Global phm policy

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komail
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Global phm policy
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2015-10-22 02:42:52
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  1. Define global interdependence
    • actions and events in one part of the world affects people in other parts of the world.
    • -implies a degree of mutual dependence or reciprocity. 
    • -cuts into economic and political sphere
  2. Power
    actual or potential influence or coercion a state (or other actor) can assert relative to others because of its political, georgraphic, economic and financial, technological, military, social cultural or other capabilities
  3. Politics
    • about the allocation of resources; who gets what, how much, and when?
    • also about decision making that impacts our daily lives through influence n budgets, social norms, rules and regulations
  4. WHO definition of Health; what are some probz with this definition; what are some strengths? What is an alternate definition?
    health is a state of omplete physical, mental, and social well-being and not necessarily the absence of disease or infirmity. 

    Alternate:health as the ability to adapt and self-manage (Huber)

    • -unattainable 
    • -contributes to medicalization
    • -minimizes autonomy

    +steps away from solely discussing physical health
  5. Define Global Health
    Focuses on issues that directly or indirectly affect health but that can transcend national boundaries
  6. What are some key tenets of global health (PASSF)
    • -global health is public health
    • -better health for all, especially vulnerable popn's 
    • -scientific approach to health promotion and disease
    • -multi-level system based interventions to address societal and health governance
    • -comprehensive framework for financing and structuring health policies and services
  7. Define Global Health System; what are its 4 essential functions? (PMSS)
    • group of actors whose primary intent is to improve health, along with rules and norms governing their interactions
    • -national govts at the core
    • -health is increasingly influenced by global policy making arenas such as trade, migration, and environment.

    • production of global goods
    • management of externalities across countries
    • mobilization of global solidarity
    • stewardship
  8. Define globalization
    Act of globalizing, or extending to other or all parts of the world; i.e. worldwide integration and development
  9. Define political economy
    concerned with interaction of political and economical processes in society.
  10. What are essential meds?
    • -intended to be available within the context of a functioning health system at all times in adequate amounts in appropriate dosage forms, with assured quality and adequate information at a price the individual and the community can afford. 
    • It must satisfy the priority healthcare needs of the popn. 
    • prioritizes prevalent conditions, older drugs of proven efficacy and safety, and single agents and generics
    • is a flexible concept, but has moral universality
  11. Why is pharmaceutical policy complex (lecture 1)
    • implications for health and economic outcomes
    • industry profit vs social welfare
    • public sector institute may not adequately provide effective drugs
    • patients may not have purchasing power.
  12. Why are drugs specialized commodities?
    • -consumer does not always choose the drug
    • -assymetry of information for consumer
    • -perceptions of drug matter
    • -consumers dont know the consequences of not taking the drug
  13. Define global diseases, neglected diseases, most neglected diseases. Draw out that diagram from the R&D lecture
    • A: global diseases, major focus of R&D, affects both developing countries and developed countries. 
    • B: neglected diseases: malaria, TB
    • primarily in developing countries
    • only marginal R&D interests
    • C: most neglected diseases
    • -ex sleeping sickness/chagas disease
    • -exclusively affects those in developed countries
    • patients are too poor for meds, thus no r&D dinterest
    • Z- R&D for non medical indications
    • -highly profitable
  14. What is BRICS, and what were the four main priorities of its development bank
    • -strengthening domestic health systems
    • -ensuring and developing access to health technologies
    • -double burden of infectious and NC diseases
    • -promoting technology transfer to developing nations
    • (support for international organizations is the actual fourth one, and a and b are actually just one priority.....probably not a test question tho)
  15. Define push and pull mechanisms
    • Push: grants from foundations and governments to non-profits to encourage product development partnerships. 
    • goal is to reduce risks and costs, but no guarantee on output

    pull mechanisms: raise potential for rewards for investment in r&d. however, problematic in estimating an appropriate reward, and problematic if the product is too narrow in its scope.
  16. What is the DNDi? What are its goals? (BCDP) What was one of its successes?
    • drugs for neglected diseases initiative
    • MSF initiative 
    • brings together various stakeholders for neglected diseases 

    • 1. develop drugs for neglected pts
    • 2. bridge r&d gap, initiate development w/ govt, industry, research
    • 3. encourage public sector co-operation
    • 4. create global awareness on the issue, with govts as main target

    ASMQ, fixed dose combo antimalarial, made in collaboration with latin america and south-east asia and DNDi.
  17. Define patent. Why do they exist?
    Allow a market monopoly for the producer, disallowing other producers to produce or market that drug (idea, product etc. )for a predefined period of time. 

    • -Exist to allow the inventor to reap commercial benefits of their invention, and to incentivize innovation
    • -may encourage DFI
    • -may allow for knowledge gain
  18. what are some negatives of patents
    • -can impede progress in technology by producing a deadweight burden
    • benefit of new knowledge would have been greater in absence of patents (other firms cant exploit knowledge on a competitive basis)
    • give firms the power to price discriminate
    • monopolizer has no incentive to improve product
  19. What is WIPO? Was it effective or ineffective?
    World intellectual property organization, served as the precursor to the WTO

    ineffective as it didnt have penalizing power, thus countries did not comply.
  20. What were the Uruguay rounds? Importance?
    • 1986-1994
    • -Marked shift of including IPR into trade talks
    • -Conclusion of these talks resulted in creation of WTO and TRIPS
  21. everything u know about TRIPS
    • -covers a wide range of IPR issues, incorporating most past IPR agreements
    • -requires member states to maintain sufficient procedures in domestic law, to extend rights to foreign patent holders and to make granting a patient dependent on adequate disclosure of invention (pretty much just extending IPR to foreign patent holders)
  22. What are the minimum requirements of TRIPS
    What are its applications?
    • -pharmaceuticals and microorganisms are patentable for 20 years from time of filing
    • -no discrimination against imported products
    • -exclusive marketing rights until expiration
    • -transitional period stratified by development in setting deadline to comply (1995/2005/2016)

