National law & policy for access to medicines
Minimum core obligations under the right to health
What is 'reasonable' state action?
Katrina Perehudoff & Lisa Forman. Journal of Human Rights Practice, 2019, 11.1: 1-21.
This article starts to define a common test for governments, advocates, and judges to assess whether States have satisfied their core obligations towards essential medicines. We propose that these core obligations imply four immediate actions based on the 'standard of reasonableness' (enshrined in the Optional Protocol to the International Covenant on Economic, Social and Cultural Rights): (1) exercise non-discrimination, (2) allocate sufficient public financing, (3) use low-cost policy options, and (4) seek international assistance when needed. Drawing on examples from domestic law and policy in Colombia, Kenya, Latvia, Peru, South Africa, and the USA, we illustrate the potential definition and scope of these four actions. Continue reading in the Journal of Human Rights Practice... (contact me for the full text).
Katrina Perehudoff, Brigit Toebes & Hans Hogerzeil. Bulletin of the World Health Organization, 2016, 94.12: 935.
This article offers governments arguments to ensure fair access to expensive, new essential medicines as part of the right to health, within their finite health budgets. We propose that the human rights principle of 'progressive realisation' justifies priority ranking medicines for reimbursement. Governments using progressive realisation and other human rights arguments can guard against 'queue jumping' expensive therapies and can reject patient claims for immediate access to low-priority, expensive medicines before all options to decrease medicines prices have been explored. Continue reading in the Bulletin of the World Health Organization...
Impact: This research is cited in the International Federation of Medical Student Associations' Policy Statement on Access to Medicines (adopted in March 2019).
Minimum core obligations under the right to sexual and reproductive health
Katrina Perehudoff, Lucía Berro Pizzarossa, Jelle Stekelenburg. BMC International Health & Human Rights, 2018, 18.1: 8.
This article examines the coherence between WHO's Model List of Essential Medicines and the right to health through the case study of mifepristone and misoprostol (designated essential medicines for medical abortion). These are the only two essential medicines that the WHO recommends to use in line with domestic law or cultural practices. We illustrate how this restrictive entry on WHO's 2017 Model List is inconsistent with current scientific evidence, with the recently elaborated General Comment No. 22 (2016) on the right to sexual and reproductive health (enshrined in the International Covenant on Economic, Social and Cultural Rights) and with the more recent WHO policy guidance on safe abortion. Continue reading in the BMC International Health & Human Rights journal...
Impact: This research is cited by the WHO Department of Reproductive Health and Research as key evidence supporting the 2019 essential medicines list revision application for mifepristone and misoprostol for medical abortion. Some of our arguments are also endorsed by the UN Population Fund. The 22nd WHO Expert Committee on the Selection and Use of Essential Medicines decided to move mifepristone and misoprostol from the 'complementary' to the 'core' list of essential medicines (in line with our arguments); however, the statement "[for use] where permitted under national law and where culturally acceptable" was not removed.
State obligations regarding universal cervical cancer control
Katrina Perehudoff, Heleen Vermandere, Alex Williams, Sergio Bautista-Arredondo, Elien De Paepe, Sonia Dias, Ana Gama, Ines Keygnaert, Adhemar Longatto-Filho, Jose Ortiz, Elizaveta Padalko, Rui Manuel Reis, Nathalie Vanderheijden, Bernardo Vega, Bo Verberckmoes, Olivier Degomme. BMC International Health & Human Rights, 2020, 20:21.
This article argues first for tailored and innovative national cervical cancer screening programmes (NCSP) grounded in human rights law, to close the disparity between women who are afforded screening and those who are not. Second, acknowledging socioeconomic disparities requires governments to adopt and refine universal cancer control through NCSPs aligned with human rights duties, including to reach all eligible women. Commonly reported- and chronically under-addressed- screening disparities relate to the availability of sufficient health facilities and human resources (example from Kenya), the physical accessibility of health services for rural and remote populations (example from Brazil), and the accessibility of information sensitive to cultural, ethnic, and linguistic barriers (example from Ecuador). Third, governments can adopt new technologies to overcome individual and structural barriers to cervical cancer screening. National cervical cancer screening programmes should tailor screening methods to under-screened women, bearing in mind that eliminating systemic discrimination may require committing greater resources to traditionally neglected groups. Continue reading in the BMC International Health & Human Rights journal...
Domestic legislation for universal health coverage
Katrina Perehudoff, Nikita Alexandrov, Hans Hogerzeil. Health Policy & Planning, 2019;34:i48-57.
This study identifies and compares legal texts from national UHC legislation that promote universal access to medicines in the legislation of 16 mostly LMICs: Algeria, Chile, Colombia, Ghana, Indonesia, Jordan, Mexico, Morocco, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Turkey, Tunisia and Uruguay. This research presents national law makers with both a checklist and a wish list for legal reform for access to medicines, as well as examples of legal texts. Continue reading in Health Policy & Planning...
Impact: This research was selected by the Medicines in Health Systems working group of Health Systems Global for publication in the journal supplement on Access to Medicines through Health Systems in Low- and Middle-Income Countries.
National medicines policies
Katrina Perehudoff, Nikita Alexandrov, Hans Hogerzeil. PLoS ONE, 2019, 14(6): e0215577.
