Medicines selection and essential medicines lists

Workshop 1

Convenors Rapporteurs

Suzanne Hill, Australia

Krisantha Weerasuriya, Switzerland

Vanchinsuren Lkhagvadorj, Fiji

Fatima Suleman, South Africa

Summary of key issues

  • Countries may start with either standard treatment guidelines or an essential medicines list - evolves over time, as capacity increases within the country.
  • Need evidence to support the review of either an essential medicines list or standard treatment guidelines and expertise to review and interpret the evidence - capacity issues exist in many countries.
  • Evidence should be used to both add and remove medicines from the essential medicines list.
  • Essential medicines list strategies need to plan for balancing the needs for acute and chronic health conditions.
  • Dealing with patients that are on medications not included in the essential medicines list adds to costs.
  • Levels of standard or specialised treatment guidelines may be developed according to country-specific needs.

Key barriers

  • Lack of expertise to evaluate the evidence on medicines for inclusion in essential medicines lists.
  • Conflict between vertical program treatment guidelines and national treatment guidelines.
  • No established processes for removing medicines from the essential medicines list once they are included.

Key enablers

  • Official approval and endorsement of the essential medicines list (by national departments of health/WHO).
  • Stakeholder involvement in the process from the outset creates ownership of the essential medicines list.

Steps to address barriers and enablers

  • Countries with limited capacity may start with the WHO Essential Medicines List.
  • National therapeutic committees need to play a role in the development and approval of all guidelines and medicines lists that are to be implemented in the country.
  • Training in essential medicines lists and standard treatment guidelines should be included in undergraduate health sciences programs.
  • Regional collaboration in capacity development may accelerate progress.

How to monitor progress in implementation

  • Regular reporting on updating and revisions to essential medicines list.
  • Assess dissemination strategies for essential medicines lists and standard treatment guidelines.
  • Review links between standard treatment guidelines, medicines procurement, distribution and use of medicines in practice.


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Financing and health insurance initiatives

Workshop 2


Convenors/Rapporteurs Moderator

Anita Wagner, USA

Madeleine de Rosas-Valera, Philippines

Dennis Ross-Degnan, USA

Summary of key issues

  • The scope and coverage of a minimum benefits plan must be defined - prioritising of activities may be required. Constraints (financial, workforce, other) raise ethical questions that must be addressed.
  • Benefits decisions based on previous care practices may not be appropriate as existing practices may not reflect quality care.
  • Products covered should match standard treatment guidelines - coverage should be based on cost-effective products (generics or branded medicines).
  • There are substantial data needs for developing a minimum benefits plan relating to disease epidemiology, standard treatment guidelines, capacity of the healthcare system to deliver care, availability and costs of medicines.
  • Need to consider health seeking behaviour, patient satisfaction with care, as well as unmet need for care and medicines for those currently unable to access health care systems.

Key barriers

  • Inadequately functioning healthcare delivery systems.
  • Lack of valid, reliable, routinely collected relevant data to inform minimum benefits plan decisions.

Key enablers

  • Data systems that allow monitoring of medicines utilisation by diagnoses - claims data alone are insufficient.
  • Public education on the value of health insurance to reduce out-of-pocket expenses.

Steps to address barriers and enablers

  • Sharing data (including prices, utilisation) between public and private sectors within countries - sharing experiences between countries.

Next steps/monitoring progress

  • Proposal for a regional network to focus on medicines benefits in health insurance schemes.
  • WHO might facilitate development of a regional database on insurance medicines benefit policies and situations. The Medicines and Insurance Coverage (MedIC) health insurance surveys could be a useful initial tool to collect country information.


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Ensuring quality of medicines

Workshop 3

Convenors Rapporteurs

Susan Walters, Australia

Bhupendra Thapa, Nepal

Andrew Brown, Australia

Manuj Weerasinghe, Sri Lanka

Summary of key issues

  • Workshop focused on unintentional poor quality medicines.
  • Quality medicines are an essential component of a national medicines policy - industry needs to have an active role in ensuring quality products are manufactured.
  • Existing WHO pre-qualification processes are limited in scope - there is a role for inter-country cooperation and collaboration to share manufacturing quality information with the possibility of harmonisation of standards.
  • Capacity of individual countries is different, making a simple solution difficult.
  • Regulators require the financial and human resources to follow up and enforce standards.

