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. The AQMTF will present its findings to APLMA leaders in August 2014.

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)

In recognition of the vital role regulatory authorities play in ensuring the availability of safe, effective and quality medicines and in-vitro diagnostics needed to reach the goal of malaria elimination by 2030, APLMA is facilitating the establishment of the Regional Regulatory Partnership for Malaria Elimination (RRPME).

The RRPME is a multi-stakeholder group comprising national regulatory authorities, technical agencies, academia, donors, product development partnerships, as well as policy and advocacy specialists.

The first meeting was held 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 were intended to support one of the six priority action items endorsed by Leaders as part of the APLMA Leaders Malaria Elimination Roadmap in 2015, namely to ensure high quality malaria services, tests, medicines, nets and insecticides.

It was also recognized from the inception 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.

The purpose of the second meeting on the RRPME, hosted by the Government of Indonesia, is to formalize the partnership and initiate a plan of regulatory support to priority countries, guided by an overarching strategic plan and operating model, informed by the latest intelligence on products of interest and the regulatory needs of the target countries.

Objectives

The specific objectives of the Jakarta meetings are to:

  • Formalize the Regional Regulatory Partnership for Malaria Elimination, with the development of a high level draft terms of reference as an intercessional deliverable.
  • Reach agreement in principle 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.1
  • Establish focal points within national regulatory authorities (NRAs), 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.
  • Confirm next steps, including action items, associated leads and the tentative date and location for the next meeting.

Building upon the above, the following considerations/principles should be taken into account in developing a strategic plan:

  • Position APLMA as the overarching platform that links, coordinates and provides accountability and direction for activities aimed at malarial elimination, taking account of and leveraging existing regulatory networks.
  • Reaffirm Malaria elimination as the end goal, requiring the elimination of both drug resistant and p vivax forms of the disease.
  • The imperative to accelerate access (market authorization) to treatments and diagnostic tests while providing balanced support for other targeted regulatory activities (such as vigilance, market control and GDP inspection) that together will help ensure the quality and appropriate use of priority products while incrementally strengthening the regulatory system in a sustainable manner.

1 Additional partners may be identified post-meeting.