TRO on con­tra­cep­tives now lifted – DOH

The Philippine Star - - FRONT PAGE - By SHEILA CRISOSTOMO With Edu Pu­nay, Marvin Sy

The tem­po­rary re­strain­ing or­der (TRO) is­sued by the Supreme Court (SC) on con­tra­cep­tives more than two years ago is now lifted, the Depart­ment of Health (DOH) said yes­ter­day.

The TRO was au­to­mat­i­cally lifted when the Food and Drug Ad­min­is­tra­tion (FDA) is­sued an ad­vi­sory declar­ing all of the 51 con­tra­cep­tive prod­ucts as “non-abor­ti­fa­cient,” ac­cord­ing to Health Un­der­sec­re­tary for Health Reg­u­la­tion Mario Villaverde.

“In my un­der­stand­ing, since the FDA had al­ready is­sued an ad­vi­sory, the TRO is lifted. There’s noth­ing wrong if FDA fur­nishes the (SC) with a copy but the lift­ing is au­to­matic,” he noted in an am­bush in­ter­view.

Villaverde had ear­lier re­it­er­ated the as­sur­ance that the DOH is well pre­pared for the full im­ple­men­ta­tion of the Re­spon­si­ble Par­ent­hood and Re­pro­duc­tive Health (RPRH) law now that the TRO is gone.

In is­su­ing the TRO in June 2015, the SC di­rected the FDA to stop re­new­ing the cer­tifi­cate of prod­uct regis­tra­tion (CPR) of all con­tra­cep­tive prod­ucts.

On the other hand, the DOH was pro­hib­ited from in­clud­ing sub­der­mal im­plants, which can stop preg­nancy for three years, in its fam­ily plan­ning pro­gram.

Re­lease of im­plants

For for­mer health sec­re­tary and cur­rent RPRH law national im­ple­men­ta­tion team head Esper­anza Cabral, pri­or­ity now should be the dis­tri­bu­tion of the sub­der­mal im­plants be­ing kept at the ware­house of the DOH.

“The first thing that the team will do is to rec­om­mend to the DOH the re­lease of the im­plants that have been held by the TRO for the last two years so they can be used by women who need them,” she added.

She es­ti­mated that some 250,000 im­plants are now in the DOH stor­age. These con­tra­cep­tives are the sub­jects of a pe­ti­tion filed by pro-life group Al­liance for Fam­ily Foun­da­tion Philip­pines Inc., prompt­ing the high tri­bunal to is­sue the TRO.

Cabral said in a sep­a­rate in­ter­view that the DOH will also have to pro­cure con­tra­cep­tives “that they have not been able to pro­cure be­cause of the TRO.”

She added that the DOH’s sup­ply of Pro­gestin-only pill is now “zero” while the sup­ply of in­jec­tale con­tra­cep­tives is run­ning out.

No need for SC or­der

There is no need for an or­der from the SC al­low­ing the dis­tri­bu­tion of the 51 con­tra­cep­tive im­plants cleared by the FDA as it was al­ready im­plied in its fi­nal de­ci­sion on the case is­sued ear­lier this year.

SC spokesman Theodore Te has re­peat­edly ex­plained that the TRO is­sued by the high court on the dis­tri­bu­tion by the DOH of two con­tracpetives, Im­planon and Im­planon NXT, is au­to­mat­i­cally lifted upon is­suance of new cer­ti­fi­ca­tion by the FDA.

Im­planon and Im­planon NXT are thin rods in­serted un­der the skin, which re­lease hor­mones that pre­vent preg­nancy for up to three years.

He cited the fi­nal and ex­ecu­tory rul­ing of the Sec­ond Di­vi­sion of the high court that voided the cer­ti­fi­ca­tions is­sued by the agency on Im­planon and Im­planon NXT and in­cluded a TRO on the dis­tri­bu­tion of such con­tra­cep­tives.

The SC de­nied the ap­peal of the DOH seek­ing to pro­ceed with the dis­tri­bu­tion of the con­tra­cep­tives and gave the FDA 60 days to de­cide on whether these im­plants are abor­ti­fa­cient or can cause abor­tion and re-is­sue the cer­ti­fi­ca­tion in its fi­nal rul­ing last April. It is­sued the en­try of judg­ment last Septem­ber.

Te also re­it­er­ated that the SC rul­ing “in­volves a TRO over two im­plants only and not all con­tra­cep­tives and not over the en­tire RH Law.”

In its 2015 rul­ing, the SC struck down the cer­ti­fi­ca­tions and re-cer­ti­fi­ca­tions is­sued by the FDA on 77 con­tra­cep­tive drugs and de­vices, in­clud­ing Im­planon and Im­planon NXT, for vi­o­la­tion of con­sti­tu­tional re­quire­ment of due process.

Tough time at Se­nate

Mean­while, the DOH and the FDA could be in for a tough time at the Se­nate when their 2018 bud­gets are taken up in the ple­nary in the next two days as a re­sult of the clear­ance given to 51 con­tra­cep­tives tagged as abor­ti­fa­cients by crit­ics of the RPRH law.

Se­nate Ma­jor­ity Leader Vi­cente Sotto III noted that the Al­liance for the Fam­ily Foun­da­tion Philip­pines Inc., which filed the pe­ti­tion be­fore the SC, is well aware of which con­tra­cep­tive prod­ucts could in­duce abor­tions and which do not.

“Ako, pagod na (I’m tired of this al­ready),” Sotto said.

With the go sig­nal given by the FDA on the 51 con­tra­cep­tives, in­clud­ing Im­planon and Im­planon NXT, Sotto said it is now the agency’s re­spon­si­bil­ity to ad­dress what­ever neg­a­tive im­pacts their de­ci­sion would have on the pub­lic.

Sotto said he ex­pects the is­sue to be taken up dur­ing the ple­nary de­bates on the 2018 bud­get where the rep­re­sen­ta­tives of the DOH and FDA would be present to de­fend their re­spec­tive bud­gets.

“Aa­ban­gan ko na lang bud­get nila (I will just wait for their bud­gets). Watch out!” he said.

Sotto said he would be watch­ing out for the cost of the con­tra­cep­tives in the mar­ket, which he said could be over­priced.

What is more of a con­cern to him, though, is the pro­cure­ment of the con­tra­cep­tives by the gov­ern­ment for im­ple­men­ta­tion of the RPRH Law, which he has been ques­tion­ing since the bill was be­ing tack­led in the Se­nate.

“It’s al­right if it’s be­ing sold in the mar­ket be­cause pri­vate in­di­vid­u­als can do what­ever they want to do with their own lives,” Sotto said.

“The point is when you use gov­ern­ment funds to buy it. Would (tax­pay­ers) agree to us­ing (their) money to pur­chase prod­ucts that could be abor­ti­fa­cients?” he added.

Sotto said that the pub­lic should re­al­ize this be­fore sup­port­ing groups be­hind the sup­ply of these con­tra­cep­tives.

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