案例 Call for Health Policy and Systems Research in the field of Access to Medicines in low-and middle-income countries
1.Introduction
In 2010,the Alliance for Health Policy and Systems Research(herein referred to as the Alliance)initiated a new project on Access to Medicines(ATM)with the aim of generating and increasing the use of policy-relevant evidence on ATM in low-and middle-income countries(LMICs)。The project adopts a health system perspective on ATM,building on the network of Alliance's partners and its expertise in health policy and systems research(HPSR)。
During its inception year,the ATM project commissioned a priority setting exercise aimed at identifying priority policy concerns and a priority HPSR agenda in ATM,suitable for LMICs1. Priority-research questions that emerged from this exercise are the following:
-In risk protection schemes,which innovations and policies improve equitable access to and appropriate use of quality medicines,sustainability of the scheme,and financial impact on beneficiaries?
-How do policies and other interventions into private markets impact on access to and appropriate use of quality medicines?
-How can stakeholders use information and data routinely collected and available in the system in a transparent way to wards improving access to and use of quality medicines?
The Alliance is eager to support research projects in LMICs that will address the priority research questions above and that will inform policies,strategies and interventions aimed at improving access to medicines.We are interested in learning about positive and negative effects on ATM of policies and interventions e.g.in risk protection schemes or private markets.The Alliance will support the publication and dissemination of the research results(peer-reviewed publications,journal supplements etc.)。The Alliance will also ensure that policy lessons and evidence relevant for implementation arrangements in LMICs will reach policy-and decision-makers in national and international fora.
2.Access to Medicines in LMICs:the need for Health Policyand Systems Research
Despite decades of successful implementation of national essential medicines program mes, ATM remains problematic for poor and vulnerable populations in many LMICs.
Health systems strengthening interventions are often designed within single building blocks of the system(health financing,human resources,health information,health service delivery, governance or medicines and health technologies(WHO 2007))and interconnections between systems components are frequently ignored.The role of medicines,for example,is commonly narrowed down to a system input,a commodity that should be available to allow service delivery. Populations'access to medicines is addressed mainly through fragmented,vertical approaches usually focusing on supply.This approach has considerable consequences:with such a vertical and isolated approach,policies,interventions and actions aimed at improving ATM can only have a limited and short-term effect as many other system constraints hamper access to care and medicines.Indeed,the vertical focus of medicine interventions may be the source of the enduring lack of access to essential medicines for vulnerable populations in LMICs.A wider systems approach to improving ATM seeks to ensure that policies are more effective at the system level and generate longer term equitable and sustainable results.
The recent priority-settingexercise performed by the Alliance identified research questions in access to medicines that demonstrate the need to explore the relationships between medicines and the other building blocks of the health system and analyze the health system determinants of access to medicines.
3.Possible research to be conducted under the call
This call aims to explore connections between medicines and three other essential functions of health systems:health financing,governance and health information.
Research conducted under this call will primarily seek to adopt a health system perspective-the research should incorporate a conceptual framework that demonstrates a health systems approach.Adopting a health system perspective may require a multi-disciplinary research team and the need to engage multiple health system stakeholders.If relevant,the research may try to explore the implications of the phenomena under study on human resources for health(capacity, workload,deployment,financial and non-financial incentives etc.).
The research application must also demonstrate a robust methodological approach adapted to the proposed research question.
We recommend that the research tries to adopt the following attributes,for which applicants will be given additional credits:
● Equity should be an underlying value of the proposed research,although the scope of the proposed research may not allow to measure actual impact on disadvantaged and vulnerable populations.
● Innovation the research should seek to promote innovation,either in the choice of research methods or the phenomena(policy,strategy or intervention)under study.
● Policy relevance the research should seek to demonstrate potential influence on policy and decision-making:e.g.relevant timing of the research in the context,engagement of policy-makers in research team,plans for dissemination and policy dialogue.
● Capacity building the research should seek to build health policy and systems research capacity for both researchers to conduct research and policy-makers to demand and use research.
Three core questions have been identified for this call:
Question 1-In risk protection schemes,which innovations and policies improve equitable access to and appropriate use of quality medicines,sustainability of the scheme,and financial impact on beneficiaries?
Medicines have been reported as contributing to a large portion of out-of-pocket expenditures in LMICs(Garg ＆ Karan 2009),their impoverishing effect has been documented(Ni?ns et al.2010).In a systematic review of research on medicines access and use in Mexico,Wirtz et al.(2008)report large inequities in medicines'access.The positive impact of pre-payment schemes on access to medicine has been demonstrated(Wagner et al.2010)；however,the design of medicines'benefit packages and pharmaceutical management strategies in pre-payment schemes maybe challenging in resource constrained settings.These have been very weakly documented in LMICs so far(Faden et al.2011).
