Siham Abdoun
Msc., PhD.

Health is a fundamental human right.
Access to health care, which includes
access
to
essential
drugs,
is
a
prere...

Drugs
can
offer
a
simple,
cost-effective
answer to many health problems if available,
affordable, of good qualit...

At least one-third of the world’s
population still lacks access to essential
medicines, as a result, millions of
chil...

A national drug policy is a common
framework
to
solve
problems
in
pharmaceuticals

WHO recommends that all count...
What is a national drug policy?
A national drug policy is a commitment to a
goal and a guide for action. It expresses
and ...

It provides a framework within which
the activities of the pharmaceutical
sector can be coordinated.

It covers both...

A national drug policy, presented and printed as an
official
government
statement,
it
is
important
because it act...

The policy document should be developed
through a systematic process of consultation
with all interested parties. In th...
Why is a national drug policy needed?
National drug policy is needed for many
reasons. The most important are:

to prese...

to identify the strategies needed to meet those
objectives, and identify the various actors
responsible for implementi...

A national drug policy is an essential part of
health policy

A national drug policy cannot be developed in
a vacuum...
 Goal

and objective of national drug
policy
The general objectives of a national drug
policy are to ensure:
1.
Acc...
3. Rational use: the promotion of
therapeutically sound and cost-effective use
of drugs by health professionals and
consum...

In addition to health-related goals there may be
others, such as economic goals. For example, an
additional objective ...

Importance of the essential drugs concept
The essential drugs concept is central to a national
drug policy because it ...
3. Encourage the correct use of health facilities
4. Control or lower the cost of medicines to the
government and the pub...

A national drug policy is a comprehensive
framework in which each component plays
an important role in achieving one o...
1) Access to essential drugs
essential drugs can only be achieved through
rational selection, affordable prices,
sustain...
Rational selection, regulatory measures,
educational strategies and financial incentives.
1. Selection of essential drugs:...

Key policy issues are:

The adoption of the essential drugs concept to
identify priorities for government involveme...
2. Affordability

Affordable prices are an important
prerequisite for ensuring access to essential
drugs in the public ...

For multi-source products: promotion of
competition through generic policies, generic
substitution and good procuremen...
3. Drug financing
Drug financing is another essential
component of policies to improve access to
essential drugs.
Key pol...

Promotion of drug reimbursement as part of
public and private health insurance schemes;

Use and scope of user charg...
4. Supply systems
The fourth essential component of
strategies to increase access to essential
drugs is a reliable supply...

Publication of price information on raw
materials and finished products;

Drug supply systems in acute emergencies;
...
2) Regulation and quality assurance
The drug regulatory authority is the agency that
develops and implements most of the ...

Independence and transparency of the drug
regulatory agency; relations between the drug
regulatory agency and the mini...

Commitment to good manufacturing practices
(GMP), inspection and law enforcement;

Access to drug control facilities...
3) Rational use
The rational use of drugs means that
patients receive medicines appropriate for
their clinical needs, in ...
Irrational drug use by prescribers and consumers is
a very complex problem, which calls for the
implementation of many di...

Establishment and support of drugs and
therapeutics committees

Promotion of the concepts of essential drugs,
ration...

Continuing education of health care
providers and independent, unbiased drug
information;

consumer education, and w...
4) Research:
Operational research facilitates the
implementation, monitoring and evaluation
of different aspects of drug p...

In
identifying
prescribing
and
problems
dispensing,
related
to
and
in
understanding the sociocultural aspects ...
5) Human resources development:
Human resources development includes the
policies and strategies chosen to ensure that
the...

Key policy issues are:

Government responsibility for planning and
overseeing the development and training of the
h...
6) Monitoring and evaluation:

Monitoring and evaluation are essential
components of a national drug policy, and
the nec...