Key barriers

  • With so many products in the market, regulatory authorities have limited capacity to assure quality.
  • Mistrust between manufacturers and regulators (policing not partnership role).

Key enablers

  • Strengthen regulatory authorities and where appropriate make use of existing quality assurance schemes, policies, standards, and share experiences between countries.
  • Develop stronger relationships between responsible manufacturers and regulators.

Steps to address barriers and enablers

  • Member states should work with WHO to initiate regional discussions on regulatory collaborations.
  • Individual governments should encourage inter-agency and industry collaboration to assess needs and develop capacity.

How to monitor progress in implementation

  • Regular country level monitoring and reporting on results of regulatory activities including inspections and product testing.
  • Regional sharing of information on quality assurance activities.


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Medicine supply and distribution

Workshop 4


Convenors Rapporteurs

Bev Snell, Australia

Klara Tisocki, Philippines

William Mfuko, Cambodia

Apolosi Vosanibola, Fiji

Summary of key issues

  • Quantification and forecasting
    • Lack of reliable, good quality data
    • Lack of oversight by dedicated staff or committee
    • Staff often not proficient in quantification methods (consumption and morbidity methods)
    • Often poor coordination between central departments and peripheral units.
  • Inventory management systems
    • Varying accuracy
    • Manual operations do not provide real-time data capture
    • Computer systems require staff training
    • It takes time to develop proficiency with the systems
    • Often there are no alternative systems for managing when computer systems are down
    • Poor data recording leads to inaccurate and unreliable data
    • Donor and vertical disease programs (for HIV, tuberculosis and malaria) often use separate reporting systems
    • Often poor linkage between stock management, essential medicines lists and standard treatment guidelines.
  • Issues in supply chain infrastructure
    • Often inadequate human and financial resources to run programs, along with poor quality buildings, limited storage and poor storage conditions
    • May be no effective donation policies or guidelines in place or where these exist they are not enforced
    • Diversion from public to private sector occurs in some settings.

Key barriers

  • Inadequate, untrained and inexperienced workforce and limited financial resources.
  • Lack of clearly articulated guidelines on ordering and supply management along with fragmented supply and distribution systems.

Key enablers

  • Essential medicines lists and standard treatment guidelines to guide the management of the supply and distribution system.
  • Adequate financial and human resources and strengthening of existing supply systems.

Steps to address barriers and enablers

  • Develop and use consensus-based supply chain management guidelines and standard operating procedures for every step of the supply and distribution chain.
  • Integrate and harmonise supply and distribution systems - recognise the importance of resilient supply chain systems as part of a functioning healthcare system.

How to monitor progress in implementation

  • Core indicators of supply chain management should be used to measure performance of the system at regular intervals.


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Generic medicines policies

Workshop 5

Convenors Rapporteurs

Azmi Hassali, Malaysia

Tuan Nguyen, Australia

Andrew McLachlan, Australia

Vandana Roy, India

Summary of key issues

  • Generic medicines are usually well established with respect to efficacy and safety and are a key strategy used by governments to contain medicines costs and improve affordable access to medicines.
  • With the expiry of patents of many 'blockbuster' medicines there is an important opportunity to save money by using generic medicines and to improve medicines access.

Key barriers

  • Mistrust in the quality of generic medicine products - bioequivalence may not be assessed.
  • Lack of appropriately skilled inspectors and monitoring to ensure the quality of generic medicine products.
  • Poor acceptance by consumers and health professionals due to quality concerns and misconceptions.
  • Mismatch between public (generic prescribing) and private (brand name prescribing) sectors.
  • Failure to fully implement generic substitution policies and guidelines.
  • Interplay between innovator and generic medicines sponsors, governments and healthcare professionals creates potential for conflicts of interest and opportunities for corruption.

