As I noted last week, the Wayback Machine has come to the rescue on the articles that appeared in the first edition of my Concise Encyclopedia of Economics. I’ve read rumors, though, that we can’t depend on its being around forever.I Blog to Differ is a reader-supported publication.
“Ironically, the publicity generated by pictures of deformed newborns in Europe led Congress to amend the U.S. drug laws to add an efficacy requirement to the existing safety rules, even though the problem with thalidomide was safety, not efficacy.”
Bring back 1961!
I had not ever quite grokked why a thalidomide safety issue should require efficacy testing. The above at least explains in this specific case exactly why “Just don’t do something - stand there!”, something never in the lexicon of leftist nor most modern politicians, period - wasn’t considered here.
Let the FDA decide efficacy for deciding whether a drug is covered by Medicare or Medicaid. Or Obamacare. It should not be determining efficacy for whether or not the drug is allowed on the market.
I bet the drug companies would be delighted to take a deal where the FDA didn’t decide efficacy and patent lengths were reduced.
I guess I'll repost my idea for a reformed patent system. This is from years of trying to come up with something I could tolerate (I detest intellectual property) and about all I will brag about is, I think it's better than what we have, but still not good.
* The inventor publishes the patent and a royalty schedule and starts production.
* Anyone can start their own production per the published royalty schedule.
* The time to first copycat establishes the patent term by some multiplier.
* Patents not reproduced within a year expire.
The incentives seem right:
* The inventor wants copies to enable the full patent term. A muddled or secretive patent will expire before anyone can reproduce it.
* A trivially obvious patent "to those skilled in the arts" will be reproduced too quickly for meaningful royalties.
* Copycats balance delay to expire the patent against fast reproduction to reduce the patent term and beat other copycats to market.
* Stalling copycats have less to fear from other copycats because they are ready to go into production themselves.
* The royalty schedule must be realistic to encourage copycats.
There are two constants to set -- the expiration interval for the first reproduction, and the multiplier for patent duration.
* If expiration is too soon, copycats will just wait it out; it must be long enough for the inventor to gain initial market share.
* If the expiration is too long, patent revelations will be locked up long enough to delay "the progress of science".
* The shorter the multiplier, the less incentive inventors have to publish patents.
* The longer the multiplier, the less incentive inventors have to keep inventing.
These could possibly be set per patent by inventors not to exceed government limits. Unfortunately, as with everything related to intellectual property and government, corruption has every incentive to lengthen the expiration period and multiplier, with no counterbalancing incentives to shorten either.
Consider two inventions, one easy, one hard.
* Steel mills have researchers constantly trying new combinations of ingredients to make harder, tougher, lighter, cheaper steels, and that turnaround is only a few days. First copycat will appear in a week, competitors will delay mass production to avoid royalties, and the invention will have too short a lifespan to be worth patenting.
* Someone modifies elephant genes to produce replaceable tusks like antlers, but what with gestation and maturation, it takes 10 years for the first tusks to fall off, and subsequent tusks fall off every year. That's 11 years for the first copycat, during which the inventor already has hundreds of elephants producing tusks.
I found this article to be a sad example (maybe the saddest because we’re talking about life or death treatments) of the evils of the regulatory state.
If there’s a worse case of our government strangling medical breakthroughs (or for that matter any life improving developments) I would like to read about them.
Supplements are freely available without any efficacy requirements, and not even safety.
Only thing is that insurance does not pay for them.
AZT CAUSED (symptoms identical to) AIDS in healthy people. The symptoms include death.
“Ironically, the publicity generated by pictures of deformed newborns in Europe led Congress to amend the U.S. drug laws to add an efficacy requirement to the existing safety rules, even though the problem with thalidomide was safety, not efficacy.”
Bring back 1961!
I had not ever quite grokked why a thalidomide safety issue should require efficacy testing. The above at least explains in this specific case exactly why “Just don’t do something - stand there!”, something never in the lexicon of leftist nor most modern politicians, period - wasn’t considered here.
Let the FDA decide efficacy for deciding whether a drug is covered by Medicare or Medicaid. Or Obamacare. It should not be determining efficacy for whether or not the drug is allowed on the market.
I bet the drug companies would be delighted to take a deal where the FDA didn’t decide efficacy and patent lengths were reduced.
I guess I'll repost my idea for a reformed patent system. This is from years of trying to come up with something I could tolerate (I detest intellectual property) and about all I will brag about is, I think it's better than what we have, but still not good.
* The inventor publishes the patent and a royalty schedule and starts production.
* Anyone can start their own production per the published royalty schedule.
* The time to first copycat establishes the patent term by some multiplier.
* Patents not reproduced within a year expire.
The incentives seem right:
* The inventor wants copies to enable the full patent term. A muddled or secretive patent will expire before anyone can reproduce it.
* A trivially obvious patent "to those skilled in the arts" will be reproduced too quickly for meaningful royalties.
* Copycats balance delay to expire the patent against fast reproduction to reduce the patent term and beat other copycats to market.
* Stalling copycats have less to fear from other copycats because they are ready to go into production themselves.
* The royalty schedule must be realistic to encourage copycats.
There are two constants to set -- the expiration interval for the first reproduction, and the multiplier for patent duration.
* If expiration is too soon, copycats will just wait it out; it must be long enough for the inventor to gain initial market share.
* If the expiration is too long, patent revelations will be locked up long enough to delay "the progress of science".
* The shorter the multiplier, the less incentive inventors have to publish patents.
* The longer the multiplier, the less incentive inventors have to keep inventing.
These could possibly be set per patent by inventors not to exceed government limits. Unfortunately, as with everything related to intellectual property and government, corruption has every incentive to lengthen the expiration period and multiplier, with no counterbalancing incentives to shorten either.
Consider two inventions, one easy, one hard.
* Steel mills have researchers constantly trying new combinations of ingredients to make harder, tougher, lighter, cheaper steels, and that turnaround is only a few days. First copycat will appear in a week, competitors will delay mass production to avoid royalties, and the invention will have too short a lifespan to be worth patenting.
* Someone modifies elephant genes to produce replaceable tusks like antlers, but what with gestation and maturation, it takes 10 years for the first tusks to fall off, and subsequent tusks fall off every year. That's 11 years for the first copycat, during which the inventor already has hundreds of elephants producing tusks.
Both have the right incentives.
I found this article to be a sad example (maybe the saddest because we’re talking about life or death treatments) of the evils of the regulatory state.
If there’s a worse case of our government strangling medical breakthroughs (or for that matter any life improving developments) I would like to read about them.
It certainly is a contender.