Monitoring of the pharmaceutical sector
through regular indicator-based surveys;

Independent external evaluation of...
A national drug policy involves a complex
process of development, implementation and
monitoring.
First,
the
policy
dev...
Finally, the effect of these activities is
monitored
and
the
programme
adjusted if necessary.
Throughout
the
process...
1. Planning
Drug policy without an implementation
plan remains a dead document. Careful
planning of the implementation ste...
There are various types of plans. The first is
probably the strategic plan to develop the
policy itself, which should spec...
2.Involving all parties
Throughout the policy process (and not only in
the development phase) there should
be
consulta...
3.
Political dynamics
Formulating and implementing a national
drug policy are highly political processes.
This is becau...

A national drug policy involves a complex
process of development, implementation and
monitoring.

First, the policy ...

Finally,
the
effect
of
these
activities
is
monitored and the programme adjusted if
necessary. Throughout the pro...
1) Planning:

There are various types of plans. The first is
probably the strategic plan to develop the
policy itself, ...
2) Involving all parties:

Throughout the policy process (and not only in
the development phase) there should be
consul...
3)Political dynamics:

Formulating and implementing a national
drug policy are highly political processes; this
is becau...

The ministry of health is the most appropriate
national authority to take the lead role in
formulating a national drug ...

In this stage all the interested parties that
need to be involved are identify, the necessary
resources, and how these...
Step 2: Identify the main problems

In order to set realistic objectives a thorough
analysis and understanding of the m...
1.
Examine the situation systematically,
2.
Identify the main problems,
3.
Make recommendations about what needs to
b...
Step 3: Make a detailed situation analysis

A more detailed situation analysis of the
pharmaceutical sector and its com...
Step 4: Set goals and objectives for a national
drug policy

Once the main problems have been defined,
goals
can
be
s...

The
selection
of
appropriate
strategies
to
achieve the objective is more complex, since it
may
involve
choosin...
Step 5: Draft the text of the policy

Once the situation analysis and an outline of
the main goals, objectives and appro...
efficacious and of good quality; and are used
rationally
by
health
professionals
and
consumers.
The
specific
object...
Step 6: Circulate and revise the draft policy

The
draft
document
should
be
widely
circulated for comments, first ...

Endorsement
responsible
by
for
government
planning,
sectors
finance
and
education is important since the successf...
Step 7: Secure formal endorsement of the policy

In some countries the document can then go
to the cabinet or parliamen...

This is a powerful demonstration of political
commitment but it can also cause problems,
as future adjustments to the p...
Step 8: Launch the national drug policy

Introducing a national drug policy is much
more than a technical task. To a la...

The policy should be promoted through a
clear
and
well-designed
information
campaign. Public endorsement by respect...
◦ Implementation of the national drug policy

A policy, however carefully formulated, is
worthless if it is not implemen...
1. Priorities for implementation

For each country the priorities for implementation
will be different. For example, wh...

In least developed countries total spending on
health and pharmaceuticals may be very low,
and the private sector not ...
2. Master plan and work plans

The national drug policy leads to an
implementation plan or master plan, which may
cover ...

Potential donor inputs should also be included,
and gaps in funding can be identified as a
guide for future donor suppo...

The master plan should be broken down into
annual action plans and work plans, which
should
be
carefully
developed
...
3. Responsibilities in implementation

As lead agency, the ministry of health should
oversee and coordinate all activiti...

Apart from the coordinating body, it is
recommended that a national consultative
forum
is
created
to
oversee
polic...

National institutions, such as the drug
regulatory agency, the pharmacy department in
the ministry of health, the centr...
4. Financial resources

It is important to match the strategies and action
plans
with
available
financial
resources...

Contributions from international and local
donors are also possible sources. However,
there should be no conflict of i...
5. Regional cooperation

Regional
cooperation
implementing
institutions
drug
and
can
be
policies.
organizations
...

Sharing information and technical expertise
can be particularly effective if the policies and
strategies are mutually ...

