Pharmaceuticals in the Environment
On Wednesday 29 November Michel Dantin MEP and Chair of the “Water& Agriculture” Working Group, together with Peter Liese MEP hosted the entitled event: Pharmaceuticals in the Environment.
Policy-makers, industry, and civil society gathered to discuss the potential policy options to curb the impact of pharmaceuticals in the environment. The Commission recently launched its public consultation on the matter providing stakeholders the opportunity to exchange their views and provide information on their perception of the problem, the need for action and what actions should be prioritised ahead of the strategy paper to be published early next year.
Michel Dantin MEP and Chair of the “Water & Agriculture” Working Group of the EP Intergroup on “Climate Change, Biodiversity, and Sustainable Development” welcomed participants by stressing that the debate on pharmaceuticals in the environment is not new. However, with the launch of the recent public consultation it will yet again be high on the EU agenda. He continued by addressing the objective of the conference, namely to try to assess the different views of the stakeholders in order to define a line on the matter that can be used to make progress in the coming weeks. It was stated that by gathering all stakeholders a genuine debate can take place furthering the consultation process also providing an opportunity to align views and examine where more discussion is needed.
Bettina Doeser, Head of Unit Clean Water, DG ENV, European Commission, presented the Commission’s work on the strategic approach to pharmaceuticals in the environment. It was pointed out that the timing of the meeting is ideal for the stage of process in which they are currently at. The Commission has been working on this topic for a long time and with the public consultation open this is now the time to reflect and provide suggestions. It was outlined that in the framework of the Priority Substance Directive (2008/105/EC as amended by 2013/39/EU), the Commission was requested to analyse the topic of pharmaceuticals in the environment. Additionally, the work lies within the context of the circular economy, 7th Environmental Action Programme, SDG 6, the Action Plan on Antimicrobial Resistance as well as the Fitness Check of EU water legislation (2019) and evaluation of the Urban Waste Water Treatment Directive. The Commission published the roadmap in April 2017 and on 22 November the public consultation was published. The Commission Communication on Strategic Approach to Pharmaceuticals in the Environment is scheduled to be published by the end of the second quarter of 2018. It was explained that the problem must be addressed by first considering the environmental impact as the starting point which also extends to public health. Key Active Pharmaceutical Ingredients (API), can have an environmental impact, and actions have to be taken at EU level due to the fact that pollution, e.g. via rivers, is transboundary. Action, however, should of course not wait until the substances are already in the environment, but be taken during their whole lifecycle before they are emitted. For that, it was said that source control should be preferred over end-of-pipe solutions and actions might be taken in several policy areas. It was stressed that pharmaceuticals are essential for citizens and the objective is not to reduce their availability or increase their cost. Further, Ms Doeser showed where different actions could be taken during the life cycle of pharmaceuticals in order to reduce their impact on the environment. In the area of use for example, doctors and consumers could be better informed of the benefits of using pharmaceuticals sustainably. In the area of waste treatment, more effective treatment could be promoted including to tackle anti-microbial resistance. Overall the aim is to improve the understanding of the risks and promote better management. Concerning the areas of action, she stated that they cannot do everything at once but that they should come to an understanding regarding the most urgent topics. As for the types of actions, various options are outlined in the background document, which provides a starting point for decisions on the strategic approach. It was said that measures would likely include continued or increased support for research, and could also include “soft” measures, e.g. guidance and raising awareness. Concluding, it was said that any legislative measures would require a full impact assessment.
Peter Liese MEP and ENVI Committee Coordinator for EPP reiterated the importance of tackling the issue as it relates both to the environment and human health. Pharmaceuticals are found in our drinking water also underlining that this issue is tackled also at local level by municipalities who have problems in delivering clean water to their citizens. In parallel, patients need medicine and the EU must be careful when developing new medicines also ensuring their reasonable cost. This double side of the problem is a huge challenge and it was regretted that the EU is dealing with this topic at such a late stage. He concluded by stressing the importance of the matter and requested that the Commission also work to deliver its promises so that future delays are avoided.
