The U.S., Capital Punishment and the ICCPR

The United States has expressed reservations to Article 6, section 5 of the ICCPR,[1] stating that “the United States reserves the right, subject to Constitutional restraints, to impose capital punishment on any person (other than a pregnant woman) duly convicted under existing or future laws permitting the imposition of capital punishment, including such punishment for crimes committed by persons below eighteen years of age.”[2]

Notably, the United States is not a party to the Second Optional Protocol to the International Covenant on Civil and Political Rights, the aim of which is the abolition of the death penalty. The rationale behind this reservation, according to the Foreign Relations Committee, is “the recent affirmation of U.S. policy toward capital punishment generally, and in particular the Supreme Court’s decision upholding state laws permitting the death penalty for crimes committed by juveniles aged 16 and 17.”[3]

Recent legal developments undermine the Committee’s rationale, however, and may warrant the reservation’s amendment. In 2005, the United States Supreme Court held the juvenile death penalty unconstitutional, as a violation of the Eighth Amendment’s proscription of cruel and unusual punishment.[4] The respondent was seventeen when he committed murder.[5] Previously, the Court had determined that “standards of decency [did] not permit the execution of any offender under the age of 16 at the time of the crime.”[6] Moreover, the Court cites to the “evolving standards of decency” as evidenced by the growing national consensus against the death penalty for juveniles.[7] The “objective indicia of consensus in this case” was the rejection of the juvenile death penalty in the majority of States; the infrequency of its use even where it remains on the books, and the consistency in the trend toward abolition of the practice.[8]

Notably, the Court discusses the ICCPR and other international treaties in its opinion, finding international consensus a factor in determining whether punishment is cruel and unusual.[9]

More recently, a federal judge in California held that the State’s death penalty system violated the Eighth Amendment.[10] Of the nine hundred individuals sentenced to death since 1978, only seventeen had completed federal habeas review and had been denied relief. Of those seventeen, each had been on death row for more than twenty-five years, and eight have been there for more than thirty years. The Court held California’s death penalty system to be arbitrary, determining that a death sentence in California is rather a “sentence of life imprisonment with the remote possibility of death ­– a sentence no rational legislature or jury could impose.”[11] Moreover the selection for execution served no penological purpose, but rather was determined by how quickly the inmate proceeded through the State’s post-conviction review process.[12]

Based on these two cases, it would seem the standards of decency and national consensus have evolved since the Committee recommended the reservation to Article 6. International pressure led by the Human Rights Committee may aid in the continuing push for the striking of this reservation.

 

Tim Joseph is a 3L and a Senior Editor for the Journal of Law and International Affairs at the Penn State University Dickinson School of Law.


 

[1] “Sentence of death shall not be imposed for crimes committed by persons below eighteen years of age and shall not be carried out on pregnant women.” (ICCPR).

[2] United States of America. Reservations to the International Covenant on Civil and Political Rights. https://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&id=IV~4&chapter=4&lang=en#EndDec.

[3] S. Exec. Rep. at 11, reprinted in 31 I.L.M. at 653.

[4] See Roper v. Simmons, 543 U.S. 551, 551 (2005).

[5] See id. at 556.

[6] See id. at 561 (citing Thompson v. Oklahoma, 487 U.S. 815, 818–838) (opinion of Stevens, J., joined by Brennan, Marshall and Blackmun, JJ.).

[7] Id. at 563–64.

[8] Id. at 567.

[9]Id. at 576 (“As respondent and a number of amici emphasize, Article 37 of the United Nations Convention on the Rights of the Child, which every country in the world has ratified save for the United States and Somalia, contains an express prohibition on capital punishment for crimes committed by juveniles under 18.”) United Nations Convention on the Rights of the Child, Art. 37, Nov. 20, 1989, 1577 U. N. T. S. 3, 28 I. L. M. 1448, 1468-1470 (entered into force Sept. 2, 1990); Brief for Respondent 48; Brief for European Union et al. as Amici Curiae 12-13; Brief for President James Earl Carter, Jr., et al. as Amici Curiae 9; Brief for Former U. S. Diplomats Morton Abramowitz et al. as Amici Curiae 7; Brief for Human Rights Committee of the Bar of England and Wales et al. as Amici Curiae 13-14. No ratifying country has entered a reservation to the provision prohibiting the execution of juvenile offenders. Parallel prohibitions are contained in other significant international covenants. See ICCPR, Art. 6(5), 999 U. N. T. S., at 175 (prohibiting capital punishment for anyone under 18 at the time of offense) (signed and ratified by the United States subject to a reservation regarding Article 6(5), as noted, supra, at 567, 161 L. Ed. 2d, at 20); American Convention on Human Rights: Pact of San Jose, Costa Rica, Art. 4(5), Nov. 22, 1969, 1144 U. N. T. S. 146 (entered into force July 19, 1978) (same); African Charter on the Rights and Welfare of the Child, Art. 5(3), OAU Doc. CAB/LEG/24.9/49 (1990) (entered into force Nov. 29, 1999) (same).”).