Harmonization in these areas could lead to a
more economical use of human, animal and
material resources, and to the de...
6. Technical cooperation with WHO;

WHO can provide a forum for exchange of
information, and can promote cooperation thr...
of 81

National drug policy.update

Published on: Mar 3, 2016
Source: www.slideshare.net


Transcripts - National drug policy.update

  • 1. Siham Abdoun Msc., PhD.
  • 2.  Health is a fundamental human right. Access to health care, which includes access to essential drugs, is a prerequisite for realizing that right. Essential drugs play a vital role in many aspects of health care.
  • 3.  Drugs can offer a simple, cost-effective answer to many health problems if available, affordable, of good quality and properly used,. In many countries drug costs account for a large share of the total health budget  Despite the obvious medical and economic importance of drugs there are still widespread problems with lack of access, poor quality, irrational use and waste disposal.
  • 4.  At least one-third of the world’s population still lacks access to essential medicines, as a result, millions of children and adults die or suffers without reason, although their disease could have been prevented or treated with cost-effective and inexpensive essential medicines..
  • 5.  A national drug policy is a common framework to solve problems in pharmaceuticals  WHO recommends that all countries formulate comprehensive and implement national drug a policy (NDP)? A policy is not static and will usually develop over time
  • 6. What is a national drug policy? A national drug policy is a commitment to a goal and a guide for action. It expresses and prioritizes the medium- to long-term goals set by the government for the pharmaceutical sector, and identifies the main strategies for attaining them.
  • 7.  It provides a framework within which the activities of the pharmaceutical sector can be coordinated.  It covers both the public and the private sectors, and involves all the main actors in the pharmaceutical field.
  • 8.  A national drug policy, presented and printed as an official government statement, it is important because it acts as a formal record of aspirations, aims, decisions and commitments. Without such a formal policy document there may be no general overview of what is needed; as a result, some government measures may conflict with others, because the various goals and responsibilities are not clearly defined and understood
  • 9.  The policy document should be developed through a systematic process of consultation with all interested parties. In this process the objectives must be defined, priorities must be set, strategies must be commitment must be built. developed and
  • 10. Why is a national drug policy needed? National drug policy is needed for many reasons. The most important are:  to present a formal record of values, aspirations, aims, decisions and medium- to long-term government commitments;  to define the national goals and objectives for the pharmaceutical sector, and set priorities;
  • 11.  to identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy;  to create a forum for national discussions on these issues.  The main objectives of ensuring equitable access, good quality and rational use are usually found in all national drug policies, but clearly not all of these policies are the same.
  • 12.  A national drug policy is an essential part of health policy  A national drug policy cannot be developed in a vacuum . it must fit within the framework of a particular health care system, a national health policy and, perhaps,
  • 13.  Goal  and objective of national drug policy The general objectives of a national drug policy are to ensure: 1. Access: equitable availability and affordability of essential drugs 2. Quality: the quality, safety and efficacy of all medicines
  • 14. 3. Rational use: the promotion of therapeutically sound and cost-effective use of drugs by health professionals and consumers. 4. The more specific goals and objectives of a national policy will depend upon the country situation, the national health policy, and political priorities set by the government
  • 15.  In addition to health-related goals there may be others, such as economic goals. For example, an additional objective may be to increase national pharmaceutical production capacity. It is critical that all the drug policy objectives are clear, so that the roles of the public and private sectors and of the various ministries (health, finance, trade and industry) and government bodies (such as the drug regulatory authority) can be specified.
  • 16.  Importance of the essential drugs concept The essential drugs concept is central to a national drug policy because it promotes equity and helps to set priorities for the health care system. quality of care and better value for money.  1. Therefore the more specific objectives are: Improve the dispensing and presentation of medicines 2. Promote the correct use of the medicines by the public
  • 17. 3. Encourage the correct use of health facilities 4. Control or lower the cost of medicines to the government and the public 5. Improve the manpower skills of qualified personal 6. Stimulate the development of the local pharmaceutical industries
