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lished the use of trade-related aspects of<br />

intellectual property rights (TRIPS)<br />

agreements and reinforced the importance<br />

of access to medicines while reaffirming<br />

the ability of governments to use<br />

the flexibilities available in TRIPS to ensure<br />

the affordability of medicines.<br />

Now the United States is pushing for<br />

what is commonly referred to as “TRIPS-<br />

Plus” allowing for a period of data exclusivity<br />

of up to 11 years beyond the date a<br />

generic version of a product would normally<br />

begin to compete with the patent<br />

holder.<br />

According to a letter highlighting a<br />

Thai survey and sent by the president of a<br />

Malaysian consumers association to the<br />

Malaysian Minister of Health in March<br />

2006, “The Thai Ministry of Health has<br />

done a study of the predicted impact of<br />

the TRIPS-Plus provisions found in US<br />

FTAs. It found that if generics were prevented<br />

by data exclusivity from entering<br />

the market for a period of ten years beyond<br />

the date when patents normally ex-<br />

pire, this would cost an extra $5400 million<br />

(at wholesale prices) per year which<br />

is 77% of the current total Thai health<br />

expenditure.”<br />

Furthermore, the adoption of TRIPS-<br />

Plus provisions would greatly harm the<br />

development of the local pharmaceutical<br />

industry, which relies on being able to produce<br />

bioequivalent products for its markets<br />

under the current protection of the<br />

TRIPS system and the other intellectual<br />

property protection mechanisms.<br />

This will be a sticky situation if the negotiation<br />

favor international originators as<br />

opposed to local generic manufacturers in<br />

<strong>South</strong>east <strong>Asia</strong>. It is also a test of the ability<br />

of the industry to mobilize itself across the<br />

region, while facing a common threat.<br />

Beyond this issue lies opportunities to<br />

strengthen what is today a multitude of<br />

medium-size players with different business<br />

agendas into a more solid, forwardthinking<br />

and opportunities-grabbing industry.<br />

In turn, this should offer plenty of<br />

areas of possible cooperation between international<br />

companies, particularly US<br />

and European, and the movers and shakers<br />

who will emerge from these trying times.<br />

For once, casting originators against<br />

generic players might end up strengthening<br />

the industry across the board.<br />

ACKNOWLEDGMENTS<br />

Pharmaceutical Technology and <strong>Executive</strong> <strong>Country</strong><br />

<strong>Review</strong>s would like to thank all companies and<br />

organizations that helped for the preparation of<br />

this review.<br />

Indonesia: Novell Pharmaceutical Laboratories<br />

www.novellpharm.com, Kalbe Farma,<br />

www.kalbe.co.id, Soho Industri Pharmasi,<br />

www.soho.co.id, Sanbe, www.sanbe-farma.com,<br />

Mensa Group, www.mensa-group.com, Dexa<br />

Medica, www.dexa-medica.com, Combiphar,<br />

www.combiphar.com,<br />

Malaysia: Kotra Pharma, www.kotrapharma.com,<br />

Apex Healthcare, www.apexpharmacy.com,<br />

Scanlab, www.scanlab.com, Dynapharm,<br />

www.dynagroup.com.my , Hi-City, www.hicity.com,<br />

Malaysian Pharmaceutical Industries,<br />

<strong>An</strong>tah Pharma, www.antah.com.my, Royce Pharma,<br />

www.roycepharma.com,YSP, www.yspsah.com,<br />

Idaman, Pharmaniaga, www.pharmaniaga.com ,<br />

Emerging Pharma, www.emergingp.com , Hovid,<br />

www.hovid.com.<br />

Singapore: ICM, www.icmpharma.com.sg<br />

Philippines: Sydenham Laboratories,<br />

www.sydenhamlab.com, Philippine International<br />

Trade Corporation, www.pitc.gov.ph, Elin<br />

Pharmaceuticals, www.elinpharma.com, Hizon<br />

Laboratories, Lloyd Laboratories,<br />

www.lloydlab.com,YSS Laboratories,<br />

www.ysslab.com , Unilab, www.unilab.com.ph ,<br />

Pascual Laboratories, www.pascuallab.com ,<br />

Danlex.<br />

Thailand: GPO www.gpo.or.th, Biolab<br />

www.biothailand.com,TO Chemicals<br />

www.togroupthailand.com, Greater Pharma<br />

www.greaterpharma.com, A.N.B. Laboratories<br />

www.anlab.com, PMS www.pms-group.net, NR<br />

Industries Group www.nr-group.com, Silom<br />

Medical, Zuellig Pharma www.zuelligpharma.co.th,<br />

Mega Lifesciences www.megawecare.com, Siam<br />

Pharmaceuticals www.siam-pharm.com.<br />

ONE STEP FURTHER<br />

For further information on the above companies,<br />

please contact us: info@ecreviews.com,<br />

www.ecreviews.com<br />

Pharmaceutical Technology SEPTEMBER 2006 89

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