Politics of the Pharmaceutical Industry and Access to Medicines

Hans Löfgren is Associate Professor in Politics and Policy Studies, Deakin University, Melbourne, Australia.

• The Pharmaceutical Industry and Access to Medicines in IndiaThe Pre-1972 Product Patent Period The Process Patent Era 1972–2005 Full TRIPS-compliance from 2005 Financial and Economic Crisis and Access to Medicines for All Challenges of Regulation of Medicines in India Price Regulation Weeding Out of Irrational Medicines: A Necessary Complement to Price ControlLaw on Banning Irrational Medicines Towards Ethical Marketing and Promotion of Medicines Promoting Transparency and Declarations of Conflict of InterestGeneral Review of all Legislations Other Issues Conclusion CIPLA: Patients before Patents Modest Beginnings Yusuf Hamied Living up to his Legacy India’s Patent Law 1972 The Three Drug Combination: Potent Cocktail A Life-saving Offer Success Story The Road Ahead Systemic Failure of Regulation: The Political Economy of Pharmaceutical and Bulk Drug ManufacturingThe Regulation of Industrial Pollution Structure and Methodology Structures of the Value Chains in the Rural Economy Pathways of Pollution in the Dairy Industry Regulatory Checks on Pathways in Value Chains Final Observations TRIPS Flexibilities and Access to Patented Medicines in IndiaUse of Trips Flexibilities Exemptions from Patentability Future Options India’s Free Trade Agreements: Implications for Access to Medicines in India and the Global SouthIntroduction TRIPS Compliance: Using the Doha Declaration in IndiaIndia’s FTA Negotiations: An Overview FTAs and Access to Medicines: Key Concerns Intellectual Property Provisions Investment (or Investor Protection) Measures Regulatory Harmonization Government of India’s Position FTAs, TRIPS and the Right to Health Conclusion At any Price? Boehringer Ingelheim, Bayer HealthCare and Baxter in IndiaThe Examined Companies How Good are the Drugs Supplied by these Companies? What about Access? Drug Treatment in the NGO, Private and Public Sectors Research and Patents Marketing and Business Behaviour Conclusion Trends and Prospects for India as a Global Generic PlayerIntroduction Regulatory Status of India in World Generics MarketsIndia’s Bilateral Trade in Pharmaceutical Products Outlook for the Indian Pharmaceutical Industry TRIPS and the Future of the Indian Pharmaceutical IndustryConclusion The Indian Patent Law and Access to Antiretroviral Drugs in Sub-Saharan AfricaTRIPS and Public Health Compulsory Licensing Parallel Imports The Scope of Patentability Indian Patent Law African Patent Laws The Impact of the Patent Status in India on Access in Sub-Saharan AfricaLacking Access to Patented Radical Innovative AntiretroviralsPatents Matter Accessing Medicines in Developing Economies Intersection between IPRs and Competition Law Refusal to Licence Pharmaceutical Patents in South AfricaSome Considerations Abbott’s Withdrawal of Medicine Registration Applications in ThailandExclusive Distribution and the High Prices of Medicines in VietnamIndian Perspective Concluding Remarks The Politics of AIDS Treatment in Brazil Introduction The Strategy of Local Generic Production Challenges to the Sustainability of an Inclusive AIDS Treatment PolicyRestricting Patent Rights to Reduce ARV Costs Conclusions Financing Pharmaceutical Research and Development: Alternatives to the Patent SystemProblems with the Patent System Alternative Mechanisms for Financing R&D Conclusion Post-scriptGlossary