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Hindustan Times
21-05-2025
- Health
- Hindustan Times
World must now build on the pandemic treaty
The world now has its first pandemic treaty that will hopefully orient its preparedness and response to avoid a repeat of the suffering endured during the Covid-19 pandemic. Member-States of the World Health Organization (WHO) adopted the landmark agreement at the ongoing World Health Assembly at Geneva. The treaty's birth has certainly not been smooth. Mooted in 2021, the initial deadline of 2024 expired amid a sea of distrust between the global South and North and swirling misinformation — such as the WHO assuming sweeping powers over sovereign member-States on ordering vaccine mandates, lockdowns, etc, forcing the global health body to issue a denial. Even now, crucial pandemic management aspects will likely have to wait for an annexure expected in a year. Key among these is pathogen access and benefit sharing (Pabs) or easier access to vaccines, life-saving treatments, and other such resources for a member-State in exchange for data on any novel pathogen surfacing within its jurisdiction. If Covid-time talks are a precedent, this will be one of the toughest hurdles. Developed nations — where the bulk of research on the relevant areas happens — had a tightfisted response to the developing and least developed world's call for sharing from their stock. On calls to ease intellectual property rights held on pandemic essentials, harnessing the TRIPS mechanism, they were unyielding. Another factor that will have a significant impact on the treaty's eventual effectiveness is the absence of the US, at WHO and within the list of likely signatories. Given it is a powerhouse of pathology and medicine research, its rejection of the treaty has serious implications for technology-sharing and surveillance, among others, hindering pandemic management. And its refusal to fund WHO — it was the body's largest historical funder — will mean the watchdog is left with very little teeth unless China or Europe fills the vacuum. The pandemic treaty is certainly a foundation, but if an edifice of global health cooperation can be raised remains to be seen.
Economic Times
13-05-2025
- Business
- Economic Times
Trump order unlikely to impact domestic generic industry working on razor-thin profits
The domestic generic drugmakers are unlikely to be impacted by the US announcement of a 30-day deadline for companies to lower the cost of prescription medicines, industry experts say. The executive order inked by US President Donald Trump, which entails the US health department to broker new prices for prescription drugs, is, however, likely to have an adverse impact on the innovator drug firms. ADVERTISEMENT "The generics industry is unlikely to be impacted, as it operates on razor-thin margins. In the US, the generics industry represents 90 per cent of prescription volumes while accounting for only 13 per cent of the market value," IPA Secretary General Sudarshan Jain said in a statement. The generics industry plays a pivotal role in ensuring medicines remain affordable and accessible, and further details on implementation mechanisms will bring more clarity, he added. Jain noted that the order emphasises that the cost of the innovation should be shared equitably among all stakeholders. "Innovator companies are expected to be affected, with a 30-day window to align their US prices with Most-Favoured-Nation (MFN) pricing," he added. He further stated that the executive order seeks to balance innovation, access and overall healthcare costs. Research and development in life sciences demands long-term commitment, substantial investment, and carries high risk. ADVERTISEMENT The IPA is a network of 23 leading Indian drugmakers, most of whom are major exporters to the US. India is the largest supplier of generic medicines with a 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories. ADVERTISEMENT Indian products are shipped to over 200 countries around the globe, with Japan, Australia, West Europe and the US as the main destinations. India has the highest number of United States Food and Drug Administration (USFDA) compliant Pharma plants outside of USA. ADVERTISEMENT As per the fiscal year 2022 report on State of Pharmaceutical Quality published by USFDA, India boasts of more than 600 USFDA registered manufacturing sites, constituting nearly 12.5 per cent of all registered manufacturing sites operating outside the US. Economic think tank GTRI has noted that the order to cut prescription drug prices by 30-80 per cent could lead to a global price adjustment with pharma firms pushing lower-cost countries like India to raise prices. India's pharmaceutical laws fully comply with the WTO's (World Trade Organisation) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). ADVERTISEMENT However, India has long resisted pressure to adopt TRIPS-plus provisions, additional patent protections often pushed by developed countries through FTAs. These include data exclusivity, automatic patent term extensions, patent linkage, broader patentability criteria, and evergreening practices. India does not allow data exclusivity. Instead, it permits regulatory bodies to rely on existing clinical trial data to approve generic medicines, ensuring faster and cheaper access. Saurabh Agarwal, Tax Partner, EY, said that while the move promises major savings for American consumers, it could face industry pushback and cause price increases in lower-cost countries as manufacturers seek to recover losses and R&D costs from these countries.
