Latest news with #Trade-RelatedAspectsofIntellectualPropertyRights
Indian Express
6 days ago
- Business
- Indian Express
India stuck to TRIPS and domestic law in UK deal, says official amid drug access concerns
India has not gone beyond the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement or domestic law in the Intellectual Property Rights (IPR)-related deal with the UK, a senior government official said on Saturday after trade experts raised concerns stating that India had moved away from its conventional position on IPR in the UK trade deal. The 'Working Group on Access to Medicines and Treatment' and trade experts pointed out that the UK deal has provisions tilting in favour of patent holders since they bring the issuance of compulsory licences — a critical tool to ensure access to affordable life-saving medicines — under greater scrutiny and constraints. 'In the IPR chapter, India has not breached the TRIPS agreement and is in compliance with domestic law. Only best practices that do not infringe on domestic laws have been adopted. Sharing of information and several such elements are part of the deal,' the government official said. The Working Group on Access to Medicines and Treatment is a network of patients, activists and professionals working towards access to affordable medicines in India. It said the UK-India FTA provisions on patents tilt the balance in favour of the patent owner and undermine access to medicines. 'There is a progressive movement towards accepting the demands of FTA partners, which is systematically debasing the public interest safeguards available in the Indian Patents Act. Article 13.6, stating the understandings regarding TRIPS and public health measures, clearly places voluntary mechanisms such as voluntary licensing as the preferred and optimal route to promote access to medicines,' the working group said. Biswajit Dhar, a trade policy expert with the Council for Social Development, said that the provisions in the UK deal favouring voluntary licences leave access to medicines in the hands of market forces and undermine the role of the government in facilitating access. 'Further, it also gives a clear signal to potential compulsory licence applicants that they are not welcome. Often, voluntary licences contain onerous conditions on the licensee and fail to bring sharp price reductions compared to compulsory licences,' Dhar said. 'There are also provisions in the IP chapter which can potentially undermine the safeguards preventing evergreening of patents. Though couched in best endeavour language, there is a provision to 'facilitate the sharing and use of search and examination work of the Parties'. The implementation of this provision would lead to the harmonisation of patentability criteria and undermine safeguards against evergreening, such as Section 3(d) of the Patents Act,' said K M Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatment. Compared to the European Free Trade Association (EFTA) IP chapter, this chapter shows further movement towards strengthening the interests of patent holders at the cost of access to medicines. The implementation of these provisions reduces the ability of the central and state governments to fulfil their constitutional obligation on the right to health, the working group said.
Hindustan Times
12-07-2025
- Health
- Hindustan Times
India's patent model a benchmark for access and innovation
Equitable access to safe, effective, and affordable medicines remains a crucial public health challenge. According to the WHO, nearly two billion people worldwide—many in low- and middle-income countries and even some in developed economies still lack access to essential medicines. Patent(Photo used for representational purpose) This global inequity raises a critical question: How can countries foster pharmaceutical innovation without making life-saving medicines inaccessible? India's experience offers a compelling answer and in 2025, the country will mark 20 years since it institutionalised that approach. When India amended its patent law in 2005 to align with the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, it did more than fulfil international obligations. It established a patient-first model that balances innovation with access a model that continues to shape global thinking. From being almost non-existent in the 1970s, the Indian pharma industry has come a long way to being one of the largest and most advanced pharma industries in the world. This success stems from entrepreneurial drive supported by policies like the Patent Act, 1970. A major shift came in 1995 when India joined the WTO and committed to aligning its IP laws with TRIPS, including product patents for pharmaceuticals. For a country with a strong generics base, this was a significant transition. However, India struck a careful balance—encouraging innovation while safeguarding public health. The pharmaceutical industry adapted quickly to this new global IP framework. The amended Patents Act in 2005 aligned with minimum standards set by TRIPS Agreement and using TRIPS flexibilities included crucial safeguards: patentability criteria that would prevent evergreening, pre-grant opposition to ensure the genuineness and quality of patent and to weed out frivolous patent applications, if any, and