Shamnad Basheer

Bio: Shamnad Basheer is an academic researcher from Nirma University of Science and Technology. The author has contributed to research in topics: Intellectual property & TRIPS architecture. The author has an hindex of 8, co-authored 30 publications receiving 327 citations. Previous affiliations of Shamnad Basheer include West Bengal National University of Juridical Sciences & George Washington University.

How to achieve international action on falsified and substandard medicines.

Abstract: Substandard and falsified medicines kill patients, yet progress on the twin challenges of safeguarding the quality of genuine medicine and criminalising falsified ones has been held back by controversy over intellectual property rights and confusion over terms. Amir Attaran and colleagues propose a global treaty to overcome the problems

India's Tryst with TRIPS: The Patents (Amendment) Act 2005

Abstract: The controversial Patents (Amendment) Act 2005 was purportedly India's final step towards achieving complete TRIPS compliance. The introduction of pharmaceutical patents and the consequent threat to an internationally renowned generic industry that has, thus far, ensured the supply of affordable drugs catapulted this legislative effort to international significance, of an extent never before witnessed in the annals of intellectual property law making in India. The 2005 Act attempts to balance out competing interests of a variety of stakeholders, including domestic generic medicine producers, the domestic research and development community, foreign multinational pharmaceutical companies, civil society groups concerned with access to medicines and (last, but certainly not least), intellectual property lawyers. Although this delicate balancing deserves some applause, an unfortunate fall-out has been the hasty introduction of provisions that go against the grain of time tested patent law principles and are likely to provide excellent fodder for litigation. This note highlights some of the main changes brought about by the 2005 Act and reflects on some of their broader implications.

The 'Efficacy' of Indian Patent Law: Ironing out the Creases in Section 3(d)

Abstract: Indian patent law recently landed itself in the eye of a TRIPS storm on account of the rejection of a patent application covering Novartis' famed anticancer drug, Glivec. The rejection stemmed, inter alia, from a unique section in the Indian patent regime (section 3(d)) that seeks to prevent "ever-greening" by prohibiting the patenting of new forms of existing pharmaceutical substances that do not demonstrate significantly enhanced "efficacy." Not only did Novartis appeal the patent office decision, but in a rather controversial move, it challenged the TRIPS compatibility and constitutionality of section 3(d). The Madras High Court ruled that section 3(d) was constitutional. It also held that it did not have jurisdiction to rule on the TRIPS issue. This paper analyses this decision within the broader framework of section 3(d) and what it seeks to achieve. It argues that although the Madras High Court was correct in concluding that section 3(d) is constitutional, the court's reasoning leaves much to be desired. In particular, the court does not fully appreciate Novartis' alleged invention and the contours of section 3(d). Though this lack of appreciation is not fatal to the constitutionality analysis by the court, it is reflective of some of the creases inherent in the wordings of section 3(d). The need of the hour is to iron out these creases in section 3(d) and to help brighten the line between pharmaceutical inventions that are patentable and those that are not. This paper not only offers suggestions on how these creases may be ironed out, but also goes on to suggest an amendment to section 3(d).While some of the suggestions in the paper are immediately implementable, other issues will necessarily involve a more detailed empirical/policy investigation. This paper highlights some of the factors that one might consider whilst undertaking such empirical investigation, a task which is likely to go to the very heart of the age-old debate about what constitutes optimal intellectual property norms for developing countries.

