Asia-Pacific, Civil Society, Development & Aid, Economy & Trade, Global, Global Geopolitics, Global Governance, Globalisation, Headlines, Health, Poverty & SDGs

HEALTH-INDIA: Campaign to Stop Monopoly of Clinical Trial Data

Keya Acharya

BANGALORE, Feb 13 2007 (IPS) - As public health groups await the outcome of Swiss pharmaceutical giant Novartis AG’s legal challenge to India’s patent law, a campaign is building up against a parallel move to obtain ‘data exclusivity’ on clinical trial data submitted to government for marketing approval.

Under the drug regulatory process any drug, whether patented or not, must pass safety, efficacy and quality tests for marketing from the Drug Controller-General of India (DGCI). The DGCI thus requires the manufacturer to submit data from three phases of clinical trials.

As per current law, the DGCI can rely on previous test data to approve subsequent generic versions of the same drug. This allows generic drug manufacturers to circumvent expensive repeats of clinical trials that translate into cheap and quick drug availability in the market.

But in 2005, the powerful Pharmaceutical Research and Manufacturers of America, (PhRMA) lobbied the United States Trade Representative to impose data exclusivity on drug trial submissions, through the US Trade Act’s ( USTA) ‘Special 301’ clause.

The Special 310 clause identifies India and most other developing countries as having inadequate intellectual property rights under the World Trade Organisation (WTO)’s trade-related intellectual property rights (TRIPS) rules.

PhRMA is based in the U.S., but its membership includes the world’s major pharmaceutical companies, including such names as Pfizer, Novartis, GSK, and Merck. Their bid for data protection, under clause 39.3 of TRIPS has found easy coincidence with the U.S.’s interests in India on nuclear deals, agricultural, trade, commerce, industry and other agreements.

Many of these pharmaceutical majors are now also outsourcing clinical trials to India through contract research organisations (CROs), ramping up profits by taking advantage of lax laws and cheaper operational costs.

An UNCTAD document explains that article 39.3 in TRIPS does not prevent a government authority from relying on test data from one company to assess similar drugs from another company, making the U.S. demand a ‘TRIPS plus’ stipulation.

If India amends its Drugs and Cosmetics Act, the DGCI will be barred from relying on test data already in its possession for approving generic medicines. The generic manufacturer, though not legally barred from producing a drug, will nevertheless be forced to repeat already-proved safety and efficacy trials, raising costs.

Public health groups assert that the implications of data exclusivity go well beyond the obvious, protesting that this is yet another move by MNCs to monopolise the drug market in India, to the detriment of public health and the market for essential generic drugs.

Should Novartis, for instance, lose its legal bid to have India’s patent law amended, it may still be able to exert market monopoly for at least 5 years, if ‘data exclusivity’ becomes legal.

“We are very clear that ‘data exclusivity’ in its present proposed form cannot be introduced into the Drugs and Cosmetics Act,’’ says Shankar Rajkumar, Advocacy officer at the Lawyers’ Collective in Bangalore.

Lawyers’ Collective and the All India Drug Action Network together with several national and international public-health organisations, including Medecins Sans Frontieres (MSF), say it is unethical to repeat clinical trials, thus driving up prices of generic drugs.

International charity Oxfam writes: “The U.S. government continues to use bilateral and regional trade agreements outside the WTO to pressure developing countries to implement TRIPS-plus standards. ”

Several public health groups, including networks of HIV positive patients have written in protest to Indian Prime Minister Manmohan Singh. These groups, though invited to discuss their concerns by India’s Ministry of Chemicals and Fertilisers, say their suggestion to allowing generic companies to pay royalty to the original drug company for use of its data, was not heeded.

The ministry is due shortly to bring out a report for tabling in Parliament, based on the outcome of several inter-ministerial meetings on the issue pending since mid-2006.

”The basic point is that data protection has to be given – but in what form is being currently weighed,” G.S. Sandhu, a high official at the ministry told IPS. Sandhu said his ministry was aware of public concerns on affordability and monopolistic trade practices.

India’s 124,995 AIDS and 5.1 million HIV positive cases pay 497 US dollars per year for first-line treatment, and approximately 3,532 dollars per year for second-line treatment. These costs will skyrocket if data exclusivity pushes generic drugs out of the market.

The Indian Network of Positives have demanded that the government now include these expensive second -line treatment drugs into its free-distribution scheme, but questions arise on how the government will afford this.

”It is not so much the affordability of second-line treatment, since all treatment is anyway expensive; it is that we are still focusing on first-line treatment to be fully established,’’ says Sujatha Rao, director general of India’s National Aids Control Organisation.

India is one of the world’s largest providers of cheap, generic drugs. MSF alone provides treatment to over 80,000 AIDS cases in 30 countries, sourcing the bulk of its generic drugs from India that has helped bring treatment costs down from 10,000 dollars annually per patient to 130 dollars.