Innovation doesn’t happen only in large university laboratories or state-of-the-art R&D facilities of wealthy multinationals.

Some of the most critically needed, effective and low-cost health innovations are occurring in low-income countries, driven by community needs and accelerated with patents and protection of intellectual property.

Innovators in these countries are showing sheer ingenuity and resourcefulness in addressing numerous local health challenges, said Sandra Barbosu (photo at left), associate director of the Information Technology & Innovation Foundation’s (ITIF) Center for Life Sciences Innovation.

“These innovators are not simply replicating solutions from wealthier nations. They’re  designing very tailored, cost-effective and impactful innovations that meet the unique needs of their populations,” she said during a webinar presented by the ITIF, a Washington, D.C. policy think tank.

Innovations are happening in very specific situations where novel therapies, medical devices and technologies are tailored to meet certain needs based on the limited resources that are available to communities, said Douglas Park (photo at right), research fellow at the University of Akron School of Law’s Center for Intellectual Property Law & Technology

However, a lot of the time such innovations result in very modular technologies that can be applied broadly, he said.

“A lot of the innovations that do happen end up being tied to globally available technologies (such as smart phones and computer systems) and end up being applicable in lots of situations outside of what we would expect,” Park said.

The ITIF, through the Innovate4Health project, has compiled 26 case studies in a new report that highlights cutting-edge health innovation from across the globe. Barbosu and Park are two of the editors of the report.

Innovate4Health, which started in 2018, is supported by ITIF, the Geneva Network and the University of Akron School of Law’s Center for Intellectual Property Law & Technology.

The report features innovators and their innovations from 18 countries across five regions: Latin America, Southeast Asia, the Middle East and North Africa, South Asia, and Sub-Sahara Africa. The case studies focus on five key themes:

• Removing practical barriers to accessing treatments.
• Simplifying treatments and diagnostics to make it easier for patients to access and use them.
• Increasing efficacy and reducing the detrimental side effects of existing therapies.
• Making personalized medicine accessible to more patients.
• Reducing the global burden of non-communicable diseases as life expectancy increases.

Many of the case studies also highlight how generating patents and protecting intellectual property within a robust IP framework is often the foundation upon which innovations in emerging economies are built, said Mark Schultz (photo at right), director of the intellectual property program at the University of Akron’s School of Law.

“IP rights give innovators the security to invest their time and resources,” he said.

In moving ideas through the innovation process and producing products, it is also often essential to have programs to assist innovators and entrepreneurs with building capacity and bringing their solutions to patients, Schultz said.

IP rights provide the security needed for these innovations to attract the investment needed to further develop and test them, and to bring them through the regulatory compliance process and into proof of concept, he said.

IP also enables key partnerships, he added. “Often, entrepreneurs and innovators need to partner with bigger companies that have the capacity to distribute their expertise to manufacture their products and comply with regulatory compliance.”

The Innovate4Health project aims to highlight the vital role of IP rights in driving innovation and to show how robust IP frameworks empower innovators, especially in developing countries, to create transformative solutions that address urgent health needs.

Examples of innovations in developing countries

M-Scan is a groundbreaking innovation developed in Uganda and helps make pre-natal care accessible to more women in underserved regions.

M-Scan is a patented, locally designed, low-cost, portable and power-efficient ultrasound probe that connects to a smartphone or laptop and delivers portable sonograms to pregnant mothers in rural Africa, at just one-tenth the cost of traditional ultrasound machines, Barbosu said.

While ultrasound is common in developed countries, the technology remains largely inaccessible in regions such as Sub-Saharan Africa, with 60 percent of women in the region going through their entire pregnancy without a single scan.

“Among other factors, this lack of prenatal care has contributed to two-thirds of global maternal deaths occurring in Sub-Saharan Africa,” Barbosu said.

Another example of homegrown innovation is NexCAR19, one of the first cancer therapies created entirely in India. The therapy was developed by local company ImmunoACT in collaboration with the Institute of Technology, Bombay.

NexCAR19 is a drug that enables the patient’s own immune system to combat leukemia and B-cell lymphomas that often develop in the lymph nodes, bone marrow, spleen and liver.

Barbosu noted that reforms in the mid-2000s that strengthened IP rights in India played a critical role in enabling life sciences companies such as ImmunoACT to secure patents for their innovations. These patents have in turn helped companies attract the funding necessary to do ambitious R&D to develop and bring transformative therapies like NexCAR19 to patients.

