Why Global Health R&D

Japan’s R&D for Global Health

Photo by Pan American Health Organization PAHO

Toward elimination and
eradication of infectious diseases

Since the launch of the Millennium Development Goals in 2000 and the subsequent Sustainable Development Goals in 2015, the international community has made significant progress in partnering against devastating infectious diseases, including AIDS, malaria, tuberculosis (the "big three") and the less-well-known but still important neglected tropical diseases (NTDs). Millions of lives have been saved by initiatives that expand access to treatment and improve public health in low- and middle-income countries.

However, even as we celebrate progress, we must stay committed to the goal of eliminating and, when possible, eradicating these diseases. To do so will require continued investment in global health R&D, and the development of new drugs, vaccines, and diagnostics.

Decline in Big Three Burden1

AIDS2
100Million
Deaths in 2016
Malaria3
44.5Million
Deaths in 2016
Tuberculosis4
140Million
Deaths in 2016
NTDs5,6
15Billion
Infected

Meeting the needs of
individuals affected by
infectious diseases

Effective and low-cost treatments for HIV, malaria, and tuberculosis exist, but are not yet accessible and available to everyone who needs them. Meanwhile, there are still no effective tools to prevent and treat some NTDs that are endemic to low- and middle-income countries. The drugs that do exist are old — developed several decades ago — and many have unacceptable side effects or are only partially efficacious7. For affected individuals, the lack of effective treatment can mean severe and lifelong disability, often associated with social stigma and a loss of economic potential.

In recent years, antimicrobial resistance (AMR) has become a global health threat as well, rendering some of the existing, low-cost tools we have relied on for centuries useless. The 2015 World Health Assembly endorsed a global action plan to tackle AMR, and at the G7 and G20 Summits that followed, AMR was at the top of the agenda for global health. A recent high-profile report estimates that by 2050, 10 million people will die every year as a result of AMR, unless the global community mounts an effective response8.

Supporting economic growth in
low- and middle-income countries

The "big three" infectious diseases and NTDs have an immense negative impact on economic potential in low- and middle-income countries. Some NTDs affect physical and cognitive development during critical growth periods, robbing children of educational opportunities and, in the long term, work. As a result, disease and poverty become a vicious cycle. NTDs cost developing economies billions of dollars every year9. To break the cycle, and support developing countries in protecting the health and potential prosperity of their citizens, new products are needed that address infectious disease more effectively, carry fewer side effects, and are affordable and accessible where needed most.

Malaria
eradication

10 million
lives saved

$4 trillion economic
benefit

The Roll Back Malaria Partnership estimates malaria eradication could produce $4 trillion in economic benefits and save an additional 10 million lives over the period 2016–203010

Global health security

Global migration, urbanization, climate change, environmental destruction, civil war, terrorism, and political unrest — all of these have contributed to an expansion of infectious diseases beyond the borders of "poor countries." In the 21st century, infectious diseases are becoming a threat to the lives of people around the world, in developed as well as developing countries’ economies. Japan, an economically stable country, has a responsibility to proactively contribute.

The major forces affecting the emergence of infectious diseases11

Urbanization and
Human Migrations

Climate Change

Deforestation

Conflict, and Political
Destabilization

Toward Universal Health
Coverage

Universal Health Coverage — the infrastructure that supports affordable health care for people around the world through health insurance, human resources, and reliable supply chains (among much else) — was identified by the World Health Organization as a political priority in the Sustainable Development Goals adopted by the United Nations General Assembly in 2015. To achieve this goal requires affordable new drugs, even in low- and middle-income countries where billions of people still lack access to necessary health care.

On September 25th 2015, countries adopted a set of goals to end poverty, protect the planet and ensure prosperity for all as part of a new sustainable development agenda. Each goal has specific targets to be achieved over the next 15 years12.

Drug development is a high-risk business

That's because new drug development isn't easy. It can take ten years or longer and an investment of hundreds of millions of dollars to develop a single medicine. The cost rises every year14, and the probability of success for a new drug that is safe and effective and passes regulatory barriers is very low.

Indeed, the business risks of drug development are high, and for drugs effective against infectious diseases in low- and middle-income countries the market price — and thus, the return on investment — is low. That creates a high barrier to investment for private companies, which are accountable to shareholders and other stakeholders. As a result, investment in new drugs for infectious diseases accounts for only about 1% of all new drug development15.

Of the 336 brand-new drugs (new chemical entities, or NCEs) approved for all diseases in 2000-2011, only four, or 1%, were for neglected diseases

The lengthy pharmaceutical R&D process and its probability of success

The length and probability of success depend on intervention and research design.

