WHO Sri Lanka
Group photo: Assisted self-assessment of the risk of corruption by the National Medicines Regulatory Authority of Sri Lanka.
© Credits

Landmark initiative to strengthen integrity in medicine regulation: Sri Lanka takes the lead with support from WHO and UNODC

1 April 2025
Highlights

In a landmark initiative, Sri Lanka's National Medicines Regulatory Authority (NMRA) recently hosted the world’s first-ever ‘Corruption risk identification and prioritization workshop’ for a National Medicines Regulatory Authority. Held from 24-26 February 2025 in Colombo, the workshop marked a significant step towards ensuring transparency, accountability, and integrity within the pharmaceutical regulatory sector.

The initiative contributes to the government’s Clean Sri Lanka project which includes a nationwide commitment to strengthening ethical values. It also supports NMRA’s commitment, supported by WHO, of strengthening regulatory frameworks and promoting equitable access to quality, safe, and affordable medical products.

“Sri Lanka has recently made excellent progress towards strengthening its regulatory system, including medical devices, with the full engagement of the Government of Sri Lanka. This is evident in the excellent decision of NMRA to organize the first assisted self-assessment of the risk of corruption, “said Saima Wazed, Regional Director, WHO South-East Asia. She added, “There is no doubt that this will serve as inspiration not just in our South-East Asia region, but beyond as well.  I am pleased that UNODC and WHO are partners in this.”

Supported by close collaboration between the World Health Organization (WHO) and the United Nations Office on Drugs and Crime (UNODC), the workshop brought together participants from the NMRA, observers from other administrations, and international experts. The focus was on identifying potential corruption risks within the regulatory processes in Sri Lanka. The next and final workshop, scheduled in the upcoming months, will focus on developing robust strategies to mitigate these risks, ensuring a more transparent and effective regulatory system.

COVID-19 vaccination of frontline workers at the National Institute of Infectious Disease, Angoda, Sri Lanka (©WHO SEARO)

COVID-19 vaccination of frontline workers at the National Institute of Infectious Disease, Angoda, Sri Lanka (©WHO SEARO)

Government spending on drugs, pharmaceuticals, and medicines constitutes one of the largest shares of national budgets, yet nearly 2 billion people globally lack access to essential medicines. Corruption is a major barrier to safe and affordable medicines and healthcare. Weak governance and lack of transparency create higher corruption risks in the regulation, selection, promotion, and distribution and sales of essential medicines.

Since its establishment in 2015 as an independent authority under Sri Lanka’s Ministry of Health, the NMRA plays a critical role in safeguarding public health by ensuring medicinal products meet safety, quality, and efficacy standards. Recognizing the need to address corruption risks, the NMRA in 2024 requested WHO and UNODC support for an assisted self-assessment, the first of its kind worldwide for a national medicines regulatory authority.



Opening of the workshop by Dr Hansaka Wijemuni, Deputy Minister of Health and Mass Media, Dr Ananda Wijewickrama, Chairman NMRA, Dr Alaka Singh, WHO Representative to Sri Lanka, and Ms Siri Bjune, Head Global Maritime Crime Programme

Opening of the workshop by Dr Hansaka Wijemuni, Deputy Minister of Health and Mass Media, Dr Ananda Wijewickrama, Chairman NMRA, Dr Alaka Singh, WHO Representative to Sri Lanka, and Ms Siri Bjune, Head Global Maritime Crime Programme, Border Management Branch, Division for Operations, UNODC. 

The three-day workshop aimed to analyze the legal and operational context of the NMRA, apply corruption risk management principles, and prioritize risks based on their potential impact and likelihood of occurrence. Participants engaged in interactive sessions led by WHO and UNODC experts, focusing on evaluating vulnerabilities within the regulatory framework and identifying effective strategies to prevent corrupt practices.

The outcomes of this initial workshop will feed into a second workshop scheduled for April 2025. This follow-up session will focus on analyzing the underlying causes of identified risks, developing detailed mitigation strategies, and agreeing on a path forward for implementing these strategies within the regulatory strengthening program.

WHO’s support extends beyond this assessment, with close and long-standing guidance to the NMRA through its broader Regulatory Systems Strengthening Programme. This partnership aims to build a robust regulatory environment that not only prevents corruption but also enhances the overall efficiency and effectiveness of the healthcare system to ensure Sri Lankan can access quality, safe and effective medical products.

As the first national medicines regulatory authority to undertake such a workshop, the NMRA is setting a pioneering example that could serve as a model for other countries. This initiative aligns with Sustainable Development Goal (SDG) 3, which aims to “Ensure healthy lives and promote well-being for all,” including achieving Universal Health Coverage (UHC). It also supports SDG 16, which seeks to “Promote peaceful and inclusive societies for sustainable development, provide access to justice for all, and build effective, accountable, and inclusive institutions at all levels.” By focusing on strengthening anti-corruption measures and fostering transparency and accountability, the NMRA is contributing to stronger governance and healthier, more resilient communities.