The European Union’s Use of the “Precautionary Approach” for Public Health Policies

A blog post by Madison Bialkowski, Junior Associate.

The Precautionary Approach provides that: “the burden of proof for potentially harmful actions by industry or government rests on the assurance of safety and that when there are threats of serious damage, scientific uncertainty must be resolved in favor of prevention.”[1] [Emphasis Added].  Public health advocates across the world increasingly invoke the precautionary approach for environmental and food safety issues.[2]  While this approach is laudable, its applicability “may undermine trust and cause confusion in practice.”[3]  The examples below demonstrate the benefits and flaws of this approach when applied to public health policies.

The Precautionary Approach is the basis for the European Union’s (“EU”) public health policies.[4]  In the 1990’s, the EU first adopted the precautionary approach in response to the outbreak of Bovine Spongiform Encephalopathy, otherwise known as BSE or Mad Cow Disease.[5]  Meat sold from BSE cows was found to be contaminated and potentially fatal to humans who ate it.[6]  As the Mad Cow Disease spread in humans, regulators were unable to make decisions on how to stop it because of limited conclusive evidence that the meat from BSE cows was dangerous.[7]  Ultimately, in order to best protect the public, the EU implemented a Precautionary Approach that included euthanizing over 4 million head of cattle and adopting guidelines for all food.[8]

Currently, the world is experiencing the COVID-19 pandemic.[9]  In a race to ensure the public’s safety, countries are encouraging their citizens to be vaccinated.[10]  Because the vaccine production and authorization was streamlined for emergency use only, there has been a lack of confidence by many in the vaccine.[11]  For instance, some who received the AstraZeneca vaccine experienced life-threatening vaccine-induced thrombotic thrombocytopenia, a rare blood clotting disorder. [12]  The EU implemented the precautionary approach in accessing the vaccines safety and suspended its use.[13]  The suspension of AstraZeneca vaccinations across the EU provoked criticism from organizations like the World Health Organization (“WHO”) and the European Medicines Agency (“EMA”) as well as from EU citizens.[14]  The WHO and EMA believed the benefits of the vaccine outweighed any potential risks,[15] and some EU citizens came to the same conclusion finding that there is more harm in getting COVID-19 than the low risk of blood clotting from the Astra Zeneca vaccine.[16]

Although the precautionary approach is widely used, regulators should be wary of its flaws.  In some cases, applying the precautionary approach may lead to more harm than good to public confidence in the government.  As can be seen with the Pandemic that has greatly affected everyone’s lives, there are situations where benefits outweigh any potential risk raised by the precautionary approach.  Furthermore, the possibility of an end to the Pandemic helps justify the risk.

[1] Bernard D. Goldstein, The Precautionary Principle Also Applies to Public Health Actions, 91 Am J. Pub. Health 1358, 1358 (2001).

[2] Id.

[3] David Isaacs, The precautionary principle, the AstraZeneca COVID-19 vaccine and mixed messaging, 57 J. Paediatrics & Child Health 472, 473 (2021).

[4] The precautionary principle: Definitions, applications and governance, at 6, (December 2015), https://www.europarl.europa.eu/RegData/etudes/IDAN/2015/573876/EPRS_IDA(2015)573876_EN.pdf.

[5] Brent S. Steel, Science and Politics: An A-to-Z Guide to Issues and Controversies 232 (Brent S. Steel eds., 2014).

[6] Id.

[7] Patrick van Zwanenberg & Erik Millstone, Late Lessons from Early Warnings: The Precautionary Principle 1896-2000, at 157 (Poul Harremoës et al. eds., 2001).

[8] Science and Politics, 232; ‘Mad cow disease’: What is BSE?, BBC (Oct. 18, 2018), https://www.bbc.com/news/uk-45906585.

[9] Alice Park, Why Countries Around the World Are Suspending Use of AstraZeneca’s COVID-19 Vaccine, TIME (Mar. 16, 2021, 12:20 PM), https://www.nytimes.com/interactive/2021/world/covid-cases.html.

[10] Safe COVID-19 vaccines for Europeans, European Commission (https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health_en.

[11] COVID-19 Vaccine AstraZeneca authorized for use in the EU, AstraZeneca (Jan. 29, 2021, 8:30 PM), https://www.astrazeneca.com/media-centre/press-releases/2021/covid-19-vaccine-authorised-for-use-in-the-eu.html.

[12] Isaacs, supra note 3; See, James Gallagher, Covid: Trigger of rare blood clots with AstraZeneca jab found by scientists, BBC (Dec. 2, 2021), https://www.bbc.com/news/health-59418123 (discussing the rare blood clotting disorder that has been linked to 73 deaths of the 50 million doses of AstraZeneca administered in the UK).

[13] Isaacs, supra note 3; Achille Ivasilevitch et al., COVID-19 and vaccination, or the new misfortunes of the precautionary principle, 18 Ethics, Med. & Pub. Health, Sept. 2021, at 1.

[14] Park, supra note 9; Ivasilevitch, supra note 13.

[15] Park, supra note 9

[16] Ivasilevitch, supra note 13.

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