Indian pharmaceutical companies have asked their government to apply diplomatic pressure on Kenya to drop provisions in The Kenya Anti-Counterfeit Act that could be used to ban generic medicines. They fear saying that the law could be replicated elsewhere in Africa with devastating consequences for their industry.
Altogether, African countries account for 14 per cent of India’s $8-billion pharmaceutical exports.
Kenya is the third largest African market for Indian drugs, many of them generics — copies of patented drugs. The country is estimated to have imported drugs worth more than $70 million last year.
According to the government of Kenya, the law is supposed to protect Kenyan consumers.
The Anti-Counterfeit Act, which was passed by parliament last December, says 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 with the patent holder.
This provision, the Indian pharmaceutical industry says, can be used to outlaw generics at the whim of patent-holders, driving generic-makers out of business in the affected countries.
The Bill’s critics say that this definition does not distinguish between mechanical details of intellectual property rights (IPRs), such as trademarks, copyright, patents and data protection from quality control issues related to medicines, which basically revolve around formulation.
The Kenyan definition of what a counterfeit medicine is, as contained in the law, also differs from that of the World health Organisation (WHO), they say.
According to Kenyan health activists, although some amendments were made following their representations to parliament last year, the Anti-Counterfeit Act still retains clauses that could have far-reaching effects on access to medicines.
Last week, the activists met to develop a common stand on the Act, which is expected to guide their lobbying efforts for further amendments.
Kenya’s Anti-Counterfeit Act will sound the death knell of India’s pharmaceutical exports to African countries as others may follow suit,” said D.G Shah, secretary-general of the Indian Pharmaceutical Alliance (IPA) in a statement.
The IPA, comprising 15 leading Indian pharmaceutical companies, accounts for over 50 per cent of India’s drugs exports.
According to Mr Shah, the provisions in Kenya’s anti-counterfeit law are “contrary to the country’s Intellectual Property Act, 2001, and don’t distinguish between different categories of goods, such as counterfeit trademark goods and pirated copyright products as is done in the Trade-Related Aspects of Intellectual Property Rights (Trips) protocol of the World Trade Organisation.
Last week, India’s Business Standard reported that IPA had written to the government seeking diplomatic intervention to have the contentious provisions in the Kenyan law removed or amended.
According to the newspaper, Mr Shah’s letter sought the help of the Indian Ministry of Commerce, the Ministry of External Affairs and Indian missions in Geneva and Kenya to persuade the government of Kenya to drop provisions that are not mandatory under the WTO’s Trips Agreement and WHO’s draft strategy and plan of action on public health, innovation and intellectual property.
Last September, Kenyan health activists said the law could threaten the flow of much needed medicines for such public health problems such as HIV/Aids and malaria.
“The Bill contains various ambiguities, which if misinterpreted or abused would be detrimental to the government’s ongoing efforts to ensure access to essential medicines for all Kenyans,” James Kamau of the Kenya Access Treatment Movement (Ketam) told The EastAfrican then.
The movement is primarily concerned with the treatment and management of HIV.
The Anti-Counterfeit Bill was first published in 2007, but lapsed when parliament was dissolved to pave the way for the general election.
The Bill was republished on July 1, 2008 as the Anti-Counterfeit Bill before its passing in December of the same year.
The law is supposed to protect Kenyans against counterfeits, which are defined as imitations that are made with the intent to deceptively represent content or origins.
Analysts say that counterfeit goods, mainly from Asian countries and China, cost the Kenyan economy millions of dollars each year.
Mr Shah’s letter also alleged, according to the paper, that African countries did not support India during the formulation of the definition of what constitutes pharmaceutical counterfeits at the World Health Assembly meeting in May 2008 in Geneva, which did not augur well for the country’s export sector.
According to the Bill, counterfeiting is “the manufacture, production, packaging, re-packaging, labelling or making, whether in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such manner and to such a degree that those other goods are identical or substantially similar copies of the protected goods.”