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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
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
Funding source: This study was financed by the World Health
* 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,
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.
Measuring Transparency in the Public Pharmaceutical Sector. Assessment
Instrument. World Health Organization. 2009
* 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
* To
pharmaceutical policy makers and other
stakeholders about transparency in the
pharmaceutical system, in order to
promote a National Drug Policy for the
* Data
collection: The methodology used
was the conduction semi-structured
interviews tailored to fit particular
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
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.
* 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
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
General Findings
Vulnerability Scores
Clinical trials
Minimally vulnerable
Marginally vulnerable
Moderately vulnerable
Very vulnerable
Extremely vulnerable
General Findings
* Public pharmaceutical sector (PPS)
has legal provisions for all the eight
* Independent appeal system
(administrative and judicial)
* Partially established and poor
standardized processes
* Deficiencies in human resources
* 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
* Registration of medicines
* Standard application form for
submission of applications, at CSU
* Team of assessors and an “Inscriptions
Committee” the decision making
* Guidance (by law)
* Timeframes
* Content of product information leaflets
* 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.
* 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.
*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
* Application and approval of promotion and
advertising materials.
* Control of the operations of medical
* Control and approval of promotion and
* 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
* 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
* 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,
* Documented procedures for management of
external experts evaluating CT applications.
* Documented procedures for decisionmaking.
* Standard format for assessment report.
*Selection of essential medicines
* 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
* Selection is carried out in accordance
with written criteria.
* 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.
* 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
* 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
*Distribution of medicines
* Stock records are reconciled with physical
counts at least every year by internal
* 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.
* 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,
* Legal disposition for disposal of unwanted
medicines, but it is not properly used.
* 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
* 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
* That each of the eight functions develop a COI
policy. Making COI form signature and
declaration mandatory.

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