Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
1.0 INTRODUCTION
Through the legal obligations to “respect,” “protect,” and “fulfill” the right to health,
governments have implicit duties to ensure that health services are provided effectively to their
populations (CESCR, 2000). One of the biggest threats to the right to health is a lack of good
governance in the health system, which limits the ability of the health system to fulfill its
essential functions, and can create opportunities for corruption. If there is a lack of concern for
basic governance principles in health care delivery, health care resources may have no impact
on the intended end user. Poor governance and corruption thus undermine health care delivery
by reducing the availability of resources and access to health care. This places the heaviest
burden on the poor and marginalized (Lewis, 2006). Corruption has been defined as the abuse of
public roles and resources or the use of illegitimate forms of political influence by public or
private parties (Johnston, 1997). The World Bank identifies corruption as the single greatest
obstacle to economic and social development. Corrupt practices in the health system can have a
threefold impact: 1) an economic impact - when large amounts of public funds are wasted; 2) a
health impact - as the waste of public resources reduces the government's capacity to provide
good quality services and products, patients may turn to unsafe medical products available on
the market instead of seeking health services, leading to poor health outcomes for the
population; and 3) a government image and trust impact - as inefficiency and lack of
transparency reduce public institutions' credibility, this decreases donor's trust in the capacity of
the government to deliver on promises and lowers investments in such countries. This happened
in Zambia when large-scale corruption by government officials resulted in a major withdraw of
health-aid for the country by donors (Pereira, 2009).
Each year, an estimated US$ 4.1 trillion is spent worldwide on providing health services but a
significant amount of this money does not reach its intended beneficiaries (Transparency
International, 2006). As one example, in the area of procurement alone, it is estimated that
between 10% and 25% of global spending on public procurement in the health system is lost to
corruption (Transparency International, 2006). In recent years, the issue of corruption and the
development of public policy to mitigate the effects of corruption have gained importance
globally. For instance, the United Nations (UN) Convention against Corruption was adopted by
the UN General Assembly in October 2003 and came into force in 2005, and raised the
importance of fighting corruption worldwide. In 2009, the UN Secretary General Ban Ki Moon
even highlighted the impact of corruption on the Millennium Development Goals (MDGs). He
publicly stated that corruption can kill development and may very well impede efforts to
achieve the MDGs (UN, 2009). While corruption is difficult to eradicate, good governance can
certainly reduce its manifestation. Despite its importance, there are few examples of how to
incorporate good governance in health system strengthening (Brinkerhoff et al, 2009).
Good governance is defined as “the exercise of economic, political, and administrative authority
to manage a country’s affairs at all levels, comprising the mechanisms, processes, and
institutions through which that authority is directed. Good governance is, among other things,
participatory, transparent, accountable, and efficient. It promotes the rule of law and equal
justice under the law. It requires the involvement of the private system, civil society and the
state and is a prerequisite for sustainable human development” (UNDP, 1997). Good
governance in the health care system is instrumental in helping to lessen the likelihood of
corruption taking place. Still, there are few studies that explicitly examine what the obstacles are
to good governance in the health care system and how to incorporate good governance
effectively. We hope our study can help fill the void in this area.
The rationale for focusing our research grant on good governance and not on corruption is also
practical. We argue that in the absence of good governance, corruption may take place. The
topic of corruption often makes policymakers and health professionals uncomfortable. As a
result, this can lead to decreased access to information as key informants may not respond to
requests for interviews. Furthermore, when they do agree to be interviewed, corruption as a
core interview topic is difficult and oftentimes challenging for key informants to communicate
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
freely about, out of fear that they may implicate themself or a colleague and potentially incur
negative consequences. This grant thus focuses on good governance as a means to probe for the
potential for corruption in the pharmaceutical system and to identify the different forms and
locations of corruption in the pharmaceutical system (i.e. kickback schemes from procurement
or extortion for access to services). This grant is also in line with the Principal Investigator’s
current proposal, supported by the World Health Organization (WHO), to establish a
“WHO Collaborating Center on Good Governance and Transparency in the
Pharmaceutical System” at the Leslie Dan Faculty of Pharmacy, University of Toronto.
