(1997; 175 pages)
All countries in the world have national pharmaceutical policies, either explicit in the form of policy documents or implicit in government actions. Very few studies have been carried out which try to compare national drug policies and to understand which policies have been successful - and why - in achieving the goals of availability, accessibility, good quality and rational use of drugs. This document describes the preliminary findings of such a study as discussed in a workshop held in June 1996 in WHO, Geneva.
The comparative analysis of NDPs: Objectives and approaches
The objectives of the research were:
• to identify strengths, weaknesses, and political dimensions of pharmaceutical policy formulation and implementation within each country;
• to propose explanations for cross national variations in performance; and
• to propose effective strategies, both national and international, that can improve pharmaceutical policy implementation.
The research initiated by the WHO Action Programme on Essential Drugs in collaboration with the Division of International Health Care Research (IHCAR), Stockholm, and the Harvard School of Public Health (Boston) was conducted by national research teams in 12 countries (Bulgaria, Chad, Colombia, Guinea, India, Mali, Philippines, Sri Lanka, Thailand, Viet Nam, Zambia, and Zimbabwe).
To achieve its objectives, the research provided a cross national, comparative framework and combined formative evaluation strategies (focusing on the process of policy formulation and implementation) and summative evaluation strategies (focusing on policy outcomes). The two main research tools used were standardized NDP indicators - for assessment of NDP performance; and political mapping - for the analysis of NDP formulation and implementation processes.
The workshop and its main outcomes
The workshop described in the document was the third step in the implementation of this collaborative project. Its aim was to provide methodological support to the research teams, to review the results, to assess the two methods and to prepare a plan for the finalization and dissemination of the research findings.
• provided one of the first occasions for countries to compare data collected in a standardized way. It showed the importance of having good methods and data and justified the WHO strategy of providing standardized methods for both national assessment and cross national comparison;
• permitted the review of the indicators and the political mapping as methods of policy analysis and assessments of NDP (field testing) and resulted in some improvements which will be incorporated in the next edition;
• allowed countries to share experiences in order to develop better approaches for policy formulation and implementation. Although there is no standard recipe for improving the policy process in countries, the workshop did come up with some useful conclusions;
• began the process of identifying specific strengths and weaknesses of existing policy from national and cross national perspectives; of generating hypotheses to explain how different pharmaceutical policies can affect the performance of the pharmaceutical sector; and of identifying specific policy innovations;
• showed the necessity to develop such research in countries with different socio-economic backgrounds; and to set up sustainable NDP monitoring systems in most countries;
• finally, enhanced the research capabilities of all the participants of the 12 countries.
The report reviews the main results of the research at this stage in relation to (i) the methods used; (ii) the national drug policies; (iii) the cross national comparison. These findings are preliminary as not all the country teams had finalized the collection and processed the data at the moment of the workshop.
Standardized indicators and political mapping
• The aim of the research was to use a set of standardized indicators to assess the achievement of the NDP and to use the political mapping technique to better analyse the process of policy formulation and implementation. During a previous workshop it was agreed that countries had the freedom to adapt or modify the indicators to better reflect their own country context. A set of common indicators should however be preserved given the comparative focus of the project. It was also suggested that a common mapping question related to the formulation process of the drug policy would probably further the process of comparison among countries. However it was decided that, given the different requirements of each country, they should be allowed to define their own questions for political mapping.
• A large percentage of the indicators was useful and did not need substantial modification. A few new indicators were constructed by country teams to better cover certain components of the pharmaceutical policy (e.g. in rational use of drugs). A number of new indicators was suggested for specific components or for additional objectives (e.g. traditional medicine). The main reasons for not applying certain indicators were the absence of data and the inconsistency in data at country level.
• Two countries used the political mapping to better understand what had happened in policy formulation and implementation and the reasons for successes and failures. One country used the political mapping to assess the chances of success of a new strategy to improve the affordability of the drugs in the private sector; the other countries looked at specific issues closely related to the components which had been assessed in the indicators' exercise.
