MAY 12 2008

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by ALECKS P. PABICO

IT WON’T be over even after the lady signs. And even after she signs it, the fight for popular access to affordable medicines won’t be over.



HAVE patent rights triumphed over public health?
All that the cheaper medicines bill needs to be enacted into law is the signature of President Gloria Macapagal Arroyo. But some legal experts lament that as enrolled, the bill passed by Congress bears “imperfections” that effectively affirm the patent rights of big pharmaceutical companies over public health, a major hurdle to bringing down drug prices.

And while the bill introduced amendments to the Philippines’s intellectual property law, the weak and flabby wording of some provisions could challenge implementation, and keep the promise of cheaper drugs locked in litigation.

Lawyer Elpidio Peria, for one, says that as soon as Arroyo signs the bill into law, the battle shifts to the drafting of its specific implementing rules and regulations or IRR. And that, he says, should teach public-health advocates to study intellectual property issues in the pharmaceutical sector more judiciously.

Peria, an associate of the Third World Network (TWN), one of the nongovernmental organizations that had supported the Senate version of the bill, says that the drafting of the law offers one lesson: It is “dangerous” to leave the debate on intractable intellectual property issues to lawyers and policymakers alone.

“The (bicameral) debates only proved the esoteric nature of intellectual property, which makes it dangerous to be left to lawyers and policymakers,” says Peria. “The (Intellectual Property) Code amendments will now have to be scrutinized closely so that its imperfections might be augmented by the IRR.”

Throughout the debate, public-health advocates and legal experts had welcomed the inclusion of amendments to the country’s intellectual property law in the final bicameral draft of the affordable medicines bill.

Undersecretary Alexander Padilla of the Department of Health (DoH) himself says that while the bill lost some of the provisions his department had championed, what is important now is that the law would contain "the more important patent flexibilities.”

The global nonprofit organization Oxfam International also says that, if applied by the government, the IP amendments "should help ensure that patent privileges of drug companies do not get in the way of promoting and protecting public health through affordable medicines."

Yet the likes of Peria worry that the “simplistic debates” on price regulation and the Generics Act amendments had obscured the bill’s IP provisions. As a result, Peria notes, the IP amendments were not fine-tuned and rid of their inherent weaknesses.

Some legal experts now fear that despite its promise of affordable medicines, the law would face difficulties in its implementation, in large part because pharmaceutical companies could take advantage of the loopholes in the patent-related amendments.

SCUFFLES OVER 'GENERICS-ONLY'
Up until the bill’s ratification by Congress in late April, the bicameral debates had focused mostly on the provision of House Bill 2844 that said only the generic names of medicines would appear on medical, dental, and veterinary prescriptions. This raised a howl among doctors who even threatened to declare a "hospital holiday" if the stipulation — which was among those being pushed by the health department — was not removed.

Later, the legislators wrestled over the House of Representatives’s proposal to create a drug price regulatory board. This further delayed the passage of the bill, which had been certified as urgent by the Arroyo administration way back in 2001.

In the end, the “generics-only” provision was dropped and the price-regulation board was replaced with a price monitoring and control mechanism that places the sole authority to impose price ceilings on the President, upon recommendation of the health secretary.

There were loud grumbles about a “watered-down” bill, but many also took comfort in the retention of several key provisions, including those on intellectual property.

"I would have been happier with the inclusion of the generics-only provision," says Akbayan party-list Rep. Ana Theresia Hontiveros-Baraquel. But she is nonetheless pleased that the IP Code amendments, which were the intent of the original bill she filed in the House, were adopted.

Ireneo Galicia, former deputy director general of the Intellectual Property Office (IPO), also says he can live with the changes in the price control and generics provisions knowing how "politically" sensitive these issues are, as long as his main advocacy, the IP amendments on patent reforms, are intact.

"No doubt,” he says, “these will help immediately bring about the lowering of prices of patented medicines via the parallel importation provision, and in the long term via the early working and new use provisions."

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