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many areas not covered in order for this to be a suitable accountability document- such as timing of plan, reporting on plan, external audit of report on plan, etc. Suggestions are made in Appendix G to expand the specifications for the annual plan and the annual report. Ex post formal annual reporting of financial and service performance with external audit and external monitoring, including by MOF of the government’s “ownership” interests related to the maintenance of the agency’s capability using the POE Policy and Monitoring Unit. Service agreement with MOH covering detail of services to be provided and funds to be provided, designed to incentivise good performance. The Health Law can provide for this as per Appendix G. Regular reporting on service agreement to MOH, eg, quarterly and a full annual report. The Health Law can provide for this. Monitoring of performance by MOH including comparative performance reports to encourage better performance. The Health Law could define MOH’s role in relation to these agencies. Readily accessible information on performance for service users, monitors, and others. The Health Law can provide for this. Adequate internal controls to support greater flexibilities to manage resources. Increased flexibilities to manage resources need to be balanced with increased accountability for performance. The framework outlined above has the basic components required to achieve this, if implemented well. The barriers to performance need to be addressed such as the very detailed budget execution method implemented by the MOF. This detailed approach to budget execution is not appropriate for an agency that has an adequate governance and accountability framework and internal financial management capabilities. Hospitals would need to develop these capabilities and the framework for governance and accountability would need to work well. Policy work on designing an accountability framework for agencies must take account of the situation in Kosovo, including the level of capability and the risks that need to be managed. It is unrealistic to expect to be able to rapidly develop a robust governance and accountability framework and to have all processes relating to this operating very well, given the constraints in Kosovo. A transition path could be developed with incremental changes that involve the adequate management of risks. Problems can be expected in moving to an agency model, but this should not justify maintaining the status quo which is characterised by some notable problems. Managers in hospitals and other agencies could be trained in management and in future, selected according to suitable criteria. If they are set up with more flexibility to manage resources, then the management role becomes more challenging. MOH could have a funding, purchasing and monitoring role instead of a direct procurement role and other direct roles in relation to hospitals and agencies, if hospitals and agencies have robust accountability frameworks. Agencies could report to the PS or Minister for high level matters like agreement on key strategic and accountability issues. With regard to the provision of services, reporting and monitoring, the agencies could report to the appropriate part of the MOH and in the case of the hospitals, this could be to the Department of Secondary and Tertiary Services. The MOH would need to develop its capabilities to effectively exercise its roles. SECTION VII: Pharmaceuticals Current situation and issues The Department of Pharmacy has two divisions: one for monitoring and one for supply. There is a director, one person in each division and two assistants serving both divisions (five in total). See Appendix F. The Kosovo Medicines Agency regulates drugs and other medical products. It is an agency of around 38 staff, reporting to the Minister. There is a separate Pharmacy Inspectorate that used to be part of the Kosovo Medicines Agency, but has recently been set up as an inspectorate reporting to the Minister. It has a staff of six being a director, an assistant and four inspectors. 24

Some issues raised by staff include: Options Problems in providing an adequate service supplying pharmaceuticals to the providers due to the incompatibility of the Procurement Law with the special conditions in the drugs sector such as urgent and changing demands, the need to be able to purchase at a price and adjust the volume rather than purchase set volumes, and other issues. The MOH needs to proposed changes to the Procurement Law. The Kosovo Medicines Agency considers that it needs more independence. The reason the agency is seeking more independence relates to difficulties experienced with the lack of financing and other input flexibility, and how this impacts on services provided by this agency. The agency advised that it is proposing a law to become an “independent agency” under the Constitution (142). Independent agencies reporting to parliament should be agencies that need to be far removed from government influence such as State Audit, Courts, Auditor General, and the Ombudsman. These are parliament’s agencies not the government’s agencies, whereas many of the agencies that exist now do not need full independence from government. While this agency provides services to external users and generates revenues about equal to its annual budget, this is not a reason in itself for increased independence, given that it is exercising a monopoly service that is a core part of the regulatory framework in the health sector (see Appendix G). A government-wide solution to the situation with agencies could be addressed in a law for agencies. The separation of the pharmacy inspectorate from the Kosovo Medicines Agency is causing some practical problems as they need to work closely together. Options for this department include: Removing the divisions as this department is too small to justify these. Consider the possibility of either including this department as a division of the Department of Secondary and Tertiary Services or consider options to enlarge the department, however we do not have sufficient information to make suggestions about options to improve the arrangements for the pharmacy functions in all the entities (MOH, Kosovo Medicines Agency and Pharmacy Inspectorate) and further work is required on this area. We are not aware of the reason why the Pharmacy Inspectorate has been created and why it reports directly to the Minister and without information on the problems that this structural change is intended to address, we are not in a position to comment. There is a proposal to enlarge the pharmacy department by bringing the warehousing and distribution functions in the MOH rather than continuing the contract to the private sector for these services. The comparative costs analysis for this proposal needs further development to take account of the full costs to the government of this proposal including the costs of owning the building and running the vehicles including depreciation, insurance, maintenance etc., as well as the opportunity costs. The performance differences between an in house service and a contracted service should also be considered, as sometimes it is possible to get a higher quality service through using contracting techniques compared to an in house service. If the decision is taken to enlarge the department by taking the warehousing and distribution functions in house then this strengthens the case for keeping the Pharmacy Department as a department and not making it a division in another department. SECTION VIII: Public health services Current situation and issues The Division of Public Health has a head of the division with three areas: an Office of Mental Health (0.5 staff); an Office for HIV AIDs (vacant) and programs for mother and child and TB (1 staff and recruiting 1 assistant that UNICEF will fund). This is an unusual collection of services to associate with public health. Public health policy, health education and promotion, and health status monitoring are not well resourced in the MOH. 25