[10] See Jones v. Chappell, 31 F. Supp.3d 1050 (C.D. Cal. 2014).

[11] Id. at 1062.

 [12]Id.

Follow-On Biologic Drugs Are Unlikely to Reduce the Price of Biologic Drugs Absent FDA Innovation

The price of pharmaceutical products has long been a source of controversy. While the recent headline of the increase of the drug Daraprim from $13.50 per tablet to $750.00 may provide an extreme example of some of the problems affecting the pharmaceutical industry, the looming costs of biologic drugs represent a far more complex and nuanced problem with few easy answers. Though generic versions of biologic drugs may offer some relief, the advent of these biosimilars, or follo-on biologics, is unlikely to result in lower prices without significant Food and Drug Administration (“FDA”) innovation.

In 2005, the European Union’s European Medicines Agency established guidelines for the approval process for follow-on biologics. This pathway predates the pathway established by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and has thus far resulted in the approval of 19 follow-on biologics for six different pioneer biologic drugs. Importantly, the impact of this regulation in the European Union’s mature follow-on biologic markets can be measured and used to predict the effects of similar regulation in America.

When analyzing the market data for follow-on biologic markets in the European Union, it is clear that the four most mature markets, and thus the markets that have the most value with regard to predicting regulatory effects in America, are for the biologic drugs erythropoietin, human growth hormone, granulocyte colony-stimulating factor, and anti-tumor necrosis factor. A recent report published by the IMS Institute for Healthcare Informatics, an American company that is the largest vendor for U.S. physician prescribing data, analyzed these markets and concluded that the extent to which biosimilar competition has penetrated the health care market is the most crucial predictor of whether the existence of a follow-on biologic actually results in lower prices for the consumer. The report suggests several ways to achieve this market penetration, including mass purchasing plans, elimination of barriers to an unrestricted free market, and establishing substitution guidelines that allow generic substitution. As the United States does not engage in the mass national purchasing that some countries belonging to the European Union do engage in, the United States should focus on eliminating barriers of entry to an unrestricted free market and promote the substitution of cheaper follow-on biologic drugs when appropriate to reduce the price of biologic drugs.

While the BPCIA established a regulatory framework for the introduction of follow-on biologics, it is ultimately up to the FDA to promulgate specific regulations for how a follow-on biologic manufacturer can bring a product to market. Importantly, this includes establishing whether a follow-on biologic is merely “biosimilar,” or if it is “expected to produce no meaningful clinical difference” to the pioneer drug and can be classified as “interchangeable.”[i] Unfortunately for biologic drug consumers, it is unlikely that a follow-on biologic will be able to meet this high bar because there is enormous pressure on the FDA from pioneer biologic organizations, including the  Biotechnology Industry Organization, to withhold making this determination until the state of the art  testing of biologics has improved.

Learning from the past, the FDA would be wise to promulgate standards that can eventually be converted into rules as the state of the art develops.[ii] These rules might eventually be able to advise companies on how to produce follow-on biological drugs that interact with a specific enzyme or incorporate a specific three dimensional motif. Furthermore, as the FDA establishes rules, it is likely able to save on screening costs[iii] that contribute to the price of biologics and affect the market penetration of follow-on biologics. However, these vastly understated shifts depend on the ability of the FDA to efficiently and consistently measure biologic drug safety and efficacy- a task that currently consumes enormous amounts of time and money, and is the principal factor contributing to the high price of biologic drugs. Thus, significant technological advancement in the state of the art of biologic drugs is likely the most significant factor in reducing the cost of the price of biologic drugs. While this advancement is likely to take years and costs billions of dollars, European data suggests that absent market penetration and substation, follow-on biologics are likely to have an insignificant impact on the price of biologic drugs in the United States absent this shift in how the FDA regulates biologic drugs.

 

Stephen Dotts is a 3L and a Senior Editor for the Journal of Law and International Affairs at the Penn State University Dickinson School of Law.


 

[i] 42 U.S.C. § 262(k)(2)(A)(i)(I-V) (2011).

[ii] See Louis Kaplow, Rules versus Standards: An Economic Analysis, 42 Duke L.J. 557, 557-629 (1992)(arguing that standards are cheap to establish but expensive to enforce and that rules are expensive establish but cheap to enforce; the FDA is wise to employ both of these methods where appropriate for maximum effectiveness; and establishing rules for a less-developed market is more prone to large companies dominating the process).

[iii] See Richard A. Merrill, Risk-Benefit Decisionmaking by the Food and Drug Administration, 45 Geo. Wash. L. Rev. 994 (1976)(arguing that FDA screening of “small-ticket” products, such as drug products, is extremely expensive when compared to utilizing industry standards to ensure product efficacy and safety).