A company or government problem?

A risk specific to the pharmaceutical industry, which is also business as usual, concerns patient safety. However governments worldwide have stepped in to control the industry. One could therefore argue that the risk moves from the pharmaceutical companies to the governments. And if all parties follow the regulations and if the regulations are adequate, the risk disappears.

Unfortunately multiple incidents of failure have resulted in patients suffering or dying from drugs, so all eight companies [1] include patient safety as a risk, in some form or another.

Some concentrate on following regulations:

“…products are subject to comprehensive government regulation by the U.S. Food and Drug Administration (FDA) and similar international regulatory agencies.”

Many complain about the cost, “Compliance with these laws and regulations is costly and materially affects the business.”

A few go straight in and take the blame directly for patient safety, without hiding behind the governments and their regulations:

“If we do not effectively manage risks to our patient safety activities, the most serious repercussion could be harm to patients.”

And of course harm to patients could also lead to severe damage to the reputation of the company, litigation, loss of trust by patients and healthcare providers, and loss of shareholder confidence.

For once I agree that patient safety is a risk that pharmaceutical companies have as an industry wide risk.

[1] I analysed the risk statements from the 2021 and 2022 annual reports of eight pharmaceutical companies, four based in USA – Abbott Laboratories, Abbvie Inc, Bristol-Myers Squibb Company, Johnson and Johnson, and four based in the Europe – AstraZenica, GlaxoSmithKline, Sanofi, Novartis.