The global se­cu­rity threat of an­timi­cro­bial re­sis­tance

Financial Mirror (Cyprus) - - FRONT PAGE -

To­day we are faced with the harsh re­al­ity that the treat­ment or preven­tion of in­fec­tious dis­eases has not made quan­tum ad­vances since the early suc­cesses of vac­cines and an­timi­cro­bial ther­a­pies. In a sense, the world is headed back­ward, as once-treat­able mi­crobes be­come re­sis­tant to ex­ist­ing ther­a­pies, and new in­fec­tions for which there are no ef­fec­tive in­ter­ven­tions con­tinue to arise.

The sit­u­a­tion rep­re­sents a se­ri­ous and im­mi­nent threat to the world. Wit­ness the global im­pact of the 2014 Ebola cri­sis in West Africa or the 2003 SARS out­break, which jeop­ar­dised even wealthy economies like Sin­ga­pore and Canada.

The emer­gence of a highly lethal and rapidly spread­ing an­timi­cro­bial-re­sis­tant in­fec­tion would lead to untold num­bers of deaths and unimag­in­able mis­ery. The con­se­quences could be sim­i­lar in mag­ni­tude to a large-scale ter­ror­ist at­tack. Com­mu­ni­ties could be walled off, na­tional bor­ders closed, and travel could be re­stricted or even sus­pended. Health sys­tems could dis­in­te­grate or col­lapse, as could economies.

The pos­si­bil­ity of such an apoc­a­lyp­tic sce­nario sug­gests that the threat of in­fec­tious dis­eases – ei­ther from mi­crobes that de­velop re­sis­tance to ex­ist­ing ther­a­pies or new mi­crobes that emerge – is among the most im­por­tant chal­lenges that hu­mankind faces. It is not just a pub­lic health risk; it is a threat to na­tional and global se­cu­rity. Thus, it must be met with a com­pre­hen­sive and ef­fec­tive so­lu­tion.

The re­search and devel­op­ment re­quired to pro­duce new medicines or vac­cines is time­con­sum­ing, of­ten tak­ing more than a dozen years. It is also very ex­pen­sive, cost­ing hun­dreds of mil­lions of dol­lars for ev­ery new prod­uct. More­over, there is no guar­an­tee of suc­cess; in­deed, for each suc­cess­ful prod­uct, there are as many as nine equally promis­ing can­di­dates that fail.

Given the risks in­volved, it is not sur­pris­ing that phar­ma­ceu­ti­cal com­pa­nies are very care­ful in their choice of in­vest­ments in new drug or vac­cine pro­grammes, se­lect­ing only those that prom­ise fi­nan­cial gains suf­fi­cient to cover the costs of both suc­cesses and fail­ures and pro­vide a rea­son­able re­turn on the re­quired in­vest­ment.

Many ideas have emerged to ad­dress this in­vest­ment prob­lem, such as of­fer­ing prizes for suc­cess­ful prod­ucts, cre­at­ing new in­cen­tives for in­dus­try in­vest­ments, and es­tab­lish­ing novel fund­ing mech­a­nisms to sup­port re­search to ad­dress emerg­ing in­fec­tious threats. All have merit and would have some im­pact, but they would lead to in­cre­men­tal ad­vances at best. A more am­bi­tious so­lu­tion is needed.

Al­most ev­ery coun­try is pre­pared to chan­nel a large per­cent­age of its GDP to­ward in­vest­ments in na­tional de­fense or se­cu­rity. The global threat of emerg­ing or re­sis­tant in­fec­tions must be viewed first and fore­most in that con­text, with all coun­tries com­mit­ted to pro­vid­ing fi­nanc­ing, in­tel­lec­tual cap­i­tal, and avail­able re­sources to sup­port the dis­cov­ery, devel­op­ment, man­u­fac­ture, stock­pil­ing, and eq­ui­table dis­tri­bu­tion of new an­timi­cro­bial agents and vac­cines.

Unless coun­tries recog­nise the risks they face, they are un­likely to make such a com­mit­ment. It might help to in­form them that the es­ti­mated cost of emerg­ing global in­fec­tious threats is $60 bil­lion per year; if in­vest­ments are made up­front, the to­tal costs could be much smaller.

Coun­try in­vest­ments should be pooled to cre­ate a sub­stan­tial pipe­line of prod­ucts to com­bat in­fec­tious threats. There are many ways this could be done. The eas­i­est would be to spread the money around to sci­en­tists in academia, prod­uct-devel­op­ment part­ner­ships, biotech firms, and larger phar­ma­ceu­ti­cal com­pa­nies as op­por­tu­ni­ties arise. This might al­low ex­ist­ing pro­cesses to move for­ward with new mo­men­tum based on the avail­abil­ity of new funds. Un­for­tu­nately, his­tory sug­gests that this wouldn’t lead to much progress be­yond the state of the pipe­line to­day.

An al­ter­na­tive would be to cre­ate a fullfledged, global, not-for-profit phar­ma­ceu­ti­cal com­pany with a re­search bud­get equal to that of the world’s top five for-profit com­pa­nies, and with the sin­gu­lar ob­jec­tive of cre­at­ing a pipe­line of prod­ucts to ad­dress the chal­lenge of in­fec­tious threats. As with any of its for-profit peers, the man­age­ment and sci­en­tific tal­ent to un­der­take this ef­fort would have to be the best avail­able, and at­tract­ing it would re­quire com­pet­i­tive com­pen­sa­tion. The man­age­ment team would be held ac­count­able for its per­for­mance by a board of in­vestors, com­pris­ing rep­re­sen­ta­tives of coun­tries that pro­vide the fund­ing and sci­en­tists who pro­vide the in­tel­lec­tual cap­i­tal.

In keep­ing with in­dus­try prac­tice, the pipe­lines would have to be built with a com­bi­na­tion of in­ter­nal re­search and in­li­cens­ing or ac­qui­si­tion of ex­ter­nal in­no­va­tion. Ad­e­quate in­fra­struc­ture for clin­i­cal tri­als would have to be built to sup­port re­search not only in de­vel­oped coun­tries, but also in re­mote re­gions where some of the in­fec­tious threats that the world faces are likely to emerge.

The new com­pany’s work would be aided by prior agree­ments among reg­u­la­tory agen­cies on the re­quire­ments for reg­is­tra­tion of new prod­ucts, among in­tel­lec­tu­al­prop­erty hold­ers on waiv­ing roy­alty rights, and among gov­ern­ments on li­a­bil­i­typro­tec­tion for the com­pany and com­pen­sa­tion for the vic­tims of un­ex­pected ad­verse re­ac­tions to new prod­ucts. The in­ter­na­tional com­mu­nity would have to in­crease avail­able man­u­fac­tur­ing ca­pac­ity, cre­ate new dis­tri­bu­tion chan­nels, and re­serve stor­age ca­pac­ity for stock­pil­ing prod­ucts that have no im­me­di­ate ap­pli­ca­tion.

It goes with­out say­ing that this would be a com­pli­cated un­der­tak­ing, with many de­tails to be worked out. But some­how we must sus­pend dis­be­lief and take ac­tion now, lest we be caught off-guard against an im­mi­nent global threat. This is a bat­tle we can­not af­ford to lose.

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