2.0 JUSTIFICATION FOR THE PROPOSED RESEARCH PROJECT
2.1 RATIONALE FOR SELECTION OF BRAZIL AS THE CASE STUDY
We will examine the issue of good governance (Figure 1) in health more narrowly through the
pharmaceutical system and in the country context of Brazil. Pharmaceuticals are key inputs into
the health sector and as we will explain below, without good governance in place, the
pharmaceutical system is potentially vulnerable to corruption. We selected Brazil as the case
study for a number of reasons. First, Brazil has the largest pharmaceutical market in Latin
America and has been a leader in terms of global pharmaceutical policies promoting access of
medicines for its population. Brazil has a large and diverse population of about 191 million
people (IBGE, Brazilian Statistics Institute, 2010), and although it is a middle-income country,
acute socio-economic disparities exist amongst its population. For instance, the three poorest
Brazilian states (Piaui, Paraiba and Alagoas) have a high percentage of families living with less
than half of the minimum salary per month, which equates to 44.1%, 42.2% and 47.6% of the
state population, respectively (IBGE, 2010).The per capita consumption of medicines in Brazil
is approximately US $51 per year; however, almost half the medicines are consumed by 15% of
the population, who represent the wealthiest segment of society (Cohen, 2006). This is despite
the fact that Brazil has domestic policy priorities to ensure access to essential medicines, and
this has led to the construction of various laws, regulations and policies to ensure good
governance in the pharmaceutical system. Secondly, Brazil has both a public and private
domestic pharmaceutical industry which provides medicines to its public health care system the
“Sistema Único de Saúde” (SUS). Brazil’s pharmaceutical system is particularly rich for the
study of good governance because all three government levels - federal, state, and municipal have diverse responsibilities regarding the delivery of medicines to the population, and therefore
are required to cooperate with each other. For example, municipalities collect revenues for
health care but may also rely on the Federal Government for discretionary fiscal transfers.
Moreover, our project is consistent with the goals of the Government of Canada, which through
CIDA has supported efforts to reform the social and public sectors and achieve greater equity in
Brazil. Finally, Transparency International ranked Brazil in 2010 as a country that likely has
high institutional corruption (Transparency International, 2010), thus suggesting that we may
indeed find areas where good governance is lacking and corruption is thriving in the
pharmaceutical system.
Brazil is a vast country with rich differences economically, socially and geographically. Given
this, we will seek to probe the good governance (or lack thereof) of pharmaceutical systems in
two Brazilian states with different socio-economic contexts, the State of Sao Paulo (one of the
wealthiest in Brazil) and the State of Paraiba (one of the poorest states in Brazil). For sure, our
case study products are clearly restricted explorations of Brazil. However, we aim to prepare our
studies so that they ideally yield results that are more generally applicable.
2.2 RATIONALE FOR EXAMINING CORRUPTION RISKS AND GOOD
GOVERNANCE IN THE PHARMACEUTICAL SYSTEM
While most rich countries spend at least 5% of GDP on health, most developing countries spend
less than half of this figure. Insufficient health budgets and the added challenge of the
HIV/AIDS epidemic has led to a general shortage of drugs, medical supplies, health care
workers, and a reduction in their salaries. This has resulted in a deterioration of general health.
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
While it is true that lack of governance in the health system is a concern everywhere,
developing countries with already scarce public resources, and oftentimes weak institutions, are
particularly vulnerable to the effects of poor governance. Weak governance in the health care
system exacerbates many existing challenges health systems face and can create new ones for
governments and patients. It increases costs, decreases the effectiveness and volume of health
care services and reduces resources, as some examples. Weak or non-existent rules and
regulations, as well as over-regulation, lack of accountability, low salaries and limited offer of
services (i.e. more demand than supply) are among the key manifestations of poor governance
in the health system. It is a reflection of the structural challenges in the health care system as
well as where it takes place within the system. The scale of corruption also varies: it can be a
direct result from state capture which is often linked with political corruption; it may be petty,
for instance, at the implementation level where the public interacts with public officials, such as
surplus payment demands from health professionals; or grand (i.e. fraud and procurement
abuse).
Weak or no governance in the pharmaceutical system creates opportunities for corruption and
results in additional barriers to drug access. Poor drug access continues to be one of the key
public health problems of today (Kohler and Baghdadi-Sabeti, 2011). There are approximately 2
billion people, or one-third of the global population, who lack regular access to medicines
(Baghdadi et al, 2008). The WHO estimates that by improving access to existing essential
medicines (and vaccines) about 10 million lives could be saved per year (WHO, 2004a). Global
inequalities in access to pharmaceuticals are caused by a number of variables including poverty,
high drug prices, poor health infrastructure, insufficient health expenditure and corruption. But
until recently, the latter was often overlooked. Fortunately, there is growing recognition among
policy makers that the pharmaceutical system can waste valuable resources allocated to
pharmaceutical products and services, and denies those most in need of life-saving or lifeenhancing medicines. Global organizations, including the WHO and the World Bank are thus
addressing the issue of lack of governance in the pharmaceutical system globally. This is
encouraging news for improving drug access for the global poor who are most vulnerable as
they are forced to make sub-optimal choices that include: purchasing less expensive drugs from
unqualified or illegal drug sellers distributing counterfeit or sub-standard drugs; not taking
needed medicines if they are unavailable in the public health system; or impoverishing
themselves by having to purchase expensive drugs in the private health system (Niens et al,
2010).
