Big Pharma presses for TRIPS+ to perpetuate monopoly

It’s another attempt by multinational drugmakers to monopolise the medicine market in the country.

After filing for patent applications for new forms of known drugs and trying to link the patent status with generic registration, MNC pharma companies are now trying to increase intellectual property (IP) protection through the drug controller’s office and prevent generic drugs from getting registered.

These firms are pressing for something called ‘data exclusivity’ under the pretext of ‘data protection’, thereby going beyond what is mandated by the trade related aspects of intellectual property rights (TRIPS) agreement of the World Trade Organisation (WTO).

The term ‘data protection’ is already well-recognised in India. It refers to non-disclosure of clinical trials data pertaining to new chemical entities (NCEs) generated by innovator companies to third parties (including generic companies) and bars unfair commercial use of that data.

Data exclusivity, on the other hand, refers to a certain period of time during which the regulator cannot rely on an innovator’s clinical trials data pertaining to NCEs in order to register a generic version of the drug.

Says Ranga Iyer, managing director of Wyeth India and president of the MNC drugmakers lobby OPPI (Organisation of Pharmaceutical Producers of India): “We are asking for a five-year period during which the regulator should not rely on innovator’s data when registering generics in the country.”

According to healthcare experts, safety and efficacy of generics can be demonstrated by showing that the drug is chemically and biologically equivalent to the existing innovator drug by doing bioequivalence and stability studies. These are faster and less expensive than full-fledged clinical and pre-clinical trials.

The Drugs Controller General of India (DCGI) relies on the innovators’ data, or on the approvals given for that drug by regulatory bodies of other countries, in order to register the generic drug in the country.

According to a legal and IP expert based in New Delhi, data exclusivity is beyond the ambit of TRIPS. “Article 39.3 of TRIPS requires countries to protect NCE data against disclosure and against unfair commercial use. But nowhere does TRIPS state that countries should provide exclusive rights to the innovator for a given period,” says the expert.

“The drugs controller relying on the data to register generics is compliant with TRIPS as the regulator is not a commercial organisation”.

Says a New Delhi-based healthcare and legal expert, working in the area of access to medicines: “If data exclusivity is granted in India, then generic players would have to conduct the entire expanse of trials, which would lead to inordinate delays in getting low-cost drugs to the market.”

However, according to Ranjit Shahani, vice-chairman and managing director, Novartis India, there is no connection between drug affordability and safeguarding data from being relied upon when registering generics.

“Research to bring out a new drug to the market needs about 8-10 years and costs $1-1.7 billion. Thus, maintaining confidentiality of data generated during this period protects the innovator and preserves incentives for continuing innovation. It also gives confidence to launch innovative medicines,” he says.