Health above all else, is the unambiguous message from the High Court of Kenya, in its recent judgment relating to the country's Anti-Counterfeit Law, 2008.
Recognising the danger of the definition of counterfeit coming in the way of generic medicines being supplied into Kenya — the Court has asked the Kenyan Government to review provisions in the Act and ensure that a citizen's right to health, life and dignity is not jeopardised.
The ruling is significant since, across different markets in the world, health and the protection of intellectual property are pitted in a head-on collision. And when called to sit on judgment in such a confrontation, the Courts are increasingly casting their lot in favour of public health.
Generics and counterfeits
The Kenyan ruling also clearly outlines that generic drugs are not counterfeits, a distinction that Indian generic-drug-makers, for instance, have had to fight for several times in overseas markets.
Generic drugs are legally manufactured, chemically-similar versions of innovative medicines that have outlived their patent-exclusivity period. They are also much less expensive than the innovative medicine, since they do not have to recover research or development costs, and have to only undertake bio-equivalence tests to prove they are qualitatively similar.
Counterfeits, though, are a down-right health hazard. They are illegal, spurious (not containing the medicinal ingredient) or sub-standard medicines.
Indian generic drug-makers have in the past had constant run-ins with the European authorities, when their consignments (merely transiting through a European country) were seized on allegations of patent-infringement. The Indian government even took the Dutch authorities to the World Trade Organisation's Dispute Settlement Body. In 2008, 16 of 17 export seizures by Dutch authorities on the basis of an anti-counterfeit EU regulation were from India. The stand-off weakened eventually, with European authorities assuring India that their products would be allowed to transit.
Health takes precedence
The Kenyan ruling says, the Anti-Counterfeit Act, if implemented as it is, poses a danger to accessing essential medicine — and this was “far greater and more critical than the protection of the intellectual property rights that the Act seeks to protect. The right to life, dignity and health of the petitioners must take precedence over the intellectual property rights of patent holders.”
“While such intellectual property rights should be protected, where there is the likelihood, as in this case, that their protection will put in jeopardy fundamental rights such as the right to life of others, I take the view that they must give way to the fundamental rights of citizens…” the judge says.
Only last month, India witnessed a similar debate boil-over, with the Patent Office issuing a compulsory licence (CL) in favour of generic drug-maker Natco. The CL allowed Natco to make a generic copy of Bayer's advanced kidney cancer drug Nexavar, on the payment of a royalty to the innovator (Bayer).
The Patent Controller's judgment was a path-breaker, signalling the Indian Government's commitment to step-in if required, to bring critical and expensive medicine within the reach of more people.
Also making a strong pitch for public health in the Kenyan counterfeit case, was a submission as “friend of the court” by Lawyer's Collective's Mr Anand Grover, who filed an amicus curiae in his capacity as the United Nations Special Rapporteur for Health.
“The Act as it stands contains an ambiguous definition of counterfeiting that if misinterpreted would impact adversely on the right to life enshrined in the Kenyan Constitution; specifically through the definition potentially conflating issues of intellectual property rights and quality control.”
Put simply, it said, there was clear danger that generic medicines would be seen as counterfeits, he said. Delighted with the final ruling, Mr Grover expected the ruling would have ramifications in the other African countries as well, as Courts follow precedents.
Indo-Afro connection
India is the single largest supplier of medicines, in volume, to Africa, says V S International founder, Mr Vidyut Shah. Not only does Mr Shah's company supply the African markets, it has also borne the brunt of having its flagship Ciprotab brand counterfeited.
Mr Shah was shocked to find counterfeit versions of Ciprotab in Nigeria, that had the “Made in India” label, but had never touched Indian shores. It was later discovered to have originated in China. Mr Shah now uses technology to stay ahead of counterfeiters.
In fact, exporters to the region observe that keeping counterfeits out of the market is one thing, but to merely echo rules adopted by the developed markets (read multinational companies), only hampers access to affordable generic medicines.
There is the danger of multinational drug-makers patenting their drugs in different markets, but not selling their products in these markets — leaving it under-serviced.
In the Indian context too, Bayer's case on Nexavar was weakened by the fact that it had not “worked” its patent, and the imported quantities were not enough for patients in the country. For generic drug exporters, the Kenyan judgment directing the government to avoid ambiguity in definitions of counterfeits helps weed out unnecessary hindrances in the use of generic medicines, says Dr P. V. Appaji, Director General of Pharmexcil (the Pharmaceutical Export Promotion Council).
The region is an important export partner for India, he adds, and about $ 1,798 million (over Rs 8,000 crore), constituting 17.3 per cent of total pharmaceutical exports has been traded to the African countries.
Another instance where an argument in favour of public health is being made in a patent-related case is in South Africa. It involves French drug-major, Sanofi-Aventis, and generic-drugs maker, Cipla, over an alleged patent infringement on Docetaxel — Aventis' cancer drug.
Making an amicus curiae submission to the Supreme Court, the TAC (Treatment Action Campaign) National Council has urged the Court to consider “the right of access to health care services” when it judges this patent-related dispute.
With the paths of public health and intellectual property crossing ever so often and in different markets, it is a reality that pharmaceutical companies are learning to live with. Governments across the world, trying to keep a check on the cost of providing healthcare to its people, are leaning on generic drug-makers to provide affordable medicines.
In such a climate, drug companies need to formulate ways to not just bring out good medicines, but also make sure they are accessible to a larger section of people as well.