Studies show that robust IP frameworks boost domestic R&D and inflows of direct investments and exports, making countries more attractive for global pharmaceutical companies, Barbosu said. “For startups, patents are particularly impactful because they help secure critical funding and achieve rapid growth.”

Startups that are granted a patent see on average 55 percent higher employment growth and 80 percent higher sales growth after five years, she said. Startups with patents are also 47 percent more likely to secure funding from VCs, banks or other public investors.

“Patents provide market power, facilitate licensing agreements and reassure investors of a startup’s ability to monetize its inventions,” Barbosu said.

Patents also enable startups to share invention details with less fear of appropriation and serve as a quality signal, demonstrating novelty and utility to markets “where information gaps tend to be quite significant,” she added.

“IP rights are foundational to life sciences innovation because they encourage investment and protect discoveries, driving economic progress and delivering transformative health solutions around the world.”

 Another case study profiled in the report is that of Herbanext, which developed a product from a plant called Euporbia hirta (known locally as Tawa-Tawa herb), which has been used by Filipino people for centuries to fight Dengue fever.

Park said Herbanext has patented the process of refining the herb and secured IP rights that can be used to support investment in the product.

Herbanext worked with the technology transfer program at the King Abdualla University of Science and Technology in Saudi Arabia to develop the company’s herbal tea product.

Not only is the product effective in treating Dengue fever, it also helps treat some of the more moderate symptoms of COVID-19, Park noted.

At the height of the pandemic in 2020-2021, he said, “this was invaluable for helping people who didn’t necessarily have access to the fancier health care medicines to treat these symptoms.”

Access to prompt, high-quality diagnosis is a problem

Many diseases that occur in low-income countries can be cured or controlled with affordable therapies, but such diseases either aren’t diagnosed or they’re misdiagnosed.

“Diagnostics is a problem in these countries because there’s a lack of laboratory staff and expertise,” said Anna Schuh (photo at right), professor of molecular diagnostics at the University of Oxford.

The logistics of procuring laboratory reagents and tests along with shipping costs and turnaround times are long and prohibitive for many of the life-saving diagnostics, she said. Often, the cost of importing lab reagents or shipping patients’ samples is exorbitant and unaffordable for the majority of people.

There is also a history in low-income countries of transferring and using outdated diagnostic technologies – some are 60 to 70 years old – that lack the precision required, especially for diagnosing non-communicable diseases, Schuh said.

“About 47 percent of the world’s population cannot access best diagnostics that are essential for diagnosing and treating diseases,” she said. “The impact is of this is that millions of lives are being shortened due to lack of or inaccurate diagnosis.”

To address this situation, Schuh co-founded and is chief medical officer of SerenOx Africa and SerenOx UK.

SerenOx provides quality assurance in diagnosis and local control of patients’ samples and the sample processing and analysis. The organization vets and certifies local laboratories in low-income countries, for example for diagnosis using DNA sequencing production.

SerenOx analyzes, in the cloud, all patients’ samples together with staff in local communities, resulting in a report authorized for diagnostics by the local collaborator.

SerenOx focuses on diagnostics using liquid biopsies, obtained from taking a simple blood sample. Such samples contain very small amounts of circulating DNA that can inform cancer diagnostics, both in the fetus but also in patients who carry tumours.

Schuh said SerenOx introduced and led the tech transfer of liquid biopsy technology to Tanzania and Uganda for the rapid and accurate diagnosis of Burkitt lymphoma, the most common cancer in children worldwide.

Burkitt lymphoma occurs only around the equator because it is linked to mosquito-borne malaria and very early infection by the Epstein-Barr virus, which is frequently seen in Sub-Saharan Africa.

“The cancer is lethal within six months of diagnosis unless it is treated,” Schuh noted. However, Burkitt lymphoma can be treated very easily and treatment is free of charge for children in all Sub-Saharan countries.

The problem is that diagnosis is very often delayed due to the absence of adequate histopathology services and facilities that can perform the invasive biopsies typically used to diagnosis Burkitt’s lymphoma.

SerenOx’s approach was to develop a test to diagnose the cancer just from a blood test from children. Data shows the turnaround time for diagnosis is just 11 days, compared with an average of 110 days with an invasive biopsy.

“This leads to improved survival of the children because they’re diagnosed more early,” Schuh said.

When children are treated with a vaccine to prevent the Burkitt lymphoma from recurring, the liquid biopsy test also can be used to look for early immune response to the vaccine, she added. “This is really important in drug development because it saves a lot of time and effort.”

