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Volume 43, Issue 4
The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.
Editor's Note: This article was published in Pharmaceutical Technology Europe's April 2019 print issue.
After several years of consultations with stakeholders followed by periods of prevarication, the European Commission has finally published a strategy (1) that will provide a basis for the European Union’s policy on pharmaceuticals in the environment (PIE). The commission has been obliged to draw up the strategy under two pieces of EU legislation-one introduced more than eight years ago on pharmacovigilance (2) and the other approved in 2013 on water pollution (3). It had also pledged to issue a PIE policy under agreements with the United Nations and other international bodies.
The publication and contents of the strategy were welcomed by a joint PIE task force of the three main European pharmaceutical trade associations. The strategy covers several areas on which the task force itself and other industry initiatives are working, such as the identification and prioritization of medicines likely to present environmental risks, more effective monitoring of environmental impacts, and greater data transparency with environmental risk assessment (4).
The industry is broadly supporting the strategy despite the likelihood that it could result in tougher PIE regulations. “There are many things in the strategy that are good, although there are others that we are concerned about,” Bengt Mattson, co-chair of the joint task force, told Pharmaceutical Technology Europe. “On the whole, it is a positive document that will allow us to be closely involved in continuous discussion among stakeholders about the best way forward on the PIE issue.”
The strategy was issued by the commission as a ‘communication’ so that it did not have to be a vehicle for presenting specific proposals for legislation. Instead it pinpoints six areas for possible regulatory and other measures to tackle what it calls the ‘emerging problem’ of pollution by pharmaceuticals and their residues.
The six areas listed in the strategy are increasing awareness of the PIE issue, filling knowledge gaps about the problem, promoting greener manufacturing, and the development of medicine less environmentally harmful, improving environmental risk assessment, expanding environmental monitoring, and more efficient waste management (1).
Any new PIE regulations-in the form of new legislation or amendments to existing regulations-may not come into force for several years because of the necessity for further consultations and other preparatory work, such as social and economic impact assessments necessary for legislative changes. Any legislative action would have to be put forward by a new commission, which is due to take office in November 2019 (5). Also, there will be uncertainties about the environmental stance of a new European Parliament, which is scheduled to be inaugurated in July 2019.
Until the two arms of the legislature are actually presented with draft regulations by the commission, the arguments about the most effective ways of dealing with pharmaceutical pollution will continue to rage among the major stakeholders-such as the pharma industry, regulators, healthcare professionals, and providers and non-governmental organizations (NGOs).
However, as a result of the publication of the strategy, the scope of the discussions will be much narrower-at least in terms of what steps can be taken with the strong support of the EU at the regional and national levels. “At least we know what will now be the focus of the discussions as laid down by the range of options selected in the Commission’s strategy,” said Mattson.
A priority will be the creation of research projects to help fill, through the EU-funded research programme, a variety of knowledge gaps. The EU has already financed in recent years at least 10 research projects on pharmaceutical pollution and waste treatment processes.
“More information is still needed to understand and evaluate certain pharmaceuticals [regarding] their environmental concentrations and the resulting levels of risks,” said the commission in the document (1). It admits that ‘no clear link’ has been established between pharmaceuticals in the environment and direct impacts on human health. But it points to a World Health Organization study showing possible effects of long-term exposure to vulnerable populations that dictate a need for a precautionary approach to the PIE problem (6).
Also, there are worries about the role of the environment in antimicrobial resistance (AMR), on which the commission has already launched an action plan (7). The PIE strategy highlights the ‘particular concern’ that emissions from some antimicrobials manufacturing plants in third countries, some of which export products to the EU, could be contributing to AMR’s global spread.
Research, including that in areas like AMR, will be a major objective of the strategy through EU-funded programmes and organizations like the Brussels-based Innovate Medicines Initiative (IMI), which has a €5-billion (approximately $5.6 billion) budget provided jointly by the EU and the pharma industry. Among the IMI’s projects is a scheme called Intelligent Assessment of Pharmaceuticals in the Environment (iPIE), which conducts research to help support regulatory initiatives.
“The industry has a lot to contribute because we should know more about our substances than others,” explained Mattson. But he also pointed out that the other stakeholders would be heavily involved in discussions on future measures, covering the whole lifecycle of pharmaceuticals.
Among the research mentioned in the strategy are schemes to support the development of ‘greener’ pharmaceuticals, which degrade more readily in wastewater treatment plants and in the environment. Also, research can be used to manage risk more effectively by increasing knowledge, for example, on the eco-toxicity and environmental fate of pharmaceuticals. Another research aim would be to find out more about the effects on humans of chronic exposure to low levels of pharmaceuticals in the environment, taking into account mixtures of multiple pharmaceutical substances.
