Thursday, November 29, 2012

Is India data secure for EU?

India, with 1.2 billion of its people looks very wealthy because of its man power. India also has very high amount of people with diseases, clinically called patients. This large number of "patients pool" available in India attracts foreign medical drug companies to outsource their clinical trials in India. In order to introduce a new drug in market, drug firms should provide clinical trial data regarding efficacy and safety of the product to regulatory authority (e.g., FDA in US). These regulatory data is mostly generated from developing countries like India with huge investment. As per the WTO agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), these regulatory data has limited time protection for new drugs. However, research and development in pharmaceuticals not always results in entirely new drugs. "Variants" of existing drug would not be considered as entirely new drug for issuing patents. But still the 'variants' or 'new chemical entities' or 'second generation drugs' need to be field tested and the data regarding safety and efficacy of the drug need to be submitted to the regulatory authority in order to introduce the drug in the market. Anyway the regulatory data of variants does not get any kind of protection. Huge drug firms from US and EU demands protection for regulatory data independently of patents. That is, whether new drug or not the clinical trial data need to be protected from unauthorized use of these data by third parties. This is also referred as "data exclusivity".

India is referred as "pharmacy of developing world" due its generic drug making companies which exports many essential drugs at affordable price. In order to introduce generic medicine in the market, the generic drug companies also have to provide clinical trial data. But these companies proves that the generic drug is equivalent to the original drug and uses the regulatory data of the original drug inventor. This is called "free riding". That is, without any investment on regulatory data, the generic companies exploits the data provided by the inventor for commercial use. Possible effects of regulatory data protection would be delay in generic variants of costly drugs, which has the potential to put public health in developing countries in jeopardy.

The drug firms in US and EU are hesitant to invest on pharmaceuticals and agricultural chemical sectors. Since, India does not seems "data secure" to them. This hesitation created by the inadequate data security in India results in blockade of possible technology  and investment transfer in the aforementioned sectors. In 2007, Satwant Reddy committee submitted a report concerning "Data Protection Provision" and it has recommended 5 years of data protection in India for the pharmaceutical products with exemption for life threatening diseases such as HIV/AIDS.

Data exclusivity has many other complex aspect attached to it. However, there need to be a balance between attracting investment and technology through enhanced data protection and public health. The TRIPS agreement ensures right of economical access to healthcare and protection of public health in developing countries (i.e., compulsory licensing...etc ). So, India must take a liberal view on data exclusivity and should make maximum use of flexibility provided by TRIPS agreement.


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