05.05.17

Louisiana Proposes that the Federal Government Bypass Patent Restrictions to Acquire Cheaper Hepatitis C Drugs

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Photo Source: Clipartfest.com

Anyone who follows U.S. public health issues – or who reads my blog posts – knows that the cost of the drugs needed to treat Hepatitis C infections is very high. The cost of these drugs is of particular concern to state health authorities who are charged with providing health care for Medicaid recipients and the incarcerated. The result is many states limiting access to treatment only to Medicaid recipients with advanced liver damage, and not making treatment available at all to those incarcerated, despite a high prevalence in this population. Louisiana estimates that it would cost the state $764 million to treat all of  35,000 residents who depend on state-funded healthcare, which would account for a quarter of the state’s $3.6 billion health care budget. This cost is prohibitive to the state, so the health officials thought through possible options. After consultation with public health and legal authorities, Louisiana has proposed that the federal government use a 1910 patent law that allows regulators to appropriate inventions, such as pharmaceutical drugs, for the use of the greater public good. This would mean that the federal government would take exception to the general patent exclusivity given to pharmaceutical manufacturers, which allows them to control the pricing and manufacture of a drug formulation for 20 years from the initial patent application date.

28 U.S.C § 1498 and the Federal Government’s authority to ignore patent rights

(DISCLAIMER: To my lawyer friends and colleagues reading this, this is a simplified explanation of the laws and policies at issue. Do not take me to task for a lack of complex statutory interpretation.)

The law at issue is 28 U.S.C.§  1498. It is a federal judicial procedure law that outlines the legal remedies available to a patent holder whose patent was breached by the U.S. Government. The law states, in summary, that the holder can sue the government for “reasonable and entire compensation for such use and manufacture.” So, if the U.S. were to utilize the patent information to manufacture an expensive drug – such as one of the patent-protected Hepatitis C treatments – the government would only need to pay the pharmaceutical company compensation for the manufacturing costs for the quantity the government diverted to a generic manufacturer under the breach, rather than the company-set market price for the quantity of the drug the government had manufactured.

The Takings Clause

The 5th Amendment of the U.S. Constitution provides, in relevant part, that the government cannot take private property for public use without providing just compensation. This Takings Clause describes the government’s right to claim eminent domain over all property within the United States if extenuating circumstances require such action. 28 U.S.C. § 1498 outlines the Takings Clause as applied to patents and copyrights. The law codifies the means (lawsuit) by which a patent holder can take against the government to address the breach, and the compensation to which he would be entitled.

Sovereign Immunity

The principle of Sovereign Immunity is that a government, or sovereign, cannot be sued in its own courts unless it expressly consents to do so. While this rule does not appear in the U.S. Constitution, it is inferred based on the principle that the government is what creates the courts to begin with, so the courts cannot compel the entity under whose authority it falls under. Think of it as workplace insubordination: as much as some employees would like to be the ones imposing rules over their bosses, that is not how the system is set up. In 1910, Congress passed 28 U.S.C. § 1498 to expressly state that the U.S. agrees to be sued in this type of patent breach matter, thus allowing a party to sue the federal government for compensation.

Prior Uses of 28 U.S.C. § 1498

The idea of invoking this statute to address high drug prices is not a novel one. This statute has been used in many times in the U.S., usually in a National Security context. The Department of Defense used the law to procure drugs in the 1960s and 1970s for millions of dollars cheaper than the patent holder’s price. Most recently, the U.S. Dept. of Health and Human Services (HHS) threatened to invoke Section 1498 to procure the antibiotic Cipro, the main drug used to treat Anthrax, which had become a public health and bioterrorism concern immediately following the attacks on 9/11.

Negotiation v. Litigation

Pharmaceutical companies have addressed the threat to their bottom line posed by Section 1498 by lobbying for the limited use of the law to only when national security requires it. Most companies have opted to enter into negotiations with government health authorities to bring down prices. It is unclear to what extent Louisiana has negotiated with manufacturers to get the drug costs down to a manageable amount.