many areas not covered in order for this to be a suitable accountability document- such as<br />

timing of plan, reporting on plan, external audit of report on plan, etc. Suggestions are made<br />

in Appendix G to expand the specifications for the annual plan and the annual report.<br />

Ex post formal annual reporting of financial and service performance with external audit and<br />

external monitoring, including by MOF of the government’s “ownership” interests related to<br />

the maintenance of the agency’s capability using the POE Policy and Monitoring Unit.<br />

Service agreement with MOH covering detail of services to be provided and funds to be<br />

provided, designed to incentivise good performance. The Health Law can provide for this as<br />

per Appendix G.<br />

Regular reporting on service agreement to MOH, eg, quarterly and a full annual report. The<br />

Health Law can provide for this.<br />

Monitoring of performance by MOH including comparative performance reports to encourage<br />

better performance. The Health Law could define MOH’s role in relation to these agencies.<br />

Readily accessible information on performance for service users, monitors, and others. The<br />

Health Law can provide for this.<br />

Adequate internal controls to support greater flexibilities to manage resources.<br />

Increased flexibilities to manage resources need to be balanced with increased accountability for<br />

performance. The framework outlined above has the basic components required to achieve this, if<br />

implemented well. The barriers to performance need to be addressed such as the very detailed<br />

budget execution method implemented by the MOF. This detailed approach to budget execution is<br />

not appropriate for an agency that has an adequate governance and accountability framework and<br />

internal financial management capabilities. Hospitals would need to develop these capabilities and<br />

the framework for governance and accountability would need to work well.<br />

Policy work on designing an accountability framework for agencies must take account of the situation<br />

in Kosovo, including the level of capability and the risks that need to be managed. It is unrealistic to<br />

expect to be able to rapidly develop a robust governance and accountability framework and to have<br />

all processes relating to this operating very well, given the constraints in Kosovo. A transition path<br />

could be developed with incremental changes that involve the adequate management of risks.<br />

Problems can be expected in moving to an agency model, but this should not justify maintaining the<br />

status quo which is characterised by some notable problems.<br />

Managers in hospitals and other agencies could be trained in management and in future, selected<br />

according to suitable criteria. If they are set up with more flexibility to manage resources, then the<br />

management role becomes more challenging.<br />

MOH could have a funding, purchasing and monitoring role instead of a direct procurement role and<br />

other direct roles in relation to hospitals and agencies, if hospitals and agencies have robust<br />

accountability frameworks. Agencies could report to the PS or Minister for high level matters like<br />

agreement on key strategic and accountability issues. With regard to the provision of services,<br />

reporting and monitoring, the agencies could report to the appropriate part of the MOH and in the<br />

case of the hospitals, this could be to the Department of Secondary and Tertiary Services. The MOH<br />

would need to develop its capabilities to effectively exercise its roles.<br />

SECTION VII: Pharmaceuticals<br />

Current situation and issues<br />

The Department of Pharmacy has two divisions: one for monitoring and one for supply. There is a<br />

director, one person in each division and two assistants serving both divisions (five in total). See<br />

Appendix F.<br />

The Kosovo Medicines Agency regulates drugs and other medical products. It is an agency of<br />

around 38 staff, reporting to the Minister.<br />

There is a separate Pharmacy Inspectorate that used to be part of the Kosovo Medicines Agency,<br />

but has recently been set up as an inspectorate reporting to the Minister. It has a staff of six being a<br />

director, an assistant and four inspectors.<br />

24

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