Drug reg­u­la­tor col­lapse dents pa­tient hopes

The Weekend Australian - Travel - - Health - Adam Cress­well

THE COL­LAPSE of plans to cre­ate a sin­gle trans-Tas­man drug reg­u­la­tor has been greeted with dis­may by con­sumer groups, who had been hop­ing the new body would prove more ‘‘ user-friendly’’ than the ex­ist­ing watch­dog and would be more trans­par­ent about think­ing be­hind its de­ci­sions.

The pro­posed Aus­tralia New Zealand Ther­a­peu­tic Prod­ucts Author­ity, or ANZTPA for short, was shelved by the New Zealand Gov­ern­ment last week when Welling­ton an­nounced it did not have the num­bers in Par­lia­ment to pass the re­quired leg­is­la­tion.

Years in the plan­ning, ANZTPA was in­tended to re­place the Ther­a­peu­tic Goods Ad­min­is­tra­tion in Can­berra and New Zealand’s Med­safe, to take over the job of as­sess­ing the safety claims of phar­ma­ceu­ti­cal and herbal drugs and med­i­cal de­vices. It had a che­quered his­tory even in its de­vel­op­ment, miss­ing two start dates af­ter orig­i­nally be­ing in­tended to start op­er­a­tions this month.

How­ever, the com­ple­men­tary medicines lobby in New Zealand had fought a long cam­paign to op­pose the har­mon­i­sa­tion, claim­ing that it would force herbal medicines sold in New Zealand to com­ply with the tougher rules in force in Aus­tralia.

Ac­cept­ing the de­ci­sion, Par­lia­men­tary Sec­re­tary for Health Sen­a­tor Brett Ma­son said the Aus­tralian Gov­ern­ment un­der­stands the dif­fi­cult po­lit­i­cal sit­u­a­tion’’ faced by the New Zealand Gov­ern­ment, and in th­ese cir­cum­stances has agreed that post­pon­ing ne­go­ti­a­tions on the joint agency is a sen­si­ble course of ac­tion’’.

The Aus­tralian Gov­ern­ment re­mains com­mit­ted to a world-class reg­u­la­tory scheme for ther­a­peu­tic goods and it will now pro­ceed in a way that al­lows both coun­tries to ex­plore other op­tions for har­mon­i­sa­tion in the in­terim,’’ he said.

The Gov­ern­ment said Aus­tralia’s ex­ist­ing reg­u­la­tor, the Ther­a­peu­tic Goods Ad­min­is­tra­tion, would con­tinue to op­er­ate un­der its ex­ist­ing full-cost re­cov­ery ar­range­ments’’, which en­sure that the cost of the TGA’s op­er­a­tions are met from fees paid by drug man­u­fac­tur­ers.

How­ever, the TGA has of­ten been crit­i­cised within Aus­tralia for a lack of trans­parency, as well as a per­ceived lack of in­de­pen­dence from the drug in­dus­try, and crit­ics had hoped the tran­si­tion to ANZTPA would op­por­tu­nity to fix th­ese flaws.

The con­sumer or­gan­i­sa­tion Choice said it wanted ‘‘ a more in­de­pen­dent and trans­par­ent reg­u­la­tor that makes in­for­ma­tion about its de­ci­sions avail­able to the pub­lic’’.

‘‘ We had been meet­ing with the TGA reg­u­larly to ad­vo­cate for the es­tab­lish­ment of a con­sumer con­sul­ta­tive com­mit­tee un­der ANZTPA, as well as a more ‘ con­sumer­friendly’ web­site,’’ a spokes­woman said.

‘‘ We hope that the de­ci­sion not to in­tro­duce a joint reg­u­la­tory sys­tem will not af­fect the TGA’s ef­forts to be­come more in­de­pen­dent and trans­par­ent. Con­sumers de­serve to know why some drugs are ap­proved and oth­ers are not, ir­re­spec­tive of the name and bound­aries of the reg­u­la­tor.’’

How­ever, an­other medicines pol­icy ex­pert — Thomas Faunce, a se­nior lec­turer in law and medicine at the Aus­tralian Na­tional Univer­sity — greeted the col­lapse of the plans as a ‘‘ good thing’’ for New Zealand. Faunce said the ‘‘ stake­holder con­sul­ta­tion’’ ses­sions held by the Aus­tralian gov­ern­ment to shape the de­vel­op­ment of ANZTPA were ‘‘ a sham and a farce’’ were de­signed to ac­cept only de­part­ment and drug in­dus­try views.

And he claimed that had the joint reg­u­la­tor gone ahead, it would have forced New Zealand to also ac­cept the obli­ga­tions foisted on Aus­tralia as part of the free-trade agree­ment with the US that came into ef­fect in 2005.

Un­der th­ese obli­ga­tions, generic com­pa­nies were re­quired to no­tify drug man­u­fac­tur­ers of their in­ten­tion to en­ter the mar­ket with a low­cost copy of a branded drug — a mea­sure that pro­moted ‘‘ ev­er­green­ing’’ of big-brand medicines be­cause their mak­ers would then have time to mount de­fen­sive ac­tion, Faunce said.

‘‘ If I was a generic drug man­u­fac­turer I would be look­ing to up sticks now and re­lo­cate to New Zealand . . . where I didn’t have to dis­close to the (big-brand) man­u­fac­turer that I was aiming to en­ter the mar­ket.’’

Rep­re­sen­ta­tive groups for the phar­ma­ceu­ti­cal gi­ants in both Aus­tralia and New Zealand said they were dis­ap­pointed with the post­pone­ment of ANZTPA. Medicines Aus­tralia said it was a ‘‘ missed op­por­tu­nity’’ but hoped sim­pli­fi­ca­tion of Aus­tralia’s reg­u­la­tory ar­range­ments would still con­tinue.



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