The exponential growth in the life science industry, accompanied by high profile multi-billion dollar mergers & aquisitions activity, and recent cyber attacks have catapulted this sector of industry into the spotlight recently. With increased public awareness of the industry and it’s internal structures also comes a heightened sense of scrutiny from global government agencies. As a result these agencies are quickly implementing an accelerated list of regulations which, if not complied with, could potentially result in substantial fines and require a company to remove their product from the market. This strict level of government enforced regulatory compliance has led to comparisons to the financial services industry of five to ten years ago.
Global governments are paying particular attention to the following areas:
- Product Safety Issues
- Data Breaches
- Intellectual Property Compliance
- Inappropriate Marketing Tactics
- Internal Corruption Issues
Additionally, agency investigators have implemented risk based inspections in order to identify weak links in the life science industry's internal systems. Overall, the industry is responding by complying with the hightened security measures, and embarking on what is poised to be a highly active few years for the industry.
Innovation Drives Growth
Life science companies are looking to scale their businesses through collaboration, informal partnerships, and acquisitions. Deloitte reports that over 70% of life science companies plan to undertake M&A activity at some point in the next 3 years, which is no doubt the result of increasing pressures to innovate and diversify within the industry. With increased collaborative efforts companies are crossing into new markets throughout the world, giving cause for increased global regulation of the industry. Many of these new regulations require companies to increase cyber security in order to securely share documentation across multiple businesses and agencies.
Global Regulations Create New Challenges
The main area driving new government regulations is patient privacy and safety. However, the current varied global regulations create obstacles for many investigating agencies to enforce all regulations on a global scale. The European Medicines Agency has and US Food and Drug Administration have begun the process of implementing global regulations with the Identification of Medicinal Products requirements and the Global Unique Device Identification Database. These regulations require life science companies to invest heavily secure document storage in order to maintain accurate, detailed product data information. Failure to comply could result in serious and significant fines for the company.
Regardless if it is the government forcing the issue or not, life science companies are clearly aware that cyber attacks and data breaches are becoming more prevalent and the amount of time to respond to each attack is diminishing. The industry as a whole is choosing to take a proactive approach and invest in protection solutions in order to increase their internal productivity, and reduce the number of risks and victims of unauthorized access.