~ Archive for Health Law / Biotech / Bioethics ~

The Changing Face of Health Law

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For a fast-paced and constantly evolving line of work, look no further than health law. Or so say Stephen Bernstein and Wasserstein Fellow Richard Weishaupt ‘74, two attorneys who have dedicated their lives to reconciling health policies with practical applications on the state level. They came to HLS recently to speak about health care law in private and public interest practice settings.

“As a health care attorney, you’re dealing in real time to bring better care faster to those who need it,” Bernstein said. As a partner with McDermott Will & Emery, Bernstein specializes in e-health, deployment of electronic health record systems, health related matters impacted by the Internet, and HIPAA. One of his recent projects was working with biotech firms to move data for the purpose of engineering their information for research and healthcare improvements. “The thing about health law is that it keeps changing. It’s energizing in that it forces you to take all these moving parts and advise clients as best you can,” said Bernstein. “You have to be a generalist.”

Weishaupt, a senior attorney with Community Legal Services of Philadelphia, agreed and highlighted his experience working on behalf of lower income employees. “Medicaid, for instance, is a large part of any state’s budget and the growing problem of fewer employers in Pennsylvania providing coverage to their employees is putting a strain on state resources in the absence of universal healthcare.”

When asked to reflect on his career, Weishaupt stressed the advantages for younger attorneys. “Health law allows you to become an expert quickly early on with a subject because your ability to impart advice arises from your knowledge of new policies and legislation,” he said.

According to Bernstein, having operated as a general counsel and served as a healthcare consultant, the rewards can be elusive. “The healthcare environment is complicated and getting more so,” he said. “The solution of how to get people access to healthcare is changing,” he said continued, alluding to Weishaupt’s Medicaid example. “At the end of the day, there are tons of opportunities for young lawyers. It’s really a question of channeling your passion.”

Seems like an exciting challenge. Be sure to check out the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics here at HLS!

The Human Rights Law Network Illustrated

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During her Winter Term, 2L Lauren Birchfield traveled to Delhi, India to work with the Human Rights Law Network on the Right to Food Campaign. Upon her return, she shared her story and photos with us.

“I spent January 2008 interning at the Human Rights Law Network (HRLN) in Delhi, India, working on the Right to Food. The Human Rights Law Network provides pro bono legal services, conducts public interest litigation, participates in advocacy, and collaborates with social movements and human rights organizations. Maintaining both litigation and publishing departments, HRLN works on issues such as Right to Food, Women’s Justice, Dalit Rights, Disability Rights, and rights for persons living with HIV/AIDS.

“Along with my colleague Jessica Corsi, I investigated and documented the history of the Right to Food Campaign, its accompanying case, PUCL v. India & Others, and the post-litigation implementation of India’s constitutional right to food. Our time in India was spent largely traveling around Delhi and other parts of the country conducting interviews with activists involved with the Right to Food Campaign. The fact-finding, research, and interviews conducted are currently being incorporated into a final document, which will be completed by June 2008. In our forthcoming paper, we intend to address not only the campaign and litigation, but also larger questions about the right to food, as well. These larger issues include food sovereignty, the effects of neoliberal economic policy and trade liberalization on the rural poor, and the relationship between food security, agricultural production, and employment rights.

“While in India, we had several opportunities to travel. These photographs document the time we spent in Uttar Pradesh and Rajasthan, as well as some of our excursions around Delhi. Our first week in Delhi, we observed and assisted on a fact-finding mission in the villages of rural Uttar Pradesh. The objective of this mission was to collect data on the status of food security in U.P.’s Banda district, and to assess how Supreme Court mandated food and employment orders were being implemented. These images depict some of the villages and the stone quarry we visited while in Uttar Pradesh.

Directly upon our return from Uttar Pradesh, we departed for Rajasthan, where we spent several days interviewing some of the key social activists involved with the Right to Food Campaign. Our first days in Rajasthan were spent in Beawar at a National Right to Information Youth Convention, where we had the opportunity to participate in a candlelight vigil commemorating the first Youth Convention that had taken place in Beawar several years earlier.

“Once we arrived back in Delhi, we spent our last ten days in India tracking down and interviewing human rights activists, economists, Supreme Court Commissioners, professors, and lawyers who had either worked directly on or were invested in food security in India. During our last few days, we also managed to squeeze in a few sight-seeing excursions. We toured the Taj Mahal, as well as some sights around Delhi, such as the Jama Masjid Mosque (Delhi’s principal mosque, which can hold up to 25,000 worshippers).

“Overall, words cannot really express how much I enjoyed both working at HRLN and my winter term experience. At HRLN I met incredibly passionate and qualified people, and was accepted into an office that recognized each of its staff members as important components in its vision for change. There was never a dull moment at HRLN - we were constantly on our feet, putting in calls to human rights activists, scheduling meetings, and traveling all over the country to interview those activists whenever and wherever they could meet with us. I greatly appreciated how much HRLN invested in us and in our project, and how much freedom is gave us regarding the project’s construction and implementation. I found HRLN a fantastic organization to work for, and I was pleased to walk away from the internship having recognized that this – this kind of work, this kind of project – is what I want to pursue as a career.”

