There are murmurs that India is considering changes in its patent law as also in the existing mechanism of ‘data protection’ under its drug regulation regime. There’s nothing unusual in this, though. Whenever India enters into bilateral trade negotiations with developed nations such speculations get amplified, as intellectual property rights (IPRs) remain one of the most contentious issues.
If factors like the leaked texts of UK-India Free Trade Agreement (FTA), India being perpetually kept under ‘priority watch list’ under Special 301 reports, and the evolving geopolitical scenario are considered, these murmurs may seem to be right. On the other hand, if we take into account India’s consistent negation of ‘TRIPS-Plus’ (protection of intellectual property rights that goes beyond the requirements in the TRIPS Agreement) texts at international forums and it being the prime mover of the recent Covid-related ‘TRIPS waiver’ negotiations, these murmurs may actually be rumours.
Be that as it may, there is no denial that India’s patent policy has been crucial for access to affordable medicines, not only within the country but for many other countries as well. Thanks to conscious change of the Indian patent regime in 1970, India today holds the tag of the ‘pharmacy of the world’, supplying generic drugs to over 200 countries, with the US ranking as the top market followed by Africa and Europe. Over 60 per cent of the world’s vaccination demand is met by India.
India has been a major Covid vaccine supplier to the world in the present time, supplying 72.3 million doses to more than 94 countries by the end of 2021. Many countries preferred the Indian vaccine due to its low-cost and ability to make large-scale export consignments, besides the effectiveness of vaccines. This was of special significance for low-income countries that could not compete with richer nations for vaccine procurement during the crisis. A similar Indian effort at the turn of the millennium was to supply affordable antiretroviral drugs for HIV to the world.
Between 2000 and 2005, when India had to amend its patent law to meet its commitments under the WTO-TRIPS Agreement, it innovatively and optimally used all the available policy spaces that it had negotiated during the Uruguay Round. There was a strong public health justification in doing so. Consequently, the impact on generic competition was minimal and post-TRIPS drug prices in India didn’t skyrocket, as were predicted then.
Today there are murmurs that India is likely to dilute Sections 3(d) and 3(e) of the Patents Act, 1970 and also remove ‘pre-grant opposition’ provision. These provisions prevent ‘ever-greening of patents’ and hence promote generic competition. Also, such provisions enhance quality of patents, which in turn balances market ‘exclusivity’ and ‘competition’ as well as ‘innovation’ and ‘access’.
In March 2023, the Indian Patent Office, acting upon a pre-grant opposition, rejected a secondary patent claim over bedaquiline, an essential drug used to treat multi-drug resistant (DR) TB. The original patent on bedaquiline is expiring in July 2023. According to an estimate, every year around 1.3 lakh DR-TB patients are added to the list in India and more than 50 per cent of such cases go undetected and untreated.
At present, bedaquiline is given under the Indian government programme, which costs around $350 per patient for a six-month course. Non-extension of patent beyond July 2023 will significantly reduce this cost burden when generic versions of bedaquiline will be available.
Undisclosed test data
There are also voices that suggest India may change its existing mechanism of protection of undisclosed test data (related to market approval of drugs) against unfair commercial use, as mandated under Article 39.3 of the TRIPS Agreement. It is now settled that mere reliance on the data by drug authority to grant subsequent marketing approvals to other generic manufacturers shall not constitute breach of data protection in the terms of Article 39.3.
Even the Satwant Committee, set up in 2004, to “consider the steps to be taken by the Government in the context of the provisions of Article 39.3 of the TRIPS Agreement”, recognised that the present practice of the Indian drug authority is TRIPS-compliant, a position consistently taken by the Ministry of Health and Family Welfare. However, the Committee did suggest adopting a calibrated approach for transitioning to a fixed-term data protection (data exclusivity) regime. But this was not taken forward.
Therefore, the question today is: Should India go TRIPS-Plus? Even though nothing stops India from doing so, it will have to give a credible public health justification should it want to deviate from its established position. Such public health justification is unlikely in the present scenario.
Lack of access to quality and affordable medicines is a major challenge plaguing Indian healthcare, pushing 3 per cent of Indians into poverty every year. More than 80 per cent of total health expenditure is out-of-pocket in India, and medicines constitute most of such expenses. Since, generic drugs are much more affordable, mandating promotion of generic competition is an imperative to a welfare state like India.
It should be noted that any policy changes in India that undermines generic competition will not only affect health expenses in poor countries, but also in developed countries like the US, UK and EU. Even developed countries are considering new strategies to enhance generic competition. For instance, the EU is considering possibility of suspending data and market exclusivity to enable registration and sale of products produced under compulsory licence in the region.
Access to affordable quality drugs is a global problem, and India provides a solution. Countries can learn from its patent law. However, if there is any consideration within the government about going TRIPS-Plus, it needs to be publicly discussed.
The writer, a former National Consultant (Trade and Health), Ministry of Health and Family Welfare, is presently working with policy think tank CUTS International