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Date: 2024-09-27 Page is: DBtxt003.php txt00019528

US Health Sector
Need for Reform

Four Steps to Transform the Pharmaceutical Industry and Survive the Pandemic ... Dealing with the Covid crisis will require taking the profit motive out of our health systems. Here’s how.

Burgess COMMENTARY
I agree with the core ideas described in this essay. Similar ideas have been around for years, and it is good that they are being written about. The challenge is for them to be implemented. The question is how to manage desirable change? Academics and the intellectual community are very good at what they do ... but when it comes to management of change, they are amateurs.
Peter Drucker, the famous management guru, observed many years ago that 'you manage what you measure', and for the past many decades we have measured profit performance very rigorously. Management to maximize profit has been sophisticated and powerful and successful. Not much else has been measured so thoroughly, though GDP growth and stock market prices are followed quite closely, in large part because they have important linkages with profit ... GDP growth makes it easier to generate profit, and stock markets respond to profit performance and result in more or less wealth.
We need to measure what really matters over and beyond profit and financial wealth ... that is economic progress and performance. We need to measure social and environmental progress and performance. We need to have easy meaningful metrics that measure quality of life (social capital) and also the complex vital environmental elements.
Investors and entrepreneurs have ignored social and environment issues (important externalities) for generations ... and to a large extent still do.
Management accounting has done a good job helping to improve profit performance. What is needed now is the 21st century version of management accountancy that will address everything that is important for a sustainable world ... easy, ubiquitous and fit-for-purpose for the 21st century.
This would be disruption that really would matter.
Best ... Peter Burgess
http://truevaluemetrics.org
Peter Burgess
Four Steps to Transform the Pharmaceutical Industry and Survive the Pandemic

Dealing with the Covid crisis will require taking the profit motive out of our health systems. Here’s how.


(PHOTO BY JOHN MOORE/GETTY IMAGES)

https://inthesetimes.com/article/pharmaceutical-industry-pandemic-covid-vaccine

Even as the Covid-19 pan­dem­ic expos­es deep struc­tur­al prob­lems with­in America’s health­care sys­tem, unprece­dent­ed efforts by many of the sci­en­tists respond­ing to the cri­sis also point the way for­ward. They are think­ing and work­ing dif­fer­ent­ly, shar­ing knowl­edge, col­lab­o­rat­ing across nation­al bound­aries, and focus­ing on deliv­er­ing life-sav­ing vac­cines and cures to all.

It is time for U.S. law and pol­i­cy to catch up. In a recent state­ment signed by more than 150 lead­ers of civ­il soci­ety groups, health­care providers, and experts on law, pol­i­cy and pub­lic health, we lay out four steps our coun­try should take to do just that:
  1. 1. Make open science the law of the land
  2. 2. Create a ​“public option” for pharmaceutical R&D and manufacturing
  3. 3. Embrace and expand compulsory licensing of intellectual property
  4. 4. Take vaccine development under public control
Covid-19 calls us to rethink a phar­ma­ceu­ti­cal sec­tor that has become an increas­ing­ly effi­cient wealth extrac­tion machine. The sec­tor takes in bil­lions of dol­lars in pub­lic funds for research and hoards the results for pri­vate gain. Drug com­pa­nies pro­duce hun­dreds of bil­lions in prof­its for their exec­u­tives and share­hold­ers by forc­ing Amer­i­cans to pay the world’s high­est drug prices — often with dead­ly con­se­quences. The sec­tor restricts access to med­i­cines — and infor­ma­tion on their true risks and ben­e­fits — through a com­plex web of intel­lec­tu­al prop­er­ty pro­tec­tions. All the while, clin­i­cal­ly mean­ing­ful inno­va­tion has been on the decline for decades.

Big Phar­ma com­pa­nies have dou­bled down on this play­book dur­ing the cri­sis, adding $51 bil­lion to their mar­ket val­ue dur­ing the pan­dem­ic as of the end of June, while extract­ing bil­lions in new pub­lic spend­ing. Price hikes on a myr­i­ad of drugs have con­tin­ued dur­ing the pan­dem­ic, includ­ing on dozens of drugs used in Covid-19 treat­ment. Mar­ket con­sol­i­da­tion and sin­gle-sourc­ing prac­tices that have con­tributed to wide­spread short­ages in essen­tial med­i­cines for years now affect drugs crit­i­cal to treat­ing the virus.

