Corruption and the Pharmaceuticals & Healthcare Sector

Corruption and the Pharmaceuticals & Healthcare Sector: A mapping of global policy issues and anticorruption measures in the pharmaceutical sector

Authors: Jillian Kohler PhD, Leslie Dan Faculty of Pharmacy & Munk School of Global Affairs, University of Toronto Gabriela Martinez, Leslie Dan Faculty of Pharmacy, University of Toronto Editors: James Sale, Transparency International UK Michael Petkov, Transparency International UK

Table of contents Background ....................................................................................... 3 Corruption and the Healthcare Sector .................................................. 5 Common Themes in the Corruption and Health Literature ...................... 8 Transparency ................................................................................. 9 Accountability................................................................................. 9 Civil Society.................................................................................. 10

Key Decision Points and Anti-Corruption Measures in the Pharmaceutical System ............................................................................................ 11 Research and Development.......................................................... 11 Registration .................................................................................. 13 Manufacturing .............................................................................. 14 Marketing Practices ...................................................................... 15 Procurement ................................................................................ 17 Distribution ................................................................................... 19 Corruption in the Pharmaceutical System at an Institutional level ... 20

Conclusions ..................................................................................... 21 Next steps ........................................................................................ 22 Bibliography ..................................................................................... 22

Background Introduction to the project Transparency International UK (TI-UK) is working with Professor Jillian Kohler and her research team at the Leslie Dan Faculty of Pharmacy, University of Toronto to identify and map key policy and structural issues priority areas of the pharmaceutical sectors at the global and national levels. This study is focused on the pharmaceutical sector as it is a microcosm of the health sector in order to increase knowledge and raise awareness about corruption in the health sector and guide TI-UK’s future work in the area.

What is Corruption?

Corruption, understood as “the misuse of entrusted power for private gain,” is considered to be one of the biggest barriers to development and growth (Michaud, Kates, & Oum, 2015; Transparency International, 2015). Corruption is without borders; it can be found in any country, in different forms, levels, and types of organisations and institutions (Bhargava, 2005).

Corruption causes havoc with economic growth, political stability, and government legitimacy, jeopardises the allocation of resources to sectors crucial for development, and encourages other types of illegal activities (Bhargava, 2005). Along with TI, global institutions such as the World Bank, the World Health Organisation (WHO), and Interpol have put dealing with the “cancer of corruption” high on their agenda (Bhargava, 2005). The World Bank’s president, Jim Yong Kim, has denounced corruption as “public enemy number one” and the United Nations secretary general, Ban Ki-moon, has emphasised that corruption is a threat to development, democracy, and stability (Michaud et al., 2015; United Nations, 2010). Addressing corruption is one of the Sustainable Development Goals (SDG 16) (Volg 2015).

Transparency International’s Work on Corruption in the Healthcare Sector Given that corruption is a significant obstacle to achieving positive health outcomes, Transparency International UK (TI-UK) is scaling up its research and advocacy in the health sector. Transparency International (TI) first focused its attention on the health sector almost a decade ago, emphasising transparency, codes of conduct, conflicts of interest, civil society participation, whistleblowing mechanisms, reducing incentives for corruption, and rigorous prosecution as the most important measures to combat corruption in the health sector. But we still need to learn more about the structures and policies that help prevent corruption and, conversely, those that foster it.

To advance TI-UK’s research, advocacy, and operational work in this area, this report aims to facilitate a global conversation about where we need to focus our attention, how we need to implement anticorruption strategies, and what is needed to achieve sustainable results. To

narrow the scope of the inquiry, we limit this probe to the pharmaceutical sector, which is an excellent microcosm of the health sector, particularly with respect to the mechanisms with which corruption can be tackled (European Commission, 2013). More specifically, we probe six core areas in the pharmaceutical sector: research and development, registration processes, manufacturing, marketing practices, procurement, and distribution. The study has limited its scope to these six areas so to focus the research and discussion, and acknowledges that other areas such as service delivery are important and should be examined in future research.

Methodology A literature review was conducted of publications from 2004 to 2015 on corruption in the pharmaceutical sector. This included books, peer-reviewed literature as well as grey literature such as working papers, reports published by international organisations and donor agencies, and newspaper articles. Google Scholar and Summon were utilised to find relevant literature using the following key words “Corruption in healthcare”, “corruption in health system”, “corruption in pharmaceutical sector”, “corruption in pharmaceutical system”, “corruption in manufacturing medicines”, “corruption in research and development medicines”, “corruption in registration medicines”, “corruption in procurement medicines”, “corruption in distribution medicines”, “marketing practices pharmaceutical companies”, “corruption marketing pharmaceutical companies”, “corruption marketing medicines” and “good governance pharmaceutical system”. The literature was selected if: (a) It focused on the pharmaceutical sector; (b) it provided new insights from already reviewed literature; and (c) it discussed policies and strategies to deal with corruption. Such literature was used to identify, summarise, and highlight existing knowledge on the topic at hand as well as to identify gaps and inconsistences in such literature. The following highlights some of the main themes and facts from the body of literature we scanned.