Dr. Babette Winter, Committee of Regions, State Secretary for Europe and Culture in the Thuringia State Chancellery, outlined that the topic is very relevant for the State of Thuringia due to its long history of industry, medical technology and their high export rates of pharmaceuticals. She pointed out that the industry should continue as it is but be responsible for the end of by-products generated by it. In the context of circular economy, the Committee of Regions participates in EU policy and supports the focus on waste hierarchy. As rapporteur on the opinion provided by the CoR it was outlined that prevention must come first followed by measures tackling environmental pollution. It was said that the opinion made a clear statement with regards to pharmaceuticals and nanomaterials as waste or discharges into the environment e.g. They were however not included in the Action Plan, calling for this to be addressed swiftly as further priorities by means of corresponding strategies. Germany produces 38 tonnes of medicine alone. In the context of circular economy, she stated that a transition requires long term commitments from all levels of governments. Local and regional authorities play a key role as they are responsible for waste collection, waste water treatment, public health care and environmental monitoring, however, many pharmaceuticals go through waste water from households and hospitals as well as veterinary medical treatment and fertilisers to the environment. It was highlighted that this is also evident in Thuringia where pharmaceuticals have been found in surface and ground water. Although, not obliged to monitor EU watch lists compounds, Thuringia carries out monitoring like several other regions. Further, regional authorities already put great effort in monitoring and that it would be challenging to increase this in the future as it is very expensive. As for the end of pipe solutions, she stated that it is very difficult and expensive to extract chemicals, especially pharmaceuticals from waste water. There are technical solutions available (e.g. active carbon and nanofiltration) but due to their high costs they could increase the charge for their citizens. She finished by highlighting that charges are already high and that it is better to find solutions at the source, also underlining the importance of raising awareness in order to minimise medicine waste. It was said that here local and regional authorities also play an important role with information campaigns running in many cities.
Jan Peter van der Hoek, Professor of Drinking Water Engineering, TU Delft (EUREAU), presented the work of EUREAU, which is the voice of Europe’s water sector, with 32 members of national water associations representing public and private drinking and wastewater services from 29 European States. Concerning pharmaceuticals, it was said that they wish to keep treatment as simple as possible meaning that end-of pipe treatment should remain the last option for dealing with the problem. It was outlined that safe drinking water as well as access to appropriate medication are human rights. However pharmaceutical residues from human and veterinary are found both in surface water and groundwater posing a threat to the aquatic environment and drinking water resources. In a study conducted in 2013, it was shown that 186 of the measured compounds were found in drinking concentrations. Despite the concentrations being low, it was said that consumption of medicines will continue to grow due to the higher aging population and that is of great concern concerning pharmaceutical pollution. In respect to EU policy, he mentioned that legislations are based on the precautionary principle, which is well aligned with the Water Framework Directive (WFD) and Drinking Water Directive. As for the strategic approach of the Commission he mentioned the considerable delay in the process but welcomed the consultations launched last week. In order to ensure a holistic approach on tackling the matter it was called for a framework that includes a mixture of measures such as voluntary actions and improvement of legal frameworks. It was stated that the EU should tackle the problem as much as possible at the source and not invest in end-of-pipe solutions which are both economically and environmentally unsustainable (e.g water bills, energy consumption and chemical by-products might increase). It was also outlined that a number of directed actions are needed at nine different levels: design, authorisation, post authorisation, marketing, hospitals, healthcare professionals, households, waste water treatment plants and drinking water. He finished by stressing the importance of active cooperation and committed exchange with all involved actors at the different levels also underlining the Dutch system as a good example of a best practice.
