Four Steps to Transform the Pharmaceutical Industry and Survive the Pandemic


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Source: In These Times

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. Make open sci­ence the law of the land

2. Cre­ate a ​pub­lic option” for phar­ma­ceu­ti­cal R&D and manufacturing

3. Embrace and expand com­pul­so­ry licens­ing of intel­lec­tu­al property

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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