When the Indian Parliament amended the patent law nearly six years ago, patient & public health groups (we campaigned too) were relieved at the inclusion of several key safeguards including a prohibition on the patenting of insignificant or minor improvements of known medicines - section 3(d). This means that pharmaceutical companies should not be able to obtain patents in India for medicines that are not actual inventions, such as combinations or slightly modified formulations of existing medicines. Such patent applications are designed to delay generic competition that could lead to lower prices. For the first time, a country emphasized stricter patentability criteria for pharmaceuticals & included provisions in its patent law stipulating that patents should only be granted on medicines that are truly new & innovative.
As a result the patent office has rejected several patent applications that do not cover a new medicine but are claims on minor modifications.
How the EU-India Free Trade Agreements affects access to medicines---
Over the past three years, negotiators from the European Union (EU) & India have met repeatedly in secret negotiations on a bilateral trade & investment agreement. EU is pushing India to sign this free trade agreement (FTA) with intellectual property (IP) & investment provisions that can delay & even prevent the production, registration, transportation & exportation of generic medicines. People who need these medicines will be left without a lifeline.
It is now upto the Indian government to accept or refuse the intellectual property & investment provisions as proposed by EU in the draft FTA text. One of the EU’s demands are Data Exclusivity
In practice, data exclusivity (DE) prevents the registration—& hence the actual sale & use of low cost generics, jeopardizing access to medicines & negatively affecting public health programmes.
Data exclusivity will introduce barriers in the registration of generic drugs under India’s drug regulatory law. Under this new style of intellectual property, India’s drug regulatory agency (the Drugs Controller General of India) will be prohibited from registering an equally effective generic medicine as long as the exclusivity over the clinical trial data submitted by a pharmaceutical company lasts - usually 5 to 10 years. Domestic producers will have to submit their own safety & efficacy data to register the generic medicines. This will oblige them to repeat clinical & preclinical trials—something that takes years. But more importantly, the repetition of clinical trials raises serious ethical concerns, since it would require withholding medicines that are already known to be safe & effective from some patients solely for registering the generic version.
Furthermore, DE would apply to all drugs, even when they do not deserve a patent according to India’s strict patent law, protecting originators from price-busting generic competition.
But if India accepts ‘Data Exclusivity’ (DE) multinational pharmaceutical companies can rely on the use of data exclusivity instead of patents to preclude generic competition. While Indian patent offices apply rigorous standards…to ensure that only innovative medicines are granted a monopoly, a pharmaceutical company merely has to submit clinical trial data to obtain a five-ten year market monopoly on a old drug including new dosage forms, new strengths, pediatric formulations & even fixed dose combinations.
Therefore DE will not permit the placing of affordable versions of new formulations of even “off patent” medicines on the market by the Indian Drug Controller.
It is crucial that the EU stop these demands of India and for India not to accept any such demands in these Free Trade Agreement negotiations.
The Indian government should not sign on to investment rules & investor- states disputes mechanisms under the India-EU FTA as it will allow foreign corporations to challenge India’s domestic policy space in several key sectors including health
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