In­ter­na­tional patent rights key to en­sur­ing ac­cess to med­i­ca­tion

Baltimore Sun - - COMMENTARY - By Robert Free­man Robert A. Free­man is a pro­fes­sor of phar­macy ad­min­is­tra­tion at the Univer­sity of Mary­land East­ern Shore. His email is rafree­man@umes.edu.

AUnited Na­tions panel re­cently re­leased a series of dis­as­trous pol­icy rec­om­men­da­tions de­signed to in­crease ac­cess to medicines in de­vel­op­ing coun­tries. The panel ig­nored ob­vi­ous solutions to help the one in three peo­ple in de­vel­op­ing na­tions who lack reg­u­lar ac­cess to medicines.

Secretary Gen­eral Ban Ki-Moon originally tasked the UN High-Level Panel on Ac­cess to Medicines with rem­e­dy­ing the “pol­icy in­co­her­ence” that ex­ists be­tween in­tel­lec­tual prop­erty rights and drug ac­cess. With that focus in mind, the panel pre­dictably — and wrongly — viewed IP pro­tec­tions as a bar­rier to ac­cess, rather than a bridge to med­i­cal in­no­va­tion.

Un­der­min­ing IP rights will not help pa­tients in de­vel­op­ing coun­tries ac­cess medicines.

A 2016 Foreign Af­fairs study sought to de­ter­mine whether strong patent pro­tec­tions in­crease the prices of drugs to de­vel­op­ing coun­tries. It ex­am­ined pre­scrip­tion drug ex­pen­di­tures over a decade in 17 coun­tries with strict IP pro­tec­tions and com­pared them to a set of coun­tries that did not have strong rules in place. It found that patents were not key drivers of higher ex­pen­di­tures.

Other studies have shown that patent pro­tec­tions, in fact, play a cen­tral role in en­sur­ing that de­vel­op­ing coun­tries have ac­cess to med­i­ca­tions.

An anal­y­sis of 68 coun­tries over the pe­riod 1982-2002 found that patent pro­tec­tions, on both prod­ucts and pro­cesses, en­cour­aged more and faster launches of new treat­ments in the de­vel­op­ing world.

More re­cently, a study of 60 coun­tries from 2000-2013 dis­cov­ered that patents are vir­tu­ally es­sen­tial for ac­cess to new drugs. In the ab­sence of a patent, the launch of a new drug — even a generic one — is un­likely.

By pro­vid­ing mar­ket ex­clu­siv­ity for a lim­ited pe­riod of time, patents in­cen­tivize bio­phar­ma­ceu­ti­cal firms to in­vest in the risky cre­ation of a new drug. It takes sub­stan­tial re­sources over many years to de­velop a drug and get it to mar­ket — and the odds that a drug ac­tu­ally makes it to the shelf are low. So bio­phar­ma­ceu­ti­cal firms need to know that they’ll have a chance of mak­ing a re­turn on their huge in­vest­ment. Patents help pro­vide that con­fi­dence.

As the U.S. State Depart­ment rightly noted, “there can be no ac­cess to drugs that have not been de­vel­oped.”

Since patents have en­abled com­pa­nies to make a com­mer­cial re­turn on most prod­ucts, they have also en­abled com­pa­nies to forego re­turns on des­per­ately needed med­i­ca­tions in de­vel­op­ing coun­tries. In the 1990s, the bio­phar­ma­ceu­ti­cal in­dus­try, see­ing a se­vere need of med­i­ca­tions in the de­vel­op­ing world, formed an ini­tia­tive called the Prod­uct De­vel­op­ment Part­ner­ship. PDPs share the fi­nan­cial costs and re­search and de­vel­op­ment fail­ure risks of dis­cov­er­ing and de­vel­op­ing medicines for dis­eases that have no com­mer­cial re­turns.

These part­ner­ships are de­liv­er­ing real re­sults. In the late 1980s, coun­tries strug­gling with malaria epi­demics did not have ac­cess to arte­sunate in­jec­tion, a state-ofthe-art treat­ment used for se­vere malaria that, com­pared to in­jectable qui­nine, re­duces mor­tal­ity by 22 per­cent. But in 2010, a bio­phar­ma­ceu­ti­cal firm ini­ti­ated a PDP, known as the Medicines for Malaria Ini­tia­tive, in or­der to de­liver more than 36 mil­lion vials of arte­sunate to de­vel­op­ing coun­tries. Ac­cess to this medicine has since saved as many as 240,000 lives.

With ini­tia­tives like these, the in­dus­try has demon­strated a will­ing­ness to part­ner with poor coun­tries to solve prob­lems and make in­no­va­tive drugs more avail­able. In­stead of fo­cus­ing on patents, the United Na­tions should be in­cen­tiviz­ing PDPs like this, se­cur­ing ad­di­tional fund­ing and ex­pand­ing their scope.

Strong IP pro­tec­tions do not choke off de­vel­op­ing coun­tries’ ac­cess to medicines. What does re­duce ac­cess are chal­lenges that these de­vel­op­ing coun­tries face daily, from un­sta­ble sup­ply chains to a lack of health care pro­fes­sion­als.

The panel should have fo­cused on bal­anc­ing pub­lic health needs with the need to en­sure long-term, sus­tain­able in­no­va­tion. That be­gins by re­in­forc­ing in­tel­lec­tual prop­erty rights — not weak­en­ing them.

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