This post was written by Sam Byfield, a Senior Policy Advisor (LiveLighter) at the National Heart Foundation of Australia (Western Australia), and an Associate of the Nossal Institute for Global Health at the University of Melbourne. For questions regarding this post please contact firstname.lastname@example.org.
On 27 February, the Framework Convention on Tobacco Control will celebrate its 10th anniversary. This milestone provides an opportunity to survey some of the FCTC’s achievements, and its broader significance in global health law and governance. Tobacco is responsible for 6 million deaths each year and the impoverishment of millions more, and accordingly the use, interpretation and contestation of the FCTC is fundamentally important not only to global health but to development and human rights more broadly.
The FCTC was adopted by the World Health Assembly in 2003, and entered into force in 2005. The FCTC and its protocols aim to ‘protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke’. The Convention has shown that the law is a crucial battleground in the protection and promotion of public health. While the term ‘framework convention’ was initially understood as a means to establish a ‘general system of governance’, from its conception the FCTC contained detailed provisions and strong obligations in a broad range of areas including protection from exposure to tobacco smoke (article 8), packaging and labelling (article 11) and advertising, promotion and sponsorship (article 13). As Jonathan Liebermann has argued, understanding that the FCTC is a ‘real’ treaty – a ‘powerful, legally binding instrument of international law’ – is fundamental to harnessing its potential.
The most recent FCTC Global Progress Report was published in 2014, and provides a valuable snapshot of progress and challenges. The report notes that since adopting the FCTC, nearly 80% of Parties have developed or strengthened tobacco control legislation, and that implementation of the Convention has progressed steadily, with the average implementation rate now approaching 60%. The report details a range of positive developments in countries at different levels of economic development, with highlights including: the establishment of over 1000 mobile courts in Bangladesh that can issue fines and jail sentences for smoking violations and illegal advertising; divestment of government funds in tobacco industry investments in Australia and Norway; and declarations of intent to achieve tobacco free status by countries including Finland, Ireland, New Zealand and the Pacific region.
International public health lawyers are increasingly called upon to formulate and advise on legal interventions to tackle noncommunicable diseases (NCDs) in low- and middle-income countries. From smoke-free place laws, to taxes on sugar-sweetened beverages, to zoning laws that encourage active transport, legal interventions are important tools to address NCD risk factors such as tobacco use, harmful use of alcohol, unhealthy diet, and physical activity.
Using laws to address NCDs can be especially challenging in low- and middle-income countries, where health and justice systems tend to be weak, there may be limited local and/or regional evidence to support these non-traditional uses of the law, and priorities such as under-nutrition and infectious diseases compete for lawmakers’ attention. In this context, it is not enough to draft technically sound laws. We must tailor laws for the local context, provide economic analysis and scientific evidence, build public support and political will, and increase local capacity to ensure successful implementation and administration.
This tough mandate goes beyond the capacities of most public health lawyers. In addition to local governments and regional offices of the World Health Organization (WHO), it is essential for public health lawyers to work closely with local experts, experts in development, medical doctors and scientists, economists, civil society organizations, and experts in communication. Read More
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This week, we have seen yet another example of tobacco industry intimidation tactics being used to stop a government from enacting laws that will save lives and protect the public health.
The Irish government announced that it is introducing plain packaging legislation, following through on its goal of becoming the first country in the European Union to ban branding on cigarette packets.
Immediately, the tobacco industry attacks. Geneva-based multinational company Japan Tobacco International (JTI), owner of the Camel, Mild Seven, Benson & Hedges and Silk Cut brands, has threatened to take the government to court if it doesn’t stop the passage of the legislation.
The general manager of JTI Ireland said that the company has informed the government that “we stand ready to file legal proceedings should it continue pushing for a 'cut and paste' policy that has failed in Australia.” And that “plain packaging puts politics before evidence.”
Politics before evidence? A failed policy?
The Australian plain packaging policy has stood up to a constitutional law challenge in the highest court, has gained significant public support including among smokers, and is the subject of ongoing studies showing its effectiveness. Just last week, the journal Addiction released a collection of scientific papers suggesting that plain packaging can deter non-smokers from taking up smoking, and may cut down the number of cigarettes smoked by existing smokers. The real-life impacts have also been measured, and show dramatic declines in smoking rates since the measures were introduced.
Though the success of these measures is incredibly encouraging, it makes you wonder why we need so much evidence and data before a democratically elected government can regulate a product that kills 6 million people every year, and in the United States, is the number one preventable cause of death and disease.
