Local health officials are bracing for an increase in the cost of anti-retroviral drugs as a result of recent changes to India’s 1970 Patent Act, which will change the way generic AIDS drugs are produced.

Dr Yitades Gebre has predicted that the legislative changes in India will have a serious effect on local programmes, as 75 per cent of the drugs currently used come from that country.

He is the chief medical officer and executive director of the Jamaica HIV/AIDS Prevention and Control Project. “It will hike the price, but we are not yet sure by how much, as it is yet to be approved. .Getting low-cost medication to Jamaica and other developing countries may be a problem. We don’t know what will happen in the next three years,” he said.

Locals living with AIDS pay $1,000 a month if they go through government programmes. Those who can prove that they cannot afford to pay, get the drugs for free. The prices of anti-retroviral (ARV) drugs have fallen sharply in Jamaica over the years, largely as a result of an agreement worked out between local ARV importer Lasmed, the pharmaceutical division of Lasco Distributors Limited, and the government.

Lasmed, which supplies the bulk of the generic AIDS drugs used locally, launched a line of anti-retroviral drugs in December 2001, under a partnership with a major Indian company, Cipla. The local company has declined comment on the recent changes in India at this time, saying it was in dialogue with its principals in that country.

Four years ago, the pharmaceutical division donated US$5 million worth of anti-retroviral drugs to the ministry of health to prevent mother-to-child transmission of the deadly virus, and has continued to be a key supporter of local programmes. It was not immediately clear if, and how, the changes in India will affect these programmes.

According to Dr Gebre, the legislative changes may translate into an average royalty payment of between three and four per cent that will be added to the existing prices of patented drugs; but it still remains to be seen what the exact price increase will be.

In March, the Indian Parliament approved changes to the 35 year-old Patent Act, which will now make it more difficult for inventors to patent products – such as generic drugs – that were not entirely original but were created using a “novel process”.

Drug activists had feared that the changes would mean all generic drugs would have to be removed from the market, but the amendments did not go that far. Generic drugs already approved can still be sold, but sellers must now pay a licensing fee.

In addition, patented drugs can still be copied to produce a generic form, but only after the patented drug has been marketed for three years and the patent holder has no objections.

Previously, Indian manufacturers had been allowed to copy drugs for production and re-export them as generics at up to 98 per cent less than the prices offered by patent holders.

According to a World Bank study in the mid-1990s, prices for four typical drugs were 10 times more expensive in neighbouring Pakistan, 17 times more expensive in Britain and 37 times more expensive in the United States than in India.

Jamaicans, like millions of AIDS patients across the Third World, had benefited from the falling prices.

Now, with the changes to India’s Patent Act, attorney-at-law Dianne Daley – from the local patent and copyright agent Foga, Daley and Company – anticipates a dramatic price increase.

“Prices will go up phenomenally. Under the World Trade Organisation’s (WTO) Trade Related aspects of Intellectual Property Rights (TRIPS) agreement, the patent holders are entitled to equitable compensation taking into account the economic value of authorisation,” she said.

The TRIPS agreement, introduced in the late 1990s, defines how products can be protected from piracy. India signed the relevant WTO agreement on the issue in 1995 as part of its economic liberalisation.

In addition to generic AIDS drugs, the recent amendments to India’s 1970 Patent Act affects everything from electronics to software and other medicines, and has been expected for years as a condition for that country to join the WTO. The issue has taken on added urgency lately, as India jockeys for a permanent seat on the UN Security Council (UNSC).

The country’s recent legislative changes have been seen, in some quarters, as a peace offering to UN Security Council member, the US – which is pushing to protect its own pharmaceutical industry. Of the five members of the UNSC – US, China, Great Britain, France and Russia – the US is the only country that has not officially agreed to back India’s bid for a permanent seat.

Now, say those who watch international issues closely, the jockeying has trickled down to impact on countries that rely heavily on cheaper ARV drugs. But Daley pointed to a possible way out for some Third World countries to keep the cost of AIDS drugs down.

“In the Doha Declaration of August 2003, developing countries were enabled exemption from remuneration for imported patented drugs, using the compulsory licencing regime,” she said.

“This means as long as the drug is patented here, the government of the producing country would be able to grant a licence to export to Jamaica, which would be exempt. But it’s an onerous bureaucratic process and most countries do not take advantage of it.”

Also of concern is a gray area in the agreement.

“The TRIPS agreement and the compulsory licence comes into effect when there is a national health crisis. But there is a question as to what constitutes a crisis,” she explained.

“The government and Ministry of Health will have to set up a regime where they comply with strict procedures required under the Doha decision and prove they have no manufacturing capacity for the required drugs.”

An estimated 22,000 Jamaicans are living with HIV/AIDS.

The Jamaica HIV/AIDS Prevention and Control Project currently covers treatment for 1,000 persons each year.

About US$23 million has been committed to the programme over the next five years, with competitive international bids now out to cover treatment at least to the end of June.

Dr Gebre said the aim is to have a procurement plan for the next three years, and despite the recent changes in India he does not expect a major, immediate impact on the supply of current drug programmes.