Doing the right thing: the enhanced case for compliance

Maintaining regulatory compliance can be relentless in the pharmaceutical industry. Each time organisations think they are on top of everything, one set of specifications is updated or a new wave of change comes along.

This can be demoralising, and draining – from a financial, time and resources perspective. A better way to drive value from an investment in compliance is to look for a wider range of wins.

Up until recently, life sciences companies would have approached regulatory requirements as a necessary evil, something to satisfy the authorities and minimise business risk. Beyond this, organisations have not typically looked for strategic benefits.

In today’s digital new world, there is a chance to treat compliance very differently. That’s as companies move away from processes built around manually filling in paper or PDF documents for each unique regulatory reporting requirement, toward building rich, dynamic databases whose contents can be re-purposed many times over.

A definitive central resource where all the required information (and more besides) can be collated, checked, refined and updated – so that anything else that happens thereafter with that information is, by default, correct and compliant.

The pharmaceutical sector has tended to be slow to adapt to the benefits of this approach - because of the legacy data, systems and processes companies have had to unravel first. But unless companies strive to do things fundamentally differently, they will be increasingly at a disadvantage.

Basing compliance activity on structured, ready-to-go data, in a consistent format, means the latest, correct information can be called up and prepared at speed using the latest digital tools to ensure efficient data exchanges with authorities, with full details/a clear line of sight across every products right along its lifecycle – for reliability traceability and protected data access.

By harnessing these characteristics, pharma companies can start to think beyond the immediate goal of compliance for its own sake, and toward the wider benefits that come with being able to quickly access great detail about products - including their application, use, and efficacy in the real world.

Traditionally, audits, inspections, complaints handling, and pharmacovigilance, have put the spotlight on non-compliance. It is why, in the US, we see lawyers and other professionals with roles dedicated to damage limitation and crisis management.

But what if positive action and pre-emptive compliance were made business differentiators? If they became a signal to the market, and to customers/patients, that a company has an enriched sense of public duty, of ‘wanting to do the right thing’?

Amid the continued Covid-19 disruption, and more recently the Black Lives Matter movement, there is an expectation that businesses review their culture, policies, and practices. Markets and customers have heightened sensitivity to whether companies are ‘walking the talk’, or whether everything they do is secondary to making a profit.

In life sciences CMC and, more recently, safety disciplines, new concepts have been developed by adopting a proactive rather than a defensive approach to compliance. The ‘Quality by Design’ initiative in CMC makes it possible to incorporate potential non-compliance risk in the development phase of the manufacturing process, for instance.

The idea is to establish methods to increase robustness, minimizing post-market manufacturing inspection impacts. And, by extension, improve the patient experience by bringing better products to market, faster.

The premise of proactive safety planning is similar – eliminating more risk at the outset, simultaneously hitting two targets: a higher/faster market success rate; and becoming a more trusted brand/supplier.

Here, risk management plans involve anticipating and paying close attention to an initial holistic review of all aspects (both positive and negative) of a product from its earliest development stages, allowed to anticipate and mitigate the safety profile of each drug.

In a world where more and more detail is captured about products, and shared with agencies right across their lifecycle - in some cases even made accessible to the public through digital channels - anticipating non-compliance becomes strategically important for a whole range of reasons.

Companies don’t just want to avoid fines; they want to improve their safety records and show the public where their priorities really lie.

Companies can still look for cost efficiencies in all of this. Rather than lament next waves of regulatory demands, smart companies will look out for them – and be ready.

This means maintaining active ‘compliance intelligence’ - proactively identifying and anticipating trends in emerging rules, laws, or good practices. Regulation rarely comes out of nowhere. First, positioning papers are composed, shared and developed.

Then, guidelines and staged implementations follow, with time allowed for transition. Where once the tendency might have been to ‘wait and see’, in case of delays or changes to requirements, companies are realising increasingly that deferring action can put them on the back foot and render them less able to capitalise on adjacent opportunities for the business, and for customers/patients.

With new waves of regulatory advancement never far away, there will never be a better to time to transform compliance measures.

We generally advise the relevant team within the company - or a suitable partner - to conduct a risk assessment within the context of the organisation’s current business model, highlighting points to anticipate as new requirements appear on the horizon.

Once official requirements are published, the next task is to perform a gap analysis identifying all the potential implication arising. These might range from a simple but time-consuming review of a number of inter-related documents and data that will be involved/affected, to potential additional technical and scientific work (e.g. to replace a banned ingredient/questionable material by another) - and then gain approval from the authorities for any changes made.

Where a company has adopted a proactive approach to compliance - better still harnessed compliance as a lever to optimise the way it develops and manages its products - then the really smart thing to do is capture the lessons learned, perform a risk assessment and engage in process changes through a controlled transformation process.

By elevating compliance to something higher, more proactive and a powerful contributor to business success and patient outcomes, companies might also consider spinning off the whole activity. This could involve appointing a dedicated team (usually associated with a risk management department), or even relying on a service partner to outsource it.

What is certain is that continuing to react to each new regulatory requirement as it comes along has long ceased to be a sustainable approach to compliance.