WTO: Africa backs India on affordable, lifesaving drugs

Africa is rallying behind India in its push to protect a controversial patent policy on medicine, to ensure that poor countries still have access to cheaper generic drugs manufactured by Indian pharmaceutical companies.

India is known as the “pharmacy of the developing world,” as medicines produced by generics companies in the country are among the most affordable in the world.

At the recent India-Africa Business Forum, African leaders agreed to support India’s stand on the full use of the flexibilities provided by the agreement on Trade-Related aspects of Intellectual Property Rights (Trips) — administered by the World Trade Organisation — at the upcoming WTO Ministerial Summit from December 15 to 18 in Nairobi.

US pharmaceutical companies such as Roche, BMS, Bayer and Pfizer, and trade lobby groups have been at the forefront of the push for a review of India’s intellectual property rights (IPR) law so that they comply with international trade norms — a move that could deny poor countries access to cheaper generic drugs manufactured by Indian firms.

Intellectual property rights are granted to inventors, artistes, and other creators regarding the use of their innovations.

Under the Indian Patents Act, if the government considers a drug to be unaffordable for the nation’s general population, it can issue a compulsory licence granting companies permission to manufacture a generic version at a fraction of the cost of the original drug. Furthermore, based on norms set by the WTO, if it is in the public interest, such a licence can be awarded by a government without the consent of the patent owner.

However, the US has been contesting this flexibility in a bid to protect its multinational pharmaceutical companies.

According to a WTO trade expert in Geneva, the IPR clause on flexibility in drug patenting will be a top agenda for the US at the WTO Ministerial Summit in Nairobi.

“The US has introduced ‘Trips-plus’ provisions that more aggressively protect patented drugs, plants, and seeds from public use and in some cases backtrack on the limited gains made in the Doha Declaration,” said the expert.

In the 2001 WTO Doha Round, the Declaration on Trips and Public Health provided a limited amount of flexibility, allowing the domestic manufacturing of generic drugs for public health crises.

The US, he said, prompted by pharmaceutical companies, has utilised international IPR to sue governments of developing countries for manufacturing generic versions of patented drugs.

In many poor countries, where the cost of patented drugs is high, cheap medicines are relied on to treat public health crises such as HIVAids, cancer as well as other potentially deadly health problems like diarrhoea.

In March 2012, for instance, India’s patent office allowed Hyderabad-based Natco Pharma to make a generic version of German pharmaceutical company Bayer’s cancer drug Nexavar. Bayer’s Nexavar reportedly costs about $4,500 a month for 120 pills while Natco’s generic version costs about $145 for a month’s dose.

Swiss multinational Novartis owns the cancer drug Glivec and it holds a patent for the drug in many countries including the US. Pfizer, another US drug company, is also involved in patent-related disputes in India.

According to an April 2013 article in the US medical journal Blood, the price of branded Glivec was $92,000 per patient, per year in the US, while in India, the drug was being sold for around $21,171.

“When patents are granted in the country, Indian generic manufacturers will not be able to automatically produce cheaper versions of these medicines, which could have a significant impact on access to affordable medicines, both in India and beyond, as many newer medicines [invented after 1995] are highly likely to be patent-protected,” said Ison Ndirangu, director of economic affairs and international trade in Kenya’s Ministry of Foreign Affairs and International Trade.

This means drugs for diseases like cancer and HIV, whose generic versions are cheaper, will not be accessible to many due to their high cost.

“African leaders agreed to support India’s role in providing high-quality, low-cost generic medicines, which are essential for healthcare around the world,” said Mr Ndirangu.

However, he said, Africa and India agreed to collaborate in the drug manufacturing sector.

“Kenya, for example, is in discussions with India to help us set up drug manufacturing plants so that we can produce the same drugs at a lower cost,” said Mr Ndirangu.

Although Kampala-based pharmaceutical firm CIPLA-Quality Chemicals Ltd, an Indian pharmaceutical company, manufactures antiretroviral and anti-malarial drugs for the East African market, the cost of production is high, which results in lower quantities, which are not enough for regional consumption.

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Before 2005, India did not grant product patents on medicines. This allowed for the production of low-cost generic versions of medicines that were patented in other countries. Competition among generic producers in India has seen the price of medicines to treat diseases such as HIV, hepatitis and cancer fall by more than 90 per cent.

India has become a key source of essential medicines, such as ARVs, at a low cost and over 96 per cent of all HIV medicines purchased by donors for treatment programmes in developing countries come from India.