2.3 WHY GOOD GOVERNANCE IS CRITICAL FOR THE PHARMACEUTICAL
SYSTEM
The pharmaceutical system is susceptible to corruption if good governance is not in place for a
number of reasons. One, the sale of pharmaceutical products is lucrative, the more so because
the final customers (patients and their families) are more vulnerable to opportunism than in
many other product markets. This is due to information gaps and often very inelastic demand.
Pharmaceutical suppliers typically are “profit-maximizers” and will choose to behave in ways
that maximize their interests. There is nothing inherently wrong with profit maximization so
long as it is not counter to the public interest. However, as scandals such as the Vioxx case
illuminate, pharmaceutical suppliers have in the past disregarded public interest for financial
gains.
The second reason why the pharmaceutical system is susceptible to corruption is that it is
subject to a significant degree of government regulation, such that if there are not appropriate
checks in place, government officials may have a monopoly on several core decision points in
the pharmaceutical supply chain, and also have some discretion in making regulatory decisions.
Government intervention is essential in the pharmaceutical system given the imperfect nature of
the market and the need to improve the efficiency of resource allocation. Also, regulation is
rationalised on the grounds of protecting human life and public health by ensuring that only safe
and efficacious medicines are made available in the market. But if there is state capture and
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
poor institutional checks on individual discretion, the public interest may be jeopardized. For
instance, governments usually determine what drugs are included on a national essential drugs
list or reimbursement list of a public health care payer. The inclusion of a drug on such a list,
particularly a reimbursement list, can mean significant financial income for a drug manufacturer
as it guarantees the product a relatively predictable market share. If there is a lack of oversight,
regulators may be able to make discretionary decisions about what drugs should be selected
based on individual gain and not on the public good.
The third reason why the pharmaceutical system is a ‘breeding ground” for weak governance is
because it often is difficult to distinguish authentic pharmaceutical products from counterfeit
ones. In many countries with weak regulation and enforcement of drug distribution standards,
the sale of counterfeit, unregistered or expired drugs are very common. The WHO estimates that
about 25% of drugs consumed in poor countries are counterfeit or substandard (WHO, 2003). It
is very difficult to control such practices particularly where patients and even health
professionals are not able to differentiate between legitimate and fake drugs. Counterfeiters are
often very skilful at copying the form, colour, trademarks and packaging of legitimate products.
While in many markets patients tend to have more confidence in recognized foreign produced
drugs, the high prices for the legitimate versions of these relative to purchasing power drives
many consumers to seek lower cost alternatives, which in many cases are not legal, safe or
reliable. These actions have had significant social costs both in terms of access to drugs,
particularly for the poor, but also in terms of the quality and safety of the drug supply. In
addition, the likelihood of developing resistance to sub-standard and/or counterfeit antibiotics is
elevated, which can result in huge health costs. It is only when there is blatant sloppiness in
copying that patients and health care providers are able to identify counterfeit medicines.
Government commitment to better governance in the system is vital particularly in low and
middleincome countries, where it is estimated that over 70% of all pharmaceutical purchases are
paid for out of pocket (WHO, 2004b) and represent the largest household health expenditure
(WHO, 1998).
3.0 RESEARCH MOVTIVATION AND CONTRIBUTION TO THE LITERATURE
In recent years, a number of studies such as: Kohler (2011) Vian, Savedoff and Mathisen
(2010), Lewis and Pettersson (2009); Vian (2008).; Cohen-Kohler et al. (2007); Lewis (2006);
and Di Tella and Savedoff (2001) have examined health and corruption and have begun to
provide examples of what strategies work best to enforce good governance and lessen the
likelihood of corruption. All of the studies have pointed out that corruption has an impact on
equity by limiting access of the poor to the health care system. Several quantitative and
qualitative studies have illustrated how the burden of corruption impacts the poor more heavily
given their limited ability to pay. The poor and marginalized can be denied access to necessary
care if payments are required for health care services (Lewis, 2000). For example, in Bulgaria,
high income urbanized patients were more likely to make informal payments and thus receive
care they needed in contrast to the low-income population (Balabanova, 1999 cited in Lewis,
2000). A study by Amnesty International on maternal health in Burkina Faso found that
corruption by health professionals is one of the primary causes of death of thousands of women
during pregnancy. Poor women may not get critical health care services simply because they are
unable to pay informal fees (Amnesty International, 2010). Further evidence comes from the
International Monetary Fund which demonstrated that corruption has a significant, negative
effect on health indicators such as infant and child mortality, even after adjusting for income,
female education, health spending, and level of urbanization (Gupta et al., 2000). Corruption
lowers the immunization rate of children, can prevent patient treatment, particularly for the
poor, and discourages the use of public health clinics (Azfar and Gurgur, 2005). The bottom line
is that corruption affects the ability of the poor to access essentiall health services. We need to
gain more knowledge about the causes and consequences of corruption in the health system and
what interventions work best to minimize it.
