Private Environmental Governance to Address Manufacturing Releases of Antibiotics

• Date: 01 July 2021

51 ELR 10576 ENVIRONMENTAL LAW REPORTER 7-2021

PRIVATE ENVIRONMENTAL

GOVERNANCE TO ADDRESS

MANUFACTURING RELEASES

OF ANTIBIOTICS

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.

SUMMARY

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 intensied 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 aord to protect themselves from the

negative impacts of pollution, are suering the most.³

A signicant 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-

nals/lancet/PIIS0140-6736(17)32345-0.pdf.

2. Id.

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 identied 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 signicant 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),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4213584/.

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.

org/news-and-articles/news-articles/2019/5/who-stresses-role-of-gmp-in-

combatting-antimicrobi.

9. J O’N  ., R  A R, T

D-R I G: F R  R-

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