NDP process, implementation and regulation - Role of the WHO

As has been indicated above however, the development of a NDP is a complex process involving formulation of policy, implementation of strategic activities aimed at achieving policy objectives and monitoring. In order to organize and prioritize requires careful planning involving all the parties along with political dynamics is needed in order to achieve a successful National Drug Policy (WHO, 2002).

28 2.5.1 Planning

Prior to policy adoption, an implementation plan is required. The implementation plan defines action points, division of responsibility, estimates the required budget and gives indicative time frame (WHO, 2002). The plan and the process leading to the expected outcome make a NDP meaningful. The strategic plan used to develop the policy should specify various steps in the development process.

2.5.2 Involving all parties

As indicated it is important for consultation and negotiations to take place with all interested groups which would normally involve government bodies, non-governmental organizations (NGOs), professional associations, academia, international pharmaceutical industries, drug sellers, doctors, pharmacists, nurses and consumer groups and their involvement is regularly necessary throughout the policy process. In addition, consultation with the Drug Regulatory Administration (DRA), district and provincial medical and administrative personnel, traditional and herbal drugs practitioners and sometimes insurance companies would be involved.

Also it may be appropriate to involve media and international organizations can also be of help in implementing the policy (WHO, 2002).

2.5.3 Political dynamics

As has been stated the formulation and implementation of a policy needs to have political authority and the participation because the aim of a policy is to achieve access to basic health care and development of a NDP is likely to require funding and changes in the regulatory framework. These changes transmitted within governmental areas will have to be proposed and a clear advantaged expressed to the other government officials outside of Health. Such advantages could be expressed by indicating that the pharmaceutical sector is likely to be more efficient and responsive to health needs. Strong political direction and sustained devolution are vital for the formulation and effective implementation of a national drug policy (WHO, 2002).

29 2.6 The steps of NDP process

Since the WHO established the proposal of a NDP, it has been promoted on the basis of having in place processes to ensure its effectiveness. The process of a good national drug policy should be built around the 3 main components of: 1).

Development, 2). Implementation and 3). Monitoring and Evaluation (Chowdhury et al., 2006).

2.6.1 National Drug Policy Development

The majority of countries have formulated and subsequently updated their NDP. In a number of countries an emergency or an important political change involving developments such as the expansion of local industry or the implementation of a global trade agreement has often created an opportunity to start the process of formulating or adjusting a policy. The WHO has proposed a process for development of a NDP to support countries in identifying the work procedure of this project. But the development process suggested by the WHO is not channeled directly at countries, where, as mentioned before each state has its own priorities, needs, specificity and factors that determine the mapping of work on their project (WHO, 2001). The development process can include;

Step 1: Organization of policy process

It is suggested that the Ministry of Health would normally lead the process of formulating a NDP and organize the process of taking forward the development of the policy structure, its objectives and its priority components. An important part is to Identify the interested parties, necessary resources, donors, assistance from other support agencies, and outside agencies such as the WHO and to make contact if appropriate with countries who had relevant experience’

Step 2: Identify the main problems

To set realistic objectives an understanding and methodical analysis of the problems in the pharmaceutical sector is generally required. It is proposed that

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expertise and knowledge is developed from gathering knowledge from experience gained from other countries and knowledgeable professionals. Also from other disciplines and backgrounds which, are gathered to examine the situation systematically, to identify the main problems which the country faces and make recommendations to overcome these issues. It is proposed that these issues and recommendations can be discussed at multidisciplinary workshops which help in formulating consolidated advice to the government

Step 3: Situation analysis

It is considered important to carry out detailed analysis of the situation in pharmaceutical sector before moving forward and then to undertake an analysis of the source of problems in order to identify potential solutions, and to choose and set appropriate strategies.

Step 4: Setting goals and objectives

After the identification of the main problems, goals can be set and priority objectives identified. This can start with discussions among key policy-makers and involve interested parties.. From these developments the discussion can become more detailed and can include more careful deliberation of the variations of interest and structural limitations within the existing system from which is important to set objectives and strategies which are attainable.

Step 5: Drafting the policy

After situation analysis and reference to NDP’s from other countries the completion of the outline of the main goals, objectives and approaches can be addressed. At this stage small groups of professionals from different areas of the MOH and Drugs Regulation and other interested parties can be brought in and can be involved during earlier stages of the process and generally draft the policy.

Step 6: Circulating and revising the draft

The Draft Policy should then be circulated for comments from members of the Ministry of Health, and other Government Ministries and Departments, also

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relevant institutions, and those considered having an interest in the private and academic sectors. Based on the comments received, after circulating the draft policy document, a further iteration of the NDP can be revised and finalized. Once a further draft is development, it is time for early discussion which will hopefully lead to in principle authorization by the government sectors responsible for planning, finance and education which is so important for successful implementation of the policy. However one aspect which is unlikely to be agreed at this time is the agreement of the budget at this stage.

Step 7: Securing formal endorsement

Once these stages are decided it is important that the Development of the Regulations is proposed and that only the enabling components of the policy are included into law. Without the operational details agreed as it may become difficult for future adjustment.

Step 8: Launching NDP

The next stage should be to launch the NDP which is one of the most important steps as it is important because the success of the policy depends on an early understanding by different sections of society and their support for the policy objectives. To assist with success the implication and benefits for all the interested parties should be clearly highlighted. In this respect knowledgeable professionals and opinion leaders can help endorse and promote the policy through a well-designed campaign. To ensure public understanding and support for the policy the media and a variety of other channels can play a major role in publicizing and making the policy availability to different target groups, (WHO,2001).