The Invention of an Investment Incentive for Pharmaceutical Innovation

Abstract: Pharmaceutical drugs are often hailed as the poster child for the proposition that patents foster accelerated rates of innovation. This sentiment stems, in large part, from the belief that pharmaceutical research and development (R&D) entails significant costs and resources. I argue that if the role of the patent regime is one of fostering higher amounts of investment in the R&D process, it is better served by a direct investment protection regime, where the protection does not depend upon whether or not the underlying idea behind the drug is “new” and “inventive,” two central tenets of patent law. Rather, any drug that successfully makes it past the regulatory filter ought to be entitled to protection, since its discovery and development entail significant investment and risk.Owing to the sub­‐optimality of the current patent regime in protecting intensive pharmaceutical R&D investments from free­-riders, I propose a comprehensive investment protection regime that helps recoup all investments incurred during the drug discovery and development process. Though similar to existing data protection regimes in some respects, it differs in others. Firstly, it enables a recovery of all R&D costs, and not only costs associated with clinical trials. Secondly, unlike patents and data exclusivity which offer uniform periods of protection, it rewards investments in a proportionate manner, wherein drug originators are entitled to protection against free­-riders only until such time as they recoup their specific investments and earn a rate of return on investment dependent inter alia on the health value of the drug.I consider a pure market exclusivity based investment protection regime but note that it is likely to foster excessive pricing and subject the market to the dictates of a single firm. In the alternative, I consider a compensatory liability model based on a novel cost sharing methodology, where follow­‐on entrants are free to manufacture the drug, but must pay a reasonable amount of compensation to the originator. Lastly, I consider a reimbursement model, where the costs of drug discovery and development are reimbursed through public funding and prizes.Once it is appreciated that the function of investment protection is better addressed through a separate regime, the pressure on patents to fulfil a role for which it is not intrinsically suited, abates. This point is an important one to appreciate, as the conflation between patent protection and investment protection has caused many to argue for a dilution of the patentability threshold.

'Policy Style' Reasoning at the Indian Patent Office

Abstract: With the introduction of pharmaceutical product patents for the first time (via the 2005 amendments to India's patents act), it is feared that there would be a steep rise in drug prices and a consequential adverse impact on access to important drugs. Civil society proponents argue that the TRIPS flexibilities available were not exploited appropriately and that adequate safeguards were not built in to ensure an affordable supply of medicines. While this concern by civil society has some merit, what it misses is the flexibility that already inheres in the Patent Office to tailor patent protection to suit policy needs. This article argues that the Indian Patent Office has had an interesting history of taking itself to be a policy guardian of sorts and demonstrating a rather conservative approach to the issue of patentability. This policy-style reasoning can be traced back to the Ayyangar Committee report, a document that formed the very basis for the current Indian patent regime. Underlying this report was the clear message that fewer patents resulted in a stronger indigenous industry, particularly in the area of pharmaceuticals and chemicals. This article demonstrates the influence of this policy document on the decisions of the Patent Office even today and posits that, rooted in a system that stressed the virtues of a weak patent system, it is likely that the Patent Office would continue with a conservative approach to the issue of patentability, even with regard to pharmaceutical inventions (that are patentable under the 2005 Act).

Introduction to Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk

Abstract: In the last several years, business leaders, policymakers, and inventors have complained to the media and to Congress that today’s patent system stifles innovation instead of fostering it. But like the infamous patent on the peanut butter and jelly sandwich, much of the cited evidence about the patent system is pure anecdote--making realistic policy formation difficult. Is the patent system fundamentally broken, or can it be fixed with a few modest reforms? Moving beyond rhetoric, Patent Failure provides the first authoritative and comprehensive look at the economic performance of patents in forty years. James Bessen and Michael Meurer ask whether patents work well as property rights, and, if not, what institutional and legal reforms are necessary to make the patent system more effective. Patent Failure presents a wide range of empirical evidence from history, law, and economics. The book’s findings are stark and conclusive. While patents do provide incentives to invest in research, development, and commercialization, for most businesses today, patents fail to provide predictable property rights. Instead, they produce costly disputes and excessive litigation that outweigh positive incentives. Only in some sectors, such as the pharmaceutical industry, do patents act as advertised, with their benefits outweighing the related costs. By showing how the patent system has fallen short in providing predictable legal boundaries, Patent Failure serves as a call for change in institutions and laws. There are no simple solutions, but Bessen and Meurer’s reform proposals need to be heard. The health and competitiveness of the nation’s economy depend on it.

A review of existing and emerging digital technologies to combat the global trade in fake medicines

Abstract: Introduction: The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, ...

