Commodities

Access to Quality Medicines & Other Technologies

The Access to Quality Medicines and other Technologies Task Force (AQMTF) advises APLMA on options for improving the availability of, and access to, quality medicines, diagnostics and other products to support malaria elimination in Asia Pacific by 2030.

The AQMTF will examine arrangements in the region for the regulation, production, procurement and distribution of medicines, diagnostics, mosquito nets, insecticides and other products used in the control and management of malaria (‘malaria control products’) and develop options for:

  • ensuring the use of best-practice evidence-based therapies, consistent with international standards, and halting the use of oral mono-therapies and medicines that do not meet international standards;
  • strengthening national regulatory capacity in malaria-affected countries, including through regional collaboration on standards and regulatory practices;
  • enhancing access to and affordability of quality medicines, diagnostics and other malaria control products. This includes options for increasing production, improving quality of manufacturing, possible incentives for private sector producers and/or improving distribution where appropriate; and
  • improving and/or increasing the use of preventive measures, including nets and insecticides.

The AQMTF will collaborate with, and build on the work of, existing global and regional organisations and networks involved in malaria control and management, to avoid duplication and accelerate progress.

The AQMTF is co-chaired by the Secretary of the Department of Health, Australia and the Secretary of the Ministry of Health and Family Welfare, India.

The AQMTF comprises senior policy officials and experts from regional countries with influence and interest in improving access to high quality medicines, diagnostics and other products, together with representatives of international organisations and non-governmental organisations with interest and expertise in malaria control, including the World Health Organization (WHO). Membership will be by invitation issued by the co-chairs in consultation with the WHO.

The AQMTF will consult with civil society and with malaria control product manufacturers, including in the private sector, as appropriate.

Meetings have been convened by the co-chairs, with Secretariat support provided by the Asian Development Bank.

Meeting Dates Venue
2nd AQMTF Meeting 9-10 June, 2014 Manila, Philippines
1st AQMTF Meeting 12-13 March, 2014 Sydney, Australia

Regional Regulatory Partnership for Malaria Elimination (RRPME)

Welcome to the RRPME platform at APLMA. This page provides a summary introduction to the Partnership. It also serves as a platform to share key information and reports on RRPME activities since early 2016.

National Drug Regulatory Authorities (NDRAs) play a vital role in ensuring the availability of safe, effective and quality medicines and medical devices needed to reach the goal of malaria elimination by 2030. For this reason, APLMA facilitates a Regional Regulatory Partnership for Malaria Elimination (RRPME); a multi-stakeholder group comprising of national regulatory authorities, technical agencies, academia, donors, product development partnerships, as well as policy and advocacy specialists. RRPME acts as an overarching platform that links, coordinates and provides accountability and direction for activities aimed at malarial elimination, taking account of and leveraging existing regulatory networks. The RRPME meetings provide regulators and partner organization with the opportunity to review progress, discuss challenges, set priority actions and announce new commitments. The RRPME aims to introduce regulatory pathways in Asia Pacific for expedited approval of and access to quality drugs and medical devices for malaria elimination. If a strong proof of concept is established for new malaria products, it could then be broadened and integrated into regional and national systems, and could be applied for other life-saving health commodities. The RRPME also aims to share best practices and encourage the roll out of mechanisms to monitor substandard and falsified antimalarial commodities and to reduce the circulation of Oral Artemisinin Monotherapies, and aims to also improve access to quality commodities for all by expanding on existing strategies and developing new ways to engage the private sector for service delivery.

First RRPME Meeting

The first meeting was held in March 31- April 1, 2016 in Bangkok to explore the establishment of a Regional Regulatory Partnership for Malaria Elimination (RRPME), during which 12 recommendations were agreed upon. These recommendations are detailed in the meeting report of the first RRPME. These recommendations were intended to support one of the six priority action items endorsed by Leaders in 2015 as part of the APLMA Leaders Malaria Elimination Roadmap, namely to ensure the availability and access to high quality malaria services, tests, medicines, nets and insecticides. It was also recognized from the outset that factors beyond the regulation of medical products must also be addressed as part of a comprehensive malaria elimination strategy, including procurement and pricing policies and supply chain issues, as well as the regulation and use of vector control products such as bed nets and insecticides.

Second RRPME Meeting

The purpose of the second meeting of the RRPME, hosted by the Government of Indonesia and held on 14-15 December 2016 in Jakarta, was to formalize the partnership and to initiate a plan of regulatory support to priority countries, guided by an overarching strategic plan and operating model and informed by the latest intelligence on products of interest and the regulatory needs of the target countries.

Specific objectives of the second RRPME meeting were to:

  • Formalize the Regional Regulatory Partnership for Malaria Elimination, with the development of high-level draft terms of reference as an intermediate deliverable.
  • Reach agreement on a preliminary strategic regulatory cooperation plan that identifies short, medium and long term activities; an operating model that defines the role of APLMA in relation to existing and new regional and international regulatory networks and supporting organizations; and guiding principles that underpin the regulatory strategy.
  • Identify priority products and the regulatory needs of target countries.
  • Confirm existing regulatory procedures and initiatives that can help support the Malaria Elimination Roadmap.
  • Establish a roles and responsibilities matrix of interested regulatory support organizations to ensure accountability, consistency and coordination of effort in countries based upon single regulatory country plans.
  • Establish Focal Points within NDRAs, national malaria programs and supporting organizations and a plan for setting up a platform for information exchange and a repository of documents related to the RRPME.

The Report and all related documents for the Second Regional Regulatory Partnership Meeting, held on December 2016, can be found here.

Five key recommendations were formulated during the meeting, and are detailed in the meeting report. The meeting successfully identified priority medicines and diagnostics for registration in individual countries to support malaria elimination efforts. The recommended next steps include the appointment of country Focal Points. As we prepare for the next meeting, the RRPME is now working in close collaboration with Focal Points to shape country specific workplans to address regulatory bottlenecks and encourage joint product assessments for better access to quality malarial products.