Interest Groups and Patent Reform in India

Indias patent reforms represent a shift in Indias policy from one of enormous opposition to revising patent laws according to the WTO, to one of compliance with many aspects of TRIPs (Trade Related Intellectual Property Rights) Agreement. Industry and civil society had a strong interest in blocking reforms on IPRs (Intellectual Property Rights), and initially played an important role in preventing reforms of Indias patent law. India has recently changed its patent regime, led by important industry groups who revised their positions, and new NGOs that promoted reform. The preferences of actors and their changing interests are important factors in the reform process. Perceived benefits from the new regime partly explain the rise of a pro-reform constituency among industry and NGOs. Yet preference formation is complex and depends on interpretation of strategies by various actors. The Indian pharmaceutical case reflects the imperatives both to forge ahead on patent reform, while protecting the generic market and restricting IPRs. NGOs that emerged to support patent reform also played a role in directing policy towards protecting traditional knowledge. The interests of actors do not always follow predictable paths, and are not fixed. Evaluating the preferences of actors rather than assuming them provides insights into the way policy processes are shaped.intellectual property rights, industry groups, NGOs, reform, preferences.

Interest groups and patent reform in India

India's patent reforms represent a shift in India's policy from one of enormous opposition to revising patent laws according to the WTO, to one of compliance with many aspects of TRIPs (Trade Related Intellectual Property Rights) Agreement. Industry and civil society had a strong interest in blocking reforms on IPRs (Intellectual Property Rights), and initially played an important role in preventing reforms of India's patent law. India has recently changed its patent regime, led by important industry groups who revised their positions, and new NGOs that promoted reform. The preferences of actors and their changing interests are important factors in the reform process. Perceived benefits from the new regime partly explain the rise of a pro-reform constituency among industry and NGOs. Yet preference formation is complex and depends on interpretation of strategies by various actors. The Indian pharmaceutical case reflects the imperatives both to forge ahead on patent reform, while protecting the generic market and restricting IPRs. NGOs that emerged to support patent reform also played a role in directing policy towards protecting traditional knowledge. The interests of actors do not always follow predictable paths, and are not fixed. Evaluating the preferences of actors rather than assuming them provides insights into the way policy processes are shaped.Intellectual Property Rights, industry groups, NGOs, reform, preferences

Valuation implications of pharmaceutical companies' R&D regulatory approval notifications

This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges. Applications to the FDA for drug approvals significantly increase shareholder wealth for NYSE firms only. The increase is driven by applications for enhancements to existing drugs, with the market anticipating the application, thus suggesting information leakage. FDA approvals also significantly increase shareholder wealth in both markets. However, there is no evidence of information leakage and the significant post-event abnormal returns support the attention-grabbing hypothesis. Enhanced drug approvals are value-relevant for both markets, which highlights the contribution of real-options to firm value

Regulating Rare Disease: Safely Facilitating Access to Orphan Drugs

While approximately one in ten Americans suffers from a rare disease, only 5 percent of rare diseases have a U.S. Food and Drug Administration (FDA) approved treatment. Congressional and regulatory efforts to stimulate the development of rare-disease treatments, while laudable, have not resolved the fundamental issues surrounding rare-disease treatment development. Indeed, small patient populations, incomplete scientific understanding of rare diseases, and high development costs continually limit the availability of rare-disease treatments. To illustrate the struggle of developing and approving safe rare-disease treatments, this Note begins by discussing the approval of Eteplirsen, the first drug approved for treating a rare disease called Duchenne muscular dystrophy. After exploring the current drug regulation system and how this impacts the availability of rare-disease treatments, this Note examines the 21st Century Cures Act’s patient experience data provisions and the currently pending Trickett Wendler Right to Try Act. Ultimately, the unmet therapeutic needs of rare-disease patients can be met while protecting patient safety, this Note reasons that, if carefully implemented, the 21st Century Cures Act and the Trickett Wendler Right to Try Act could work in tandem to safely facilitate patient access to rare-disease treatments

Facing the Trial of Internationalizing Clinical Trials to Developing Countries: Some Evidence from Mexico

In pursuit of innovation, developing countries play an increasingly relevant role for multinational pharmaceutical firms. Driven partly by cost considerations but also by some host country-specific scientific and technological factors, global drug companies increasingly relocate part of their drug development activities to those countries. In particular, expansion of clinical trials performed in some of the more advanced developing countries is notable over the last years. This paper critically addresses some of these issues with particular reference to Mexico. The latter case equally illustrates some challenges developing countries face to accommodate and govern local performance of clinical trials according to strict internationally accepted regulatory and ethical principles.Internationalization of R&D, Governance of clinical trials, Developing countries, Mexico

Promotion of access to essential medicines for Non-Communicable Diseases: Practical implications of the UN Political Declaration

Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term effective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with efficient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment offer useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off-patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent conflicts of interest need to be identified and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a difference be made to the lives of hundreds of millions of current and future patients with NCDs

Consequences of disclosing clinical trial results: Evidence from the food and drug administration amendments act

We examine how the U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007, which requires additional disclosures regarding clinical trial results, impacts information asymmetry between the disclosing pharmaceutical firm and capital market participants, the general public, academics, and practitioners. We document a reduction in information asymmetry in capital markets. We also document an increase in adverse event and product problem complaint reports filed against the pharmaceutical firms to the FDA and a higher number of drug and medical device recalls for affected firms after the FDAAA enactment. Finally, cross-sectional analyses suggest that the increase in FDA complaint reports and recalls after the FDAAA enactment was more prominent in firms with a higher bid-ask spread decrease. Taken together, our results suggest that the FDAAA has some benefits for both investors and consumers

The Globalization of Innovation: Pharmaceuticals

Analyzes trends in the global pharmaceutical industry, with a focus on intellectual property creation, business relationships, value-chain activity, and opportunities in India and China. Includes profiles of Indian and Chinese pharmaceutical firms