  • 18.  A national drug policy is a comprehensive framework in which each component plays an important role in achieving one or more of the general objectives of the policy (access, quality and rational use). The policy should balance the various goals and objectives, creating a complete and consistent entity.
  • 19. 1) Access to essential drugs essential drugs can only be achieved through rational selection, affordable prices, sustainable financing and reliable health and supply systems. Each of the four components of the access framework is essential but not sufficient in itself to ensure access. Similarly, rational drug use depends on many factors, such as:
  • 20. Rational selection, regulatory measures, educational strategies and financial incentives. 1. Selection of essential drugs: Drug selection, preferably linked to national clinical guidelines, is a important step in ensuring access to essential drugs and in promoting rational drug use, because no public sector or health insurance system can afford to supply or reimburse all drugs that are available on the market.
  • 21.  Key policy issues are:  The adoption of the essential drugs concept to identify priorities for government involvement in the pharmaceutical sector, and especially for drug supply in the public sector and for reimbursement schemes;  Procedures to define and update the national list(s) of essential drugs;  Selection mechanisms for traditional and herbal medicines.
  • 22. 2. Affordability  Affordable prices are an important prerequisite for ensuring access to essential drugs in the public and private sectors.   Key policy issue are: Government commitment to ensuring access through increased affordability;  For all drugs: reduction of drug taxes, tariff and distribution margins; pricing policy;
  • 23.  For multi-source products: promotion of competition through generic policies, generic substitution and good procurement practices;  For single-source products: price negotiations, competition through price information and therapeutic substitution, and TRIPS-compliant measures such as compulsory licensing, “early workings” of patented drugs for generic manufacturers and parallel imports.
  • 24. 3. Drug financing Drug financing is another essential component of policies to improve access to essential drugs. Key policy issues are:  commitment to measures to improve efficiency and reduce waste;  increased government funding for priority diseases, and the poor and disadvantaged;
  • 25.  Promotion of drug reimbursement as part of public and private health insurance schemes;  Use and scope of user charges as a (temporary) drug financing option;  Use of and limits of development loans for drug financing;  Guidelines for drug donations.
  • 26. 4. Supply systems The fourth essential component of strategies to increase access to essential drugs is a reliable supply system.  Key policy issues are:  Public–private mix in drug supply and distribution systems;  Commitment to good pharmaceutical procurement practices in the public sector;
  • 27.  Publication of price information on raw materials and finished products;  Drug supply systems in acute emergencies;  Inventory control, and prevention of theft and waste;  Disposal of unwanted or expired drugs.
  • 28. 2) Regulation and quality assurance The drug regulatory authority is the agency that develops and implements most of the legislation and regulations on pharmaceuticals, to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. Key policy issues are: government commitment to drug regulation, including the need to ensure a sound legal basis and adequate human and financial resources;
  • 29.  Independence and transparency of the drug regulatory agency; relations between the drug regulatory agency and the ministry of health (MoH);  Stepwise approach to drug evaluation and registration; definition of current and medium-term registration procedures;
  • 30.  Commitment to good manufacturing practices (GMP), inspection and law enforcement;  Access to drug control facilities;  Commitment to regulation of drug promotion;  Regulation of traditional and herbal medicines;  Need and potential for systems of adverse drug reaction monitoring;  International exchange of information.
  • 31. 3) Rational use The rational use of drugs means that patients receive medicines appropriate for their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest cost to them and their community.
  • 32. Irrational drug use by prescribers and consumers is a very complex problem, which calls for the implementation of many different interventions at the same time. Efforts to promote rational drug use should also cover the use of traditional and herbal medicines. Key policy issue:  Development of evidence-based clinical guidelines, as the basis for training, prescribing, drug utilization review, drug supply and drug reimbursement;
  • 33.  Establishment and support of drugs and therapeutics committees  Promotion of the concepts of essential drugs, rational drug use and generic prescribing in basic and in-service training of health professionals;  The need and potential for training informal drug sellers;
  • 34.  Continuing education of health care providers and independent, unbiased drug information;  consumer education, and ways to deliver it;  financial incentives to promote rational drug use;  regulatory and managerial strategies to promote rational drug use.
  • 35. 4) Research: Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy. It is an essential tool in assessing the drug policy’s impact on national health service systems and delivery, in studying the economics of drug supply,