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Corruption and the Healthcare Sector Corruption is often difficult to detect and even harder to track and verify, due to the grey area between corruption and inefficiency. Further, what is corruption and what is common practice (such as “gratitude” payments to doctors) varies from country to country due to cultural and sociological differences (Michaud et al. 2015). For example, gift giving and tipping healthcare professionals is widely accepted in some countries but considered a form of corruption in others (Bhargava, 2005). The scale of corruption also varies; it may be “petty,” as in bureaucratic processes, or “grand,” as at the policy or legislative level (United Nations Development Programme, 2011). Corruption takes place when there is pressure to abuse power, when individuals are able to rationalise their corrupt acts through social norms, and when there is a high opportunity of abusing power with minimal consequences (Department for International Development, 2010; Vian, 2008).

Each year an estimated USD 5.3 trillion is spent worldwide on providing health services, yet as much as 6 percent or USD 300 billion is lost to corruption and errors (World Health Organisation 2010b). In developed countries, the cost of corruption is estimated to be from USD 12 to 23 billion per year (World Health Organisation, 2010b). In procurement alone, estimates of global spending losses due to corruption range from 10 percent to 25 percent (TI, 2006).

In 2010, the United Kingdom’s Department for International Development (DFID) noted that “tackling corruption in the health sector is essential for achieving better health outcomes” (Department for International Development, 2010). Corruption negatively impacts public health budgets, the price of health services and medicines, and the quality of care and medical products; as well, it threatens a country’s ability to provide universal health coverage by increasing the price of health care (European Commission, 2013). Corruption diverts resources from the public sector, making it difficult to appropriately fund operations and maintenance that help ensure increased access and quality care (Michaud et al., 2015; United Nations Development Programme, 2011; Vian, Savedoff, & Mathisen 2010). Of equal importance, corruption undermines public trust in governments and its services, the willingness of health professionals to take government instructions and warnings seriously, and patients’ willingness to make use of health services (Organisation for Economic Cooperation and Development, 2015).

Corruption weakens health care systems because it can undermine service delivery, medicine access, proper management, and financing (Organisation for Economic Cooperation and Development, 2015). For patients, corruption can have life-and-death consequences because of its significant negative effect on infant and child mortality, education, health spending, and urbanisation (United Nations Development Programme, 2011; Nussbaum, 2006). Corruption is also inequitable; it harms the poor and marginalised the most by limiting the availability and quality of public patient care. The bottom line is that tackling corruption in the healthcare sector is important for ensuring economic development and positive health outcomes (Organisation for Economic Cooperation and Development, 2015).

The healthcare sector is particularly vulnerable to corruption. First, we find asymmetric information relations throughout—for example, between patients and healthcare providers, suppliers, and regulators—making patients heavily reliant on providers to supply the most accurate information and quality care (World Health Organisation, 2009a). Second, health care is an inelastic commodity that does not allow for bargains or for the patient to easily seek less

expensive services or products, particularly in emergency situations (European Commission, 2013). Third, there is a high level of uncertainty in the demand for health services because it is difficult to predict disease outbreaks, thus challenging service providers’ ability to predict the supplies and services that will be needed in the future (Savedoff, 2006; United Nations Development Programme, 2011). Fourth, the health and pharmaceutical sectors are highly complex, highly regulated, and governed by multiple stakeholders with high levels of discretion at multiple decision points (World Health Organisation, 2009a). If there are not sufficient checks and balances in place, health regulations and decision-making may be subject to regulatory capture and individual discretion (Hussmann, 2011; Vian, 2008). Last, the healthcare sector is highly decentralised, which makes it challenging to standardise and monitor the provision of health services and pharmaceutical products (European Commission, 2013). Corruption in the health sector can result in embezzlement and theft of public health budgets, collusion, bribes and kickbacks in procurement that can result in overpayment of goods and services, and diversion or theft of health products at multiple points in the distribution chain (Hussmann 2011; Organisation for Economic Cooperation and Development 2015; Transparency International, 2006).

Rationale for the Selection of the Pharmaceutical Sector The pharmaceutical sector is a microcosm of the health sector. Understanding where its vulnerabilities lie has the potential to help policy makers and others identify priority areas on which to focus research and interventions to reduce the likelihood of corruption in this sector and inform broader strategies in the health system. The pharmaceutical sector is a complex system with multiple decision points and stakeholders. It is also characterised by many market and government failures. These include asymmetrical access to information at all levels, including between consumers and healthcare providers, manufacturers and healthcare providers who prescribe medicines, and governments and manufacturers (Kohler & Ovtcharenko, 2013).

The core decision points that are found throughout the sector all need to work effectively so that the whole system functions well.

We discuss six key decision points in the pharmaceutical sector and highlight how corruption may manifest itself in each of them: research and development (R&D), registration processes, the manufacturing of medicines, marketing practices, the procurement of medicines, and the distribution of medicines (Kohler & Ovtcharenko, 2013). These six areas make up the core of the pharmaceutical sector supply chain which fits within the wider pharmaceuticals & healthcare sector value chain.

This study will focus on core issues and priority areas to address in the pharmaceutical sector.

