Interventions in the Kosovo Pharmaceutical Sector: Success or Failure?

1. Interventions in the Kosovo Pharmaceutical Sector: Success or Failure? Arifaj-Blumi D

2. The presentation • Objectives: • To describe the current situation in the pharmaceutical sector of post-war • Kosovo. • To describe the types of interventions, achievements and failures. • To identify the main constraints in their implementation. • Design/methodology: • Descriptive analysis. • Use of existing documents. • Reports from the MoH and International Organizations. • Personal experience. • Systematic analysis of the situation in the pharmaceutical sector. • Setting: • National.

3. Countryinformation Where are we on the map? • Population • 2 million • The youngest population • in Europe • 50% under the age of 23 • 8% above the age of 60 • 50% lives in poverty • 12% in extreme poverty • Unemployment rate: above 50% • GDP in 2003 per capita ~ €820 • while per capita income ~ €1150 Kosovo is the red colored surface

4. Governance • Before 1998 Kosovo was administered by Serbia, Yugoslavia. • Since the end of the war (1999) Kosovo has been administered by the United Nations under the authority of Security Council Resolution 1244. • First Ministries created on March 2002 when UN started to shift responsibilities to the Kosovo Provisional Institutions of Self-Government. • Highly decentralized country – 30 Administrative structures (Municipalities) resulting in 30 Health Directorates. • 2003 Kosovo General Budget totaled €489 million. • Health Situation • Most common conditions: PTSD (Post traumatic stress disorder); cardiovascular; respiratory; renal and GI diseases. • TB is declining progressively but the incidence is still high 67/100,000. • HIV/AIDS incidence is still very low. Only 46 cases are reported (?)

5. Pharmaceutical Sector • Before the 1998-99 war, Kosovo lacked the authority to regulate and control the Pharmaceutical Sector. • After the war, in absence of institutions, laws and regulations, sector’s development has had to start from scratch. • Main stakeholders: • Initially UN/WHO (the role of “MoH”) • Joint Interim Administrative Structure • EU as the major donor • As of 2002, the Ministry of Health • The challenge: • To develop an efficient and sustainable Pharmaceutical System that corresponds • both with Regional and European Union standards.

6. Current Resources: • Who pays for the medicines? • In 2003 total budget for public health sector was €44,4 million, ~ €21 per capita. • ¼ of the total public health budget spent on pharmaceuticals ~ €5 per capita. • Government provides Essential Medicines to all public health facilities for free. • Medicines not included in ELM are available in the private market and it is in • patient’s responsibility to find and pay for them. • No health insurance coverage and no reimbursement schemes for medicines exist. • Prices for pharmaceutical products are not regulated. • No pharmaceutical industry exists. Small scale production in the “private • laboratories”. • No international aid on pharmaceutical supplies except GDF providing • TB medicines. • EU is providing technical expertise with one expert in the field of regulations. • Sufficient number of qualified/licensed pharmacists but not properly distributed.

7. Interventions (not in chronological order) • Availability and Accessibility: • Essential List of Medicines (ELM) developed in 1999, updated in 2000 and 2003. • Public supply system established. • - Pharmaceutical products procured with the international tendering on • annual basis as per ELM (tender executed by contracted UN-OPS Agency, • using the MoH’s financial resources). • - MoH contracts services for storage and distribution with private companies. • - Essential Medicines distributed to all public health facilities and ex-state • pharmacies (now managed by a contracted company which initially was • created as public/private corporate supported by UN/WHO/EU but never • managed to become what it was suppose to be and now functions purely as • a private company.

8. Legislation and Regulations: • Drug Regulatory Agency established in 2000. • The Pharmaceutical Division established within the MoH in 2002. • Regulation on controlling import, wholesale and retail enforced in 2000. • Provisional Marketing Authorization is at first stages of implementation. • The Draft Law on Medicines is waiting for approval. • The first draft regulations recently drawn for: • - Medicines Pricing Control • - Prescription Policies • - Reimbursement Schemes • The Quality Control Laboratory approved to be established in 2004.

9. Rational Drug Use • EML printed and distributed. • Medicines Formulary printed and distributed. • Drug and Therapeutic Committees established (but no longer functioning). • Training on Good Prescribing Practices for Family Doctors. • Training on Drug Management for upgrading course for Family Medicine Nurses. • Printing and distribution of information materials on generic/brand names. • Monitoring and Evaluation • Survey on Prescribing Indicators (2000 and in 2003). • Survey on availability and affordability of EM (bi-monthly, covering year 2001). • Monitoring accessibility (on regular basis). • Monitoring availability and accessibility of TB drugs (2000). • Rapid Assessment of Drug Management Practices in PHC (2001).

10. A simplified summary of select indicators • Availability: • -In bi-monthly survey covering year 2001, EM were available in average 62%. • Prescribingindicators at the Primary Health Care Level: • 2000 2003 • Average number of drugs per patient: 2.3 2.5 • Drugs prescribed by generic name: 49% 58% • Drugs prescribed from EDL: 39% 52% • Patients prescribed injections: 33% 48% • Patients prescribed antibiotics: 53% 40% • Patients prescribed benzodiazepines: 13% 20% • Patients prescribed corticosteroids: 12% 17% • Patients prescribed analgesia: 58% 70%

11. Were the interventions sufficient?…let’s check some facts • The pharmaceutical market remains under regulated. • Patients pay a high, unknown “out of pocket” sum for their medicines. • A large number of unlicensed pharmacies continue to operate. • Medicines enter into the market without being registered. The Provisional • Marketing Authorization started to be implemented just a few months ago. • The plan to establish a Quality Control Laboratory is not yet implemented. • Medicines are imported from many developing countries and cases of harmful • substances in the medicines were reported and confirmed. • Rx Medicines are accessible even without prescription. • Standard Treatment Protocols were not being developed yet and poor • prescribing practices are frequently identified. • Hospital pharmacies are very poorly managed. • Availability and accessibility to Essential Medicines remains poor.

12. Conclusions • Despite continued efforts, interventions taken and international support, • the pharmaceutical sector is still not sustainable. • The main constraints to effectively implementing the reforms are: • Institutional and political • Fluid political and social situation in the country. • Overlapping and conflicting authority between UN and national political structures. • The absence of adequate laws and enforcement. • The poorly coordinated and delayed privatization of state property. • Large scale decentralization of executive authorities making the implementation • of policies difficult. • The lack of political commitment among many stakeholders to develop and support • long term strategies to create a sustainable pharmaceutical sector.

13. Financial and Managerial • The absence of a strategy for the health financing system which delayed • the implementation of medicines financing strategies. • A completely centralized medicines public procurement system, managed by an • external agency based in Copenhagen on behalf of MoH has made it very difficult • to coordinate and accurately address needs. (This policy has been changed in 2004). • Lack of strategies to ensure the quality control of medicines. • The lack of sound epidemiological data making it difficult to assess needs. • The procurement of services for storage and distribution was often politicized. • Failure in the creation of a public-private corporate to manage the Essential • Medicines of the public sector resulting in many unresolved problems. • Lack of monitoring and evaluation activities on regular basis. • Pharmacists prefer to work in the private sector, very few willing to work in • the public sector. • Were the interventions a success or a failure? You judge…