Of course, this is not quite how Pharmafutures 5 puts it but it’s what they seem to be suggesting and I think they’re right. Here’s how they put it, “today’s binary decision making at the point of regulatory approval and price setting would need to be replaced by iterative, dynamic decision-making that adapts as evidence is accrued, and value determined overtime.” Presumably that would not happen in open consultative meetings.
Pharmafutures is a high-powered think tank set up by institutional investors to make sure that pharma doesn’t lose its social licence: enough support from governments to make a profit and to stay in business.
I agree completely with their suggestions on a new way of flexible approval. “Today’s zero-sum approach to authorisation could be replaced with a model of adaptive licensing suﬃciently robust to guarantee safety and eﬃcacy on approval, at the same time as being suﬃciently ﬂexible to allow for iterative evidence building over time.” This would remove the current absurd situation where a risky medicine (e.g. diclofenac — with a high risk of stomach bleeding, stroke and heart attack) is grandfathered in to over-the-counter sales in many countries while Vioxx (rofecoxib) which was safer on every count and preferred by patients was withdrawn because it combined some risks with being new. However, Pharmafutures doesn’t go far enough: no medicine can be completely “safe and effective”; some, though, are safe enough to use because of the beneficial effects that they have. (Read my 2011 Pharmaceutical Executive story on this issue and how both government and pharma can be more truthful here)
I think I also agree with their idea of crowd sourcing decisions about value. “Models could be adjusted …. to ones that reﬂect changing perceptions of the absolute and relative value of a medicine based on evidence accrued as it is used in clinical practice.”
Sophia Tickell founded Meteos, the organisation that runs these discussions. How all of this will look to Sophia Tickell’s former colleagues at Oxfam, I’m really not sure — Oxfam tend to reach for the diazepam at the very thought of private meetings between payers, regulators and industry. Hear a 4 minute interview with Tickell on the Deutsche Welle talking about the report. Here’s the report itself (you have to download either the executive summary or the full report)