Scare of Avian Flu Revisits India: A Bumpy Road Ahead

With the threat of an avian flu pandemic once again looming over eastern India, issues regarding patents and affordability and accessibility of drugs have taken center stage. The key priority of India should be to remain prepared to address the public health crisis effectively, by stockpiling the drug tamiflu so that it can be easily distributed and administered to the needy.India had been confronted with a serious threat of avian flu in 2005-06, but past experience shows that, despite having some of the broadest and most comprehensive compulsory patent licensing laws, India's policymaking elite shied away from fully exploiting these legal 'flexibilities.' Fortunately, the danger of avian flu did not turn into a substantial public health crisis that year. Under this backdrop, this paper explores various ‘flexibilities’ available in the Indian patent law and suggests short term and long term strategies to effectively tackle the impending danger of an avian flu pandemic, and similar public health crises in future. This paper will discuss potential areas of conflict between the indigenous generic drug firms and the multi-national companies with respect to TRIPS compliance in the event that these flexibilities are exploited. This paper also highlights the administrative constraints and the economic viability of the compulsory licensing system. Finally, this paper shows how political will is often more critical than having well documented provisions in statute books to respond to such situations effectively

The TRIPS Article 23 Extension Stalemate Continues: A Way-Ahead for the Developing Countries

405-422The GI-extension debate has brought conspicuous public attention on the unusual characteristic of the TRIPS Agreement. Unlike other classes of intellectual property, the TRIPS Agreement provides a pecking order in the levels of protection for a single definition of subject matter. While most of the Members admit that the pecking order in the levels of protection has neither logical nor legal basis, they continue to vehemently defend their positions on GI-extension. Though the debate over extension of Article 23 started out largely as a North-North issue, the current debate is an interesting amalgamation of North-North conflict and North-South split. This paper examines the provisions of TRIPS Agreement regarding GIs and utilizes the submissions made to the TRIPS Councils to critically analyse the issue of Article 23 extension in the background of North-South face-off. This article also evaluates the possibility of higher protection in addressing distinctive circumstances confronted by the developing countries. This paper concludes that in view of the diverging interests among Members, the current TRIPS Agreement provisions regarding protection of GIs should be maintained as the minimum standard to achieve an acceptable agreement, and the question of GI-extension should be decided after examining the issue on two counts - the allowances that would required to be conceded elsewhere in exchange for agreement on GI-extension, and the liabilities linked with protecting GIs of other Member

Battling with TRIPS: Emerging Firm Strategies of Indian Pharmaceutical Industry Post-TRIPS

301-317The full scale compliance of TRIPS Agreement essentially represents a big step in the opposite direction as it effectively ended more than three decades of protection for Indian companies and terminated legal ‘reverse engineering’. The new patent regime throws a new challenge to the Indian pharmaceutical industry to maintain its competitiveness and profitability. This study investigates emerging firm strategies of the Indian pharmaceutical companies to overcome the challenge posed by new patent regime. The study concludes that the industry is witnessing a transition phase, and is undergoing consolidation and restructuring. The industry is adopting a mix of competitive and collaborative business and R&D strategies in the emerging business environmen

Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study

International audienceBackground: Current management practices and outcomes in weaning from invasive mechanical ventilation are poorly understood. We aimed to describe the epidemiology, management, timings, risk for failure, and outcomes of weaning in patients requiring at least 2 days of invasive mechanical ventilation. Methods: WEAN SAFE was an international, multicentre, prospective, observational cohort study done in 481 intensive care units in 50 countries. Eligible participants were older than 16 years, admitted to a participating intensive care unit, and receiving mechanical ventilation for 2 calendar days or longer. We defined weaning initiation as the first attempt to separate a patient from the ventilator, successful weaning as no reintubation or death within 7 days of extubation, and weaning eligibility criteria based on positive end-expiratory pressure, fractional concentration of oxygen in inspired air, and vasopressors. The primary outcome was the proportion of patients successfully weaned at 90 days. Key secondary outcomes included weaning duration, timing of weaning events, factors associated with weaning delay and weaning failure, and hospital outcomes. This study is registered with ClinicalTrials.gov, NCT03255109. Findings: Between Oct 4, 2017, and June 25, 2018, 10 232 patients were screened for eligibility, of whom 5869 were enrolled. 4523 (77·1%) patients underwent at least one separation attempt and 3817 (65·0%) patients were successfully weaned from ventilation at day 90. 237 (4·0%) patients were transferred before any separation attempt, 153 (2·6%) were transferred after at least one separation attempt and not successfully weaned, and 1662 (28·3%) died while invasively ventilated. The median time from fulfilling weaning eligibility criteria to first separation attempt was 1 day (IQR 0–4), and 1013 (22·4%) patients had a delay in initiating first separation of 5 or more days. Of the 4523 (77·1%) patients with separation attempts, 2927 (64·7%) had a short wean (≤1 day), 457 (10·1%) had intermediate weaning (2–6 days), 433 (9·6%) required prolonged weaning (≥7 days), and 706 (15·6%) had weaning failure. Higher sedation scores were independently associated with delayed initiation of weaning. Delayed initiation of weaning and higher sedation scores were independently associated with weaning failure. 1742 (31·8%) of 5479 patients died in the intensive care unit and 2095 (38·3%) of 5465 patients died in hospital. Interpretation: In critically ill patients receiving at least 2 days of invasive mechanical ventilation, only 65% were weaned at 90 days. A better understanding of factors that delay the weaning process, such as delays in weaning initiation or excessive sedation levels, might improve weaning success rates. Funding: European Society of Intensive Care Medicine, European Respiratory Society

Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study

Background Current management practices and outcomes in weaning from invasive mechanical ventilation are poorly understood. We aimed to describe the epidemiology, management, timings, risk for failure, and outcomes of weaning in patients requiring at least 2 days of invasive mechanical ventilation. Methods WEAN SAFE was an international, multicentre, prospective, observational cohort study done in 481 intensive care units in 50 countries. Eligible participants were older than 16 years, admitted to a participating intensive care unit, and receiving mechanical ventilation for 2 calendar days or longer. We defined weaning initiation as the first attempt to separate a patient from the ventilator, successful weaning as no reintubation or death within 7 days of extubation, and weaning eligibility criteria based on positive end-expiratory pressure, fractional concentration of oxygen in inspired air, and vasopressors. The primary outcome was the proportion of patients successfully weaned at 90 days. Key secondary outcomes included weaning duration, timing of weaning events, factors associated with weaning delay and weaning failure, and hospital outcomes. This study is registered with ClinicalTrials.gov, NCT03255109. Findings Between Oct 4, 2017, and June 25, 2018, 10 232 patients were screened for eligibility, of whom 5869 were enrolled. 4523 (77·1%) patients underwent at least one separation attempt and 3817 (65·0%) patients were successfully weaned from ventilation at day 90. 237 (4·0%) patients were transferred before any separation attempt, 153 (2·6%) were transferred after at least one separation attempt and not successfully weaned, and 1662 (28·3%) died while invasively ventilated. The median time from fulfilling weaning eligibility criteria to first separation attempt was 1 day (IQR 0–4), and 1013 (22·4%) patients had a delay in initiating first separation of 5 or more days. Of the 4523 (77·1%) patients with separation attempts, 2927 (64·7%) had a short wean (≤1 day), 457 (10·1%) had intermediate weaning (2–6 days), 433 (9·6%) required prolonged weaning (≥7 days), and 706 (15·6%) had weaning failure. Higher sedation scores were independently associated with delayed initiation of weaning. Delayed initiation of weaning and higher sedation scores were independently associated with weaning failure. 1742 (31·8%) of 5479 patients died in the intensive care unit and 2095 (38·3%) of 5465 patients died in hospital. Interpretation In critically ill patients receiving at least 2 days of invasive mechanical ventilation, only 65% were weaned at 90 days. A better understanding of factors that delay the weaning process, such as delays in weaning initiation or excessive sedation levels, might improve weaning success rates