Published in · 2 min read · May 30, 2020
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The culture of quality and compliance has lately become a buzz phrase among my Pharma colleagues. People often list the root causes, as lack of accountability, incompetent or corrupt leadership, an absence of consequences, and deeply ingrained cultural norms and expectations. People can skirt the law with impunity and get off scot-free by bribing government officials. Such practices become norms and increase the risks of traffic accidents by diverting enforcement from real violators.
Politicians and businesspeople often consider these acts as a cost of doing business. No one pays attention to the actual reason for compliance and enforcement.
As a whole, the Pharma industry is not immune to such abuses, and it is unfair to isolate Indian culture as inherently corrupt. Many countries, including the US, has a history of high-profile crimes — remember the generic drug scandal of the late eighties?
http://www.nytimes.com/1989/10/02/opinion/the-generic-drug-scandal.html
Similar scandals are not unknown in other countries, including the European nations and yes, China.
http://www.bbc.com/news/world-europe-12155639
http://money.cnn.com/2013/07/16/news/china-bribery-gsk/index.html
So human nature is the same. Why do scandals occur? What makes people behave the way they do? We can boil down these root causes to the following five factors.
Knowledge and Awareness
Do people know of doing things the right way? (procedures, instructions, training, regulations)
Are they aware of what the right things to do in a given situation? (Ethics,
Etiquette, Code of Conduct, laws)
Are they aware of the consequences for themselves and others? (Social and personal responsibilities)
Aptitude/Skills
Do people have the skills to carry out a particular task or function (Training, instructions)?
Means
Do they have the tools, the responsibility, and the authority to act?
Motives
What drives their behavior? Is it personal gain, e.g., save time, effort, or money. Is it fear of losing one’s job or displeasing the boss? Is it because of their blatant disregard of authority? (Ego?)
Opportunity
Did they have the opportunity? (No one was looking, no enforcement mechanism and they can get away without consequences)
Whenever a company is demonstrating a culture of non-compliance, it must begin by looking at these causes. We will cover each of these in detail in the next set of articles.
