Roll out of new antimalarial medicines needs a holistic approach

Reaching the 2030 goal of a malaria-free Asia Pacific requires health systems that enable national regulatory authorities (NRAs) to ensure the availability of safe, effective and quality medicines, and diagnostics. This is the underlying principle of the Asia-Pacific Regional Regulatory Partnership (RRP), which met for the fourth time last week. The latest gathering of RRP partners was hosted in Phnom Penh by the Government of the Kingdom of Cambodia’s Ministry of Health.

The World Health Organization (WHO) and the Asia Pacific Leaders Malaria Alliance (APLMA) co-convened the two-day RRP meeting, which brought together Asia Pacific country representatives from NRAs and national malaria programmes, as well as other international and regional partners.

The meeting was an opportunity to report on progress with implementing agreed RRP workplans and to confirm action plans and priorities for capacity building in this area. It also included an update on the timeline for rolling out priority antimalarials and diagnostics as well as an Asia Pacific announcement of the ‘Medicines We Can Trust’ campaign, which highlights the risks of substandard and falsified medicines for malaria elimination.

The RRP is a dynamic and flexible platform that provides strategic direction, planning and overall coordination to regulatory development with antimalarial medicines and diagnostic tests as an entry point for discussion. The partnership harnesses the expertise of stakeholders in the regulation of medical products, and leverages technical assistance initiatives to expedite introduction of existing and new priority malaria treatments and diagnostic tests to the Asia Pacific market.

Participants in the latest RRP meeting acknowledged that effective roll out of new candidate priority antimalarial medicines – such as tafenoquine for the treatment of Plasmodium vivax malaria – requires a ‘whole of system’ approach, ranging from coherent policy environments, and robust registration processes, through to systems for monitoring the safety and quality of new health products. Yet many countries lack the systems and capacities they need to achieve such access.

For example, despite the five years since stringent regulatory authorities approved the first novel TB medicine in over 40 years, the use of bedaquiline remains very limited today. Costs and concerns over adverse events may have contributed to hesitation in the adoption of bedaquiline. It is clear that in addition to national registration, implementation challenges such as affordable procurement and effective market control and pharmacovigilance programmes should be comprehensively addressed as part of a holistic access and delivery strategy.1

To avoid the same fate, the complete value chain for tafenoquine and related G6PD point-of-care diagnostic tests must link together essential R&D efforts, effective regulatory, delivery and pharmacovigilance systems, as well as efforts to ensure equitable access to new health technologies among the most vulnerable populations and remote communities.

In response to such challenges, the Australian Government's Health Security Initiative for the Indo-Pacific region and Australia’s Therapeutic Goods Administration (TGA) are designing a programme to improve NRA registration systems in priority RRP countries. The Bill and Melinda Gates Foundation (BMGF) is also supporting activities to improve vigilance systems as part of the Smart Safety Surveillance (3S) global initiative. Participants in last week’s RRP meeting also identified immediate priority regulatory strengthening activities that will form the basis of a 12-month action plan, including training users of minilabs for sample testing in Lao PDR and Cambodia as a priority.

The WHO also provided an update on the WHO Coalition of Interested Partners (CIP) Network that is targeted for launch in September 2018 and that will incorporate the RRP. The CIP aims to “improve coordination, efficiency and consistency of regulatory activities and standards” among all stakeholders and across disease areas, as explained by Mr Mike Ward, Coordinator of the Regulatory Systems Strengthening Team at WHO Headquarters in Geneva.

The RRP continues to enable regulators, national malaria control programmes and partner organizations to review progress, discuss current challenges, and set priority actions towards strengthening regulatory capacity for essential health products and in support of regional health security.

During its latest meeting, Her Excellency Dr Or Vandine, Director General for Health in Cambodia highlighted the importance of partnerships and of cross-border collaboration, especially in tackling the challenge substandard and falsified medicines. We are also grateful for the active participation of Dr Heng Bunkiet, Director of the Department of Drugs and Food, MoH Cambodia, and Dysoley Lek, Deputy Director of the Cambodia National Malaria Center.

RRP partners attending the meeting included the WHO Western Pacific Regional Office (WPRO) and Cambodia country office, the BMGF, the Australian Department of Foreign Affairs and TGA, the Duke-NUS Centre of Regulatory Excellence (CoRE), United States Pharmacopeia, and the Asian Development Bank. Other participants included the Global Fund, the Medicines for Malaria Venture (MMV), PATH and the Foundation for Innovative New Diagnostics (FIND).

Between meetings, the RRP partners are actively engaged with member countries to address priority regulatory system needs through targeted technical support.

The delegation from the Lao PDR Government generously expressed interest in hosting the next RRP meeting, to be held in 2019.

1 Tiziana Masini et al. 2018. Will regulatory issues continue to be a major barrier to access to bedaquiline and delamanid? European Respiratory Journal.