SOULY PHANOUVONG, SIMON BARRACLOUGH, KEN HARVEY*

 

* Dr Souly Phanouvong is Technical Advisor for Drug Quality Control, Global Assistance Initiatives, The United States Pharmacopeia. Dr Simon Barraclough and Dr Ken Harvey are Senior Lecturers, School of Public Health, La Trobe University, Australia. For further information contact Dr Phanouvong at The United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, USA. Tel: +1 301-816-8582, fax: +1 301-816-8374, e-mail: sxp@usp.org

IT is more than a decade since WHO advocated that its Member States develop and implement national drug policies (NDPs), with the goal of making effective and safe drugs of good quality available and affordable to all, and promoting their rational use1. Many countries have responded to the call by developing such policies. Seventy-two countries have official drug policy documents, which they have sought to implement with varying degrees of success**. This article suggests five essential elements for effective policy implementation. These elements emerged from the findings of a study entitled Medicines for All? The challenge for developing and implementing national medicinal drug policies in Australia, Thailand, the Philippines and Laos². Methods used for data collection combined a comprehensive analysis of original policy documents, secondary literature, and data from semi-structured interviews with 125 local and international informants in all four countries. The study was conducted at La Trobe University, Melbourne, Australia, between 1995 and 1998.

** Data obtained from the WHO world drug situation survey 1999.

While successful implementation depends on a range of general prerequisites, such as adequate funding, effective organizational structures, committed and qualified human resources, and the recognition of the plurality of opinions, five elements were conspicuous in each country's experience. These are: setting realisable goals and objectives; political will and commitment on the part of governments; legislative and regulatory frameworks; legitimacy; and the cooperation (and if necessary co-option) of stakeholders.

1. SETTING ATTAINABLE OBJECTIVES

Setting attainable goals and objectives has not been an easy task for policymakers, particularly in limited resource settings, because this involves a complex process of policy-making. It requires them to examine thoughtfully and strategically how to meet objectives within a specified political, cultural and socioeconomic situation. The experience of Lao People's Democratic Republic, Thailand, and the Philippines showed that establishing certain objectives without a thorough consideration of the capability of personnel and availability of financial resources limited effective implementation. For example, improving equity of access to essential drugs required the Government of Laos to spend at least US$1 per capita per year on drugs. But after more than eight years of policy implementation, this goal has not been achieved. This is largely because, at the time of policy formulation, no appropriate, detailed and factual studies were undertaken on the Government's financial capacity. Policy implementation was largely dependent upon foreign financial assistance.

A similar situation occurred in the Philippines with the policy component on pharmaceutical production. Despite more than 15 years' implementation, there is still much to be addressed. There are two main reasons for this. Firstly, most drug manufacturers, both Filipino and multinational companies, do not produce basic raw materials and active substances. The industry is involved almost exclusively in compounding and packaging finished products from imported raw materials. Secondly, the capacity of Philippine owned companies to meet demand has, in part, been overestimated³.

Since the early 1980s, the Thai National Drug Policy has attempted to rationalise drug procurement in the public sector by recommending, through a Ministerial Order, that all public hospitals use at least 80% of their Government drug budgets to buy drugs on the National List of Essential Drugs⁴. Although all community health centres complied with this policy, no major hospitals did; instead they used only half of their budgets for drugs on the National List because they needed specialised medicines⁵. Several informants noted that non-compliance was justified, arguing that the Order is merely an administrative measure rather than a binding directive. Many hospitals, therefore, did not comply; nor were any sanctions or penalties imposed.

2. POLITICAL WILL AND COMMITMENT

Political will is one of the most important elements in an NDP. Not only should there be commitment on the part of the government, including the health minister, the prime minister and the cabinet, but also the key stakeholders. The success of introducing an NDP largely stemmed from the willingness, capability and commitment of the key players at the individual, ministerial and parliamentary levels. In most countries studied, the ministers for health and the cabinet played a crucial role in policy initiation.

