DNDi's briefing document for the 74^th World Health Assembly.

DNDi's interventions:

Agenda item 13.4: Global Strategy and Plan of Action on public health, innovation, and intellectual property

The Global Strategy and Plan of Action is a roadmap of critical actions to secure innovation and access.  It is still not fully implemented. The main challenges identified have become more pronounced during COVID-19. 

 DNDi urges Member States to accelerate action. In particular:   

• Provide funding for the WHO for the Expert Panel’s priority actions 
• Promote and develop sustainable financing mechanisms to support R&D, which should separate the price of final products from R&D costs
• Ensure TRIPS flexibilities are implemented in national legislation, with technical support from the WHO where needed. Support the WHO and partners work on patent databases and pooling and enact other policies for the pro-access management of intellectual property to ensure timely and equitable access
• Support WHO, as well as regional and national regulatory agencies, to strengthen regulatory systems, including collaborative regulatory & clinical trial registration processes, to ensure timely registration of safe and effective health technologies
• Implement recommendation 4 from the Expert Review Panel on transparency of the cost of R&D, which plays a critical role in incentivizing and projecting costs for further investment, ensuring fair pricing, and ensuring a public return on public investments in R&D. COVID-19 exemplifies the need for transparency throughout the pharmaceutical development chain to inform public investments and strategies. This need was widely cited at the recent Fair Pricing forum.
• Support the resolution on strengthening local production of medicines and other health technologies to improve access to safe, effective and affordable health technologies. This should be a means to accelerate and focus the GSPoA recommendations on concrete deliverables on technology transfer, regulatory capacity and sustainable financing. Manufacturing needs should be mutualized across disease areas where feasible, pool demand and explore common delivery and access mechanisms.

Agenda item 17: WHO’s work in health emergencies and strengthening preparedness for health emergencies

The global response to COVID-19 is enabling major scientific advances and the development of new health technologies at unprecedented speed but is also exposing structural inequities that hinder innovation of and equitable access to life-saving health tools. The Independent Panel for Pandemic Preparedness and Response highlighted the need to transform the international COVID-19 architecture into a "truly global end-to-end platform for vaccines, diagnostics, therapeutics, and essential supplies, shifting from a model where innovation is left to the market to a model aimed at delivering global public goods."

In the short-term, urgent steps must be taken to ‘course-correct’ for COVID-19.

DNDi urges Members States to:

• Share supply of vaccines and ensure equitable allocation to countries in need, with a focus on the populations at highest risk
• Support the TRIPS waiver for all COVID-19 technologies
• Support C- TAP or other IP pooling and technology transfer mechanisms and use leverage to ensure companies come to the table to share know-how and technology
• Make investments in manufacturing capacity hubs in LMICs for vaccines and therapeutics
• Ensure investments in treatments, diagnostics, and health systems  

In the longer term, for future pandemic preparedness mechanisms, enabling policies must be put in place to ensure the benefits of scientific progress will be equitably shared and considered global public goods, available to all.   

DNDi urges Member States to: 

• Ensure researchers, experts, civil society, and political leaders from LMICs are equal partners in all governance mechanisms
• Commit to and condition funding on transparency and open sharing of research knowledge, data, and costs
• Guarantee that health tools are free of IP restrictions and develop more permanent mechanisms and rules for persistent IP obstacles, technology transfer, equitable allocation, and affordable pricing
• Mobilise massive resources for investments in ‘pathogen-agnostic’ R&D and cross-cutting strategies that can benefit R&D efforts across disease areas

Agenda item 16: Committing to implementation of the Global Strategy for Women’s, Children’s and Adolescents’ Health 2016-2030

DNDi and Medicines for Malaria Venture (MMV) welcome progress in the implementation of the Global Strategy for Women’s, Children’s, and Adolescents’ Health. However, the need for research and development of health tools to address the needs of children and women, who are disproportionately affected by infectious disease but whose specific medical needs are often neglected, has not been sufficiently highlighted. 

Children are among the most neglected in drug development and paediatric formulations of drugs are often not developed. The needs of children with HIV illustrate this neglect where the development of optimal paediatric formulations still lags 20 years behind that of adults and whilst significant progress has been made in antimalarial development, more options are needed. Supporting research including paediatric trials and accelerating processes for developing, registering, and making available paediatric drug formulations is imperative.   

