51 ELR 10576 ENVIRONMENTAL LAW REPORTER 7-2021
GOVERNANCE TO ADDRESS
by Michael G. Mahoney
Michael G. Mahoney is a Visiting Scholar at the Environmental Law Institute, and previously was Vice President
and Assistant General Counsel and Chief Environment, Health, and Safety Compliance Counsel for Pfizer.
Demand for generic pharmaceuticals has resulted in China and India becoming the largest producers of
these products in the world. Pollution from pharmaceutical manufacturing in both of these countries is a rec-
ognized environmental and public health problem, and the release of residual antibiotics is a contributor to
antimicrobial resistance, which is projected to result in 10 million deaths per year by 2050 unless significant
action is taken. This Article argues that implementation of voluntary sustainabilit y standards is needed to
address pharmaceutical manufacturing wastewater pollution, that this approach would drive market demand
for pharmaceuticals produced in this way, and that this market response should also drive other manufactur-
ers to improve their operations.
The Lancet Commission on Pollution and Health
concluded that pollution is the largest environ-
mental cause of disease a nd premature death in the
world today.¹ Diseases caused by pollution were responsible
for an estimated nine million premature deaths in 2015
(16% of all deaths worldwide).² Rapid industrialization and
urbanization have intensied pollution and resulting envi-
ronmental health risks, especially in developing countries.
Pollution stunts economic growth and exacerbates poverty
and inequality in both urban and rural areas; and poor
people, who cannot aord to protect themselves from the
negative impacts of pollution, are suering the most.³
A signicant portion of the pollution in developing
countries such as China and India results from the man-
ufacturing of goods for export to developed countries,
including in the pet rochemica l, chemic al, and pharma-
ceutica l sectors. Industrial growth is f ueled, in large part,
by developed countries’ consumer demand for lower-cost
products. is industrial growth, coupled with the lack of
environmental regulations or poor enforcement of regula-
1. Philip J. Landrigan et al., e Lancet Commission on Pollution and Health,
391 L 462 (2018), available at https://www.thelancet.com/pdfs/jour-
3. World Bank, Pollution, https://www.worldbank.org/en/topic/pollution (last
visited May 26, 2021).
4. International Trade Administration, India—Country Commercial Guide: En-
vironmental Technology, https://www.trade.gov/knowledge-product/india-
environmental-technology (last published Aug. 25, 2020).
tions (collectively, gaps in the environmental rule of law
(EROL)), are the key reasons for these serious pollution
problems in developing countries.
Consumers’ demand for lower-cost generic pharmaceu-
ticals has resu lted in China and India becoming the largest
producers of these products in the world. Pollution from
pharmaceutical manufacturing in both of these countries
is a recognized environmental and public health problem.
e release of residual antibiotics from pharmaceutical
manufacturing has been identied by the World Health
Organization (W HO) as a contributor to antimicrobial
resistance (AMR), which is projected to result in 10 mil-
lion deaths per year by 2050 unless signicant action is
taken to address this global health issue.
5. Steven Bernard & Amy Kazmin, Dirty Air: How India Became the Most Pol-
luted Country on Earth, F. T, Dec. 11, 2018.
6. D.G. Joakim Larsson, Pollution From Drug Manufacturing: Review and
Perspectives, 369 P. T R S’ B 20130571 (2014),
7. e primary cause of antimicrobial resistance (AMR) is the mismanage-
ment of antibiotics; however, the mismanagement of other anti-infectives,
including antifungal and antiviral products, also contributes to the issue.
e private environmental governance approach discussed in this Article to
address residuals in manufacturing wastewaters can and should be applied
for other anti-infectives.
8. Ana Mulero, WHO Stresses Role of GMP in Combatting Antimicrobial Re-
sistance, R. A. P. S’, May 16, 2019, https://www.raps.
9. J O’N ., R A R, T
D-R I G: F R R-
Copyright © 2021 Environmental Law Institute®, Washington, DC. Reprinted with permission from ELR®, http://www.eli.org, 1-800-433-5120.