Environmental pharmaceutical pollution, antimicrobial resistance and medical counterfeiting

By Felicia Velardo, PhD candidate in International Law, School of Law, University of Salerno

The extensive literature reviewing the effects of the COVID-19 pandemic reveals underexplored research topics that deserve enhanced attention. In this respect, it has to be noted that certain environmental and criminal spillover effects – in particular, pharmaceutical pollution and the counterfeiting of medical products and vaccines (the latter to be addressed in Part II) – seem to have been almost neglected.

In contrast to previous health emergencies, COVID-19 has generated unexpected short- and long-term effects on the environment. National lockdowns have temporarily improved air quality around the world as a result of reduced carbon emissions due to travel restrictions and industrial inactivity.[1] Yet, the production of single-use plastic packaging and utensils as well as personal protective equipment (PPE) have dramatically increased, turning “coronavirus waste” into a new form of global pollution. The massive use of PPE – as recommended by the World Health Organization (WHO)[2] – has raised serious concerns regarding the impact of disposable face masks and gloves on the volume of non-biodegradable and non-recyclable waste potentially ending up in the environment and ultimately into the oceans.[3] Undoubtedly, the sound disposal of PPE and other medical waste in times of pandemics poses additional challenges to waste management. This could lead to uncontrolled dumping or open air incineration, causing both environmental pollution and human exposure to infectious agents and toxic substances.

In addition to waste management issues, COVID-19 has brought about less visible consequences in terms of pharmaceutical pollution and possible knock-on effects related to antimicrobial resistance (AMR). As it is well known, the treatment of millions of people infected with the novel coronavirus has required a massive use of drugs. This creates the inevitable risks of environmental spillovers due to the improper disposal of unused medicines and the dispersion of their residues in wastewater through patients’ excreta. On top of that, therapies based on combinations of antivirals and antibiotics – applied to severe COVID-19 patients according to clinical protocols approved by the WHO[4] – have added further concerns with regard to their potential contribution to the natural development of antibiotic-resistant pathogens. This concern was clearly expressed by the WHO in its guidance on the clinical management of COVID-19. It recommended against antibiotic therapy for patients with suspected or confirmed mild or moderate COVID-19 – except for cases of suspicion of a bacterial infection – in order to avoid the possible upsurge of AMR during the pandemic and beyond.[5] The same cautious and responsible approach was recommended during the first challenging months of the pandemic response. Virologists suggested clinical protocols to treat COVID-19, severe pneumonia and superinfections on the basis of antibiotic stewardship principles.[6]

In order to avoid that the COVID-19 pandemic exacerbates these phenomena and the ensuing impact on ecosystems and human health, all governments are urged to apply the relevant normative and policy frameworks designed by international organizations to mitigate the effects of both pharmaceutical pollution and AMR.

So far, the WHO has addressed the issue of chemicals of pharmaceutical origin present in the environment in the framework of the Pre-qualification of Medicines Programme, the Member State Mechanism on Substandard/spurious/falsely labelled/falsified/counterfeit medical products and the Global Strategy for Containment of Antimicrobial Resistance. Moreover, chemical and pharmaceutical pollution has been addressed to varying degrees in WHO reports and guidelines on health care waste management, and in the assessment of health risks of pharmaceuticals in drinking water.[7]

The United Nations has been considering this issue since 2015 in the context of the Strategic Approach to International Chemical Management (SAICM).[8] In 2015, environmental pollution from drugs was defined an emerging political issue and included in the definition of “Environmentally Persistent Pharmaceutical Pollutants”.[9] In fact, according to SAICM, the problem has a global reach and calls for cooperation and coordination between the WHO, the joint United Nations project on the sustainable procurement of pharmaceuticals (an inter-agency project gathering the United Nations Environment Programme-UNEP, the United Nations Development Programme-UNDP, the United Nations Population Fund-UNFPA and the United Nations Office for Project Services-UNOPS) and the Strategic Approach itself.

Moreover, UNEP’s Frontiers Report of 2017 describes AMR deriving from the discharge of drugs and particular chemicals into the environment as one of the most worrying health threats today.[10] Notably with regard to healthcare waste management during the COVID-19 pandemic, UNEP has issued specific guidance identifying key challenges and priorities, sharing the best available practices and offering recommendations and guidelines, also with specific regard to pharmaceutical waste.[11] In particular, UNEP has called upon all countries, and especially developing ones, to tackle this problem by adopting adequate policies and regulations and to take action to operationalize the international regulations and guidance issued by different international institutions, including the WHO, UN-Habitat[12] and other UN agencies.[13]

At European Union level, Directive 2013/39/EU provided that the European Commission set up a strategic approach with regard to water pollution caused by pharmaceutical substances.[14] With its communication to the European Parliament on the European Union Strategic Approach to Pharmaceuticals in the Environment, the Commission delivered on that obligation. The Commission confirmed that “pollution caused by some pharmaceuticals is an emerging problem, with well-documented evidence of risks to the environment and, particularly in relation to antimicrobial resistance, to human health”.[15] The proposed EU Strategic Approach is meant to support both the achievement of Sustainable Development Goals 3, 6 and 12 (with regard to health protection, clean water and chemical waste related issues) and the implementation of the EU One Health Action Plan against AMR and the Global Action Plan on AMR.

The exceptional magnitude and duration of COVID-19 urge that all these strategies and operative frameworks are effectively implemented and adapted to the current pandemic response needs. Inter-institutional cooperation and synergies between the existing regimes are the best foundations to enhance coordination of efforts at both regional and global levels in order to mitigate the overall environmental impact of the pandemic and the ensuing adverse side effects on human health.