Reg­u­la­tion not al­ways in pub­lic’s in­ter­est

The Weekend Australian - Travel - - Health - TONY LEWIS

PRE­VEN­TIVE health­care strate­gies are de­scribed by the fed­eral Gov­ern­ment ‘‘ as a first-or­der eco­nomic chal­lenge’’ be­cause they hold the key to in­creas­ing work at­ten­dance rates and pro­duc­tiv­ity, as well as eas­ing pres­sure on the over­all health bud­get.

The Com­ple­men­tary Health­care Coun­cil (CHC) en­dorses this view and has long ar­gued that com­ple­men­tary health­care prod­ucts have an in­te­gral role to play in as­sist­ing the pub­lic with pre­ven­tive health­care. Con­sumers them­selves recog­nise this, which is why de­mand for qual­ity prod­ucts con­tin­ues to grow.

For this rea­son, ar­gu­ments call­ing for ma­jor changes to the reg­u­la­tory sys­tem which gov­ern com­ple­men­tary medicines are not in the pub­lic in­ter­est. What needs to be in­jected into the de­bate is some re­al­ism re­gard­ing the very tan­gi­ble ben­e­fits of­fered by a di­verse range of com­ple­men­tary medicines rel­a­tive to the ex­cep­tion­ally low risk they pose for the con­sumer.

The CHC con­sid­ers con­sumer in­ter­ests to be pri­mary in all that we do. For this rea­son, en­sur­ing con­sumers have ac­cess to safe, af­ford­able and ef­fi­ca­cious prod­ucts to as­sist them main­tain op­ti­mum health is some­thing we take very se­ri­ously. We en­gage read­ily with all those who are gen­uinely in­ter­ested in propos­ing changes which will ben­e­fit the pub­lic. How­ever, ar­gu­ments pro­posed in the Med­i­cal Jour­nal of Aus­tralia in Jan­uary (2008;188:21-25, re­ported in Week­endHealth on Jan­uary 12-13), sug­gest­ing com­ple­men­tary and al­ter­na­tive medicines should un­dergo the same de­gree of eval­u­a­tion as phar­ma­ceu­ti­cal drugs, are mis­lead­ing and run counter to con­sumer in­ter­ests.

We need to re­mind our­selves of crit­i­cal facts when we con­tem­plate sub­stan­tive re­vi­sion to the reg­u­la­tion of com­ple­men­tary medicines. In 2003, the pre­vi­ous Gov­ern­ment com­mis­sioned an ex­pert com­mit­tee on com­ple­men­tary medicines in the health sys­tem. Its terms of ref­er­ence specif­i­cally in­cluded con­sid­er­a­tion of whether the ex­ist­ing na­tional sys­tem of reg­u­la­tory con­trols re­gard­ing com­ple­men­tary medicines met ap­pro­pri­ate stan­dards of qual­ity, safety and ef­fi­cacy.

The ex­pert com­mit­tee, com­prised largely of med­i­cal and phar­ma­ceu­ti­cal pro­fes­sion­als, con­cluded that the cur­rent reg­u­la­tory sys­tem pro­vided the level of scru­tiny and eval­u­a­tion con­sis­tent with the level of risk, and was there­fore ap­pro­pri­ate.

Later there was a fur­ther de­tailed re­view of the sys­tem in the lead-up to the im­ple­menta- tion of a joint reg­u­la­tory scheme (since aban­doned) with New Zealand. Once again the struc­ture of the cur­rent sys­tem was en­dorsed. Why then, should we seek to re­visit the is­sue, given th­ese re­cently com­pre­hen­sive re­views?

It is im­por­tant to note that all in­gre­di­ents used in listed com­ple­men­tary medicines have been re­viewed and deemed safe by the Com­ple­men­tary Medicines Eval­u­a­tion Com­mit­tee (CMEC).

