REUTERS/China Daily

This post was written by Alberto Alemanno, O’Neill Institute Scholar .  It was originally published at http://albertoalemanno.eu/category/blog. Any questions or comments about this post can be directed to alemanno@hec.fr.

Barely a day goes by in China without news of yet another food safety scandal. This situation is seriously affecting not only the Chinese’s sentiment of trust towards their local products but it is also disrupting the economic viability of their entire food supply chain. As a result, the Chinese newly-elected leaders are consulting extensively to reform their highly-fragmented and historically reactive food safety system.

The post Reforming Food Law in China appeared first on O'Neill Institute Blog.

The O’Neill Institute Summer Program on Non-Communicable Diseases and the Law application deadline is extended to Friday, May 31!

Apply Now!

For a detailed outline of each day’s courses and more information about the program please visit: http://www.law.georgetown.edu/oneillinstitute/summerprogram/

About the Summer Program

As global efforts to address non-communicable diseases (NCDs) are accelerating, complexity is increasing and the importance of law is becoming more apparent. Understanding the powers, duties and constraints created by law is now essential not only for lawyers, but also for officials and advocates working on NCDs.

The O’Neill Institute Summer Program on NCDs and the Law will take a global approach to the issues, while also drawing upon case studies from domestic law. Participants will enhance their understanding of the global burden of NCDs, contemporary developments at the international level, international instruments governing NCDs, best practice regulation, the intersection of human rights and NCDs and the intersection of trade, investment and NCDs.

About the  O’Neill Institute

The O’Neill Institute for National and Global Health Law at Georgetown University was established in 2007 to respond to the need for innovative solutions to the most pressing national and international health concerns.  Housed at the Georgetown University Law Center in Washington D.C., the O’Neill Institute reflects the importance of public and private law in health policy analysis.  The O’Neill Institute is comprised of a diverse network of faculty, fellows, staff, affiliates, and alumni. Our team includes renowned scholars, policymakers, and practitioners with a diversity of talents, experience, and expertise in the fields of law and health.  The O’Neill Institute draws upon the University’s considerable intellectual resources, including the School of Nursing and Health Studies, School of Medicine, the Public Policy Institute, and the Kennedy Institute of Ethics.

The post Summer Program Application Deadline Extended! appeared first on O'Neill Institute Blog.

“Beatriz”, a 22-year old woman, is pregnant with an anencephalic fetus. She has been diagnosed with several illnesses, including lupus and renal failure. Her anencephalic fetus will die almost immediately, likely in the first hours or days after the birth. Her pregnancy is threatening her life. Her family is extremely poor and her likelihood of survival diminishes with each day that passes. Yet, abortion is not an option for Beatriz.

Beatriz lives in El Salvador. As most Latin American countries, El Salvador criminalizes abortion having a total abortion ban, which does not contemplate any exception for the health or the life of a pregnant woman. The Huffington Post, quoting the New York Times, explains that “El Salvador has not only a total ban on abortion but also an active law-enforcement apparatus — the police, investigators, medical spies, forensic vagina inspectors and a special division of the prosecutor’s office responsible for Crimes Against Minors and Women, a unit charged with capturing, trying and incarcerating an unusual kind of criminal.”[1] Thus, Beatriz may have to decide between saving her life or going to jail.

On April 26, a group of United Nations independent human rights experts called on the government of El Salvador to provide life-saving treatment to Beatriz. “We urge the Government of El Salvador to take all necessary measures to ensure the protection and full enjoyment of the right to life, and to the highest attainable standard of health for Beatriz, in accordance with international human rights law,” said the UN special rapporteurs on right to health, torture, and violence and discrimination against women, Anand Grover, Juan E. Méndez, Rashida Manjoo and Kamala Chandrakirana, respectively.

On April 29, the Inter-American Commission on Human Rights granted Beatriz her requested for  precautionary measures. The request for precautionary measures alleged that the Committee of the hospital where Beatriz had been admitted had determined that an abortion was necessary in order to save her life. Doctors have not gone ahead with the abortion because they fear they could be prosecuted. They requested government permission to perform it, but, as the Commission ratified, there has not been a response from the State. The petitioners expressed that the lack of implementation of the recommended medical treatment could affect the rights to life, integrity and health of the Beatriz. The measures granted by the Commission urged the Salvadoran State to provide Beatriz with the medical treatment indicated by her doctors in accordance with her wishes within 72 hours, in order to protect her life, personal integrity and health. The government still has not done so.

