Dr. Luis Guillermo Jiménez –Herrera Department of Pharmaceutical Care and Clinical Pharmacy, Faculty of Pharmacy, University of Costa Rica. Dr. Ma. Soledad Quesada-Morúa Department of Pharmaceutical Care and Clinical Pharmacy, National Drug Information Centre, Faculty of Pharmacy, University of Costa Rica ABSTRACT * * * * * * Problem statement: Access to good-quality medicines remains very limited in many parts of the world due to many causes, one of them being corruption. In 2004, the WHO initiated the Good Governance for Medicines Project in an effort to undermine this problem. Costa Rica is the first country in Central America to carry out the assessment phase of this program. Knowing the weaknesses and strengths of the public pharmaceutical sector can help when working on mechanisms for transparent processes that assure safe, available, affordable, and good-quality medicines. Objective: To measure the level of transparency and vulnerability to corruption of the public pharmaceutical sector in Costa Rica in eight basic functions: registration, licensing, inspection, promotion, clinical trials, selection, procurement, and distribution. Design: The present study is descriptive and qualitative, and it used semi-structured interviews to key informants (KI) to provide information on the vulnerability to corruption, using structural indicators and a quantification of the level of transparency for each function. These indicators were converted to a 10-point scale to analyze and compare the degree of susceptibility to corruption and to determine the level of transparency in each function, from extremely vulnerable (EV); to minimally vulnerable (MiV). 109 KI were interviewed, according to their involvement in the pharmaceutical sector and their knowledge of it. The KI interviewed were from the public sector (85%), private sector (13%), and academia and NGOs (2%). For all eight functions a minimum of 8 to 10 interviews were obtained. Results: The assessment on the eight functions revealed that the public pharmaceutical sector of Costa Rica has different vulnerability scores for each function, being the most vulnerable the inspection of pharmaceutical establishments, and the least vulnerable procurement of medicines. Conclusions: The assessment findings allow an overview of the pharmaceutical public sector in Costa Rica that has a regulatory structure prone to improvement, especially in personnel selection, standard operating procedures, and written guidelines in conflicts of interests specific for each function. To minimize corruption, a structural platform with transparent processes should be developed, as well as a proper national drug policy that helps articulate the entire medicines chain, promoting its strengths and diminishing its weaknesses. Funding source: This study was financed by the World Health Organization. Introduction * Medicines are vital to the best health results of the populations. For this statement to be true, medicines have to be accessible and of good quality. Regrettably, there are many factors that do not contribute to make this a reality, being the lack of transparency in the pharmaceutical system one of them1. * Costa Rica is the first country in Central America to carry out the assessment phase of WHO “Good Governance for Medicines” project. This assessment gives the reader an insight of the vulnerability of corruption in the eight basic functions of the medicines supply in Costa Rica: registration, licensing, inspection, promotion, clinical trials, selection, procurement and distribution. * Knowing the weaknesses and strengths of the public pharmaceutical sector in Costa Rica can help obtain better health results for the population and develop mechanisms that can help establish transparent processes that assure safe, available, affordable and good quality medicines. 1 Measuring Transparency in the Public Pharmaceutical Sector. Assessment Instrument. World Health Organization. 2009 Objetives * To assess the level of level of transparency and vulnerability to corruption in eight basic functions of the medicines chain in the pharmaceutical sector in Costa Rica to get to a construction of an ethical framework and code of conduct that will help with the good governance of medicines * To explore the perceptions of pharmaceutical policy makers and other stakeholders about transparency in the pharmaceutical system, in order to promote a National Drug Policy for the country. Method * Data collection: The methodology used was the conduction semi-structured interviews tailored to fit particular circumstances of the public pharmaceutical sector in Costa Rica. * Clearance from authorities: the director and Chief for Bureau of Registration and Control (BRC)was briefed, as well as the authorities of the Medicines Bureau of the Social Security System (CCSS), who briefed higher authorities. * Key informants selection: a list of KIs was obtained from authorities of CCSS and BRC. The KIs provided with more KIs as well. There were KIs from all levels. In some functions (procurement and registration), the KIs are mainly from the government, because of the country’s pharmaceutical sector characteristics. For the functions of inspection and licensing it was not possible to obtain more than 8 or 10 KIs. Method * National Assessors: are professors that work for the Pharmaceutical Care and Clinical Pharmacy Department of the Pharmacy Faculty of the University of Costa Rica, and are investigators of the Institute for Pharmaceutical Investigations (INIFAR). Neither of them have any relation with the Ministry of Health or the social security fund (CCSS) of Costa Rica. * Adaptation to national context: he questionnaire forms were adapted to national context, by inclusion or exchange of certain words or phrases for the better comprehension of some questions. Details of these changes are described later in this document. General Findings Vulnerability Scores Distribution Procurement Selection Clinical trials Promotion Inspection Licensing Registration 8.14 Minimally vulnerable 7.96 Marginally vulnerable 7.85 6.29 6.19 Moderately vulnerable 4.74 4.34 Very vulnerable Extremely vulnerable General Findings *Strengths * Public pharmaceutical sector (PPS) has legal provisions for all the eight functions * Independent appeal system (administrative and