Pharmaceutical transparency

Definition

Phar­ma­ceu­ti­cal trans­parency broadly refers to the pub­lic avail­abil­ity and pub­lic report­ing of infor­ma­tion gen­er­ally relat­ing to the mar­kets for med­i­cines, vac­cines and other health prod­ucts across the whole value chain. This includes increas­ing trans­parency on the actual costs of clin­i­cal tri­als, which is often kept secret and invoked by prod­uct devel­op­ers and other indus­try actors to make gen­er­ally unproven claims about research and devel­op­ment costs. Prod­uct devel­op­ers and other indus­try actors often then cite those unproven claims about research and devel­op­ment costs to jus­tify high prices of health tech­nolo­gies. Phar­ma­ceu­ti­cal trans­parency also includes the need to increase pub­licly avail­able infor­ma­tion about the prices paid by pri­vate enti­ties and pub­lic pro­cure­ment agen­cies to acquire health tech­nolo­gies. Lack of patent sta­tus trans­parency can pre­vent or delay sev­eral types of pol­icy inter­ven­tions to facil­i­tate equi­table access to health tech­nolo­gies, such as com­pul­sory licens­ing. Phar­ma­ceu­ti­cal trans­parency there­fore fur­ther includes the need for increas­ing pub­licly avail­able and reported infor­ma­tion about patent sta­tus.

States are increas­ingly rec­og­niz­ing the impor­tance of improv­ing trans­parency in the mar­ket for med­i­cines, vac­cines, and other types of health prod­ucts. This increas­ing recog­ni­tion led to the 2019 WHA Res­o­lu­tion on improv­ing the trans­parency of mar­kets for med­i­cines, vac­cines, and other health prod­ucts, avail­able in the Lan­guage Com­pendium. Fur­ther com­mit­ments to increase trans­parency in the mar­ket for vac­cines, med­i­cines, and other tech­nolo­gies should include man­dates to dis­close per patient costs of clin­i­cal tri­als, regard­less of out­comes.

Precedents

2022 HRC Res­o­lu­tion on access to medicines, vaccines and other health products

• “Reaf­firm­ing the impor­tance of improv­ing the trans­parency of mar­kets, costs and sup­ply chains for med­i­cines, vac­cines and other health prod­ucts across the whole value chain, and tak­ing into con­sid­er­a­tion res­o­lu­tion WHA72.8 of 28 May 2019, adopted by the World Health Assem­bly at its sev­enty-sec­ond ses­sion” (p. 3)

2022 HRC Res­o­lu­tion on ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to the coronavirus disease (COVID-19) pandemic

• “Stress­ing the impor­tance of improv­ing the trans­parency of mar­kets for med­i­cines, vac­cines and other health prod­ucts across the whole value chain, and tak­ing note of World Health Assem­bly res­o­lu­tion WHA72.8 of 28 May 2019” (p. 4)

• “Requests all States, inter­na­tional orga­ni­za­tions and rel­e­vant stake­hold­ers to com­mit to trans­parency in all mat­ters relat­ing to the pro­duc­tion, dis­tri­bu­tion and fair pric­ing of vac­cines, in accor­dance with national and regional legal frame­works, and urges States to take imme­di­ate steps to pre­vent spec­u­la­tion and undue export con­trols and stock­pil­ing that may hin­der afford­able, timely, equi­table and uni­ver­sal access for all coun­tries to COVID-19 vac­cines” (p. 6)

2021 HRC Res­o­lu­tion on ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to COVID-19

• “Stress­ing the impor­tance of improv­ing the trans­parency of mar­kets for med­i­cines, vac­cines and other health prod­ucts across the whole value chain, and tak­ing note of World Health Assem­bly res­o­lu­tion WHA72.8 of 28 May 2019” (p. 2)

• “Requests all States, inter­na­tional orga­ni­za­tions and rel­e­vant stake­hold­ers to com­mit to trans­parency in all mat­ters relat­ing to the pro­duc­tion, dis­tri­bu­tion and fair pric­ing of vac­cines, in accor­dance with national and regional legal frame­works, and urges States to take imme­di­ate steps to pre­vent spec­u­la­tion and undue export con­trols and stock­pil­ing that may hin­der afford­able, timely, equi­table and uni­ver­sal access for all coun­tries to COVID-19 vac­cines” (p. 5)

2019 WHA Resolution on improving the transparency of markets for medicines, vaccines, and other health products

• “Not­ing the impor­tance of both pub­lic- and pri­vate-sec­tor fund­ing for research and devel­op­ment of health prod­ucts, and seek­ing to improve the trans­parency of such fund­ing across the value chain” (p. 2)

• “Seek­ing to pro­gres­sively enhance the pub­licly avail­able infor­ma­tion on inputs across the value chain of health prod­ucts, the pub­lic report­ing of the rel­e­vant patents and their sta­tus, and the avail­abil­ity of infor­ma­tion on the patents land­scape cov­er­ing a par­tic­u­lar health prod­uct as well as its mar­ket­ing approval sta­tus” (p. 2)

• “1. URGES Mem­ber States in accor­dance with their national and regional legal frame­works and con­texts:
  (1) to take appro­pri­ate mea­sures to pub­licly share infor­ma­tion on the net prices2 of health prod­ucts;
  (2) to take the nec­es­sary steps, as appro­pri­ate, to sup­port dis­sem­i­na­tion and enhanced avail­abil­ity of, and access to, aggre­gated results data and, if already pub­licly avail­able or vol­un­tar­ily pro­vided, costs from human sub­ject clin­i­cal tri­als regard­less of out­comes or whether the results will sup­port an appli­ca­tion for mar­ket­ing approval, while ensur­ing patient con­fi­den­tial­ity;
  (3) to work col­lab­o­ra­tively to improve the report­ing of infor­ma­tion by sup­pli­ers on reg­is­tered health prod­ucts, such as reports on sales rev­enues, prices, units sold, mar­ket­ing costs, and sub­si­dies and incen­tives;
  (4) to facil­i­tate improved pub­lic report­ing of patent sta­tus infor­ma­tion and the mar­ket­ing approval sta­tus of health prod­ucts;
  (5) to improve national capac­i­ties, includ­ing through inter­na­tional coop­er­a­tion and open and col­lab­o­ra­tive research and devel­op­ment and pro­duc­tion of health prod­ucts, espe­cially in devel­op­ing coun­tries and low- and mid­dle-income coun­tries (LMICs), includ­ing health prod­ucts for the dis­eases that pri­mar­ily affect them, as well as for prod­uct selec­tion, cost-effec­tive pro­cure­ment, qual­ity assur­ance, and sup­ply chain man­age­ment” (p. 2)

2019 HRC Resolution on access to medicines and vaccines

• “Reaf­firm­ing the impor­tance of improv­ing the trans­parency of mar­kets for med­i­cines, vac­cines and other health prod­ucts across the whole value chain, and tak­ing into con­sid­er­a­tion res­o­lu­tion WHA72.8 adopted by the World Health Assem­bly at its sev­enty-sec­ond ses­sion” (p. 2)