India has called an ?extraordinary? meeting of the ambassadors of all African countries in the Capital this week to register its strong protest against a recently passed Anti-Counterfeit Act in Kenya that could severely restrict the market for Indian generic drugs into Africa.
At stake is a market that is worth over Rs 4,000 crore every year and growing fast. Exports of Indian medical products and fine chemicals to Kenya were worth over Rs 342 crore in 2007-08.
Indian drug companies specialise in producing medicines that have gone off patents. But the timeline for a patent on a drug to expire is not the same across countries. So manufacturers of generic drugs take care when exporting to a country to keep track if the medicine has gone off patents there. But the Kenyan legislation goes a step further. It says that Kenya can protect the intellectual property rights (IPR) of drugs not only registered in Kenya, but also outside its territory. This would mean if the patent rights of a drug exported from India to Kenya is not registered in India but say in Jordan, Kenya will have the right to take legal action against the Indian drug company by labeling the Indian product as counterfeit.
The Indian government is concerned as similar moves are being planned by other nations in the continent too. The meeting, involving the ambassadors and high commissioners of all African nations, has been officially described ?extraordinary?, by the government departments involved.
?Normally, IPR can be exercised only within the territory of a country where it is registered. The Kenyan law is contrary to the principle of territoriality. It is against the international law, Trips (trade-related aspects of intellectual property rights) and the basic jurisprudence on counterfeit drugs and IPR,? a government official, requesting anonymity, said.
The government and the trade experts, FE talked to said they suspected the thrust for the copycat African legislations was being instigated by some multi-national drug companies.
?Some of the countries may not have comprehended that by bringing in these laws, they are losing out on affordable healthcare. Generic medicines are essential to fight diseases like AIDS, cholera, malaria, hepatitis and even malnutrition if the cost of public health care is not to become exorbitant,? another official said.
The differences are indeed substantial. For instance, drugs like Crocin to treat fever are available in India at Re 1 per tablet. The price is Rs 16 for the same in a neighbouring country, as a pharma company holds the patent rights for it.
The major generic drug producing countries in the world are India, China, Brazil and Indonesia. But drug companies in Japan as well as in the European Union have also begun foraying into the sector, including establishing tie-ups with companies in these countries.
Shipra Tripathi, director and head of Africa division at CII said, ?India is best equipped to provide internationally certified and affordable drugs of comparable quality to African countries. This
legislation (of Kenya) is against the basic tenets of providing affordable healthcare and against the Millennium Development Goals. Indian industry bodies will make all efforts to provide African drug controllers the means to understand the research capacity of India drug providers and, therefore, convince them that this legislation should be taken off completely?.
At this stage India is, however, not contemplating a high-profile legal battle, although it is confident it is successfully challenging the legislation at the WTO. ?Since Africa is our partner and has a lot of friendly ties, we would like to keep that as the last option?, an official said.
New Delhi has already launched a major diplomatic exercise in Africa by asking Indian ambassadors to African countries to take up the issue with the ministers of health and trade as well as opinion leaders of each country. It will argue that the issue is not a matter of market access for generic medicines from India, but one of ensuring that healthcare systems in those countries remain affordable for their citizens.
Later this year, Indian industry is expected to launch a large campaign to promote pharmaceuticals from India in not only Kenya, but also Tanzania, Uganda, Botswana and Namibia. The campaign will also touch North African states like Libya, Egypt and Sudan and those in Western Africa like Morocco, Senegal and Chad.