Conference opening and Opening address
The conference began with a ‘welcome to country’ ceremony from Mr Michael West, a cultural representative of the Metropolitan Local Aboriginal Land Council who are the traditional custodians of the land, air, water and culture within their boundaries.
Dr Suzanne Hill, the Chair of the Australian Pharmaceutical Benefits Advisory Committee, formally opened the conference, speaking on behalf of the Australian Minister for Health, the Hon Tanya Plibersek.
Dr Henk Bekedam from the Western Pacific Regional Office of the World Health Organization (WHO) welcomed conference delegates on behalf of the WHO.Professor Andrew McLachlan, the Chair of the Organising Committee for the conference, welcomed delegates on behalf of the Australian organisers
The Hon Tanya Plibersek MP
Australian Minister for Health
Speech delivered by
Dr Suzanne Hill
Pharmaceutical Benefits Advisory Committee
I would like to begin by acknowledging the traditional custodians of the land on which we meet, and pay my respects to their elders, both past and present.
It is a great pleasure to be with you today on behalf of the Australian Minister for Health, Tanya Plibersek.
Australia is pleased to again host an international conference on national medicines policies – an opportunity for constructive sharing of knowledge, skills and experiences on this vital aspect of health care.
I am delighted to see so many countries from across the South East Asia and Western Pacific regions represented here today, along with visitors from countries further afield including the United States, the United Kingdom and Europe.
Australia led the way with our National Medicines Policy. Established in December 1999, it continues to evolve to meet the changing needs and circumstances of government, consumers, health professionals and industry.
Of course there are initiatives in other countries which will be of great interest to Australians and could help to make a good system even better – which is what the exchange at this conference is all about.
Similarly the Australian approach can be of interest even though it may not be directly transferable to some countries.
Different countries in our region are at different stages in their development and implementation of health system and medicines policies.
They will need to ensure their own medicines policies are developed to best serve their people and their health systems.
We are all here to learn.
In this afternoon’s plenary session, Professor Lloyd Sansom will provide a more detailed account of Australia’s experience in implementing our National Medicines Policy.
For now, I would like to highlight the partnership approach which has underpinned that implementation.
The policy framework is based on partnerships between:
- governments (Commonwealth, States and Territories)
- health educators
- health practitioners and other healthcare providers
- the medicines industry
- patients and their carers.
All of these partners work together to promote the four central objectives of the policy.
- timely access to medicines that Australians need at a cost individuals and the community can afford
- ensuring that all medicines meet appropriate standards of quality, safety and efficacy
- quality use of medicines by consumers and health professionals
- maintaining a responsible and viable medicines industry.
First, timely access to affordable medicines.
The Pharmaceutical Benefits Scheme (PBS) is the primary means through which the medicines policy is implemented to ensure reliable, timely and affordable access to a wide range of medicines for all Australians.
The inclusion of medicines on the PBS is done on advice of an independent statutory authority, the Pharmaceutical Benefits Advisory Committee. The Committee considers not only the clinical effectiveness of a medicine but also its cost-effectiveness before recommending it to Government. It is this process that has helped Australia achieve highly competitive prices for new and innovative medicines.
The Government currently subsidises over 4,000 medicines through the PBS, making it one of the most accessible and affordable medicine subsidy schemes in the world.
Some of the subsidies provided by the PBS – on rare and expensive medicines – are very large.
The overall cost of the PBS represents a large portion of the health budget. In 2005–06 the PBS represented 12.8% of all Commonwealth Health expenditure. In 2010–11 that percentage had grown to 14%.
In fact, the PBS is expected to cost the Australian Government around $9.4 billion in 2011–12, which is an increase of 6.1% on 2010–11.
This investment is a direct reflection of the commitment the Australian Government has to the PBS because, just as it has done since 1948, it provides all Australians with affordable access to the medicines they need. And in combination with providing funding and support to around 5,000 pharmacies it also ensures these medicines can be accessed in a timely fashion, wherever in Australia you are.
Ensuring the ongoing sustainability of this system is of the utmost importance to the Government. This is why consecutive governments have introduced various reforms to ensure the correct balance between taxpayer-funded PBS subsidies, contributions from consumers and an environment that encourages industry to bring new medicines to Australia.
I am sure that you will be hearing more about the PBS and the approvals process during the course of the conference.
The second priority of the National Medicines Policy is that medicines meet appropriate standards of quality, safety and efficacy.
One of the major mechanisms for this is the Therapeutic Goods Administration (TGA). The TGA is responsible for ensuring that therapeutic goods available for sale and supply in Australia are safe and fit for their intended purpose.
Before a prescription medicine can be marketed in Australia it must be included in the Australian Register of Therapeutic Goods. In order to register a new medicine in Australia, a sponsor must submit an application together with supporting data to the TGA. The TGA evaluates the data to establish the quality, safety and effectiveness of the product when used as intended.
The TGA also usually seeks advice from two independent, expert advisory committees, before deciding to approve or reject a new product.
The third objective of the medicines policy is quality use of medicines.
It means –
- selecting management options wisely
- choosing suitable medicines, if medicine is needed
- using those medicines safely and effectively.
The National Prescribing Service (NPS) is the Australian Government’s implementation body for quality use of medicines under the medicines policy.
The NPS provides independent advice to prescribers, pharmacists and consumers to support decisions about medicines, and raise awareness about the quality use of medicines.
The work of the NPS covers all prescription, non-prescription and complementary medicines and many of its programs are targeted directly towards areas of specified need.
