2. Presenter Disclosure
The following personal financial relationships with
commercial interests relevant to this presentation
existed during the past 12 months:
2
Gabriel Armas-Cardona, Esq.
No relationships to disclose.
3. Challenge of Court-driven Access to Medicine
Patients are suing to access medicines that are
prohibitively expensive.
1. How should courts respond?
2. Does the right to health have anything useful to
contribute here?
3
4. What is the Right to Health?
“ … [T]he right of everyone to the enjoyment of the
highest attainable standard of physical and mental
health.”
Article 12(1) of the International Covenant of Economic, Social
and Cultural Rights (ICESCR)
It is justiciable; a court can adjudicate a violation
Not an absolute right:
Limited “to the maximum of [a State’s] available
resources,” (ICESCR, Art 2(1))
4
5. Justiciability Success Story: HIV/AIDS Medicine
By the 90s, there were medicines that helped control
HIV/AIDS (e.g. AZT)
The LGBTI community in the US fought hard for these
Global South governments didn’t include them in public
health systems
In part because of inertia and in part because of high costs
Incongruity in countries that care about rights
It looks like a violation of the right to life to deny medication to
someone dying from HIV/AIDS
Marginalized communities were most effected; very strong argument
that equity demanded a response
Governments acquiesced. Brazil was the first by
including ARV treatment in public health system in 1997
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6. The Downside of Justiciability: Judicialization
Judicialization: courts make policy choices that are
better suited to expert agencies or the political
branches
Underlying issues of Judicialization:
Judges cannot review an entire health program in an
individual case
Judges should not be second-guessing experts
Prioritizes patients that can hire a lawyer, i.e. the middle class
Pragmatic Concern: Judicialization can shift
resources away from priority public health concerns
to individual, expensive treatments
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7. Low barrier of entry for Brazilian courts
Public Ombudsman and good access to justice
Writ of security, Mandado de Segurança (like the writ of
amparo throughout Latin America): a legal tool to get
immediate judicial attention for an alleged rights violations
The Supreme Court constitutionalized a right to
health that explicitly ignores available resources!
7
Judicialization:
Brazil’s Access to Medicine cases
8. “Between the protection of the inviolable
rights to life and health … and the upholding
… of a financial and secondary interest of
the State, … the judge [is compelled] to only
one possible solution: that which furthers
the respect of life and human health . . . .”
Sup. Fed. Ct. Recurso Extraordinário No. 271.286-8 of 2000
8
Judicialization:
Brazil’s Access to Medicine cases
11. Judicialization: Bad, but not that Bad
Judicialization complained of only in drug cases
Justiciability tackles many issues
Non-discrimination
Public goods like sanitation
Brazilian courts were able to bypass political gridlock
Unnecessary long waits
People died while waiting for health care
Allegedly, delays due to institutional inefficiency
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12. Judicialization: Bad, but not that Bad
Regressive redistribution was slight compared to
general public health system
Arguably an example of the inverse equity hypothesis
Most medicines sued for were already in the national
plan. Off-plan drugs were typically similarly priced.
Drug costs were only 1-2% of MoH drug budget
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13. Hepatitis C and Sofosbuvir
About 3.2 million Americans have Hepatitis C
Leading infectious disease killer in the US
The FDA approved the Hepatitis C cure Sofosbuvir
(Sovaldi) in late 2013
Sofosbuvir has a very high success rate (>90%) and
less side effects than previous methods
Included on WHO’s Model Essential Medicine List
Problem: Sofosbuvir’s list price is $84,000 for an
entire regimen.
Still cost-effective from a public health perspective!
13
14. Prisons and Medicaid Health Obligations
Both state prisons and Medicaid must provide
healthcare
Medicaid can deny a treatment only if its prescribed
use “is not for a medically accepted indication” as
determined by the FDA.
Prisons can’t demonstrate “a deliberate indifference
to serious medical need.”
No restriction based on available resources!
14
15. Sofosbuvir Breaking State Budgets
Even with discounts, state prisons paid a median
price of $76,084 per patient in 2015
$63,509 for sofosbuvir/ledipasvir (Harvoni)
Matt Salo, executive director of the National
Association of State Medicaid Directors:
Providing drugs to all those infected with Hepatitis C
“would blow up state budgets.”
