Even as India is working hard to allay the doubts of African countries on the quality and safety of medicines supplied by its domestic companies, Kenya, the third-biggest African market for Indian medicines, is planning a new legislation against “counterfeiting” that could seriously jeopardise India’s medicine exports to that country.
Domestic industry fears that other African nations may follow suit.
The Anti-Counterfeit Bill, 2008, placed before the Kenyan parliament recently, indicates that copies or generic versions of all products having patent protection in Kenya or elsewhere can be considered “counterfeit” in case of an intellectual property dispute.
Since a majority of medicines manufactured by Indian companies are under patent protection in some country or the other (though they do not enjoy patent protection in India or Kenya), the definition, in its current form, can be misused to delay or prevent supply of low-cost generic medicines to Kenya, industry experts fear. Kenya imported Rs 342.4 crore worth of medicines in 2007-08. Africa accounts for 14 per cent of India’s $8-billion medicine exports.
“African countries have been the most vocal critics of Indian pharmaceutical industry for export of sub-standard and counterfeit products for the last several years. We have expressed our concern about such exports time and again and even suggested measures to address the concerns. Kenya’s Anti-Counterfeit Bill, if enacted, will ring the death knell of India’s pharmaceutical exports to African countries as others may follow suit”, says DG Shah, secretary general, Indian Pharmaceutical Alliance (IPA).
The IPA, with its 15 member companies, accounts for over 50 per cent of India’s medicine exports.
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Incidentally, a majority of the African nations and India are on two sides of the table in the ongoing talks to review the World Health Organisation’s definition of “counterfeiting”. While India opposes all attempts to link intellectual property issues with “counterfeiting”, African nations have a different view.
“The Kenyan definition is contrary to the IP Act, 2001, and doesn’t distinguish between different categories of goods (e.g. counterfeit trademark goods, pirated copyright products) as is done in Trips (Trade-Related Aspects of Intellectual Property Rights of World Trade Organisation). The definition is ‘Trips-plus’ as it includes non-obligatory issues for inclusion under Trips”, Shah complains.
Pharmaceutical Export Promotion Council officials said they would look into the matter.
In a letter to the department of pharmaceuticals, Shah has sought the help of the Ministry of Commerce, the Ministry of External Affairs and Indian missions in Geneva and Kenya to convince the government of Kenya to prevent it from taking more international obligations than required under the WTO’s Trips Agreement and WHO’s “Draft Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property”.
The letter alleges that “the African lobby did not support India on the Scope and Definition of Counterfeit Medicines at the World Health Assembly meeting in May 2008 in Geneva”. It also says that some of the African members had accused India of opposing the (WHA) resolution to protect its export of sub-standard medicines”.