HEALTH: Global Poor to Suffer If Denied Indian Generic Drugs – Experts

By Ranjit Devraj Reprint | | Print |

Ranjit Devraj

NEW DELHI, Feb 22 2005 (IPS) - If the Indian Parliament ratifies a decree on patents that seeks to bring India’s massive generic drugs industry in line with World Trade Organisation (WTO) rules, it will hurt poor patients – especially those suffering from HIV/AIDS – not only in this country but also globally, say activists and experts.

Millions of Indians will not be able to afford the 99 percent increase in the cost of the medicines. Further, 5.1 million Indians, 38 percent of them being women, are suffering from HIV/AIDS, totaling up to approximately 12 percent of the HIV- positive people in the world.

The argument for a stronger patent regime for pharmaceutical companies – in accordance with WTO requirements – is made on the basis of the heavy capital investment costs for research and development that goes into the creation of a new drug.

But the Washington-based Global Campaign Against Indian Patents Amendment (GCAIPA) argues otherwise.

”It is critical for people suffering from HIV/AIDS that India does not lose its continuing supply of anti-retroviral drugs and generic medicines. This decree if it becomes law will prove to be a serious setback, at this time when health activists and medical professionals are trying to deal with rising incidents of malaria and tuberculosis in India,” said GCAIPA in a petition to the Indian government.

”Not only Indians, but also a majority of the African nations (Ghana, South Africa etc) that are importing inexpensive generic drugs from India stand to lose the battle against death due to HIV/AIDS,” added the international lobby group.

India’s pharmaceutical industry is the fourth largest in the world in terms of volume with exports reaching an estimated 200 countries globally. But this has been achieved largely because India has been reluctant to allow the patenting of pharmaceutical products.

The Patents Ordinance, passed on Dec. 26, escaped public attention largely because that was the day the Asian tsunami struck killing more than 220,000 people and wreaking havoc on the coasts of a dozen countries around the Bay of Bengal.

But the Indian Parliament must ratify the ordinance within six months, in order for it to become law. Activists and experts are now working overtime to educate people on its implications and lobbying to get politicians to vote against it in Parliament.

What troubles campaigners most, according to B.K. Keyala, one of India’s foremost experts on patent law, was the haste in rushing through the decree by circumventing Parliament and excluding flexibilities allowed under the Trade- Related Aspects of Intellectual Property Rights (TRIPS) of WTO.

”On the other hand several sections which were beyond TRIPS requirements and were TRIPS plus were included,” Keyala told IPS.

At the Doha Ministerial Conference in November 2001, WTO member states agreed that the TRIPS agreement does not and should not prevent members from taking measures to protect public health. They underscored the ability of countries to use the flexibilities that are built into the TRIPS agreement, including compulsory licensing and parallel importing. And they agreed to extend exemptions on pharmaceutical patent protection for least-developed countries until 2016.

The TRIPS agreement says products made under compulsory licensing must be predominantly for the supply of the domestic market. This applies to countries like India that can manufacture drugs. It limits the amount they can export when the drug is made under compulsory licence.

This has an impact on countries unable to make medicines and therefore wanting to import generics. And they would find it difficult to find countries that can supply them with drugs made under compulsory licensing.

On Aug. 30, 2003, WTO members agreed, in the so-called TRIPS Plus, on legal changes to make it easier for countries to import cheaper generics made under compulsory licensing if they are unable to manufacture the medicines themselves. The decision waives exporting countries obligations.

Keyala and other experts have little doubt that the effect of the Patents Ordinance – if it becomes law – would put the price of ordinary drugs way beyond the reach of ordinary people not only in India but also in countries that bulk import generic drugs from this country.

Said Mira Shiva, well-known physician attached to the Voluntary Health Association of India (VHAI): ”As far as India itself is concerned, the bottom line is that even today a large majority of people cannot afford to buy medicines and this includes medicines for HIV/AIDS.”’

Against such arguments, India’s Commerce Minister Kamal Nath has stated publicly that Indian pharmaceutical companies will continue to manufacture and export drugs invented before 1995 including twelve of the most commonly used anti-retrovirals (ARVs).

”We are going in for higher patent protection to allow India to become a hub for global medical research taking advantage of cost savings and the vast pool of scientific and technical manpower available in this country,” Nath said.

Shiva said Nath’s grand statements, eagerly lapped up by pliant newspapers, on how the Patents Ordinance would improve research and development, increase (rather than decrease) the export of generic drugs and put Indian pharmaceutical companies in the big league of global players were completely misleading.

”What is important to note in all this din is the deafening silence of the Union Health Ministry which should be the one most concerned,” said the medical activist.

William Haddad, the noted campaigner for the import of cheap generic drugs into the U.S. said during meetings with Indian experts earlier this month that the Patents Ordinance was ”extremely unfortunate” and that TRIPS itself was not in the interest of public health.

Haddad, often called the ”father of generics” in the United States and represents the Generic Manufacturers Association said the generics business in his country would be crippled if bulk drugs and raw material from India ceased to be available as a result of the new legislation.

Haddad said he did not buy the argument that drug prices in the U.S. were high because of the high cost of research but saw it as an alibi used by Trans-National Corporations (TNCs) to maintain high prices.

Many Indians were alerted to the dangers of the Patents Ordinance after an editorial that appeared in the ‘New York Times’ on Jan. 18 observed that it had ”little to do with free trade and more to do with the lobbying power of U.S. and European pharmaceutical industries.”

The ‘Times’ editorial said that as a consequence of the new rules, India’s copycat industry for newer drugs would effectively end – therefore doubly hitting the world’s poor by ”cutting off the supply of affordable medicines and removing the generic competition that drives down the cost of brand name drugs”.

According to Amit Sen Gupta, a physician with the voluntary agency, Delhi Science Forum, the government’s arguments in favour of the Patents Ordinance have been a mix of half-truths and untruths that need to be challenged in Parliament.

”For example, the oft-repeated argument that 97 percent of drugs are off patent and will not be affected is at best a half-truth because there is no basis for that figure,” he said.

What is of real concern is the rate at which drugs turn obsolete and this, said Gupta, was especially true of drugs used to treat infectious killer diseases such as tuberculosis, malaria and pneumonia and now HIV/AIDS.

”The issue is not just drugs that are off patent – the more important concern is that new drugs required to replace old ineffective drugs will be patented and thus become unaffordable,” he told IPS.