One of these is antibiotic resistance – a key challenge currently facing Australia and many of the countries represented here today, and the focus of Workshop 6.
Last February, the NPS launched a five-year program to address antibiotic resistance within the Australian community, initially targeting health professionals, with a consumer component launched in April 2012.
A new government program to support quality use of medicines involves monitoring the use of medicines after they have been listed on the PBS. Postmarket monitoring of the way medicines are used in clinical practice will improve medication safety, evidence development, quality use, effectiveness and cost-effectiveness.
This conference is also looking at some postmarket monitoring of medicines. In particular those used in the management of pain. This will be another area where the discussions at this conference offer a valuable learning opportunity for all.
Objective four of the National Medicines Policy is maintaining a responsible and viable medicines industry.
The Government and the peak body representing the majority of suppliers to the PBS, signed a four-year Memorandum of Understanding (MOU) – to promote the efficiency and sustainability of the PBS, and support a viable and responsible medicines industry in Australia.
This MOU provides for a period of stable pricing policy and improved listing timetables for all suppliers, in exchange for more competitive prices for generic medicines on the PBS. This agreement is delivering over $1.9 billion in savings to the PBS over five years.
In the past two years, the Government has also introduced measures to make it easier for companies to list new and innovative medicines on the PBS and new tax incentives to support research and development. This is coupled with its fifth agreement with Australia’s community pharmacies which not only ensures that medicines are available when they are needed, but has also recently contributed over $1 billion in savings over five years to support the sustainability of these services.
In all of these ways, partnerships are continuing to help the Australian Government to deliver medicines to Australians who need them.
There will be a further opportunity for partnership with consumers from 1 July 2012 when the Personally Controlled Electronic Health Record becomes available.
This e-health innovation has the potential to improve the efficiency and safety of health care, including use of medicines, by reducing transcription errors and duplication.
Medicines are essential to the health of any person and any nation. Medicines policy is of great importance, which is why the Australian Government has supported this conference through the NPS, the Department of Health and Ageing and AusAID.
It is another example of a valuable partnership. The Government thanks the NPS, the University of Newcastle and the World Health Organization for their hard work in bringing this conference to fruition.
I have great pleasure in declaring the conference open.
National medicines policies and universal access to medicines
Madeleine de Rosas-Valera, Philippines
Andrew McLachlan, Australia
Budiono Santoso, Western Pacific
Kathleen Holloway, South East Asia
Lloyd Sansom, Australia
Michael Rawlins, United Kingdom
Dr Budiono Santoso highlighted that since the conference on national medicines policies held in 1995, most countries of the Asia Pacific region have developed national medicines policies that embrace the key elements of medicines access, safety, efficacy and rational use. However, in many countries these policies are not fully implemented. A key issue was the availability and affordability of essential medicines.
A critical barrier for access to medicines is significant out-of-pocket expenses, particularly in the private healthcare sector. Out-of-pocket medicine expenses account for most health expenditure and these costs can drive low-income earners below the poverty line. The procurement cost of medicines is a key issue. One solution that has been implemented is a Price Information Exchange website (piemeds.com) to voluntarily share the prices of medicines procured in the public sector in an attempt to achieve transparency.
The quality and safety of medicines remain concerns in the Asia Pacific and around the world as a result of a lack of rigorous regulatory control. For example, the contamination of glycerine (used in liquid dose forms) with di-ethylene glycol has led to numerous deaths across many countries over the last three decades.
Dr Santoso reinforced the key issues in successfully implementing national medicines policies to improve health outcomes for people in the Asia Pacific region. These include:
- Political commitment to policy and processes.
- A focus on the health services delivery system (including appropriate funding and staffing and an efficient medicines delivery system).
- The need for monitoring progress in policy implementation.
- Information exchange, sharing of experiences and consultation.
Successful implementation of a national medicine policy requires a functioning health system.
Dr Kathleen Holloway addressed the question of the evidence of benefit from the successful implementation of national medicines policies. She highlighted some challenges in policy implementation including the prevalence of unsafe practices (for example pulverising and mixing medicines), inappropriate medicines promotional activities and the lack of policies in place to encourage the rational use of medicines.
Central to this presentation was an analysis of data to investigate whether public sector medicine use is better in those countries with pharmaceutical policies compared to those countries without such policies. This study drew on medicines policy data from questionnaires sent to ministries of health in 2003 and 2007 and quantitative data on public sector medicine use in 58 countries for 2002-08 from the WHO databases of medicines use indicators. Although the comparability of the data was problematic, the study found that a number of policies intended to improve rational medicines use and medication safety were correlated with better medicine use. Furthermore, it was found that the more policies that were implemented, relating to rational use of medicines, the better the overall use.
The implication is that implementing policies is critical to improving medicines use and that the most significant effects are observed when a number of policies are implemented together. Dr Holloway concluded that an integrated coordinated package of strategies and policies is needed to improve medicines use.
Emeritus Professor Lloyd Sansom presented the Australian experience on implementing national medicines policy. His presentation provided a historical perspective on the emergence and maturity of the Australian National Medicines Policy including the key role that consumers played. In particular, he highlighted that many of the key structures that facilitated the objectives of the policy, such as a strong medicines regulatory body and a scheme supporting subsidised access to medicines, were well established before the Australian policy was accepted and approved by all arms of government. Central to the success of the implementation of the Australian National Medicines Policy has been the focus on health outcomes for Australian consumers and the partnership approach.
