News: Announcement

GHTC Executive Director Dr. Kristie Mikus issued the following statement in response to the release by the World Health Organization (WHO) of new guidance on best practices in clinical trials. This guidance comes following a two-year development effort prompted by the 2022 adoption of a World Health Assembly resolution on strengthening clinical trial capacity. GHTC has been engaged in robust consultations with the WHO Science Division throughout the process.“Clinical trials are the backbone of medical progress, helping translate promising discoveries from a lab into proven solutions for the patients and communities who need them worldwide. We welcome the release by WHO of new clinical trial guidance, which will support countries, industry, and researchers in conducting better, more inclusive clinical trials during both ordinary times and health emergencies. We particularly applaud the guidance’s focus on strengthening trial infrastructure in low-resource settings and expanding the inclusion of groups traditionally underrepresented in clinical research, including children and pregnant and lactating women and individuals.  Every region should have the capacity to conduct high-quality research, and every person deserves to benefit from the fruits of science. Today’s release of WHO clinical trial guidance is a step forward in realizing that vision.” 

The Global Health Technologies Coalition (GHTC) welcomes commitments by G7 nations to advancing health research and development (R&D) included in the G7 Apulia Leaders’ Communiqué. GHTC was pleased to see G7 leaders explicitly recommit to ending HIV/AIDS, tuberculosis, and malaria, in particular, through support for the Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as neglected tropical diseases and polio as public health threats by 2030, and to countering the effects of climate change on infectious diseases. While it was encouraging to see this signal of political will at the highest level of government, it was disappointing that leaders fell short of offering new funding pledges or specific plans to realize these aims. We also welcome the expression of support by G7 leaders for the Pandemic Fund, which included a call for expanding the donor base and securing at least US$2 billion in new pledges and cofinancing. Given that the fund could prove a powerful new financial instrument for strengthening R&D and regulatory capacity in low- and middle-income countries, we hope that G7 leaders will follow through and provide new commitments as part of the fund’s replenishment this fall. On antimicrobial resistance (AMR), it was encouraging to see leaders vow to support public-private partnerships and implement push and pull incentives to accelerate the development of new antimicrobials and other tools to combat AMR. We also appreciate the G7 articulating support for an “ambitious” Political Declaration for the United Nations High-Level Meeting on AMR, with concrete targets and an evidence-based panel to drive action. We hope that in the coming months, new R&D targets will be included in the final text to complement the current high-level global targets outlined in the zero draft. While we applaud G7 leaders for voicing their continued support for research initiatives to confront emerging and enduring health threats, we now call on them to match their statements with follow-through and financial pledges to translate these commitments into reality. 

This year’s World Health Assembly represents a pivotal moment for global leaders to put in place policies that will bolster our preparedness against emerging threats and reinvigorate the battle against longstanding health challenges. As member states consider agenda items before this year’s assembly, the Global Health Technologies Coalition (GHTC) urges policymakers to prioritize the following actions to accelerate global health innovation:Adopt a resolution on antimicrobial resistance (AMR) with bold new commitments to spur the development of new tools and improve global surveillance capacity. This should include a pledge by member states to increase investments and incentives for research and development (R&D) of new antimicrobials and other tools—ensuring these innovations are designed to reach underserved populations and those in low-resource settings—as well as to support the creation of a new global AMR laboratory network to strengthen diagnostic capacity. In advance of the United Nations High-Level Meeting on AMR this September, it is also imperative that United Nations agencies hold an open, inclusive consultative process to define global AMR priorities.Pass the proposed resolution on maternal and child health, setting into action its call for increased R&D to address the often-neglected health needs of women and children. Member states should support the ongoing work of the World Health Organization (WHO)-led Global Accelerator for Paediatric Formulations Network, which coordinates stakeholders to address treatment gaps for children and seeks to align their national HIV/AIDS R&D investments with priority needs identified in WHO’s Paediatric Antiretroviral Drug Optimization list. To address treatment and prevention gaps for pregnant and lactating individuals, countries must also prioritize the inclusion of pregnant and lactating people in research and clinical trials.Substantially increase investments in R&D to meet the goals set forth in the WHO strategies on tuberculosis and neglected tropical diseases. To achieve the Global Strategy for Tuberculosis Research and Innovation, member states should increase domestic investments in tuberculosis R&D in line with fair share targets and supercharge research efforts to develop novel vaccines, point-of-care diagnostics, and improved therapies—ensuring tools are fit for purpose for underserved populations. To support the neglected tropical diseases roadmap, WHO and member states should position impacted countries to lead in R&D priority-setting, promote South-South collaboration models, and consider the growing impact of climate change on disease burdens. Additionally, to accelerate access to new health products, countries must also support WHO’s divisions on Science and Access to Medicines and Health Products in advancing approaches to better align WHO’s prequalification procedure and national and regional regulatory approval processes.Advance a pandemic agreement and proposed amendments to the International Health Regulations over the finish line. Too many lives have been lost and too much is at risk to let these critical processes fail. On the accord, member states must soften entrenched positions and work with earnestness to forge a consensus path forward that spurs inclusive R&D while ensuring all countries benefit from the fruits of science and innovation. Any agreement should include clear enforcement and accountability provisions and pathways to finance and strengthen research capacity in low- and middle-income countries.It is GHTC’s hope that countries will meet the moment on this historic opportunity to supercharge R&D efforts to combat future pandemics and other ongoing global health challenges.

GHTC welcomes the recent announcement by the World Health Organization (WHO) that it will apply parallel, rather than sequential, processes in developing guidelines recommending the use of novel health products and certifying their safety and efficacy via prequalification (PQ) and/or Emergency Use Listing (EUL). Many of our members and partners have highlighted how the prior procedure, which required guidelines to be in place as a prerequisite to EUL or PQ, was a major bottleneck for innovative products—adding significantly to approval timelines and delaying access to critical new health technologies in low- and middle-income countries.We believe that this new parallel process, which was first trialed during the pandemic for COVID-19 products, could significantly improve and accelerate access to vital innovative health technologies in countries that rely on WHO recommendations for the use of these products. We urge WHO to provide additional details on the implementation of this new process and encourage the PQ program to provide a platform for continued feedback and input from key stakeholders, including product developers, national regulators, procurers, and civil society.We believe that WHO’s PQ program continues to be an essential link in the regulatory ecosystem, and we hope this is just one of several steps WHO will take to reduce bottlenecks and improve the program’s efficiency and impact.