This study finds that WHO’s 2001 guidelines to develop and implement a national medicines policy have guided the content and language of many subsequent national medicines policies. WHO and national policy makers can use the principles and the practical examples identified in this study to further align national medicines policies with human rights law and with Target 3.8 for universal access to essential medicines in the Sustainable Development Goals. Continue reading in PLoS One...
Impact: This research is cited in a 2019 Lancet Oncology comment by access to medicines advocates calling for effective national policies to make the new essential cancer medicines on WHO's 21st Model List of Essential Medicines affordable.
Domestic constitutional law
Journal article: Essential medicines in national constitutions: Progress since 2008
Katrina Perehudoff, Brigit Toebes, Hans Hogerzeil. Health and Human Rights, 2016, 18(1): 141–156.
In 2015, twenty-two domestic constitutions enshrine the protection and/or the promotion of medicines as part of the right to health. Since 2008, State duties to fulfil medicines rights have been expanded in five constitutions, maintained in four constitutions, and regressed in one constitution. Terminology used to describe these rights has evolved over time to include more human rights standards (Ecuador, Panama), to enshrine the phrase 'access to medicines' (Bolivia, Dominican Republic, Ecuador), and to protect the public from access barriers in international trade agreements and/or intellectual property rights (Bolivia, Ecuador). Government commitments to essential medicines are an important foundation of health system equity and are included increasingly in domestic constitutions. Continue reading in the Health and Human Rights journal...
Impact: This research is cited in the Access to Medicines chapter of the Health & Human Rights Resource guide, an advocacy tool published by the FXB Centre for Health & Human Rights at Harvard University.
Journal article: Access to medicines in national constitutions
Katrina Perehudoff, Richard Laing, Hans Hogerzeil. Bulletin of the World Health Organization, 2010, 88:800.
Constitutional recognition of the right to access to medical products and technologies is a country progress indicator in WHO's Medium-Term Strategic Plan for 2008-2013. This study reports that four national constitutions (of 186 constitutions; 2%) specifically mention universal access to medicines. The constitutions of Ecuador and Panama specify that national medicine policies shall be established and implemented to achieve the constitutional obligations. Constitutional frameworks can be valuable aspirational statements on which to base other legislation and policies; the examples identified in this recent WHO study could serve as a model. Continue reading in the Bulletin of the World Health Organization...
Impact: This article is cited in the 2018 Model Drug Law for West Africa: A toolkit for policy makers published by the West Africa Commission on Drugs, in the 2016 WHO guide on the role of the law in advancing the right to health, in the WHO's presentation on access to medicines at the UN Human Rights Council Social Forum on February 18, 2015, by the Lancet NCDs Action Group, and in the 2011 WHO report on the constitutional right to health in the South East Asia Region. The data from this article was reported by the UN Special Rapporteur on the Right to Health in the 2008 Lancet report on health systems & the right to health by Backman et al.
This article is based on my Masters thesis titled "Health, essential medicines, human rights and national constitutions", defended at the Vrije Universiteit Amsterdam in 2008.
Domestic case law
Lucía Berro Pizzarossa, Katrina Perehudoff, José Castela Forte. Health & Human Rights Journal, 2018.
In response to the current debate around universal health coverage and flood of domestic legislation concerning high-priced medicines in Uruguay, we review a sample of 42 amparo claims for the reimbursement of medicines in 2015. We found that the circuits of appeal fail to give predictable legal argumentation, including for nearly identical cases. Moreover, the Uruguayan courts' interpretation of the state’s core obligations to provide essential medicines and ensure non-discriminatory access is not consistently aligned with international human rights law. We conclude that medicines litigation in Uruguay offers relief for some individual claims but may exacerbate systemic inequalities by failing to address the structural problems behind high medicines prices. Continue reading in the Health & Human Rights Journal...
Impact: This article is cited by Yale Law Professor Amy Kapczynski as "an excellent new paper that argues that courts should assess the adequacy of the state’s attempts to spend efficiently and lower prices, including by using TRIPS flexibilities, when they are faced with plaintiffs seeking access to high-cost medicines that the state argues are not cost-effective," in her work titled 'The Right to Medicines in an Age of Neoliberalism' published in Humanity: An International Journal of Human Rights, Humanitarianism and Development (2019).
Right to health indicators in health systems
Katrina Perehudoff, Nikita Alexandrov, Hans Hogerzeil. Global Public Health, 2018.
We present a follow-up report of eight indicators for access to medicines in 195 countries, initially reported in the Lancet in 2008 by the UN Special Rapporteur on the Right to Health. Between 2008 and 2015 we observed increased numbers of constitutions recognising access to medicines (7–13 countries), countries with a national medicine policy (118–122) and with a national list of essential medicines (78–107). Public spending on pharmaceuticals decreased or rose modestly in most of the 44 countries. Median availability of a basket of lowest-priced generics increased in the public (63%–70% n = 9 countries) and private (84%–92% n = 10) sectors. Median child immunisation rates remained constant for measles (around 90%) and improved for three doses of diphtheria-tetanus-pertussis (79%–86%). These eight indicators are useful and feasible, but should be further strengthened and expanded. Our follow-up report serves as a reference point for progress towards SDG Target 3.8 on essential medicines. Continue reading in Global Public Health... (contact me for the full text)