Local and regional manufacturing

Definition

Local and regional man­u­fac­tur­ing broadly refers to the man­u­fac­ture of health prod­ucts at the local or regional lev­els, par­tic­u­larly in low- and mid­dle-income coun­tries. Health prod­ucts encom­pass a wide range of health prod­ucts includ­ing small-mol­e­cule drugs, bio­log­ics, vac­cines, diag­nos­tics, and cell- and gene-ther­a­pies. Enhanc­ing local and regional man­u­fac­tur­ing capac­ity is increas­ingly being rec­og­nized as nec­es­sary to ensure equi­table access to health prod­ucts. Enhanc­ing local and regional man­u­fac­tur­ing can also increase health sys­tem resilience and reduce depen­dence from for­eign indus­try and polit­i­cal pow­ers. Local capa­bil­i­ties can be enhanced with inter­ven­tions that include pub­lic, pri­vate, and phil­an­thropic man­u­fac­tur­ers.

Strength­en­ing the capac­ity to man­u­fac­ture health prod­ucts locally or region­ally often requires build­ing phys­i­cal infra­struc­tures, increas­ing tech­ni­cal skills, improv­ing reg­u­la­tory envi­ron­ments, pub­lic pro­cure­ment, non-exclu­sive intel­lec­tual prop­erty licens­ing, and open shar­ing of knowl­edge. The occur­rence of these types of inter­ven­tions is dri­ven by legal and pol­icy frame­works, as well as polit­i­cal will for instance to increase domes­tic invest­ments and other national efforts. Long term and sus­tain­able local and regional man­u­fac­tur­ing capa­bil­ity can be cre­ated by strength­en­ing research and devel­op­ment capa­bil­i­ties.

Sev­eral ini­tia­tives are under­way to strengthen local and regional capac­i­ties to man­u­fac­ture health prod­ucts, many of them moti­vated by global inequitable dis­tri­bu­tion dur­ing the COVID-19 pan­demic. As reflected in the Lan­guage Com­pendium, sev­eral inter­na­tional prece­dents have called for sup­port to these and other ini­tia­tives to strengthen local and regional man­u­fac­tur­ing.

Precedents

2022 Resolution on elevating pandemic prevention, preparedness and response to the highest level of political leadership

• “Rec­og­niz­ing the need to sup­port devel­op­ing coun­tries in build­ing exper­tise and in devel­op­ing local and regional man­u­fac­tur­ing capac­i­ties for tools, includ­ing by build­ing on efforts under the COVID-19 Vac­cine Global Access (COVAX) Facil­ity, with a view to devel­op­ing improved global, regional and local man­u­fac­tur­ing, han­dling and dis­tri­bu­tion capac­i­ties while fur­ther enabling the increased use of health tech­nolo­gies and the dig­i­tal trans­for­ma­tion of health sys­tems” (p. 3)

• “Empha­siz­ing the need to improve access to qual­ity, safe, effec­tive and afford­able vac­cines, ther­a­peu­tics, diag­nos­tics and other health tech­nolo­gies, inter alia, through build­ing capac­ity for local and regional pro­duc­tion, espe­cially in low- and mid­dle-income coun­tries, tech­nol­ogy trans­fer on mutu­ally agreed terms, coop­er­a­tion with, sup­port to and the devel­op­ment of vol­un­tary patent pools and other vol­un­tary ini­tia­tives, such as the World Health Orga­ni­za­tion COVID-19 Tech­nol­ogy Access Pool and the Med­i­cines Patent Pool, and pro­mot­ing generic com­pe­ti­tion in line with the World Health Orga­ni­za­tion road map for access to med­i­cines, vac­cines and other health prod­ucts, 2019–2023” (p. 4)

• “Calls upon Mem­ber States to pro­mote the trans­fer of tech­nol­ogy and know-how and encour­age research, inno­va­tion and com­mit­ments to vol­un­tary licens­ing, where pos­si­ble, in agree­ments where pub­lic fund­ing has been invested in research and devel­op­ment for pan­demic pre­ven­tion, pre­pared­ness and response, to strengthen local and regional capac­i­ties for the man­u­fac­tur­ing, reg­u­la­tion and pro­cure­ment of needed tools for equi­table and effec­tive access to vac­cines, ther­a­peu­tics, diag­nos­tics and essen­tial sup­plies, as well as for clin­i­cal tri­als, and to increase global sup­ply through facil­i­tat­ing trans­fer of tech­nol­ogy within the frame­work of rel­e­vant mul­ti­lat­eral agree­ments” (p. 6)

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

• “Seri­ously con­cerned also that the sup­ply of health prod­ucts and tech­nolo­gies is depen­dent on man­u­fac­tur­ing facil­i­ties con­cen­trated in few coun­tries and that the lack of ade­quate infra­struc­ture and logis­tics exper­tise to store, dis­trib­ute and deliver diag­nos­tics, med­i­cines, vac­cines and other health prod­ucts and tech­nolo­gies, par­tic­u­larly in devel­op­ing coun­tries, among other fac­tors, ham­pers efforts to achieve diag­no­sis, treat­ment and vac­ci­na­tion tar­gets for sev­eral dis­eases, at the right time, safely and effi­ciently, espe­cially in the con­text of health emer­gen­cies” (p. 4)

