Regional Financing for Malaria Task Force (RFMTF) Update

Manila, Philippines 09th June 2014 Regional Financing for Malaria Task Force (RFMTF) Update

Background 7th East Asia Summit – commitment on Regional Responses to Malaria Control and Addressing Resistance to Antimalarial Medicines 8thEast Asia Summit - welcomed the establishment of the Asia-Pacific Leaders Malaria Alliance (APLMA) Noted that the work of the two APLMA taskforces on access to quality medicines and other technologies and regional finance would begin

Terms of Reference • Review and update estimates of funding needs and gaps • Review impacts of proposed changes in the global financing environment • Assess the case for expanding existing or developing new financing mechanisms ; and • Develop options and recommendations to mobilise and channel sustained financing for malaria in the Asia-Pacific region

Progress • First meeting of Regional Financing for Malaria Task Force convened in Hong Kong 12th May 2014 • Membership: • Chair: C. Lawrence Senior Managing Director of Government Relations, MetLife Japan • Members: Senior positions from within Government, Ministries of Health, Academia, Private and civil society sectors, Development Partners, WHO, donor community

Summary of Task Force Meeting • Impressive progress but Asia Pacific remains a hot spot for malaria • Economic and financing challenges common to all countries, but also some important differences • An existing financing gap in controlling malaria, which is increasing due to reductions in available external funds • Also financing gap • Regional and collective actions • Private sector • Collective action in regional approach • In regions economic self-interest to invest • Challenges are more political and financial than technical

Next Steps • Finalize outcome statement for consideration at 9th East Asia Summit • Develop roadmap and workplan for Task Force • Commission research and studies to identify current and future projected and prioritized financial gaps at both regional and national level for both drug resistance and control / elimination • Scope out potential financing mechanism for strategic regional activities • Identify governance options for regional financing mechanism • Develop Business Cases for increased investment in malaria by governments, donors and private sector • Identify and evaluate potential innovative financing mechanisms • Future composition of Task Force may change

Asia-Pacific Context and Challenges • Resistance to oral artemisinin-based combination therapies • High-prevalence of substandard and counterfeit antimalarial drugs (SSFFCs) • Weak health care service delivery for hard-to-reach and mobile populations • Lack of provider and consumer knowledge regarding the disease and rational use of medicines

Asia-Pacific Context and Challenges • Increasing resistance to oral artemisinin-based combination therapies • High-prevalence of substandard and counterfeit antimalarial drugs (SSFFCs) • Weak health care service delivery for hard-to-reach and mobile populations • Lack of provider and consumer knowledge regarding the disease and rational use of medicines

Regulatory Strategy and Challenges

Regulatory Strategy and Challenges “Drug regulation is a public policy response to the perceived problems or perceived needs of society. Consequently, drug laws need to be updated to keep pace with changes and new challenges in their environment”. Effective drug regulation: A multicountry study by WHO

National Drug Regulatory Authority Framework

Relative Capacity for Quality Assurance More Stringent Less Stringent SRA Countries PIC/S Countries Other Countries • 44 member countries Focus countries in the region Cambodia Myanmar Vietnam Lao Prequalification

Capacity for Quality Assurance in the Asia Pacific region More Stringent Less Stringent SRA Countries PIC/S Countries Other Countries Cambodia Myanmar Japan Indonesia Malaysia Lao Vietnam Australia Singapore New Zealand Taiwan Japan is member of ICH, Australia is an Associate country

Regulatory gaps resulting in increasing resistance to ACTs • Weak National Drug Regulatory Authorities (NDRAs) • Lack of post-market surveillance • Lack of drug quality testing due to weak National Laboratory infrastructure • Lack of consumer awareness and education • Weak coordination among NDRAs in the region7 7. Phanouvong, S. (2013b) Presentation at the WHO Bi-regional Meeting on Healthy Borders in the GMS, August 2013, Bangkok

Options for Interventions(focus on regionally-based interventions)

Intervention 1Ensure product quality in Asia-Pacific • Reviews the marketing applications using its normal standards for authorization • Issues “Tentative approval” in place of “full” approval- if product has marketing protection in the U.S • USAID allows purchase of "full" or "tentative" FDA approved products • Article 58 of Regulation, operates in co-operation with the WHO to review product registration. • This review is for markets outside of the EU • Mechanism applied to 2 ACTs already: • Pyramax®, (pyronaridine-artesunate) • Eurartesim® (dihydroartemisinin-piperaquine)

Intervention 1Ensure product quality in Asia-Pacific Could Asia Pacific provide additional capacity to the work being conducted by WHO’s Prequalification program? By USFDA? By EMA? Only ICH members, obeservor and associate countries?PIC/S countries also? New Zealand? Australia and Japan? Singapore? Malaysia? Indonesia?

Intervention 2Wipe-out the widespread distribution of sub-standard and counterfeit pharmaceutical products

Build Consumer Awareness

Heat Index Build Consumer Awareness

Heat Index Build Consumer Awareness Pollution Index

Heat Index Build Consumer Awareness Pollution Index Drug Quality Index

Catalyze Consumer Involvement Consumer Involvement NDRA

Build Consumer involvement: NDRA Websites

Consumer Involvement Consumer Involvement NDRA Healthcare Blogs

NDRA’s using Facebook

Consumer Involvement Consumer Involvement NDRA

Consumer Involvement

National Drug Regulatory Authority Framework Build NDRA capacity

Intervention 3Strengthen private sector industry to attain higher quality manufacturing standards Strengthen Private Sector Through provision of technical assistance Catalyze Self Regulation Through involvement of industry associations

Strengthen private sector Strengthen private sector industry to attain higher quality manufacturing standards

India case study – Building Capacity There are more than 10,000 manufacturing sites in India WHO and SRA Approved sites PIC/S country approved 1,500 sites Certified by international procurement agent Certified by various NDRAs Approved by central and state Drug Regulatory Authority (WHO cGMP) State Level Approved (GMP – Schedule M) (8000-9000 units)

US-FDA inspected facilities for Finished Pharmaceutical Products and Active Pharmaceutical Ingredients (outside USA) Source: Pharmexcil data 2012

Intervention 4Phase-out oral artemisinin-based monotherapies(as part of ‘Emergency Response to Artemisinin Resistance’)

Intervention 4Phase-out oral artemisinin-based monotherapies(as part of ‘Emergency Response to Artemisinin Resistance’) • Monitoring/control/Pharmacovigilance • Wipe out AMTs from illegal market • Post Marketing Surveillance Manufacturing/Import/Distributor/Retail Revoke license Policy Halt all new AMT registration Human Resource Management Create taskforce of inspectors Coordination Share results with countries in the region

Regional Financing for Malaria Task Force (RFMTF) Update