Proposal for the 2023 G7 Summit

Building a global architecture to ensure access to health technologies for
Neglected Tropical Diseases (NTDs)
October 2022
Asia Africa Medical Innovation Consortium (AMIC)
Neglected Tropical Diseases Subcommittee1

With the establishment of the GHIT Fund (Global Health Innovative Technology Fund) in Japan, thefirst funding agency of its kind in the world, the development of new technologies for NTDs is being
actively conducted in Japan. In contrast, however, there is no global system in place to bring these
new technologies to the patients in need in developing countries. Our hope is that the Japanese
government will lead the discussion on access to health technologies for NTDs at the 2023 G7 summit
to further ensure that innovation is used to improve the health of patients globally.

NTDs refers to a group of 20 diseases defined by WHO, including lymphatic filariasis, onchocerciasis,schistosomiasis, mycetoma, rabies, leprosy and other wide-ranging diseases. While many of these
diseases are believed to be able to be eliminated or controlled, 1.7 billion people worldwide are still
being affected. This is a challenge shared by all humankind for creating a vicious cycle of healthdisparities and poverty on a global scale, and is clearly stated in Target 3.3 of SDGs Goal 3; "By 2030,
end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases […]”.
In 2013, the GHIT Fund, a public-private fund, was established in Japan to support research anddevelopment, investing approximately 26.9 billion yen to date in the development of drugs for malaria,
tuberculosis, and NTDs. Thanks to these efforts, several drugs are currently under development in thefield of NTDs and are expected to be launched in the near future.
However, due to the lagging development of health care systems and basic infrastructure in the regions
where NTDs are endemic, alongside the lack of an internationally established mechanism to deliver
NTDs medicines to patients in developing countries, it is unclear whether these medicines could actually
improve the health of the endemic regions. Without further global efforts, it is difficult to foresee whether
the products that are created with the investment of Japanese funds, technology, and their expertise will
actually be implemented in the field.

1This subcommittee is a group of dedicated stakeholders who aim to contribute to the global effort to control NTDs bydeepening collaboration among industry, government, academia, and the private sector in Japan. The Japan Alliance of
Globally Neglected Tropical Diseases (JAGntd) at the Institute of Tropical Medicine, Nagasaki University serves as thesecretariat.

1Japan has a long history of having a strong presence among the international community in the field ofinfectious diseases. During the G8 Kyushu-Okinawa Summit in 2000, the establishment of the Global
Fund for AIDS, Tuberculosis, and Malaria was triggered when Japan, as the chairing country, addressed
the fight against infectious diseases as a major issue. In June 2022, the Japanese government alongwith stakeholders from around the world signed the Declaration of Global Partnership for NTDs
(commonly known as the Kigali Declaration).
We hope that the upcoming G7 Summit in 2023 will address the support for the development of accessto medicines for NTDs as one of the agenda items, and discuss how end-to-end support should beprovided. The prevalence of NTDs is an indicator of the lagging development of health systems, andissues on this topic can be positioned as a concrete example in building universal health coverage andresilient health systems, which are the pillars of the Japanese government's global health strategy.
The major problems in the field of access to medicines for NTDs are that the supply of medicines islargely unsustainable due to an over-reliance on donation by a couple of pharmaceutical companies, andthe absence of a global framework to bring medicines to patients in endemic areas. Compared toHIV/AIDS, malaria, TB, and AMR (antimicrobial resistance), the field of NTDs lacks organizations,partnerships, and mechanisms to provide a sustainable supply of health technologies and to support thecontrol activities in developing countries.
It is necessary to develop a global framework by creating new organizations that support NTDs,
expanding the scope of existing organizations, or strengthening new partnerships among existingorganizations. Furthermore, it is desirable for this framework to have the following functions:
AT THE GLOBAL LEVEL⬥SUSTAINABLE PROCUREMENT OF MEDICINE — While the basic premise is that patients shouldbe able to obtain medicines at affordable prices, it is necessary to avoid excessive reliance on
donation of medicines by pharmaceutical companies and to develop a procurement system thattakes advantage of market principles. To achieve this, a new system, such as a pooled procurement
mechanism, should be established as well as pooled funding in which governments of developed
and developing countries and international funds participate. It should guarantee the ability tonegotiate prices using bulk purchasing of medicines and “Advanced Market Commitment (i.e.
advance purchase guarantee)”, and provide pharmaceutical companies with incentives for drugdevelopment to enable sustainable procurement of high-quality NTD medicines.

⬥ACCELERATION OF REGULATORY APPROVAL AND GUIDELINE DEVELOPMENT —Coordination and support should be provided to shorten the time required to obtain Prequalification(PQ) by WHO and to be adopted into WHO guidelines. It should also serve as a liaison withregulatory agencies in developed countries and countries where NTDs are endemic.

2

AT THE REGIONAL & COUNTRY LEVEL⬥ACCELERATION OF CLINICAL TRIALS — In countries where NTDs are endemic, there are often
delays in clinical trials due to the time required to enroll patients in clinical trials. Collaboration withAfrican Medicines Agency, for example, should be sought to speed up and streamline clinical trials
in NTD-endemic countries.

⬥TRANSFER

OF DRUG MANUFACTURING TECHNOLOGIES — R&D companies withmanufacturing sites in developed countries may not be able to sustainably manufacture and supply
NTDs drugs by themselves due to financial reasons. For this reason, support should be provided forthe transfer of manufacturing technology from the organization responsible for R&D to theorganization responsible for manufacturing.
⬥STRENGTHENING OF HEALTH SYSTEMS AND NTD PROGRAMS — To ensure that medicinesreach patients, it is essential to 1) strengthen primary health care and health insurance systems fordiagnosis and treatment, 2) enhance the capacity of laboratory networks, 3) strengthen the supply
chain of medicines and health information systems including pharmacovigilance, 4) improverecognition of the medicine among patients and health care providers to create demand and raiseawareness, 5) educate patients and healthcare professionals about prevention, early diagnosis andtreatment, and 6) establish a system that enables the proactive participation of residents in thetarget areas. However, NTDs-endemic countries have significant shortcomings in medical
infrastructure, human resources, and capacity to adequately implement these measures, so
assistance should be provided to compensate for these shortcomings.

Supporting Organization

●
●
●
●
●
●
●
●
●
●
●

Agenes Inc.
Astellas Pharma Inc.
The Japanese Society of TropicalMedicine
Japanese Society of Metabolic Medicine
Keishinkai Medical Corporation
Eiken Chemical Co., Ltd.
Eisai Co., Ltd.
Department of Microbiology, Oita
University School of Medicine
Glocal Research Center for Infectious
Diseases, Oita University
Kao Corporation
Department of Infectious Diseases,
School of Medicine, Keio University

●●●
●
●
●
●
●
●
●
●

3Saraya Co., Ltd
Shionogi & Co., Ltd
Sysmex Corporation
Koichi Suzuki Laboratory, Department ofClinical Laboratory Medicine, Teikyo
University Faculty of Medical Technology
Clover Health International (NPO)
DNDi Japan (NPO)
SDGs Promise Japan (NPO)
Nagasaki University
Japanese Society for Parasitology
Japan Pharmaceutical Manufacturers
AssociationJapan Society for One Health Science