European Commission push for IP provisions may restrict access to cheaper ‘Made in India’ generic medicines

Source: Times of India

14 April 2015

Fears over EU plan for strict drug patent regime

NEW DELHI: As Prime Minister Narendra Modi and German Chancellor Markel are set to discuss the India-EU free trade agreement, public health groups and Indian pharmaceutical companies are concerned that the European Commission may push for stringent patent regime for cheaper medicines manufactured at home.

There are concerns that the European Commission may push for intellectual property provisions creating trade barriers and restricting access to cheaper ‘Made in India’ generic medicines across the world.

Through the bilateral agreement, EU is trying to impose stringent patent norms on Indian generic medicines during transit. For instance, if a drug is patented in EU and is exported to a third country via EU, it can seen as patent rights violations. The proposed agreement also suggests heavy penalties for such infringements. There are other such provisions, which are not limited to the supplier but also brings under the scanner the exporter and treatment providers.

Though the FTA also contains provisions that can be significant for India with the expected change in global trade, increased levels of IP protections pose a severe threat to the country’s public health as well as the drug manufacturing industry, which is major export revenue churner.

The proposed FTA seeks to slash tariffs by 90% over 10 years from the implementation of the pact. The EU accounts for almost 17% of the India’s total exports. The region is currently India’s largest trading partner with bilateral trade worth $130 billion in 2013-2014.

“The ‘Make in India’ campaign is a push by the Indian government to encourage India as a manufacturing hub. However, increased levels of intellectual property in areas such as pharmaceuticals could potentially come at the expense of undermining public health provisions and local production which have made India the ‘pharmacy to the developing world’ supplying affordable generic versions of life-saving medicines”, says Leena Menghaney, Head-South Asia, MSF Access Campaign.

While EU has been pushing India to adopt provisions beyond World Trade Organization’s (WTO) Trade-Related Intellectual Property Rights (TRIPS), any commitment beyond TRIPS will impact healthcare affordability.

So far, there have been 13 rounds of negotiations over the FTA or Broad-Based Trade and Investment Agreement (BTIA) with the last one in 2012. Sources say certain damaging provisions such as patent term extensions and data exclusivity have already been removed by EU negotiators or rejected by India’s Department of Industrial Policy and Promotion (DIPP) from the proposed deal.

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