Dear Colleagues! This is Pharma Veterans Blog Post #495. Pharma Veterans welcomes sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi onWordPress, the top blog site. Please email to firstname.lastname@example.org for publishing your contributions here.
Continued from Previous…… This series is based on report compiled by Jilian Clare Cohen1, Monique Mrazek2, and Loraine Hawkins3 for World Bank.
Corruption is a factor which has wide ranging implications.
Quality of a product has direct bearing on the outcome of therapy at the minimum, and serious health hazards, including death at the maximum. In all countries, quality measures and regulations are in place, thanks mainly to WHO which has provided guidance and arranged trainings at its own cost. The implementation of regulations is, however, responsibility of countries’ own health regulators. If the enforcement is not strong, it may lead to poorer quality of drugs coming on to market. Another serious problem of laxity from regulators is the availability of spurious or counterfeit drugs which would play havoc with people’s health and lives. Various estimates, some as high as 30%, have been put forward about counterfeit drugs selling on the world market. Major countries involved in producing and shipping such drugs are the same, which are big producers of drugs anyway. Counterfeit drugs may or may not contain the same substance, in the same quantity, and of the same quality, and may lead to unexpected consequences. However, like addictive substances (Drugs), this is multibillion dollar business and is not easy to counter.
Quality of a product is not a constant which would be automatically always maintained. Each production batch needs the same meticulousness to maintain quality.
Health regulators are required to monitor all elements of supply chain/production to ensure quality. It starts from raw material sources, covers production, quality testing at all stages, and logistics till it reached the patient properly. A lot remains to be desired in this long spectrum in developing countries, such as Pakistan.
The report further says, “Further, a lack of quality control has undermined the possibility of generic price competition in some countries where a failure to ensure generic interchange leads to product selection based on consumer confidence in a given brand. Even when there are seemingly strong institutional checks and balances in place, such as in the United States, fraudulent activity can nevertheless occur. Since 1986, False Claims Act judgments and settlements for fraud have totaled US$12 billion, with most of these being against well known drug makers. One of the largest of such settlements was against drug maker Serono who agreed in October 2005 to pay US$704 million to settle a fraud case involving its product Serostim (a human growth hormone product) for charges involving kickbacks to doctors and pharmacies, illegal off-label marketing and sale of diagnostics designed to spur Serostim prescriptions that were not approved by the United States Food and Drug Administration.
The presence of corruption in any one of the critical decision points in the pharmaceutical system from manufacture to retail sales can be detrimental to a country’s ability to improve the health of its population by limiting population access to quality medicines and thereby reducing the health gains associated with the proper use of pharmaceuticals. While corruption in the pharmaceutical system can affect the entire population, it is typically the poor that are most susceptible to its detrimental effects. Where the public health care system affords coverage of pharmaceuticals, it is the poor who are obviously more dependent on the system than the rich and who suffer the consequences of its mismanagement. In most poor countries drugs are purchased out-of-pocket by consumers and represent a significant share of household consumption on health care. Governments in these countries still have a responsibility to ensure that even the poorest can access quality essential drugs. Broadly speaking, good governance is a sine qua non for ensuring access of the population to essential medicines.”
United States has the most reported cases involving various kinds of corruption in health sector, although it has a very stringent system in place. Fabricated clinical reports were published, false claims were made over long periods, information about serious side effects was withheld from doctors and patients which led to serious consequences, unnecessary devices like coronary stents were placed in scores of patients and so on. The most significant point is that these misdemeanors were committed by the Big Pharma. On these counts, they have paid billions of dollars in compensation, but it has not deterred them entirely. On the other hand, it is also in the US that entire batches medicines are voluntarily withdrawn by the manufacturers when a quality issue is detected.
If the US has such issues, where do we stand? In Pakistan, did we have any successful prosecution of any Pharma involved in corrupt practices? Did we see any manufacturer recalling a batch due to quality issues? The answers are in negative. This does not mean all is perfectly well; it means we are not paying attention.
To be Continued……
Disclaimer. Most pictures in these blogs are taken from Google Images which does not show anyone’s copyright claim. However, if any such claim is presented, we shall remove the image with suitable regrets.
- Jilian Clare Cohen – University of Toronto, Canada
- Monique Mrazek – Latin America
- Loraine Hawkins – London