provisions for compulsory licensing in the public interest. Over the past two decades, India's patent framework has become a global example of balancing innovation with access to medicines. For instance- the pre-grant opposition mechanism, used to prevent the grant of patents on salts, polymorphs, formulations, and other derivatives that do not meet patentability criteria set by Indian Patent Act This ensures weak applications are rejected during examination itself. As a result, Indian companies have been able to launch generic versions of drugs immediately after the primary patent expires, ensuring timely access to affordable medicines. Without this safeguard, patients would have faced delays and higher costs. Over the last two decades, India has demonstrated that a balanced intellectual property (IP) framework can drive innovation while safeguarding access to medicines. In 2005, only three pharmaceutical product patents were granted in India; by 2008, this number rose to 1,369. Today, India is among the world's fastest-growing IP jurisdictions, with a 15.7% increase in patent filings in 2023, ranking sixth globally. Pharmaceuticals and Medtech now account for around 15% of filings, reflecting the sector's growing innovation capacity. However, this balance is under increasing strain. Several countries are pushing for TRIPS-plus provisions in trade agreements—extending patent terms, introducing data exclusivity, and patent linkage all which risk delaying generic entry. Additionally, some innovators are using both patent and regulatory frameworks to extend monopolies through tactics like patent thickets and product hopping. Such practices threaten to increase medicine prices and limit access, particularly for India and many countries dependent on Indian generics. India has resisted these pressures, recognising the risks to domestic and global health security. Protecting this calibrated IP framework is critical for sustaining affordable access to medicines. Meanwhile, India's pharmaceutical industry has expanded from $3 billion in 1999 to $58 billion in 2024 cementing its role as the pharmacy of the world. Net foreign exchange earnings surged from $1.1 billion to $19.5 billion. The Covid-19 pandemic further underscored India's importance, as it supplied medicines to over 150 countries. Globally, even developed regions like the EU and US are rethinking their pharmaceutical IP policies to curb abuse and ensure access. In the US, legislative efforts like the Affordable Prescriptions for Patients Act and the Drug Competition Enhancement Act aim to curb practices such as patent thickets and product hopping. With over $250 billion worth of global drug patents expiring between 2022 and 2030, Indian companies have a major opportunity in biosimilars, complex generics, and innovative therapies. In last two decades, the country's IP model continues to serve as a global benchmark for balancing innovation with public health. India's philosophy remains rooted in a simple principle: innovation and access are not competing goals; they are complementary imperatives. Good health policy isn't about choosing between science and society; it's about designing systems where both can thrive, and India's IP framework proves it's possible. This article is authored by Archana Jatkar, associate secretary general, Indian Pharmaceutical Alliance.
Indian Express
12-05-2025
- Business
- Indian Express
Donald Trump's new pharma order could increase pressure on India to hike drug prices, stocks tank on margin worries
Global pharma companies could ramp up pressure on India to raise the prices of drugs in India and other developing markets, as US President Donald Trump's new executive order is set to force companies to align US drug costs with cheapest ones abroad. Trump said he would introduce a 'most favoured nation' (MFN) policy whereby the US pays 'the same price as the nation that pays the lowest price anywhere in the World'. 'Prescription drug and pharmaceutical prices will be reduced, almost immediately, by 30 per cent to 80 per cent. Prices will rise throughout the world in order to equalise and, for the first time in many years, bring fairness to America. I will be instituting a Most Favoured Nation's policy, whereby the United States will pay the same price as the nation that pays the lowest price anywhere in the world,' Trump said in a social media post. 'For many years, the world has wondered why prescription drugs and pharmaceuticals in the United States are so much higher in price than in any other nation—sometimes being five to ten times more expensive than the same drug, manufactured in the exact same laboratory or plant, by the same company,' Trump said. International trade experts said Trump's executive order may offer immediate relief to American patients, but it is likely to trigger a global price recalibration—with pharmaceutical giants intensifying pressure on lower-cost markets like India to raise their prices as the low cost markets would determine prices in the lucrative US market. India's generic drug industry, which is not only a source of low-cost medicines in India but also in the US and UK, has long been a bone of contention for large pharma companies in developed countries. These companies argue that weak intellectual property rights in India leave them uncompetitive. Trump's executive order follows the US placing the Indian patent regime on its 'Priority Watch List' for intellectual property rights (IPR), which has a significant bearing on drug manufacturing. Head of think tank Global Trade and Research Initiative (GTRI), Ajay Srivastava, said that Trump's MFN pricing policy should be a wake-up call, as pharmaceutical companies facing tighter price controls in the West will be forced to redouble their efforts to raise prices in markets like India. 