• “Deeply con­cerned about the loss of lives and liveli­hoods and the dis­rup­tion to economies and soci­eties caused by the COVID-19 pan­demic, and its neg­a­tive impact on the enjoy­ment of human rights around the world, par­tic­u­larly for women and girls, and rec­og­niz­ing that the COVID-19 pan­demic has high­lighted the crit­i­cal need to pre­vent and pre­pare for poten­tial dis­rup­tions of the sup­ply chain for essen­tial med­i­cines and other health tech­nolo­gies, includ­ing through the strength­en­ing of local pro­duc­tion, and there­fore wel­com­ing res­o­lu­tion WHA74.6 of 31 May 2021, adopted by the World Health Assem­bly at its sev­enty-fourth ses­sion, on strength­en­ing local pro­duc­tion of med­i­cines and other health tech­nolo­gies to improve access” (p. 5)

• “

  Urges States and all rel­e­vant stake­hold­ers, in order to ensure timely, equi­table and unhin­dered access for all per­sons to safe, afford­able, effec­tive and qual­ity med­i­cines, vac­cines, diag­nos­tics and ther­a­peu­tics, and other health prod­ucts and tech­nolo­gies with a view to advanc­ing the real­iza­tion of the Sus­tain­able Devel­op­ment Goals:

  (a) To pro­mote research and capac­ity-build­ing ini­tia­tives, and to enhance inter­na­tional coop­er­a­tion on and access to sci­ence, inno­va­tion, tech­nolo­gies, tech­ni­cal assis­tance and knowl­edge-shar­ing, includ­ing by pool­ing ini­tia­tives, while appre­ci­at­ing the sub­stan­tive efforts many States have already made to this end;

  (b) To take all mea­sures nec­es­sary to strengthen regional and local pro­duc­tion, by pro­mot­ing inno­v­a­tive modal­i­ties of global part­ner­ships and tech­nol­ogy trans­fers, on mutu­ally agreed terms, and to facil­i­tate trade in med­i­cines, vac­cines and other health prod­ucts;

  (c) To share data and results in accor­dance with inter­na­tion­ally agreed prin­ci­ples, includ­ing shar­ing of pathogens, sam­ples and genetic sequenc­ing data, and ensure the fair and equi­table shar­ing of ben­e­fits that arise from their uti­liza­tion, in accor­dance with inter­na­tional access and ben­e­fit-shar­ing instru­ments;

  (d) To pro­mote the trans­fer of tech­nol­ogy and know-how on mutu­ally agreed terms, and to encour­age research, inno­va­tion and com­mit­ment, where pos­si­ble, to vol­un­tary licens­ing in all agree­ments in which pub­lic fund­ing has been invested in research and devel­op­ment;

  (e) To assist in efforts to build capac­ity through train­ing and finan­cial sup­port for devel­op­ing coun­tries to pro­duce health tech­nolo­gies, includ­ing mRNA vac­cine tech­nol­ogy;

  (f) To explore ways to pro­mote equi­table access and fair dis­tri­bu­tion of health prod­ucts, includ­ing the pos­si­ble estab­lish­ment of a global end-to-end plat­form;

  (g) To advance the health and care work­force invest­ment agenda, with a spe­cial focus on the pri­mary health-care work­force and employ­ment of women at all lev­els;

  (h) To take mea­sures to ensure acces­si­ble and afford­able access to health-care sys­tems for per­sons with dis­abil­i­ties;

  ” (p. 7)

2021 Resolution on science, technology and innovation for sustainable development

• “Also encour­ages Mem­ber States to pro­mote local inno­va­tion capa­bil­i­ties for inclu­sive and sus­tain­able eco­nomic devel­op­ment by bring­ing together local sci­en­tific, voca­tional and engi­neer­ing knowl­edge, mobi­liz­ing resources from mul­ti­ple chan­nels, improv­ing infor­ma­tion and com­mu­ni­ca­tions tech­nol­ogy and sup­port­ing infra­struc­ture devel­op­ment” (p. 7)

2020 Resolution on comprehensive and coordinated response to the coronavirus disease (COVID-19) pandemic

• “Calls upon Mem­ber States and all rel­e­vant stake­hold­ers to pro­mote research and capac­ity-build­ing ini­tia­tives, as well as to enhance coop­er­a­tion on and access to sci­ence, inno­va­tion, tech­nolo­gies, tech­ni­cal assis­tance and knowl­edge- shar­ing, includ­ing through improved coor­di­na­tion among exist­ing mech­a­nisms, espe­cially with devel­op­ing coun­tries, in a col­lab­o­ra­tive, coor­di­nated and trans­par­ent man­ner and on mutu­ally agreed terms in response to the COVID-19 pan­demic and towards advanc­ing the Sus­tain­able Devel­op­ment Goals” (p. 11)