Strengthening regulatory systems globally: a crucial step towards pandemic preparedness and response

Mukherjee, Sanjana; Goodman, Leah

doi:10.1136/bmjgh-2023-012883

Cited by 3 publications

(3 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Section: Our Proposalmentioning

confidence: 99%

“…WHO assists countries in strengthening their NRAs as only 26% of member states have functioning NRAs. 74 Afrigen is working to ensure regulatory compliance, working closely with the NRA in South Africa. 57 Identify credible, trusted sources of health information, promote health literacy and create a national scientific advisory committee to disseminate accurate and reliable information during a pandemic.…”

Section: Bmj Global Healthmentioning

confidence: 99%

See 1 more Smart Citation

Lessons learnt from COVID-19 to reduce mortality and morbidity in the Global South: addressing global vaccine equity for future pandemics

Martin,

Maleche,

Gay

et al. 2024

BMJ Glob Health

View full text Add to dashboard Cite

COVID-19, which killed more than 6 million people, will not be the last pandemic. Vaccines are key to preventing and ending pandemics. Therefore, it is critical to move now, before the next pandemic, towards global vaccine equity with shared goals, intermediate steps and long-term advocacy goals. Scientific integrity, ethical development, transparency, accountability and communication are critical. Countries can draw on lessons learnt from their response to the HIV pandemics, which has been at the vanguard of ensuring equitable access to rights-based services, to create shared goals and engage communities to increase access to and delivery of safe, quality vaccines. Access can be increased by: fostering the spread of mRNA intellectual property (IP) rights, with mRNA vaccine manufacturing on more continents; creating price transparency for vaccines; creating easily understandable, accessible and transparent data on vaccines; creating demand for a new international legal framework that allows IP rights to be waived quickly once a global pandemic is identified; and drawing on scientific expertise from around the world. Delivery can be improved by: creating strong public health systems that can deliver vaccines through the lifespan; creating or strengthening national regulatory agencies and independent national scientific advisory committees for vaccines; disseminating information from reliable, transparent national and subnational surveillance systems; improving global understanding that as more scientific data become available, this may result in changes to public health guidance; prioritising access to vaccines based on scientific criteria during an epidemic; and developing strategies to vaccinate those at highest risk with available vaccines.

show abstract

Section: Our Proposalmentioning

confidence: 99%

Section: Bmj Global Healthmentioning

confidence: 99%

Lessons learnt from COVID-19 to reduce mortality and morbidity in the Global South: addressing global vaccine equity for future pandemics

Martin,

Maleche,

Gay

et al. 2024

BMJ Glob Health

View full text Add to dashboard Cite

show abstract

“…Regional pooled procurement initiatives, such as those mentioned in the previous section, and surveillance networks, including the ASEAN Public Health Emergency Coordination System (APHECS) and the Eastern Mediterranean Public Health Network (EMPHNET), can strengthen demand forecasting and supply management systems [ 98 – 100 ]. Alongside these efforts, the philanthropic sector is also making important investments in ‘bottom-up’ mechanisms for characterising and strengthening demand for ID mAbs [ 26 ].…”

Section: Key Challenges and Enablers For Advancing Access To Mabs For...mentioning

confidence: 99%

Novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries

Malhotra,

Cameron,

Gotham

et al. 2024

PLOS Glob Public Health

View full text Add to dashboard Cite

Monoclonal antibodies (mAbs) are revolutionizing management of non-communicable diseases in high-income countries and are increasingly being advanced for a range of infectious diseases (IDs). However, access to existing mAbs is limited in low- and middle-income countries (LMICs), and investment in developing fit-for-purpose mAbs for IDs that disproportionately affect LMICs has been limited. Underlying these access barriers are systemic challenges, including a lack of commercial incentives to target LMIC markets and complexity in manufacturing and regulatory processes. Novel strategies are needed to overcome systemic access barriers for mAbs. We outline key areas where new approaches could address these barriers, based on a multistakeholder consultation in March 2023. Three disease-market archetypes are identified to guide thinking about business models tailored to different contexts. New business models are needed to incentivize development and manufacturing of ID mAbs and to ensure mAbs are optimized with a target product profile and cost of goods that enable use in diverse LMIC settings. Lessons can be applied from voluntary licensing strategies and product development partnerships that have shown success in catalysing development and affordable supply for a range of infectious diseases. Technology transfer will be key to expand LMIC research and manufacturing capacity and to enable sustainable and diversified supply. Improved market intelligence, demand aggregation mechanisms, and portfolio-based manufacturing models could be used to de-risk commercial investment and establish a sustainable manufacturing ecosystem for affordable mAbs. Novel regulatory approaches and robust technology transfer may reduce data requirements and timelines for biosimilar approvals. Trailblazer products, with coordinated “end-to-end” support from funders, can demonstrate proof of concept for pathways to accessible mAbs across a broader range of LMICs. Research funders; local, regional, global health agencies; and, private sector partners should commit to implementing innovative partnerships and end-to-end strategies that enable equitable access to mAbs for infectious diseases in LMICs.

show abstract

Emergências em Saúde Pública: o papel das agências reguladoras para a resiliência do sistema de saúde. O caso do Brasil

Pepe,

Albuquerque,

Oliveira

2024

Revista Panamericana De Salud Pública

View full text Add to dashboard Cite

RESUMO O desempenho dos sistemas de saúde está relacionado à garantia do direito à saúde, um importante componente dos direitos humanos, que inclui o direito à proteção da saúde. A ação regulatória do Estado visa diminuir riscos à saúde, contribuindo para melhorar o desempenho dos sistemas de saúde, especialmente no que tange aos princípios da integralidade e da equidade. Este artigo tem por objetivo discutir a resiliência na perspectiva das agências reguladoras nacionais, especialmente frente às Emergências de Saúde Pública (ESP) e sua contribuição para a resiliência dos sistemas de saúde, tomando como modelo a atuação da agência reguladora brasileira, a Agência Nacional de Vigilância Sanitária (Anvisa). A regulação sanitária, no contexto das ESP, vem aperfeiçoando suas práticas regulatórias e atuando em diversas frentes. As agências reguladoras se utilizaram de instrumentos regulatórios específicos para agilizar o acesso a produtos eficazes e seguros para o enfrentamento de pandemias, para a assistência de qualidade e para a comunicação com a sociedade, e, no caso da Anvisa, também atuou sobre novos objetos, como o acompanhamento do desenvolvimento de respiradores pulmonares. É crucial reconhecer a interdependência entre o aprimoramento da capacidade de resposta e o desempenho para enfrentar as ESP. São exemplos a rápida aprovação de vacinas contra a Covid-19, permitindo acelerar a vacinação, bem como a colaboração das agências reguladoras e, no caso brasileiro, a atuação da Anvisa para reforçar o papel do Sistema Único de Saúde (SUS) e do direito à saúde face à desinformação e ao negacionismo.

show abstract

Strengthening regulatory systems globally: a crucial step towards pandemic preparedness and response

Cited by 3 publications

References 6 publications

Lessons learnt from COVID-19 to reduce mortality and morbidity in the Global South: addressing global vaccine equity for future pandemics

Lessons learnt from COVID-19 to reduce mortality and morbidity in the Global South: addressing global vaccine equity for future pandemics

Novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries

Emergências em Saúde Pública: o papel das agências reguladoras para a resiliência do sistema de saúde. O caso do Brasil

Contact Info

Product

Resources

About