Physician-assisted suicide is back in the news this month. On February 4th, a group of doctors and terminally ill patients filed a lawsuit asking a court to legalize aid in dying to terminally ill patients in the state of New York. On February 6th, Canada’s Supreme Court struck down a ban on physician-assisted suicide for competent adults in a unanimous decision. On February 11th, a 53-year-old woman battling aggressive leukemia sued California, seeking the right to physician-assisted death for the terminally ill in that state. And on February 20th, Newsweek will circulate an issue that includes the following cover story: “Death Becomes Them: The Dutch Are Choosing Euthanasia if they’re Tired of Living. Others May Soon Follow”.
The Executive Board of the World Health Organization recently finished its special session on the Ebola virus disease outbreak in West Africa and its 136th regular session. Significantly, the Executive Board adopted a resolution, EBSS3.R1 (Ebola Resolution), during the special session. This Resolution makes significant pronouncements and calls for a broad range of actions.
However, a big question, as aptly pointed out in a recent N.Y. Times editorial, remains unanswered. This “big question” is: “whether the organization’s 194 member states will set aside their typical politicking on behalf of national self-interests and allow [WHO] to function as the global health leader it ought to be.” To begin predicting whether the motivation and mandate for change exists to answer the N.Y. Times “big question” in the affirmative, it may be helpful to highlight particular aspects of the Ebola Resolution.
Below are five observations regarding the Ebola Resolution:
This post originally appeared on the HealthLawProf Blog. The original blog can be found here.
The values of public health, personal choice, and parental rights have collided in an intense debate over mandatory vaccinations. Senator Rand Paul argued that parents have the right to choose: “The state doesn’t own your children. Parents own the children.” The overwhelming weight of science supports the safety and effectiveness of immunizations. Parental choice also does not extend to decisions that impose risks on the community. While libertarian values stress autonomy to make self-regarding decisions, it does not give license to place harm others. But if an individual’s right ends at the point that its exercise jeopardizes the safety of others, then why do states allow parents to opt out of vaccinations? The reason boils down to overbroad exemptions granted by many states. The Constitution doesn’t require states to grant exemptions, but lobbying by a minority of parents has resulted in a tragedy of the commons.
First some background. Vaccine preventable diseases are on the rise—diphtheria, pertussis, tetanus, measles, mumps, and rubella. Parents are delaying or selectively administering vital immunizations for their children, often opting out entirely. The CDC declared measles eliminated in 2000. But in 2014, the United States recorded a record number of cases—644 cases from 27 states, more than three-fold higher than any previous year. In January, a measles outbreak started at Disneyland, diffusing to 14 states, re-igniting the immunization debates.
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Good news? Walmart may be next in line to help police the dietary supplement industry.
Let me explain. Yesterday, the NY state attorney general’s office accused four national retail chains – GNC, Target, Walgreens and Walmart – of selling fraudulent and mislabeled dietary supplements based on findings that four out of five of the products did not contain any of the herbs mentioned on the label.
The New York Times reported that the “investigation came as a welcome surprise to health experts who have long complained about the quality and safety of dietary supplements.” Though certainly welcome, was this discovery really a surprise?
For years, investigation after investigation has revealed an industry riddled with corruption and deception. Consider a very small, random sampling of the Food and Drug Administration’s (FDA) archives of recall announcements for dietary supplements manufactured or sold in New York [note, FDA’s publicly available archives only go back as far as 2004].
2004: Kingsway Trading Inc. of Brooklyn, NY, is recalling the dietary herbal supplements DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT (CONCENTRATED) and CARDIOFLEX as they contain Aristolochic Acid, and present a serious health risk to consumers. Aristolochic Acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. Products that contain Aristolochic Acid have been associated with several occurrences of kidney failure.
2008: Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 – 84810, sold in 30 capsule plastic bottles. The recall is effective immediately and is being undertaken because this lot of STARCAPS contains an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.
2013: U.S. Food and Drug Administration is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.
This time however, the attorney general went after the actual retail outlets, adding another layer of accountability. From a legal perspective, this is an interesting twist. Traditionally, the dietary supplement industry has been the “wild west” of product regulation for FDA. Over twenty years ago, regulators decided that dietary supplements ought to be regulated like food, not drugs, and so the process for oversight and safety control is largely left to the manufacturers [for a discussion of industry’s history, listen to this episode of the Diane Rehm show]. Additionally, dietary supplement manufacturers can make health claims and place new products on the market so long as the manufacturer has “substantiation that the claim is truthful and not misleading.” However, these claims are not evaluated by FDA, so the agency insists that a product’s label contain the following statement prominently displayed, and in boldface type:
"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
Besides the extraordinarily limited oversight of FDA, the Federal Trade Commission may hold bad dietary supplement actors accountable for unsubstantiated claims, but only after an actual harm has been committed. To learn more, see here.
