Asia Pacific Conference on National Medicines Policies

doi:10.18773/austprescr.2013.093

Conference Report contents

This supplement reports on the proceedings of the Asia Pacific Conference on National Medicines Policies, held in Sydney, Australia, on 26-29 May 2012.

It was prepared by Dr Jane Robertson, Chair of the Scientific Program Committee, and does not necessarily represent the views of NPS, WHO, University of Newcastle or the Australian Government Department of Health and Ageing.

The Conference report is published as a supplement to Australian Prescriber online free of charge.

More detailed summaries of the symposia, workshop discussions and presentations in the plenary sessions are available on the Conference website.

Citation: Asia Pacific Conference on National Medicines Policies. Conference Report. Aust Prescr 2013;36 Suppl 1:S1-56.

Foreword, acknowledgements, preface

The Organising Committee, the Scientific Program Committee and the International Reference Panel are pleased to present this report of the Asia Pacific Conference on National Medicines Policies 2012.

In offering their support for this conference, the Australian Government and the World Health Organization demonstrated their commitment to national medicines policies in the region and confirmed the importance of robust and effective national medicines policies if the objectives of universal access to needed medicines and rational use of medicines are to be achieved.

The enthusiasm of the delegates and their willingness to openly share their views and experiences of implementing national medicines policies was testament to the commitment of those many individuals working in the region to deliver on the promises and potential for improved health care embodied in universal access to medicines.

We hope that the open and frank discussions of the barriers and enablers to policy implementation, and the emphasis on next steps and strategies that can be applied to overcome these barriers, provide guidance and direction for national efforts to extend policy implementation in the Asia Pacific region.

Professor Andrew McLachlan
Chair
Organising Committee
Sydney, August 2013

Executive summary

Introduction

According to the World Health Organization (WHO), a national medicines policy defines a framework for setting and monitoring medium- to long-term objectives in the public and private pharmaceutical sectors.1 The objectives of national medicines policies have not changed substantially over time, namely within the scope of a national health policy to ensure equitable access to and the rational use of safe and effective medicines of good quality and at a price both individuals and society can afford.

Despite the commitment to a national medicines policy in many countries, progress on the implementation of these policies has been inconsistent. In reality, most of the major causes of human morbidity and mortality in developing countries can be prevented or treated with existing essential medicines. For millions of people in these developing countries, problems of access to essential medicines remain. Medicines are often not available or affordable. They may be low quality or fraudulent products and they may be inappropriately used in practice. Consumer out-of-pocket expenses on medicines account for a substantial proportion of total healthcare expenditures in developing countries, and for many people on lower incomes, these out-of-pocket expenses push them below the poverty line with major health consequences.

Australia is unusual among developed countries in having had a functioning national medicines policy since 2000. The policy has the health outcomes of Australians as its objective and is usually described in terms of four arms or pillars:

equitable access to necessary medicines
medicines of high quality, efficacy and safety
quality use of medicines
a viable and responsible medicines industry.

During the opening session of the conference, Emeritus Professor Lloyd Sansom described the Australian policy as providing an ethos or framework for action. It is a set of broad high-level principles shared by all stakeholders, upon which processes, systems, resources and behavioural change can be developed and evaluated.

Given the importance of medicines to health care and overwhelming evidence of problems with medicines’ access and affordability in the Asia Pacific region, the overall aim of this conference was to advocate action to implement national medicines policies. This will promote universal access to needed medicines of assured safety, efficacy and high quality, and their rational use, by integrating national medicines policies into the healthcare systems of the participating countries. Important outcomes of the conference were agreed priorities and strategies to enable further implementation of national medicines policies across the region.

Conference objectives

To share knowledge, skills and experiences delegates have gained as they have moved to implement elements of their national medicines policies.
To understand the major enablers and barriers to policy implementation.
To determine the current priority elements of national medicines policies for implementation in participating countries.
To consider an evaluation framework to monitor implementation of national medicines policies for the region.
To strengthen networks and collaboration across the region to effectively implement national medicines policies.

Participants

Conference participants included policy makers, those working in government, health professionals, researchers and academics, representatives of consumers and civil society, non-government organisations, the pharmaceutical industry and those involved in quality use of medicines activities.

