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

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.

Country information Population Kosovo is the red colored surface 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

Governance Health Situation 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 (?)

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.

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.

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.

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.

EML printed and distributed. 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).

A simplified summary of select indicators Availability: -In bi-monthly survey covering year 2001, EM were available in average 62%. Prescribing indicators 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%

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.

Conclusions Institutional and political 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.

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…