Why India-UK FTA may push medicines out of ordinary Indians’ reach

As India is set to formally sign a free trade agreement (FTA) with the UK on Thursday (July 24), there may not be many surprises. The details about tariff, mobility, and social security charge, among other things, are already in the public domain — although the text of the FTA is not.

With the Union Cabinet’s approval to the deal on Tuesday, two days ahead of the signing, the text is expected to be made public later this week.

Mysterious IPR chapter

There is, however, one area of the deal that remains shrouded in mystery — the chapter on intellectual property rights (IPR). This chapter is likely to have provisions that may seriously impact ordinary Indians in terms of cost and accessibility of medicines.

A policy paper, UK-India Trade Deal: Conclusion Summary, released by the UK’s Department for Business & Trade on May 15, when the trade talk concluded but was not signed, began ominously: “This chapter will go far beyond India’s precedent in FTAs, building on our shared commitments in numerous international IP treaties and the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which is the international baseline of intellectual property protection.”

The chapter didn’t reveal the specifics. But it reinforced the agenda that a leaked text of the intellectual property chapter used in the negotiations by the UK carried much earlier in 2022 — months after the trade talk began.

Also read: Cervical cancer: Big Pharma’s greed-driven unethical games in India

Advantage Big Pharma

That leaked text carried several provisions that directly played into the hands of Big Pharma, allowing evergreening of patents, diluting procedural safeguards against exploitations, extending patent periods beyond 20 years, etc.

These would, if adopted, allow Big Pharma to keep the cost of medicines unreasonably high and out of reach for ordinary Indians.

The Médecins Sans Frontières (Medicine Sans Frontiers, or MSF), which accessed and studied the leaked text, listed some of these provisions: “Treat any new medical use for known substance or composition as capable of being a patentable invention” (evergreening), not to allow objections being raised by a third party before the grant of patent, “provide additional sui generis protection to patents” (extending patent term beyond 20 years, provide data exclusivity, no periodic disclosure on working of the patent, failure to disclosure of information “shall not constitute grounds for opposition, revocation or refusal to grant a patent”, etc.

In layman language, the deal amounts to this:

A) Allows companies to get new patents even if they’re using an old medicine in a slightly different way (this is known as evergreening).

B) Doesn't let outsiders (like other companies or public groups) raise objections before a patent is officially granted.

C) Gives extra protection to patent holders, such as:

i) Letting the patent last more than 20 years

ii) Keeping their research data secret (data exclusivity)

iii) Not requiring them to regularly show how the patent is being used

iv) Not cancelling or rejecting a patent just because some information wasn’t shared

Procedural safeguards diluted

These are two sets of provisions. One set found its way later to the EFTA-India Trade and Economic Partnership Agreement (TEPA), signed on March 10, 2024 and five days later, incorporated into the Patents (Amendment) Rules of 2024, through an “extraordinary” gazette notification on March 15, 2024.

The other set had new provisions that require amendments in multiple Indian laws, the Patents Act of 1970 and Drugs and Cosmetics Act of 1940.

The first set of provisions are expected to be part of the FTA with the UK – because they are already part of the TEPA of 2024 and the Patents (Amendment) Rules of 2024. The fate of the other set would be known when the text is made available.

The first set consists of four provisions diluting the procedural safeguards against evergreening.

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Risk of data exclusivity

The other set (in the leaked text) further weakens the safeguards requiring changes in Indian laws: permitting new medical use or composition as patentable invention (evergreening), permitting patents beyond 20 years and “data exclusivity”.

None of these may necessarily get in but these have generated serious concerns among civil rights activists who work to protect citizens against Big Pharma.

Roshan Joseph, regional adviser to the MSF, says the chances of “data exclusivity” getting in is higher because India and TEPA had discussed it and promised to revisit it a year later. That time is now (TEPA was signed in March 2024). “We need to worry about it being made into a law,” he warns.

Effort to browbeat India?

Data exclusivity goes beyond the TRIP and prevents generic drugs from entering the market by prohibiting regulatory authorities (India’s CDSCO) from relying on the original test data to assess and approve its generic version.

Without data exclusivity, introduction of a generic medicine needs much easier bio-availability and bio-equivalence tests on smaller samples for the test of safety and similarity with the original medicine.

With data exclusivity, a generic medicine will have to wait for the expiry of the exclusivity period or conduct fresh and independent clinical trials for the same medicine — which is prohibitively costly — even if the original one isn’t patented.

Leena Menghaney, public health IP lawyer, warns against all these provisions, especially “data exclusivity” where she sees a concerted effort by developed countries to browbeat India.

She says: “India should stay vigilant and not allow barriers to affordable medicines to be written into FTA negotiations with the UK, EU, Swiss, and the US — countries that have traditionally backed the interests of their big pharmaceutical corporations. India must hold the red line in FTA talks and reject TRIPS-plus demands like data exclusivity that link the Indian FDA to IP enforcement, undermining the registration of affordable generics.”

She notes that in one such case in the US (Colchicine for treating gout) data exclusivity led to the removal of low-cost versions and a spike in prices.

Also read: India, UK seal landmark trade deal amid US tariff shadow

Why citizens need protection

Here are three examples to demonstrate why it is important to guard against unreasonable power to Big Pharma in FTAs (through the IPRs).

Many will recall how India made history by using “compulsory licences” incorporated in the Patents Act of 1970 in 2003. It led to the first-of-its-kind manufacturing of life-saving cancer drug Sorafenib in 2012 — as an alternate to Bayer’s Nexavar at a small fraction of cost.

At the time, a monthly dose of Sorafenib cost Rs 8,800 (3%), while Nexavar cost Rs 284,428 — saving thousands of poor cancer patients. That success was never repeated and the new Patents Rules of 2024 rules out that possibility.

Rampant evergreening

A 2018 study by the Azim Premji University, Pharmaceutical Patent Grants in India, found, “The majority (72%) of granted patents for pharmaceuticals are secondary patents, granted for marginal improvements over previously known drugs for which primary patents exist.” That is, evergreening is rampant. Through it, Big Pharma keeps cost of medicines artificially high.

Here is yet another example for those who think Big Pharma deserves its profits.

In September 2022, an international team of researchers published a study after evaluating prices of 60 new drugs approved in the US during 2009-2018 and found “no association” between R&D and pricing on the one hand and curative value and pricing on the other.

Days later, the University of California published a paper saying: “Companies are estimated to spend somewhere between $1 billion and $3 billion on average to bring a single new product to market. In 2019, the US drug market generated more than $490 billion in revenue…”