However, with the exception of Australia, once the policy was launched, the role of these initial key players diminished. Rather, implementation was largely dependent upon the capability of policy implementers at sub-ministerial level, as well as the degree of government commitment to provide resources. There was a strong perception amongst study informants that a decrease in political will and commitment had occurred in Laos, Thailand and the Philippines, and that this had slowed the progress of NDP. In other words, in these countries, initial political will was not sustained; it reached a peak at the formulation stage then declined as the policy aged and governments changed. By contrast, in Australia where successive governments showed commitment to continued funding of NDP programmes (despite some subsequent cuts), the policy was implemented more effectively.

Involving the community in drug policy at a seminar on rational use of medicines in the Philippines

Photo: A. Hardon

It is important that policy-developers possess some skill in mobilising and convincing key government officials (especially the minister and vice-ministers for health and finance), and political figures to make resources available. Several informants suggested that government officials, especially in health and pharmaceuticals (including health legislators and administrative officers), together with those in related fields, should all be actively involved in the NDP formulation process. When changes of health minister or changes of government are imminent, policy advocates in the bureaucracy and outside should start to educate and lobby the potential new ministers and political figures for support and cooperation. The experience of Thailand, the Philippines and, to a lesser extent, Australia, showed that new governments or new ministers were often initially reluctant to provide continuing support for NDP, especially if they were from a political party with different attitudes and priorities.

3. LEGISLATIVE AND REGULATORY FRAMEWORK

The effective enforcement of legislation and regulations is vital. The Therapeutic Goods Act and the National Health Act for instance, have provided a strong legal framework for assuring the quality, safety and efficacy of medicinal drugs in Australia.

Most study informants stated that in countries with limited resources and where rules and regulations on quality assurance are less effectively enforced, as has been the case in Laos, Thailand and the Philippines, trading of substandard drugs remains an issue to be addressed.

In an ideal policy environment, prescribing and dispensing should be kept separate for professional and ethical reasons. In practice, however, these two activities are conducted concurrently by many doctors and pharmacists in the Philippines and Thailand, and even more so in Laos, in their private practices. This is partly due to legislation and regulations on prescribing and dispensing practices not being effectively implemented. However, in order to separate prescribing and dispensing functions, the attitudes and behaviour of prescribers, dispensers and also consumers need to be changed towards rational drug use. Attitudinal and behavioural change can be achieved through an effective enforcement of the relevant laws and regulations, the implementation of educational programmes, and by introducing incentives. Experience in other countries has shown that effective implementation of a legal framework can be achieved through strict sanctions and penalties where the parties concerned (doctors, pharmacists and health workers) are mandated to perform their work under strict regulation.

4. THE NEED FOR LEGITIMACY

Regulatory measures are more effective if they are considered legitimate by those being regulated. Legitimacy is not the same thing as legality. Policy development and implementation must involve seeking to establish the legitimacy of NDPs.

In countries where people have a culture of respect for the rule of law and government policies, NDP programmes were more likely to achieve their objectives. For example, in Australia, the high acceptance of stakeholders of the National Health Act, contributed to the success of equity of access policy implementation. To increase the acceptance of the Philippine NDP and to legitimise the Generics Act, policy-makers mobilised not only Government officials, political figures, academics and health professionals, but also consumers, the media, and the Church⁶. While the pharmaceutical companies have complied with the policy in terms of generic labelling, this aspect of policy is actively opposed by the Philippine Medical Association for prescribing. The Association did not accept generic prescribing as legitimate, even though it was legislated. In Australia persuasive means were used by the Government to enhance policy legitimacy. Economic incentives to increase the policy's level of acceptance and compliance with legislation could be offered through an insurance scheme or the Government reimbursement and remuneration systems.

Good policy-making requires listening to stakeholders' views; this, in turn, requires an effective mechanism of communication and coordination and sufficient time for comments on the draft policy document. Key stakeholders should be invited at the earliest stage of policy development, i.e. conceptualisation or initiation, to give their opinions and involvement in order to become part and owner of the development process. Later this will promote key stakeholders' acceptance of the policy and engage their responsibilities in the implementation. Failure to recognise the plurality of opinions can result in policy unfeasibility.