Key enablers - the four Cs

  • Coordinate the implementation of generic medicines policies including procurement, reimbursement, retail price controls, and reference pricing to support the uptake of generic medicines.
  • Communication - regulators to make clear statements about the procedures involved in approving generic medicines and promote trust in the quality of generics to the community.
  • Commitment to procedures and infrastructure to demonstrate, evaluate and promote bioequivalence and maintain product quality to build confidence in generic medicines.
  • Community trust - educate public/consumers and health professionals to support understanding and confidence in generic medicines, and allow informed choices by consumers.

Steps to address barriers and enablers

  • Integrate generic medicines policies within the broader framework of national medicines policies and make active efforts to promote confidence in their quality and use.

How to monitor progress in implementation

  • Regular reporting on monitoring for the quality, price and use of generic medicines.
  • Assess changes in consumer and healthcare professional attitudes to generic medicines.


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Antimicrobial resistance and rational use of antibiotics

Workshop 6

Convenors Rapporteurs

Mary Murray, Australia

Niyada Kiatying-Angsulee, Thailand

Michael Chai, Malaysia

Debra Rowett, Australia

Summary of key issues

  • Antibiotic resistance is a growing but ‘invisible’ problem and, with few new antibiotics being developed and poor present use, it is a global issue requiring immediate action.
  • Contributors to antimicrobial resistance include:
    • Lack of access to affordable health care, leading to self-medication with antibiotics, combined with truncated courses of treatment due to poor knowledge and costs.
    • Poor use of antimicrobials based on patient demand not clinical need.
    • Poor use of up-to-date treatment guidelines, which are lacking altogether in some countries.
    • Inappropriate availability of antibiotics and use of sub-standard products.
    • Widespread use in animals for food production.
    • Global trade and travel that facilitate cross-border transfer of resistance.

Key barriers

  • Complexity – the dynamics of resistance, lack of knowledge and surveillance, misguided expectations, economic incentives in health systems and unregulated access in many settings.
  • Overcrowding in hospitals, poor infection control practices, the lack of reliable diagnostic tools and laboratory facilities mean infections may not be correctly identified and treated.
  • Time pressures when it is easier to prescribe an antibiotic than explain why it is not needed – powerful flow-on effects where pharmacists and drug sellers copy doctors’ prescribing.

Key enablers

  • Government recognition of antibiotic ‘crisis’ and commitment to action and resources including regulation of all actors in the supply chain including quality assurance and sanctions.
  • A prescriber ethos: ‘my individual behaviour impacts groups and systems around me’.
  • Communication material and processes that engage people emotionally in the issue.
  • Restricting access and therefore use of antibiotics by making them prescription-only medicines.

Steps to address barriers and enablers

  • Build partnerships and strengthen collaboration to make antibiotic resistance visible, and connect the enablers in a resourced national antibiotics policy platform to the national medicines policy.
  • Training in antimicrobial resistance in undergraduate and continuing health professional education programs to promote rational prescribing and dispensing of antibiotics – link research projects and training.

How to monitor progress in implementation

  • Policy platform for monitoring, evaluation (outcomes and impacts) and course corrections.


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Medicines safety

Workshop 7

Convenors Rapporteurs

John McEwen, Australia

Socorro Escalante, Vietnam

Anita Kotwani, India

Judith Mackson, Australia

Summary of key issues

  • Diversity in the region in country size, population, delivery and supply of medicines, and dependence on public and private sectors.
  • Need for country-specific national medicine safety programs embedded within a national medicines policy.
  • Medicines safety is more than adverse drug reaction monitoring and includes appropriate medicines, appropriate sources of supply, availability of unbiased information, as well as mechanisms to identify problems with medicines and processes to deal with them.
  • There needs to be unbiased information for the safe use of medicines available to doctors, pharmacists, nurses and consumers.
  • Stringent regulatory framework must exist for efficacy, quality and safety of medicines.
  • Proper vision and an ethos for setting up and working for safety of medicines is required.
  • There are challenges in access to expert clinical advice and prompt laboratory testing in some resource-poor settings.

Key barriers

  • Poor access to unbiased information, poor consumer health literacy and language barriers.
  • Lack of proper vision and framework to support a medicines safety program.

Key enablers

  • Experiences of countries that have good medicines safety programs.
  • WHO expertise on the implementation of medicines safety.