Risk protection schemes should be understood here in their broad definition,including social health insurance,tax-based systems,voluntary contribution schemes or innovative mechanisms such as micro-financing etc.This should be considered in the light of the recent international move to universal coverage.The scope of the research should go beyond the assessment of the impact of risk protection schemes on medicines'access but also document success and failures of implementation arrangements.Specific examples of research questions are as follows:
● What revenue collection,pooling and purchasing arrangements in risk protection schemes enable better access to quality medicines for poor and disadvantaged populations?
● How can risk protection schemes expand to cover unmet medicines needs while minimizing supplier-induced demand?
● How can risk protection schemes contribute to an effective control over price of medicines?
● What are the most effective contracting arrangements or provider payment methods to control utilization and ensure medicines access?
● Can risk protection schemes be expanded to cover private and informal health service delivery structures,such as accredited drug outlets?
● How can the beneficiaries of risk protection schemes be stimulated to better use medicines(adherence,use ofgenerics,improved health seeking behavior etc.)?
● How do beneficiaries of risk protection schemes respond to changes in the financial burden of medicines and how does this response affect their access toand use of quality medicines?
Question 2-How do policies and other interventions into private markets impact on access to and appropriate use of quality medicines?
Cameron et al.(2009)report on the lower availability of essential medicines in the public sector compared to the private markets of LMICs；the difference is even more striking for selected essential medicines needed to treat chronic conditions(Mendis et al.2007).Despite potentially higher prices,the private health market is widely used and preferred by patients(Mills et al.2002；Ma?ga et al.2003；Chalker et al.2005).Documented interventions into private health markets have been analyzed in a systematic review by Patouillard et al.(2007)and the authors conclude that better evidence of the impact of interventions on quality and use of health care is needed.
Interventions into private markets considered here may vary in nature and scope；they may result from commercial practices(e.g.medicines'promotion)or may be implemented with the purpose of controlling or regulating the market(e.g.price controls or contracting)；they may be financial(e.g.subsidies)or non-financial(e.g.medicines'information).Specific research questions maybe as follows:
● How can contracting with different organizations in private markets efficiently meet public objectives of medicines quality,access and use?
● Can risk protection schemes be expanded to cover private and informal health service delivery structures,such as accredited drugoutlets?
● Which innovative financing mechanisms in private markets(e.g.micro-financing)improve medicines access?
● What are the determinants of price variations in private pharmaceutical markets?
● What are the effects of pricing policies in the private sector on medicines quality,access and appropriate use?
● Which strategies and innovations could improve perception and use of generic medicines in the private sector?
● Which innovative strategies targeting individuals and organizations in the private sector improve health seeking behavior,and demand and use of quality medicines?
● How can information on medicines'access,utilization,price or quality be collected in the private sector and used for better decision-making by patients,providers,health managers or policy-makers?
Question 3-How can stakeholders use information and data routinely collected and available in the system in a transparent way towards improving access to and use of quality medicines?
Information on medicines exists in a fragmented manner in most health systems and is held by multiple stakeholders such as regulatory authorities,procurement agencies,risk protection schemes,health providers,and private companies etc.who may have no interest or advantage in communicating.This research question aims to address this fragmentation,with the underlying hypothesis that better organization and sharing of information will support greater use of evidence in decision-making,better utilization ofmedicines and improve access.
Specific research questions maybe as follows:
● Which routine monitoring systems can be used to effectively track variations in price quality and availability of medicines in order to inform decision-making?
● Which innovative methods can be used to share medicines'information held by multiple stakeholders on different aspects of pharmaceutical systems(e.g.selection,procurement,price, quality,prescription behavior,consumption behavior,etc.)?What are the effects of these methods on access toand use of quality medicines?
● How can market surveillance data be used to evaluate pharmaceutical policies and strategies?
● What is the effect of medicines'in formation disclosure on access to quality medicines and health system performance(e.g.disclosure of information on medicines research and innovation,registration,procurement and price,quality,utilization etc.)?
● What is the impact of medicines information collection and disclosure on utilization of quality medicines by consumers and their health seeking behavior?
● Howdo feedback and disclosure of information on performance of different actors in the pharmaceutical system influence their behavior and affect access to medicines(e.g.in the context of results-based financing arrangements)?
● Which indicators can be used to monitor and evaluate risk protection schemes with regard access to and utilization of quality medicines?
● How can information on medicines access,utilization,price or quality be collected in the private sector and used for better decision-making?
Research conducted under this call for all three questions above may be retrospective or prospective(within the budget limits of the grant).Activities may aim at documenting and analyzing reforms,interventions or innovative implementation arrangements,and their impact on ATM.The research may also initiate innovative stakeholders'participation and information sharing,and document their effect on ATM.
There is substantial overlap between the three main research questions addressed under this call.If relevant,applicants may therefore choose to combine research questions in their applications.