Re­searchers point to R&D treaty to spur new in­fec­tious dis­ease treat­ments

As cur­rent in­cen­tives to pro­mote the de­vel­op­ment of new in­fec­tious dis­ease treat­ments have yet to reach their po­ten­tial, re­searchers in a new Food and Drug Law Jour­nal pa­per sug­gest form­ing a re­search and de­vel­op­ment treaty.

Jonathan Dar­row

The “most far-reach­ing” pol­i­cy tool “may be a re­search and de­vel­op­ment treaty, which would pro­vide a fo­cal point for fu­ture glob­al co­or­di­na­tion, pro­vide a long-term com­mit­ment to fund­ing, and build on what has been learned from ex­ist­ing ap­proach­es,” au­thors Jonathan Dar­row, Michael Sin­ha, and Aaron Kessel­heim of the Pro­gram on Reg­u­la­tion, Ther­a­peu­tics and Law (POR­TAL), Har­vard Med­ical School and Brigham & Women’s Hos­pi­tal write.

Michael Sin­ha

The au­thors not­ed that such a treaty would be an in­ter­na­tion­al agree­ment that lever­ages a glob­al base of po­ten­tial re­sources, “but could al­so re­duce du­plica­tive ef­fort, en­sure eq­ui­table con­tri­bu­tions by na­tions that are sen­si­tive to each na­tion’s abil­i­ty to pay, and help to en­sure a sta­ble fund­ing stream over time,” they write.

The POR­TAL re­searchers al­so ex­plain how cur­rent in­cen­tives are not bear­ing the fruit that was ex­pect­ed when they were cre­at­ed, not­ing par­tic­u­lar­ly how the an­tibi­ot­ic mar­ket has not re­spond­ed to patent-based in­cen­tives.

Aaron Kessel­heim

“The pub­lic health val­ue of in­fec­tious dis­ease prod­ucts is poor­ly cor­re­lat­ed with mar­ket-based fi­nan­cial in­cen­tives be­cause of the un­usu­al dis­ease, pa­tient, prod­uct, and pub­lic health char­ac­ter­is­tics of this mar­ket,” they write. “An un­der­stand­ing of the un­usu­al char­ac­ter­is­tics of the in­fec­tious dis­ease mar­ket­place helps ex­plain why the mar­ket-based ap­proach­es im­ple­ment­ed by Con­gress have so far pro­duced on­ly mod­est re­sults.”

Such mod­est re­sults mean Con­gress may have to go back to the draw­ing board to come up with new in­cen­tives.

“Ex­ten­sions of patent or statu­to­ry ex­clu­siv­i­ties such as those found in the GAIN Act are linked to mar­ket size, not pub­lic health val­ue, and in any event of­fer dis­tant rev­enues with heav­i­ly dis­count­ed present val­ues,” the re­searchers write. “Pri­or­i­ty re­view vouch­ers cre­ate time­ly re­wards for the suc­cess­ful de­vel­op­ment of cer­tain trop­i­cal in­fec­tious dis­ease prod­ucts, but their val­ue is de-linked from the pub­lic health val­ue of the new­ly cre­at­ed in­fec­tious dis­ease prod­uct—like in­fec­tious dis­ease mar­kets them­selves.”

They al­so point to non­prof­it and pub­lic-pri­vate or­ga­ni­za­tions such as DN­Di and CARB-X as ex­am­ples of how to ac­cel­er­ate de­vel­op­ments.

The pa­per comes as FDA Com­mis­sion­er Scott Got­tlieb called for re­im­burse­ment re­forms for an­timi­cro­bial treat­ments re­cent­ly, with “a mix of mile­stone pay­ments and sub­scrip­tion fees for de­vel­op­ers of FDA-ap­proved prod­ucts with high eco­nom­ic and clin­i­cal val­ue, tar­get­ed at mul­ti-drug re­sis­tant or­gan­isms and linked to proven clin­i­cal out­comes.”


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

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Paul Hudson, Sanofi CEO (Getty Images)

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Roger Perlmutter, Merck R&D chief (YouTube)

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

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David Chang, Allogene CEO (Jeff Rumans)

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Bryan Roberts, Venrock

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