4.0 RESEARCH OBJECTIVES
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
We aim to achieve four major goals related to good governance in the pharmaceutical system:
1. Examine good governance characteristics (consensus oriented, accountable,
transparent, responsive, equitable and inclusive, effective and efficient, follows the
rule of law, participatory - as per Figure 1 below) throughout the key “decision
points” in the pharmaceutical system. Based on the conceptual framework illustrated
in Figure 1 we will examine issues such as do patients have to pay surplus charges for
publicly funded pharmaceutical services? Are medicines unavailable in public health
systems because they have been diverted to the private system? Are drug formulary
decisions participatory?
2. Identify the factors that facilitate or impede the presence of good governance in
the pharmaceutical system. We will seek to understand what factors facilitate or
impede good governance in core areas such as budget planning, procurement,
regulation, and drug egistration.
3. Compare and contrast good governance in the pharmaceutical system between
states and among different levels of government. There is a lack of rich comparison
in the literature on good governance in the health system between different socioeconomic contexts. This research hopes to uncover what socio-economic factors (if any)
may contribute more to the presence of good governance. Given Brazil’s diversity in
socio-economic conditions, particularly between states, it is an ideal study site for this
objective. We will focus on the State of Sao Paulo and the State of Paraiba.
4. Determine what interventions best support policy change that can strengthen good
governance in the pharmaceutical system. For example, the public posting of medical
supply prices can help prevent collusion between suppliers, there is evidence that
regular external and internal audits can help ensure budgets are being spent
appropriately, and citizen scorecards can help decision makers identify where potential
problems lie. Ideally our findings from our case studies will be generalizable to other
contexts.
5.0 RESEARCH PLAN
5.1 CONCEPTUAL FRAMEWORK
We will examine the following characteristics of good governance in key decision points of the
pharmaceutical system:
Figure 1. Characteristics of Good Governance (UNESCAP, 2012)
The above characteristics will be examined throughout the pharmaceutical system. To do this,
we will use (1) case studies; (2) key informant interviews with public officials, health
professionals, patients international organization and industry representatives, and (3) analysis
of legislation, regulations, government reports, policy documents and commentary, and
academic literature to corroborate data provided during key informant interviews.
5.2 METHODOLOGY
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
Pursuant to the main research objectives of the project, four methodological approaches will be
used to dentify key factors that are integral to both the optimal usage of the legislation, policy
and regulations:
1) Historical analysis of political processes and actors that have informed the design and
contentof the legislation, policy and regulation relevant to good governance in the
pharmaceutical system at the federal level.
2) Present-day descriptive case studies on good governance in the pharmaceutical
system through the lens of the role of the federal, state and municipal governments in:
a. The State of Sao Paulo;
b. The State of Paraiba.
3) Analysis of political, economic and socio-cultural factors that impact the present
and future viability of the legislation, policy and regulation required for pharmaceutical
system good governance.
4) Comprehensive legislative/policy reviews relevant to good governance in the
pharmaceutical system.
1) Historical analysis of political processes and actors
An historical approach involving an inquiry into the political process and the key actors
surrounding the formation of the legislation, policy and regulations will take place. This, in turn,
will aid in the understanding of the political forces and climate that gave rise to the various laws
relevant to good governance in the pharmaceutical system. Specifically, we will examine the
positions and roles of key political actors, interest groups and generic and patent-protected
pharmaceutical industry members that have informed the law. Contextual factors such as the
availability of financial and institutional resources will also be examined.