The presentation mapped the course of policy development and implementation in Australia including the roles of expert committees, the availability of resources (for example Therapeutic Guidelines, Australian Medicines Handbook), engagement of stakeholders and key action organisations (such as NPS MedicineWise). Professor Sansom said that the need for a national medicines policy was led by Australian consumers and the primacy of the consumer was central to strategies to implement the policy and the quality use of medicines. He concluded that although Australia’s policy is not perfect, it provides a focus and structure to deal with future health demands for the benefit of all stakeholders. Lastly, Professor Sansom encouraged delegates to reflect on the progress to date and to see that significant change and improvement in this sector is possible.Sir Michael Rawlins, chairman of the UK National Institute for Health and Clinical Excellence, provided an international perspective on the implementation of medicines policy with a focus on health technology assessment. He highlighted the need for comprehensive assessment processes to investigate comparative effectiveness and the resource implications for decision making in the context of national medicines policies. The presentation considered the limitations of the hierarchy of evidence (including the lack of empirical evidence) and the need to consider the context in allocating limited health resources. Central to the presentation was the concept of 'distributive justice', meaning the socially just allocation of resources.
Access to medicines, national medicines policies and health care reform
Henk Bekedam, Western Pacific
Suzanne Hill, Australia
Sun Jing, China
Kazuko Kimura, Japan
Soonman Kwon, South Korea
Amit Sengupta, India
China: Health care reform and the essential medicines system to ensure universal access – experiences of China
Dr Sun Jing described the nationwide comprehensive and systematic health care reform that has been carried out since 2009 in China. A framework of universal access to basic health care has been established, national coverage of basic health insurance has increased, and the benefit package available to citizens has been continuously improved with the aim of decreasing individual out-of-pocket health expenditure. The basic public health services have been strengthened by secured government funding. Primary care in both urban and rural areas has been reinforced. The essential medicines system commits to equal physical and financial access to quality medicines and their rational use.
The Chinese Government is committed to further reforms to improve the universal basic health insurance system, to consolidate the essential medicines system and broaden implementation of the zero mark-up policy, and to enhance the operation of primary care. However, a fully secured system of universal access to safe, efficient, convenient and affordable basic health care will not be achieved until 2020.
Japan: Experiences in implementing a policy on universal coverage of health insurance
Professor Kazuko Kimura noted that Japan celebrates 50 years of implementation of universal coverage of health insurance. The origins of the system can be traced to 1905 and the Kanebo Company and Yawata steel enterprise which established Mutual Aid Associations for employees to provide comprehensive benefits including health care. The Health Insurance Act of 1922 covered workers from factories, mines and transport - around 3% of the population. The National Health Insurance Act followed in 1938, and since 1961 all citizens have been covered.
Improved access to medicines has been followed by improvements in health outcomes. Child mortality rates for infectious diseases and vaccine preventable diseases dropped sharply between 1950 and 1965, and high adult mortality from tuberculosis rapidly declined between 1950 and 1977. Access to antihypertensive drugs and reduced dietary salt intake contributed to the lowering of average blood pressures in the 1960s. Healthy lifestyle, compulsory education, established healthcare systems, good water supply systems, maternal health as well as strong government stewardship, and universal access to medicines and medical care contribute to Japanese life expectancy being the longest in the world.
South Korea: Pharmaceutical policy in Korea: Role of health insurance in pricing, reimbursement and monitoring
Professor Soonman Kwon described the Korean national health insurance system that provides universal coverage of the population. Health insurance benefits for medicines are based on a positive listing system that includes formal economic evaluation. Prices of originator medicines are negotiated between the insurer and the pharmaceutical manufacturer. The prices of generic medicines are fixed as a percentage of the originator drug.
Measures are in place to monitor the behaviour of prescribers and to contain pharmaceutical expenditure, including monitoring and prescriber feedback in the areas of expenditure, polypharmacy, and the use of generics and antibiotics. There are financial incentives to prescribers for savings in costs. The real-time drug utilisation review checks precautions for age and pregnancy, duplications, and adverse interactions. These programs use information technology, and information on provider performance on medicines use is also disclosed on the website of the insurer.
Pharmaceutical expenditure accounts for a large share of health expenditure. Payment system reforms for healthcare providers have been proposed, but not implemented due to strong opposition.
India: Working towards universal health coverage in India
Dr Amit Sengupta described the situation in India as a paradox. While India is the third largest producer of medicines (by volume) in the world, it also has the largest number of people (more than 650 million) without secured access to essential medicines. A key barrier to access in India is extremely high out-of-pocket expenses for health care as public expenditure on health is low (around 25% of total health care expenditure). More than 75% of out-of-pocket healthcare expenses relate to medicine purchases. Retail sales account for more than 80% of the total value of medicines consumed.
Challenges for the health system in India are the need for significantly enhanced coverage by the public health system (requiring increased procurement and distribution of medicines) and the need for price controls for essential medicines. An additional challenge relates to changes in global and domestic policy environments, including implications of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The acquisition of Indian generic manufacturing companies by transnational corporations points to the vulnerability of generic drug production in India, with consequent impacts on access to affordable medicines.
The experiences of these countries highlight that assuring universal access to medicines is most often a step-wise process. Importantly there is some evidence to support the argument that better access to medicines leads to better health outcomes at the population level. The challenges differ according to setting, however progress towards universal access to medicines requires government commitment to policy implementation through effective legislation, and financial resources to sustain and expand systems.
