Latest news with #WorkingGrouponAccesstoMedicinesandTreatment


Indian Express
3 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.


Time of India
4 days ago
- Business
- Time of India
Experts flag UK-India FTA over patent terms, access to drugs
Mumbai: Experts in intellectual property law and civil society groups in India have raised concerns that provisions in the UK-India Free Trade Agreement , Comprehensive Economic and Trade Agreement (CETA), may dilute compulsory licensing norms and jeopardise future access to affordable lifesaving medicines. As part of the Indian Patent Act, the country has the rights to invoke compulsory license for any lifesaving medicines or vaccines and call upon domestic generic players to supply it during a national emergency in the public interest. Explore courses from Top Institutes in Please select course: Select a Course Category others Digital Marketing Data Science Project Management Others CXO Healthcare Operations Management healthcare PGDM MCA Artificial Intelligence Degree Product Management Finance Data Analytics Leadership Cybersecurity Public Policy Data Science Management Technology Design Thinking MBA Skills you'll gain: Duration: 16 Weeks Indian School of Business CERT - ISB Cybersecurity for Leaders Program India Starts on undefined Get Details KM Gopakumar, co-convenor of Working Group on Access to Medicines and Treatment, said the deal amounts to giving a backdoor entry to TRIPS (Trade Related Intellectual Property Rights) plus provisions and goes beyond the minimum standards set by the World Trade Organization, which India has so far resisted in multilateral trade forums. The group said the UK-India FTA provisions on patents tilt the balance in favour of the patent owner and undermines access to medicines. The UK-India FTA says, "The parties recognise the preferable and optimal route to promote and ensure access to medicines is through voluntary mechanisms, such as voluntary licensing , which may include technology transfer on mutually agreed terms." Biswajit Dhar, retired professor of economics at Jawaharlal Nehru University, noted that India was moving away from its sovereign rights by placing emphasis on voluntary license (VLs). "It will kill the essence of the compulsory licensing mechanism and even within the legal framework, India has issued only one CL to Natco Pharma (for Bayer's kidney cancer drug sorafenib)," he noted. He said VLs come with restrictions of pricing that are determined by the innovator Big Pharma companies. "Often voluntary license contains onerous conditions on the licensee and fails to bring sharp price reduction compared to the compulsory licenses," Dhar added. Gopakumar said that India places a higher threshold for examination and grant of patents, but if the FTA deal is any indication, it may result in "functional harmonization" and lead to dilution in the grant of patent. However, a few other patent experts told ET that the FTA seeks to keep a balance between India's current IP regime with public health and the UK's preference of protecting various IP rights. The FTA seeks to create a Working Group on IPR. On patents, India's important safeguards such as Section 3(d) (which blocks evergreening of patents) of the Indian Patent Act, and oppositions have not been disregarded and it should help in India's status as the world's generic drug manufacturer and protect access to medicines for domestic patients.