Access to medicines is an essential component for achieving universal health coverage, because they are necessary to provide high-quality care that is affordable and accessible (Bigdeli, Peters, & Wagner, 2014). However, access to medicines continues to be a global health issue, since one-third of the world’s population continues to lack access to essential medicines (United Nations Development Programme 2011). Inadequate access to medicines is a result of bigger failures in the health system, as it is a symptom of bigger problems in the way in which health systems are organised, financed, and delivered (World Health Organisation 2004). Health systems that perform well are able to provide adequate access to medicines (World Health Organisation 2004). Medicines and the policies and mechanisms through which the

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pharmaceutical sector is governed are closely linked to the entire health system (Bigdeli et al., 2014).

Medicines and the Pharmaceutical System within a Health System Context

Adapted from Bigdeli M, Peters DH, Wagner AK (2014). Medicines in Health Systems: Advancing access, affordability and appropriate use. Alliance for Health Policy and Systems Research. World Health Organisation, Geneva, Switzerland.

Medicines comprise as much as 20 to 30 percent of the world’s total healthcare expenditure; the cost of medicines is expected to reach $1.3 trillion by 2018, a 30 percent increase from 2013 (IMS Institute, 2014; World Health Organisation, 2010c). Such high medicine expenditure has been recognised as an obstacle for promoting and ensuring universal health coverage and access to medicines, since it puts constraints on government’s already limited public health budget (World Health Organisation, 2010c). Coupled with changing demographic and disease patterns, this expense makes ensuring the integrity of the pharmaceutical supply chain crucial for global health (Kohler, Mackey, & Ovtcharenko, 2014). The health and pharmaceutical sectors require strong governance structures to oversee and balance multiple competing interests, stakeholders, and high levels of discretion in decision making (Bigdeli et al., 2014).

Global institutions such as the World Health Organisation (WHO), the Global Fund to Fight AIDS, TB and Malaria (Global Fund), the World Bank, and the Medicines Transparency Alliance (MeTA) have increased their efforts to improve healthcare access and health outcomes by focusing on the pharmaceutical sector. As one example, the WHO launched a Good Governance in Medicines Programme that measures transparency and accountability in countries’ pharmaceutical supply chain to assess their pharmaceutical system’s vulnerability to corruption (World Health Organisation, 2009a). Successful interventions in the pharmaceutical system can have a ripple effect on the entire health system and any improvements in the pharmaceutical sector will result in health system strengthening and the promotion of health equity (Bigdeli et al., 2014).

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Common Themes in the Corruption and Health Literature Corruption in the healthcare system can happen in a multitude of settings. Savedoff and Hussmann (2006) point out that “corruption in the healthcare sector is not exclusive to any particular kind of health system. It occurs in systems whether they are predominantly public or private, well-funded or poorly funded, and technically simple or sophisticated” (Savedoff & Hussmann 2006, 4). Corruption also manifests itself in different ways depending on the environment in which the health system operates. In addition, as where there is a grey area between what is considered to be corruption or inefficiency, there is no simple “one size fits all” anticorruption model for the health sector, and the success and applicability of anticorruption policies are dependent on the setting in which they are developed and implemented (European Commission 2013; United Nations Development Programme, 2011).

Much research illuminates how anticorruption policies are prone to be formulated quickly and without the appropriate research needed to ensure their proper design and successful implementation. A U4 Anti-Corruption Resource Centre assessment of various countries undergoing the development and implementation of anticorruption policies pointed out that “information, knowledge, and understanding of corruption continue to be a great weakness for the formulation and prioritisation of anticorruption initiatives” (Hussmann, 2007, 28). Existing literature also suggests that the prevalence of corruption in a country’s health sector is a reflection of structural issues in its health care system (United Nations Development Programme 2011). Fighting corruption would therefore entail addressing management issues as well as motivations and opportunities for engaging in corrupt behaviour (Department for International Development, 2010; Lewis, 2006). It would include addressing ineffective managerial structures, inappropriate financing mechanisms, insufficient healthcare capacity, insufficient funding, and ineffective allocation of resources (European Commission, 2013).

Ciccone, Vian, Maurer, and Bradley (2014), for example, emphasised in a comprehensive review that good governance has a positive influence on health outcomes. Lewis (2006) recognises good governance as a critical factor for ensuring efficient healthcare systems and for mitigating mismanagement. Global institutions such as the World Bank, the WHO’s Good Governance in Medicines Programme, the Global Fund, and MeTA have used a range of good governance approaches to combat corruption (Kohler et al., 2014). Good governance has also been recognised as one of the key building blocks of the health system, helping ensure that adequate policies, effective oversight, and strong accountability mechanisms are in place for its proper design and management (World Health Organisation 2009a, 2010a). The complexities of the health system require tailored governance approaches to identify vulnerabilities to corruption, waste, mismanagement, and fraud (Kohler et al., 2014). However, research also suggests that while a relationship between good governance and lack of corruption is assumed, finding causality between a lack of good governance and corruption is difficult to quantify in practice (Kohler et al., 2014).

