GENEVA/NEW DELHI— Following news that India and the European Free Trade Association (EFTA) – which comprises Iceland, Liechtenstein, Norway, and Switzerland – are close to finalizing a trade deal, Doctors Without Borders/Médecins Sans Frontières (MSF), Public Eye, and Delhi Network of Positive People warned that if the final text retains the currently-included harmful intellectual property proposals, access to affordable medicines for millions of people around the world may be severely undermined.
Dr Farhat Mantoo, Executive Director, MSF South Asia said MSF has appealed to the Indian government through a letter to the Prime Minister to continue rightfully rejecting the inclusion of intellectual property provisions in the EFTA negotiations that are harmful for access to affordable medicines from India. “If accepted, these IP provisions will have drastic consequences on access to medicines and the health of patients in India and beyond. Millions of lives depend on India putting people’s health first and being able to continue supplying generic medicines globally,” Dr Mantoo warned.
Patrick Durisch, Health Policy, Public Eye, Switzerland, noting that while India represents less than 1% of the total Swiss pharmaceutical product exports, Switzerland’s persistent demands behind closed doors for more restrictive intellectual property provisions, even though India’s patent law is TRIPS-compliant, will unduly strengthen the monopoly rights of its pharmaceutical industry at the expense of patients in India and beyond. “This is a blatant example of Switzerland putting corporate profits over public health and human rights – and it underlines the urgent need for a sustainable Swiss foreign economic policy,” Durisch pointed out.
Loon Gang, Founder, Delhi Network of Positive People, India, said though people may see the FTA as a US$ 100bn investment deal with Switzerland and Norway for him, and other people living with HIV, the FTA was a direct threat to their lives. “If this FTA goes through with provisions like data exclusivity introducing new IP barriers in India, then those who will suffer will be people like us across low- and middle-income countries who rely on affordable, generic versions of new drugs for treatment,” he said, reminding that prices of newer medicines drop by over 90% when there is generic competition from India
So, for the multinational pharmaceutical industry, data exclusivity will expand their monopolies and profiteering by blocking the availability of generics from India, he said nothing that India has been through this before with the EU-India trade agreement and other FTAs, where similarly harmful provisions undermining access to medicines were rejected and withdrawn. He appealed to India to stand firm again.
The negotiations between India and EFTA for a Trade and Economic Partnership Agreement (TEPA) have been ongoing since 2006. After a five-year hiatus, trade talks were revived in recent weeks and are nearing conclusion according to the Swiss Federal Department of Economic Affairs, Education and Research, with Switzerland, home to many multinational pharmaceutical corporations, and India, a key manufacturer of generic medicines, aiming to finalize negotiations on the intellectual property (IP) chapter of the EFTA trade deal ahead of April 2024. Alarmingly, the IP proposals currently on the table go beyond what is required in international trade rules, and may result in India being forced to change its national patents and drug regulatory laws.
One of the key concerns is the proposal to introduce an additional IP barrier called ‘data exclusivity’ (DE), as DE would delay the registration of generic versions of new medicines or new formulations for a set period, even when there is no patent on the medicine. This would result in generic manufacturers either needing to wait out the exclusivity period or repeat expensive clinical trials. In cases where a new medicine is patented, data exclusivity could block compulsory licences that may be granted to generic manufacturers to produce medicines at lower prices.
Over the last two decades, the fact that India did not have data exclusivity in its law facilitated the affordable entry of new drugs for HIV, tuberculosis (TB) and viral hepatitis, which MSF has been able to use to treat people in their care. Implementing data exclusivity now has the potential to jeopardize access to essential medicines in general, as well as to delay the approval of generic versions of newer medicines, such as paediatric formulations for new TB drugs for which patents have expired. In Jordan, for example, where data exclusivity was introduced as part of the US-Jordan FTA, a study found that of 103 medicines registered and launched between 2002 to 2006 that had no patent protection in Jordan, 79% had no competition from a generic equivalent because of data exclusivity.
– MSF
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