Ongoing monitoring activities are important at both system and healthcare professional level. Information technology can support these activities.
The contents of benefit packages need to be reviewed to ensure the sustainability of health insurance systems and their relevance to a country’s healthcare needs. Progress towards cost containment, affordable medicines and universal access will sometimes be impeded by industry and health care professionals with vested interests. In all of the countries represented in this plenary session, universal access to medicines remains a work in progress.
Experiences of implementation of national medicines policies
Budiono Santoso, Western Pacific
Anthony Smith, Australia
Lucky S Slamet, Indonesia
Salmah Bahri, Malaysia
Lamphone Syhakhang, Laos
Melenaite Mahe, Tonga
Indonesia: Implementing medicines policies in the decentralised environment
Dr Lucky S Slamet described the introduction of a revised Indonesian National Medicines Policy in 2006 in response to new challenges posed by a global medicines industry and a decentralised medicines management system in Indonesia. An important strategy of the policy is the revitalisation and implementation of the national essential medicine concept and a focus on a robust quality assurance system. Decentralised supply requires efficient planning, financing, procurement, and distribution systems. All public health facilities are obliged to procure generic essential medicines.
Data monitoring since the introduction of the revised policy suggests some improvements in the availability of essential medicines in public health centres, although this falls far short of ideal and results vary between hospital and district health facilities.
The quality assurance system remains a centralised function (National Agency of Drug and Food Control), with regulations, standards, and enforcement activities imposed by the national government. While decentralisation and effective quality assurance have been key factors in maintaining the accessibility and affordability of good quality medicines in Indonesia, there are ongoing challenges in balancing functions in a decentralised environment.
Malaysia: Pharmacy transformation planning; reform for universal access to medicines
Dr Salmah Bahri outlined strategies for pharmacy transformation in Malaysia consequent to the 2006 Malaysian National Medicines Policy. A number of strategies were introduced to support the objectives of the policy including:
- Improving the legislation and regulation of medicines and pharmaceutical quality assurance activities.
- Strengthening the supply of medicines through effective delivery services of medicines.
- Ensuring the affordability of medicines through effective monitoring of drug price, generic policies and drug financing.
- Improving the quality use of medicines by enhancing clinical pharmacy services, providing training and education to healthcare providers and the general public.
Effective strategies to address medicine affordability are a particular challenge. Good governance for medicines is inculcated in best pharmacy practices and the management of the entire pharmaceutical sector. A new pharmacy bill, pharmacy liberalisation, benchmarking and accreditation of pharmacy facilities will soon be introduced. At the central level, the Pharmaceutical Services Division will be responsible for the ongoing implementation of strategies to achieve the medium- and long-term goals of the policy.
Laos: Implementing national medicines policies in resource constrained environments
Dr Lamphone Syhakhang described revisions to the Lao National Drug Policy in 2000. In addition to a focus on essential medicines, the policy also promotes the use of traditional medicines.
Quality assurance systems have been strengthened through the development of law and regulations, and there have been improvements in drug selection, registration, licensing and procurement procedures. Inspections of public and private pharmacies, pharmaceutical companies and factories have been carried out. Good pharmacy practice, good wholesaling practice and good manufacturing practice have been promoted.
The rational use of medicines has been improved through training for health staff and education of the general public. In addition, standard treatment guidelines have been developed, and drug and therapeutics committees have been formed. Village revolving drug funds have enhanced access to essential medicines. However, many challenges remain, particularly in building the capacity of the drug regulatory authority in law and regulations enforcement, strengthening the quality assurance system, improving the rational use of medicines and ensuring the sustainability of revolving drug funds.
Pacific Island countries: Implementing national medicines policies in small island states
Ms Melenaite Mahe noted that the recommendations of key meetings of ministers and directors of health in 1995, 1997, 1999 and 2009 have translated into the construction or drafting of national medicines policies in 14 Pacific Island countries. This has occurred with the assistance of technical and financial support from development partners and other stakeholders. A priority has been ensuring access to essential medicines. Policy implementation has generally been carried out by pharmacy departments. Information and knowledge acquired is shared with all the Pacific Island countries.
The specific example of Tonga was mentioned. Priority activities implemented since the endorsement of the Tongan National Medicines Policy in 2000 include:
- Development and enactment of key pharmaceutical legislation.
- Development of standard treatment guidelines and essential medicines lists.
- Strengthening the procurement and inventory management systems.
- Public awareness programs on rational use of medicines.
- Establishment of a national drug and therapeutics committee.
Common challenges in the Pacific Island countries are a lack of political will and commitment to policy implementation, lack of qualified personnel and high staff turnover, lack of cooperation with other ministries, inadequate funding for pharmaceutical activities and delays in the endorsement of legislation. Medicines policies should be aligned with and linked to broader health policies and plans. Inter-country collaboration in some areas has proved to be essential.
These country examples highlight the challenges of implementing the many aspects of a national medicines policy. While the specific issues may differ according to setting, common themes are the need for government commitment to policy implementation, the availability of adequate human and financial resources to support medicines related activities, and the importance of a medicines policy being seen as part of the broader healthcare system. As issues regarding quality assurance and medicines selection are addressed and more efficient supply systems are put in place, attention is turning to the rational use of medicines. Training of healthcare professionals and education of the general public about appropriate use of medicines are key strategies to improve medicines use in practice.