The presumed impact of the NY Attorney General’s current investigation will be to add a layer of accountability to retailers. Of course, any supplier, and that includes retail stores selling private label brands, should be accountable for the integrity of the products they sell. However, in light of yet another egregious harm against the consumer, we need to ask some larger questions. Is placing the role of monitoring consumer safety with the supplier, such as Walmart, the best move to serve the public health? Or is it time for FDA to step up its game in protecting the consumer?
The best way to ensure that consumers can safely purchase products such as dietary supplements off of retailers’ shelves is for Congress to imbue FDA with real authority to properly regulate these products and the necessary funds to make it work. FDA’s regulation of the food industry is already headed in this direction. In response to increasing numbers of food-based health scandals causing all sorts of injuries to consumers, Congress passed the Food Safety Modernization Act changing FDA’s ideological approach to food safety from reactionary to a focus on injury prevention. The same ideological and regulatory overhaul must happen in the dietary supplement industry, a natural course of action given that the two industries have always been treated alike. Until then, as one nationally recognized expert observed, the consumers best bet is to simply Skip the Supplements.
You thought all was taken care of with Ebola, that the epidemic in West Africa was coming to an end. That’s what has been in our newspapers, the Ebola headlines when we still see them.
And looking across the three countries, it is true. Cases in Liberia have plummeted from their heights. More recently, cases in Guinea fell to the lowest level in months (though then edged upward). And even in Sierra Leone, after continuing to soar tragically upward well after cases in Liberia had begun falling, cases have fallen dramatically. Today, thankfully, the storyline is increasingly one of progress, recovery, returning to a more normal existence.
But before the drop-off in Sierra Leone, it had spiked well after the international community became fully seized of the Ebola crisis.
Something particularly awful happened in Sierra Leone at the end of last year, even after the world’s highly belated mobilization against Ebola. Dr. Dan Lucey of Georgetown University has been on the frontline against Ebola in Liberia and Sierra Leone, and bears witness. In this recent talk (at 1:01-1:03 mark), he relates how the treatment center he was working at in Freetown, Sierra Leone’s capital, had to turn Ebola patients away in December because it was full. People in the most desperate condition, vomiting, bleeding, in great pain, turned away from an Ebola treatment center established for just such people. Turned away, with no treatment, so very likely to die, and quite possibly infect others, bringing this same suffering to them. Read More
Soon after the measles outbreak originating in Disneyland became widely publicized in the media, the satirical newspaper The Onion published a “commentary” titled: “I Don’t Vaccinate My Child Because It’s My Right To Decide What Eliminated Diseases Come Roaring Back.” Yes, The Onion’s content is meant to be humorous and, as Wikipedia describes it, “surreal or alarming.” And yet, this “commentary” quite accurately captures not only the anti-vaccination parent attitude, but also the extremely dangerous outcomes of their actions.
I am a lawyer trained in global health law—I work at the intersection of public health and the law. It was not until I was at Georgetown Law pursuing the masters in laws (LL.M.) in Global Health Law that I came to appreciate the value of vaccines and to understand that we are part of a population, and that our actions can have wide implications for the health of others. The measles outbreak could have easily been prevented. The disease was eradicated in the United States in 2000 through a widespread vaccination campaign, but while eliminated, the unvaccinated still run the risk of contracting the disease from anyone entering the country who is infected. The current measles outbreak has grown to 95 cases across California, Michigan, Arizona, Utah, Washington, Colorado, Oregon, Nebraska, and even Mexico. Read More
On January 22, President Obama stated in regards to marijuana legislation “What I am doing is asking my Department of Justice just to examine generally how we are treating nonviolent drug offenders. Because I think you’re right, what we have done is instead of focusing on treatment, the same way we focused say with tobacco or drunk driving or other problems where we treat it as a public health problem, we've treated this exclusively as a criminal problem. And I think that it’s been counterproductive and it’s been devastating in a lot of minority communities. It presents the possibility at least of unequal application of the law and that has to be changed.”
This statement follows the trend that some states have been setting in legalizing recreational marijuana. On January 1, 2014 –a little over a year before this statement—Colorado became the first state to sell recreational marijuana, followed closely by Washington in July. These states will soon be followed by Oregon and Alaska who passed similar legislation in the November elections. While it may be too soon to judge the success of Colorado’s policy, we can analyze the initial implementation and start looking for the elements needed for a smooth transition in drug policy from criminalizing to approaching it from public health and regulatory lenses. Read More
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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.