"no-one owns the patent for spinach, so the FDA can't find a target to force to pay for the studies"

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#1

Title excerpted from a comment thread about The Nutrition Gap: Are Doctors Ready to Think Outside the Pillbox? The comment nicely illustrates the strong connection between a particular (U.S.) safety/efficacy regulatory regime and patents. Decoupling them would bring many benefits, including:

  1. Reduce various corruptions of testing. The party funding the testing would not be motivated to find a result other than the truth, nor could anyone strategically withhold cheaper alternatives from testing.
  2. Reduce the rationale for subjecting medicine to patents (testing/approval a large part of high investment that needs to be recouped in order to be made by for-profit entities) which exacerbate various access to medicine and wealth inequality issues.
  3. 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.

The “nutrition gap” article concerns one of the third point, in this case dietary therapies. Excerpt:

Leaps in technology and research have made it possible to understand how food influences our epigenetics, our microbiomes, and our metabolomes. And yet, many of the diseases that have pushed our country into a health-care crisis—obesity, diabetes, inflammatory disorders—continue to be treated and monopolized by expensive pharmaceuticals, while patients are increasingly adopting tools to measure the parameters of their own health. Our society is burdened by the cost of drugs and is ready, culturally, to look into the benefits of dietary change as a preventative or even a therapeutic approach. But are we doctors ready to think outside the pillbox? If not, the nutrition gap won’t close anytime soon.

Note “monopolized” above seems to refer to the hold of drugs on medicine as the preferred intervention, not the monopolies held on specific drugs by phrama companies due to patents. Of course there is a connection. The latter is somewhat implicit in “expensive pharmaceuticals”.

Sometimes, perhaps usually, “alternative” therapies are worse than the currently best drug intervention. I wonder how price sensitive the choice between drug and non-drug therapies is: do off-patent and thus cheaper drugs help people avoid poor alternative therapies?

But the main point of this post is to point out the coupling of safety/efficacy regulation and patents, and the need for decoupling. I know there is a literature on exactly this, happy to receive pointers on the best pieces to read first.

I’m also very keen to understand the most promising paths toward that decoupling, and whether any directly commons-favoring policy could play a role. Personalized/precision medicine would seem to demand a change in regulation toward more incremental testing, away from huge (and high investment, high corruption) testing. Could more incremental testing be blessed by regulators on the condition of no patents, and funding made available for such testing?


Opening Lincoln Labs' "Lobbying for the Future"
Fix the knowledge economy, not patents (re The Economist 1851 and 2015)
IP harmonization is bad for IP science
Comparative effectiveness research