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    The future of health and medicine in low- and middle-income countries

    To fight COVID-19 and other health issues, people must trust that vaccines, medicines, and other medical products are quality-assured and can be available at scale worldwide. Devex looks at what it takes for cutting-edge innovations to deliver on the promise of a healthier future.

    By Devex Editor // 27 May 2020
    Devex looks at what it takes for cutting-edge innovations to deliver on the promise of a healthier future. Photo by: USP

    In the throes of the COVID-19 pandemic, researchers and manufacturers are racing against the clock to discover antivirals and vaccines to treat and ultimately prevent the deadly disease. Other cutting-edge innovations are also under development that could revolutionize care for an array of illnesses. Their successful adoption depends on trust in such products and the health systems that administer them.

    While medical breakthroughs may often reach Western populations in a matter of months or years, they rarely reach low- and middle-income countries at the same pace and quality. This inequity diminishes trust in medical innovations and health systems.

    In the current health crisis, both are being strained, said Jeff Sturchio, CEO of Rabin Martin, a global health strategy consulting firm that helps clients improve health and access to global health technologies. With trust, he said, comes more rapid adoption of innovations, which leads to improved health outcomes for large populations.

    Prior to the COVID-19 health crisis, USP — an independent, nonprofit, scientific organization that sets quality standards for medicines, food ingredients, and dietary supplements — and the Massachusetts Institute of Technology Center for Collective Intelligence, took a look at this issue and launched an online exercise called the Trust CoLab.

    In celebration of USP’s 200th anniversary, the Trust CoLab engaged with over 100 global experts in health and medicine and crowdsourced opinions on what it would take for new discoveries and innovations in medicine to improve health and save lives throughout the world. The exercise resulted in the development of four possible scenarios for the state of health and medicine in 2040 — which varied based on the focus of medical innovation, the role of regulators, and the leveraging of public quality standards.

    “These scenarios inspire recognition of the importance of the public’s trust, and guard against the dangers that rapid change sometimes presents,” said Kathleen Kennedy, executive director, MIT Center for Collective Intelligence.

    The resulting report — “Trust or Consequences 2040: Will innovations in health and medicine deliver?” — highlights how decisions made now will affect the future health landscape. Despite predating the current pandemic, a recurring theme in the report was the increasing frequency of global crises and their ability to cause wide scale change. COVID-19 is one such global crisis, with the potential to fundamentally change the health landscape long term.

    Below are three factors that global experts identified as critical to shaping a more equitable future of medicine.

    The report’s four potential future scenarios:

    Scaling the tried and true. A series of rolling crises spur collaboration while medical advances occur and are implemented incrementally. The focus is on baseline care, provided to all.

    Dangerous uncertainty. Problems with big data and artificial intelligence lead to health care failures. Unequal distribution of access means only the rich receive the most advanced treatments. The efficacy and safety of science-based medicine is called into question.

    A world of difference. The successful application of big data and AI leads to advances in personalized medicine and prevention, diagnosis, and treatment informed by genetic information. Not everyone has access.

    Solving tomorrow’s problems. Smart and deliberate innovation is broadly distributed. Advances in big data and AI create genetic diagnostic tools that are applied globally. Diseases become more predictable and the focus of health care is on prevention. New treatments also emerge.

    1. Improved collaboration

    The formation of Gavi, The Vaccine Alliance in 2000 and the Global Fund to Fight AIDS, Tuberculosis and Malaria in 2002 are examples of collaboration to support medical innovations that already exist. According to the “Trust or Consequences 2040” report scenario of “scaling the tried and true,” crises such as COVID-19 are likely to “spur effective global collaboration.”

    Indeed, that has been the case, Sturchio said, calling the current speed and level of collaboration “unprecedented.” For example, public-private partnerships have recently emerged to address the pandemic, including the Bill & Melinda Gates Foundation COVID-19 Therapeutics Accelerator, with the Wellcome Trust, Mastercard, and several other public and private entities; and the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, program, with the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, and a number of private sector companies.

    Yet, when it comes to medicines supply chains, Michael Levy, vice president of research and innovation at USP, believes the pandemic could amplify protectionist or nationalistic tendencies and result in less collaboration between countries as they focus on ensuring continued access to medical products for their own populations.

    MIT CCI’s Kennedy explained that the pandemic has identified vulnerabilities in the global health supply chain; many countries rely on one another for their supply of medicines or ingredients for medicines. But, in the current situation, illness and lockdowns are affecting the production and distribution of products between locations. In some cases, countries have opted to temporarily restrict the export of medicines and ingredients they manufacture in order to safeguard their own population, leaving other countries with a deficit.