2.6.2. NDP Implementation

In order to attain success from the 8 stages above it is suggested that a carefully formulated policy is insignificant if it is not implemented through a “Master Plan”, which includes the main structural plan for establishing the NDP through identifying the main issues, requirement and needs of the health care system. Every component of a policy requires a detailed strategy and specific action plans.

32 2.6.2.1 Priorities for implementation

However although the Steps above can be discussed within each country who consider the introduction of a NDP the priorities of each country can vary and hence the priorities of implementing the policy differ. For instance rational use and cost of medicines could be of concern in countries having broad health care coverage with no access issues. Therefore, implementation of a drug policy would normally be focused on regulating the market and the cost without affecting sustainable access and equity. In contrast the focus of the policy in least developed countries may be on increasing access to Essential Medicines.

Prioritization of implementation in both cases could be decided by the severity of problems under consideration and the potential of achieving the objective with available resources and making a meaningful impact (Chowdhury et al., 2006).

2.6.2.2 Master plan and work plans

From the NDP it is likely that there will be generation of an implementation plan which can illustrate the development structure for each component of the policy and indicates what needs to be done and who is responsible. At this stage it is possible to obtain some ideas about the required budget and a rough time frame associated with development and implementation, although overall the introduction of a fully operating NDP has in other countries taken around 5yr. By having an outline Master Plan it helps in instigation, operation, what should be communicated and monitored by all parties involved. It is suggested for proper execution, of the master plan that is should be divided into periods such as annual action and work plans then developed accordingly with the various agencies involved in its implementation. Approaches for each component, such as identifying the responsibility, the major tasks, and defining the target output, the time frame and the outline budget would normally be outlined in the plan (Chowdhury et al., 2006).

2.6.2.3 Responsibilities in implementation

It is proposed that a co-ordination body designated by the Ministry of Health should supervise and coordinate all activities. They should monitor the implementation

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process and the targets to be achieved. It is also considered to be important for national consultative forum to be created to maintain countrywide support, and to ensure that the major stakeholders are consulted and involved (Chowdhury et al., 2006).

2.6.2.4 Financial resources

The matching of strategies and action plans with available financial resources is also important. Also it is indicated that it should be made clear what allocations will come from government funds, the contributions from international and local donors and the revenue generated from drug registrations and fees comprise the usual funding sources (WHO, 2001).

2.6.2.5 Regional cooperation

In implementation of drug policies, it is also considered important that there are regional cooperation, skills, expertise and facilities in different countries, and what support can be given by institutions and organizations. It has been reported that cooperation between countries on a regional basis is increasing on a wide variety of policy and economic issues. It is proposed the greater harmonization in drug regulatory standards could results in a more economical use of resources.

A typical example of regional partnerships: are the Association of South-East Asian Nations (ASEAN), the European Union (EU) and the Organization of African Unity (OAU). (WHO, 2001)

2.6.2.6 Technical cooperation with WHO

In addition to the support provided the countries and associations listed above, the WHO has previously provided an information exchange forum and further promote a cooperation through training courses and research projects. They have for some time helped to form professional networks, and provides training and research through collaborating centers, and also helped developing NDP’s by providing technical information and key documents.

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In addition to all of these support areas there is regularly, the International Conference of Drug Regulatory Authorities (ICDRA) and also training courses which are conducted to discuss drug regulatory matters and drug policy issues (WHO, 2001).

2.6.3 National Drug Policy Monitoring and Evaluation

Once in place it is suggested that Monitoring and Evaluation is essential to ensure the program is progressing satisfactorily. This can occur through various methods such as:

1. Organization of the data collection.

2. Data collection procedure.

3. Analysis and reporting of the obtained findings.

4. Survey implementation.

5. Determination of the cost of the most important drugs.

The supervisory visits and routine and sentinel reporting which can be used for monitoring and reviewing the implementation of planned activities. The Monitoring and evaluation of a system is a constructive management tool that allows a continuous assessment of progress and also provides transparency creating a standard in comparison with other countries (Carr et al., 2007).

2.6.3.1 Indicators for monitoring

Initially in carrying out the above it is important to determine the progress achieved and to set realistic and achievable performance standards or targets. Once that is completed indicators to measure changes can be selected and used to compare and assess whether the targets are being achieved. These indicators are required to be measurable, clear, valid and reliable.

Categories of policy indicators include: structural indicators, background information, process indicators and the outcome indicators. These indicators should be highly standardized so that trends can be identified.

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Some of the important main indicators can cover the following aspects:

■ Having access to Essential Drugs, and other indicators on medicine financing schemes, and on public supply management; which can provide information on access to essential drugs;

■ Ensuring the function and efficiency of the quality control laboratory, regulatory authority, and handling of drugs to maintain the quality provide information about drug quality;

■ Evaluating the prescribing and dispensing of drugs should be done using a list of essential drugs and the clinical guidelines, which should provide drug use information patterns.

It is suggested that by using an indicator-based method of evaluating the pharmaceutical situation it can be useful for all parties involved in the pharmaceutical field. These studies and its results can provide clarity of the problems in the country so that Policy-makers, implementers and managers can reassess their strategies and priorities.

The results can also be useful to international agencies and donors to focus on the areas that require support and to determine the significance of investing resources in the areas in order to achieve best impact (Abdollahiasl et al., 2014).

2.6.3.2 Multi-country comparative evaluations

It is also helpful during overall evaluation to include other multi-country studies, and international collaborations on policy issues which can assist national policymakers in learning about innovative approaches (WHO, 2001).

2.6.3.3 Periodic evaluations

Finally after the NPD has been introduced and been in operation for a period of time, it is suggested that its working within the country should be evaluated periodically by professionals either from the country or from other countries or other agencies to monitor its continued development and also to suggest any improvements if appropriate (Abdollahiasl et al., 2014).

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2.7 Examples of National Drug Policies in Operation in other Developing