Protect India's Generic Medicines and Patent Laws: MSF to the European Commission

As India and the European Union pick up their Free Trade Agreement (FTA) talks on April 12, Médecins Sans Frontières (MSF) wrote to the European Commission to ensure that the talks remain free of provisions that could jeopardize the production of affordable generic medicines in India and the world’s access to them.

The India-EU FTA talks started in 2007, were on hold in 2013. Rocky negotiations in 2009 resulted in the leak of certain documents from the talks that pressurised India’s patent laws, which allow the generic pharmaceutical industry to make affordable versions of expensive drugs originally made by multinational corporations. The documents showed that the EU’s push for intellectual property (IP) provisions could adversely impact the production of generic medicines in India and their supply to countries that need them.
Though multiple objections that came during the earlier rounds of the talk, got these provisions off the table, the concern raised by MSF – an international medical charity and aids organisation – is that they could be back. The letter to the European Commission says that “both parties have agreed to resume technical discussions concerning the FTA, including the chapter on intellectual property (IP) provisions.”

According to the MSF, the EU is proposing an ambitious enforcement mechanism for IP rights that will drag to court even third party procurers of generic drugs, such as MSF itself that supplies affordable drugs to low income countries around the world. The mechanism will increase the scope of wrongful searches, seizures, and legal action against legitimate drug suppliers. The EU’s proposed provisions will give patent holders, that is the MNC that develops the drug , the right to draw everyone in the manufacturing and supply chain into litigation.

The call for ‘provisional injunctions’ will let courts stop any generic medicine from reaching the market, based simply on suspicion of patent violation and not the actual proof.

The border enforcement measures that EU wants, will disrupt the supply of medicines to other countries, allowing countries through which the medicine passes, to confiscate it based on the suspicion of patent violation.

The MSF asked the European Commission (EC) that these provisions, especially to do with patents, be completely removed from the talks on IP enforcement.

MSF’s alarm, as it says in the letter, comes from a February 2018 report by the European Commission on “the protection and enforcement of intellectual property rights in third countries is rolling back the EC’s prior commitments to support production of essential generic medicines and the use of Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to address public health needs.”

The letter adds that the EC report criticizes India’s criteria for patentability, compulsory licensing and revocation of patents under the Patents Act, despite the fact that these provisions are compliant with international WTO rules and are intended to protect against the abuse of the patent regime and to enable access to affordable generic medicines.

India, known as the pharmacy of the developing world, uses its laws to grant licences to domestic generic companies to reverse engineer the exorbitant drugs made by MNCs. These cheaper drugs not only reach Indian patients but crucially, those in other low to middle income countries where the originator drugs are unaffordable. These patent laws have repeatedly put India under the US and the EU’s bad books.

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