Bengt Mattson, Chair of the Pharmaceuticals in the Environment Task Force, European Federation of Pharmaceutical Industries and Associations (EFPIA) introduced the Eco-Pharmaco-Stewardship initiative, which has been developed with the aim to provide knowledge and data enabling assessments of sustainability of pharmaceuticals. In regards to the discussion, he stated that he shares the concerns of the panel but on some specific details they differ in opinions. For instance he does not agree in applying Environmental Risk Assessment (ERA) as part of the risk/benefit evaluation during the authorisation process of medicine. It was outlined that there is agreement on how pharmaceuticals enter the environment and the more that can be done upstream to prevent pollution is pivotal. It was said that the concept of Eco-Pharmaco-Stewardship entails the need for collaborating actions across the life cycle of pharmaceuticals also underlining that the industry has a responsibility in the manufacturing phase. Three pillars of the initiative were mentioned where industry has a larger role to play than in other parts of the life cycle. The first pillar relates to encouraging research to assess the impact of pharmaceuticals in the environment. Since 2006, medicines have to comply with certain criteria but the drugs that have been authorised beforehand have to be taken into consideration as well. It was said that this has led to collaboration with the Commission and the creation of the iPIE project, which addresses the issue of legacy products that don’t have complete environmental data-sets and generate a prioritisation plan. The second pillar addresses managing effluents from pharmaceutical sites globally. It was stated that collaborating and sharing best practices is pivotal concerning manufacturing and treatment of waste water. It was mentioned that many of their members are active in the Pharmaceutical Supply Chain Initiative, which addresses various issues related to sustainability. Further, only part of the medicines used in Europe are manufactured here showcasing the complexity of the supply chain. Additionally, the issue of antimicrobial resistance is becoming more apparent and the environmental dimension of AMR is addressed through this pillar as well. The third pillar deals with the extended ERA reiterating the opposition of that being part of the risk/benefit evaluation for human medicines. It was said that market authorisation should be based on medical reasons only. However, the organisation supports the idea to extend the ERA throughout the life cycle. It was said that the focus should be on the level of substance entering the environment and that resources should be prioritised only on those substances that pose a potential risk to the environment. It was concluded by highlighting the work of the industry concerning waste medicines and their campaign for raising awareness on proper management of unused medicines entitled #MedsDisposal. Overall the industry is working to develop a good framework to address the issues also sharing the same concerns underlining that it is important not to jeopardise access of medication for patients.
Adela Maghear, Pharmaceuticals Policy Officer, Healthcare without Harm Europe (HCWH), which is a non-profit coalition of hospitals, healthcare systems and health professionals, local authorities, and environmental and health organisations working to ensure that every person has the right to environmental health and access to health care. They have launched the only EU wide campaign, Safer Pharma, to help inform citizens about the impact of pharmaceutical residues in the environment. Specifically, they aim to achieve new EU legislation that starts curbing pharmaceutical pollution which in turn will lead to a measurable reduction of pharmaceuticals in the environment over time. In this way, the environment will be protected from pharmaceutical pollution at all stages of their life cycle. Moving away from their objectives, she stated some important facts on the issue. A study conducted in 2014 on the presence of pharmaceuticals showcased that 631 pharmaceuticals from the 713 that were analysed were present in water bodies across 71 countries. Additionally, pharmaceutical pollution is linked to antimicrobial resistance and research has demonstrated that there is potential for endocrine disrupting pharmaceuticals to impair reduction in fish and inhibit algae growth. She then pointed out some limitations on the matter reiterating the uncertainties regarding the risks that low levels of pharmaceuticals may pose to human health. It was said that it is still unknown of the emergence and spread of antimicrobial resistance via the environment, however research is ongoing. In addition, there is limited capacity and access to ERA datasets, which do also not include certain products. It was also suggested to have a catch up procedure for old molecules, meaning substances that have been on the market prior to 2005 for veterinary products and 2006 for human products which are not included in current ERAs. Support was also given to take into account the ERA for the overall benefit risks when applying for market authorisation. Another limitation stated is that the good manufacturing practices do not address discharges of APIs into the environment, and that they are not considered polluting substances in the Industrial Emissions Directive. It was also said that waste water treatment technologies are unable to completely remove pharmaceuticals and that there is no EU-wide targeted monitoring of pharmaceuticals in surface and ground waters. It was said that the Commission should provide Member States with guidelines on this. There is a lack of awareness among health professionals and general public on the environmental aspects calling for education on the proper consumption and procurement practices. Further, implementation and efficiency of collection schemes throughout Europe are scattered and deficient. She finalised by highlighting some areas of actions and where further research is needed. More studies are needed on the impact of pharmaceuticals on children as well as on chronic exposure. It was concluded by stressing that many pharmaceuticals are already present in the environment and the need to undo past mistakes.