Countries from the Asia Pacific region officially represented at the conference were Afghanistan, American Samoa, Australia, Bangladesh, Bhutan, Brunei Darussalam, Cambodia, China, Cook Islands, Fiji, India, Indonesia, Japan, Kiribati, Laos, Malaysia, Marshall Islands, Federated States of Micronesia, Mongolia, Myanmar, Nauru, Nepal, New Zealand, Niue, Northern Mariana Islands, Pakistan, Palau, Papua New Guinea, Philippines, Samoa, Singapore, Solomon Islands, South Korea, Sri Lanka, Taiwan, Thailand, Timor Leste, Tonga, Tuvalu, Vanuatu, Vietnam and Western Samoa. In addition, the conference attracted delegates from the USA, France, Netherlands, South Africa, Switzerland and the UK.

The conference program

The emphasis of the conference was on sharing experiences. To this end, the conference included a number of plenary sessions with invited country presentations:

National medicines policies and universal access to medicines (presentations from WHO Western Pacific Regional Office, South East Asia Regional Office, Australia, and the UK).
Access to medicines, national medicines policies and healthcare reform (presentations from China, Japan, South Korea, and India).
Experiences of implementation of national medicines policies (presentations from Indonesia, Malaysia, Thailand, Laos and the Pacific Islands).
Challenges to implementation of national medicines policies: solutions and unresolved problems (presentations from Bangladesh, Sri Lanka, Vietnam, and the Philippines).

The conference program included four symposia focusing on important topics in the Asia Pacific region:

Legislation to ensure the sustainability of national medicines policies
Monitoring medicines use
Consumer education and health literacy
Access to and use of opioid medicines.

In addition, there was a special session presented by the United Nations Population Fund titled ‘Universal access to reproductive health services and commodities: Opportunities for national medicines policies/universal access to medicines collaboration’.

A key feature of the conference was a series of nine workshops focusing on different components and challenges associated with the implementation of national medicines policies. The workshop topics were:

Medicines selection and essential medicines lists
Medicines financing and health insurance initiatives
Ensuring quality of medicines
Medicines supply and distribution
Generic medicines policies
Antimicrobial resistance and rational use of antibiotics
Medicines safety
Advertising and promotion of medicines
Rational use of medicines.

Exploring the issues

This report provides summaries of the conference presentations and workshops. Given the importance of the symposia and workshops as forums for the exchange of ideas and the development of strategies for further implementation of national medicines policies, there is relatively more emphasis on these discussions than on the plenaries in this report. The output of each symposium and workshop was a structured dot point summary of key observations relating to the topic, comments on the key barriers to, and enablers of policy implementation, practical steps to address the barriers and enablers and comments on how to monitor progress in the implementation of that aspect of a national medicines policy.

The conference report is published as a supplement to Australian Prescriber at www.australianprescriber.com/supplement/36/1/1/56. More detailed summaries of the sessions are available at www.apcnmp2012.com.au.

Key observations

Many of the recommendations of the 1995 conference remain important for participants in the 2012 conference:

Recognising health as a human right.
Embedding a national medicines policy within a health systems policy framework.
The importance of political will to introduce appropriate legislation and to support policy implementation.
The need to provide adequate human and financial resources for national medicines policy activities.
Enforcing legislation and regulations to ensure affordable access to high quality, safe and effective medicines.

However, in 2012 the emphasis has changed. In 1995 the conference focused on establishing national medicines policies and convincing decision makers of their value. The focus of the 2012 conference was the successful implementation of national medicines policies, using experiences across many countries to propose strategies to enhance policy implementation and sustain national medicines policy activities into the future.

Health as a human right

This right is embodied in the WHO Constitution:

the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.²

Improving health has many dimensions including adequate shelter, sanitation, improving nutrition, and education along with the provision of appropriate and affordable health care for the prevention and treatment of disease. Medicines will be competing with other programs for scarce resources. However, health is being increasingly viewed as a major issue in, perhaps even an indicator of, economic growth and development particularly in low and middle income countries. Medicines and their judicious selection, availability and use are important in effective health care.

Political commitment to policy and processes

In a number of countries, the early gains in national medicines policy implementation have been lost due to a lack of ongoing political commitment and loss of policy champions. Governments need to recognise the importance of a strong legislative framework and a commitment to enforcing the law. Existing systems need to be strengthened and financial resources mobilised to address regional problems in providing access to medicines of appropriate quality, safety and efficacy. National medicines policies and activities to support them need to be presented as a compelling business case for governments to support and resource.

National medicines policies need to be embedded in health policies and health systems

National medicines policies should not exist in isolation. They need to be considered as part of the delivery of high quality health services. The policy milieu extends beyond health systems policy, given that national medicines policies have substantial financial implications and will be affected by financial policy and trade considerations, international treaty obligations, industry policies, education policies and the legislative and regulatory framework of the country. The policy landscape increasingly includes public-private partnerships. These need to be negotiated, monitored and evaluated for their impact on health service delivery.