This is not the first time that the Commission has granted precautionary measures in these circumstances. In 2010, the Inter-American Commission granted precautionary measures to protect the life of “Amalia” a Nicaraguan woman that needed an abortion in order to save her life. Even though, in 2009, the Commission had also granted precautionary measures in the case of X and XX in which a Colombian woman’s 14-year old daughter, who was raped and was pregnant, was denied the right to a legal abortion[2], the case of Amalia was the first one in which the Commission recognized that States have the obligation to provide abortion services in extreme cases and to protect the lives of the woman.  The case of Beatriz is the second precedent in the Commission and opens a widow of hope for many women that are being denied abortion services and risking their lives. 

The post Inter-American Commission Grants Precautionary Measures to Save the Life of Beatriz appeared first on O'Neill Institute Blog.

About the Summer Program

As global efforts to address non-communicable diseases (NCDs) are accelerating, complexity is increasing and the importance of law is becoming more apparent. Understanding the powers, duties and constraints created by law is now essential not only for lawyers, but also for officials and advocates working on NCDs.

The O’Neill Institute Summer Program on NCDs and the Law will take a global approach to the issues, while also drawing upon case studies from domestic law. Participants will enhance their understanding of the global burden of NCDs, contemporary developments at the international level, international instruments governing NCDs, best practice regulation, the intersection of human rights and NCDs and the intersection of trade, investment and NCDs.

For more information, or to apply, please visit: http://www.law.georgetown.edu/oneillinstitute/summerprogram/

Guest Lecturers

Alberto Alemanno, Associate Professor, HEC Paris         

Katherine DeLand, World Health Organization

Lauren Dunning, Legal Policy Analyst, RENEW Los Angeles County, Department of Public Health, Division of Chronic Disease and Injury Prevention

Trevor Gunn, Managing Director, International Relations, Medtronic Inc and Adjunct Professor, Georgetown University, School of Foreign Service

David Hammond, Associate Professor, School of Public Health & Health Systems, University of Waterloo

Laurent Huber, Director, Framework Convention Alliance

Jonathan Liberman, Director, McCabe Centre for Law and Cancer, Cancer Council Victoria and Union for International Cancer Control (UICC)

Alan Morelli, CEO, OptimisCorp

Hana Ross, Managing Director, International Tobacco Control Research, American Cancer Society

Allyn Taylor, Visiting Professor, O’Neill Institute / Georgetown University Law Center

Godfrey Xuereb, Team Leader, Population-based Prevention, Surveillance and Population-based Prevention Unit, Prevention of Noncommunicable Diseases Department, World Health Organization

The post O’Neill Institute Summer Program – Speakers appeared first on O'Neill Institute Blog.

Together they led a presentation and discussion on drug sale management in China. The first half of the presentation discussed drug distribution administration in China, including the general situation about drug administration, the organization structure of CFDA (China Food and Drug Administration), responsibilities of CFDA, the business environment for drug distribution companies in China, and existing problems in the regulatory process of drug distribution. Mr. Chen analyzed that the excessive number of drug distribution companies is a contributing factor to a lengthy supply chain, increasing drug prices as well as counterfeit and substandard drugs. However, reducing the redundant companies is hard in China because they are important tax sources and job creators for the local economy. To solve these issues, China is encouraging mergers and acquisitions within the drug distribution industry and increasing legal enforcement. Mr. Wu introduced regulations related to pharmacies, development of online drug sale, and supervision in China in the second half of the presentation. In addition, he compared differences between China and the U.S. including pharmacy service and administration. The presenters answered the audience’s questions about definitions of counterfeit and substandard drugs in Chinese law and responsibilities of corresponding offices regulating drug sales.

Mr. Chen and Mr. Wu are two visiting scholars under the blue bird visiting scholar program that demonstrates the strong partnership between the O’Neill Institute and the Shanghai FDA.  Since Fall 2011, the O’Neill Institute has hosted eight officials for detailed comparative research on drug and medical device safety issues. In Fall 2013, O’Neill Institute will host another two SHFDA officials to conduct research on food safety.

For more information about the China Health Law Initiative, please visit: http://www.law.georgetown.edu/oneillinstitute/global-health-law/china-health-law-initiative.cfm. 

For more information about the Shanghai FDA, please visit: http://www.shfda.gov.cn/gb/node2/node3/node2045/index.html.

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International Human Rights Treaties and Tobacco Control

Significant advances have been made, and continue to be made, in international tobacco control. However, more policy attention still needs to be paid to the link that exists between tobacco consumption and poverty. The burden of the tobacco epidemic is not fairly distributed: while overall tobacco consumption is decreasing in the developed world, it continues to increase in developing countries. The disparity in consumption exists not only between countries, but also within countries. In developed countries, consumption is higher among lower income families.Although the reasons behind this trend are not fully known, tobacco consumption has a significant impact on the lives and economies of lower income families in developing and developed countries. As such, tobacco control policies need to fully recognize the links between tobacco and poverty.

