1. Policy track summary ICIUM 2011 – 18 Nov 2011

2. Policy track topics 1.The pharmaceutical policy process 2.Quality and safety of medicines in LMIC 3.Policy interventions to improve rational use of medicines in LMIC 4.Providers and promotion 5.Consumers, good governance for medicines, and Medicines Transparency Alliance

3. General observations We need explicit policies on which implementation plans can be based Data collection, analysis and effective presentation is essential for political support and change Multidimensional approaches, repetition, and reinforcement are necessary for sustainability Peers make good trainers and should be brought to the workforce All prescribers and the community need to be targeted in educational interventions on promotional activities For all committees documents on CoI, criteria for selection of members, SOPs, and minutes of meetings should be publicly available

4. Specific observations There is limited evidence for palliative care policies Safety interventions can be effectively implemented in hospitals Targeted interventions to educate the community and health care workers can be succesful ATM Index is a potentially useful tool for monitoring at least part of the industry Country marketing practices frequently do not match stated company marketing policies Countries should have strong, practical and implementable policies to regulate all aspects of drug promotion The WHO guidelines on donation are comprehensive and would have prevented the burden of useless donations

5. Drivers of effects at system level An integrated pharmaceutical management reporting system with mandatory reporting and public feedback helps to improve performance A multifaceted approach can integrate advocacy strategies in palliative care with the national medicines policy To get high penetration of generic medicines an integrated policy with strong political support by a “champion” is needed Recognition linked to performance assessment and positive incentives facilitate participation and behavioural change An important part of the good governance for medicines is improving transparency and accountability Important factors that affect the corruption: professional ethics and personal values; lack of transparency and accountability and poor legislation enforcement

6. Unintended effects of (absence of) policies Health litigation is an unintended effect of “right to health” clauses in the constitution which may have positive or detrimental effects on the pharmaceutical system and practice of rational use of medicines, depending on country context Corruption was reported as a main driver for high medicine prices

7. Policy recommendations – system strengthening and collaboration NMRAs to be strengthened and supported Medication management standards need to be included in overall healthcare quality improvement systems Reward and recognition of good performance needs to be built into management and supervision systems Involve payers, patients and health authorities at all levels in implementation of essential medicines programs including selection Regarding drug promotion, there needs to be increased political will for change with transparency and stakeholder collaboration Strengthen the empowerment of the community and involvement of civil society. These groups need to be able to report on promotional activities and especially the breaching of codes at the end user level. Addressing use and access issues should be approached using a holistic health systems framework Managing conflicts of interest in the supply chain may help to decrease corruption

8. Policy recommendations – policy implementation and monitoring A structured multi stakeholder, multidisciplenary approach to the policy process ensures ownership by all partners Objective monitoring of the impact of policy measures should be built into policy implementation from the outset When considering effects of policy measures policies at the state or regional level should be taken into account Establish cost consequences / benefits of effective interventions. This will require appropriate methods. Level of commitment and a multidisciplinary approach are crucial to the implementation and sustainability of good governance

9. Policy recommendations – transparency and dissemination Greater transparency needs to be shown by the industry about their promotional activities and ethical standards Best practices in relation to ADR and medication error reporting need documentation and dissemination. Institutionalize effective proven interventions. Publish (raise awareness) of successes. A list of documents related to good governance in pharmaceutical sector in countries need to be disclosed for public

10. Policy recommendations – actions and evaluations at country level Each country needs to do a baseline and periodic assessment of pharmacovigilance performance using the new set of indicators More studies on promotional activities need to be done and data collected in LMICs Education on promotional activities and advertising should be introduced to all health workers in their training programmes Regulators need to identify the steps that will reinforce acceptance of the quality of generic medicines. MOHs should enforce the national policy on drug donations based on the WHO drug donation guidelines; the donor and recipient country should strictly enforce adherence to the guidelines

11. Research questions (1) Does external accreditation effectively improve the implementation of medication safety interventions? What are the long term effects and sustainability of educational interventions in the community and also on health workers, not only focusing on knowledge and skills but also on behaviour and health outcomes.

12. Research questions (2) How do you maximize the effectiveness of essential medicines lists, including 1) raising public awareness 2) linking to payments, incentives, reimbursement 3) involving stakeholders, insurers, payers, 4) linked to standard treatment guidelines, 5) the place of traditional medicines, and 6) the process of selection (experience vs. evidence) and implementation practices? What are the best mechanisms for increasing generic prescribing? What promotes sustainability of interventions?

13. Research questions (3) Are essential medicines criteria appropriate for specific therapeutic areas such as but not limited to palliative care? What are the targets for and feasibility of the proposed pharmacovigilance indicators, and to which extent do these differentiate good from bad performance?

14. Research questions (4) What is the role for combined or group approaches to procurement in particularly small markets, e.g. paediatric TB medicines? Evaluate the outcomes of promotional activities for health care workers and patients How does wording of the right to health in a national constitution affect the amount of related litigation within the country? What is the impact of the disposal of expired or/and unwanted medicines on the environment? What is the effect of availability and use of GGM documents related to conflict of interests, ethical criteria on country practices? What are the challenges for countries in researching their progress on fighting corruption and promoting good governance? Development and sharing of research frameworks