Drugs, lies and red tape

Com­pul­sory li­cences to pro­vide af­ford­able medicines have been in limbo. Pharma in­dus­try pins hopes on a diabetes drug

Down to Earth - - COLUMN -

Fcoun­try that has is­sued just one com­pul­soOR A ry li­cence (CL) for the man­u­fac­ture of a patented drug, In­dia has earned un­war­ranted no­to­ri­ety. Ever since the In­dian Patent Of­fice granted a CL in 2012 to a Hyderabad-based gener­ics com­pany to man­u­fac­ture an ex­or­bi­tantly priced can­cer drug at a frac­tion of the cost charged by the multi­na­tional phar­ma­ceu­ti­cal com­pany that in­vented it, the CL is­sue has been trapped in a web of hy­per­bole, lies and fear. As In­dia be­came the tar­get of a vil­i­fi­ca­tion cam­paign by pharma mncs and the US ad­min­is­tra­tion as a coun­try that does not pro­tect in­tel­lec­tual property rights (iprs), the gov­ern­ment beat a quiet re­treat on CLs.

Read­ers of this col­umn would know that a CL is a le­gal pro­vi­sion that al­lows coun­tries to over­ride patents with­out the con­sent of the patent owner to meet pub­lic health re­quire­ments. It is en­shrined in the wto agree­ment on iprs as one of the flex­i­bil­i­ties on patents and al­though its crit­ics might claim that the CLs can be is­sued only in the case of a health emer­gency, this is not true. wto says clearly that “coun­tries are free to de­ter­mine the grounds for grant­ing CLs”. How­ever, such was the fe­roc­ity of the at­tacks on In­dia that the De­pat­ment of In­dus­trial Pol­icy and Pro­mo­tion (dipp), the nodal agency for iprs,which was plan­ning to is­sue CLs on three life­sav­ing drugs to treat var­i­ous types of can­cers,did an about­turn in 2013.

In­dian com­pa­nies have also mud­died the wa­ters on CLs.In 2008,gener­ics maker Natco at­tempted to get CLs for F Hoff­man La Roche’s lung can­cer drug,Tarceva,and Pfizer’s kid­ney can­cer drug, Su­tent, for sup­ply­ing th­ese medicines to Nepal.It in­voked Sec­tion 92A of the Patents Act that al­lows ex­port of patented pharma prod­ucts to any coun­try hav­ing in­suf­fi­cient or no man­u­fac­tur­ing ca­paci- ty to meet its pub­lic health needs.That ar­gu­ment did not hold wa­ter with the Patent Of­fice.

Natco got its act to­gether to sup­ply Bayer’s can­cer drug, so­rafenib to­sy­late, used to fight liver and kid­ney can­cer, by slic­ing off 97 per cent of the cost—from

2.8 lakh for a month’s treat­ment to just 8,800.It sought a CL un­der Sec­tion 84(1) of the law which says li­cences can be is­sued if rea­son­able re­quire­ments of the pub­lic have not been met.This in­cludes avail­abil­ity at a “rea­son­ably af­ford­able price”. That CL was granted.

How­ever, the next ap­pli­ca­tion by bdr Phar­ma­ceu­ti­cals in 2013 to make dasatinib, a blood can­cer drug sold by its US in­ven­tor Bris­tol-My­ers Squibb (bms) failed at the out­set.Al­though bdr said it would sup­ply the drug which re­tailed at

1.66 lakh for a month’s treat­ment at 8,100, the CL was re­jected be­cause the firm did not first seek a vol­un­tary li­cence (VL) from bms as re­quired by law.On June 29,the Delhi High Court,which was hear­ing a patent in­fringe­ment suit on das­tanib,up­held bms’s patent, rais­ing ques­tions about bdr Pharma’s odd strat­egy. Log­i­cally, the com­pany should have re-ne­go­ti­ated a VL with bms and then ap­plied again for a CL.

CLs have been in limbo for over three years.Now,af­ter a long gap comes an­other CL ap­pli­ca­tion from Lee Pharma of Hyderabad for a CL to make a diabetes drug. Lee wants to make a generic version of saxagliptin,a drug to treat Type-2 diabetes.The drug, orig­i­nally patented by bms in 2007, was trans­ferred to As­traZeneca. Lee does not of­fer dra­matic price re­duc­tions as in the case of can­cer drugs,but it points out In­dia has 66.84 mil­lion di­a­bet­ics,of whom 60.15 mil­lion suf­fer from Type-2 diabetes mel­li­tus which can only be man­aged through med­i­ca­tion. Lee has strictly fol­lowed pro­ce­dure and ev­ery­one is wait­ing with bated breath for the out­come.

Newspapers in English

Newspapers from India

© PressReader. All rights reserved.