreement provides for global sharing of pandemic influenza viruses within a network of public health laboratories. Organizations and companies outside of this network can also access this pool of viruses after making a partnership contribution to and signing a material transfer agreement with WHO, in which they agree to share benefits. While the agreement only covers flu, some see it as a model that could resolve the disputes over the Protocol and genetic materials and sequence sharing, and create a timelier pathway for researchers looking to combat emerging infectious and other global diseases.

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Dr. Rohit Ramchandani, who we met at the American Society of Tropical Medicine and Hygiene Annual Conferenc. Dr. Ramchandani does research to innovate global treatment options for childhood diarrhea at the Johns Hopkins School of Public Health in Baltimore, Maryland and the University of Waterloo. My name: Rohit Ramchandani, DrPHWhere I work: Johns Hopkins School of Public Health in Baltimore, Maryland and the University of WaterlooI’m funded by: US Agency for International DevelopmentMy research: My research focuses on diarrhea in children…the second-leading cause of death in children under five globally…These are close to 500,000 deaths that are happening every year, most of which are preventable, and treatable. They’re treatable with medicines, oral rehydration salts [ORS] and zinc. That’s the globally recommended treatment for diarrhea. But the problem is, in many low- and middle-income countries, access to these medicines is not where it should be, particularly in rural communities. So we looked at that issue of access. We did it by leveraging human-centered design approach. And we really focused on the details and the challenges that mothers face treating their children with diarrhea…Our research showed that 40% of the time, mothers are preparing ORS in the wrong concentration: either too diluted, or too concentrated. That can lead to hypernatremia, that can make the diarrhea even worse, or the efficacy gets reduced if it’s too diluted. So we actually worked with a local pharmaceutical company in Zambia to shrink down then size of the ORS sachets—the standard all over the world is a one-liter sachet—we shrunk those down to make 200-mililiter sachets, and then we made the packaging double as a measurement vessel for the right amount of water…One of our key funders during our scale-up phase was USAID—their Discover Health Program. They played a fundamental role in some of the social marketing we were doing as we were scaling up the development of our diarrhea treatment kit.Motivation: There’s just a fundamental issue of justice in the world…We often think of innovation being new product development, high technology, but things like ORS and zinc—innovation can happen really in the delivery side of things. And that’s really where our innovation focused.Why federal support is critical: I think this is low-hanging fruit. Diarrhea, as one of the leading causes of death in the world for children—we have the solutions, we know what to do, and these kinds of innovations can really make a huge difference in saving lives.…[And] there’s a health security argument [to do this work]. The world is getting smaller and smaller every day. We are inextricably linked to one another. When I’m not in the lab: I’m a dad! I’m a dad of two amazing young girls. They inspire me every day. It makes my work in child health that much more meaningful—the inspiration I get from them. I want all parents to have that.

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Dr. Vinayak Joshi, who we met at the American Society of Tropical Medicine and Hygiene Annual Conference. Dr. Joshi is working on a diagnostic for cerebral malaria with support from the National Institute of Allergy and Infectious Diseases.My name: Vinayak Joshi, PhDWhere I work: VisionQuest Biomedical Inc.I’m funded by: National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)My research: We are developing a user-friendly, fully automated, and simple-to-use diagnostic for cerebral malaria. Today, cerebral malaria misdiagnosis causes hundreds of thousands of deaths in African children. With improved diagnostic accuracy, we can prevent many of those deaths and associated disabilities. Motivation: My background is in machine learning software development for medical diagnosis. In my PhD research, I developed an algorithm for detecting malarial biomarkers in eyes. Later, I got a chance to visit one of the malaria clinics—and I learned that this particular kind of malaria, cerebral malaria, is one of the largest killers of children in Africa—and I actually witnessed a child’s death which left an impression on my mind. Rather than just focusing on developing an algorithm, I reasoned that developing a tool that would lead to greater accessibility and was affordable to the target population in Africa, would make a significant humanitarian contribution.Why US federal support is critical: One of the major goals of this work is to prevent deaths in young children. For such two- to three-year-old kids—it is one of the biggest global health problems. After a child is affected with cerebral malaria, one needs to take action in 24 to 48 hours, otherwise it results in death. It may not be always reported in the news media, but hundreds of thousands of deaths occur every year from this issue. The death toll and neurological disability in children caused by this disease are important problems, often overlooked by the world outside of sub-Saharan Africa. The United States does a lot of noble work in different countries, in health care, development, other infrastructure, and I think this is one of the problems that should receive more attention. There are many technologies being developed, but developers can’t find the channels to commercialize them, because the African market is not where you make money—you do it for humanitarian purposes. But to develop any product you need money, and I think the US government should look into it. They should support the institutions that produce the tools but have to find sources of funding to commercialize these technologies and make them accessible to the target population.When I’m not in the lab: I like a lot of traveling—it’s one of my hobbies. I don’t particularly like to go to top tourist destinations. I like to explore new, unexplored parts of the country. 

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Dr. Aileen Marty, who we met at the American Society of Tropical Medicine and Hygiene Annual Conference. Dr. Marty works at Florida International University and serves on the President’s Advisory Council for Combating Antibiotic-Resistant Bacteria.My name: Aileen Marty, MDWhere I work: Herbert Wertheim College of Medicine, Florida International University I’m funded by: The US government has supported my research since I began doing research back in the early 1970s. Right now, I’m involved with PACCARB, the President’s Advisory Council for Combating Antibiotic-Resistant Bacteria.My research: We’re interested in not only resistance by bacteria to antibiotics, but also by other pathogens such as fungal agents, and eventually hope to also focus on antihelminthic agents, and so forth. We are taking a look at it from a one health perspective, which means we try and understand how the agriculture industry may impact the use and availability of antimicrobial agents for humans, what is going on in the environment that’s also altering these things, as well as stewardship and appropriate use of antibiotics and antimicrobials in hospitals and in clinics throughout the United States and throughout the world, and see how those interface with one another. The CDC [US Centers for Disease Control and Prevention] recently put out a document about antimicrobial resistance that’s highly important. It says we’re already in an era where, for a number of very serious bugs or germs, we are out of antibiotics that actually work. If we do not solve this problem, we’re going to find ourselves in the situation we were in prior to the 20th century. And that impacts much more than infections directly, because modern medicine relies on us not having infections in order to do the surgeries that we’re doing. And to help people with autoimmune diseases like psoriasis or cancer treatments that decrease a person’s immune systems, we depend on the availability of good functioning antibiotics and antimicrobial agents at the right time in the right place for the right patient.Motivation: I love humanity—and I seriously believe that we all have a role to play in making sure that we leave behind a better world than the world we came into. And I become very inspired when I work with young minds, and I make sure that they see the connections between the different systems of the world and how we need to be stewards of the earth.Why US federal support is critical: We mustn’t think of it only in terms of it being global. You must realize that we in the United States are part of the globe. Moreover, individuals who live in the United States, who are citizens of the United States, travel worldwide. And what happens in Bangladesh has an impact on what happens in New York. Look at the recent measles outbreak in New York state, for example. That outbreak originated with an outbreak in Ukraine that passed via Israel and was brought to the United States—and think about what that has done. When we manage outbreaks where they arise, wherever that is, we minimize the footprint there and decrease the risk everywhere. When I’m not in the lab: In my personal life, I have a huge family, which I love dearly, and many, many good friends, and we spend a lot of time coming up with good community plans for helping people. And I belong to the Florida Clinicians for Climate Action, and through that organization we are going to synagogues and churches and other houses of worship where we are explaining the public health impacts of climate change to our people.