A common sense approach to getting things done is being embraced by more heads of pharma. Regulations are progressing towards good sense and basic objectives. The recent welcoming of a more structured approach to managing risk is probably the best recent example of the convergence of the needs of patients (as represented by the regulators) and businesses. Clinical and Safety leaders are using a well thought out risk management framework in order to spot potential risks and tackle them in order of priority. They are then doing suitable things to mitigate them. The regulators acknowledge this, understand that they are managing their business appropriately and leave them to get on with it. It is pure common sense.
Drug development is a place where common sense would suggest that welcoming independent opinion and approval of new products would be highly beneficial. This would mean more people or agencies adopting a role similar to that of the UK’s National Institute of Health and Clinical Excellence (NICE). NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. It will currently only approve a drug if it has obvious long term patient benefits and always considers the fuller implications of new products, such as economic viability relative to existing similar products and so on.
The long-term health of patients and community is obviously key – so regulators may well become aligned to this. This could mean that approval decisions are based on longer-term benefits, which would drive requirement for extended clinical trials – to get the data. This would, in turn, make trials more expensive, and slow time to market. This being the case, patent rules would require change, and investment models within the industry would shift. Can you imagine big pharma portfolio decisions being informed by regulators, looking to satisfy specific unmet needs?
Assuming that one day this approach is adopted, what could it mean for pharma companies? Well, they are already working hard for the medium term benefit of the patient and the short term good of the business, so how about changing their model so that they are working hard for the long-term health of both?
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