Previously mentioned one way to decouple “a particular (U.S.) safety/efficacy regulatory regime and patents” so as to among other benefits “broaden the scope of therapies that can be tested and thus gain status in medical profession, many of which may be cheaper and more widely available than new drugs, many of which are currently under-utilized or poorly-utilized because they are left to quacks.”
Comparative effectiveness research is one mechanism. The Evidence Points to a Better Way to Fight Insomnia includes a brief description and example:
Which remedy would be best for me? Lunesta, Ambien, Restoril and other drugs are promised by a barrage of ads to deliver sleep to minds that resist it. Before I reached for the pills, I looked at the data.
Specifically, for evidence-based guidance, I turned to comparative effectiveness research. That’s the study of the effects of one therapy against another therapy. This kind of head-to-head evaluation offers ideal data to help patients and clinicians make informed treatment decisions. As obvious as that seems, it’s not the norm. Most clinical drug trials, for instance, compare a drug with a placebo, because that’s all that’s required for F.D.A. approval. In recognition of this, in recent years more federal funding has become available for comparative effectiveness research.
When it comes to insomnia, comparative effectiveness studies reveal that sleep medications aren’t the best bet for a cure, despite what the commercials say. Several clinical trials have found that they’re outperformed by cognitive behavioral therapy.
Comparative effectiveness research was apparently part of U.S. health reform and disliked by drug companies (2009). Some jurisdictions (eg UK) have bodies that use the method to evaluate therapies. A recent article urging more sharing of comparative effectiveness research data.
It is not clear to me to what extent comparative effectiveness research has been leveraged worldwide and to what extent it is potential. But conceptually it sounds like a promising method for expanding the search space for health interventions beyond those motivated by monopoly profits as well as having potential for including cost and even broad social impacts of freedom, equality, and security in evaluation of therapies.