The pharmaceutical industry and national medicines policies - panel discussion
Eugene Salole, Australia
Dennis Ross-Degnan, USA
Reiner Gloor, Philippines
Sivalal Sadasivan, Malaysia
Will DeLaat, Australia
Ric Day, Australia
The industry plenary session focused on the approaches and attitudes of the pharmaceutical industry towards national medicines policies in the Asia Pacific region. The panel considered a number of specific questions:
- What are the effects of public-private partnerships on access to medicines in the Asia Pacific region? Is there a role for differential pricing in improving access to needed medicines?
- Is there a role for pharmacoeconomic analysis in low and middle income countries?
- What are key issues in the security of the pharmaceutical supply chain?
The role of public-private partnerships
The panel recognised the importance of engaging with the pharmaceutical industry to discuss strategies to improve medicines access and use in low and middle income countries. In doing so, generic manufacturers are as relevant as originator companies as stakeholders in the discussions concerning access to medicines. Industry initiatives and partnerships to improve access should be guided by corporate responsibility principles and will be judged by how well they 'fit' the national medicines policy model. Effective models for improving medicines access in the region may include market segmentation and differential pricing, voluntary licensing, comprehensive patient access programs, and long-term philanthropic donations. The panel noted that the voice of the consumer is central to a properly constituted and functioning policy.
Discussions on new business models for industry have been prompted by concerns about the increasing prevalence of market failures. Examples include increasing antimicrobial resistance and the urgent need for discovery and development of new antibiotics, and the need for new treatments for neglected diseases. Options that have been identified to address these issues include pre-competitive research and development funding mechanisms and product development partnerships.
The marketing of pharmaceuticals in the region received attention. Patchy policies and practices that are clearly not aligned with the principles of the rational use of medicines are a substantial issue for the region. Low and middle income countries generally have less effective regulations about promotion, although it was acknowledged that this was a problem in all countries and regions.
The panel discussed the Access to Medicine Index. This index aims to competitively rank the activities of pharmaceutical companies in promoting access to medicines in low and middle income countries. The purpose is to try to quantify the range of pharmaceutical company practices with respect to access to medicines according to the principles of rational use. Performances are ranked from poor to excellent as a mechanism to promote stakeholder ownership, dialogue and action. The idea of showcasing best practice as a competitive stimulus as well as being attractive to an enlightened industry was of interest to the panel.
The role of pharmacoeconomic analysis in low and middle income countries
The panel noted that there was considerable expertise in pharmacoeconomic analysis in the region that could be helpful to these countries. It was suggested that a resource listing the various agencies and academic institutions involved in this work would be helpful for low and middle income countries in the region. The policy would assist in having all stakeholders involved in setting goals, roles and responsibilities to achieve affordable access, continued supply and quality use.
Security of the pharmaceutical supply chain
There was support for transparency among manufacturers and wholesalers when difficulties in supply are foreshadowed. This engagement would be promoted by a robust medicines policy. The panel acknowledged that supply chain integrity is a complex issue. Inadequate cold storage facilities at local pharmacies and distribution centres are a particular concern.
A surprising proportion of generic drugs in the region are of poor quality. These problems are often overshadowed by discussions and concerns over counterfeit or fraudulent drugs, but substandard medicines are a much greater issue. Stronger regulatory agencies could be encouraged by cooperative arrangements with developed countries and agencies in order to enhance standards, training, and procedures. Problems with good manufacturing practice throughout the region could also be addressed by these measures. In addition, there are opportunities for sharing the results of quality assurance activities between countries in the region.
There has been a substantial shift in thinking over time. Where once it was broadly perceived that industry had no place in discussions about improving access and use of medicines in low and middle income countries, the current view is that the pharmaceutical industry should be engaged. The comprehensive nature of a developed and appropriately implemented national medicines policy provides a framework, for example, for developing the Access to Medicine Index, product development partnerships, pooling research and development funding, and antibiotic development. The pharmaceutical industry is involved in the distribution of pharmaceuticals and the responsible promotion of medicines, and has legitimate interests in reasonable pricing for medicines and transparency around pricing decisions.
Challenges to implementation of national medicines policies: solutions and unresolved problems
Krisantha Weerasuriya, WHO, Switzerland
Janette Randall, Australia
Zafrullah Chowdhury, Bangladesh
Palitha Abeykoon, Sri Lanka
Socorro Escalante, Vietnam
Madeleine de Rosas-Valera, Philippines
Bangladesh: A long history of national medicines policy: where are we now?
Dr Zafrullah Chowdhury reflected on the pioneering work on national medicines policies with the introduction of the National Drug Policy in Bangladesh in 1982. Activities at that time included the import of raw materials on international competitive tender, price fixation of all essential medicines by government and a ban on the manufacture of antacids and oral vitamins by foreign companies. Over 1700 harmful or unnecessary medicines were deregistered and destroyed. Most drug prices dropped by 50–75% in two years. Drug registration procedures and the quality of medicines improved. Since then, Bangladesh has achieved near self-reliance in the manufacture of quality essential medicines. However, some of the early gains have been lost.
While the prices of some essential medicines are reasonable, others are not. The government introduced the Indicative Price System, violating procedures in the drug policy. Under these revised processes, the prices of 117 drugs and vaccines are fixed by the Drug Regulatory Authority and the rest by manufacturers. In the absence of continuing education for practising physicians, irrational prescribing is common. Pharmaceutical company representatives have taken the role of teachers for doctors. An excellent drug policy will fail to protect patients without ongoing support and commitment of politicians and bureaucrats to rigorous and transparent processes and regular, high quality continuing education for medical practitioners.