For the complete article and issue please visit: http://www.healthbridge.ca/TPRN_Newsletter_11.pdf

The post O’Neill Institute’s Work on Global Tobacco Control Featured in Tobacco and Poverty Research Network Newsletter appeared first on O'Neill Institute Blog.

This post was written by Lawrence O. Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law at Georgetown University.  Professor Gostin is also a University Professor and director of a World Health Organization Collaborating Center on Public Health Law and Human Rights.  For more information about this post, please contact gostin@law.georgetown.edu. The original post can be found at the news@JAMA blog.

On April 1, India’s Supreme Court ruled against drug company Novartis regarding its claim for a patent on the lucrative and widely used cancer drug imatinib (marketed by Novartis as Gleevec in the United States and as Glivec elsewhere). To many, this high-profile 7-year legal battle, Novartis v Union of India, epitomized a vexed relationship between health advocates and the pharmaceutical industry.

Civil society believes that affordable access to essential medicines is an ethical imperative, even a human right. But industry sees the intellectual property system as a vital incentive for innovation. Both positions are undoubtedly true, but they often come into tension. Companies point to the high costs of research and development in bringing a lifesaving or life-extending drug to market. But this view collides with human morality and personal tragedy when a patient cannot access a life-sustaining medication.

In denying Novartis’ claim, the Court affirmed that India’s standard for patentability exceeds that of the United States or the European Union. In the United States, companies can often extend the patent life of a drug simply by tweaking its formula or dosage (a practice known as “evergreening”). But the Court ruled that India’s patent laws require more: it is not enough that a new compound is different; the modified drug must also improve patient treatment.

The Court’s reasoning was narrow. To comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that is administered by the World Trade Organization, India began granting pharmaceutical patents in 2005, but only for drugs created after 1995. Novartis patented Gleevec’s original chemical form in 1993 and subsequently filed patents on modified forms of this compound. But the Court decided that Novartis did not prove that Gleevec offered “enhanced or superior efficacy” as required under India’s 2005 patent law. Gleevec can cost $70 000 annually in the United States, while Indian generic versions cost about $2500 a year. After the ruling, Novartis argued strenuously in a letter to the New York Times that Gleevec is not an instance of evergreening, insisting that its first patented compound was not viable as a medicine and that Gleevec is a transformational therapy.

What is most important about this case is that India now has a strong legal position against “me-too” drugs (making small changes to a drug to extend a patent) and that many other developing countries could now adopt a similar standard. Despite the Court’s narrow reasoning, the Novartis decision could have far-reaching implications. Multinational pharmaceutical companies are seeking strong patent protections in emerging economies, particularly given declining revenues for medications in Europe and North America. According to the New York Times, India is the world’s leading supplier of generic drugs, exporting $10 billion of generic medicines annually; together with China, it produces more than 80% of the active ingredients for all drugs used in the United States. A ruling in Novartis’ favor could have altered the global landscape in regard to access to medicines.

However, by deciding in India’s favor, the Court’s decision could embolden other emerging economies (such as Argentina, Brazil, Thailand, and the Philippines) as they debate domestic intellectual property regulation and its compatibility with their obligations under TRIPS. At the same time, developed countries are seeking stricter intellectual property protection in bilateral and regional trade agreements, such as the Trans-Pacific Partnership, which the United States is currently negotiating. The Indian Supreme Court’s decision will place pressure on richer countries to insist on stronger patent protection in future trade negotiations.

The clash between the right to health and protection of intellectual property has thwarted “north/south” relationships between developed and developing countries for more than a decade, culminating in the suspension of the Doha Round trade negotiations in 2008—with each side blaming the other. It may be that the tensions will never subside without a different formula for protecting intellectual property rights while allowing access to medicines. Proposals for tiered pricing of drugs depending on a country’s level of development would ease the tension.

Others have called for a Health Impact Fund, financed by governments, which would reward companies that register with the fund for medicines that save the most disability-adjusted life-years. The World Health Organization has been negotiating a research and development treaty to offset some of the cost of pharmaceutical research, but it is unlikely to go forward.

What seems entirely clear is that the vexing problem of access to medicines will continue to drive a wedge between developed and developing countries unless the international community finds an innovative solution. It is in all parties’ interests to seek common ground, with perhaps the most achievable progress being a negotiated agreement on tiered pricing.

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

The post From JAMA Forum: The Clash Between Industry and Civil Society Over Generic Drugs appeared first on O'Neill Institute Blog.

