Generics now face trouble in Africa

Indian generic drugs are facing a lot of trouble world over. Besides the many ‘in-transit’ EU seizures, and the high percentage of generic pharmaceuticals seizures by the US customs (which will be covered in a subsequent post), African countries are now looking towards new ‘anti-counterfeit’ legislation which are believed to have been due to the persuasion of European based multinational pharmaceutical companies. And as can be guessed, suggestions of persuasion by MNCs imply a maximalist IPR enforcement attitude. One of the first ones to have come into existence is the Anti-Counterfeit Act, passed by Kenya in Decemeber 2008. The problematic part of the legislation is that it recognises intellectual property rights of pharmaceutical products registered in any part of the world and not just in the country of export or import. This means that the intellectual property rights of a pharmaceutical product which is patented in any other country can be enforced in a sale of the generic version of that drug by India to Kenya.

Currently this legislation has been enacted by Kenya, however Indian officials fear that this will also influence other African countries of export such as Uganda, Peru and Ghana. The legislation claims that copies or generic versions of all products having protection in Kenya or anywhere else will be considered ‘counterfeit’. The aim of this legislation is in line with developed countries efforts at the WIPO to implement a regime which would recognise a patent registered in one country, world-wide. India is also likely to ask Kenya to review this legislation in order to protect its exports. The Financial Express also points out the timing at which this is coming. By the year 2012, the global pharmaceutical market will see approximately $123 billion worth of products lose their patents. Given that the expiry time line for drug patents differs across countries, it’s really problematic that the Kenyan legislation protects the intellectual property rights of drugs that are registered even outside Kenya. This gives good reason to believe that the Kenyan legislation has been influenced by vested interests.

The legislation also lacks a differentiation between the definitions of spurious goods and counterfeit goods. While one implies a sub-standard product – a public health issue, and the other merely refers to alleged IPR violations and do not necessarily compromise on quality of the product and this is not reflected in the legislation. According to the East African Community Customs Union, 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.

As per the Economic Times, India along with Brazil will be lodging a complaint with the WTO alleging that that the EU based MNCs are persuading African nations to enact these anti-counterfeit laws. D.G Shah, secretary-general of the Indian Pharmaceutical Alliance (IPA) has said that these multinations pharmaceuticals, not being able to compete with the cheaper and efficacious medicines produced by India, are now resorting to underhanded tactics.
Kenya’s Anti-Counterfeit Act will sound the death knell of India’s pharmaceutical exports to African countries as others may follow suit,” he said. Altogether, African countries account for 14 per cent of India’s $8-billion pharmaceutical exports. Aside from the growth in exports of Indian drugs to Africa which will be affected by this legislation, Africa’s access to drugs at affordable prices will also be affected.

Recently, on 24th April, India’s Commerce Secretary Mr. G.K.Pillai called for an extraordinary meeting of Ambassadors of all African countries and addressed them regarding this new development. Centad (Centre for Trade and Development), has made available a brief summary of Mr. Pillai’s speech. Mr. Pillai drew attention to the maximalist approach to enforcing IPRs that multinational pharmaceuticals backed by developed countries such as USA were taking. Their efforts in subtly circumventing the minimum standards clause in TRIPS by pushing for a more TRIPS-plus regime in regional agreements were also noted. “Having failed at the WIPO, they are attempting to succeed through the backdoor by strategically detaining our drugs at ports and convincing African countries to bring in such legislations,” Mr Pillai said. Noting the seriousness of the diseases which the countries needed to fight, he laid down the potential scenario where only branded and patent-protected medicines were allowed and generics were not, thus creating an oligopoly for the MNCs involved and raising costs by a huge margin for the affected.

At the meeting, he also brought up the issue of a conflict with the Doha declaration of 2001. According to this, members may grant compulsory licenses for exporting medicines to countries that lack manufacturing facilities. He emphasized that this provision would be rendered meaningless if African nations enacted laws that restricted legitimate trade in generic medicines. The Secretary also pointed out that the Doha Declaration stated that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO members right to protect public health and, in particular, to promote access to medicines for all.


  1. AvatarAnonymous

    Dear Swaraj
    Excellent post infact I would say eye opner News and good coverage.It would affect Indian generic business at large especially Cipla like company.
    I would request you to please provide more information on this if it is possible to provide like compartive “counterfit ” definition of Kenya and other world



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