The Government of Malawi is committed to meeting the goal of quality, equitable and affordable UHC, as set out in the national Health Sector Strategic Plan II 2017–2022. An essential health package (EHP) aims to provide equitable access to quality health care by covering the costs of essential services. However, the annual cost to fully implement the EHP (US$247 million) far exceeds available resources, and there are calls for an urgent review of the cost-effectiveness of the EHP, the national Essential Medicines List and related standard treatment guidelines. Furthermore, Malawi continues to face challenges in reducing its communicable disease burden, including TB, malaria and NTDs, while being faced with a rising epidemic of non-communicable diseases.

ADP has engaged with a range of government stakeholders to identify priority areas for ADP interventions, including: the development of an enabling legal and policy environment; regulatory system strengthening; and improved procurement policy and planning.

ADP is supporting the work of the multi-sectoral Technical Working Group (TWG), mandated to recommend policy and legal reforms that impact affordable access to health technologies. Led by the Ministry of Justice and Constitutional Affairs (MOJCA), the TWG is an important forum to ensure policy coherence across the sectors of innovation, access and delivery.

Strengthening medical products regulation

Through its partnership with the African Union Development Agency (AUDA-NEPAD), ADP is also supporting the process of domestication of the AU Model Law on Medical Products Regulation. Malawi has adopted national legislation domesticating the provisions of the AU Model Law; as a follow up, ADP has initiated discussions with both the MOH and MOJCA on technical support for the policy, legal and regulatory required for effective implementation of the legislation.

For regulatory systems strengthening, ADP is working with the Malawi Pharmacy, Medicines and Poisons Board (PMPB) to identify areas of strengths and opportunities to further improve the regulatory functions. A self-benchmarking report (completed in May 2019), which identified specific capacity gaps within the regulatory system, will guide capacity strengthening activities during the period 2019–2020.

Supporting efforts to improve safety monitoring

The national pharmacovigilance centre was recently established within the PMPB, to meet the urgent need for strengthening institutional and human capacity on safety monitoring, particularly in light of the current roll-out of the new malaria RTS,S vaccine. ADP is working with PMPB to identify capacity strengthening priorities and has supported the training of personnel from the National Pharmacovigilance Centre on best practices for pharmacovigilance, delivered by the WHO Collaborating Centre for Pharmacovigilance and the International Society of Pharmacovigilance. In addition, ADP is supporting activities to integrate pharmacovigilance systems within the public health programme and strengthening reporting channels and tools for health care providers.

Addressing health procurement challenges

Building on country priorities identified by national stakeholders, ADP engaged with senior representatives from the Central Medical Stores Trust (CMST), MOH and the Public Procurement and Disposal of Assets Authority to identify priority health procurement challenges and design required interventions. Based on this, ADP support will focus on the development of a training module to improve medical equipment procurement planning and technical specification development for CMST personnel. In addition, ADP will collaborate with the national NTD control programme to document challenges in the procurement of a diagnostic test for onchocerciasis, as a learning tool to inform future procurement planning exercises.