Source: Japan Pharmaceutical Manufacturing Associations. Text Book 2016-2017

To break the established pattern and ensure that potentially lifesaving medicines advance, governments, companies, universities, research institutes, nongovernmental and nonprofit organizations, and international organizations must cooperate across sectors and borders. A public-private partnership fund for product development provides incentives and mitigates risk for corporations, universities, and research institutes, so that they can all proactively engage in global health R&D.

Cross-border collaboration is equally important. Developing drugs for diseases endemic to low- and middle-income countries means partnering with local agencies in endemic countries on clinical trials. It also means partnership and cooperation between Japanese and international institutions and organizations that are familiar regulatory issues, quality control, manufacturing, and distribution in the countries where new tools will be manufactured and used.

Bridging Japan and the global community to accelerate global health R&D
GHIT Fund

The Global Health Innovative Technology Fund (GHIT) was established to solve the challenges associated with drug development for infectious diseases and achieving Universal Health Coverage under the Sustainable Development Goals. GHIT secures funds for product development through international public–private partnerships and invests in open innovation, drawing on Japan's scientific and pharmaceutical capabilities combined with overseas resources and networks to create lifesaving tools.

GHIT links Japanese and overseas institutions involved in global health R&D, including governments, private companies, foundations, nongovernmental organizations and nonprofit organizations, and United Nations agencies, and encourages dialogue on product development, access, and delivery.

Between 2013, when the GHIT Fund was founded, and June 2018, 42 Japanese institutions and 61 overseas institutions were engaged in product development through GHIT's investment platforms. GHIT’s R&D portfolio continues to expand, and we aim to acquire regulatory approval of two products by March 2023.

Access to these basic tools for health is critical to the economic growth and stability of low- and middle-income countries, where the burden of infectious disease has been and remains highest.

日本の科学・創薬技術をグローバルヘルスに

Japan’s R&D for Global Health

Reference

  1. The Global Fund. Results Report 2017. https://www.theglobalfund.org/media/6773/corporate_2017resultsreport_report_en.pdf
  2. World Health Organization Fact Sheet in Japanese. http://www.japan-who.or.jp/act/factsheet/360.pdf
  3. World Health Organization Fact Sheet in Japanese. http://www.japan-who.or.jp/act/factsheet/094.pdf
  4. World Health Organization Fact Sheet in Japanese. http://www.japan-who.or.jp/act/factsheet/104.pdf
  5. Uniting to Combat Neglected Tropical Diseases. Reaching a Billion. Ending Neglected Tropical Diseases: A gateway to Universal Health Coverage Fifth progress report on the London Declaration on NTDs. http://unitingtocombatntds.org/wp content/themes/tetloose/app/staticPages/fifthReport/files/fifth_progress_report.pdf
  6. World Health Organization Fact Sheet in Japanese. http://www.japan-who.or.jp/event/2017/AUTO_UPDATE/1704-5.html
  7. Hotez PJ et al. (2016) Eliminating the Neglected Tropical Diseases: Translational Science and New Technologies. PLoS Negl Trop Dis 10(3): e0003895. doi:10.1371/journal.pntd.0003895
  8. Michele Cecchini et al. ANTIMICROBIAL RESISTANCE IN G7 COUNTRIES AND BEYOND: Economic Issues, Policies and Options for Action. https://www.oecd.org/els/health-systems/Antimicrobial-Resistance-in-G7-Countries-and-Beyond.pdf
  9. World Health Organization: http://www.who.int/neglected_diseases/diseases/en/
  10. The Global Fund: Results Report 2017 https://www.theglobalfund.org/media/6773/corporate_2017resultsreport_report_en.pdf
  11. Hotez PJ (2016) Neglected Tropical Diseases in the Anthropocene: The Cases of Zika, Ebola, and Other Infections. PLoS Negl Trop Dis 10 (4): e0004648.
  12. United Nations Information Centre. http://www.unic.or.jp/activities/economic_social_development/sustainable_development/2030agenda/sdgs_logo/
  13. The Japan Times. https://www.japantimes.co.jp/opinion/2017/12/08/commentary/japan-commentary/aiming-truly-universal-health-coverage/#.WtbL5tPFIUE
  14. DiMasi JA et al. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Economics. 2016;47:20‐33.
  15. Pedrique B et al. The drug and vaccine landscape for neglected diseases (2000-11): a systematic assessment. Lancet Global Health, Early Online Publication, 24 Oct 2013.http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(13)70078-0/fulltext