• The two methods used in the research were relevant to assess the performance of a given national drug policy and the policy process. The various categories of indicators achieved their goals. The outcome indicators provided a good picture of the national situation in relation to the four objectives of the NDP. The structural and process indicators allowed the assessment of the level of implementation of the main components of the NDP. The indicators revealed new things on the policy and illustrated the importance of using certain types of data such as the financial data. They were helpful tools for focusing actions on deficiencies, and for finding solutions based on data and analysis. The method of political mapping helped policy-makers to systematically analyse the support and opposition for a proposed policy; consult with the major stakeholders on their views; analyse opportunities and obstacles to change; design a set of creative and effective strategies for change; and assess and track the processes of implementation.
Strengths and weaknesses of national drug policies
In most countries covered in the research, the systems/structures/mechanisms needed for effective implementation of a national drug policy were in place. However, they often did not function properly. Participants were able to identify strengths (e.g. established structures, comprehensiveness of the policy, etc.) and weaknesses of their country national drug policies (e.g. lack of implementation of rules, lack of concerns for financing and pricing issues, etc.).
In all countries there were components of the NDP which received more attention from decision makers and senior management staff; in most of the poorest countries these components were essential drugs lists and public procurement of drugs under INN. The situation was slightly different in middle income countries where the main components varied according to the objectives of the policy. Secondly, in all countries some things were easier to do than others: put the structures in place, improve the public sector, develop components not calling for drastic changes in behaviour, etc. Thirdly, it was difficult at this stage of the research to draw conclusions on the relative importance of each component in achieving the objectives of the NDP. Finally, there were linkages between components and between components and objectives (e.g. absence of quality assurance system → poor quality of drugs, withdrawing irrational drugs → less irrational use of drugs, etc.).
In addition, the research clearly demonstrated that policy-making can not simply be a technical process but must also be a political process. Policy-makers need both technical and political analysis in order to be effective. Policy-making does not stop with the official adoption of a policy but continues on through the phase of implementation. Some common strategies may exist in national drug policies; it is however unlikely that a simple recipe exists for managing the formulation and implementation of all national drug policies. The approaches need to be developed and refined within specific national political contexts. They need to be adapted over time to fit evolving political circumstances and the problems that emerge in transforming the policy into practice.
Lessons from cross national analysis
The comparative cross national approach pursued in the research was valuable as, even at this very preliminary stage of analysis, it was possible to better explain the particular aspects of each country's policy and to identify more universal aspects of policy-making. The review of the variations among countries led to some tentative explanations, including:
• There was an obvious positive link between the performance of NDP and the economic development, although this did not apply for all the aspects of the policy.
• A number of technical components when implemented adequately made a great difference in terms of output: for instance a bad selection of drugs and an inefficient procurement system led invariably to shortages of drugs; on the contrary, a good registration system had a positive impact on rational use of drugs, a local manufacturing industry seemed to have a positive influence on prices of drugs as long as the country were big.
• Countries with no local industry (national or multinational) could implement the main aspects of NDP with fewer problems.
• Compulsory use of an EDL in the public sector was just a first step in improving availability and affordability. These objectives seemed more difficult to achieve in countries where the pharmaceutical market was mostly private and where there was no regulation of drug prices.
• The geographical situation of countries was also an important factor in the difference in performance, e.g.: to be an island was an advantage as it made drug imports easier to control.
• A few motivated people could make a difference between success and failure mainly to get things started, but to rely on only a few people was dangerous as it did not ensure sustainability.
• Improvements of the NDP through radical changes were more likely to happen when there were political windows of opportunity. When such opportunities presented themselves (e.g. new regimes) it was possible to implement quick, radical and widespread changes. When such opportunities were not available, it could be better to use a step-by-step approach.
• Technical soundness and/or economic rationality of a policy did not always imply that the policy was politically viable.