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Continued from Previous…… This series is based on report compiled by Jilian Clare Cohen1, Monique Mrazek2, and Loraine Hawkins3 for World Bank.
Corruption is spread easily across many areas if the regulatory systems are inefficient and/or incompetent. Pharmaceutical business is among the most regulated businesses and is therefore subject to the same phenomena. Not long ago, Pharma was rather loosely regulated. However, there have significant changes in the last three decades or so. The regulators have identified areas where corruption may occur and have installed regulations to control this. The implementation, however, varies from country to country.
Academics have always helped to identify potential areas of corruption through research and analysis. Robert Klitgaard is an American academic, former president of Claremont Graduate University and former dean of the Frederick S. Pardee RAND Graduate School, where he was also the Ford Distinguished Professor of International Development and Security. He currently serves as university professor at Claremont Graduate University.
Klitgaard is the author of the books The Culture and Development Manifesto (2021), Controlling Corruption (1988) and Tropical Gangsters (1990), which contributed to a worldwide movement against corruption. His combination of case studies and analytical frameworks is also demonstrated in his other books, including Choosing Elites (1985), Elitism and Meritocracy in Developing Countries (1986), Adjusting to Reality: Beyond ‘State vs. Market’ in International Development (1991), Corrupt Cities (2000), and Addressing Corruption Together (2015). Klitgaard has been an advisor to many governments on economic strategy and institutional reform, and his consulting work and research have taken him to more than thirty countries in Latin America, Asia, and Africa. He has been called “the world’s leading expert on corruption” (The Christian Science Monitor). (Source: Wikipedia).
Klitgaard developed a framework to understand/predict corruption which is given below.
Monopoly (M) + Discretion (D) – A (Accountability) – T (Transparency) = Corruption
The above model can help the decision makers and policy makers to understand and identify circumstance which allow for Monopoly and Discretion, and which are made further vulnerable due to limited Accountability and Transparency.
Pharma business has several key decision points which are vulnerable to corruption. Even if corruption occurs at one point, it may have significant impact on the outcome, and the delivery of effective and safe medicines at affordable prices may be compromised.
Three words, Corruption, Inefficiency, and Incompetence should be focused on to understand better. It may not be possible in all cases to clearly differentiate occurrence of Incompetence or Inefficiency which leads to corruption, as the first two create the vulnerability on which corruption fosters. The difference is that Corruption is a deliberate act, while Incompetence and Inefficiency may not have an intent to do wrong. The outcome, however, is the same.
The report, referred to in these blogs, identifies six core decision points.
STRUCTURE OF THE PHARMACEUTICAL SECTOR: SIX CORE DECISION POINTS AND ANATOMY OF CORRUPTION
The six main areas in the pharmaceutical sector that are key decision points and prime targets for corruption are:
- Selection (for public procurement)
- Drug Prescribing and Dispensing by pharmacies
The primary objective is to implicitly point out areas which allow for monopoly and discretion and promote strategies to help solidify transparency and accountability in the system. This framework is consistent with WHO’s recent work on transparency and pharmaceuticals.
Decision Point One: Manufacturing
Manufacturing of pharmaceutical products requires compliance to GMP (Good Manufacturing Practice) to ensure “that the products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”. GMP is a set of written guidelines which is updated from time to time based on newer findings. GMP covers all areas of manufacturing (and beyond), including handling of raw materials, storage, production, packaging, and labeling.
According to WHO, adherence to GMP helps to diminish the risks inherent in pharmaceutical production, particularly, cross-contamination (including unexpected contaminants) and mix-ups caused by, for example, false labels put on containers.
“There are a number of steps that can be taken to improve adherence to GMP requirements. First, it is important to ensure that GMP is legally defined and that appropriate consequences for non-adherence are defined by law. Many countries still do not have a legal definition or legislated enforcement of GMP… It is also important to point out that the definition of a GMP requirements is not universally standard and do differ between countries/enforcement agencies. Even the definition of GMP is not identical between WHO, the European Union, and the US Food and Drug Administration. Differences in the definition of these requirements can result in negative, unintended consequences.”
“Second, even if there is a strong legally defined GMP standards in a country, adherence will depend on the capacity to credibly enforce these. Some countries have found it effective to have regular and random inspections of not only the manufacturing premises but also the inspection of drugs at various stages of the market process from manufacture or import to retail in order to mitigate the risk of counterfeit or substandard drugs. The quality of these inspections would depend on adequate financing of the drug regulatory agencies to ensure that there are a sufficient number of appropriately screened and trained, and adequately paid inspectors. Inspectors should be put on a rotating schedule for the manufacturing sites to minimise the development of bias.”
Pakistan has a well-defined GMP standard. With the support of WHO, trainings of regulatory staff and pharma personnel have been carried out on several occasions. At this level, Pakistan is much better placed than many other developing countries. Our problem in general is not lack of adequate regulations, it is adequate, transparent, across the board execution. The political polarization and alignment have been made to become integral part of regulating system through political appointments and promotions of chosen ones, and transfers and sidelining of those not following in line. Our problem, in short, is IMPLEMENTATION OF RULES.
To be Continued……
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- Jilian Clare Cohen – Toronto, Canada
- Monique Mrazek – Latin America
- Loraine Hawkins – London