Arguments on each side of the Myriad case center on protecting innovation. The U.S. patent system boasts a successful history of protecting large investments in research, which result in innovative products. In the case at hand, Myriad Genetics has invested almost two decades and hundreds of millions of dollars into its research. Supporters of Myriad and the right to patent genes more broadly argue that without these protections locked in place, a company has no incentive to invest in discovery.

Conversely, proponents of more open data sharing maintain that traditional intellectual property protections are outdated and will stifle future innovation. For instance, Harvard geneticist Heidi Rehm noted in response to the Myriad case, “having one company control the data for genes is contrary to the way medicine is developing.” According to this line of thought, the paradigm for drug discovery has changed. Scientific discovery supporting research for new therapies is premised on access to quantities of data too large for any single researcher, company or university to efficiently generate on its own. Today, the success of drug development is dependent upon “collaborating and sharing intellectual property at the very outset,” explained former FDA Commissioner Andrew von Eschenbach in a 2013 seminar at the Lahey Hospital and Medical Center on combination products. “No company… can ever get as big as it needs to be to do everything on this,” he observed.

This debate over whether the law should allow for institutions to patent genetic discoveries raises the more general policy question of what good a patent will do for its holder and for the public health in light of advances in technology and basic understanding of science, biology, and disease? If scientific achievement is now predicated on access to large amounts of data, do those invested in drug development, including the government, academia, and industry, need to retool an incentive system to support the knowledge sharing needed to progress?

Data sharing at various stages of scientific discovery is already well underway. In January 2013, the British Medical Journal pledged to only publish results of clinical trials where the sponsoring company or researcher agrees to provide detailed study data upon request. Beginning in 2014, the European Medicines Agency, pledged access to all complete clinical trial data sets submitted to outside investigators. Private companies like GlaxoSmithKline have made similar promises.

While intellectual property law does and will continue to play an important role in medical innovation and entrepreneurship, its application to each stage of development needs to adapt to the realities of modern science. If scientific advancement depends on access to large amounts of data, including access to identified genes, so do the profits on the therapies these discoveries will deliver down the line. “Do we have the right legal framework [in the U.S.] that allows for sharing of IP? I don’t know,” surmised von Eschenbach. “There’s going to be winners and losers here. Those countries that create the right legal systems to encourage that are going to be the winners. The game has begun.”

The post The Power of Sharing: Rethinking the Future of Intellectual Property and Biomedical Research appeared first on O'Neill Institute Blog.

This post was written by Lawrence O. Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law at Georgetown University.  Professor Gostin is also a University Professor and director of a World Health Organization Collaborating Center on Public Health Law and Human Rights.  For more information about this post, please contact gostin@law.georgetown.edu.

At first glance, why wouldn’t society want to allow prisoners to voluntarily donate organs? It seems like it is a win-win: the prisoner can exercise his or her choice (some would say “right”) to save a life, while society wins by reducing the scarcity of life-saving organs. But what seems like a win-win is unethical and unbefitting a democracy.

I have talked with many prisoners and seen the conditions in which they exist. Prisoners’ lives are determined almost completely by their keepers, and they will do almost anything to make their lives better, in the hopes of  less isolation, better conditions and even parole. Despite rules that organ donations should not affect prisoner conditions, they will believe otherwise. Free consent is not truly possible under coercive conditions.

Beyond the inherently coercive environment, many prisoners are mentally ill, poor and uneducated – and some are very young – rendering them incapable of giving informed consent. While in prison, they face despair and loneliness— exacerbating their emotional distress. As a confined population, prisoners could be “educated,” even persuaded or enticed, by wardens and the state to donate their organs. 

Beyond the problems of subtle coercion or inducement, it also may be unsafe to use prisoners for organ donation because they have much higher rates of infection from H.I.V. and hepatitis than the general population. Although screening tests are good, they are not perfect, and confirmatory tests can be expensive. Transplant recipients, therefore, are placed at increased risk of contracting serious diseases — another reason to be cautious about prisoner donations.

Prisoners awaiting death are even more susceptible to exploitation, and their desperation provides a greater inducement to donate. It would place the medical profession in the unethical position of harvesting organs from executed prisoners. What’s more, the form of execution would have to be modified to preserve organs, keeping them in tact and healthy.

There are other ways to solve the donor shortage within the general population. The United Kingdom, for example, requires driver license applicants to answer a question about organ donation. It would even be possible to have an “opt out” process, with drivers automatically agreeing to donations unless they specifically refuse. In a civilized society, it is preferable to encourage the entire population to exercise their civic duties, rather than rely on the vulnerable and confined.