  • 36.  In identifying prescribing and problems dispensing, related to and in understanding the sociocultural aspects of drug use.  Key policy issues are: ■ the need for operational research in drug access, quality and rational use; ■ the need and potential for involvement in clinical drug research and development.
  • 37. 5) Human resources development: Human resources development includes the policies and strategies chosen to ensure that there are enough personnel available trained to and motivated implement the components of the national drug policy. Lack of motivation and appropriate expertise has been a critical factor in the failure to achieve national drug policy objectives.
  • 38.  Key policy issues are:  Government responsibility for planning and overseeing the development and training of the human resources needed for the pharmaceutical sector;  Definition of minimum education and training requirements for each category of staff;  career planning and team building in government service;  The need for external assistance (national and international).
  • 39. 6) Monitoring and evaluation:  Monitoring and evaluation are essential components of a national drug policy, and the necessary provisions need to be included in the policy  Key policy issues are:  Clear government commitment to the principles of monitoring and evaluation;
  • 40.  Monitoring of the pharmaceutical sector through regular indicator-based surveys;  Independent external evaluation of the impact of the national drug policy on all sectors of the community and the economy
  • 41. A national drug policy involves a complex process of development, implementation and monitoring. First, the policy development process results in the formulation of the national drug policy. Second, strategies and activities aimed at achieving policy objectives are implemented by the various parties.
  • 42. Finally, the effect of these activities is monitored and the programme adjusted if necessary. Throughout the process careful planning and the involvement of all parties are needed, and the political dynamics have to be considered at all times.
  • 43. 1. Planning Drug policy without an implementation plan remains a dead document. Careful planning of the implementation steps and activities necessary to arrive at the expected outcome throughout the process. is important
  • 44. There are various types of plans. The first is probably the strategic plan to develop the policy itself, which should specify the various steps in the development process, and especially plan for the involvement of as many stakeholders as possible. After the policy has been adopted, an implementation plan, or master plan, is needed, which typically covers a 3–5-year period.
  • 45. 2.Involving all parties Throughout the policy process (and not only in the development phase) there should be consultation, dialogue and negotiations with all interested groups and stakeholders. These include education, pharmacists other trade, and ministries industry), nurses, (higher doctors, local and international pharmaceutical industries, drug sellers, academia, organizations (NGOs), nongovernmental
  • 46. 3. Political dynamics Formulating and implementing a national drug policy are highly political processes. This is because such a policy usually seeks to achieve equity of access to basic health care, primarily by making the pharmaceutical sector more efficient, cost effective and responsive to health needs.
  • 47.  A national drug policy involves a complex process of development, implementation and monitoring.  First, the policy development process results in the formulation of the national drug policy.  Second, strategies and activities aimed at achieving policy objectives are implemented by the various parties.
  • 48.  Finally, the effect of these activities is monitored and the programme adjusted if necessary. Throughout the process careful planning and the involvement of all parties are needed, and the political dynamics have to be considered at all times.
  • 49. 1) Planning:  There are various types of plans. The first is probably the strategic plan to develop the policy itself, which should specify the various steps in the development process, and especially plan for the involvement of as many stakeholders as possible. After the policy has been adopted, an implementation plan, or master plan, is needed, which typically covers a 3–5-year period.
  • 50. 2) Involving all parties:  Throughout the policy process (and not only in the development phase) there should be consultation, dialogue and negotiations with all interested groups and stakeholders.  These include other ministries (higher education, trade, industry), doctors, pharmacists and nurses, local and international pharmaceutical industries, drug sellers, academia, nongovernmental organizations (NGOs),
  • 51. 3)Political dynamics:  Formulating and implementing a national drug policy are highly political processes; this is because such a policy usually seeks to achieve equity of access to basic health care, primarily by making the pharmaceutical sector more efficient, cost effective and responsive to health needs.
