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December 29, 2014

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Home » Opinion » Chinese Views

Global action best cure for “fake” drug controversies

PEOPLE selling fakes are often the target of popular anger. But the arrest and indictment of a Chinese man on charges of selling “fake” medicines has triggered a wave of sympathy for him.

The suspect in question, Lu Yong, was arrested last year for selling an Indian-made generic cancer drug named Veenat. He was released on bail in March pending trial. Since the national food and drug administration has never authorized the import of Veenat, meaning the drug lacks the proper legal paperwork, it has long been deemed “fake.”

However, for many of Lu’s customers, he is more savior than suspect. Three hundred buyers have signed a petition pleading for leniency. They are people with chronic myelocytic leukemia, a disease for which a drug called Glivec offers the best treatment. It is made by Swiss multinational pharmaceutical company Novartis.

The problem is that Glivec is extremely expensive. At about 23,000 (US$3,710) to 25,000 yuan a bottle, it is effectively priced out of reach for many patients.

Instead, they turn to the cheaper Indian generic Veenat, which is roughly identical in ingredients and dosage, and has proved as effective in clinical trials. The price of Veenat can range from several hundred yuan to 3,000 yuan a packet, depending on whom you choose to buy from.

That Lu — himself a leukemia patient — chose to purchase and resell the drugs to fellow patients is probably inspired more by altruism than profits. And considering that the online sale of Veenat has been going on for years, many angrily slammed the state for “ignoring the plight of leukemia patients.”

In fact, the reality is more complex than meets the eye. Since China is a signatory to the Bern Convention on International Property Rights, the country must ensure that any patented drugs be prevented from falling victim to its notorious counterfeit culture during their legal patent protection period.

In principle, no domestic pharmaceutical companies are allowed to produce generic alternatives to the essential drug Glivec. Otherwise, it would constitute an infringement of IPR.

India, while also a signatory to the Convention, has cited an exception clause that enables it to manufacture patented medicines when patent ownership is believed to be a significant threat to public interest and well-being. A conflict of interests inevitably grows out of this legal interpretation.

According to an article written by economists Joseph Stiglitz and Arjun Jayadev, “But it (India) has long been a flashpoint in battles over expansion of pharmaceutical companies’ global IP rights, owing to its dynamic generics industry and its willingness to challenge patent provisions both domestically and in foreign jurisdictions.”

While India has stood up to Western pharmaceutical companies, to the praise of champions of the poor, the decision in itself is not without controversy. Nor is China really prioritizing patent protection at the price of, say, “ignoring the plight of leukemia patients.”

Public interests

A story run by the Beijing News on December 22 pointed out that China has similarly installed a legal caveat in the case of application of patent laws, stipulating that even before patents expire, domestic pharmaceutical firms can legally produce generics on strictly public interest grounds.

Nonetheless, this clause has been left latent, as administrative approval is simply too time-consuming, and many firms opt to wait for patents to expire, an anonymous FDA official is quoted as saying in the report.

In a more promising development, China has begun to manufacture its own Glivec-type generic since July last year because the patent of Glivec expired in April 2013.

Yet due perhaps to scant publicity, concerns about counterfeit products, or a small scale of production, homegrown generics haven’t been able to replace the Indian-made Veenat.With many still reliant on Veenat to sustain their lives, it surprises no one that the arrest of Lu would cause such a backlash: anger that some debatable patent protection provisions seem deemed more important than the lives of its people.

Yet sensationalism is the wrong remedy for the debate over patents. There is no denying that Lu did break the law, but given both the patent expiry and the desperateness of his situation — and that of the fellow patients — we expect him to receive no more than a slap on the wrist.

However, more needs to be done to help those forced to buy “fake” medicines from India, such as producing generics under legal conditions or including them under a more extensive, generous health care network.

Overhauling IPR laws

Of course, the allegations against Lu also call for overhauling existing international IPR laws.

Since development of drugs like Glivec entails a huge amount of research money, arbitrary government efforts to cap their price or encourage the manufacturing of generics will be counterproductive, hurting incentives to produce them and leaving patients worse off.

Instead of being reduced to a struggle of individual countries, the fight over patents ought to be taken to a higher level, with the international community pushing for inclusion of legal arrangements that contest and restrict patent ownership when public interests are at stake. Subsidies can be considered to compensate pharmaceutical companies for revenues lost to the legal production of generics.

Ultimately, however, the best way to alleviate the woes of leukemia patients like Lu is spend more on R&D to develop China’s own substitute for Glivec, at, of course, heavily reduced prices.




 

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