Anticorruption efforts that translate good governance principles are considered to be the standard for tackling sector vulnerabilities (Hussmann, 2011). Savedoff and Hussmann (2006) suggest that “corruption in healthcare is less likely in societies where there is broad adherence to the rule of law, transparency and trust, and where the public sector is ruled by effective civil service codes and strong accountability mechanisms” (Savedoff & Hussmann 2006, 4). Certain

aspects of good governance are most relevant for developing countries, such as governance mechanisms to guarantee impartiality, safety, and quality in medicines or the prevention of bribes or kickbacks (Kohler et al, 2014). Others are more relevant in developed countries, such as preventing illegal marketing practices and fraud (Kohler, 2014).

The implementation of good governance measures is laden with potential barriers. For example, a study conducted by Kohler and Ovtcharenko (2013) on global good governance for medicines initiatives led by international organisations such as the World Bank and WHO reported that these organisations encountered many obstacles linked to culture and behavioural factors, resistance to change, lack of political support and commitment, and lack of resources. Time, capacity and commitment all count here. Most importantly, the study suggests that while more focused good governance efforts that target a specific area could be useful, they alone may not result in the systematic changes necessary to improve the overall performance of the health system (Kohler & Ovtcharenko, 2013). Within good governance the study identifies three broad anti-corruption measures that are effective within the pharmaceutical sector.

Transparency Transparency has been defined as “a principle that allows those affected by administrative decisions, business transactions, or charitable work to know not only the basic facts and figures but also the mechanisms and processes� (Transparency International, 2009). Transparency is seen as an effective tool for exposing corrupt activity, since access to information about decision making and performance can increase accountability and inform citizens (European Commission 2014; Hussmann 2011; Organisation for Economic Cooperation and Development 2015; Transparency International, 2006; United Nations Development Programme 2011; Vian 2008). In healthcare, transparency involves the public availability of information such as health budgets, performance indicators, prices of medicines, procedures, and guidelines, as well as the creation of public databases for such data (Transparency International, 2006; Vian 2008). However, in order to ensure adequate transparency levels, information must be publicly accessible in the simplest and most user-friendly forms and quality data assurance mechanisms must be in place in order to ensure the reliability of the data being reported (Vian, Sayedoff & Mathisen, 2010).

Accountability Accountability is considered to be one of the key elements of good governance. Accountability is defined as holding institutions or organisations accountable to those who will be affected by the decisions or actions they take (United Nations Economic and Social Commission for Asia and the Pacific, 2013). Accountability involves the measurement of goals and results, the justification of those results to internal and external monitors, and sanctions for non-performance or corrupt behaviour (Brinkerhoff, 2004). Accountability is widely recognised as a critical element for improving health system performance, since it reduces abuse, assures compliance with standards and procedures, and improves performance and learning (Brinkerhoff, 2004).

Accountability is also viewed as a way to deal with cultural tolerance towards corruption, which is one of the main barriers to decreasing corruption in healthcare. Accountability is therefore seen as a mechanism to guarantee that corruption is not tolerated (European Commission, 2013).

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Civil Society The inclusion of civil society in the formulation of policies and monitoring of the overall health system is considered to be a necessary element in efforts to curb corruption in the health sector (Kohler et al., 2014). Civil society includes individuals and organisations that are independent of the government, such as consumer organisations, pressure groups, NGOS, and the media. It is a “third sector� of society that can help enhance the control and accountability of governments and institutions (European Commission, 2013). Civil society engagement has been suggested as a tool for increasing external accountability of governments, institutions, and corporations through complaint procedures, watchdog organisations, awareness-raising campaigns, information systems, and fraud hotlines (European Commission 2013; Vian 2008). However, the implementation of policies that explicitly aim to increase civil society participation has proven to be difficult; governments often use such measures as window dressing, failing to provide them with legislative authority to really hold governments and institutions accountable for their actions (Kohler & Martinez 2015; Vian 2008).

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Key Decision Points and AntiCorruption Measures in the Pharmaceutical System Research and Development Corruption in Research and Development Actors

Features

Risk Factors

Industry, Researchers Government Regulators

• • •

Negative results from clinical trials go unpublished Ghostwriting of articles with positive results Downplaying of adverse side effects and over-reporting of positive results, which may not be representative of the actual results of clinical trials

•

Drug trials being funded, designed, and managed by the pharmaceutical industry Lack of transparency in clinical trial data such as list of protocols and full study results Lack of disclosure of all financial contributions made to medical research units in charge of clinical trials

• •

Transparency and access to information through mandatory clinical trial registration and publication of results are commonly cited as helpful tools to curb corruption in research & development (R&D) (Lemmens & Gibson 2014). For example, the pharmaceutical industry does not make its raw data publicly available, making it impossible to verify whether the reported results are accurate (Elliott & Landa, 2010). The research-based industry association Pharmaceutical Research and Manufacturers of America (PhRMA) justifies this by claiming that it is the owner of such data and therefore has the right to decide who to disclose them to (Angell, 2008).