  • 52.  The ministry of health is the most appropriate national authority to take the lead role in formulating a national drug policy. There are  seven steps for formulating NDP which are: Step 1: Organize the policy process  The first step is to decide how to organize the development process that will identify the structure of the policy, its major objectives and its priority components.
  • 53.  In this stage all the interested parties that need to be involved are identify, the necessary resources, and how these can be obtained.  The need for assistance from WHO, donors or countries with relevant experience should also be assessed.  This stage can be carried out within the ministry of health with support from a small committee of selected experts.
  • 54. Step 2: Identify the main problems  In order to set realistic objectives a thorough analysis and understanding of the main problems in the pharmaceutical sector are needed. There are various ways of carrying out an initial situation analysis of which is to select team of expert with experience in policy formulation; These experts should act as independent advisers and come not only from the ministry of health but also from other disciplines; they should :
  • 55. 1. Examine the situation systematically, 2. Identify the main problems, 3. Make recommendations about what needs to be done and what can be done, 4. Identify possible approaches. 5. Formulating their recommendations, these recommendations can be discussed at one or more multidisciplinary workshops, in order to formulate consolidated advice to the government.
  • 56. Step 3: Make a detailed situation analysis  A more detailed situation analysis of the pharmaceutical sector and its components may be needed. This should further analyze the source of the problems, in order to identify potential solutions, choose the most appropriate strategies, set priorities, and serve as a baseline for future systems of monitoring and evaluation.
  • 57. Step 4: Set goals and objectives for a national drug policy  Once the main problems have been defined, goals can be set and priority objectives identified.  For example, if one of the priority problems is lack of access to essential drugs, one of the priority objectives should be to improve the selection, affordability essential drugs. and distribution of
  • 58.  The selection of appropriate strategies to achieve the objective is more complex, since it may involve choosing from among very different approaches. A helpful procedure is to make a workshop involving a small number of key policy-makers. The situation analysis should justify the choices and serve as the basis for decisions. The outlined objectives and strategies should interested parties. be discussed with all
  • 59. Step 5: Draft the text of the policy  Once the situation analysis and an outline of the main goals, objectives and approaches have been completed, a draft text of the national drug policy should be prepared; it should set out the general objectives of the policy. In most countries this will be to ensure that essential drugs are accessible to the entire population; The drugs are safe,
  • 60. efficacious and of good quality; and are used rationally by health professionals and consumers. The specific objectives should also be described. Drafting of the policy can be done by a small group of experts who have been involved in the earlier stages of the process. Examples of national drug policy documents from other countries may be consulted.
  • 61. Step 6: Circulate and revise the draft policy  The draft document should be widely circulated for comments, first within the ministry of health, then in other government ministries and departments, and finally to relevant institutions and organizations outside the government, including the private and academic sectors.
  • 62.  Endorsement responsible by for government planning, sectors finance and education is important since the successful implementation of many elements of the policy will depend on their support as well. Once this wide consultation is complete, the draft document should be revised in the light of the comments received, and finalized
  • 63. Step 7: Secure formal endorsement of the policy  In some countries the document can then go to the cabinet or parliament for endorsement. In others it will remain an administrative document that serves as basis for implementation plans and changes in the law and regulations. In some countries the entire national drug policy document has become law.
  • 64.  This is a powerful demonstration of political commitment but it can also cause problems, as future adjustments to the policy may become difficult. It is therefore recommended that only certain enabling components of the policy are incorporated into law, without too many operational details
  • 65. Step 8: Launch the national drug policy  Introducing a national drug policy is much more than a technical task. To a large extent the policy’s success will depend on the level of understanding of different sectors of society, and on their support for its objectives. The implication and benefits for all interested parties should therefore be stressed.
  • 66.  The policy should be promoted through a clear and well-designed information campaign. Public endorsement by respected experts and opinion leaders can be very useful. Information should be disseminated through a variety of channels to reach different target groups. The media can play a major role in ensuring public understanding and support for the policy. Some countries have organized high profile launches.
