Strengthening Pharmaceutical-Sector Governance

 

Improving governance throughout pharmaceutical systems contributes to more effective, efficient, accountable, participatory, and transparent institutions, which in turn leads to more resilient and sustainable health systems.

Attaining the goals of universal health coverage—for which medicines are crucial—requires clear policies, robust legislation, and sound management practices supported by good governance. This premise is relevant to pharmaceutical systems, which are particularly vulnerable to corruption due to the economic value of medicines (approximately 25% of the total health care expenditure in low- and middle-income countries, with nearly half of out-of-pocket expenditures attributable to pharmaceuticals) and the multiplicity of stakeholders. Governance plays a critical role in reducing opportunities for corruption and mitigating other system inefficiencies. It also shapes the ability of the health system to respond to challenges and institute reforms.

MTaPS assists countries in strengthening pharmaceutical-sector governance, which is a key objective of USAID’s Vision for Health Systems Strengthening for the medical products health system function, and achieving the global sustainable development goal of improving access to essential medicines and health technologies through:

  • Increasing transparency and accountability throughout the pharmaceutical system
  • Improving and enforcing evidence-based medicines policies, laws, regulations, guidelines, norms, and standards
  • Increasing stakeholder engagement and empowerment, including civil society and consumers
  • Working with country stakeholders to identify areas in need of reform in the pharmaceutical sector

MTaPS helps countries:

  • Conduct data transparency surveys, develop or improve disclosure and transparency policies and procedures, and improve and monitor mechanisms for disseminating and sharing public information (e.g., prices of publicly procured medicines)
  • Evaluate, strengthen, and monitor the performance of governance bodies such as pharmaceutical tender boards and audit committees and help them to adapt and implement model accountability frameworks and tools, including terms of reference that clarify roles and responsibilities, conflict of interest policies, and channels for sharing information
  • Institute auditable track and trace systems for publicly procured medicines and related finances and work with government agencies, multistakeholder groups, and civil society organizations (CSOs) to develop and implement tools for identifying and reporting corruption and fraud threats, establish whistleblowing and complaint systems, and build capacity to analyze findings and manage risks
  • Develop or improve policies, legislation, and guidelines that support the country’s priorities and goals of health programs such as TB and maternal, newborn, and child health; convene stakeholder consultations that include civil society and gender and minority representation; and formulate and oversee implementation plans
  • Assess mandates, clarify roles and responsibilities, and develop and implement risk-based plans to build the capacity of national and local regulatory authorities and other agencies to oversee and enforce policies, laws, and regulations that support access to effective medicines and protect patients from harm
  • Develop toolkits and build the capacity of stakeholder groups, including civil society and patient groups (e.g., HIV and TB) to advocate for reforms, greater transparency, and effective government oversight of the pharmaceutical sector; engage in policy and legislative dialogue; and convene public forums to monitor the progress of reforms
  • Map stakeholders, work with existing CSOs to form consumer groups, create opportunities, and develop platforms for greater citizen and consumer engagement in policy discussions and social accountability initiatives, including monitoring the country’s progress toward the sustainable development goal of improved access to essential medicines and health technologies
  • Mobilize stakeholders and create coalitions to identify and advocate for needed reforms for strengthening pharmaceutical systems and country self-reliance, build local capacity to lead stakeholders in evidence-based policy analysis and planning, and implement improvement plans

For more information, contact:

Senior Principal Technical Advisor, Governance

Helena Walkowiak

hwalkowiak@mtapsprogram.org