A combination of regulatory pressures and incentives could be used to persuade pharmaceutical companies to switch to more environmentally benign medicines. For example, procurement policies could be more widely applied to encourage greener pharmaceutical design and production processes.
A more fundamental move would be “to explore how extended producer responsibility could play a role in supporting action to improve the efficacy of water treatment,” according to the commission.
As pharmaceuticals and their production processes become greener, regulations could be changed to target more pharmaceutical substances considered to be an environmental risk. Under the Water Framework Directive (WFD) (8), the EU’s main legislation on preventing water pollution, pharmaceuticals with similar effects could be put into risk categories limiting their water concentrations.
Under the Industrial Emissions Directive (9), the primary legislation for applying pollution controls on pharmaceutical manufacturing plants, state-of-the-art production processes may have to be employed in the production of certain medicines and active ingredients.
The strategy document even suggests that the EU exert its influence through ‘dialogue and co-operation’ to encourage non-EU countries to take action on pharmaceutical emissions from plants suspected of contributing to global AMR.
Among other key strategy options is raising the efficiency of environmental monitoring of pharmaceuticals and improving their risk assessment. It suggests increasing environmental expertise among regulators involved in environmental risk assessment of medicines. Ways should be examined of giving the public more access to information from environmental risk assessments and relevant toxicological thresholds, while taking into account dataâprotection rules.
To expand monitoring, the commission will consider adding more pharmaceuticals to the WFD’s ‘watch list’. Also, it will support studies on the monitoring of pharmaceutical substances not only in fresh and marine waters but also in soils, sediments, and wildlife.
The feasibility of monitoring of AMR microorganisms and genes could be considered, including their inclusion in the EU’s Europeâwide survey of soil conditions with observations being made at 250,000 sample points.
As the EU prepares to become much more active in controlling pharmaceuticals in the environment, industry is warning that regulatory and other initiatives must be based on science and risk. “We are worried that general limits on concentrations of pharmaceutical substances will be imposed, which are not justified on the basis of science or risk,” Mattson explained. “We don’t want pharmaceutical substances to be banned or restricted just because they are hazardous without taking into account risks of exposure. Medicines are intrinsically hazardous, otherwise they would not have beneficial effects on patients.”
Nonetheless the commission says in the strategy document that it will foster exchange of information between EU states on best practices in taking environmental considerations into account in ‘the choice of therapy’.
Also, it will consider the findings of recent evaluations of chemicals under the EU’s Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) legislation (10) on chemicals safety “as regards links with medicinal products legislation in relation to environmental protection.” Currently, pharmaceutical substances, except intermediates used in production, are exempt from REACH regulations.
There is a danger that as the EU subjects medicines to more environmental controls, the long-established divide between medicines and environmental regulations will start to become blurred and there could be a conflict of interests between the two.
1. European Commission, “Communication: European Union Strategic Approach to Pharmaceuticals in the Environment” (Brussels, 11 March 2019).
2. European Union, “Directive (and) Amendment No. 2010/84 on Community Code Relating to Medicinal Products for Human Use” (Brussels, 15 December 2010). “Regulation (and) Amendment No 1235/2010 laying down Community procedure for the authorization and supervision of medicinal products for human and veterinary use” (Brussels, 15 December 2010).
3. European Union, “Directive No. 2013/39 on priority substances in the field of water pollution” (Brussels, 12 August 2013).
4. Inter Associations Initiative Pharmaceuticals in the Environment Task Force, “Joint Press Statement on European Union Strategic Approach to Pharmaceuticals in the Environment” (Brussels, 12 March 2019).
5. European Commission, “Political Leadership,” accessed 14 March 2019.
6. WHO, “Pharmaceuticals in Drinking Water,” accessed 12 March 2019.
7. European Commission, “EU One Health Action Plan against Antimicrobial Resistance (AMR)” (Brussels, June 2017).
8. European Union, “Directive No 2000/60 Establishing Framework for Community Action in the Field of Water Pollution” (Brussels, 23 October 2000).
9. European Union, “Directive No. 2010/75 on Industrial Emissions (Integrated Pollution Prevention Control)” (Brussels, Belgium, 24 Nov. 2010).
10. European Union, “Regulation No 1907/2006 Concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)” (Brussels, Belgium, 18 Dec. 2006).
Pharmaceutical Technology Europe
Vol. 31, No. 4
When referring to this article, please cite it as S. Milmo, “Regulating Pharmaceuticals in the Environment,” Pharmaceutical Technology Europe 31 (4) 2019.