Time of India
13-05-2025
- Business
- Time of India
Trump order unlikely to impact domestic generic industry working on razor-thin profits
The US order to lower prescription drug prices is unlikely to impact Indian generic drugmakers, as they already operate on low margins, experts say. The move mainly affects innovator pharma companies required to align prices with global benchmarks. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads The domestic generic drugmakers are unlikely to be impacted by the US announcement of a 30-day deadline for companies to lower the cost of prescription medicines, industry experts say. The executive order inked by US President Donald Trump , which entails the US health department to broker new prices for prescription drugs, is, however, likely to have an adverse impact on the innovator drug firms."The generics industry is unlikely to be impacted, as it operates on razor-thin margins. In the US, the generics industry represents 90 per cent of prescription volumes while accounting for only 13 per cent of the market value," IPA Secretary General Sudarshan Jain said in a generics industry plays a pivotal role in ensuring medicines remain affordable and accessible, and further details on implementation mechanisms will bring more clarity, he added. Jain noted that the order emphasises that the cost of the innovation should be shared equitably among all stakeholders."Innovator companies are expected to be affected, with a 30-day window to align their US prices with Most-Favoured-Nation (MFN) pricing," he further stated that the executive order seeks to balance innovation, access and overall healthcare and development in life sciences demands long-term commitment, substantial investment, and carries high IPA is a network of 23 leading Indian drugmakers, most of whom are major exporters to the is the largest supplier of generic medicines with a 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic products are shipped to over 200 countries around the globe, with Japan, Australia, West Europe and the US as the main has the highest number of United States Food and Drug Administration (USFDA) compliant Pharma plants outside of per the fiscal year 2022 report on State of Pharmaceutical Quality published by USFDA, India boasts of more than 600 USFDA registered manufacturing sites, constituting nearly 12.5 per cent of all registered manufacturing sites operating outside the think tank GTRI has noted that the order to cut prescription drug prices by 30-80 per cent could lead to a global price adjustment with pharma firms pushing lower-cost countries like India to raise prices. India's pharmaceutical laws fully comply with the WTO's (World Trade Organisation) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).However, India has long resisted pressure to adopt TRIPS-plus provisions, additional patent protections often pushed by developed countries through include data exclusivity, automatic patent term extensions, patent linkage, broader patentability criteria, and evergreening practices. India does not allow data exclusivity. Instead, it permits regulatory bodies to rely on existing clinical trial data to approve generic medicines, ensuring faster and cheaper Agarwal, Tax Partner, EY, said that while the move promises major savings for American consumers, it could face industry pushback and cause price increases in lower-cost countries as manufacturers seek to recover losses and R&D costs from these countries.
Time of India
12-05-2025
- Business
- Time of India
US drug price cuts may push pharma giants to raise prices in India: GTRI
US President Donald Trump's proposal to slash prescription drug prices by 30% to 80% could prompt global pharmaceutical companies to push for higher prices in lower-cost countries like India, the Global Trade Research Initiative (GTRI) warned on Monday. The plan, which involves signing an executive order implementing a "Most-Favoured Nation" (MFN) pricing policy, is likely to lead to a worldwide price recalibration, according to GTRI Founder Ajay Srivastava. 'It is likely to trigger a global price recalibration, with pharmaceutical giants intensifying pressure on lower-cost markets like India to raise their prices by tightening patent laws through trade negotiations,' Srivastava told news agency PTI. As drugmakers face price caps in developed markets, they are expected to target emerging economies to offset losses and recover research and development costs. Srivastava noted that trade agreements will increasingly become the new battleground for pharma intellectual property rights. 'The battleground is no longer just legal, it has moved to trade negotiations. India must respond with strategic clarity and unyielding resolve,' he said. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like AI guru Andrew Ng recommends: Read These 5 Books And Turn Your Life Around in 2025 Blinkist: Andrew Ng's Reading List Undo India's resistance to so-called TRIPS-plus provisions — stricter intellectual property protections often demanded in free trade agreements (FTAs) — has been key to maintaining affordable drug access. These provisions include data exclusivity, extended patent terms, patent linkage, and broader patentability rules that could hinder generic competition. The GTRI emphasised that India's current patent regime fully complies with the WTO's TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement. It allows quick approval of generics by relying on existing clinical data, does not permit evergreening, and safeguards public health. 'From antiretrovirals for HIV to affordable cancer therapies, India's pharmaceutical industry is vital to global health,' Srivastava added. 'The world depends on India's generics. Preserving this model is not only in India's interest — it is a moral and global necessity,' the think tank said. Saurabh Agarwal, Tax Partner at EY, echoed similar concerns, stating that while the move may benefit American consumers in the short term, it could lead to pricing pressures on countries like India. 'The move promises major savings for American consumers but could face industry pushback and cause price increases in lower-cost countries as manufacturers seek to recover losses and R&D costs,' Agarwal said. Stay informed with the latest business news, updates on bank holidays and public holidays . AI Masterclass for Students. Upskill Young Ones Today!– Join Now
Economic Times
12-05-2025
- Business
- Economic Times
India has not accepted 'data exclusivity' demand by UK to protect generic drug firms
Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel India has not accepted the demand of the UK for inclusion of a 'data exclusivity' provision in the free trade agreement , announced on May 6, in a bid to protect the interests of the domestic generic drugs industry, an official said. During the negotiations, the UK had asked to include this provision in the trade pact."But India has not accepted that. There is no fear for the Indian generic industry from this agreement. In fact, it is our very important objective to see that the generic drug industry flourishes," the official sector plays a key role in India's exports, which are also exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining a marketing licence for low-cost versions during the tenure of this India had also rejected a similar demand from the four-nation EFTA bloc in their free trade agreement negotiations. The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The pact was signed in March 2023 and will be implemented later this UK ( AstraZeneca and GSK ) and Switzerland ( Novartis and Roche) have some of the major pharma firms of the generic drug industry is estimated at about USD 25 billion, and the country exports 50 per cent of its expert said that data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the WTO (World Trade Organization).India and the UK on May 6 announced the conclusion of the free trade agreement, which will make British Scotch whiskey and cars cheaper in India, while reducing duties on Indian imports such as garments and leather products here.