Substandard and counterfeit medicines: a systematic review of the literature

Abstract: Objective: To explore the evidence available of poorquality (counterfeit and substandard) medicines in the literature. Design: Systematic review. Data sources: Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013. Eligibility criteria: Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines. Study appraisal and synthesis: Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income. Data extraction: Data extracted: place of study; type of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations included; origin of the drugs; chemical analysis and stated issues of counterfeit/substandard medicines. Results: 44 prevalence studies were identified, 15 had good methodological quality. They were conducted in 25 different countries; the majority were in low-income countries (11) and/or lower middle-income countries (10). The median prevalence of substandard/counterfeit medicines was 28.5% (range 11–48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (p<0.000; 95% CI 0.21 to 0.32). No individual data about the prevalence in upper middle-income countries and high-income countries were available. Limitations: Studies with strong methodology were few. The majority did not differentiate between substandard and counterfeit medicines. Most studies assessed only a single therapeutic class of antimicrobials.

Reducing the Global Burden of Cardiovascular Disease, Part 2: Prevention and Treatment of Cardiovascular Disease.

Abstract: In this second part of a 2-part series on the global burden of cardiovascular disease, we review the proven, effective approaches to the prevention and treatment of cardiovascular disease. We specifically review the management of acute cardiovascular diseases, including acute coronary syndromes and stroke; the care of cardiovascular disease in the ambulatory setting, including medical strategies for vascular disease, atrial fibrillation, and heart failure; surgical strategies for arterial revascularization, rheumatic and other valvular heart disease, and symptomatic bradyarrhythmia; and approaches to the prevention of cardiovascular disease, including lifestyle factors, blood pressure control, cholesterol-lowering, antithrombotic therapy, and fixed-dose combination therapy. We also discuss cardiovascular disease prevention in diabetes mellitus; digital health interventions; the importance of socioeconomic status and universal health coverage. We review building capacity for conduction cardiovascular intervention through strengthening healthcare systems, priority setting, and the role of cost effectiveness.

Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis.

Abstract: Importance Substandard and falsified medicines burden health systems by diverting resources to ineffective or harmful therapies, causing medical complications and prolonging illnesses. However, the prevalence and economic impact of poor-quality medicines is unclear. Objective To conduct a systematic review and meta-analysis to assess the prevalence and estimated economic burden of substandard and falsified essential medicines in low- and middle-income countries. Data Sources Five databases (PubMed, EconLit, Global Health, Embase, and Scopus) were searched from inception until November 3, 2017. Study Selection Publications were assessed to determine whether they examined medicine quality and the prevalence and/or economic burden of substandard and falsified medicines in low- and middle-income countries. Studies with a sample size of 50 or more were included in the meta-analysis. Data Extraction and Synthesis The study is registered in PROSPERO and reported via the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Study quality was assessed using an adapted Medicine Quality Assessment Reporting Guidelines scoring metric. Multiple reviewers conducted the data extraction and quality assessment independently. Main Outcomes and Measures Prevalence and/or estimated economic impact of substandard and falsified medicines. Results Two hundred sixty-five studies that estimated the prevalence of poor-quality essential medicines in low- and middle-income countries were identified. Among 96 studies that tested 50 samples or more (67 839 total drug samples), overall prevalence of poor-quality medicines was 13.6% (95% CI, 11.0%-16.3%), with regional prevalence of 18.7% in Africa (95% CI, 12.9%-24.5%) and 13.7% in Asia (95% CI, 8.2%-19.1%). Of studies included in the meta-analysis, 19.1% (95% CI, 15.0%-23.3%) of antimalarials and 12.4% (95% CI, 7.1%-17.7%) of antibiotics were substandard or falsified. Eight approximations of the economic impact, focused primarily on market size, with poor or undisclosed methods in estimation were identified, ranging from $10 billion to $200 billion. Conclusions and Relevance Poor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines. Trial Registration PROSPERO Identifier:CRD42017080266