The Hindu
4 days ago
- Business
- The Hindu
The UK-India FTA tilt the balance in favour of patent owner and undermines access to medicines: experts
The U.K. -India Free Trade Agreement (FTA) provisions on patents tilt the balance in favour of the patent owner and undermines the access to medicines, said experts on Friday at a discussion on the agreement's implication for access to medicines. Expressing their concerns over provisions in the recently signed agreement that could impact access and affordability of medicines in India, experts noted that certain intellectual property (IP) and regulatory clauses may delay or limit the production of life saving generics, impacting patients in India and across the Global South. 'There is a progressive movement towards accepting the demands of FTA partners, which systematically debasing the public interest safeguards available in the Indian Patents Act,'' warned professor, Centre for Economic Studies and Planning, JNU (Retd), Biswajit Dhar, explaining that the preference on voluntary licenses leaves the access to medicines in the hands of market forces and undermines the role of the government in facilitating access to medicines. 'Often voluntary licenses contain onerous conditions on the licensee and fail to bring sharp price reduction compared to the compulsory licenses,' he said. He further said that under the Indian Patents Act every year the patent holder must submit details of working of patents in India. The annual submission information will now be submitted once in three years and the confidential information contained in the submission shall not be made available in the public domain. Added Jyotsna Singh, co-convenor of the working group on Access to Medicines and Treatment: ``This effectively compromises the ability of potential compulsory license applicants to prove unmet demands, which constitute a ground for compulsory license. It clearly tilts the balance heavily in favor of the pharmaceutical transnational corporations allowing them to easily get away by hiding the denial of access to medicines due to high prices on access. ' 'There are also provisions in the IP chapter which can potentially undermine the safeguards preventing evergreening of patents,'' said K. M. Gopakumar, co-convenor of Working Group on Access to Medicines and Treatment adding that though couched in best endeavor language there are provisions 'facilitate the sharing and use of search and examination work of the Parties'. 'The implementation of this provision would lead to the harmonization of patentability criteria and undermine safeguards against evergreening such as Section 3 (d) of the Patents Act,'' he said. Meanwhile, Sanjaya Mariwala, executive chairman and managing director of OmniActive Health Technologies welcoming the move said that India's exports to the UK went up by 12.6% last year, and this deal gives us a chance to build on that growth. 'But it's not just about trade volumes—what stands out is the scope it opens-up in healthcare. With regulatory barriers coming down, Indian healthcare companies will find it easier to operate in the UK, and that can lead to more affordable services and better collaboration between the two systems. That's a space worth watching. At the same time, we can't lose sight of the fact that Free Trade Agreement (FTAs) only work well when businesses at home are strong. As more of these agreements are signed, we need to back our local entrepreneurs and MSMEs with the right support—finance, infrastructure, policy clarity,'' he said. Adds Bhavin Mukund Mehta, director, Kilitch Drugs: 'The India UK FTA by formalising zero duty access for nearly 99% of Indian pharmaceutical and medical device exports, provides long term clarity and a much needed boost for the Indian pharma industry. With the UK's pharma market projected to grow from about $45 billion now to $73 billion by 2033, and India's generics segment already crossing $910 million in exports in FY 24, this agreement will strengthen India's presence in UK drug stores and broader supply chains. For niche, high quality manufacturers that align with global standards, this is truly a game changer.'' Previously the Commerce Ministry had said that zero tariff provisions under the FTA are expected to significantly enhance the competitiveness of Indian generics in the UK market, which remains India's largest pharmaceutical export destination in Europe. Currently, India exports $23.31 billion globally and the UK imports nearly $30 billion, but Indian pharma accounts for under $1 billion. The pharma sector has 56 tariff lines, which is just 0.6 per cent of the total, the document stated. Despite the small representation, the pharmaceutical sector holds high value and strategic importance, especially in global trade, the document added. India's pharmaceutical industry is the world's third largest by volume and 14th largest in terms of value. The sector's exports rose 10% year-on-year to $30.5 billion in FY 2024-25. The industry is leading in the manufacture of high-quality generic drugs at competitive prices over the last 30 years. 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.


The Hindu
7 days ago
- Health
- The Hindu
Eliminate unnecessary animal studies, establish clear conditions for comparative clinical trials, say healthcare advocates
There is an urgent need to eliminate unnecessary animal studies, and establish clear conditions for requiring comparative clinical trials for affordable biosimilars without compromising safety and efficacy, members of civil society said in a letter to the Central Drugs Standard Control Organisation (CDSCO) on the draft guidelines on biosimilars. Also read:India takes first step to remove animals from drug-testing process A biosimilar is a biological medicine like another already approved biological medicine. While it is not an exact copy, it is clinically similar in terms of safety, purity, and potency. Biosimilars are developed to be a more affordable alternative to the reference biologic, increasing access to treatment options and potentially lowering healthcare costs. 'These guidelines mark a significant step toward making affordable, lifesaving biosimilars available to Indians suffering from serious illnesses like cancer, diabetes, and auto-immune disorders like arthritis. Biosimilars offer hope to patients by providing lower-cost alternatives to expensive biologic medicines. In India, where many struggle to afford basic healthcare, these drugs can transform lives. The draft guidelines are progressive as they have simplified the approval process, but we believe additional changes can make biosimilars even more accessible, ethical, and affordable, while maintaining safety and quality,'' the group, which includes patient advocates, healthcare organisations, and concerned citizens, said in its letter. 'The proposed guidelines on seeking reduced animal testing are encouraging. However, without a complete waiver, we are looking at increased costs and delayed access to affordable biosimilars. So, by eliminating these tests, India can lower production costs, speed up the biosimilar development, and uphold ethical standards, as well as make biosimilars more affordable for patients,' K.M. Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatment, a civil society network for affordable healthcare, said. There is also a global trend to make clinical efficacy studies an exception rather than a rule, Mr. Gopakumar added. 'The draft guidelines' provision to skip clinical trials when a biosimilar is proven similar through lab tests is a positive step. But the language used grants significant discretion to the licensing authority and carries the risk of regulatory arbitrariness. Moreover, it could be exploited by originator companies to initiate legal action against biosimilar manufacturers, alleging potential compromises in safety and quality,'' he warned, adding that the group is demanding a clear definition for the situation where a biosimilar developer needs to carry out comparative clinical trials. Calling on the CDSCO to ensure the finalised guidelines on biosimilars remain free from any conflict of interest, the group said that the 2025 Draft Guidelines on Similar Biologics offer an opportunity to advance India's healthcare system. 'By removing animal studies, clarifying clinical trial waivers, and prioritising affordability, India can make biosimilars more accessible, reduce ethical concerns, and reinforce India's leadership in affordable medicine. We request that you incorporate these recommendations and engage with civil society, patient groups, and healthcare advocates as you finalise the guidelines,'' the group has urged the CDSCO.