  • 67. ◦ Implementation of the national drug policy  A policy, however carefully formulated, is worthless if it is not implemented. Every drug policy needs an overall implementation plan or “master plan”; each component of the policy needs a detailed strategy and specific action plans.
  • 68. 1. Priorities for implementation  For each country the priorities for implementation will be different. For example, when health care coverage is broad and access to drugs is not a problem, rational use and the cost of drugs is likely to be of concern. In such a situation, implementation of a drug policy will focus on regulating the market and control costs without decreasing sustainable access and equity.
  • 69.  In least developed countries total spending on health and pharmaceuticals may be very low, and the private sector not geared to meeting the needs of the majority of the population. In this situation the focus of the policy will be more on increasing access to essential drugs.  Priorities for implementation should be based on the severity of the problems, and on the potential for success in achieving the objective and making an impact with available resources.
  • 70. 2. Master plan and work plans  The national drug policy leads to an implementation plan or master plan, which may cover a 3–5-year period. This implementation plan show up for each component of the policy what needs to be done and who is responsible, estimates the budget requirement and proposes a rough time frame. If resources are insufficient without external input, a set of priority activities should be identified that can be performed within existing resources.
  • 71.  Potential donor inputs should also be included, and gaps in funding can be identified as a guide for future donor support. The master plan facilitates monitoring and follow-up, and it is important that it is communicated to all parties involved.
  • 72.  The master plan should be broken down into annual action plans and work plans, which should be carefully developed with the various agencies involved in implementation.  These plans should outline the approaches and activities for each component, specifying in detail who is responsible, listing the major tasks, and describing the target output, the detailed time frame and the exact budget.
  • 73. 3. Responsibilities in implementation  As lead agency, the ministry of health should oversee and coordinate all activities, and monitor the extent of implementation and the achievement of targets. In some countries a separate unit within the ministry, with its own budget and personnel, coordinating body. acts as the
  • 74.  Apart from the coordinating body, it is recommended that a national consultative forum is created to oversee policy implementation. This is essential to create and maintain countrywide support for the policy, and to ensure that the major stakeholders remain informed and involved.
  • 75.  National institutions, such as the drug regulatory agency, the pharmacy department in the ministry of health, the central medical stores, and district or provincial health offices, are key players in drug policy implementation; other agencies dealing with finance, trade, economic planning and education. Given the multi-sectoral nature of pharmaceutical issues it is important not only to obtain but also to maintain agreement on the policy objectives.
  • 76. 4. Financial resources  It is important to match the strategies and action plans with available financial resources. Allocations from government funds and income from drug registrations and fees are the usual funding sources. The responsible agencies should have a mechanism for actively seeking funds and be able to secure regular funding from the government.
  • 77.  Contributions from international and local donors are also possible sources. However, there should be no conflict of interest in accepting donor contributions, for example, when donors are interested in funding activities that are of low priority in the national drug policy.
  • 78. 5. Regional cooperation  Regional cooperation implementing institutions drug and can be policies. organizations useful in Countries, can share information, expertise, skills and facilities.  Exchanging experiences helps to ensure that best practices are promoted, that mistakes are not repeated and that limited resources are used effectively
  • 79.  Sharing information and technical expertise can be particularly effective if the policies and strategies are mutually relevant and easy to adapt. Harmonization of drug regulatory standards can be one outcome of successful technical and regulatory cooperation among countries.
  • 80.  Harmonization in these areas could lead to a more economical use of human, animal and material resources, and to the development of regionally or internationally agreed standards. During the process of harmonization each country must ensure that the areas being harmonized can be implemented and are relevant to national interests.
  • 81. 6. Technical cooperation with WHO;  WHO can provide a forum for exchange of information, and can promote cooperation through regional and international training courses and through inter-country research projects. WHO collaborating centers’ and other centers are also involved in training and research, forming professional networks and exchanging information among cooperating countries

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