Ethical questions and challenges

In an environment of resource constraints and competing demands for limited financial resources, there will be difficult ethical questions to confront. If it is not possible to provide for all people, how can governments allocate resources to maximise the benefits of policy interventions? Decisions need to be supported by high quality evidence and take account of societal values, recognising that equity is an important goal of universal access. Transparent decision-making frameworks along with active monitoring and evaluation of policy activities are required to ensure that systems are effective, efficient and sustainable.

Health literacy and engagement of civil society

Civil society has an important role in maintaining pressure on governments and decision makers to continue to value and to deliver on health care. The dialogue on resource allocation must engage all levels of civil society, especially the consumers of health care. Greater awareness and understanding of health issues and active community engagement will need to be underpinned by improvements in health literacy. In many settings there is an abundance of information and promotional activity from the pharmaceutical industry, but a relative lack of health literacy and objective information meeting consumer needs. Furthermore, it is essential that governments and societies continue to place a high value on health literacy as a long-term investment in the health of each nation's people.

Sufficient financial and human resources

Capacity building to fulfil the functions of a national medicines policy was a recurring theme of the conference. Adequate staffing and task-specific training are essential to implement national medicines policies, along with adequate financial resources to retain and develop high quality staff. Through strategic collaboration, international and regional experts can help to train local staff in areas such as the law, quality assurance, regulatory control, medicines procurement and the design, development, delivery and evaluation of programs for the rational use of medicines.

Monitoring and appropriate use of health and medicines data

Routine collection of relevant health and medicines data is required to monitor the effectiveness and efficiency of existing systems and to assess progress in national medicines policy implementation. Data collection and analysis need to be timely. Information needs to be provided to decision makers and stakeholders in ways that are easy to understand and provide a platform for action. There is an urgent need for training staff in data collection, analysis and interpretation of health and medicines information. IT systems offer the promise for cost-efficient data collection but need to be designed to support monitoring and evaluation. Data are needed to demonstrate the value of implementing national medicines policies.

Collaboration and relationship building

Regional partnerships and networks may help overcome capacity constraints. Recognising medicines evaluations and quality assurance activities conducted by other drug regulatory authorities provides an opportunity to minimise the duplication of effort. Sharing experiences, challenges, resources and solutions will support further activities to implement national medicines policies.

Advocacy

An important missing link in implementing national medicines policies is the voice of the consumer. This reflects the failure of the national medicines policy movement to engage effectively with communities and to socialise and politicise the issues of medicines access and affordability. The consumer viewpoint must be heard and community values and priorities incorporated in policy development and decision making. Effective civil society action will require champions to energise the debate and advocate for change on behalf of those who will benefit most from effective national medicines policies.

Conclusion and next steps

An overwhelming view of the conference was of the value and importance of regional collaboration and networks, to share experiences, information and expertise. The conference provided an important platform for starting to build these collaborations and networks. The conference discussions gave rise to a number of important action items that can help stimulate further implementation of national medicines policies in the Asia Pacific region.

The next steps involve dissemination of the conference outcomes to policy makers and those actively involved in the medicines-related activities. In addition, follow-up activity will involve developing a small number of regional projects that foster relationship building and information exchange, and that encourage data collection and reporting both within and between countries.

Delegates gave overwhelming support to a future conference on national medicines policies in three to five years to continue the dialogue and reflect on progress towards universal access to needed medicines of assured safety, efficacy and quality, and their rational use.

The boundaries and names shown and the designations used on the map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the leagal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for ehich there may not yet be full aggreement.

The Cook Islands, Niue, Tokelau and Tonga are also part of the WHO Western Pacific Region but are not shown in this map projection.

Data Source: World Health Organization map production: Public Health Information and Geographic Information Systems (GIS) World Health Organization

Action items

The plenary sessions, workshops and symposia identified important medicines-related activity where action is required. A number of actions were common to multiple aspects of a national medicines policy:

the need for capacity building
the importance of data collection and analysis for monitoring progress in implementing national medicines policies
opportunities for regional collaboration and information sharing.

1. Capacity building and information sharing

Regional collaboration to build capacity for evaluation of medicines for inclusion on a national essential medicines list.
Sharing expertise for the design, development, delivery and evaluation of rational use of medicines and medicines safety programs led by regional experts.
Sharing of health and medicines-related data on:
- medicines prices in the public and private sectors
- medicines regulation and quality assurance activities
- successes and failures with rational use of medicines activities.

