Pharmaceutical Pollutants under the Spotlight

Pharmaceutical Pollutants under the Spotlight

This story from Brenda Koekkoek was published as an article on ChemicalWatch

A call for attention and action on environmentally persistent pharmaceutical pollutants was presented at the 4th International Conference on Chemicals Management (ICCM4) in September 2015. Stakeholders of the Strategic Approach to International Chemicals Management (SAICM) will consider a proposal to include environmentally persistent pharmaceutical pollutants as an emerging policy issue at ICCM4 developed by the Governments of Peru and Uruguay together with the International Society of Doctors for the Environment. It identifies the need for greater awareness and policy engagement; enhanced coordination and collaboration amongst different initiatives and actors; and greater capacity to assess and manage risks, at a global level, and particularly in developing countries.

The proposal lists seven activities that should be taken (see Box) and notes that there are three main pathways that pharmaceutical products reach the environment:

  • releases during manufacturing processes;
  • human and animal excretion; and
  • unused or expired pharmaceutical products from hospitals or households.

It also identifies a number of perceived gaps, including:

  • gaps in understanding the risks of chronic low level and early exposure to children and the foetus via drinking water or food as well as possible combined, synergistic effects;
  • lack of understanding of the fate, and effects of chemicals of pharmaceutical origin in the environment;
  • very limited environmental monitoring programmes and lack of comparable sampling systems; and
  • no available test methods to assess negative effects after long term environmental diffuse exposure in humans, aquatic microorganisms and other wildlife.

During last December’s preparatory meeting for ICCM4 – the second Open-Ended Working Group (OEWG) – some participants emphasised the far reaching potential impacts of environmentally persistent pharmaceutical pollutants, as well as the importance of promoting collaboration and cooperation, and avoiding duplication. At the meeting via a technical briefing, three intergovernmental organisations, the UN Food and Agriculture Organization (FAO), the World Health Organization (WHO) and the Organisation for Economic Co-operation and Development (OECD), jointly presented their ongoing and planned programmes of work relevant to the issue.

Environmentally persistent pharmaceutical pollutants were first considered in the context of Saicm at the first OEWG held in November 2011 in Belgrade, when they were discussed alongside endocrine disrupting chemicals.

At that time, there was some discussion as to whether pharmaceuticals fell within the scope of Saicm, because of a footnote to paragraph (3(b)) in its Overarching Policy Strategy. This footnote specifies that “the Strategic Approach does not cover products to the extent that the health and environmental aspects of the safety of the chemicals and products are regulated by a domestic food or pharmaceutical authority or arrangement.” At the first meeting of the OEWG, the UN Environment Programme (Unep) clarified that pharmaceuticals are not in Saicm’s scope, considering the footnote in paragraph 3(b), but chemicals released to the environment from disposal or use may be considered if the releases are not regulated by a pharmaceutical authority or arrangement. Participants at the first OEWG took note of the merit of the issue and encouraged further development of the proposal by the proponent after ICCM3 in 2012.

The international context

The study of the presence of pharmaceuticals in the environment is multi-disciplinary, and a number of initiatives already exist, including extensive studies within the research community. Evidence is emerging that the issue is of a global nature. An international workshop took place from 8-9 April 2014 in Geneva, Switzerland, entitled Pharmaceuticals in the environment – global occurrence, effects, and options for action. It included information from a recent project by Germany’s water research institute, IWW Water Centre, which highlighted the occurrence of pharmaceutical chemicals in at least 71 countries, in the five UN regions, with a total of 631 different chemicals of pharmaceutical origin detected, from oestrogens to analgesics to antibiotics to lipid-lowering drugs and others.

In considering human pharmaceuticals, the WHO actively addresses pharmaceuticals and the environment through programming on access to quality medicines, “greening” healthcare, anti-microbial resistance as well as drinking-water quality and safety. The WHO has indicated that human exposure to pharmaceuticals in drinking-water can be reduced through preventative approaches, including: regulations, take-back programmes and consumer education regarding disposal of unwanted pharmaceuticals, minimising entry of pharmaceuticals into the environment. In addition, the WHO has noted that future research may be helpful to understand potential health risks, in particular for sensitive groups. The FAO addresses veterinary pharmaceutical uses.

Furthermore, a recently released report Connecting Global Priorities: Biodiversity and Human Health by the WHO and the Convention on Biological Diversity (2015), recognises that while “antibiotics and other pharmaceuticals are essential for human health and also play an important role in veterinary medicine”, measures are required to reduce environmental contamination from the release of pharmaceuticals and their active ingredients. 

The OECD is expecting results of a scoping study on emerging pollutants in water in 2016 that will provide a compilation of methods, existing and emerging, to monitor presence and effects in freshwater bodies and an inventory of policy responses by countries; as well as identify possible opportunities for international cooperation. This study should help inform the international community on the topic.

What’s next?

At the April 2014 workshop, participants suggested that cooperative action under Saicm “could initiate the multi-sectoral multi-stakeholder approach needed to prevent, reduce and manage pharmaceuticals entering the environment on a global scale, to use synergies in raising awareness and to guide prescription, application and disposal patterns, as well as to strengthen capacities in developing countries and countries with economies in transition.” 

Environmentally persistent pharmaceutical pollutants will be on the agenda at ICCM in September for consideration as an emerging policy issue under Saicm, presenting an opportunity for its stakeholders to influence policymaking and to promote increased attention to the topic at global, regional and national levels. 

Discussions that took place at the second meeting of the OEWG2 in December 2014 suggest that Saicm stakeholders are willing to consider cooperative and collaborative actions in this area towards the achievement of the 2020 goal of protecting human health and the environment from harmful chemicals. Ultimately, participants at ICCM4 will discuss the proposal and have the decision-making authority to decide on any possible next steps. 

To-date, experience in addressing the five emerging policy issues in Saicm has demonstrated that these initiatives tend to be most successful when resources are made available and when a suite of tailored activities are mapped to the needs set out by stakeholders. It is important to reflect on the required commitment and ownership to take effective action in the Saicm context, including the resource requirements, in order to learn from efforts undertaken under the existing emerging policy issues to-date and to encourage all stakeholders to engage in the process from the outset. 

There are clear opportunities for the scientific community, international organisations and the pharmaceutical industry to increase its responsibility, efforts and collaboration in this area, whether or not it is ultimately agreed as an “emerging policy issue” under Saicm.

Box: Seven proposed modalities for initiating cooperative action

  1. Establish an international project that builds on existing activities, including at the international level.
  2. Work in synergy with the emerging policy issue of endocrine disrupting chemicals that already exists under Saicm given the similarity of action points and actors.
  3. Exchange information and network though regional and sub-regional workshops and discussion forums and a relevant website.
  4. Provide international support to build capacity in developing countries and countries with economies in transition.
  5. Create an international network of experts, including scientists, risk managers and others.
  6. Coordinate with ongoing initiatives at national, regional and international levels.
  7. Work and build synergies with other relevant existing initiatives, such as World Health Organization (WHO) programmes and related Saicm initiatives (such as, endocrine disrupting chemicals) as well as other existing regional and national initiatives.
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