It is clear that the state of Louisiana sees its Hepatitis C crisis as a public health priority, and in my Hep C policy world, that is great news. However, that is overshadowed by the apparent helplessness it feels to properly address the issue. Invoking Section 1498 should be seen as a last resort, and the proposal of such will hopefully motivate all relevant parties to come back to the negotiating table to allow the state to gain access to these life-saving treatments at a more manageable price.

(For further reading on the use of Section 1498 to acquire HCV drugs, see http://yjolt.org/sites/default/files/Kapczynski_18YJoLT275_gk_0.pdf)

Posted in FDA, National Healthcare, Uncategorized; Tagged: .

05.01.17

Remembering Tandala, 1977: Elucidating Ebola

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Forty years ago, in June 1977, a nine-year old girl died of acute hemorrhagic fever at a hospital in Tandala, Zaire (now the Democratic Republic of Congo).[i] Her post-mortem blood sample arrived at CDC-Atlanta nine days later, and despite the lack of refrigeration during shipping and its subsequent bacterial infection, scientists were able to positively identify the Ebola virus disease as the cause of death.

This new outbreak in Tandala – despite being defined as a single fatal case – and its subsequent investigation were significant in broadening our understanding of this new and horrible disease. This was the first naturally-occurring outbreak since Ebola was discovered and named nearly six months prior during the simultaneous outbreaks of Nzara, southern Sudan (now South Sudan) and Yambuku, northern Zaire, which killed more than 400 people.[ii][iii] (NB: Another case of Ebola had since occurred by laboratory infection in England due to accidental stick of contaminated needle, but the single individual recovered.) To this day, scientists have been unable to determine any linkage between the Nzara and Yambuku outbreaks; in fact, they would not discover that they were separate outbreaks of two different strains for another four years, so in 1977, the virus was still “Ebola”.[iv]

First, the Tandala outbreak extended Ebola’s endemic zone almost completely across the width of northern Zaire, along the Zaire (now Congo) River basin. The distance between Nzara and Yambuku is about 450 miles; the Tandala outbreak took place an additional 200 miles west of Yambuku in northwest Zaire. Tandala informed us that the previous outbreak was not just “a lightning strike”, and that the disease had a presence in the region.

Figure 1: Map of the First Three Ebola Outbreaks.

Second, the epidemiological investigations that took place following the Tandala outbreak revealed that the virus had been circulating in the area, both before and after June 1977. One such investigation that took place from late 1977 to early 1978, found that two suspect cases at Tandala Hospital matched the case definition of Ebola, retrospectively, but no laboratory samples had been obtained from the two individuals, who had died in November and December 1977, six months after the June case. A family member of one of the deceased had been ill with similar symptoms and survived. Serum testing on the survivor revealed Ebola antibodies.

Additionally, investigators obtained serum specimens that had been drawn from missionaries in February 1977, four months prior to the June case. One of these individuals’ samples tested positive for Ebola antibodies. The individual, a Tandala Hospital physician, described being sick from Ebola-like symptoms in May 1972, five years prior to the June case, and almost four years prior to the Nzara-Yambuku outbreak. The physician, whose hospital records backed up his story, had lacerated his finger during the autopsy of another person who had died from a hemorrhagic illness that had been clinically diagnosed as yellow fever.

Finally, the investigation surveyed the area proximal to Tandala for historical or serological evidence of Ebola. After obtaining blood samples from 1,096 people from nearby villages, 79 individuals (7%) were found to have Ebola antibodies, despite no one being able to give an account of clinically severe Ebola disease.

After Tandala, there would not be another Ebola outbreak until July-October 1979, nearly two years later. That outbreak would take place, amazingly, in Nzara, the same Sudanese village from 1976… but, that is a story for another time.[v]

40 years ago, Tandala showed us what we had been missing – the Ebola virus had been circulating for some time both before and after the 1976 outbreak, and in a wider area than previously known. Similarly, we are continuing to learn more in hindsight about other diseases that are affecting us today; a recent discovery has shown that Zika circulated freely and silently in West Africa for the last twenty years,[vi] and research is forthcoming that the virus circulated in Central Africa 35-45 years ago[vii]. These discoveries allow us to understand more fully the footprint of diseases, and stress the importance of looking backwards, as well as forwards, in order to best understand how to prepare for and detect disease outbreaks.