International debate surrounding transparency in R&D has focused on pushing for clinical trial registries (Lemmens & Gibson 2014). Regulatory bodies have made several attempts to increase transparency. The WHO has developed a clinical trial database while in the United States the FDA Amendment Act was introduced, which requests clinical trial registration and results reporting. The 2008 Declaration of Helsinki also brought forward the most influential international research ethics standards which require any clinical study involving humans to be

registered in a public clinical trial register before recruitment and for the disclosure of all results, including negative and inconclusive ones (Pansieri, Pandolfini, & Bonati 2015, Lemmens & Gibson 2014). However, the present literature suggests that clinical trial registers are only part of the solution, given that such measures often do not require the disclosure of information on randomised control trials (RCTs) that have already been conducted—leaving out information for most of the medicines that are in today’s market (ibid.). In addition, the European Medicines Agency has introduced the most rigorous policy for disclosing clinical trial data to date, the Publication of Clinical Data for Medicinal Products for Human Use. Starting in 2016, this policy will require the public disclosure of clinical study reports, which are the most complete and comprehensive final reports of RCTs, within a year of the trial’s completion. This information will be accessible to researchers and even available for download (Opinion 2015; Pansieri et al., 2015). The policy also requires the creation of public databases that list all ongoing CRTs along with full protocols and results, to safeguard the integrity of the studies and minimise reporting bias (Pansieri et al., 2015).

Despite these efforts, in many countries pharmaceutical companies are not required to publish information on RCTs; analyses of clinical trial registries demonstrate that industry often violates this requirement where it exists (Rodwin, 2013). It has therefore been suggested that such policies be implemented at an international level to ensure uniformity in data disclosure, particularly in less developed nations that do not have proper regulatory systems to maintain standards (Pansieri et al., 2015). WHO endorsed this proposal in 2015, publicly calling for the disclosure of every clinical trial result, both past and present (Pansieri et al., 2015). The disclosure of information should also extend to the mandatory reporting of all financial contributions made by pharmaceutical companies to medical research units and academia (Transparency International 2006). This should be coupled with proper enforcement mechanisms and sanctions to ensure that breaches in codes of conduct are followed by consequences.

Transparency measures could also be used with accountability measures like the Dodd-Frank Whistleblowing Program that provides whistleblowers an incentive for reporting corruption activity by awarding them with 10 to 30 percent of the penalties recovered from those found guilty of corrupt behaviour under the law (Brown 2013).

Other suggested measures to curb corruption include increasing legal consequences for academics engaging in ghostwriting by utilising national laws such as the Racketeer Influenced and Corruption Organisations Act (RICO), banning authors guilty of ghostwriting from future journal submissions, and using professional organisations as a way to punish researchers (Sterm & Lemmens 2011). Changing the journal acceptance process to a two-stage review process where trials are assessed their methodology prior to being conducted and whether deviations from the methodology have also been suggested (Brown 2013). The International Committee of Medical Journal Editors (ICMJE) has published standards for biomedical research that request detailed information on exactly what each author has contributed to the article under review that can be used by journals also exist (Stern & Lemmens 2011). Other suggestions include an insurance scheme to provide an incentive for pharmaceutical companies to disclose clinical trial data information for failed trials in exchange for decreased R&D costs (Brown 2013).

To address the issue of lack of innovation in R&D, changing the way in which new drugs are priced has been suggested. Reference based pricing, which involves setting a standard price based on the lowest priced drug of the same class that is already available has been suggested to push industry to fund R&D research that is more innovative. Such practices are already in place in countries like Canada, Germany, Netherlands, New Zealand, Norway and Spain (Gagnon 2013). Another suggested policy is value based pricing, which involves evaluating new drugs and pricing them based on their therapeutic value (Gagnon 2013).

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Registration Corruption in Registration Processes Actors

Industry and regulatory agencies

Features

• • • •

Risk Factors

• • • •

Purchase of public positions in regulatory agencies Bribery/extortion/kickbacks to speed the process or approve the registration of a product High levels of discretion in the registration process Lack of ethical conduct, standard operating procedures, and guidelines for reporting conflicts of interest Underfunding and lack of institutional capacity Lack of qualified staff Lack of transparency in the publication of justification for decisions Lack of monitoring of medical devices and pharmaceutical products after registration and licensing

Some of the literature reports that setting up a well-resourced independent regulatory body responsible for the evaluation of all documents and requirements for pharmaceutical products and medical devices, as specified by standard operation procedures (SOPs) and guidelines, is helpful to curbing corruption in the registration process (Department for International Development, 2010; European Commission, 2013). Independent committees of experts with the necessary scientific, medical, and technical knowledge are encouraged to review applications (World Health Organisation, 2009a). These regulatory bodies should have written guidelines and procedures, in order to discourage inappropriate action on the part of assessors and to allow suppliers and manufacturers to appeal against decisions (Baghdad-Sabeti et al., 2009). Such written guidelines should explicitly outline the criteria for approving a pharmaceutical product and provide guidance on exemptions, fast track registration, timeframes for processing applications, and criteria for selecting external experts (World Health Organisation, 2009a). Codes of conduct for internal staff and external experts, including conflict-of-interest guidelines and the mandatory declaration of any relationships that may influence decision making, should also be established (United Nations Development Programme, 2011).