2) Present-day descriptive case studies
Case study research and analysis is characterized as an empirical enquiry used for qualitative,
in-depth analysis identified in a limited, contemporary context such as a national policy
application, and in studies where the researcher has little or no control of the events to be
analyzed. Case studies have been the preferred strategy used by economists, political scientists
and social researchers as it provides greater flexibility when observing and identifying research
variables. Critics of this research method have identified limitations to the investigative process,
pointing out that small numbers of cases offer no grounds for establishing reliable, general
findings, and that investigators may encounter biases in particular responses which can
influence the study’s final results. However, this particular research method can be justified as
the most appropriate for this research program because the particular study objectives require
the flexibility allowed only through the case study research method, as opposed to the use of
other methods, such as historical analysis and general survey research mechanisms. The data
collection and analysis that will be derived from the use of this case study sampling technique
will help yield findings that are high quality detailed descriptions about each case, rather than
empirical generalizations, which would be captured by a randomized sampling approach. In
using a case study method there is an acknowledged potential of collecting biased data, thus all
results will be triangulated with a variety of data sources and techniques to identify the diverse
characteristics and central themes that emerge within this case and to reduce the impact of bias
on the research sample.
We will seek to probe the good governance (or lack thereof) of pharmaceutical systems in two
Brazilian states with different socio-economic contexts, the State of Sao Paulo (one of the
wealthiest states in Brazil) and the State of Pariaba (one of the poorest states in Brazil). Here,
we will examine indicators of good governance in key areas of the pharmaceutical supply
system that will include but not be limited to the following points in the pharmaceutical system:
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
a) Public expenditure management: including budgeting, planning, budget execution,
monitoring and tracking. This is a key focus given that much public monies are typically
wasted due to corruption and improper information systems. There are already well known
tools in place which can be applied to build up transparency and accountability, such as the
Public Expenditure and Financial Accountability (PEFA) framework and the Public
Expenditure Tracking Surveys (PETS).
b) Public procurement: including linkages to budgeting and regulations. Public procur
ement is commonly susceptible to corruption if good governance is not in place. The focus
on procurement needs to be comprehensive and include an examination of all stages of the
process, including quantification of need/demand, budget allocation, supplier payment,
acceptance of shipments and distribution to end users.
c) Drug distribution and logistics: Poor storage conditions can lead to losses either
through the mismanagement of pharmaceuticals (leading to their expiration) or plain
corruption (theft of medicines). Shipments can be stolen at many points in the delivery
system including by port personnel, crime syndicates that organize large-scale thefts from
warehouses, and by drivers along the delivery route. Even if drugs reach their intended
destination, government officials and health facility workers may steal drugs for their own
use or profit. Incentives for diversion may be more of a risk in the distribution and storage
of expensive medicines such as anti-retroviral drugs. Here we will examine how drugs are
delivered from the manufacturer to the end user.
d) Drug regulatory governance: Often drug regulatory agencies are poorly funded with
limited staff and institutional capacity. If the legislative and regulatory environment is
weak and there is a lack of transparency and accountability in the processes, suppliers may
pay off government officials to register their drugs without the requisite information. In
other cases, government officials may deliberately delay the registration process to solicit a
bribe or to favour another supplier.
Questions for the above subjects and more areas will be based on the WHO Measuring
Transparency in the Public Pharmaceutical System Assessment Instrument (Baghdadi et al,
2008) which the Principal Investigator assisted in developing and has had experience applying
in Costa Rica and Bulgaria (See Appendix I).
3) Analysis of contextual factors that may impact good governance
This analysis will identify the contextual factors that impede or facilitate good governance in
Brazil’s pharmaceutical system and inform policy recommendations to better facilitate access to
medicines. General contextual factors, such as international human rights treaties and other
institutions, regulations, political environment, and economy will be examined.
4) Substantive and procedural legislative/policy review
How current laws (domestic and international) and accompanying provisions and regulations
are implemented will be evaluated. This will provide an understanding of the strength of the
legislation that is designed to support good governance in the pharmaceutical system. Our focus
will primarily be at the federal level and will include, but not be limited to, a review of the
management contract (contrato de gestão) between the Brazilian Ministry of Health and the
National Health Surveillance Agency (ANVISA), designed to measure the performance of
ANVISA (ANVISA, 2006). We will also explore Brazil’s ratification of international and
regional human rights treaties and the extent to which these are reflected in domestic legislation.
More specifically, our work will entail the following:
1. Substantive Review
A focus on the substantive aspects of the good governance law will seek to uncover areas
of ambiguous language in the legislation, unnecessary complications and restrictions, and
to identify areas that are effective.
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
2. Procedural Review
In addition to the substantive scope of the bill, we will examine the procedural aspects of
the laws, such as timelines for amendments, appeal processes, and availability and impact
of infrastructural support required to make use of legislation.