Tandala also showed us that the 1976 Ebola outbreak was not a “one-off”, and that we should be ready for it to emerge again. Today, we continue to emerge from the shadow of the 2014-2015 West African Ebola pandemic, the most catastrophic outbreak yet. Despite all we have learned about the virus in the last 40 years, there is still much we do not know, and are racing to discover, such as its natural reservoir, and how to vaccinate for and treat Ebola virus disease. Forty years and nearly thirty Ebola outbreaks later, we are still coming to terms with what we learned in Tandala in 1977.

 

 

 

[i] Heymann DL, Weisfeld JS, Webb PA, Johnson KM, Cairns T, Berquist H. 1980. Ebola Hemorrhagic Fever: Tandala, Zaire, 1977-1978. J Infect Dis. 142, 372-376.

[ii] WHO. Ebola haemorrhagic fever in Sudan, 1976. Bull World Health Organ. 1978;56:247–270.

[iii] WHO. Ebola haemorrhagic fever in Zaire, 1976. Bull World Health Organ. 1978;56:271–293.

[iv] Cox NJ, McCormick JB, Johnson KM, Kiley MP. Evidence for two subtypes of Ebola virus based on oligonucleotide mapping of RNA. J Infect Dis. 1983;147:272–275.

[v] Baron RC, McCormick JB, Zubeir OA. Ebola virus disease in southern Sudan: hospital dissemination and intrafamilial spread. Bull World Health Organ (1983) 61(6):997.

[vi] Bobby Brooke Herrera, Charlotte A Chang, Donald J Hamel, Souleymane Mboup, Daouda Ndiaye, Godwin Imade, Jonathan Okpokwu, Oche Agbaji, Amy K Bei, Phyllis J Kanki; Continued transmission of Zika virus in humans in West Africa, 1992-2016. J Infect Dis 2017 jix182.

[vii] Saluzzo JF, Miller J, Vincent T, and Gonzalez JP. 2017. A “Zika” Odyssey: A Case Study of Arbovirus Discovery (Central African Republic 1973-1983). Manuscript in preparation.

Posted in Global Health; Tagged: .

05.01.17

Constitutional Challenge to Ohio HIV Criminalization Law

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This post was written by Sean Bland and Safura Abdool Karim, a 2017 Global Health Law LL.M. Candidate at Georgetown University Law Center.

On May 17, 2017, the Supreme Court of Ohio will hear oral arguments in State of Ohio v. Batista, a constitutional challenge to an Ohio law (R.C. 2903.11(B)(1)), which makes it a felony assault for a persons living with HIV to engage in sexual conduct without prior disclosure of their HIV status. Orlando Batista was convicted of felony assault for failing to disclose his HIV-positive status to his girlfriend before having sex with her and was sentenced to 8 years imprisonment, the maximum allowed under the law. The Ohio First District Court of Appeals affirmed the conviction. The Supreme Court of Ohio granted review of the law and Batista’s conviction and sentence.

 

Grounds of Challenge

Batista is challenging the law on two grounds. The first is on the grounds that the law violates the Equal Protection Clauses of the Ohio and United States Constitutions. Batista argues that the law is not rationally related to its purpose of preventing the spread of HIV. This is because criminalization does not reduce the rates of HIV transmission and perpetuates out-dated stigma against people living with HIV. In fact, the law criminalizes conduct that carries a negligible risk of transmission such as condom use or viral suppression through antiretroviral treatment. Batista also argues that there is no rational basis for the law to distinguish between HIV and other communicable diseases (such as Hepatitis C). In addition, Batista argues there is no rational basis to distinguish between the modes of transmission of HIV by criminalizing transmission through sexual conduct but other modes of transmission such as sharing needles.