SerenOx is now expanding its liquid biopsy test from a childhood cancer diagnosis to a multi-cancer detection test, again using a simple blood sample drawn from patients. The organization is using a patented algorithm, called TriOx, to test patient samples locally under SerenOx’s quality assurance and then the data will be analyzed in the cloud.

SerenOx also has developed a suite of tests to identify mothers carrying sickle cell disease, an inherited blood disorder, including diagnosis of fetuses from 10 weeks of pregnancy onward.

Schuh noted that 400,000 infants worldwide are born with sickle cell disease and 95 percent of them die within the first five years of life.

“It is very important to establish the diagnosis at birth, or even better before birth, so that the mothers can be followed up during pregnancies and can be taught and early death can be prevented in those children,” she said.

SerenOx Africa’s initiative includes a service laboratory with a clinic based in Dar es Sallam in Tanzania, offering quality-assured molecular testing for the first time in East Africa.

The lab and clinic, which specializes in early-cancer detection and the diagnosis of blood diseases, also is fully certified as an intervention clinical trial unit, so can be used for  research and development of novel drugs.

Local innovators are uniquely positioned to understand their community’s needs

The absence of innovation and manufacturing of high-quality medical devices in the Middle East and North Africa region deprives communities of access to life-saving and life-enhancing health care technologies and therapies.

Enter InCurA, a company based in Egypt, with the vision to democratize access to health care solutions.

InCurA “is an IP factory for medical devices,” said Mousa Salem (photo at right), the company’s co-founder and chief technology officer.

InCurA identifies a medical and market need and then utilizes the latest advances in machine learning to develop a novel line of technologies and deliver them, via the company’s network of low-cost manufacturers and distributors, to patients with the greatest needs.

An example of InCurA’s technologies include a product called “Curaseal,” a 100-percent plant-based hemostatic powder that achieves rapid blood-clotting ability in seconds and is completely absorbed by the body in less than three days. The product can help control capillary, venous and arteriolar bleeding, such as during surgical procedures.

Barbosu pointed out that the 26 case studies of innovations in emerging economies revealed that local innovators are often uniquely positioned to understand their community’s health care challenges.

The pattern across the case studies is of innovators leveraging very deep and fine-grained cultural and social insights to develop solutions that are both practical and impactful, she said.

“Local innovators frequently create cost-effective technologies that are tailored to research-constrained settings,” such as portable diagnostic tools or treatments adapted to prevalent diseases in those regions.

Local innovators also navigate logistical barriers such as addressing limited infrastructure or designing solutions for rural populations with restricted access to health care, Barbosu said.

Their proximity to local communities allows them to identify “pain points” that might be overlooked by external stakeholders, and to iterate solutions that align with the community’s cultural norms and chronic realities and needs, she said.

“I think this shows that by empowering local innovators through funding, intellectual property protections and partnership, this can accelerate progress in [providing solutions for people’s health].”

One of the key lessons for global health innovation is the importance of focusing on context-specific solutions rather than a one-size-fits-all approach, Barbosu said. “I think there’s lots to learn that can be applicable to developed countries in more remote areas.”

Park said a lot of the innovators have personal stories of families or friends or even the innovators themselves who’ve often had direct personal experiences with the health care problems they’re finding solutions for.

“I think that speaks a lot to both how health care resources are distributed, that we see a lot of innovation happening because necessity is the mother of invention,” he said. “In places where people have a lot of needs that aren’t being met, they are that much more motivated to find other ways to meet those needs.”

Schuh said there are many challenges for health innovation in developing countries, from attracting funding to support innovators and kick start their innovations, to inadequate supply chains.

During the COVID pandemic, health care providers realized that even “simple” diagnostic equipment, like disposable lateral-flow diagnostic devices, which can test for biomarkers in samples such as saliva, blood, urine and food, weren’t being produced locally on the African continent.

In many countries, a regulator or government coordination or trade agreements often aren’t in place, resulting in huge delays in getting necessary medical equipment into the country.

“On the other side of the coin, the opportunities [for innovation] are equally huge because we know that Africa is the fastest-growing country in terms of population,” Schuh said.

Some African countries are relatively wealthy and have a rapidly-evolving middle class, she said. “The populations and societies are changing at a speed that you can’t even imagine.”

Africa also is experiencing a “cancer pandemic” and there are problems with cardiovascular disease, diabetes and obesity in some urban areas, Schuh said.

“There are huge challenges but at the same time also huge opportunities for developing appropriate diagnostics in those areas of non-communicable diseases.”

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