Sri Lanka: A long history of national medicines policy: where are we now?
Dr Palitha Abeykoon traced the history of attempts to provide efficacious, affordable and safe medicines to the Sri Lankan population, from the visionary pioneering initiatives of Professor Senaka Bibile nearly five decades ago to the adoption of a comprehensive national medicines policy in 2005. In addition to assessment of the efficacy, safety, and quality of medicines and the promotion of their rational use, the national medicines policy includes considerations of need and cost-effectiveness as criteria in the registration of medicines. While the policy objectives are clear there have been political, social and technical difficulties encountered in enacting the legislation necessary to effectively implement the national medicines policy.
The key issue in Sri Lanka is the implementation gap. Without political commitment, support and leadership implementation efforts will founder and the activities of interested lobby groups and opponents can slow progress. The difficulties of change management cannot be underestimated. Acceptance of change by healthcare professionals and re-education of consumers and other stakeholders is not easy. If not managed carefully, comprehensive reform can end up as piecemeal exercises, and in isolation, only some of the changes may be positive. It is important to recognise that ‘medicines are politics’ and to ‘seize the moment’ to garner the necessary political support and commitment for change.
Vietnam: Balancing industry development and public health
Dr Socorro Escalante, presenting on behalf of Dr Truong Quoc Cuong, described activities undertaken by the government of Vietnam in recent years towards strengthening the local production of pharmaceuticals. In doing so, the challenge has been to balance economic and industry goals with public health goals. The government aims to meet 70–90% of Vietnam’s needs for medicines through local production by 2030, using the production standards of developed countries.
Local pharmaceutical production can be beneficial to Vietnam if it can respond to the most pressing public health needs, which are access to medicines, especially for diseases of high public health importance, that are affordable, safe, effective and quality assured. Currently however, the local industry produces more vitamins and medicines for symptomatic treatment rather than products for the most pressing illnesses such as non-communicable diseases, HIV/AIDS and tuberculosis, and life-saving medicines for mothers and children. Creating the balance means shifting the paradigm of the local production agenda from trade to public health, and moving indicators of success from market share and per capita consumption to measures of quality, availability and affordability of key medicines.
Philippines: From commitment to action: ensuring access to essential medicines in the Philippines
Dr Madeleine de Rosas-Valera described the Philippines 1988 Generics Act as the source of the guiding principles of people empowerment, quality assurance, rational drug use, self-reliance, and tailored procurement for subsequent government programs related to drug policy. The Philippine national drug formulary was developed to support the Generics Act, and provides the basis for drug procurement. Amendments in the National Health Insurance Act followed and included the Drug Price Reference Index as the basis for the reimbursement of drugs and medicines, and the creation of the Food and Drug Administration to assure the safety and quality of medicines. The Cheaper Medicines Act was introduced to encourage competition in the pharmaceutical sector and provide power to the State to regulate drug prices. Successive interventions have been designed to encourage safety and quality, access and availability, accountability through reliable supply systems, and a strengthened health system that is supported by efforts towards good governance, transparency and public–private partnerships in health. Monitoring and evaluation occurs through the Essential Drug Price Monitoring System. However, problems remain with limited market competition for crucial essential medicines, irrational drug prescribing, dispensing and use, and the limited capacity of the Food and Drug Administration to monitor and regulate drug establishments.
General pointsThese countries highlight the importance of legislation for managing medicines issues. However, legislation alone is not sufficient – there must be political will, commitment and support for the policy and leadership for policy change. Without recognition of the political dimension to medicines policies and the importance of political support, implementation efforts will fail, the views of opponents and lobby groups may prevail, and important measures to address access and availability of essential medicines will be thwarted.
National medicines policies: where will we be in 2030?
|Lloyd Sansom, Australia||Michael Rawlins, United Kingdom|
Sir Michael Rawlins, chairman of the UK National Institute for Health and Clinical Excellence, said the next 20 years will see the demand for health services increase and the prevalence of disease alter as social and economic development and population demographics change. There will be a shift in many countries from a dominance of acute life-threatening illnesses to a greater emphasis on disease prevention and the management of chronic disease. The incidence of cancer will increase as the population ages and many cancers will probably become a ‘chronic illness’ with multiple lines of therapy following a pattern of disease progression and remission. At the same time, we will see a greater understanding of molecular pathogenesis with a growing number of targeted, but expensive, new drugs and the development of therapeutic vaccines. Science will continue to provide new advances in therapeutics. New challenges will emerge. Examples include pandemics because of a more mobile global population, changes in disease patterns in regions influenced by climate change and multiresistant organisms.
The demands and costs of health services will increase and the capacity of nations to provide equitable access will continue to be a challenge. More and more nations will address the ‘value for money’ of new technologies across competing demands for health resources. Governments and instrumentalities will need to make deliberative choices of resource allocation and look at ways to improve the use of medicines by their populations. There will need to be a global perspective of health and a greater acknowledgement of health as a major issue in economic growth and development, particularly in low and middle income countries.
The issues facing health systems in the next 20 years will be a mixture of the new and old challenges. What will not change is the need for a framework in which these challenges can be addressed. While individual countries will have different health systems and competing demands, the principles of product quality, access (including affordability), relevant and appropriate best practice guidelines, rational or quality use of medicines and health advocacy will always be present. National medicines policies will continue to assist in improving the quality of health care for the next 20 years and beyond. They may evolve in their appearance, but the principles are timeless.
