Guest Blog | RPC LLP | Risk management and regulation - an opportunity for life sciences innovators?
Compliance, regulation and red tape can be burdensome for manufacturers, but should they be viewed more positively? Risk management has the potential to add value and longevity to a product – and to offer an opportunity for growth. Here are reasons why investing in risk management should be a guiding principle for the entire product development cycle, from the initial concept right through to marketing and post-market surveillance:
The seeds for defending a product from expensive litigation or regulatory investigation can often be sown at the concept stage. A brilliant new idea shouldn’t leave the drawing board until it's been scrutinised by regulatory, compliance and legal teams. This will only save money in the future. If your new product carries with it the risk of injuring users, patients could bring claims alleging that you were negligent in your design, that it falls short of the level of safety the public is entitled to expect, or that it was not of satisfactory quality. Evidence of well-run trials at an early stage can be a shield to help to defend such claims, and if testing shows cause for concern, action can be taken to address it. If the product can be defended in the long term it will be around for longer and generate more sales.
Protect against litigation
For products in regulated sectors, such as medical devices or pharmaceuticals, compliance with regulations can be an opportunity to add greater credibility to your product. Even products that do well in trials can spring nasty surprises in the future. Look at the pain-relieving drug rofecoxib (Vioxx). It passed clinical trials and was approved by the FDA, but anecdotal evidence that it carried an increased risk of heart attack led to withdrawal of the drug and huge litigation. Eventually, the manufacturer's field data was shown to reflect the anecdotal evidence. If that had been collected earlier, the manufacturer could have avoided litigation and directed resources to other products.
Avoid over reliance on the regulator
Regulators can be slow to keep up with scientific advances and the more innovative the product, the less guidance they will be able to offer. Going "beyond compliance" to try to predict what regulators will eventually demand is essential if you want to avoid the risk of falling foul once they catch up.
Keep up with developments
Don’t forget the importance of monitoring social and legal media; comments and complaints can have a huge effect on a brand's reputation. Part of your risk management strategy should include monitoring social media and press releases generated by claimant law firms, not just to keep up with potential problems but to keep abreast of patient concerns. Innovative manufacturers must walk a tightrope created by rising expectations. On the one hand, you want to be at the forefront of revolutionary technology to meet patient demands, on the other, the public is increasingly likely to complain or sue if expectations are not met.
There are ever more regulations to consider, as the industry prepares for new medical devices and clinical trials regulations. It can seem that the legal and regulatory framework places a heavy burden on those who want to innovate, but those who invest in compliance, and risk management can stay ahead of their competitors.
Pete Rudd-Clarke and Rowan Brown, RPC
Guest blogs are written by third parties and do not necessarily represent the views of the BIA