08.03.11

Drugs, Babies, Nursing Homes, Cigarettes, and Death: A Year of Health Law at the Canadian Supreme Court

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Given the importance of health as a public policy issue and its profound effect on an individual’s life, it is not surprising that courts are frequently called upon adjudicate health sector claims.  Due to the government’s increasing health sector regulation and, in Canada, its role as health system insurer, the government often appears as a party in health sector cases.  Although this post is a summary of the past year’s decisions from the Canadian Supreme Court, U.S. courts and policymakers face similar issues, for example, the balance between governmental accountability and judicial deference, the right to privacy versus the importance of the free exchange of information, and the rights of individuals versus communities in the context of scarce health resources.  Furthermore, litigation in Canada can impact the U.S., given their proximity and economic ties.          

November 2010:  Privacy of Proprietary Drug Information

Although the Supreme Court of Canada reserved judgment in Merck Frosst Canada Limited v. Minister of Health, it is likely to release its decision in the fall.  Little is known about the facts of this case due to a publication ban, but the federal government allegedly disclosed proprietary information relating to Merck’s drug Singulair (an asthma medication), in contravention of a five-year moratorium on the disclosure of information following drug approval.  Merck also alleged that information had been disclosed without notice, in contravention of federal privacy legislation.  This case has broader implications for the economy and health sector innovation, as it may diminish the incentive for biotechnology investment and medical research in Canada. Read More

Posted in Uncategorized;

08.01.11

What Does It Mean to Inform?

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This post was authored by Sam Halabi, J.D., M.Phil., Assistant Professor, University of Tulsa College of Law.

What Does it Mean to Inform?

In response to the graphic warnings released by the U.S. Food and Drug Administration on June 21, 2011, tobacco firms have asserted that the warnings violate their First Amendment rights by forcing them to say something they don’t want to about their products and deprive them of their Fifth Amendment rights because the warnings “take” 50% of the front and back panels of a cigarette pack without paying for the space (or the trademarks that appear there).  Both theories share an underlying theory about the nature of the government’s interest in the regulation of tobacco products in general and cigarettes in particular: that the interest extends only so far as to “inform” an adult consumer about product risks. 

That theory, woven through the longer catalogue of tobacco manufacturer complaints about the Family Smoking Prevention and Tobacco Control Act, is actually right on the mark.  Government should care about informing adult consumers.  But, if the definitions of “inform” or “information” are drawn as narrowly as cigarette manufacturers propose, courts will endanger the comprehensive approach Congress deemed necessary to address the social costs cigarettes impose and the tactics cigarette manufacturers use to promote consumption, especially among adolescents.  According to cigarette manufacturers, judges should construct an imaginary world where a consumer (who very probably looks like the judge him or herself) stands in front of a single shelf in a store, in front of a row of cigarette packs, all of which contain the same well-known dangerous ingredients.  Again, according to the manufacturers, the judge should imagine the state with the power to write directly on each cigarette pack the least burdensome, factual characteristics about cigarettes – milligrams of nicotine, milligrams of tar, trace amounts of radioactive metals, etc.  Perhaps the government might also be able to write general warnings about the health implications of smoking.  More than that, the state has violated the freedom of speech.  Read More

Posted in FDA, Tobacco, Uncategorized; Tagged: , , .

07.22.11

Workshop on Legal issues in Tobacco Control for Latin American Attorneys

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The O’Neill Institute for National and Global Health Law at Georgetown University, in collaboration with the Campaign for Tobacco Free Kids, the International Union Against Tuberculosis and Lung Disease, and the Framework Convention Alliance for Tobacco Control organized a workshop on Law and Tobacco Control in Rio de Janeiro on June 15-17, 2011.

This training workshop is part of a legal capacity building strategy, underway since 2008, to empower tobacco control efforts in Latin America. There were more than twenty participants from Argentina, Bolivia, Brazil, Colombia, Chile, Ecuador, Mexico, Paraguay, Peru, and Uruguay.  Participants were from academia, government and civil society organizations.

The workshop addressed topics such as: i) the role of judicial tribunals and strategic litigation on in the area of tobacco control, ii) consumer protection law and tobacco control, iii) packaging and labeling of tobacco products, iv) labor law and tobacco control and v) intellectual property rights, investment law and the right to health with regards to tobacco regulation. Among other presenters, Oscar Cabrera and Juan Carballo, of the O’Neill Institute highlighted tobacco regulations’ connections with the right to health and coordinated the discussion about litigation strategies in Latin America.

 Representatives from the organizing institutions: Oscar Cabrera (Deputy Director at the O´Neill Institute for National and Global Health Law at Georgetown University), Jonás Romo (International Union Against Tuberculosis and Lung Disease), Patricia Sosa (Campaign for Tobacco Free Kids), and Luiz Antonio Santini (Aliança de Controle do Tabagismo)

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Posted in FCTC, Global Health, Tobacco, Uncategorized, WHO; Tagged: , , .

07.14.11

Does This Outfit Make Me Look Healthy?

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Today, New York opens its runways for the first Africa Fashion Week, bringing the work of emerging African designers to the catwalk, and showcasing a growing industry that bridges a gap between a poverty stricken continent and one of the most profitable consumer bases in the world: the woman’s closet. 

Designers are already exploiting the beauty of the African continent: the producer of this week’s shows reports photographing African styles in American stores to inspire her Nigerian relatives to seize this movement.  Bringing African designers and manufacturers into the fold of this booming industry will open doors to economic prosperity and creative outlets.   

Yet Africa Fashion Week symbolizes more than economic opportunity and the globalization of design.  Turning attire into a commodity serves as a reminder of the darker side of fashion: the direct impact that the industry has on models, as well as the surrounding culture.  Read More

Posted in Global Health, National Healthcare, Trade; Tagged: , , .

07.14.11

Not just India: The EU-India trade negotiations and global drug access

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This post was authored by O’Neill Institute summer research assistant Sean Dickson, JD/MPH candidate at the University of Michigan.

Since 2007, the EU and India have been negotiating a bi-lateral free trade agreement (FTA) with quite a few stumbling blocks. The most recent was a declaration by India, delivered via a UNAIDS press release, that it would not implement data exclusivity rules on pharmaceutical testing data as requested by the EU. India’s position as the “pharmacy of the developing world” is based largely on its limited intellectual property (IP) protections for pharmaceuticals, leading it to produce more than 85 percent of the first-line antiretroviral drugs used globally to treat HIV. While data exclusivity provisions would not affect these and other existing generic medicines produced in India, they would inhibit the future development of generic treatments. If implemented, data exclusivity would mean that global access to essential medicines would be based on individual exceptions to patent protections, such as compulsory licensing, rather than a market-driven system of generics. Read More

Posted in Global Health, Trade, Uncategorized;

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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