We welcome the establishment of the Global Accelerator for Paediatric Formulations Network (GAP-f), of which DNDi and MMV are members, as an important step to promote innovation of and access to quality, safe, efficacious, and affordable medicines for children.  

There is a knowledge gap in understanding the impact of medicines in females, especially for pregnant and lactating women, and women of childbearing age, who are often excluded from clinical trials due to concerns about effects on the foetus, resulting in delays in the availability of medicines. DNDi developed a proposal for a safe, ethical framework for the recruitment of women susceptible to and becoming pregnant in clinical trials and MMV have the Malaria in Mothers and Babies (MiMBa) strategy to guide their work. These and other proposals to ensure responsible strategies in gender-responsive drug development should be integrated into the strategy. 

DNDi and MMV urge Member States to ensure that innovation of −and access to− medicines for children and women is integrated into the strategy, including a requirement to report on progress. 

Agenda item 26.3: WHO reform (World NTD Day) and Agenda item 26.4: The global health sector strategies on, respectively HIV, viral hepatitis, and sexually transmitted infections, for the period 2016-2021 

DNDi welcomes the progress noted in each of the existing strategies for HIV, viral hepatitis, and sexually transmitted infections. However, significant challenges in reaching the SDG 2030 elimination goals for these diseases must be addressed as part of the new strategies.

For Hepatitis C: Most countries are still not close to meeting the existing treatment and diagnostic targets.  Not enough patients are diagnosed and, contrary to what is often claimed, access to affordable curative treatments is not a reality, particularly in high burden countries. Actions to remove barriers to scaling up diagnosis and treatments, including using TRIPS flexibilities to allow generic competition, are urgently needed.

For HIV: Only 53% of the 1.8 million children living with HIV globally were diagnosed and on treatment, and much more must be done to rapidly scale up access to optimized paediatric antiretroviral formulations as soon as they are approved; generate the evidence necessary for HIV-exposed infant prophylaxis; and explore new delivery systems for adolescents who face unique adherence challenges. A more ambitious research agenda for advanced HIV is also critically important to reduce HIV-related mortality including in relation to cryptococcal meningitis.

For STIs: The growing threat of drug resistant infections is highlighted in the report on STIs; for example decreased susceptibility or resistance to last line treatments for gonorrhea. Greater surveillance, development of new tests and treatments, and robust strategies for appropriate use and stewardship will be needed.

We urge Member States to actively engage in the development and implementation of new HCV, HIV, and STI strategies.   

DNDi also supports the resolution on World NTD day, but more is needed to reach elimination targets. In all four disease areas progress can only happen with sustained political will, appropriate health tools  to close diagnostic and treatment gaps and sustainable financing.

Agenda Item 13.5: Antimicrobial resistance

Statement on behalf of the Drugs for Neglected Diseases initiative, supported by the Global Antibiotic Research and Development Partnership (GARDP) 

We thank WHO for the comprehensive report and its support, together with funders and partners, to GARDP to develop new treatments to address drug resistance. 

The consequences of COVID-19 should encourage investment and international cooperation to prepare for and address the on-going impacts of antimicrobial resistance. The growth of drug-resistant infections is a silent pandemic. If left unchecked, humanity will be unable to treat common infections like pneumonia, infections in newborns or secondary bacterial infections in viral pandemics. Like COVID-19, drug-resistant bacteria can infect anyone, of any age, in any country. Unlike COVID-19, we can prepare now. The drug-resistant microbes are known, and meaningful change can be achieved with sufficient political will and resources.  

Currently, the response is off course. 

WHO’s latest review of antibacterial agents in development confirms that the 43 antibiotics currently in clinical development are insufficient to address drug resistance. 

Many countries lack adequate access to existing antibacterial treatments.  

Member States can take the following measures to strengthen national and global responses to drug resistance: 

• Invest in the development of medical countermeasures for priority infections as a critical element of preparedness.   
• Ensure that access to diagnostics, treatments, and vaccines for all is a cornerstone of preparedness and response. New and existing mechanisms should be developed and funded to accelerate and secure equitable and affordable access to treatments. 
• Expand global cooperation across geographies and sectors, within a One Health framework. No country, organization, or sector can tackle AMR alone. 
• Ensure low- and middle-income countries are equal partners in a comprehensive global response. 

Our collective success in fighting this pandemic will depend on governments developing a more robust, coordinated, and equitable approach.