Action: Maintain a register of regional expertise to enable countries to quickly identify resources to assist with medicines safety problems.

Action: Create and maintain networks of interested healthcare professionals and policy makers for specific areas of policy activity – for example antimicrobial resistance – to facilitate discussion, information sharing, problem solving and capacity development.

2. Data collection and analysis for monitoring policy implementation

Regular monitoring and reporting on:

Drug regulatory authority staffing and functions, and outcomes of regulatory activities including inspections and product testing.
Procurement, access and use of opioid medicines within each country.
The performance of medicines supply systems.
Reproductive health program-specific indicators.
Medicines availability, use and affordability (including out-of-pocket expenses).
Monitoring of prices, use and quality of generic medicines.
Antimicrobial resistance, prescribing practices, ease of antimicrobial availability and consumer use of antibiotics.
Outcomes following identification and analysis of medicines safety problems.
Indicators relating to regulation, advertising and rational use of medicines.

Action: Examine routinely collected medicines-related data within country to assess usefulness for monitoring and reporting activities. When this does not exist, establish minimum data sets and standardised methods to provide useful data to inform and monitor program delivery.

Action: Develop limited sets of validated indicators relevant to each national medicines policy activity to be used for within-country monitoring and to facilitate between-country comparisons.

Action: Use examples of data collection and analysis to advocate for human and financial resources to support national medicines policy activities and to sustain ongoing monitoring.

3. Legislation to ensure sustainability of national medicines policies

Action: Promote dissemination and sharing of best practice legislation, regulations, codes and standards.

Action: Promote greater collaboration between the legal and health sectors regarding laws related to medicines and national medicines policies through engagement in topic-specific projects.

Action: Develop country level programs to train medicines inspectors on the evidence required to pursue successful prosecutions in the court system.

Action: Conduct country level reviews of penalties, sanctions and successful prosecutions for breaches of medicines laws.

4. Health insurance and health care financing

Action: Develop a regional database on insurance medicines benefits policies and situations. The health insurance surveys of the Medicines and Insurance Coverage initiative (see Appendix 4) could be a useful initial tool to collect country information.

5. Access to and use of opioid analgesic medicines

Action: Develop policies and guidelines on prescribing and availability of opioid medicines within a country.

6. Medicines industry

The conference provided an important opportunity to engage in discussions on industry roles and responsibilities with national medicines policies. Both multinational and local manufacturers of branded and generic medicines need to participate in discussions on mechanisms to increase medicines access, ensure quality products are available and maintain the security of the supply chain, improve policies and practices around promotion, and address needs for antimicrobials and medicines for neglected diseases. There is a need to explore new business models that recognise the need to balance profits with affordable and universal access to medicines, particularly in low and middle income countries.

Action: Engage stakeholders (industry, regulatory authorities, consumers, health professionals, academia) to examine paths to progress affordable and universal access to medicines in low and middle income countries. Tools such as the Access to Medicine Index (see Appendix 4) may provide a mechanism for monitoring industry activity and progress towards universal access objectives.

7. Reproductive health services and commodities

Action: Explore the possibilities for collaboration between procurement and supply of essential medicines and the provision of reproductive health services and commodities.zdb

Symposia

Special Session

Universal access to reproductive health services and commodities: Opportunities for national medicines policy/universal access to medicines collaboration

Convenor	Rapporteurs
Peter Zinck, Fiji	David Lee, USA Mary Hemming, Australia

Summary of key issues

Maternal mortality rate remains alarmingly high in many developing countries.
Family planning is still an unfinished agenda.
Reproductive health supplies are commonly out of stock at service delivery points.

Key barriers

Lack of policies and adequate funding to support reproductive health programs.
Weak bureaucracies limit the implementation of agreed policies in some countries.
Complex systems of funding, multiple procurement agencies, logistics operators, and reproductive health service providers hamper efficient service delivery.
'Silo' approaches and fragmented systems contribute to duplication and inefficiency.

Key enablers

Improved information and supply management systems.
Collaboration in providing reproductive health services and commodities, and essential medicines, through national medicines policies.
A regional policy framework needs to be developed and requires commitment and implementation.

Steps to address barriers and enablers

Political will and action are needed to align reproductive health activities with national medicines policies and to build partnerships and collaboration.
Reproductive health commodity supply management systems need strengthening and integration to ensure security of supply and avoid stock-outs.
Human resource development to support, implement and maintain programs.

How to monitor progress in implementation

Regular monitoring and reporting on reproductive health program specific indicators.
Regional sharing of monitoring information based on comparable minimum data sets.

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