The second ground of challenge is that the law violates the First and Fourteenth Amendments of the United States Constitution because it compels speech and infringes on the right to refrain from speaking. Batista contends that the law constitutes content-based regulations and, as a result, government must adopt the least restrictive means to achieve its purpose. Since the law is broad and encompasses conduct that carries a minimal or non-existent risk of transmission, Batista contends that it is unconstitutional.

 

State Arguments

The State of Ohio argues that the law does not violate the Equal Protection Clause because because the state has an interest in controlling the spread of HIV and in ensuring consent to sexual conduct. The state also argues that the law does not violate the First and Fourteenth Amendments because the law is only restrictive insofar as it is essential.

 

Amicus Briefs

Various organizations filed amicus briefs to assist the Supreme Court of Ohio by offering information relevant to the case. The Center of HIV Law and Policy and eight other organizations filed a joint amicus brief. The amicus brief builds upon the two constitutional challenges raised by Batista and raises an additional ground. The organizations argue that the law violates the Equal Protection Clause because it arbitrarily singles out persons with HIV for differential treatment while no other classes of people are required to disclose private medical information prior to sexual conduct. In addition, they argue that the law does not reduce the spread of HIV and promotes stigma against persons with HIV. Finally, they argue that the law violates prohibitions against discrimination on the basis of disability under the Americans with Disabilities Act.

 

Implications

This case may have important implications for the constitutionality of similar laws across the United States. Currently, thirty-two states and two U.S. territories have HIV-specific criminal laws that only apply to people with HIV, and other states use general criminal laws to prosecute people on the basis of their HIV status. Since 2008, there are been more than 260 prosecutions under these laws despite the fact that there is no scientific evidence to support such laws.

Posted in Uncategorized; Tagged: , .

04.27.17

At the Intersection of Brain Development & the Criminal Justice System: Young Adult Courts

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This post was written by Laura Malavé-Seda and Rebecca Reingold.

Image Courtesy of the Center for Court Innovation

In the summer of 2015, San Francisco established the U.S.’s first Young Adult Court (YAC), which strives to align opportunities for accountability and transformation with the unique needs and developmental stage of eligible young adults, ages 18-25. It acknowledges the fact that “[o]ur traditional justice system is not designed to address cases involving these individuals, who are qualitatively different in development, skills, and needs from both children and older adults”.

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Posted in Uncategorized; Tagged: .

04.19.17

“Speaking truth to power:” a call for praxis in human rights

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This message was written by Alicia Ely Yamin, O’Neill Institute Director, Health and Human Rights Initiative and originally published by Open Democracy. Any comments or questions can be directed to aey7@law.georgetown.edu.

While conservative populist nationalism surged in the last year, I do not agree that its ascendance was inevitable. But I do believe that the human rights community writ large—from North and South alike—must grasp this opportunity to turn to a praxis grounded in struggles against abuses of power, of all sorts. The word “praxis” suggests the need to connect philosophical ideas and theory with real-life experience and action in the political world, yet there is a tendency at this time to be defensive or critical of the human rights discourse, and neither of these positions fully captures empirical realities. There are equally tendencies to argue that the way forward is to focus on national, grass-roots movements or, alternatively, to reinforce a rules-based internationalism. I do not pretend to know—or even think that—there is a single path forward. But I do fervently believe that the justified alarm around recent events provides an opportunity for profound reflection on human rights theory and practice that cannot be wasted.

Marx famously said that he was not interested in understanding the world but in changing the world. But now more than ever, we need to understand the world in order to change it, if we are to have any hope of seeing “a social and international order” where everyone can effectively enjoy their human rights. Human rights are, or should fundamentally be, about the regulation of power—as shields from tyranny in the public square and private bedroom; as curbs on public lassitude and private greed that undermine social justice; but also, and urgently, as challenges to the structures of thought that also drive patterns of suffering and indignity across the globe. Over the decades, promoters of human rights pushed the bounds of human and governmental agency; re-interpreted norms in light of different populations’ experiences; showed the porousness and arbitrariness of divides between the public and private, and between the political and economic realms in the traditional “liberal state”; and created institutional frameworks and procedures at national and international levels. Throughout, the single most important source of human rights consciousness and energy has come from the diverse people who have been affected by, and collectively struggled against, what Paul Farmer has elegantly termed “pathologies of power.”

