Governance in Pharmaceutical Systems PDF

Governance PART 1  SESSION OBJECTIVES 1. Understand the impact of governance on pharmaceutical management practices, including medicine registration, quality assurance, procurement, storage and distribution, financing, and the promotion and use of medicine...

Governance PART 1  SESSION OBJECTIVES 1. Understand the impact of governance on pharmaceutical management practices, including medicine registration, quality assurance, procurement, storage and distribution, financing, and the promotion and use of medicines. 2. Understand the principles of good governance 3. Use real-world scenarios to apply principles of good governance and management and identify potential governance failures 4. Investigate the challenges in governance at both global and national levels. 5. Explore the consequences of poor governance in medicine supply management 6. Delve into South Africa's National Medicines Policy, Public Finance Management, and Medicine’s Act, understanding their pharmaceutical governance and management implications. 7. Formulate strategies to improve governance in pharmaceutical management  Definitions Multiple definitions and interpretations of ‘governance’ Some definitions are built on technical government functions and administrative tasks, i.e., World Bank (2000): “Economic policymaking and implementation, service delivery, and accountable use of public resources and regulatory power” “the process of decision making and the process by which decisions are implemented (or not implemented)” (UNESCAP 2009). Other definitions – linked to how the government connects with other sectors and with citizens, i.e. USAID: "pertain to the ability of government to develop an efficient, effective, and accountable public management process that is open to citizen participation and that strengthens rather than weakens a democratic system of government.“ All definitions emphasise authority, power, and decision-making in various institutions, policy, and public administration  MSH – WHAT IS GOVERNANCE Setting strategic direction and objectives for an organization; Making policies, laws, rules, regulations, or decisions; Raising and deploying resources to accomplish the organization’s mission, Strategic goals, and objectives; Overseeing the work of the organization to achieve its mission  Expectation: Resources = Intended results (access to medicines) Poor governance (consequences): GOOD Corruption GOVERNANCE: EXPECTATIONS “the abuse of entrusted power for private gain” VERSUS Poor accountability and transparency REALITY Weak incentives for responsiveness and performance Limited engagement of citizens in health affairs Overall low levels of health system effectiveness  Why are the aforementioned principles and definitions of governance are relevant for CLASS pharmaceutical systems whose core role is DISCUSSION ensuring access to medicines?  THE PHARMACEUTICAL SYSTEM Important decisions at all levels = access to essential medicines Medicines: prescribed, dispensed, and used safely and appropriately Structures, people, resources, processes (interactions) Vested interests at each decision-making point APPLICATION TO THE MEDICINE SUPPLY CYCLE  P H A R M AC E U T I C A L M A R K E T: H I G H LY R E G U L AT E D, B U T U N E T H I C A L P R AC T I C E S C A N O C C U R  CONSEQUENCES OF POOR GOVERNANCE Increase in pharmaceutical budgets Medicine price inflation Bribes Unethical practices Theft of medical supplies Sale of counterfeits Harm to patients Other consequences?  SPECIFIC ISSUES FOR MEDICINE Maximum effectiveness and efficiency Transparency and accountability: Medicine registration Medicine quality Procurement Storage and distribution Medicine financing Promotion and use of medicines Ensuring equity and legitimacy in processes and the outcomes CONSEQUENCES = IMPACT ON PATIENT LIVES!!  What are some of the CLASS interventions to improve DISCUSSION governance in pharmaceutical systems?  FRAMEWORK FOR STRENGTHENING GOVERNANCE  Strategic Vision: Leaders have a broad and long- term perspective on health and human development, along with a sense of strategic direction for such development1  Participation: All men and women should have a voice in decision-making for health, either directly or through legitimate intermediate institutions that represent their interests1  Transparency: Processes, institutions and information should be directly accessible to those concerned, and enough information provided to understand and monitor health matters1  Consensus-orientation: Good governance of the health system mediates differing interests to reach a broad consensus on what is in best interests of the group1  Rule of Law: Legal frameworks pertaining to health should be fair and enforced impartially, particularly the law on human rights related to health  Equity: All men and women should have opportunities to improve or maintain their health and well- being  Effectiveness and efficiency: Processes and institutions should produce results that meet population needs and influence pre-determined outcomes while making the best use of resources  Responsiveness: Institutions and processes should try to serve all stakeholders to ensure that policies and programs are responsive to the health and non-health needs of its users  Accountability: Decision-makers in government, the private sector, and civil society organisations involved in health are accountable to the public, as well as to stakeholders  TOOLS TO PROMOTE GOOD GOVERNANCE IN MEDICINES National medicine policies, laws and regulations Framework for how pharmaceutical products are regulated in a country Responsible agencies and entities operating without conflict of interest Examples in the South African context? Defined good pharmaceutical management practices manufacture selection inventory management and distribution prescribing and dispensing Standard operating procedures with clear lines of accountability  APPLICATION – HOMEWORK!! Read the article below and answer the questions that follow. https://www.timeslive.co.za/news/south-africa/2023-09-05-south-africa-overpaid-for-covid-19- vaccines-health-justice-initiative/ 1. What aspects of good governance were compromised in the article above, and what impact did it have on society? Reminder: Participation quiz