For more about this issue please explore Professor Gostin’s in depth works on the subject available below.

From a Civil Libertarian to a Sanitarian

 http://sphhs.gwu.edu/events/download/phgr/Gostin_handout.pdf

‘Old’ and ‘new’ institutions for persons with mental illness: Treatment, punishment or preventive confinement?

http://www.sciencedirect.com/science/article/pii/S0033350607003575

The post The Incarcerated Are Too Vulnerable to Consent appeared first on O'Neill Institute Blog.

On 17 April 2013 the O’Neil Institute for Global Health Law and Georgetown University Law School hosted a symposium that considered family building with donor gametes. The focus of the symposium was new families formed as a result of using donor gametes, the issues such family formation raise (such as information release to donor conceived people, what makes a parent, and what makes a family). International and national perspectives on information release to donor conceived people were discussed.

The moderator, Adjunct Professor Susan Crockin introduced the panel noting that assisted reproductive technology has greatly impacted family building as we know it. Anovulatory women, sterile men, single parents, and same-sex couples all look to donor gametes, and potentially surrogacy, to build biologically connected families. The growing use of such technology raises important social, legal and ethical issues including growing issues of how to recognize such families, and how to impart information to donor-conceived people.

Sonia Allan, Ph.D., discussed release of information to donor-conceived people. A brief history of gamete donation and anonymity was given, emphasizing that the focus in the past has been upon recipient parents, donors and the clinics/doctors involved in the process and social, ethical and legal issues that encouraged secrecy. Dr Allan noted however that there has been greater emphasis in some countries for openness, and focus upon the offspring. She gave an overview of countries that require non-anonymous donation; methods of information release (registers; clinic based); trends and further developments. She discussed jurisdictions including a number of states in Australia, Sweden, Switzerland, Austria, the Netherlands, Finland, Norway, New Zealand, and the United Kingdom. Victoria, Australia was discussed as an example of a jurisdiction in which the law since 2010, requires that donor conceived offspring be notified of their status via an addendum to their birth certificates. Victoria and New South Wales, are now also considering whether all donor conceived offspring should have access to information about their donors regardless of when they were conceived. The advantages and disadvantages of register versus clinic-based information were discussed.

The second speaker, Sonia Suter, MS, JD followed with an overview of US law on resolving parentage issues involving gamete donation and surrogacy.  Her talk addressed some of the presumptions and gendered assumptions that underlie determinations of legal parentage as the law tries to sort out parentage in the face of complicated ART arrangements. Interesting comparisons were made by considering various U.S. state decisions concerning legal parentage in instances of sperm donation and surrogacy. Issues were highlighted concerning how genetic and gestational parents are viewed. Inconsistencies in views dependent upon the type of assisted reproduction being utilized and whether the focus was egg donor, sperm donor or surrogate, were highlighted.

Andrea Braverman, PhD., gave a psychosocial perspective of the ‘new family’. Dr. Braverman highlighted that family is thought of as a social concept rather than a genetic concept. Nevertheless, there are now genetic, social and gestational ways of becoming a parent. Multiple choices are available for the method of conceiving a child. Multiple uses of language now apply to how a ‘mother’ or a ‘father’ may be defined. Similarly, language has changed about how ‘donors’ are referred to. ‘Things shift’ in terms of what we think of as a family. Things also shift as to how we perceive the role of the donor. Importantly, things shift over a person’s lifetime. The major shift recently has been to think about what the new family formation means for individuals within them. Dr. Braverman highlighted that this is varies across families, and that there is no ‘one’ answer for all. The importance of genetic versus social kinship is a deeply personal thing, and there are many factors that interplay when people consider who they think of as ‘family’.

Stephen H. Pool, PhD., Director of Fairfax Cryobank, closed with an important and interesting insight into sperm donor practices in the United States. He discussed anonymous versus open identity option donation in the U.S. giving a sperm bank perspective. He highlighted that the demand for open identity option donation has increased in the U.S. however that there is still a demand for anonymous sperm donation. Dr. Pool showed interesting statistics from the cryobank in which approximately a third of heterosexual and same-sex couples still state they would prefer anonymous donation if given a choice. A higher number of single women said they preferred open ID sperm. Dr. Pool gave insight into how both anonymous and open ID donation takes place and the sort of information and practices that accompany both. He highlighted that with anonymous donation in the U.S. sometimes extensive information is available including silhouettes, voice recordings, photos, written essays, as well as medical, educational and person details (interests, family background). He closed by stating as more offspring come forward and we move into the future we may see further changes, but that currently in the U.S. both anonymous and open I.D. donation will continue to take place.

 An interesting and informative question and answer session ensued.

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