HLS Students Take 6 of 7 Prizes in Food & Drug Law Writing Competition

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Professor Minow just forwarded me a list of our 6 winners of the Food and Drug Law Institute’s H. Thomas Austern Memorial Writing Competition. The students were in Peter Hutt’s winter term course Food and Drug Law:

John Murphy (”Mandatory Labeling of Foods Made from Cloned Animals: Grappling with Moral Objections to the Production of Safe Products”) - First place, Short Paper

Amanda Lydon (”The FDA’s Decision to Make Emergency Contraception Available Without a Prescription: Guaranteed Access for Women or Just the First Step?”) -Honorable mention, Short paper

Daniel Gorlin (”Starving Off Death: An Assessment of the Pharmaceutical Industry’s Strategies to Protect Blockbuster Franchises Upon the Loss of Marketing Exclusivity”) - First place, Long paper

Leah Satine (”Is My Yogurt Lying? Developing and Applying a Framework for Determining Whether Wellness Claims on Probiotic Yogurts Mislead”) - Second place, Long paper

Brianna MacDonald (”Perspectives on FDA’s Regulation of Nanotechnology: Emerging Challenges and Potential Solutions”) - Honorable mention, Long paper

Evan Diamond (”Reverse-FOIA Limitations on Agency Actions to Disclose Human Gene Therapy Clinical Trial Data”) - Honorable mention, Long paper

Sunstein to Join HLS Faculty

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In case you missed it on the home page, Cass Sunstein ‘78 is coming to HLS. Read the article here. Rumor has it that he may be offering a 1L reading group in the fall (but I could be wrong).

The Law of Climate Change

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As a former senior member of the White House staff, serving President Bill Clinton as Chairman of the White House Climate Change Task Force and Deputy Assistant to the President for Environmental Initiatives, Roger Ballentine brings a lot of relevant experience to the table. I had the chance to visit his course a few weeks ago. A winter term course offering, The Law of Climate Change explored the developing legal, business, and policy frameworks relating to climate change.

On the day I visited, Ballentine was discussing the legal frameworks and developments for climate change over time. Since 1970, the Environmental Protection Agency (EPA) has regularly published a list of pollutants considered harmful for the public health. Congress delegated the authority for establishing pollutant guidelines to the EPA which in turn has allowed individual states to regulate guidelines for many pollutants within their own borders. Sources of pollution considered “mobile”, such as car emissions, remain under the direct jurisdiction of the EPA. Still, the challenges of regulation on the state and federal levels have highly been contentious.

Take for instance the EPA’s legal position on global warming that was reversed at the request of the energy industry. “Under the Clinton Administration, EPA’s legal position was that carbon dioxide was a pollutant under the federal Clean Air Act and that EPA had legal authority to regulate emissions by industry and coal power plants,” explained Ballentine. The then General Counsel of the EPA, Jonathan Cannon, claimed that carbon dioxide and other greenhouse gases were indeed air pollutants subject to EPA regulation. Subsequently, under the Bush administration, Cannon’s successor Robert Fabricant reversed the Cannon memo denying the ability of the EPA to regulate greenhouse gases. He further determined that the EPA was not authorized to set greenhouse gas emission standards for vehicles. “There really are frustrating inconsistencies,” said Ballentine.

After class, I was able to catch up with 2L Zach Gerson, an editor for the Environmental Law Review and board member of the Environmental Law Society, who sees Ballentine’s class as an essential precursor to a career in environmental law. “I believe that global Climate Change is one of the biggest challenges facing the world today and that a legal framework for addressing that challenge is actively developing right now. The complex nature of climate change raises complex legal questions, and I think it is fascinating to be able to be in a cutting edge class where the focus is not only what the law currently is, but also on how the law is actively changing to meet a profound new challenge. It is rewarding to be in a law course that incorporates other disciplines so heavily rather than focusing only on legal doctrine. Climate change is inherently linked with science, economics, business, and politics, and perhaps because there is not yet clear law for climate change issues, this course has been enjoyable because it can focus on how those other disciplines are interacting with the law as it develops.”

China and the Problem of (E)-Waste

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HLS has a number forums in which visiting scholars can share insights of their research projects with the HLS community. One example is the Visiting Scholars and Research Colloquium, which recently hosted Jung-hoon Kim, a Professor of Law from Seo-Kyeong University in Seoul, South Korea. Professor Jung-hoon Kim recently conducted a study that examined the environmental conflicts surrounding the disposal of electronic waste (e-waste), such a circuit boards, through the lens of environmental justice in China. Kim suggested that the importer/exporter relationship of electronic waste between developing and developed countries has economic benefits that laced with egregious human rights violations that demand worldwide reform.