When con­sid­er­ing whether com­ple­men­tary medicines were ef­fec­tive, the ex­pert com­mit- tee con­sid­ered that the ex­ist­ing guide­lines for lev­els of ev­i­dence pro­vided suf­fi­cient frame­work to as­sess ef­fi­cacy. Spon­sors of com­ple­men­tary medicines are re­quired to hold ev­i­dence of their prod­ucts’ sta­bil­ity and ef­fi­cacy, and cer­tify so at the time of list­ing. This data can be re­quested and re­viewed at any time by the TGA. Con­cerns re­gard­ing to what ex­tent the TGA ad­e­quately au­dits prod­ucts po­ten­tially points to a re­source is­sue — not a fail­ing of the list­ing process it­self.

How­ever, re­gard­ing ef­fi­cacy, no medicine whether reg­is­tered or not, works for ev­ery­one who uses it ev­ery time they use it. Fur­ther, as with listed medicines, many reg­is­tered medicines such as com­mon anal­gesics, an­ti­fun­gals and cough reme­dies are based on well-known in­gre­di­ents that are not sub­mit­ted to a full safety and ef­fi­cacy eval­u­a­tion each time a spon­sor wishes to launch a new brand.

In­ter­est­ingly, the ex­pert com­mit­tee noted that that this frame­work may not be well un­der­stood by ei­ther prac­ti­tion­ers or con­sumers and rec­om­mended that ed­u­ca­tional in­for­ma­tion be dis­sem­i­nated. The CHC strongly sup­ports ad­dress­ing this weak­ness.

For the de­trac­tors of com­ple­men­tary medicines, a vexed is­sue re­lates to con­sumers be­ing duped by false or mis­lead­ing ad­ver­tis­ing on some com­ple­men­tary health­care prod­ucts. The Com­ple­men­tary Health­care Coun­cil re­it­er­ates that ad­ver­tis­ing of all non-pre­scrip­tion medicines must con­form to the strict re­quire­ments of the Ther­a­peu­tic Goods Ad­ver­tis­ing Code. Sanc­tions ap­ply for breaches of those re­quire­ments.

We be­lieve that en­force­ment of such sanc­tions is a nec­es­sary and fit­ting re­sponse to those who fail to com­ply with ex­ist­ing re­quire­ments, and ar­gue ad­di­tional re­sources should be made avail­able to the TGA to en­sure this hap­pens. Quite sim­ply, let’s im­ple­ment the sys­tem we cur­rently have in its en­tirety be­fore de­ter­min­ing that any changes are nec­es­sary.

As with all reg­u­la­tory sys­tems, the Com­ple- men­tary Health­care Coun­cil ac­knowl­edges there is al­ways room for im­prove­ment and we sup­port in­formed mea­sures that do so. But we also be­lieve that in the light of in­creased con­sumer de­mand, gov­ern­ment pol­icy should bet­ter ac­knowl­edge the vi­tal con­tri­bu­tion com­ple­men­tary medicines play in Aus­tralia’s health­care sys­tem. Specif­i­cally, we pro­pose the fol­low­ing: Ed­u­ca­tion of med­i­cal/health­care prac­ti­tion­ers of the low-risk com­ple­men­tary medicine/health­care op­tions avail­able for pa­tients where rel­e­vant,

Ed­u­ca­tion and rais­ing the aware­ness of the com­mu­nity about com­ple­men­tary health­care op­tions to en­able them to make in­formed de­ci­sions in re­la­tion to their health­care and health main­te­nance,

Gen­er­a­tion of data/in­for­ma­tion on com­ple­men­tary medicines in re­la­tion to clin­i­cal ef­fec­tive­ness and eco­nomic con­tri­bu­tion to the health­care bud­get in or­der to un­der­pin bal­anced pol­icy and clin­i­cal de­ci­sion mak­ing.

Aus­tralia cur­rently has one of the most highly reg­u­lated sys­tems in the world. The risk posed by the prod­ucts, rel­a­tive to their ben­e­fit is justly re­flected in our ex­ist­ing leg­isla­tive pro­vi­sions. In­creased reg­u­la­tion will re­sult in low-risk, ef­fi­ca­cious prod­ucts be­com­ing less ac­ces­si­ble and af­ford­able to the pub­lic. Tony Lewis is ex­ec­u­tive di­rec­tor of the Com­ple­men­tary Health­care Coun­cil

Com­ple­men­tary medicines: It’s im­por­tant that they are af­ford­able and ef­fi­ca­cious

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