Treating Oregon prisoners would cost 4x total prison
health care budget
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16. States Respond by Restricting Access
16
19
29
34
37
0 5 10 15 20 25 30 35 40
HIV status
Limit prescriber type
Liver disease stage
Drug and alcohol usage
Restrictions State Medicaid
programs impose on Hepatitis C
treatment (n=42)
None of these restrictions meet medical criteria
17. How Courts can Contribute to Good Policy
1. Use dialogic justice – talk with the agency
Review—with some deference—state agencies’ claims of resource
availability. Ensure efficient allocation.
Colombia’s T-760; South Africa’s Soobramoney
2. Have the agency create a policy w/ stakeholder input
Ensure evidence-based and non-discriminatory
HIV/AIDS cases
3. Insist on a time-bound plan
Make the state agency set a deadline for full coverage
Brazilian sanitation cases
Monitor implementation
India’s Vineet Narain; T-760; Federal oversight of CA prisons
Optimistic ideal: require a larger health budget
17
18. Thank you for your time
18
Questions?
Gabriel Armas-Cardona, Esq.
Gabe.Armas-Cardona@nyu.edu
@GArmasCardona
Editor's Notes
Hello, talk discuss the good from the right to health, avoiding the problem of judicialization
Made for non-lawyers in mind. meh.
[Unsure] Show of hands: likely no time
how many lawyers?
How comfortable are you with the right to health? [hand down for up, hand fully up if totally comfortable]
"the individual right to health is the right to equal concern and respect and to a fair share of the available resources, within the best possible system." – Gloppen
For the US fight, watch How to Survive a Plague
End: If HIV, why not other illnesses? It has, diabetes, Parkinson disease, Alzheimer’s, hepatitis C, and multiple sclerosis
SA’s TAC case was in 2002
(Don’t read the middle)
Beihl et al. study
Beihl et al. study
2007, Health ministry spent 2.5 billion on medicine. So 20 mil is only 0.8%. 47mil is 1.9%
(Joke: Halloween colors)
Drug cost: 47 million USD
Beihl only looked at the state of Rio Grande do Sul
2nd source: (Brinks and Gauri, 2014)
“Side-note, there are newer Hep C cures, but my focus is on Sofosbuvir both because it’s the most well-known and studied and because the policy questions it raises are applicable to any high-cost drug”
Cost-effectiveness includes considering stopping the spread of the disease to others.
List of drugs: Sofosbuvir from Gilead. Sofosbuvir + Ledipasvir is called Harvoni. Epclusa is the newest drug, it is Sofosbuvir + Velpatasvir, also from Gilead. Zepatier, the new cheap one from Merck.
Legal requirements
State medicaids likely pay slightly less than prisons do.
Dr. Steven Shelton, medical director of Oregon’s state prison system, estimated it would cost more than $200 million to treat Oregon prisoners with the disease, an amount four times greater than the system’s entire annual health care budget.“
Source: Barua et al, 2015
PROBLEMS
AASLD = American Association for the Study of Liver Diseases
Drug and alcohol: National Institute of Health & AASLD guidelines include PWID. Requiring 6 months without drug use before starting HCV treatment is not supported in medical literature. Further, Medicaid doesn’t deny medications for other infectious disease due to drug and alcohol usage.
Liver disease: It is acceptable to prioritize patients with more advanced fibrosis. The problem is 31 of these 34 states exclude entirely patients with mild to moderate fibrosis (F1 and F2)
Prescriber type: inconsistent with current practice; non-specialists are currently treating HCV with interferon-based treatments
HIV status: Some states require ART treatment
Mention lawsuits: Indiana, Massachusetts, Minnesota, Pennsylvania, and Colorado. Like the cases in Brazil, these cases are justified; we want them.
“Courts are already involved”
Dialogic: Colombia’s T-760
Deference: while it’s typical for courts to defer to the final decisions of administrative bodies, this is about reviewing the underlying budget that guides those decisions. This is much more than a traditional procedural review.
Efficiently allocated -> inefficient allocation presumptively shows they’re not using maximum of available resources. Example: Michigan is paying full price for Sofosbuvir. Why? There is a Federal drug discount program; is there a reason Michigan is not taking advantage of it?
Monitoring state’s implementation is done in the United States. similar to how Federal courts oversaw the realignment of California’s prisons. Even Governor Gerry Brown who dislikes the judicial oversight noted that “court intervention had forced vast improvements to a system that was in crisis.”
Earlier this year -> Kansas supreme court ruled education budget cuts as unconstitutional, forcing the state legislature to increase funding.
For the last part, another possibility is compulsory licensing or drug price caps.