O.K. First the tough part: bringing yourself to want to read about “Data Exclusivity” and “Investment Rules.” Granted, not the most common buzz words you hear about in media, but it’s actually very interesting. More so, if you have even a peripheral interest in what all the fuss is with regards to the EU-India Free Trade Agreement talks.
Anyway, there’s a great piece from MSF that does a pretty good job of outlining the problems with granting Data Exclusivity and tweaking Investment Rules when it comes to generic drug production.
Here’s the part on Data Exclusivity, if you’re more keen to just get on with reading it than clicking through to the whole article:
Data exclusivity (DE) is a backdoor way for multinational pharmaceutical companies to get a monopoly and charge high drug prices, even when their drug has been found to not deserve a patent, or the patent has expired – DE would apply to all drugs.
If India accepts DE, the agency in charge of approving medicines for use in the country would not be allowed to register a generic version of a medicine for a period of time – usually 5 to 10 years. To register a generic, producers rely on the clinical trial data provided by the originator company to show the drug is safe and effective. All the generic has to prove is that it is identical to the originator product. But if DE were in place, the originator company’s clinical trial data would be protected by ‘exclusivity’ and generic producers would therefore have to submit their own safety & efficacy data to register the generic medicines. This would oblige them to repeat clinical trials—something that would take years and be incredibly expensive, not to mention unethical, as it would involve withholding a drug that has already proven to be effective from some of the participants in the trial.