[Ip-health] opinion piece on changes to India patent law

[Amy Kapczynski]

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[ Picked text/plain from multipart/alternative ]

This opinion piece appeared this weekend in Outlook, a weekly Indian
magazine similar to Newsweek here.

ak

http://outlookindia.com/full.asp?
fodname=3D20041227&fname=3DColumn+Drug+%28F%29&sid=3D1

> OPINION
>
> A Bitter Pill For Aam Aadmi
>
> Why is the government afraid to openly debate a move that may
> quadruple drug prices?
>
> RAHUL RAJKUMAR, AMY KAPCZYNSKI, ACHAL PRABHALA
>
> While we are distracted by fallen gods and bickering billionaires,
> decisions are being made behind closed government doors that could
> mean the difference between life and death for millions of Indians.
> The issue is India's patent law, and this government's decision to
> avoid any public or parliamentary debate, to sneak in an ordinance
> (probably based on the bill introduced by the previous regime) to
> adhere to a World Trade Organisation (WTO) requirement that forces
> India to offer patents on medicines by January 1, 2005. The new patent
> law may lead to sky-rocketing prices-the cost of some medicines may
> double, triple, quadruple, or go even higher.
>
>
> Indian pharmaceutical companies may suffer serious setbacks, as could
> patients, for whom medicines already comprise an estimated 40-50 per
> cent of treatment costs.
>
>
> Patents are temporary monopolies granted by the government and,
> because they block competition, they allow inventors a free hand with
> pricing. When economists want evidence of just how high medicine
> prices could go after patents are introduced, they look, for instance,
> at Pakistan-which allows patents. A recent study showed that the
> antibiotic ciprofloxacin costs eight times more in Pakistan than in
> India. Recently, India granted exclusive marketing rights-similar to a
> patent-to Swiss company Novartis for a medicine that works wonders on
> a rare form of cancer called chronic myeloid leukaemia. Novartis is
> trying to use its rights to shut out local manufacturers, who charged
> as little as Rs 9,000 per month for the medicine, so that it can
> charge Rs 1,20,000 per month without competition.
>
>  As it is, few patients can afford the lower prices; so how can they
> possibly pay more?
>
>  It was this that India had in mind in 1970, when it did away with
> colonial-era patents on medicines. In part, because of this decision,
> India became the world's biggest-and often cheapest-producer of
> generic medicines. Companies like Cipla and Ranbaxy have taken the
> world by storm-slashing the cost of a year's supply of AIDS drugs from
> $10,000 to $140. This has made it possible to treat AIDS in India, and
> other poor countries-and, through treatment, to turn a death sentence
> into a manageable chronic disease, like asthma or diabetes. Now, in
> order to comply with the WTO's trips agreement, India has to offer
> patents on medicines. No one knows how many medicines could come under
> patents-but many drugs developed in the last 10 years, and all those
> that may be developed in future, are at risk.
>
>  Who stands to gain? The MNCs that have huge coffers and a head start
> in r&d. As trade economist Jagdish N. Bhagwati noted, in the 1980s,
> software and pharma MNCs muscled their way into the WTO. They had a
> prophetic vision: if they could export strong intellectual property
> laws from the US and Europe to the rest of the world, they could
> extend their monopolies to new territories, and kill competition from
> emerging markets in one fell swoop. US and European governments
> readily obliged their corporate patrons. The result is an agreement
> that requires WTO members to adhere to minimum standards of
> intellectual property protection.
>
>  The dominant logic of patents is: more protection =3D more revenue =3D
> more innovation. But while profits for pharma MNCs will increase in
> Indian markets, economists conclude that since this increase will be
> so small-globally speaking-it will not spur local r&d. Indian patients
> will just pay much more for medicines. But none of this has to happen.
> By being shrewd about how it implements trips, India can comply with
> WTO rules, protect the health of its constituents, and continue to
> serve as a model for the developing world.
>
>  First, the new law must be changed so that India can refuse patents
> on minor innovations. Why give companies huge profits for simply
> combining two known compounds, or reformulating an old drug? Indian
> law has some curbs on the scope of patents; these must be
> strengthened.Consider this. It has been widely reported that there are
> 4,000 pharma patent applications in India's "mailbox", waiting to be
> examined. But according to the US government, only about 250 new
> chemical entities have been discovered in the 10-year period that the
> mailbox covers. Other applications are probably for variations on
> known medicines-new formulations, dosages, etc. This blanket
> patenting-a common practice in the US-can be prevented by a strict law
> that limits patents to major innovations.
>
>  =A0Just as importantly, the new law must streamline the 'compulsory
> licensing' process, which allows the government to override patents on
> medicines when, for example, they aren't reasonably priced. Lastly,
> the new law should also maintain an important provision in the current
> Patents Act that permits challenges to frivolous patent applications
> before they are granted. Unless these steps are taken, red tape and
> costly lawsuits will tie India's generic industry in knots. Though
> these proposals are consistent with trips, they aren't included in the
> proposed ordinance. In fact, the government has acted in near-secrecy,
> closeting the revision process to a small ministerial group that has
> refused to invite public comment or publish a working draft of the
> bill. Unfortunately, the UPA is poised to push through almost the
> same, heavily criticised bill proposed last year by the NDA.
>
> Ironically, India has been a model of how to use trips flexibilities
> to ensure access to affordable medicines. A humane, shrewd patent law
> was a cornerstone of this commitment to public health. There can be no
> retreat from this. For, at stake is the price of life. Can the Indian
> government seriously think that it isn't high enough already?
>
>  (Amy Kapczynski is Yale University fellow in Law & Public Health;
> Achal Prabhala is an ipr researcher; Rahul Rajkumar is a Yale Law
> School student. Contact: essentialmedicines.org)
>
>
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