'The battleground is no longer just legal—it has moved to trade negotiations. India must respond with strategic clarity and unyielding resolve. As global pharmaceutical firms turn to free trade agreements (FTAs) to extract Trade-Related Aspects of Intellectual Property Rights '(TRIPS)-plus' commitments, India must hold the line on its patent regime—one that enables affordable access, prevents monopolistic extensions, and safeguards public health,' Srivastava said. India's pharmaceutical laws fully comply with the WTO's Agreement on TRIPS. However, India has long resisted pressure to adopt 'TRIPS-plus' provisions—additional patent protections often pushed by developed countries through Free Trade Agreements (FTAs). These include data exclusivity, automatic patent term extensions, patent linkage, broader patentability criteria, and evergreening practices, Srivastava said. A pharma industry executive told The Indian Express that the order will not have a negative impact on Indian generic manufacturers and exporters, and would instead squeeze the margins of distributors or patent drug manufacturers. 'If I sell at, say, $1, the actual cost paid by the pharmacy is $9–10. Around $8 is taken by the distributors. In the generic space, if he really wants to do something and bring down the price, he needs to attend to this supply chain lobby—then definitely that will help American patients,' the Indian pharma executive told this paper on condition of anonymity. The executive further explained that out of the $670 billion US pharma market, only 21 per cent is generics, while the remaining 79 per cent or so are patented drugs. 'In generics, price erosion has already happened. In the generics space, there is only one big gap. If it is addressed, that would be good for our country also. What is happening is that over five or six distributors are ruling the entire US market in generics. They are also keeping their profit out of the US,' the executive said. In generics, the money is hidden in the supply chain, which Trump has to attend to. The problem for the US is that currently, these patented drug manufacturers are keeping their head offices mostly outside the US—in Ireland, Europe, etc.—and they are getting exorbitant profits mainly in the US, which they are keeping out, the person quoted above said. The comments triggered a sell-off in pharmaceutical stocks on Monday amid concerns that profits could be hit if firms have to cut prices in the US. In India too, pharma stocks tanked.
New Indian Express
12-05-2025
- Business
- New Indian Express
India hasn't accepted UK 'data exclusivity' demand in FTA to protect generic drug firms
CHENNAI: India has declined the United Kingdom's request to include a 'data exclusivity' clause in the Free Trade Agreement (FTA) announced on May 6, in order to protect the interests of its domestic generic drug industry, a Commerce ministry official confirmed. During the FTA negotiations, the UK proposed adding a provision that would grant exclusive rights over clinical trial data to innovator pharmaceutical companies. However, Indian officials did not agree to this request. 'There is no threat to the Indian generic drug industry from this agreement. In fact, ensuring the growth of the generic sector is one of our key priorities,' sources in the Commerce Ministry were quoted as saying by news agencies. India's generic pharmaceutical sector plays a significant role in the country's exports, which continue to grow. The industry is valued at around USD 25 billion, with nearly 50% of its output being exported. What is Data Exclusivity Data exclusivity protects the clinical trial data that innovator companies generate to prove the safety and effectiveness of new drugs. This protection can prevent competitors from using the same data to gain marketing approval for cheaper generic versions during the exclusivity period. By securing exclusive rights to their data, original drug makers can delay the entry of low-cost alternatives into the market. India had earlier rejected a similar demand from the four-member European Free Trade Association (EFTA)—comprising Iceland, Liechtenstein, Norway, and Switzerland—during FTA talks concluded in March 2023. That agreement is expected to come into force later this year. Some of the world's leading pharmaceutical companies, such as AstraZeneca and GSK (UK), and Novartis and Roche (Switzerland), are based in these countries. An expert noted that the concept of data exclusivity goes beyond the scope of the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which India adheres to. The India–UK FTA, announced on May 6, includes mutual benefits: British Scotch whisky and cars will become cheaper in India, while tariffs on Indian exports like garments and leather goods to the UK will be reduced.