judicial) *Weaknesses * Partially established and poor standardized processes * Deficiencies in human resources selection * No written criteria for selecting neither internal, nor external experts. * Recruitment is not based on merit nor expertise in the area * No written guidelines on Conflict of Interest (COI) * No Standard Operating Procedures (SOP) Results * Registration of medicines *Strengths * Standard application form for submission of applications, at CSU * Team of assessors and an “Inscriptions Committee” the decision making body. * Guidance (by law) * Timeframes * Content of product information leaflets *Weaknesses * Overall lack of written criteria * Approving a medicinal product for registration * Exemptions and fast track registration * Written guidelines for the assessors or the IC on how to assess applications. * TORs for external experts. Results * Licensing of pharmaceutical business * Strengths * Provision for control of imports and exports as well. * “Licensing Protocols” * Administrative and technical requirements that should be met in order to get a license to operate * Weaknesses * No criteria * Exemption specified in the law or regulations. * Selecting neither internal, nor external experts. * No pre-licensing inspection. * No continued post-licensing inspection * Inspection of establishments * Strengths * Inspection Unit. * Weaknesses * Poor legal system for inspection. * Human resources are insufficient. * Inspectors not necessarily have training and/or experience in pharmaceutical manufacturing, quality control, community pharmacy, detection counterfeits/substandard products, legal procedures, etc. * Inspectors are not required to submit their report with recommendations to the head of the inspections local unit for a peer review. Results *Control of medicine promotion * Strengths * “Publicity Committee” (PC) * Supervises the promotional materials for marketed medicinal products. * Standards for labelling, package inserts and product information. * Weaknesses * No written guidelines and/or documented procedures. * Application and approval of promotion and advertising materials. * Control of the operations of medical representatives. * Control and approval of promotion and advertising. * Weak sanctions in case of violations. * No written comprehensive Ethical Criteria for Medicinal Medicines Promotion * Advertising to physicians and health-related professionals, general public. * Promotion by medical representatives. * Symposia and other scientific meetings, speakers fees and consultancies. * Not all promotion materials are approved before its use. Results * Control of clinical trials * Strengths * Legal mandate to authorize and regulate CTs. * Guidelines/procedures according to major international guidelines on CTs (Declaration of Helsinki, the CIOMS, WHO GCP). * CONIS: carry out on-site inspection of CTprotocols and sites * Data base on all approved/rejected CT applications. * Various independent ethics committees (IEC) in Costa Rica. * Private * National security system * Universities * Weaknesses * No written criteria for selecting neither internal, nor external experts for CONIS. * Insufficient human resources. * No written procedures * To assess CT applications, variations/amendments. * Documented procedures for management of external experts evaluating CT applications. * Documented procedures for decisionmaking. * Standard format for assessment report. Results *Selection of essential medicines *Strengths * LOM revised every 2 years * Prevalent diseases, treatment facilities, the training and experience of available personnel and financial resources. * Central Pharmacoterapeuthics Committee (CPC) composed of health professionals. * Selection is carried out in accordance with written criteria. *Weaknesses * No TORs or SOPs for PCP * The members of the CPC do not sign a conflict of interest form. * The Ministry of Health has a National Formulary Committee, but is not active at the moment. Results * Procurement of medicines * Strengths * Different procurement functions performed by different offices or committees * Comité de Ficha Técnica, Comité de Compra de Medicamentos. * Essentially limited to a national essential medicines list (ability to procure non essential medicines). * Order quantities according to reliable estimate of actual need, financing mechanism, in largest possible quantities. * Various types of procurement methods, based on the amount of the purchase. * There is an information system, SIGES, to monitor the medicine procurement process. * Each medicine shipment is physically inspected * Batch samples sent to quality control laboratories (random sampling). * All documents (inspection report and laboratory testing results) are archived. * Weaknesses * Internal and external audits of financial and technical performance not publicly available. * System for inspection to verify the quality and quantity of the products does not work very efficiently. Results *Distribution of medicines *Strengths * Stock records are reconciled with physical counts at least every year by internal staff. * Functioning communication system between the suppliers and the end user for ordering, re ordering and complaint. * Inventory management system. * Coding system used to identify government medicines. *Weaknesses * Expedite port clearing system, but has weaknesses in physical inspection and storage (not optimal storage conditions for humidity, temperature, etc). * Not an adequate transportation system (for humidity, temperature [exception, vaccines]). * Legal disposition for disposal of unwanted medicines, but it is not properly used. General Recommendations * National drug policy that can integrate all the components of the medicines chain * To improve MINSA`s regulatory role * To endow with more technology, human resource, as well as material and financial resources. * Fostering SOPs in all levels of each function of the medicines supply chain * Reduction of political influence on the decision making process of the medicine chain. * Development of Terms of references (TORs) for committees, group work; to establish clear functions and responsibilities for every position to be filled. To promote a process working model * That each of the eight functions develop a COI policy. Making COI form signature and declaration mandatory.