(Weekly Organ of the Communist Party of India (Marxist)
June 06, 2010
Free Trade or Re-inventing Colonialism?
THE India EU
Agreement (FTA) talks have been on for some time, as have been some
talks -- notably
The difference between the FTAs and the earlier trade talks under the WTO regime is that while the multilateral talks under WTO are relatively open with texts in the public domain, the FTA talks are shrouded in secrecy. This is what happened with the FTA India had reached with ASEAN and it was only after the cheap imports of palm oil hit the Indian market, the people learnt the danger of such secret trade negotiations.
The EU Draft states: “The provisions of this chapter shall complement and further specify the rights and obligations between parties beyond those under TRIPS and other international treaties in the field of intellectual property to which they are parties. [ Article 8, para 3].” It further states as subjects, “For the purpose of this Agreement, intellectual property rights embody copyright, including copyright in computer programs and in databases, and rights related to copyright, rights related to patents, trademarks, trade names in so far as these are protected as exclusive property rights in the domestic law concerned,… plant varieties, protection of undisclosed information…” [Article 8, para 3]
The key provisions that the EU wants to push in the area of medicines are the extension of patent protection by five years, more barriers for generic manufacturers using patent linkage and data exclusivity. All these measures are attempts to extend the sphere of patents and retain their monopoly well past the normal time period of 22 years granted under TRIPS. Let us look at each of these provisions.
ATTEMPTS TO EXTEND
THE SPHERE OF PATENTS
For extension of patents, the EU argument is that patent life needs to be extended in India by another five years beyond TRIPS as Indian patent office takes time for approving patents [Article 17.3, para 1,2, 3]. We are not aware of any patent office that does not take time for processing patent applications. In any case, law cannot be changed for procedural delays. In case EU feels its companies are losing money due to long delays in the patent office, the correct procedure would be to ask the commerce ministry to streamline this procedure and not ask the Indian parliament to change the law! And not achieve this through secretive trade negotiation allegedly for “Free Trade”. Ironically, extension of monopoly is now freedom to trade!
Data exclusivity has been the subject matter of heated debates between big pharma on one hand and public health groups and generic drug manufacturers on the other. It is based on the claim of big pharma that the data it generates from clinical trials and submits to the regulatory authorities should be considered the exclusive property of the drug companies and cannot be used even by the regulatory authorities. If data exclusivity is accepted, the generic companies who want approval from the drug regulator for their generic version – chemically identical to that of the earlier patent protected ones --they have to conduct new drug trials and generate the same data that is there already with the regulatory bodies. This data monopoly is generally claimed for a further period of five years, effectively stopping cheaper generic versions of the patented products therefore for another five years. The EU has not specified the number of years it wants data exclusivity, but given what we are seeing elsewhere, it will be for at least a five year period. In effect, the EU is asking for the patent protection of all medicines to be extended five years for delays in patenting and another undefined number of years on account of data exclusivity [article 18, para 2].
The EU draft
asks also for
what is known as “patent linkage”. Patent linkage is a system in
Drug Controller refuses to grant or delays a marketing approval to a
drug manufacturer if the drug is already patented. This ‘linkage
requires that the generic manufacturer prove to the drug regulator that
drug for which he seeks approval is not covered by a valid patent. The
to create a second tier of protection for patent monopoly. In
clause in the EU draft refers to what are now being called as Border
[Article 36]. The EU is concurrently changing its laws to effectively
generic medicines that do not conform to their patent law from
transported through EU countries. The IBSA summit recently took note of
measures and called them as violations of WTO provisions and
A number of seizures of Indian medical consignments to third world
This list of problems in the EU draft is by no means exhaustive. It just covers some of the more blatant examples where the EU FTSA seeks to subvert Indian law. There are many more instances, particularly in copyright portion where EU is asking for an extension of the rights of publishers and music/film companies. These also need careful examination to ensure that we are not giving away public’s rights to satisfy big EU copyright holding media companies.
EU is asking
The government should not proceed any further on the India-EU FTA and all other FTAs unless all current proposals, negotiating drafts are debated and discussed in parliament and with state governments. The government has no right to negotiate away peoples’ rights to medicines and health.