    To remedy this, countries can diversify the sources of medicines and their key ingredients, Levy said. This would strengthen their drug supplies while increasing transparency across supply chains, and strengthening regulatory oversight — including entering into recognition and reliance agreements with other countries’ regulatory authorities.

    Local advanced manufacturing, such as continuous manufacturing, could help countries bolster their domestic production of medicines, but countries should still collaborate, Levy added. “It's unrealistic to imagine that a country is going to supply 100% of its medicines. However, all countries, not just LMICs, should, to the extent possible, strive to have multiple, diversified sources, including domestic ones, for their essential medicines.”

    Benjamin Botwe, a Ghana-based independent consultant on medicines regulation and quality assurance, suggested harmonizing health systems and supply chains across regions. “Health ministers should be talking together, finding disease patterns, and finding interventions that can be put in place because medicines move across borders whether officially or unofficially,” he said.

    Without sufficient flexibility, systems can break down under stress, creating shortages that provide opportunities for counterfeit medicines to make their way into supply chains and jeopardize trust, Sturchio said.

    2. Innovation around new therapies

    In the last decade, big data, artificial intelligence, and genetic medicine have begun to enter the health care space. COVID-19 has helped accelerate the application of these innovations, Kennedy said.

    But, according to Levy, the report identifies two axes that are critical to the future of health care. “The first is around innovation … will innovative medicines, health care practices, and so on deliver on their promise? The other axis is around equity: Will everyone have access to those innovations?” he asked.

    New products can be too expensive for immediate roll out in lower-income countries and the cost of research can prevent countries from innovating themselves, Botwe said.

    Yet new technologies such as mobile health, innovative distribution methods, and advanced manufacturing could help LMICs to leapfrog, Levy said. “Continuous manufacturing, which is used in many other industries, has not been widely adopted within the pharmaceutical sector. This is an example of an innovation that LMICs could lead,” he said. “It requires less upfront capital, smaller facility and environmental footprints, and could allow local manufacturers to competitively meet local demand for quality medicines or ingredients.”

    “All countries, not just LMICs, should, to the extent possible, strive to have multiple, diversified sources, including domestic ones, for their essential medicines.”

    — Michael Levy, vice president of research and innovation, USP

    To ensure a best-case scenario — where medical advances lead to an improved focus on baseline care and higher levels of trust in systems and innovations globally — regulators should consider how public quality standards can broaden the adoption of new technologies or therapies, Levy said. “Quality standards are critical to ensuring trust because they ensure that everyone is meeting the same minimum threshold or quality of products,” he said.

    For example, USP public quality standards are developed by experts and designed to strengthen trust and deliver the greatest benefits to the greatest number of people. Standards advocate for patients, including the most vulnerable, as it’s nearly impossible for individuals to vet potential treatments, Levy said.

    “Regulation should not be seen as a means of trying to restrict people’s innovation, but rather to help people to comply,” Botwe said, adding that regulations must be practical and well-communicated. “Let people know the benefits of regulation, why medicines are being regulated, why health systems are being regulated, and they’ll get into it.”

    Sturchio said it’s a case of making sure that the right mechanisms are in place. “Then we'll have a world in which people will trust the systems that are providing the health care interventions they need and trust that the health care systems are actually going to take care of their needs as well as their neighbors.’”

    3. Access to existing therapies

    While there is a need for new medicines and vaccines, the report gleaned that improving the delivery of existing products could also yield improved trust and global health outcomes. Governments, private sector companies, and international organizations are all interested in closing the gap between access to existing essential medicines and new ones, Sturchio said.

    “LMICs ... don't want to live in a world where some people get access to new cancer therapies that can extend their lives significantly, while people in poorer countries end up dying much sooner than they would have to because they can't get these new treatments,” he said.

    While often people focus on the cost of new therapies as the insurmountable barrier, access is about more than just price, Sturchio said.

    “[Medicines] have to be available by being registered in countries, so regulatory systems are really important. They have to be accessible and that means that you need global supply chains that can deliver them reliably and sustainably. They have to be adopted by physicians and prescribed, and the population needs to accept them,” he said.

    “Trust or Consequences 2040” predicts that over the next 20 years, drug development and approval, AI and big data, genetic medicine, and personalized medicine have the potential to revolutionize health care. However, Sturchio believes their success relies on developing collaborative mechanisms and a focus on equitable access.

    “Unless everybody is safe, nobody's safe … Global problems need global solutions, and that requires the kind of collaboration across borders and sectors that we’re already beginning to see in response to the coronavirus pandemic.”

    Read the full report and find out more about what the future of health and medicine could look like.

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