ICIUM 2011
Medicines Policy, Regulation, and Governance

The ICIUM 2011 Medicines Policy, Regulation, and Governance track welcomes abstracts addressing the following topics: processes for changing medicines policies; medicines selection and guidelines in national systems; good governance, transparency and issues around conflicts of interest at the health care and financing institutions level; how to improve the use of medicines by health care providers; and the role of consumers, patients and community systems in policy making and policy and program implementation. In particular, we seek to discuss work on:

1 - The POLICY PROCESS

  • Information driving policy: what is the landscape of health systems that have prompted health reforms?
  • Process for change: are reforms best achieved through a top down approach or a consensus building approach?
  • Key players for reforms: traditionally, government drives reforms, but what are potential contributions (or barriers) coming from the private sector (health professional organizations, academia, trade sector, donor or multilateral organizations) and politicians?
  • Documenting reforms: successes and failures are both important substrates for policy improvement. How to learn from "silent service" efforts, which may lead to under-recognized positive outcomes?
  • Examples of regulatory capture: how to prevent these from happening?

2 - NATIONAL SYSTEMS, PROGRAMS AND POLICIES

  • Medicines selection and guidelines, with a particular focus on process and outcomes: for example comparative studies of national lists over time, or between countries and the WHO Model List, or description of the effects of changing from experience-based selection to evidence-based selection.
  • Formulary systems can make or break health systems. What are lessons from countries on the process of selecting essential medicines?
  • Can a national formulary improve universal access to health products and rational use?
  • How can a national formulary prevent corruption in terms of procurements of medicines? What about centralized procurement?
  • How important is health technology assessment of pharmaceuticals towards making a formulary work?
  • How important is it that pharmacovigilance systems are integrated into the formulary?
  • Do national health insurance schemes play a role in the selection process (reimbursement and coverage for formulary medicines) and do they influence utilization?

3 - HEALTH CARE AND FINANCING INSTITUTIONS

This area will focus on good governance, transparency and issues around conflicts of interest (COI), including:
  • Methods of curbing corruption, promoting good governance, transparency and accountability in the pharmaceutical sector, and its impact on health systems strengthening;
  • Declaring, identifying and managing conflict of interest in the pharmaceutical sector;
  • Assessing transparency and good governance in pharmaceutical systems;
  • Actions following COI: how is conflict of interest handled?

4 - HEALTH CARE PROVIDERS

This area will focus on improving the use of medicines by health care providers (including doctors, pharmacists and other health care professionals), promotion, quality of product and Good Pharmacy Practice:
  • Ethical relationships between industry and clinicians: is self regulation the key to success or does it need a government (drug regulator) intervention?
  • How should drug regulatory agencies approach health workers complaints of poor quality medicines (therapeutic failures) that are observed in clinical practice?
  • Depending on national regulations – how should conflict between dispensing doctors and prescribing pharmacists be managed? How do these practices vary?
5 - CONSUMERS, PATIENTS AND COMMUNITY SYSTEMS

This area covers consumers, patients and community systems: 

  • What is their role in policy making and on policy and program implementation? How to assess their role?
  • Part of drug promotion is targeted to patients (disease awareness, disease mongering). How can this be evaluated?
  • What are the experiences from the United States and New Zealand on direct-to-consumer-advertising?
  • Conflict resolution - what to do when religion intervenes with state health policies?