An accountability mechanism, such as a body or institute dedicated to monitoring internal conflicts of interest and ethical misconduct is crucial, along with an appropriate course of action for misdemeanours and both internal and external audits (World Health Organisation, 2009a).

Registered devices need to be monitored to ensure that they continue to comply with the essential requirements under which they were licensed (European Commission, 2013).

Transparency measures such as the creation of public online databases for products under review and already registered can reduce the number of unregistered drugs on the market and expedite the registration process (United Nations Development Programme, 2011).

Finally, publishing registration and marketing approval procedures on government websites can ensure that both industry and the public are aware of the registration process—information that can later be used to denounce any inefficiencies or corrupt activity (European Commission, 2013).

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Manufacturing Corruption in Manufacturing Practices Actors

Manufacturers and Regulators

Features

• •

Producing counterfeit or sub-standard medicines Bribery/extortion of inspectors

Risk Factors

• •

Lack of GMP certification Lack of uniformity in GMP certification across nations and even within countries Unskilled and untrained staff

•

Much of the literature recommends that manufacturers abide by Good Manufacturing Practices (GMP) standards and institutions enforce GMP certification. This is considered an important step that will increase transparency of quality control in the manufacturing pipeline (World Health Organisation, 2009). Anticorruption measures include ensuring the presence of a legal basis for GMP requirements, because many countries still lack a legal definition or legislated enforcement mechanisms for GMP (Cohen, 2007; Cohen et al., 2007). Random but regular inspections and enforcement of sanctions can also help ensure better adherence to GMPs (Cohen, 2007; Cohen et al., 2007). Random batch testing can also be conducted to identify substandard products before they enter the market (Cohen et al., 2007). This requires a sufficient number of trained and well-paid inspectors capable of conducting such testing (Cohen, 2007). Inspectors should also have rotating schedules on manufacturing sites in order to ensure that they do not develop close relationships with those whom they are auditing (Cohen et al., 2007). Other anticorruption measures involve transparency techniques, such as publicly posting a list of compliant manufacturers and shaming noncompliant ones (Cohen, 2007).

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Marketing Practices Corruption in Marketing Practices Actors Features

Industry and healthcare professionals • • • •

Risk Factors

• • • •

Direct influencing of prescriptions: tangible gifts including money, sponsorship and consultancy contracts Indirect influencing of prescriptions: intangible gifts such as conferences in vacation destinations Undue positive list promotion Post-market surveillance mechanisms used to advertise medicines and hide adverse side effects Close relationship between healthcare professionals and industry with a lack of regulatory guidelines for such relationships Lack of independent post-market surveillance mechanisms Lack of public funding to assure professional training Underfunding in research

Measures to decrease vulnerabilities to corruption in marketing practices focus on regulating and monitoring the relationships between healthcare providers and the pharmaceutical industry The establishment of controls may limit the unethical promotion and marketing practices that inappropriately influence research, medical education, prescribing, and policy making (Lipworth & Kerridge, 2013). This can be achieved by establishing codes of conduct and of ethics at the national and supranational level that call for the mandatory disclosure of conflicts of interest, honorariums, funding connections, and other relationships between doctors and industry (European Commission, 2013).

The United States implemented the Physician Payment Sunshine Act, which requires companies to post on an online database information on the payments they have made to physicians of over USD 10 as well as aggregate payments of more than USD 100 to a single physician (Sismondo 2013, Moran, 2014). Like any other measure, this suggestion requires continued monitoring and enforcement; pharmaceutical companies that have been convicted of corrupt marketing practices under the Sunshine Act have posted incorrect information about those practices on the database (Moran, 2014).

Increased fines and criminal penalties have been suggested for deterring unethical marketing practices. However, these fines often have little financial impact compared to the profit margins industry makes from sales generated by such practices. For example, since 1991, the industry has paid USD 30 billion in criminal fines in the US for Medicare fraud, unlawful promotion, kickbacks, monopolistic practices, and failure to disclose clinical trial data. However, this is less than half of what the industry made in 2009 alone (Gagnon 2013).

Instead, a suggested alternative solution is to implement tax promotional activities such as the ones introduced in Italy in 2005 that requires all international and national pharmaceutical companies to pay five percent of their total promotional expenditure to the government to fund independent R&D (Gagnon 2013). Countries have begun moving towards funding public R&D laboratories for the development of new medicines and pharmacovigilance. For example, New

Zealand’s Medicine and Medical Devices Safety Authority has begun conducting post-market surveillance studies through the University of Otago and the US’s National Institute of Health has begun creating a public R&D lab for developing new drugs (Lemmens & Gibson 2014).

Legislation such as the mandatory prescription of generic medicines in preference to brandname pharmaceuticals or of the most cost-effective option has been proposed to deal with direct prescribing influences. However, in studies conducted in Estonia and Spain physicians continued to prescribe brand-name medicines over generics despite legislation prohibiting such behaviour (European Commission, 2013). Other suggested policies include mandatory reporting of physician prescription practices in order to track unjustified prescribing (Rodwin, 2013) and the production of independent information about pharmaceutical products for doctors and other health professionals to use for prescribing (Fischer, 2014). Another alternative is the use of bioethical rating labels on pharmaceutical products that may make consumers think twice before purchasing a product from companies that are considered to be unethical (Miller 2013).