5. CO-OPTION AND COOPERATION OF STAKEHOLDERS

Co-option involves the absorption into the policy-making elite of actual or potential opponents in order to contain or eliminate both their motivation and capacity to oppose. Such absorption is usually brought about by both persuasion and the judicious use of inducements - commonly in the form of an offer of a position at some level of actual or symbolic leadership or participation in decision-making⁷. Co-option is a recognised political tactic for dealing with opposition. If there is strong opposition from one of the key stakeholders, the policy is unlikely to succeed. For example, the generics labelling and advertisement policy in Thailand was aborted during its introduction, despite a ministerial order for its promulgation. This occurred largely because the pharmaceutical industry did not accept the policy. The Food and Drug Administration took the case to the Juridicial Council for an opinion. The Council, by a majority of votes, ruled that the Ministerial Order on generic labelling was unconstitutional. The resistance of the drug industry was a reaction, in part, to consumer groups urging the Food and Drug Administration to withdraw from the market all drugs without generic names on their labels⁸.

In contrast to the failure of the Thai policy reformers to win over their opponents, Australian policy-makers ultimately succeeded in mollifying opposition. In the 1940s initial attempts to introduce a free access scheme for 139 essential drugs were opposed by the Medical Association and were unsuccessful. When a new Government was elected in 1949, lessons had been learned. It was realised that any health plan, including the pharmaceutical benefits scheme, could not be enacted without the co-option of the medical profession. A cooperative approach to the profession was achieved partly by the appointment of a prominent member of the Medical Association as Minister for Health⁹. Similarly, in the 1990s, Australia used the co-option strategy with all key stakeholders in its attempt to implement the Quality Use of Medicines Policy in a partnership building approach.

REALISM, CONSULTATION AND UNDERSTANDING

The problems accompanying the introduction of NDPs in many countries were not only related to technical, legal, socio-economic and cultural issues, but were also political. This was because the policy had major consequences for the interests of key groups, including government, medical and pharmaceutical professionals, the pharmaceutical industry and consumers. Conflicts of interest, opposition and attempts to prevent policy implementation were a common feature in all four policy processes. The more radical the proposed changes were, the more the process of policy development was problematic and political. Policy formulation must therefore be based upon realistic goals and must involve all interest groups - even those opposed to the policy. Moreover, policy-makers must both think and act in a strategic way to ensure that an effective regulatory framework underpins policy and, more importantly, the need for policy reform is understood and accepted by both health care providers and consumers.

References

1. WHO. Guidelines for developing national drug policies. Geneva: World Health Organization; 1988.

2. Phanouvong S. Medicines for All? The challenge for developing and implementing national medicinal drug policies in Australia, Thailand, the Philippines and Laos. PhD. Thesis La Trobe University 1999. (Unpublished). Copies are available from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland).

3. Pharmaceutical and HealthCare Association of the Philippines, 1994. Philippine Pharmaceutical Industry Fact Book. Pharmaceutical and HealthCare Association of the Philippines, 3rd ed. July, Makati.

4. MOPH, 1994. [Ministry of Public Health Order 127/2535 on the use of Government budget to purchase drugs for MOPH health facilities]. Thailand Ministry of Public Health. (In Thai).

5. Working Group on Drug Procurement and Distribution, 1994. [Drug procurement and distribution in Thailand]. In: Technical Working Group for analysis of the Thai Drug System. Thai Drug System. Thailand Health Research Institute, National Health Foundation, Food and Drug Administration and Health Systems Research Institute. Ministry of Public Health. Thailand, pp. 316 - 473. (In Thai).]

6. Bengzon A. National drug policy: international perspectives. Australian Prescriber 1991;14(1):6 - 11.

7. Selznick P. Co-optation: a mechanism for organisational stability. In: Merton et al. eds. Reader in bureaucracy, pp. 135 - 37. New York: The Free Press; 1952.

8. Wibulpolprasert S, Kornkasem M. Civil society and drugs: lessons learned from evaluation of policy on generic labelling and advertisement control in Thailand [sic]. Paper presented in the 1st International Conference on Improving Use of Medicines (ICIUM), State of the Art and Future Directions. 1 - 4 April 1997, Chiang Mai, Thailand.

9. Harvey K, Murray M. Medicinal drug policy. In: Gardner, H., ed. The politics of health: The Australian experience, pp.238 - 80. Melbourne: Churchill Livingstone; 1995.