Feedback on workshop and symposium discussions
Kumud Kafle, Nepal
Jane Robertson, Australia
Reports from four symposia, nine workshops and a special session on reproductive health commodities were presented to delegates. The overarching themes in the reports were the importance of political commitment to national medicines policies and their implementation, and the recognition that adequate financial and human resources were required to sustain and expand national medicines policies activities. Other important themes were identified.
National medicines policies need to be embedded in health policies and health systems
Policy activities need to be considered as part of the delivery of high quality health services.
Infrastructure and the need for strengthening existing systems
While national medicines policies exist in many settings, implementation is inconsistent and the infrastructure to support implementation is missing. In some settings, early gains have been lost due to a lack of ongoing political commitment and loss of policy champions.
The importance of a strong legislative framework and a commitment to enforcement of the law
Laws provide the framework and commitment to national medicines policies. Regulations, standards, codes, and guidelines can be used to support policy implementation and provide greater flexibility as they are easier to change than legislation. Successful prosecutions will reinforce the message that there are consequences for illegal activity and breaches of codes of practice.
Capacity building across all domains of policy activity
Adequate staffing and task-specific training are essential. International and regional experts can help to train local staff in areas including the law, quality assurance and procurement.
The need to prioritise activities
Given the limitations in financial and human resources available, choices will have to be made. Decisions need to be supported by good evidence and take account of societal values, recognising that equity is an important goal of universal access. Defining minimum benefits insurance packages for medicines will involve trade-offs between costs and the scope of coverage.
The importance of measuring and monitoring
The routine collection of relevant and informative data is essential. Without data, it is not possible to assess improvements or worsening of performance against agreed standards or benchmarks over time. There is a need for skilled staff who are able to analyse and interpret data at both local and national levels.
Using tools and resources that have already been developed
Given capacity constraints, countries should use best practice models and existing tools for legal frameworks, drug selection, quality assurance, procurement and distribution of medicines.
Collaboration and relationship buildingRegional partnerships and networks may help overcome capacity constraints. Recognising medicines evaluations and quality assurance activities conducted by other drug regulatory authorities will minimise the duplication of effort. Sharing experiences, challenges and solutions will support further policy implementation.
Advocacy for implementing national medicines policies: what will make a difference?
Budiono Santoso, Western Pacific Regional Office, WHO, Philippines
Mary Murray, Australia
Carol Bennett, Australia
Amit Sengupta, India
Sun Jing, China
Niyada Kiatying-Angsulee, Thailand
Michael Chai, Malaysia
The session chairs confronted the conference with several challenges:
- The national medicines policy movement had not, until now, effectively socialised or politicised the issue.
- The policy primarily served citizens who did not understand its importance in their lives.
- Forming and engaging champions for national medicines policies beyond technical contexts
Speakers drew on various experiences and contexts to reflect on these challenges.
Carol Bennett outlined the history of the Consumers Health Forum (CHF) of Australia since 1985 when the government of the day provided the mechanism for the consumer voice in health policy development. The CHF agenda has widened beyond medicines policy to include the shaping of the health system:
- Achieving better outcomes for the health consumers who pay for and use the health system.
- Improving the quality, accessibility and accountability of the health system and making it more responsive to health consumers’ needs.
- Driving reform in work practices, information sharing and consumer engagement.
Consumers were partners in the development and implementation of the National Medicines Policy from the outset. The consumer voice was not limited to one CHF representative, but included those of the aged, multicultural, Aboriginal and veteran communities. CHF’s work continues to provide value in policy debates, basing its policy on the views of the consumers it represents.
Dr Amit Sengupta from India reflected on the ‘silos’ inadvertently created between the two movements of access to medicines and rational use of medicines. Early activists including Salvador Allende (Chile) and Seneka Bibile (Sri Lanka) focused on essential drug programs and ensuring access to medicines in resource poor settings. In the 1990s, reforms to trade and intellectual property rights changed the balance, with increasing power and influence divested to pharmaceutical companies. With the HIV/AIDS epidemic ravaging Africa, it seemed that chief executive officers of large corporations decided on access to medicines, effectively determining who would live and who would die. Since then there have been successes with the Medicines Access Campaign in a number of countries − court cases in South Africa, the Doha Declaration, and the production and supply (by Cipla) of generic HIV medicines for poor countries. This activism, while narrowly focused on HIV, had visibility and impact, and resulted in better access to critical medicines. Progressing affordable access and rational use requires cooperative rather than separate advocacy efforts in order to deliver good health outcomes for consumers and society. Both access and rational use need to be part of an advocacy for health that addresses the collective ills in society, so that improved health is an outcome of development.
Dr Sun Jing described the process of healthcare reform in China. It has been a mixed top-down and bottom-up process in which the government set the direction of the reform policy, based on academic and consultant input, and amended it after wide online input and rounds of consultation hosted by the Premier. The top-down approach consists of structural change at all levels to support the change of direction with clear mandates, annual work plans and quantitative targets for focal agencies. Local governments have full rights to implement innovative strategies towards achieving the agreed goals. Bottom-up approaches work by ensuring that the evidence obtained from pilot programs undertaken locally lead to changes in the central policy. Policy can also be adjusted through the People’s Representative Conference and the Political Consultation Conference. Hence the process is a practice-learn cycle that secures orderly transition to a predetermined goal.
Dr Sun reflected on the increasing visibility of social organisations in China. There is increasing donor funding to these organisations. They have increasing roles in policy development for treatment and care and their increased lobbying power is helping secure patient access to affordable life-saving medicines.