The discussion with the audience highlighted the possibility of extending the ERA, which would ensure that actions and data are collected following the market authorisation and risk and mitigation measures will be taken if and when appropriate. The importance of ensuring a safe environment while also providing access to medicines was reiterated also calling for the environmental risks to be examined from the very start. The Commission also responded by stating that the post marketing authorisation ERA issue is included in their document but no position has yet been taken on the matter. The discussion also referred to the delay of the Commission and how further delay can be prevented. It was said that it often comes down to political will and the priorities set. It was mentioned that in order to prevent delays in the past the Commission has moved forward without conducting an impact assessment. However, there should be solid legislation on the matter. It was also pointed out that certainty is needed on the matter of pharmaceuticals as it will also play a role in upcoming legislation on the WFD and Urban Waste Water Directive. The need to also link pharmaceuticals with water reuse and water scarcity was raised. It was stated that with the Commission’s launch of the consultation, the train is now running and no further delays are foreseen. The importance of external input from stakeholders was reiterated in order to make the work of the Commission as substantial as possible. As for the upcoming document, it was said that no legislative proposal is foreseen, however as a subsequent step legislative measures could follow at a later stage. A point on the difficulty of carrying out an ERA was also made. In particular, it was said that the assessment would have to be for each substance specifically and that there should be no reason for complete exclusion. Additionally, it was said that the technologies should focus on hitting the problem at the source and particularly in the production phase of medicines through consultation processes. It was highlighted that there is strong collaboration with the industry on this. The importance of prevention was also raised and the need to focus on the behaviour of consumers in order to reduce consumption and become more aware of the environmental aspects. It was also said that doctors and healthcare professionals need to be better educated on the matter and that they play a role in reducing pharmaceutical waste. It was mentioned that green medicine should be a mandatory course for healthcare professionals. It was pointed out that if medicines are used incorrectly their value will never be realised. With regard to more research it was said that more needs to be done to examine the effects on children and also to further examine the risks, remembering that occurrence does not necessarily equate to risk. The need for awareness and collaboration among all stakeholders was reiterated.
Peter Liese MEP and Chair concluded the conference by stating that the final solution is not yet clear but that there are good ideas on the table. With regards to enforcing hard criteria in the approval process, caution should be exercised as it is not beneficial to delay or prohibit necessary medicines. It was added that the issue of pharmaceuticals in the environment is a cross border problem calling for collaboration and learning from best practices in Member States as well as third countries. The approval of certain substances should be made not only on the substances themselves but also on the way they are used. It was said that this is ongoing for the use of veterinary medicines providing guidelines and restrictions on certain usages. With regards to waste disposal more precise rules could be enforced in order to also change the behaviour of healthcare professionals and ensure a healthy environment.
Michel Dantin MEP and Chair presented the final remarks by highlighting some issues that were not raised in the discussion such as the cocktail effect and role of the consumers and patients. It was said that pesticides and medicines in the environment are basically part of the same issue. The need to raise awareness among consumers on the effect that the different type of products have was raised. With regards to the WFD and the need to achieve good status between now and 2021 or 2027, this issue must be set high on the agenda in the EU river basin districts. It is also linked with water reuse and leads to uncertainty in its use for farming. It was concluded by emphasising the need for the EU to be more consistent in its policies to tackle the issue.