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Procurement Corruption in Procurement Actors

Industry and procurement officials Bribes to individuals: money, leisure and trips, discounts Bribes to medical institutions: money, conference participation, free supply of materials, research funding Corruption occurs in all phases of the procurement process:

Features

1. Pre-bidding: Needs assessment, circumvention of tender procedures, tailored tendering 2. Bidding: bribery and kickbacks during bid evaluation, favoritism, collusion or market division in bidding 3. Post-bidding: false invoicing, changing contract agreements

Risk Factors

• • • • • •

Decentralised procurement system Lack of procurement guidelines that mitigate individual discretion Lack of SOPs to technically judge bids Lack of pricing transparency in procurement, including information on tender processes, terms and conditions, final decisions, medicine pricing Lack of conflict of interest declarations and measures to deal with such conflicts Lack of price monitoring

The procurement of medicines is a complicated process that may take place at the national level or be decentralised to the facility level. How the procurement process is set up and carried out is important (United Nations Development Programme, 2011). A WHO study (2011) reported that “most high income countries do not have procurement guidelines and usually do not use national procurement schemes.” It also found that only 30 percent of members of the European Union had developed national procurement guidelines (World Health Organisation, 2011). This lack of minimal managerial order and oversight is considered to be a fundamental weakness in countries’ public procurement systems (Lewis, 2006). Therefore, policies that aim to address corruption in procurement are centred on ensuring efficiency and management in the procurement system.

The creation of an unbiased expert committee with clear policies and guidelines that are followed throughout the entire year—particularly near the end of a fiscal year when there is an increased risk of corruption—is also considered to be an important measure (United Nations Development Programme, 2011). It is suggested that this measure should be followed by clarifying decision-making processes through written guidelines and SOPs that can be referred to in order to hold individuals accountable in case corrupt behaviour is detected (Vian, 2008).

Conflict-of-interest declarations can also be used to manage ties between physicians and the pharmaceutical industry and to avoid pre-bidding corruption (European Commission, 2013).

Procurement should also be carried out through the use of strong procurement infrastructures, such as e-procurement. Electronic bidding can help disseminate information about procurement procedures and results and encourage price competition. This is important, because it has been found that the risk of corruption increases when there is a high level of decentralisation, a low number of suppliers, a low number of bids, and relatively high prices (European Commission,

2013; Vian, 2008). Other suggested options include centralising the maximum price of pharmaceuticals, prequalifying suppliers to ensure they are reliable, establishing a product defect reporting system, and providing constant technical assistance and training to procurement officers to ensure that procurement is carried out based on evidence and technical knowledge (Vian, 2008; United Nations Development Programme, 2011).

Transparency is an important component of anticorruption measures in procurement. Strong emphasis has been placed on ensuring transparency in pricing, which includes ensuring that information on tender bids, offers of tenders, terms and conditions, contract awards, and evaluation processes is publicly available on the Internet (Transparency International, 2006).

Ideally, these measures contribute to curbing price gouging, price manipulation, and overpayments (United Nations Development Programme, 2011). However, transparency measures should offer data that are consistently reported, reliable in terms of quality, and presented in a format that can be easily used to identify potential issues and hold agents accountable. This involves increasing coverage of who is required to disclose information, improving the reliability and accuracy of data, and assuring consistent and reliable access to disclosed information in a practical format (Waning & Vian, 2008).

Accountability mechanisms such as sanctions and fines may help deter unethical behaviour (United Nations Development Programme, 2011). Using these mechanisms involves monitoring of adverse drug reactions, procurement performance indicators, and prices of supplies (United Nations Development Programme, 2011; Transparency International, 2006; United Nations Development Programme, 2011). An expert committee with the necessary resources could be set up to oversee the entire procurement system, including internal and external audits to detect corrupt behaviour and sanctions for officials engaging in corrupt behaviour (Department for International Development, 2010).

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Distribution Corruption in the Distribution of Medicines Actors Features

Risk Factors

Healthcare Providers, Distributors •

Theft or tampering of medical supplies

•

Issues with remuneration of healthcare professionals, including low salaries and irregular payroll Lack of SOPs and guidelines for medicine shipments and stockrooms Lack of inventory control measures, physical protection, and security of medical products

• •

Some authors point out that remuneration levels are the cornerstone of incentives for performance and theft deterrence (Lewis, 2006; European Commission, 2013). Low wages may encourage corruption by providing individuals with a reason to rationalise stealing as an alternate income source for their knowledge or services. While higher salaries are often proposed to curb corruption, evidence surrounding this suggestion is inconclusive. Instead, it has been reported that employment security and recruitment and promotion criteria are of greater importance than salary increases (Rauch & Evans, 2000).

