I have an undergraduate degree in European History, French Revolution to the Present, which was then 1978. Perhaps not the most marketable of college degrees but for a lover of history it was a ton of fun. One of my favorite study subjects was the French Revolution, particularly the phase from 1789-1792; the period of almost Constitutional Monarchy, before the King was executed and the Terror set in. While this part of the Revolution failed, it does not mean that was not a noble effort by the French people, who had been inspired in large part by the success of our American Revolution.
In the spring of 1789, King Louis XVI, called the Estates-General into session. It was a national assembly that represented the three “estates” of the French people – the nobles, the clergy, and the commons. The Estates-General had not been assembled since 1614, and its deputies drew up long lists of grievances and called for sweeping political and social reforms.
The Third Estate, which had the most representatives, declared itself the National Assembly and took an oath to force a new constitution on the king. Initially seeming to yield, Louis legalized the National Assembly under the Third Estate but then surrounded Versailles with troops and dismissed Jacques Necker, a popular minister of state who had supported reforms. In response, Parisians mobilized and on July 14 stormed the Bastille, a state prison where they believed ammunition was stored, and the French Revolution began. On this date in 1789, one of the most dramatic events occurred; The Oath of the Tennis Court, where the deputies of the Third Estate, which represent commoners and the lower clergy, met on the Jeu de Paume, an indoor tennis court, in defiance of King Louis XVI’s order to disperse. In these modest surroundings, they took a historic oath not to disband until a new French constitution had been adopted.
The Oath of the Tennis Court was recorded for each member who took part. In other words, there was full documentation of who took the oath and the substance of the oath taken. It was a very good example of what I continue to hammer as the three most important things in Foreign Corrupt Practices Act (FCPA) compliance, that being Document, Document, and Document. However, many people ask what that means more than simply writing something down.
I am currently attending the UL EduNeering Leadership Forum and there are several compliance representatives from the pharmaceutical industry in attendance. One thing I have learned is that the pharmaceutical industry has a definition of Good Documentation Practice (GDP), which describes standards by which documentation is created and maintained in the industry. Although the US Food and Drug Administration (FDA) sets some GDP standards, others fall under the Current Good Manufacturing Practice (cGMP). Finally, all pharmaceutical, bioscience and healthcare companies, as well as their vendor partners, must observe GDP or face warnings or penalties levied by the FDA.
In an article by Barry Peters and Heather D. Ferrence, entitled “Importance of Implementing Good Documentation Practices”, they note that the World Health Organization (WHO) says the some of the purposes of GDP include:
Moreover, “an essential part of all aspects related to Good Manufacturing Practices (GMP), adhering to GDP helps prevent errors within various processes, such as product quality and safety, state of manufacturing facilities and other related activities, and ensures that each company is following strict standard operating procedures (SOPs). In a regulated industry, such as pharmaceuticals, quality cannot be assured without accurate documents and GDP.” Finally, it is to be noted that “it is imperative that all documentation is concise, legible, accurate and traceable.”
Adapting the authors’ suggestions specific to the pharmaceutical industry, I submit the following for your consideration in your Document, Document, and Document practices in FCPA compliance:
To the above list I would add some additional suggestions:
Setting and following good document practices is an essential aspect of compliance with federal regulations, such as the FDA, who governs large aspects of the pharmaceutical industry, and other federal laws such as the FCPA. So in addition to documenting your actions, you should also follow a written protocol for document maintenance and subsequent modifications.
Visit the FCPA Compliance and Ethics Blog, hosted by Thomas Fox, for more commentary on FCPA compliance, indemnities and other forms of risk management for a worldwide energy practice, tax issues faced by multi-national US companies, insurance coverage issues and protection of trade secrets.
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© Thomas R. Fox, 2014
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