3. Impact Analysis
A general impact analysis of the relevant legislation, policy and regulations will further
illustrate their practical viability. This analysis will investigate:
o A survey of the various procedural and practical costs that are required or
anticipated on the part of using legislation, policy and regulations relevant to good
governance;
o The presence of procedural incentives and disincentives to make use of the above;
and,
o The bureaucratic path required.
We will also investigate processes related to public consultations on pharmaceutical issues,
public hearings that aim to ensure a transparent and democratic process for the entire
population in health policy (ANVISA, 2003) and how well the role of ombudsmen works
in areas relevant to good governance in the pharmaceutical system.
5.3 FORMULATION OF CONSTRUCTIVE POLICY RECOMMENDATIONS
Recommendations for improvements to the good governance in the pharmaceutical system will
build upon the preceding analysis of historical, present and future contextual factors, legislation
and policy, as well as an understanding of the practical realities to realizing good governance.
The study will highlight not only past and present day barriers, but will attempt to anticipate
future threats to the viability of it. Areas such as unclear language and procedural impediments
will be identified with a view to addressing flaws in the legislation. Also, the information
gathered from our research will illuminate deficiencies in good governance, whether they exist
in governmental infrastructure, financial and human resources or sheer lack of effort and
interest. We have unique access to key data sources through our partners in Brazil and the
Principal Investigator’s contacts at the World Bank and WHO.
5.4 DATA SOURCES
The assembled research team has unique access to key data sources including access to global
institutions, government policy makers and their relevant documentation. The team is deeply
familiar and authored in the relevant pharmaceutical policy, good governance/corruption, and
legal literature and intimately networked with the WHO Essential Medicines and Other Drugs
Department. The prior policy, management and research experience of team members at the
World Bank, WHO and UNDP will bear positively on the complexity of this study.
Case studies based in the States of Sao Paulo and Paraiba
Policy documentation and commentary
Legislation, amendments, regulations
Academic literature
Key informant interviews
Our main data sources will be the case studies that examine good governance in the
pharmaceutical system in the context of the States of Sao Paulo and Paraiba and key informant
interviews. Relevant academic literature from the disciplines of political science, law,
economics, medicine and the social sciences will be used to incorporate fundamental
perspectives, principles and approaches in our understanding of key issues surrounding drug
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
access and legislation. We will closely examine relevant policy documentation and
commentary, in addition to laws, policies and regulations from Brazil.Interviews with key
stakeholders, informants and other experts will provide additional insight into the design and
utility of the legislation and policy.
Key Informant Interviews
In-depth, qualitative key informant interviews of a purposive sample of approximately 40-50
persons at all levels of government (municipal, state and federal), chosen for their first-hand
knowledge about of relevant subject matter germane to the good governance of Brazil’s
pharmaceutical system, will be conducted. The interviews will be loosely structured. This
method is advantageous in that it provides information directly from knowledgeable persons; it
provides flexibility to explore new ideas rather than structuring the informants’ responses in
terms of the researchers’ hypotheses; and such interviews are inexpensive to conduct (USAID,
1996). Limitations are that they may be biased if key informants are not chosen carefully, their
findings may be difficult to validate, and the interviewer’s biases can affect the outcomes.
Findings from these interviews will be triangulated with additional data to help corroborate or
reject findings. Limitations are that they may be biased if key informants are not chosen
carefully, their findings may be vague, difficult to validate, and the interviewer’s biases can
affect the outcomes.
Some potential key informants in Brazil are:
a. Federal/State Public Health Officials: Public health officials will be targeted for key
informant interviews in Brazil. The purpose of these interviews will be to obtain information on
their perceptions on public policies, legal instruments relevant to pharmaceutical good
governance. Possible informants include: Rocha Santos Padilha (Minister of Health); Paulo
Gadelha (Director of Fiocruz Foundation); Hayne Felipe da Silva, (Director,
Farmanguinhos/Fiocruz), Jorge Bermudez (Fiocruz), Carlos Morel (Fiocruz), José Carvalheiro
(Sao Paulo Health Institute and Fiocruz); Dirceu Grecco (Director of Brazilian National
Program on STD/HIV); Dirceu Raposo de Mello (National Health Surveillance Agency ANVISA) and; Aloizio Mercadante, (Minister of Science, Technology and Innovation).
b. Global Institutions: We will approach health policy advisers from the Pan American Health
Organization (James Fitzgerald, Coordinator of the Strategic Fund), the World Bank (Armin
Fidler, Director of Health and Nutrition), WHO (Guitelle Baghdadi-Sabeti, Strategic Adviser)
as well as the Inter-American Development Bank (Andre Medici, Senior Health Economist in
the Social Development Division). The purpose of these interviews is to learn how these
international organizations approach health policy and work to guarantee good governance,
transparency and accountability and consequently equity in health.
