Pharmaceuticals Big Pharma’s Compliance Departments Lacking Knowledge of New Technologies

Editor: Dominik Stephan

A recent study reveals that compliance departments in pharmaceutical companies have insufficient knowledge regarding new technologies. 90% of the questioned companies agreed that compliance is in fact “lagging behind”, making regulatory requirements obsolete. But the very same study also shows first signs of a positive development…

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(Source: Public Domain / CC0 )

In the study, a team of researchers and analysts of Camelot Management Consultants examined the extent to which pharmaceutical companies are aware of the risks and opportunities that new technologies bring to their compliance practices and how they view digitalization and the use of new technologies from a compliance perspective. The results were mixed: Even though the majority of respondents (94 percent) agreed completely or somewhat with the statement that digitalization makes it faster and easier for companies to meet compliance requirements, 90 percent are also of the opinion that compliance is often lagging behind the development of new technologies, which means that regulatory requirements are often missing or obsolete.

One of the most interesting outcomes of the study is that 68 percent of the entrepreneurs in the survey do not believe that their internal compliance or quality assurance departments are keeping them up to speed on the risks and opportunities associated with the use of new technologies. Instead, they rather rely on their own (internet) research. “Compliance departments in the pharmaceutical industry need to become much more knowledgeable about new technologies in order to keep up with the progress of digitalization,” says Dr. Josef Packowski, Managing Partner at Camelot, in commenting the findings of the study.

New technologies are currently especially prevalent in areas where compliance risks are not regarded as centrally relevant. This includes training (89 percent), documentation (78 percent), and environmental protection (76 percent).

How digitalization impacts different lines of business

When asked which areas of their business are being impacted the most by digitalization, 56 percent of respondents cited their marketing and sales departments, followed by research and development (22 percent). This makes for an interesting change when compared to last year’s findings: At the time, supply chain and logistics were named as the areas impacted the most by digitalization, while today this sentiment is only shared by 17 percent of respondents. These numbers suggest that the first phase of digital transformation has already been completed.

Looking ahead, 42 percent of survey respondents said that they do not see a new wave of digitalization impact their logistics and supply chain operations for another five years. In manufacturing (35 percent) and drug development (29 percent), respondents even expect a 15-year span before digitalization will have any relevant impact.

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