Generating evidence for change: Implementing the post-ICIUM research agenda Dennis Ross-Degnan, ScD Harvard Medical School and Harvard Pilgrim Health Care WHO Collaborating Center in Pharmaceutical Policy Boston, USA

Overview  Research methods  Cross-cutting research areas  Other research gaps  Who will pay for research?

Research Methods  Best practices in multi-disciplinary, multi-method health systems research to evaluate complex interventions  Development of methods for political analysis, stakeholder mapping, and other qualitative methods in pharmaceutical policy research  Development of methods for WHO Level 2 surveys to ease data collection, improve reporting, link facility and household analysis, and increase use by policymakers  Training in use of accessible longitudinal research methods for policy analysis using routine data IMS Institute for Health Care Informatics Global Health Research Program Call for Proposals on Dec 1, 2011 Defined policy themes Will combine provision of IMS Health data with training in their use

Research with a Health Systems Focus  Impacts of new business models to promote judicious access to newly developed antibiotics  Changes in transparency, accountability, efficiency and access in new multi-stakeholder engagement processes  Impact of emergence of resistance (antibiotics, antimalarials, HIV and TB medicines) on health and economic outcomes  Impacts of different components of community awareness and advocacy campaigns on awareness, behavior, and access

Medicines and Insurance Coverage  Impact of reducing financial barriers to health care through insurance coverage on utilization, outcomes, financial burden, and non-health expenditures  Targeted analyses of effects of policy and program changes in insurance systems, such as formulary management, benefit design, provider contracting, or educational outreach activities  Extent to which health insurance coverage leads to increases in utilization of medicines that meet unmet needs, versus encouraging clinically unnecessary overuse of medicines

Information Technology  Evaluation and return on investment of scaling up promising m-Health interventions to improve supply chain management and patient adherence  Impact of use of electronic dispensing and medical record systems on provider behavior, efficiency, safety  Use of information technology to support AMR containment activities

Generic Policies and Medicines  Generic medicines, including barriers to entry, market uptake, patterns of use, effects of competition on price, consumer and provider perceptions  Research and dissemination of information about the quality of generics in the public and private sector supply chain and  Impact of interventions to change consumer and provider perceptions about quality of generics (assuming adequate evidence of quality)

Role of Private Sector and Consumer Preference  Performance of private sector providers related to appropriate use of medicines and its determinants  Link between public and private sector practice  Research on supply chain mark-ups and a ‘reasonable’ markup for private sector sellers that can be standardized and monitored  Private sector access to ACTs and TB medications  Joint facility and household surveys to link care seeking, provider choice, medicines availability, and household access

Other Research Gaps  Disaggregated statistics on the role of gender, geography, and socioeconomic status in access to medicines, quality of care, and outcomes  Cost of inefficiencies in health care systems and their impacts on access and health outcomes  More and better-designed studies of the impact of national policies to reduce medicines prices  Factors that promote sustainability of interventions and costs and cost-effectiveness of bringing effective interventions at scale

Other Research Gaps  Best practices of pharmaceutical companies to improve access and appropriate use  Pharmacovigilance structural and process indicators  Public health impacts of counterfeit medicines  Impacts of affordability on adherence  Medicine use in chronic conditions among children, adolescents, elderly  Availability, use, costs, and effects on clinician behavior of rapid diagnostic tests  Best methods for supervision in settings with multiple competing priorities and low resources

Who (not WHO) Will Pay for Research?  Advocacy for alignment and coordination of donor and country research funding in pharmaceuticals around the ICIUM 2011 agenda  Need for a policy research set-aside in large donor programs, such as The Global Fund, PEPFAR, UNITAID, World Bank, Gates and Clinton Foundations  Lobby for investment of government funds in policy evaluations  Greater emphasis on research using available routine data (IMS Health, insurance programs, hospital electronic systems), with initial investments to develop data sources for research

ICIUM 2011 More than 600 More than 200 One research study each to advance the ICIUM 2011 research agenda will mean over 800 pieces of well- designed research from over 80 countries for the 4 th ICIUM conference!!