c. Health Professionals and Patients: Doctors, nurses and pharmacists working in both rural
and urban environments will be targeted for key informant interviews. Interviewing health
professionals who are delivering the services and products to the populations is critical to the
project in terms of understanding where potential areas of weakness may exist in a given health
system. Key informants will be identified through various associations and also through snowball technique. Patients will also be targeted at different points in the health care system (i.e.
primary and secondary care) so we can learn about their perceptions of good governance in the
pharmaceutical system.
d. Pharmaceutical and Medical Supply Industry Representatives: Interviews with both
domestic and international pharmaceutical industry (both generic and research-based)
representatives will be conducted to understand how the private system interacts with the public
health system in Brazil and what challenges good governance in the system. We will also
interview key procurement officers and medical stores personnel. Key informants will include:
Eloi Domingues Bosio (President – Interfarma, Brazilian Pharma Association) and Adriana
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
Diaféria (Legal Director, Farmabrasilis – Brazilian Association of National Pharmaceutical
Industry).
e. Civil Society Representatives: We will contact with key informants from civil society to
probe their views on pharmaceutical system governance. Potential key informants include: Eric
Stobbaerts (Head, Drugs for Neglected Diseases Initiative (DNDi)-Latin America), Gabriela
Chaves (Doctors Without Borders, MSF-Brazil), Renata Reis (Brazilian Interdisciplinary
Agency of AIDS – “Agência Brasileira Interdisciplinar de AIDS” - ABIA), Regina Lancelloti
(President, Support Group for People with Hepatitis C) and Lucia Nader (Director, Conectas
Human Rights).
All key informant interview participants will be initially approached through an invitation letter
explaining the purpose of the study. Follow up calls will be made so a critical mass of
participants is guaranteed. The interviews will be semi-structured and open-ended and will be
based on a list of key issues, such as the key informants perceptions and behaviors surrounding
public health policies, legal instruments and practices coming from different actors related with
the pharmaceutical public health care system that can guarantee transparency, accountability
and good governance, and as well how citizens and other actors are aware of the problems and
needs under this system, and their willingness to endorse policy reforms that address these
measures. This research presents minimum risks. Key informant interviews will be
advantageous for this study as they will provide information directly from knowledgeable
persons, flexibility to explore new ideas and they are inexpensive to conduct. The questions
comprising the key informant interview guides will be tailored to be appropriate to each
interviewee’s context.
5.5 DATA ANALYSIS
Key informant interviews will be recorded and transcribed for data analysis. Transcripts will be
subject to the application of content analysis (Berg, 1995; Strauss and Corbin, 1994; Holstein
and Gubrium, 1994), which will require the following steps. A first reading will be undertaken
to develop an understanding of the major issues identified. Second, more readings will be
carried out to generate a list of themes and issues that is as complete as possible. Third, a
systematic coding frame will be developed, rearranging the data to fit systematically into
themes. This will involve synthesizing the data and abstracting from it. The next step will
involve one or more readings to apply the coded themes. A final reading will be undertaken to
ensure that there are no missing issues that need to be addressed. Finally, the data will be
mapped and interpreted using the codes to map the extent and type of phenomena and find
associations between themes with a view to provide explanations. The data from Brazil will be
translated from Portuguese into English, when necessary, and the qualitative software
programme, NVivo, will be used to analyze all data.
Document Analysis
Reports from global institutions, domestic pharmaceutical legislation and regulations, annual
reports from the federal, state, and municipal levels of government as well as health services
officials will be collected and compared. This phase in the methodology will provide a cross
check of evaluations between the perspectives of different key informants; this is known as the
“triangularization” of data, a process often used in the case study research method when
multiple sources of evidence are analyzed.