Dr Niyada Kiatying-Angsulee from Thailand reflected on the importance of people’s engagement and ownership of policies that affect their lives. Change is often complex and difficult, and involves small steps. Thailand has evolved a framework for change in social and health issues that links the creation of relevant knowledge, social movement and political involvement. Change requires all three dimensions, and collaboration between many interest groups with commitment and shared vision. There have been examples of joint action for a national medicines policy in Thailand:
- Patient and consumer groups (HIV, renal failure, family network and Thai Drug Users Network)
- Local and international non-government organisations (Health and Development Foundation, FTA watch, Raks Thai, Médecins Sans Frontières, Oxfam)
- Academia and professionals (law, social pharmacy, drug system monitoring and development program)
- Government and Civil Society e.g. the Governing Board of the Thai Health Promotion Foundation is chaired by the Prime Minister, with half the Board members from independent social organisations.
Dr Michael Chai from Malaysia spoke of the importance of involving the community of stakeholders if a policy is to be relevant, understood, sustainably implemented and its course regularly reviewed and corrected. It may seem appropriate to adopt successful policies from elsewhere, however context is important. While resource constraints are often cited as a difficulty in policy development and implementation, it may be that weak institutions, poor human rights, disregard for the rule of law and democratic processes, corruption, and ethnic and religious tensions are limiting progress. Vested interests may hijack policy agendas and disenfranchise some groups. It is often difficult to have effective consumer advocacy within countries and there is an emerging role for networking across borders to increase the consumer profile and visibility, and to plan strategies to engage with policy-makers. This is the strategy behind the ReAct process in South East Asia for multisector action on antibiotic resistance. National policy platforms are built by connecting people across borders. Collaboration is essential for increasing consumer advocacy within
The consumer voice must be heard. People need to be engaged at all levels of society, and different contexts must be taken into account in the shaping of health policy. Viewing policy implementation outcomes from local perspectives is essential in understanding the impacts on people. However, few countries have effective mechanisms for consumer, citizen, community or local engagement. These processes have different meanings in different settings. The success of people’s advocacy will depend on effective mobilisation of resources and collaboration with existing social advocacy groups, academics and other health professional advocates. There are roles for policy champions, peer educators and peer-to-peer movements to engage people. It takes time and resources to establish an effective framework and processes to develop and influence policy. The contribution to national medicines policies of people for whom policy is designed is important. The objectives and goals of national medicines policies are framed around affordable access to safe and effective medicines in order to improve health outcomes for all patients and communities. Advocacy at global and regional levels must support this.
Kathleen Holloway, South East Asia Regional Office, WHO, India
Lloyd Sansom, Australia
Dennis Ross-Degnan, USA
Budiono Santoso, Western Pacific Regional Office, WHO, Philippines
What progress has been made?
Emeritus Professor Lloyd Sansom
This conference on national medicines policies has been the first regional meeting for a number of years. At our first meeting in Sydney in 1995, the topic was about the establishment of national policies and what we needed to do to convince decision makers to commit to the creation of a framework in which key issues of quality, access and rational use could be discussed. It also recognised for the first time that our core focus was to improve the health of the consumer and to encourage advocacy by and on their behalf. The topic of this meeting has been not about the creation of national medicines policies but their implementation. For those of us fortunate enough to be present at the two meetings, it has been outstanding to see the enormous development in the practical application of the key principles that underpin the elements of a national medicines policy. That is not to say that we have solved all the problems or that we have prevented new issues emerging that threaten to undermine those principles. However, what we have seen is that the presence of an active national medicines policy and the networking that flows from the policy has enabled us to be in a position, both as individual countries and as a networked region, to address the issues and to propose and advocate solutions.
Sometimes the process of behavioural change can be extremely slow and frustrating and we may doubt the advantage of having a national medicines policy. However, what this meeting has absolutely confirmed is that, on reflection, very significant advances have been made. We sometimes forget what it was like before and reflections on the past can be extremely informative and affirming. However, it must be remembered that the only thing that we can change is the future and without a national medicines policy to guide us, the approach to medicines policy will be fragmented and lack focus and direction.
The conference has renewed our commitment to continue to advocate on behalf of consumers and all other partners involved in promoting and improving health through medicines use as a component of a health system, and for the continuing and further development of the health outcomes that emerge from having a national medicines policy. The road is long, but this conference has reaffirmed our direction and re-energised us to continue on the journey, a journey that will sometimes be hard and will require us to detour for a while or even to retrace our path. The goal is still clear and our friends and colleagues from the region will also be there to help if we ask, because they also have the same goal although their pathways may be different.
Dr Budiono SantosoThis conference highlighted many practical aspects in the implementation of national medicines policies. It did not confine discussions to how to develop policies, but how to implement them to ensure that the needed medicines are available and accessible, and that they are of assured quality and rationally used for the health of the people. Significant progress has occurred since the first conference in 1995. Relevant indicators are now available to measure such progress and to monitor different elements of national medicines policies, enabling us to know where we are and where we need to go. Obviously, there are still many challenges ahead. Despite commitment from national governments and stakeholders, policy implementation involves a complex political process, and furthermore, it is often hindered by weak regulatory and health system environments. Hence, we should not be locked up in lengthy and complex political debates, neither can we be complacent only looking at the statistics on indicators. We need to move beyond them, to improve the health system and to make the needed medicines accessible for the people. After all, national medicines policies are about people and how to improve their health. The policies and indicators are not the goal, but only a means to better serve the people.