Companies operating in the life sciences sector are being forced to tackle an increasingly complex regulatory landscape. As firms strive to develop new products to match patient needs, greater innovation is often accompanied by greater risk, with non-compliance leading to severe financial penalties and significant reputational damage. Risk of non-compliance is heightened when operations span international boundaries, forcing firms to comply with multiple regulatory frameworks across different areas of their business. It is a complex challenge and, given the broadening scope of regulatory requirements in recent years, one that is likely to become only more so in the short to medium-term.
Multiple frameworks across diverse business functions
In addressing the challenge, it is important to remember that large firms will typically face compliance obligations in areas as diverse as finance, environmental performance, data security, sales and marketing, clinical research and product quality assurance. And in most mature organisations, compliance requirements in each of these areas will have traditionally been managed within silos, each clearly distinct from the other. But as regulatory requirements have expanded, they have become less mutually exclusive, with significant crossover between different areas.
Greater collaboration between competitors and partners
This makes it very difficult to gain a true organisation-wide understanding of requirements and obligations, and companies have responded not only by focusing more resource on the issue, but also by promoting greater collaboration between competitors and partners in order to help the entire industry to meet the challenge.
An ethics-based approach to compliance
An approach adopted by many forward-thinking firms is to implement an ethics-based system of compliance, one that relies on personal and corporate integrity, and that promotes a consistent approach at every level and within every department. Such an approach may include embedding compliance targets within employees’ objectives, and defining a clear vision of what is expected at individual and business unit level. Some firms even go so far as to link employee reward and remuneration with compliance behaviours and performance.
Strong compliance equals competitive advantage
The ability to understand and manage these ever-changing regulatory frameworks has become a key competitive advantage, because a good track-record on compliance can help firms in many ways. Not only does it mean avoiding the costly fines associated with non-compliance, it also strengthens the brand, and can play a major role in helping to attract leading talent.
Good patient care the ultimate objective
Ultimately, compliance requirements should not be viewed as a box to be ticked. One must remember that regulations are put in place not to stifle innovation, but to protect the lives and wellbeing of patients. So it is only right and fair that companies are compelled to comply with stringent regulations. And those that prove best able to successfully negotiate the regulatory environment whilst maintaining their ability to develop new products, these are the ones that will flourish.
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