(1997; 175 pages)
2.2 Preliminary interpretations based on NDP indicators
A number of hypotheses were made at the beginning of the research on the policy process in order to better understand why things work or do not work. These hypotheses were based on a review of the literature and on the experience acquired by the collaborating institutions in the field of drug policies. The hypotheses are related to the implementation of the key components, and cover issues such as speed and easiness of implementation; importance of the various components and links between components (for more details, see questionnaire in Annex 4). The following paragraphs are based on the discussions during the workshop and the results of the indicators.
(a) Are there components which have received more attention?
In all the countries there are components of the NDP which have received more attention than others and have been implemented first. For instance, in Chad, Guinea, Sri Lanka and Zambia, the essential drugs list, the improvement of the drug procurement in the public sector and the strengthening of the regulatory aspects (inspection, registration, legislation) have received more support than the other components. In Colombia, the development of the pharmaceutical care services has been the main purpose of the policy. Priorities to reach this goal were set as follows:
availability of drugs → accessibility → quality → rational use
Therefore, the components which received more attention in Colombia were: legislation and regulation; essential drugs selection and drug registration; drug allocation in the health budget; pricing policy.
In India, the pricing issues were the ones receiving more attention because of the pressure of the industry and the GATT agreement. In the Philippines, while availability and affordability were main objectives of the policy, limited public funds and the difficulty of dealing with the economics of pharmaceuticals prevent strong action in this field. The quality assurance aspects (strengthening of the Bureau of Food and Drugs) received more attention, probably because the main actors of the NDP were closely linked to BFAD. Rational use of drugs was also the focus of a large number of activities. On the contrary, although only drugs on the EDL can be procured in the government sector; nothing really substantial has been done in terms of improving public procurement procedures including quantification of drugs needs. In Zimbabwe, legislation, essential drugs selection, drug distribution in the public sector received priority; this was linked to the priorities decided by the National Drug and Therapeutic Policy Advisory Committee and to the fact that financial and technical resources were available for these activities. Viet Nam focused on improving quality assurance systems including registration, legislation and regulations.
Based on these first findings, it seemed that in most countries the improvement of the availability of essential drugs in the public sector through proper selection, good procurement and distribution has been given priority. However, two middle income countries, India and the Philippines, which have developed very comprehensive and different drug policies behaved differently: one has favoured the issue of pricing due to the fact that one of the main objectives of the Indian policy is to strengthen the domestic pharmaceutical industry; the other has implemented first the components related to quality because the main technical people involved in the policy were "quality people" and policy-makers and because the policy aims to expand the coverage through the use of generic drugs in the private sector.
(b) Are there components which were easy to implement?
In all countries there are things which are easier to do than others. First the structures are relatively easy to set up (EDL, drug regulatory authority, procurement mix) but in many cases because of lack of resources, things do not function very well (Guinea: "the international aid is willing to support the establishment of central medical stores but the operating costs for supervision - fuel... - are very difficult to finance"). Secondly, components related to activities of the private sector are less easy to implement (Guinea, Thailand, Viet Nam). Thirdly, components which involve important changes in behaviour like improving use of drugs are also difficult to implement; in addition, they require collaboration between the Ministry of Health, the Ministry of Higher Education, district and local health authorities, the social security systems when they exist, medical associations and the academics (Colombia, Mali, Sri Lanka and Viet Nam). Finally if the policy is seeking drastic changes and is implemented on a large scale, it is always difficult to think in terms of linear progress, things can work at a moment because of strong political support and deteriorate later when the context changes (the Philippines).
In countries with strong decentralization like Colombia and the Philippines, the extent to how easy or difficult it is to implement a component is related mainly to the extent of governance of the Ministry of Health over each component and its operational capacity for implementing each component in a decentralized context. In Colombia, the Ministry of Health has governance for structuring the following components: legislation and regulation; essential drugs selection and drug registration; drug allocation in the health budget and pricing policy. However, because of the decentralization context, implementing those components (process) requires participation of district and local health authorities. So, the governance is shared heavily with the district and local governments, a process which is not easy, due to their poor operational capacity.
(c) Are there components which have been more important for achieving the NDP objectives than others?
Bulgaria, the Philippines and Thailand felt that all components were important, if one component was developed more than another "success will be temporary". Zimbabwe stated that the components should be developed all together but for each of them there are basic activities which need to be carried out and "you need at that level to make priorities". In Sri Lanka "since the state dominates the health care sector, public sector procurement made a bigger impact on achieving the two objectives of essential drugs availability and accessibility". In Guinea it seemed that improvement of diagnosis and prescribing practices in the public sector led to a general improvement of use of drugs. In Viet Nam the reorganization of the system and the improvement of management had positive effects on the drug situation. It was also realized by the teams that one cannot expect pharmaceutical systems to be functioning better than the health care system as such, although they may in some cases show the way (Sri Lanka).
(d) Are there any linkages in performance across components?
Although most countries agreed that there are clear linkages between components and between components and objectives, the issue was not thoroughly discussed as the results have not yet been fully analysed by the teams and the coordinators. However, a few obvious linkages were noted: absence of quality assurance system and low quality of the drugs on the market (Guinea), use of generic drugs in the public sector and low cost of treatment compared to what is happening in the private sector (Chad); withdrawing irrational drugs (no paediatric formulation of antidiarrhoeals) meant less irrational use (Sri Lanka); good public sector procurement influenced private sector (Sri Lanka); good quality of drugs meant better acceptance of generic prescribing and dispensing (Thailand); using tenders meant increased availability of drugs, improving training influenced rational use of drugs (Zimbabwe). In Guinea there was no linkage between information and continuing education which performed very badly and rational use of drugs which was quite good; as said earlier it seems that prescribers in the public sector were well trained and influenced practices in the private sector. The same remark applied to Zimbabwe where despite continuous training, stock management has not improved. This of course lead to questions on the best strategies to improve practices and on the content of training.
National drug policies: preliminary interpretations
NDP indicators: In all countries there are components of the NDP which have received more attention; in most of the poorest countries these components are essential drugs lists and public procurement of drugs under INN. The situation is slightly different in middle income countries where the main components are not the same in all the countries and vary 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 which do not call for drastic changes in behaviour, etc. Thirdly, it is 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 are 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.). More in-depth analysis is however needed to identify reliable trends.