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Category: International
Big relief for Big Pharma: Indian Patent Office rejects application for compulsory license
By a detailed order passed last week, the Indian Patent Office rejected an application for compulsory license filed by a generic drug manufacturer BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) seeking a license of Bristol Myers Squibb’s (“BMS”) Indian patent for an anti-cancer drug. The Indian Patent Office found that BDR had not made out a prima facie case for grant of a compulsory license since it had not made efforts to obtain a voluntary license from BMS on reasonable terms and conditions.
Though the Indian Patent Office did not go into the merits of BDR’s application and rejected it on preliminary grounds, this victory will help restore pharmaceutical companies’ faith in the Indian patent system.
11/7: “Reproductive Rights around the Globe”
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11/7: “Reproductive Rights around the Globe”
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10/22: Globalization and the Future of Health Law: Harmonization or Diversity?
Petrie-Flom Center Faculty Co-Director I. Glenn Cohen will give the introduction for this event featuring Belinda Bennett, Professor of Health and Medical Law, University of Sydney.
From its earliest stages, the themes of recognizing rights and managing risks have been constant features of health law debate. More recently, globalization has become an important theme for health law. International human rights law and global public health have, for example, both become important aspects of contemporary health law. In this context, it is no longer sufficient for health law to have a purely national focus. Analyzing these trends in the development of health law, Professor Bennett considers the future development of health law and whether the trend towards globalization will lead to greater harmonization or greater diversity.
Lunch will be provided.
Handling Debate by Threatening Legal Action: Anti-Vaccination Activists in Israel
Dorit Reiss has a new op-ed in The Times of Israel describing defamation suits that are being brought in the midst of the vaccination debate. Take a look.
Anti-vaccination activists in Israel have recently resorted to threatening critics with defamation suits over comments in online social-media discussions. This is not a new tactic: In several countries, anti-vaccination activists have brought lawsuits against critics, with very little success in actually winning cases but with a potential chilling effect on the discussion. Such a tactic is inappropriate – both because of its effect on the market of ideas and because the anti-vaccination activists themselves regularly engage in personal attacks on critics. Israeli Courts or disciplinary boards should not support or allow this attempt to silence vaccine advocates, and Israeli citizens and supporters of Israel deserve to know this tactic is used.
Taking China’s Food Safety Problem Seriously (II)
By Ching-Fu Lin
[See Part I here.]
In response to the melamine-tainted milk scandal in 2008, China replaced its outdated Food Hygiene Act with the Food Safety Law, which came into effect in 2009. The 2009 Food Safety Law includes provisions on risk assessment methods, establishment of a food safety committee, mandatory product recall requirements, and unification of food safety standards. However, this legal reform has left many key areas of the regulatory framework intact—such as industry compliance and law enforcement.
First, the crucial problem of overlapping competencies among responsible authorities is not addressed in the 2009 Food Safety Law. Although the Ministry of Health (MOH) is mandated to take the lead on food safety regulation, the current state is flawed as multiple agencies are only organized in a loosely coordinated system. For example, the State Food and Drug Administration (SFDA), the Ministry of Agriculture (MOA), the State General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and the Ministry of Commerce (MOC) all take part in the regulation of the entire food supply chain. The result is a fragmented regulatory environment, which creates blind areas for agencies to push responsibility away, and therefore, perpetuate rather than alleviate loopholes in routine control. Thus, timely response and cooperation is difficult.
Taking China’s Food Safety Problem Seriously (I)
By Ching-Fu Lin
Why should we be concerned about China’s food safety problem? A recent opinion by Adam Minter on Bloomberg offers yet another tough criticism on China’s food system: “For more than a decade, China has earned a reputation as one of the world’s worst food-safety offenders.” Melamine-tainted milk, rat meat sold as lamb, recycled “gutter oil” for cooking, and most recently, juice made from rotten fruit, Chinese food producers never cease to surprise us with their “creativity” in economic adulteration. The Chinese government, however, has failed to establish an effective regulatory system beyond executing violators and political campaigns. The Chinese consumers continue to react with desperation to these endless food safety crises, smuggling bunks of infant formula from Hong Kong and other countries.
But why should we care?
According to testimony before a subcommittee of the House Foreign Affairs Committee in May, food products of Chinese origin have dominated the U.S. food market in areas such as tilapia (77.5%), apple juice (65.2%), cod (52.7%), processed mushrooms (34.1%), garlic (27.4%), clams (16.1%), frozen spinach (16.0%), and salmon (12.7%). The Chinese food imports are also expected to increase by about 10% annually until 2020. Faced with the huge volumes of foods imported into the US every year, the Food and Drug Administration has only been able to inspect about 2.3% of the total imports from China in 2011 (which is, well, an improvement compared to 1.3% in 2007). Moreover, the U.S. Department of Agriculture announced last month that China’s poultry processing inspection system is equivalent to its US counterpart. That is, processed chicken from China is determined as meeting US food safety standards (even if there are no on-site USDA inspectors in the processing facilities) and granted it access to the US market.
In an interdependent world trading system, regulatory failure in one country can spill over to many others, resulting in adverse public health repercussions in the latter country. We should take China’s food safety problem seriously.
Haiti in a Time of Cholera
In the midst of “the world’s worst and fastest-spreading cholera epidemic“, with more than 685,000 infected and approximately 8,400 dead, five Haitian families are suing the United Nations in federal court in the Southern District of New York. The families are seeking $2.2 billion for the Haitian government’s relief efforts and unspecified damages for Haitian families affected by the outbreak. Despite evidence which indicates that cholera was introduced by UN peacekeepers, the UN has yet to admit responsibility and has denied compensation to the victims, though it continues to provide assistance to Haiti. The UN argues that immunity precludes legal recourse, and undoubtedly will move to dismiss the complaint. Aside from the legal arguments regarding immunity, the question remains whether the UN has a moral responsibility to provide compensation and more robust remediation measures, particularly because there were “documented sanitation deficiencies” at a UN camp that has been identified as the source of the outbreak. As we await a decision from the court, and a response from the UN, cholera continues to kill nearly three Haitians each day.
The priorities in the benefit packages vs. the priorities of those who dole out the benefits
In my last post I promised I would provide details about the new piece of statutory legislation that was recently enacted by the Colombian Congress on the right to health, but first I should talk a little more about the prior jurisprudence that set the stage for it–especially since there’s so much of it. Every year, hundreds of thousands of right-to-health cases go before judges in Colombia, and some estimate that up to one out of every five Colombians has used the judicial system to gain access to health services.
By far, most of these cases are won by the plaintiff. And they should be.
Nearly 90% of the cases that involve procedures, and over 30% of the cases for medications, involve benefits that are actually already covered by the public benefit package (plan obligatorio de salud, or POS). And most of these aren’t over particularly expensive, complicated, or scarce benefits in the POS. The most frequently litigated medications are omeprazole (Prilosec) and oxygen. The most frequently litigated procedures aren’t even the procedures themselves, but specific parts of the procedures that aren’t explicitly listed in the bundle of benefits covered by the POS. For example, the POS covers colostomies, but the insurance companies systematically deny the colostomy bags. “We’ll open the hole in your flank, but it’ll be on you to figure out what to do with the excrement that’ll start oozing out. . .”
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