RAD­HI­CA DE SIL­VA

Se­nior Mul­ti­me­dia Re­porter

rad­hi­ca.sookraj@guardian.co.tt

Se­ri­ous al­le­ga­tions of reg­u­la­to­ry abuse with­in the Chem­istry, Food and Drug Di­vi­sion (CFDD) emerged dur­ing the sixth meet­ing of the Pub­lic Ad­min­is­tra­tion and Ap­pro­pri­a­tions Com­mit­tee (PAAC), where mem­bers raised con­cerns that “spe­cial per­mis­sions” may have been used to by­pass es­tab­lished pro­ce­dures to im­port drugs such as Ozem­pic in­to the lo­cal mar­ket.

Com­mit­tee chair­man Jagdeo Singh ques­tioned CFDD in­spec­tor Dr Deryck Pat­tron about the reg­u­la­to­ry sys­tem af­ter Pat­tron de­nied in­tro­duc­ing con­tro­ver­sial doc­u­men­ta­tion re­quire­ments known as Form A and Form B.

Singh told the com­mit­tee the frame­work ap­peared con­tra­dic­to­ry and po­ten­tial­ly open to abuse.

“You have the cre­ation of a frame­work where peo­ple could not qual­i­fy be­cause of Form A, yet 1,898 spe­cial per­mis­sions were grant­ed even though doc­u­ments were miss­ing,” Singh said. “You cre­ate an un­ten­able frame­work with a back door that does not com­ply.”

Singh pressed of­fi­cials on why spe­cial im­port per­mis­sions were ap­proved de­spite in­com­plete doc­u­men­ta­tion, sug­gest­ing the process al­lowed com­pa­nies to by­pass the for­mal drug reg­is­tra­tion sys­tem.

Com­mit­tee mem­ber David Nakhid al­so ques­tioned who ul­ti­mate­ly ben­e­fit­ed from the arrange­ment.

“Who ben­e­fit­ed from this? We want some ac­count­abil­i­ty,” Nakhid said, not­ing that cer­tain com­pa­nies ap­peared to dom­i­nate sup­ply with­in the lo­cal phar­ma­ceu­ti­cal mar­ket.

“These com­pa­nies have more sup­ply in the mar­ket, and they pri­ori­tise the pay­ment. When we see the process­es, it’s glar­ing—a mo­nop­o­li­sa­tion of the mar­ket,” he added.

Singh de­scribed the sit­u­a­tion as a case of “reg­u­la­to­ry avoid­ance re­sult­ing in reg­u­la­to­ry cap­ture, where reg­u­la­tions may be struc­tured in ways that ben­e­fit a se­lect group of play­ers.”

Com­mit­tee mem­ber Dr Prakash Per­sad al­so ex­pressed con­cern about the use of spe­cial per­mis­sions for com­mer­cial ac­tiv­i­ty.

“Spe­cial per­mis­sion ought not to be grant­ed for trade,” he said, not­ing that in one Joint Se­lect Com­mit­tee meet­ing alone, 157 such per­mis­sions were grant­ed.

The com­mit­tee al­so heard con­flict­ing tes­ti­mo­ny re­gard­ing the ori­gins of Forms A and B, which some stake­hold­ers say cre­at­ed bar­ri­ers to reg­is­ter­ing phar­ma­ceu­ti­cal prod­ucts.

For­mer Drug In­spec­torate Unit mem­ber Im­ti­az Hy­dar Ali told the com­mit­tee the forms be­gan as in­ter­nal check­lists but lat­er evolved in­to for­mal reg­u­la­to­ry re­quire­ments.

How­ev­er, Singh said the ev­i­dence pre­sent­ed was “di­a­met­ri­cal­ly op­posed.”

“We have ev­i­dence from Mr Ali say­ing Dr Pat­tron changed the forms uni­lat­er­al­ly in 2017, and then we have Dr Pat­tron say­ing the forms were al­ready in ex­is­tence,” Singh said.

He al­so raised ques­tions about how the forms were print­ed bear­ing the na­tion­al coat of arms.

“No pub­lic ser­vant at that lev­el could sim­ply walk in­to the Gov­ern­ment Print­ery and in­struct that these be print­ed,” he said.

Pres­i­dent of the Pri­vate Phar­ma­cy Busi­ness Re­tail As­so­ci­a­tion Glen­wayne Su­chit al­so told the com­mit­tee that in­creas­ing­ly com­plex re­quire­ments in­tro­duced in re­cent years have made it dif­fi­cult for small and medi­um im­porters to reg­is­ter phar­ma­ceu­ti­cal prod­ucts.

Su­chit said while doc­u­men­ta­tion such as cer­tifi­cates of analy­sis are stan­dard re­quire­ments, new­er de­mands—in­clud­ing de­tailed in­for­ma­tion on colour­ing agents and la­bel ink—were ex­ces­sive.

He warned that the sys­tem could po­ten­tial­ly be used to block some com­pa­nies while al­low­ing oth­ers to se­cure ap­provals.

The com­mit­tee al­so heard that phar­ma­ceu­ti­cal com­pa­ny Smith Robert­son and Com­pa­ny Ltd re­ceived the largest share of the mil­lions al­lo­cat­ed for drug pay­ments, with one tranche see­ing the com­pa­ny re­ceive $50 mil­lion out of an $80 mil­lion al­lo­ca­tion for sup­pli­ers.

Mem­bers were told that the Na­tion­al In­sur­ance Prop­er­ty De­vel­op­ment Com­pa­ny (NIPDEC) ini­tial­ly rec­om­mend­ed a more eq­ui­table dis­tri­b­u­tion of funds based on out­stand­ing in­voic­es old­er than 90 days.

How­ev­er, the agency lat­er re­ceived in­struc­tions from the Min­istry of Health’s ac­count­ing of­fi­cer to ad­just al­lo­ca­tions and pri­ori­tise larg­er sup­pli­ers.

Ev­i­dence pre­sent­ed to the com­mit­tee showed that Smith Robert­son con­sis­tent­ly re­ceived be­tween 30 and 60 per cent of cer­tain al­lo­ca­tions—sig­nif­i­cant­ly more than oth­er com­pa­nies, which in some cas­es re­ceived be­tween ten and 20 per cent of pay­ments owed to them.

Of­fi­cials con­firmed that emails from the Min­istry of Health di­rect­ed NIPDEC to ad­just pay­ment al­lo­ca­tions, in­clud­ing in­struct­ing that some small­er sup­pli­ers be “fac­tored out” of spe­cif­ic dis­tri­b­u­tions while larg­er com­pa­nies were paid us­ing loan funds.

The com­mit­tee con­tin­ues to ex­am­ine the phar­ma­ceu­ti­cal sup­ply chain and the pay­ment al­lo­ca­tion sys­tem amid con­cerns that con­cen­trat­ing pay­ments among a few large sup­pli­ers could cre­ate vul­ner­a­bil­i­ties in the na­tion­al drug sup­ply sys­tem.

For­mer Health Min­is­ter Ter­rence Deyals­ingh at­tend­ed the meet­ing but did not speak. Con­tact­ed af­ter­wards, Deyals­ingh said he was not re­quired to ad­dress the com­mit­tee.