Action Point 7: Lessons from COVID-19

SARS-CoV-2 was discovered in December 2019 in Wuhan, China, and on 30 January 2020, following the recommendations of the Emergency Committee, the WHO Director General declared that the outbreak constitutes a Public Health Emergency of International Concern (PHEIC) (1).

During the pandemic, National Regulatory Authorities (NRAs) have been at the forefront of ensuring timely access to COVID-19 medical products. They have been under an unprecedented amount of attention from the public, the media, and governments. They have successfully delivered Emergency Use Authorizations for COVID-19 vaccines and relevant medicines, although it did not always sufficiently translate into timely access. However, NRAs also have had to address multiple challenges, facing fake information and falsified products, new expectations for post-marketing surveillance, practical aspects of the regulation of certain medical devices, or working with new stakeholders.

This already reflects a significant improvement compared to the situation at the time of the 2009 H1N1 pandemic. Since then, three SEARN Members have reached Maturity Level 3 for vaccines against the Global Benchmarking Tools (GBT), confirming that a stable, well-functioning and integrated regulatory system is in place for these products, and related activities have been conducted in 5 other Member States.

On 11-12 April 2022, a virtual conference was also organized to address the needs expressed by SEARN members and provide solutions to COVID-19 related issues faced by NRAs in region and longer-term recommendations to strengthen regulatory preparedness.

To further collect and analyze the experience from this pandemic, the Assembly adopted on 8 June 2022 the SEARN Work Plan 2022-2023 requesting all working groups to work on the action point 7 to ‘Develop a document compiling and reviewing the COVID-19 experience of NRAs to improve regulatory preparedness’.

General objective

To improve NRA preparedness in the region for future public health emergencies based on a review of the experience gained from COVID-19.

Specific Objectives

1. To develop an analytical framework to organize the collected information
2. To identify and review sources of information on experience from COVID-19 in the region, including collection of further information as needed
3. To identify and address remaining preparedness gaps

Through the struggles of addressing the unprecedented challenge posed by the COVID-19 pandemic, all NRAs which participated in the survey identified successes and areas for improvement.

Several countries highlighted successes which could benefit all countries and could be further shared with the Network in the upcoming months, such as (among other):

• Bangladesh: the early mobilization of stakeholders of a large scope of medical products to address the emerging threat, the mobilization of the NCL, the efforts of market surveillance and control and cold chain management, the development of an AEFI reporting app
• Bhutan: the implementation of reliance to ensure timely access to quality, safe and effective medical products, and solidarity
• Indonesia: reliance and flexibility for GMP inspections, the use of IT tools, the implementation of a PASS for COVID-19 vaccines, post market surveillance for traditional medicine and health supplement products, communication during the pandemic and the creation of a cyber patrol
• Nepal: the timely action of the Department of Health Services to ensure compliance with Good Storage and distribution Practices
• Thailand: the regulation of medical devices during the pandemic, and the implementation of a risk-based approach by the Thai FDA and the NCL
• Timor-Leste: the engagement with political and religious leaders and partners

Areas for improvement mostly fell under:

• capacity building at the individual level: training on general regulatory functions and specific issues related to the pandemic
• capacity building at the organisation level: support in developing the legal basis, guidelines and SOPs
• international collaboration: information sharing, convergence
• accelerating lot release
• strengthen the systems for medical devices, including IVDs

When requested in which fields SEARN could improve preparedness, the participants highlighted:

• Capacity building (the question of transition from Emergency Use Authorizations to full Marketing Authorizations has been raised on several occasions)
• Experience sharing between the countries
• Timely access to emerging knowledge and standards and reactive capacity building on new concepts
• Facilitating information sharing and reliance

• The Pandemic Influenza Preparedness (PIP) Framework
  The PIP Framework is a landmark international arrangement that brings together Member States, industry, other stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response. It aims to improve global pandemic influenza preparedness and response. through improving and strengthening the sharing of influenza viruses with human pandemic potential; and also by increasing the access of developing countries to vaccines and other pandemic related supplies.
• Guidelines on regulatory preparedness for provision of marketing authorization of human pandemic influenza vaccines in non-vaccine-producing countries
  These WHO Guidelines provide guidance to NRAs of non-vaccine-producing countries on the regulatory oversight of pandemic influenza vaccines for use in public health emergencies.
• The Global Benchmarking Tool
  The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems, as mandated by WHA Resolution 67.20 on Regulatory System Strengthening for medical products. As part of this tool, several regulatory functions include sub-indicators related to preparedness.
• Conference on Addressing challenges of regulating COVID-19 medical products in South-East Asia. This conference focused on the challenges faced by regulators in the South-East Asian region for COVID-19-related products, highlighting the importance of integrating vigilance systems, improved cooperation between public health laboratories and national regulatory agencies, and dedicated regulatory pathways and flexibilities to address the pandemic's whole product lifecycle.
  

  Addressing challenges of regulating COVID-19 medical products in South-East Asia - Meeting Highlights of the virtual conference - 11-12 April 2022

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• Lessons learned from COVID-19 pandemic: Virtual meeting, New Delhi, India, 19 October 2021: link. This work discussed the key learnings from the COVID-19 pandemic response, including the need for whole-of-government and whole-of-society arrangements, strengthening primary health care systems, effective engagement of the private sector, clearer and realistic guidance, digital and information technology, timely sharing of pathogen information, and exploring and establishing regional stockpiling and supply chain systems.
• Promising practices and lessons learnt in the South-East Asia Region in accessing medical oxygen during the COVID-19 pandemic: link. This work focused on the best practices in managing medical oxygen during the COVID-19 pandemic, which include developing and institutionalizing an oxygen management plan and establishing an integrated digital ecosystem for a comprehensive oxygen response.
• India’s CCRAS (Ministry of Ayush) Dossier on mitigation of COVID-19 through traditional medicines: Research and Development Initiatives of Ministry of Ayush for COVID-19: link This work summarized the Initiatives undertaken by the Ministry of Ayush during the pandemic, including providing guidelines, training, deployment of staff, R&D initiatives, and a national repository.

• Address the gaps identified in this work through the action points already proposed in the 2023-2024 workplan including dedicated sessions in the relevant working group to share good practices with other countries