6.0 FEASIBILITY OF ACHIEVING PROJECT GOALS
Brazil is a complex, large country so we are necessarily focusing our grant on a limited number
of states. We have selected states with vastly different socio-economic conditions as a means to
initiate an examination of the issue of good governance in the pharmaceutical system. We know
these states are not the “universe” of Brazil but they will provide us with some good preliminary
data on pharmaceutical good governance. We also recognize that good governance may be a
topic that is difficult to probe given its association with corruption. Still, the feasibility of
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
achieving the goals of the project is strong. One, the Principal Investigator has spent over a
decade devoted to both operational and theoretical research in the area of health and corruption
so she is familiar with the literature and has operational experience specific to good governance
in the pharmaceutical system. As such, she has an understanding of what obstacles may present
themselves when probing the issues and by diversifying key informants, knows how to ensure
adequate information collection. Second, the Principal Investigator has a working knowledge of
the Portuguese language and is knowledgeable about Brazil’s culture, health care system and
politics given her prior field work on Brazil’s pharmaceutical system for the World Bank over
the course of four years. Three, the Principal Investigator has spent over twenty years
conducting key informant interviews with individuals involved in the health area in countries all
over the world (for the World Bank, consultant for various international organizations, and
research as an academic) so is familiar with how to organize interviews, overcome potential
obstacles as well as to use the data effectively. Fourth, the Principal Investigator has a good
network of contacts thanks to her prior work at the World Bank, WHO, UNDP and PAHO.
Fifth, the project is one of the core research areas of the Principal Investigator who has spent the
past ten years working on the topic of corruption and health. Lastly, through the collaboration of
partners in Brazil at the University of Sao Paulo and at the NGO, Universities Allied for
Essential Medicines, we will have access to key informants and key documents from Brazil.
The Principal Investigator will also be assisted by her Co-Investigators, Warren Kaplan, PhD,
MPH, Esq and Lisa Forman. LLB, MA, SJD. Both have experience globally working on issues
related to pharmaceutical policy and have legal training. Dr. Kaplan is an attorney, specializing
in intellectual property, licensing, contracts and business law, has extensive consulting
experience in the pharmaceutical sector, and has also worked recently in the private and public
sectors on generic medicines policies. Dr. Forman is a legal scholar whose work focuses on the
relationship between international human rights law and trade-related intellectual property rights
in relation to access to medicines in low and middle income countries. Drs. Kaplan and Forman
will assist in the literature review and analysis of treaties, legislation, policy and statutory
documents. Finally, through the collaboration of Karen Hussmann, a global expert in health and
corruption policy, who has worked extensively with the UNDP in the implementation of good
governance in health projects, we will ensure that our project methods and findings are sound
and operationalized effectively. She will also help us access relevant data from the UNDP,
which is the lead UN institution on the issue of good governance.
7.0 DISSEMINATION OF FINDINGS
Research will be presented as it progresses in many forms. We will develop a series of draft
working papers and as they are refined they will be presented for critique in academic settings,
as opportunities allow. Likely Canadian venues include the Leslie Dan Faculty of Pharmacy and
Munk School of Global Affairs, University of Toronto, and the annual conference of the
Canadian Society for International Health. International venues will also be pursued for critique
of research as opportunities arise (i.e. IDB, World Bank and WHO seminars). The Principal
Investigator will seek formal publication of research findings in peer-reviewed scholarly
journals (i.e. Health Policy and Planning, International Journal of Health Services, The Lancet,
The CMAJ, and Globalization and Health). She also plans to publish findings in the media,
where appropriate.
8.0 SIGNIFICANCE
This research provides much needed inquiry into a relatively new area in health policy - what is
good governance of the health system, how does it manifest itself and what is its impact on
practice – and hopes to explore examples which can illuminate the opportunities/barriers to
good governance specifically in the pharmaceutical system. Based on the findings from the
research, we hope to craft policy recommendations about what interventions will work best and
longest to maximize good governance and reduce the risk of corruption. There is a need for
rigorous academic research to examine its actual or potential impact on public health
particularly for the poorest. This research is in keeping with CIHR’s strategic focus on health
Jillian Clare Kohler, Research Proposal
“Evaluating Governance, Accountability and Transparency in Brazil’s Pharmaceutical System”
and equity as an absence of good governance, coupled with poor corruption controls can lead to
corruption in the health system, denying the most vulnerable to core health care services.
Lessons learned from this project will be of interest to policymakers, health professionals and
the private sector globally, particularly as there is a growing interest in the global development
community on how to improve governance in the health system and ensure development
assistance is spent effectively and responsibly.
9.0 TIMELINE
Activity
Projected Timelines
Literature review, data and document
collection (legislation, policy, regulations);
concurrent document analysis.
September 2012 – September 2013
Develop data collection tools (interview
questions), consent forms, apply for ethics,
schedule and coordinate key informant
interviews.
September 2012 – December 2013
Key Informant Interviews and Policy
Framework Development; concurrent
interview transcription and analysis,
document collection and analysis.
Jan 2013 – May 2015
Final analysis, development of policy
recommendations, manuscript preparation.
June 2015 – June 2016
Dissemination
Ongoing from September 2013 to
1 year
14 months
16 months
1 year
– September 2016