“In spite of the determination of the UN Commission on Human Rights that everyone has a right to live in a world free from toxic pollution and environmental degradation,” explained Kim, “violations of these rights occur in poor communities where companies illegally operate environmentally hazardous facilities.” To further explain environmental justice, Kim introduced a two-axis approach that provided for fair treatment and meaningful involvement in which the mutual needs of the importer and exporter countries are met. “Because environmental justice is a human right, it can be regarded as a goal of the entire human race… rich countries should not externalize their pollution treatment cost to poorer neighbors through imports.” said Kim.

Yet, due to the economic benefits of the trans-boundary movement of hazardous waste to both developed and developing countries, the problem continues. As Kim pointed out, the cost-benefit analysis to a developed country for exporting its hazardous waste in lieu of facing strict domestic regulations is too tempting. Likewise, this business creates many jobs for laborers and farmers in the developing country who have been hit by high unemployment and poverty rates.

To illustrate his point, Kim presented the case study of Taizhou, China, a small port industrial city whose e-waste intake skyrocketed over ten years from 10,000 tons in 1992 to 1,500,000 tons at the end of 2004. Upon import, the waste is handled by thousands of workers hired to extract bullion from the discarded electronics. “In addition to pollution and the frequency of injury among workers, the e-waste business is stripping countries of their domestic jobs and thwarting the development of environment-friendly technology,” he said.

To close, Kim proposed a World Environmental Organization (WEO). “The WEO could push for comprehensive regimes or governance to deal with trans-boundary hazardous waste, air pollution, water pollution, and climate change problems,” Kim explained. Among the possible benefits of the WEO would be identifying gaps in existing overage of international environmental problems and bridging interactions between international trade agreements to implement reforms. “The question of how to get worldwide participation is a difficult one… but we must begin to work towards a solution.”

Programs of Study: the 2L and 3L Curriculum

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We have had a lot of press about the new 1L curriculum, but I thought it made sense to mention the changes to the way we look at the 2nd and 3rd year.

This website, Upper-Level Programs of Study, gives the details.

Law and Public Health

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One of the great advantages of Harvard Law School is that we are surrounded by terrific graduate schools…like the School of Public Health. I recently interviewed Professor Michelle Mello who is on the faculty there, but is teaching a course this semester at the Law School called Law & Public Health. I asked her about this course, her courses and research at the School of Public Health (hint: she does take on HLS students from time to time as research assistants), and the joint JD/MPH program that she helped put together.

Have a listen:

Podcast: Michelle Mello

Ethics, Law and Biotechnology

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Matt Gordon is a co-president of Ethics, Law and Biotechnology, a student organization that addresses the core issues at the intersection of law, medicine, public health, bioethics and biotechnology. When not discussing and debating the issues themselves, the students bring in outside speakers to help frame the subject at hand. “We’re in the planning stages of putting something together with the Petrie-Flom Center,” says Gordon, “A panel discussion around patent law and it’s intersection with providing drugs to people who can’t afford it, in the developing world in particular.” A panel last fall examined how the Supreme Court might theoretically address bioethics issues in genetics. When it comes to event planning, “…we really welcome input from the members,” he says.

The Petrie-Flom Center has an inaugural class of 20 fellows, including Gordon, who attend weekly luncheons and seminar-style presentations when not performing related research. Classes he’s taken include Health Care Law, Health Policy Workshop and Food and Drug Law, among others. “The amount of courses in this area is increasing and will continue to increase,” says Gordon, citing a growing enthusiasm for the subject among students.

Before arriving at HLS, Gordon received an undergraduate degree in biology, then a master’s in public health. That’s when law school caught his eye.

This summer, he’ll be splitting his time between two firms, both chosen very carefully. “One of my main criteria…was that each of them have an established, broad health care/FDA practice. I’m hoping to get a real good exposure to law in this area from the private perspective, because that’s a perspective I don’t have yet.”

Podcast: Matt Gordon (8:00)

Flom Global Health & Human Rights Initiative

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I saw this in my inbox this morning and thought it was worth a mention here. You may have listened to my earlier interview with Einer Elhauge, the faculty director of the Petrie-Flom Center. He promised a lot of new and intresting initiatives. Here is one of them:

“The Joseph H. Flom Global Health and Human Rights Initiative is a new partnership between Harvard Law School’s Human Rights Program and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. Its mission is to promote academic research as well as engagement in practical measures to develop and apply global public health and human rights norms.

“The initiative is offering a post-graduate fellowship starting in September 2006. The role of the fellow will be to lead research or clinical projects on global health and human rights. This is a one- or two-year full-time residential fellowship paying an annual stipend of up to $60,000 plus benefits. Applicants should have background and expertise in the field of global health and human rights, and must hold a degree in law.

“Detailed information about the fellowship and how to apply is available at this link. Applications are due no later than June 16, 2006.”

I suspect HLS grads would have an inside track on such a fellowship…

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