This real­i­ty is what dri­ves our call for the long-term trans­for­ma­tion of the phar­ma­ceu­ti­cal sec­tor from one cen­tered on pri­vate prof­it to one cen­tered on pub­lic health and the pub­lic good. Our pro­pos­al explains how.

First, cod­i­fy open sci­ence prac­tices that accel­er­ate inno­va­tion, reduce costs and strength­en the evi­dence base on which our med­i­cines sys­tem rests. We must change our laws to pre­vent drug com­pa­nies from keep­ing secret for years or decades valu­able med­ical data, such as clin­i­cal tri­al results and man­u­fac­tur­ing details — some­times with the coop­er­a­tion of gov­ern­ment agen­cies. Instead, our laws should encour­age — even require — broad, ready, equi­table access to sci­en­tif­ic knowl­edge across a drug’s entire life­cy­cle, from test tube to pharmacy.

Sec­ond, cre­ate pub­lic sec­tor capac­i­ty for full-cycle phar­ma­ceu­ti­cal inno­va­tion and pro­duc­tion of essen­tial med­i­cines: a ​“pub­lic option” for end-to-end dis­cov­ery, devel­op­ment and man­u­fac­tur­ing. Unlike for-prof­it drug com­pa­nies, a pub­lic med­i­cines agency would focus where the med­ical need is great­est. Pub­lic phar­ma would also cre­ate addi­tion­al man­u­fac­tur­ing capac­i­ty, com­bat­ing short­ages. We know this works: Sci­en­tists at U.S. gov­ern­ment lab­o­ra­to­ries invent­ed HIV pre­ven­tion ther­a­py (“HIV PrEP”), and the non­prof­it Drugs for Neglect­ed Dis­eases Ini­tia­tive has shep­herd­ed numer­ous drugs through clin­i­cal tri­als to patients.

Third, use the full pow­er of com­pul­so­ry licens­ing to ensure access to essen­tial med­i­cines. Intel­lec­tu­al prop­er­ty rights are often the only bar­ri­er to gener­ic com­pe­ti­tion, which low­ers prices (some­times by 95% or more) and expands sup­ply. The U.S. gov­ern­ment already has the legal author­i­ty — which it used as recent­ly as the 1970s—to issue com­pul­so­ry patent licens­es to accel­er­ate gener­ic com­pe­ti­tion. But in recent years it has lost the will to do so, even in the face of sky­rock­et­ing prices and recur­ring short­ages. The U.S. gov­ern­ment should not only use, but expand, com­pul­so­ry licens­ing beyond patents to trade-secret man­u­fac­tur­ing infor­ma­tion and reg­u­la­to­ry exclusivities.

Fourth, take the vac­cine indus­try into pub­lic own­er­ship to assure its prod­ucts are avail­able to all. The vac­cine indus­try is per­haps the stark­est exam­ple of the fail­ure of our cur­rent sys­tem. Until the Covid-19 pan­dem­ic hit, Big Phar­ma had most­ly aban­doned vac­cine devel­op­ment despite bil­lions of pub­lic dol­lars spent on incen­tives. High-pro­file suc­cess­es like the Ebo­la vac­cine in 2019 were fund­ed, dri­ven, and led by gov­ern­ment research agen­cies. By mak­ing vac­cines ful­ly pub­lic, either patent-free or freely and afford­ably licensed through a glob­al pool, we can prop­er­ly rec­og­nize that vac­cines are a pub­lic good, not a prof­it center.

To survive this pan­dem­ic, pre­pare for the next one, and final­ly solve the innu­mer­able every­day health prob­lems that Amer­i­cans face — from find­ing EpiPens to pay­ing for insulin—the pub­lic must reclaim con­trol over a phar­ma­ceu­ti­cal sys­tem that puts private profit above all else. We must find the will to reori­ent it around pub­lic health and pub­lic good.

Dana Brown is direc­tor of The Next System Project at The Democracy Collaborative. Christo­pher Morten is the clin­i­cal teach­ing fel­low and super­vis­ing attor­ney in the Tech­nol­o­gy Law and Pol­i­cy Clin­ic at the New York Uni­ver­si­ty School of Law.

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