Steps to address barriers and enablers

  • Medicines safety activities should be embedded within the national medicines policy.
  • A network of Asia Pacific countries to share experiences and expertise for medicines safety program implementation.

How to monitor progress in implementation

  • Monitoring the outcomes following identification and analysis of signals of problems.


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Advertising and promotion

Workshop 8

Convenors Rapporteurs

Ken Harvey, Australia

Shila Kaur, Malaysia

Jared Hyams, Australia

Edelina Dela Paz, Philippines

Summary of key issues

  • WHO ethical criteria are still relevant - the challenge is to embed an ethical ethos into the behaviours of pharmaceutical industry and health professionals ('it takes two to tango').
  • Country regulations (based on WHO code) need to be enforced, breaches of codes and standards need to be appropriately penalised and publicised to facilitate deterrence.
  • The unregulated internet marketing of medicines poses challenges for regulators and law enforcement - consumer education should discourage online purchase of medicines.
  • The boundaries of medicines advertising need to be well defined (that is, information versus promotion) and the limitations of pre-clearance of advertising material recognised.
  • Promote transparency of medicines industry payments to health professionals (monetary and in-kind gifts, funding of continuing medical education) and consumer groups - for example, the US Sunshine Act.

Key barriers

  • Increasing outlets for medicines advertising (TV, online).
  • Monitoring advertising is a large and difficult task, especially for monitoring evidence for claims made - regulations are difficult to enforce and penalties need to be easily applied.
  • Industry opposition to regulation of advertising and promotion of medicines.

Key enablers

  • Develop ethical frameworks and monitoring of medicine advertising compliance.
  • Work with regulators and law enforcement agencies (Interpol for internet activities).
  • Use regulations rather than legislation - inform the public about violations and sanctions.

Steps to address barriers and enablers

  • Strengthen pre-approval process for medicine advertising - increase powers to enforce laws and regulations.
  • Provide independent, objective information to health professionals and consumers.

How to monitor progress in implementation

  • Monitor medicines industry-sponsored activities including continuing medical education, advocate for independent education arrangements, and track complaints and sanctions applied.
  • Development and regular reporting on indicators relating to regulation and advertising.
  • Monitor the processes of self-regulation to ensure standards are adequate and appropriate independent mechanisms are in place to manage breaches.


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Rational use of medicines

Workshop 9

Convenors Rapporteurs

Lynn Weekes, Australia

Kumud Kafle, Nepal

Nimmi Athuraliya, Australia

Michael Nunan, Australia

Summary of key issues

  • Implementing the rational use of medicines is often forgotten or considered too hard.
  • Needs to be aligned with all other elements of a national medicines policy to be effective.
  • Less than 50% of countries are implementing policies based on WHO recommendations for rational use of medicines.
  • It is critical to define the problem to prioritise actions and design interventions.
  • Political will is needed and can be engendered by data and supported by activism.
  • Sustainability should be included in planning for rational use of medicines.
  • There should be official endorsement of a body responsible for rational use of medicines within each country.

Key barriers

  • Workforce – rational use of medicines requires a broad skill base in program design, knowledge translation, educational strategies, behaviour change, communication, project management and evaluation.
  • Absence of data to clearly define problems with medicine use.
  • Misalignment of incentives, training, recognition and reward systems in the health sector.

Key enablers

  • Supportive and enforceable regulatory framework for rational use of medicines.
  • Solutions that are relevant to culture and setting - these will be supported by appropriate evidence.
  • Accountability and transparency for everyone engaged in the rational use of medicines.

Steps to address barriers and enablers

  • Twelve key interventions advocated by WHO offer a comprehensive approach to the rational use of medicines.
  • Support and resource drugs and therapeutics committees and rational use of medicines champions.
  • Information sharing across the region on successes and failures of rational use of medicines activities.

How to monitor progress in implementation

  • Evaluate specific interventions and programs - this requires data and skills in analysis.
  • Use existing networks, such as the International Network for the Rational Use of Drugs and the International Society of Drug Bulletins, and social media to communicate and engage with consumers and healthcare professionals and to evaluate impact.


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