Activists warn of US pressure to change drug regulatory system

Drug regulatory system

Source: DNA | June 26, 2017

In the past, the US government has successfully pressurised India to change its pro-public health stance, and there may be renewed demands for more concessions

As US President Donald Trump and Indian Prime Minister Narendra Modi meet at the White House on Monday, activists warn that US pressure on India to change its drug regulatory and patent system, could result in millions of people losing affordable medicines.

The US government — backed strongly by the pharmaceutical lobby — is expected to step up pressure on several governments, including India and others in Asia and Latin America, to enforce and protect intellectual property of pharmaceutical corporations — an approach that has led to high drug prices in the US and around the world by limiting competition. In the past, the US government has successfully pressurised India not to issue any compulsory licenses to make affordable versions of patented medicines available.

“The United States has a history of pressurising India to change its pro-public health stance on intellectual property. Ahead of his meeting at the White House, we’re urging PM Modi not to cave into any pressure from the US,” said Leena Menghaney, South Asia Head for international NGO Médecins Sans Frontières’s (MSF) Access Campaign.

The high prices that pharmaceutical corporations charge, are preventing people in both developing and developed countries from accessing medicines they need. For example, in the US, one new Hepatitis C medicine was introduced at $1,000 (Rs 64,000 approximately) per pill, whereas in India the entire course of treatment for hepatitis C costs close to $500. In India, HIV regimens that were priced at $10,000 per person per year 15 years ago now cost $100 per year due to generic competition.

It is expected that there will be renewed pressure by the US on India to make more concessions, such as extending the term of patent beyond twenty years and lowering the standards for granting patents.

“Aiming to boost the monopoly rights of pharma corporations overseas, the US government is using several tactics to push India to make changes to its drug regulatory system that will restrict generic competition by linking the registration of medicines to their patent status, called patent linkage,” said Jessica Burry, Pharmacist for MSF’s Access Campaign.

“The US is also pushing India to implement ‘data exclusivity’, a mechanism that will prevent the Indian drug regulatory authority from considering a generic applicant’s dossier for marketing approval for the exclusivity term, even when patents no longer apply or exist,” added Burry.


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