The Guardian
15-04-2025
- Business
- The Guardian
The Guardian view on Donald Trump's industrial policy: inward turn by ultimatum
Globalisation is out; reshoring is the new realism. Intel's half-built Ohio campus and Nvidia's US supercomputer plan demonstrate the very different routes taken by Joe Biden and Donald Trump in the search for homegrown tech dominance. Mr Biden relied on institutions: grants, land and investment incentives. That approach has stalled after last year's election, rendering Intel's plant idle. Mr Trump prefers court politics: flattery, pressure and tariff threats. Nvidia's move seems driven less by design than executive ultimatum. Industrial strategy lives on – but, and this is a concern, increasingly through presidential menace, not policy. There's another important message in the Nvidia announcement. In an era where ideas spread freely, power lies not in invention but in chokepoints, such as artificial intelligence supercomputer fabrication, that determine who can scale those ideas into global platforms. Remember that as the US braces for a backlash over the breakdown of the old trade order. The Harvard economist Ricardo Hausmann has noted that Mr Trump's miscalculation is focusing on goods trade, while ignoring the bigger game: services, intellectual property (IP) and investment. Boeing's most profitable division is services, not manufacturing – but both will be hit by China's decision to block further deliveries of its jets. Prof Hausmann warned that developing countries may retaliate by undermining the global Trade-Related Aspects of Intellectual Property Rights agreement. Known as Trips, the IP regime stands behind $632bn in US overseas profits. If Mr Trump has a plan, it's well hidden. But perhaps his strategy is simply this: if others want to copy yesterday's technologies or challenge IP norms, let them. The US, by this logic, will just invent the next indispensable thing – and charge to access it. America is a leader in AI, biotech and platform services. But recent developments complicate this picture. Open-source AI such as China's DeepSeek shows that frontier tech no longer needs a Silicon Valley address. In pharmaceuticals, a similar contradiction plays out. Eli Lilly's blockbuster weight-loss drug Mounjaro had its formula made public under Food and Drug Administration rules – the price of market access. That transparency fuelled a global flood of generics and counterfeits. It's the Trips dilemma: innovation demands openness, but imitation thrives where enforcement lags. Now, in a sharp escalation, the Trump administration has launched a national security probe into pharma imports. China, India and the EU, all major exporters, are in US crosshairs. The deeper irony is that since 1945 the US has built its global position by championing openness – in science, trade and finance – yet it is now walling off supply chains and invoking security doctrines to shield its markets. Meanwhile, the very IP regime that helped extract 'rents' from the world economy is under strain. The US may still dominate, but it's on the defensive – onshoring production and securing chokepoints. In January, Mr Trump threatened 100% tariffs on any country daring to sidestep the dollar – and hence powerful US Treasury sanctions. If developing countries begin to renege on Trips – no longer seeing value in enforcing patents in return for access to increasingly closed markets – the consequences will reach far beyond US firms. In 2023, India paid $14bn to foreign entities for using IP, up from $1.9bn in 2009, without much meaningful benefit in return. For now, the US may still invent the future. But whether America can own it, monetise it or exclude others from it remains uncertain. The age of innovation may be global. The age of power, increasingly, is not.
