A strong IP regime is crit­i­cal for Malaysia

The Star Malaysia - - Focus - By LOH FOON FONG foon­fong@thes­tar.com.my

PHARMACEUTICAL com­pa­nies have been ac­cused of mak­ing slight mod­i­fi­ca­tions to their drugs to ex­tend a patent life span.

This has re­sulted in calls for the govern­ment to not recog­nise process meth­ods for patent­ing, and al­low­ing only molec­u­lar pa­tents. How­ever, the Pharmaceutical As­so­ci­a­tion of Malaysia (PhAMA) ar­gues that mod­i­fi­ca­tions do make a dif­fer­ence.

Dif­fer­ent salts, for in­stance, have been patented be­cause in pharmaceutical process, they have dif­fer­ent phar­ma­co­log­i­cal prop­er­ties and would ex­ert dif­fer­ent ef­fects on pa­tients, it says.

“And de­spite it be­ing in pub­lic do­main or knowl­edge, one is not able to pre­dict which salt form is able to pro­vide the de­sired ther­a­peu­tic ef­fects,” it says, in re­sponse to lo­cal drug com­pa­nies pro­duc­ing gener­ics com­plain­ing that big pharmaceutical com­pa­nies had patented prod­ucts that were not novel.

The Star re­cently re­ported that the lo­cal play­ers had asked the govern­ment to be stricter in is­su­ing pa­tents.

Ac­cord­ing to PhAMA, both in­no­va­tive and generic pharmaceutical com­pa­nies do file for and own pa­tents but pa­tents are granted on the ba­sis of nov­elty, in­ven­tive steps and in­dus­trial ap­pli­ca­bil­ity.

It says that af­ter dis­cov­er­ing a com­pound and reg­is­ter­ing it as a patent, a drug com­pany has 20 years of pro­tec­tion for the patent where it will then carry out pre-clin­i­cal tri­als, and Phases 1 to 3 clin­i­cal tri­als, all which may take 10 to 12 years. Af­ter the tri­als, the com­pany sub­mits the results for prod­uct reg­is­tra­tion and the author­ity will eval­u­ate the doc­u­ment.

It says that gen­er­ally, com­pa­nies file for patent glob­ally in mul­ti­ple coun­tries al­most at the same time.

PhAMA pres­i­dent Chin Keat Chyuan says that In­tel­lec­tual Prop­erty (IP) rights are de­fined by the World Trade Or­gan­i­sa­tion as “rights given to peo­ple over the cre­ations of their minds.”

“The re­search and de­vel­op­ment ef­forts that are un­der­taken by in­no­va­tor pharmaceutical com­pa­nies are high-risk and costly ven­tures with no guar­an­tee of pos­i­tive re­turns. Once a drug has been suc­cess­fully cre­ated, it is sus­cep­ti­ble to be­ing copied by third par­ties through re­verse en­gi­neer­ing as pharmaceutical com­pounds can be eas­ily im­i­tated once they have been dis­cov­ered.

“Hence, a patent would pre­vent a third party from ex­ploit­ing an­other per­son’s in­ven­tion and un­justly ben­e­fit­ing from it with­out any le­gal con­se­quences,” he says.

Chin says that a strong IP regime is crit­i­cal for Malaysia to boost its com­pet­i­tive­ness, es­pe­cially to at­tract for­eign direct in­vest­ment while at the same time en­cour­age tech­no­log­i­cal ad­vance­ment and in­no­va­tion.

The pharmaceutical in­dus­try re­gards pa­tents as the most im­por­tant le­gal pro­tec­tion for the lim­ited time the com­mer­cial rights of the drugs and medicines that they in­vented, he says.

PhAMA also re­futes al­le­ga­tions that the Pa­tient Ac­cess Scheme (PASc) locks-in pa­tients and does not ad­dress the high cost of drugs. “The ques­tion of pa­tients not be­ing able to gain ac­cess to drugs due to high price is not ap­pli­ca­ble be­cause the govern­ment has al­lo­cated for the drugs in the for­mu­lary,” it says, stress­ing that the PASc gives poor pa­tients ac­cess to the treat­ment.

The pharmaceutical com­pany ap­plies to the Health Min­istry to ben­e­fit the pa­tients and this al­le­vi­ates the govern­ment’s fi­nan­cial bur­den, it adds.

It is a pub­lic-pri­vate partnership which the in­dus­try pro­posed and pa­tients were ei­ther given full or par­tial spon­sor­ship of the drugs by drug com­pa­nies, says PhAMA, adding that there are PASc guide­lines to ad­here to.

Asked about the cri­te­ria for choos­ing pa­tients and the terms of dis­con­tin­u­ance, PhAMA says that the pa­tients are se­lected by doc­tors at the Health Min­istry and the terms are set by the min­istry.

Ac­cord­ing to PhAMA, be­tween 2013 and 2016, more than 10 PhAMA mem­bers of­fered PASc in Malaysia, ben­e­fit­ting some 12,000 pa­tients.

The ap­proach is in line with one of the UN Sustainable De­vel­op­ment Goals tar­gets to pro­vide univer­sal health coverage, and the sec­ond strate­gic thrust of the Eleventh Malaysia Plan, which fo­cuses on im­prov­ing well­be­ing for all, says Chin, adding that it wel­comes the re­view of of the PASc by the Na­tional Au­dit Depart­ment.

The Health Min­istry’s phar­macy prac­tice and de­vel­op­ment divi­sion has re­cently con­sulted the depart­ment to re­view hos­pi­tals’ med­i­ca­tion pro­cure­ment prac­tices, par­tic­u­larly on hospi­tal staff accepting free gifts and bonuses in th­ese deals.

Ac­cord­ing to an on­line por­tal re­port on Oct 5, pre­lim­i­nary find­ings showed that there had been no un­eth­i­cal prac­tices.

Chin be­lieves that gener­ics alone are not the so­lu­tion to medicine ac­cess.

“Nearly all of the World Health Or­gan­i­sa­tion’s ‘es­sen­tial medicines’ are avail­able at re­duced, off-patent prices, but more than a third of the world’s pop­u­la­tion still has no ac­cess to them.

“Also, de­spite In­dia be­ing home to the largest and most vi­brant generic in­dus­try in the world, for the 40% of the pop­u­la­tion that lives on less than US$2 (RM8.40) per day, medicines and other health­care needs are not af­ford­able at any price,” he says, adding that the lack of in­fra­struc­ture also poses a bar­rier to ac­cess.

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