    • -the first three min requirements are also applications. 
    • -limit scope of exceptions from IPR and grant compulsory licences only under certain circumstances
    • to enforce patent rights
  23. Outcomes from the Can-US free trade agreement
    • -granted patent holders a period of protection from compulsory licensing
    • -changed patent expiry from 17 years from issuance to 20 years from filing.
  24. Outcomes from NAFTA
    • effectively anticipated TRIPS, thus Canada was already TRIPS compliant in 1992. 
    • also introduced the patent medicines (notice of compliance) which linked NOC to patient expiration.
  25. What are the three main ways CETA will influence drug prices in Canada
    • patent term restoration
    • data protection
    • patent linkage and right of appeal
  26. Define patent term restoration; why might it be problematic
    • goal is to compensate patent owners for lost time between filing of patent application and approval.
    • CETA allows a max 2 year extension
    • rationale is to minimize stalling of regulatory process
  27. Define data protection; why might it be problematic
    • Canada extended data protection to 8 years
    • CETA wants 10 years
    • NAFTA+ TRIPS permit 5 years. 
    • essentially delays access to clinical data, to delay the approval of generics
  28. Define patent linkage and right of appeal
    Patent linkage: drug approval is linked to patent expiry. 

    right to appeal: when generic alleges a patent is not infringed, the case goes to federal court. if the federal court rules against the innovator, the innovator can now appeal.

    • may actually increase efficiency by decreasing dual litigation 
    • may add an additional 6-18 months to approval process.
  29. Define governance
    Governance is the process by which authority is conferred on rulers, by which they make the rules, and by which those rules are enforced. deals with formal and informal actors involved in decision making and how they are selected and linked with society
  30. Global governance for health vs global health governance  (HPEW)
    • GGH
    • Beyond health sector
    • political challenge
    • works towards equitable health system
    • looks at actors within and outside health system

    • GHG:
    • within health sector
    • technical and political challenge
    • works towards efficient health system
    • looks at actors within the health system
  31. WHO main purpose
    Main objective: the attainment by all people of the highest possible levels of health

    • provides global health leadership through:
    • developing standards and policy
    • shaping research agenda
    • assisting countries in program development and coordination
  32. 2 of WHO's main projects
    good governance for medicines programme (raises awareness of impact of corruption in pharma sector; strengthens medicines' regulatory and supply management systems through increased transparency and accountability)

    • Prequalification program: 
    • -aims to make quality priority meds available
    • -builds national capacity for sustainable manufacturing and monitoring
  33. What is MeTA
    Medicines transparency alliance

    • multi-stakeholder initiative set up in 08 involving public private and civil society interests. 
    • aims to improve disclosure, transparency, accountability of meds and make essential meds available
    • (also shows up in the corruption lecture)
  34. What is health action interantional
    • dutch civil society NGO
    • recognized for thier global medicines policy expertise
  35. Global Fund
    partnership between various stakeholders to attract manage and disburse resources to fight AIDS, TB, Malaria
  36. Gates foundation
    provides funding and grants to innovative projects that address poverty and poor health.
  37. GAVI
    brings together public and private sectors with goal of creating new and underused vaccines for children in world's poorest countries. 

    • provides support through: 
    • -new and underused vaccine provision
    • -immunization services
    • -health system strengthening
    • -supporting civil society orgz that are contributing to health outcomes
  38. MSF
    • created to be nimble (like a ninja-in contrast to WHO)
    • mandate concerns emergency relief. 
    • also involved in access to essential meds.
  39. OXFAM international
    • aim is to find lasting solutions to poverty, suffering and injustice
    • very left wing and critical of private industry
  40. World Bank
    • Goal is the global eradication of poverty. 
    • Commitment to promoting foreign trade, intl investment and facilitating capital investments

    less focused on anti-corruption interventions but rather on broader health system strengthening projects.
  41. World Bank project cycle (ECLS)
    • Evaluation
    • country assistance strategy
    • lending
    • supervision
  42. Define corruption
    World bank definition: 

    behaviour on the part of officials in the public and private sectors in which they imporperly and unlawfully enrich themselves or those close to them, or induce others to do so, by misusing the position in which they're placed
  43. What are some motivations for corruption
    • financial need
    • Greed
    • poor institutional checks
    • passiveness
    • power abuse
    • non-trasparency
    • poor incentive structures for honest performance
    • opportunity or risk vs benefit
  44. how/what does corruption hurt? (EVAC)
    • -efficiency in national health budgets
    • -credibillity and civil trust of public institutions
    • -value of donor funds for development
    • -access to safe medical products
  45. why is the healthcare sector vulnerable to corruption
    • complex sector--uncertainty prevails
    • assymetric info between providers patients and suppliers
    • complex interaction of many stake holders with varying accountability
    • standard enforcement limited due to limited financial and human resources 
    • regulatory agencies often not impartial
    • corruption versus ineffeciency- lines often blurred
  46. why the ceutical system susceptible to corruption
    • 1) drug sales generate high income
    • 2) requires state regulations due to imperfect nature of market
    • 3) advances in technology are making it harder to distinguish authentic products from falsified products
    • lack of legislation/enforcement
  47. Define wicked problems (OSPEP)
    • hard to measure outcomes
    • no template to the problem or a simple solution
    • its pervasive
    • embedded in other failures
    • its tough to know there's a problem
  48. Characteristics of good governance (TEA-REP)
    • Transparent, accountable, efficient
    • rule of law
    • equal justice under law 
    • Private civil and state sector participiation

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