Kenyan court ruling, a boost for Indian generics exports

A Kenyan court’s recent landmark order could be the much needed shot in the arm for Indian pharma companies trying to gain greater access to the African generic (or off-patent) drugs market.

The ruling of the High Court of Kenya said Kenya’s Anti Counterfeit Act, 2008, severely limits or threatens to limit access to affordable and essential drugs as well as medicines, including generic medicines for HIV and AIDS.

The court asked the Kenyan Government to amend the Act to ensure that the rights of those dependent on generic medicines are not jeopardised.

The judgement is significant for Indian companies because a fifth of India’s drugs and pharma exports worth over Rs 50,000 crore goes to Africa, according to industry estimates. Besides, one-fourth of the world’s generics and a fifth of the world’s drugs are made in India.

India has in the past repeatedly taken up the issue of anti-counterfeit legislation not only with Kenya but also with other East African nations such as Tanzania, Uganda, Burundi and Rwanda, trying to pass similar laws or policies.

Indian officials had maintained that such legislations, being brought in allegedly at the behest of certain multinational drug giants, could affect India’s exports of generic drugs — most of them affordable life-saving medicines — to Africa.

These laws seek to equate legitimate generics with counterfeit drugs, a move that could affect the health security of many economically-backward Africans, they said.

In fact, the High Court ruling in effect echoed these sentiments saying the right to life, dignity and health of people like the petitioners — who are infected with the HIV virus — cannot be secured by a vague proviso in a situation where the law enforcement officers may not have a clear understanding of the difference between generic and counterfeit medicine.

The court observed that the danger that the petitioners see in the possibility of the terms ‘generic’ and counterfeit’ being used interchangeably arises out of instances where generic medication has been seized while in transit on the basis that it is counterfeit.

Such seizures have affected users of generic drugs in developing countries which, like Kenya, have large populations dependent on generic HIV medication for survival, it noted.

“The nature of international trade being the way it is, the risk of seizure of generic drugs bound for Kenya, whether at Kenyan ports or outside this country, cannot be ruled out,” the judgement said.

SEIZURES OF INDIAN DRUGS

Interestingly, the order noted the incidents of such seizures by customs authorities in the Netherlands of generic drugs for HIV destined for Brazil in December 2008 and the seizure in Germany of generic drugs manufactured in India which were bound for Vanuatu.

Following the ruling, UNAIDS’ Executive Director, Mr Michel Sidibé, said in a statement that, “A vast majority of people in Kenya rely on quality generic drugs for their daily survival. Through this important ruling, the High Court of Kenya has upheld a fundamental element of the right to health.”

“This decision will set an important precedent for ensuring access to life-saving drugs around the world,” he said.

Further, Mr Sidibé said, “We must have both generic drugs and strong anti-counterfeit laws. Generic drugs give more people access to life-saving treatment, while anti-counterfeit laws keep people safe.”

India’s total pharma exports to Africa grew 32.64% to $1.58 billion in 2010-11 from $1.19 billion in 2009-10

Indian pharma companies have brought down the cost of drugs in Africa for HIV/AIDS treatment for one patient for one year from $12,000 to currently less than $400.

Similarly, in tuberculosis and malaria, Indian companies and the Government are trying to bring down cost of vaccines.

India maintains that its generics and its pharma industry are fully compliant with WTO’s TRIPs norms

>arun.s@thehindu.co.in

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