Creating divisions in warehouses for separate physical areas, personnel policies, and operation procedures may help prevent theft (Vian et al., 2010). Institutional checks and balances such as dividing functions between cashiers and accountants have been suggested to help control against fraud (European Commission, 2013). Other specific measures include the physical protection and security of medicines through SOPs for medicine shipments, stockrooms that include locked and gated compounds, divided areas with controlled access based on drug value, surveillance systems, satellite tracking of delivery trucks, and screening of all employees before and after employment (United Nations Development Programme, 2011). All of these measures need to include monitoring and accountability procedures such as frequent internal and external audits, the electronic monitoring of medical supplies, and whistleblowing mechanisms for the public and internal staff. Higher penalties for bribery, collusion, or theft are also seen as important to decrease willingness to engage in corrupt behaviour (Department for International Development, 2010).

Corruption in the Pharmaceutical System at an Institutional level Institutional corruption within the pharmaceutical sector can have an impact on policies at a national level. Institutional corruption takes place when there are influences that are legal and even ethical in nature that divert institutions or governments from their intended purpose, which has direct implications on their effectiveness in achieving their desired goals (Lessig, 2013).

Institutional corruption within the pharmaceutical sector takes place as a result of misalignment of the industry’s profit maximising interests and public health needs.

This type of corruption takes place through large-scale lobbying and political contributions, which have allowed the pharmaceutical industry to manipulate political decision makers to pass legislations that are beneficial for industry but detrimental to public health needs. For example, reports have stated that the pharmaceutical industry spent USD 21.3 million on the 2012 US federal elections (Jorgensen 2013). While such contributions are not illegal in nature, they have direct implications on the level of influence pharmaceutical companies have on decision makers, which can have negative effects on public health needs. In the United States legislation has been implemented that compromises the ability of the FDA to achieve its goal. As a result, the FDA has become underfunded, further limiting its enforcement capabilities (Light et al 2013).

Institutional corruption also takes place on the ground through the commercialisation of physicians and their prescribing habits. This type of institutional corruption has led to fewer new molecular entities – new medicines provide limited or no therapeutic advantage over existing ones. Pharmaceutical companies no longer need to create new and innovative drugs as they have found new ways to market and encourage physicians to prescribe newer and more expensive medicines that are not innovative or provide therapeutic advantage over older drugs (Gagnon 2013).

Conclusions There is consensus that corruption in the health sector is costly and particularly harmful in terms of limiting access to essential health care services for the population. The study probed the complexity of health sector corruption by focusing the literature review on the pharmaceutical system, as it can be understood as a microcosm for the health sector. What works best to limit corruption appears to be less clear, as it is often case and context specific and linked to the fact that corruption in the health sector is complex, dynamic and can happen in a multitude of settings.

At a global level, dealing with corruption centres around hard and soft international law and the creation of international standards and guidelines to be adopted by national governments and practiced by the pharmaceutical industry. Transparency and accountability are commonly cited as essential tools for helping to reduce the likelihood of corruption from occurring. At a national level, including civil society in policy formulation, decision-making and implementation is also often cited as a positive technique in the fight against corruption.

Anticorruption measures highlighted by the literature tend to be specific to the particular “site” of the pharmaceutical system and include improving institutional checks and balances, such as stronger and better implemented regulations and policies, oversight, better protection for “whistle blowers”, financial incentives to refrain from engaging in corrupt behaviour, and increasing the use of technology in processes so that the human potential for corruption is minimised.

Next steps The research team has completed a literature and policy document review to contextualise issues. The project will now extend to interview key informants within the sector to ask for their knowledge and opinions on the issues outlined in the literature. The University of Toronto and Transparency International UK’s research teams will complete up to 40 key informant interviews with anticorruption experts in academia, international organisation, NGOs and industry associations.

The research teams will analyse the data by coding the key informant interview data to identify core themes and subthemes using the qualitative research software HyperResearch. A number of key informant interviews have already been conducted and preliminary themes are as follows: •

•

•

•

•

•

At a global level, curbing corruption in the health sector remains a challenge due to that global anticorruption policies often do not specifically focus on healthcare. There is a need for more funding to conduct specific research on corruption in healthcare, particularly for the pharmaceutical sector. This involves being strategic about how money is spent to ensure initiatives being implemented have the highest impact.

Transformative reforms to curb corruption in healthcare should involve changing the current mind-set surrounding medicines and healthcare as being private goods to essential goods. This will increase moral accountability among decision makers to health outcomes and public health needs.

Engagement with governments, the private sector and civil society is essential for change. This involves increasing accountability among decision maker’s actions, mobilising the private sector into the decision making process, and exploring how to best engage with the private sector to operationalise change.

While the Sustainable Development Goals appear to be a great step towards the development of international laws and regulations to deal with corruption, there is uncertainty surrounding their effectiveness in dealing with the issue of corruption.

The use of technology to minimise human involvement in various decision points of the pharmaceutical supply chain such as the procurement and distribution of medicines has been suggested. This involves the implementation of computerised systems that will facilitate the monitoring and tracking of outcomes and inefficiencies to increase accountability.

Other suggested measures to curb corruption include implementing whistleblowing mechanisms, introduced valued based pricing of medicines, track prescribing habits, enforce sanctions, engage in quality sampling along the pharmaceutical supply chain, increase publicly funded R&D, implement ethical standards, increase education and training, and engage in more effective financial management.

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