Yet the nature of power abuses that rights seek to confront has evolved. Struggles against “traditional” oppression and brutality, as well as in defense of democratic institutions, clearly remain pressing. But it is also true the international order for which post-War institutions were built is now “the global order”. And a global elite, which conservative nationalists cynically decry for their own interests, has captured this global order. Indeed, neoliberalism has become a hegemonic form of organizing the world, as well as our collective consciousness.

When everything from health care to genetic information is commercialized, and everything from romantic relationships to politics (the epitome of this being Trump) to the public square itself (as in Facebook) becomes a marketing opportunity, meaning is hollowed out. When decisional autonomy is reduced to “consumer choice,” it degrades the idea of what being human means. And human rights depend, more than anything else, on this simultaneously inter-subjective and collective idea of humans as subjects of reason and conscience, members of a polity, and agents of change.

When rights are no longer “the magic wand of inclusion and exclusion, of visibility and invisibility, of power and no power… the marker of our citizenship and our relation to others” that US black feminist scholar Patricia Williams so eloquently described, we need to understand not just why but also what to do. We cannot confront hegemonic power the same way as we have historically confronted domination; as French critical theorist, Henri Baudrillard argues, hegemony is fought not from the outside in but the inside out.

Thus, it is not surprising that responses to this alienating and exclusionary discourse of modernity are fundamentally anti-modernist—from radical Islamic groups to the Christian fundamentalists who mix racist and misogynistic aspirations with legitimate economic frustration in the US and seek to sow uncertainty, chaos and violence to undermine the existing order at national and global levels. Nor is it surprising that in place of the pluralist constitutionalist visions modernism offered, human identity for these groups is reduced to a series of binary adjectives untethered to the complexity of reality—white/black, Christian/Muslim, immigrant/citizen, gay/straight, male/female, etc.

So, what can we do in the human rights community? Of course many in this diverse community are already engaged in collective reflection, as this forum attests. But I believe that we must reach across silos as well as across North/South and academic/activist divides to be able to more effectively deploy rights frameworks and tools to subvert the forms of hegemonic power that so pervasively colonize our consciousness.

The power of hegemony lies in the acceptance of the inevitability of a given set of social structures and processes, to the point where they cease to be seen as mutable political arrangements and become the “way things are”. Speaking truth to power requires that the human rights community stand outside the magical circle of belief about the neoliberal understanding of the progress in the world. The ever-greater abdication of responsibility by states (and some institutions of global governance) to private actors, is, after all, a political stance about the role of markets in allocating social goods, and the meaning of accountability. It’s not a neutral quest for greater efficiency and innovation.

The way in which knowledge and systems of knowledge are (re)produced can, however, be more subtle. For example, the creation of human rights indicators, has been driven by the very real need to go beyond the symbolism of norms and capture policy efforts and outcomes, especially in economic and social rights. Yet the recent exponential surge in the adoption of such indicators (often quantitative and synthetic, meaning combining two or more measures), by donors, governments and global institutions suggests that only what gets counted, counts.

The goal of enabling objective cross-country comparisons appears naturally desirable, reasonable and neutral. Nonetheless, it is precisely the abstraction from social context—and therefore from complexities such as what legal norms imply in different societies, the meaningfulness of participation and other process concerns—that can cause these crystallized metrics to sometimes obscure more than they reveal about the power dynamics at play. Rather than better capturing reality, such indicators may well come to define reality. And over-reliance on such technocratic exercises may well undermine our consciousness of the need to struggle against the structural obstacles within countries and in the global order.

The human rights community has already developed methods to identify harmful gender stereotypes or inadvertent discrimination, along with criteria for assessing and making inequity in policy and budgetary efforts visible. Now, it needs to develop a praxis for exposing and disrupting the discourses that structure our collective imaginations, as well as destabilizing neoliberal paradigms that impoverish our conceptions of development, democracy, and the meaning of being human.

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