Stefan Berggren Marine and Water director, Sweden Circular Economy and Water Emerging pressures on Water and Marine Pharmaceuticals (Sweden) Stefan Berggren Marine and Water director, Sweden

“.. hand over to the next generation a society in which major environmental problems have been solved, without increasing environmental and health problems outside Sweden’s borders.” The overall goal of Swedish environmental policy is to hand over to the next generation a society in which the major environmental problems in Sweden have been solved, without increasing environmental and health problems outside Sweden’s borders. Photo: Bent Christensen

Environmental Quality Target No 4: A Non-Toxic Environment - The occurrence of man-made or extracted substances in the environment must not represent a threat to human health or biological diversity. - Concentrations of non-naturally occurring substances will be close to zero and their impacts on human health and on ecosystems will be negligible. - Concentrations of naturally occurring substances will be close to background levels. Under the Generation Goal, there are 16 Environmental Quality Targets, adopted by the Parliament, that describe what quality and state of the environment are sustainable in the long term. One of these EQT is A Non-Toxic Environment. [läsa upp de två första punkterna på bilden ]

The Milestone Target of increased environmental consideration in EU pharmaceutical legislation and internationally (October 2013): “By 2020, decisions have been made in the European Union or internationally which mean that existing and possible new rules on medicinal products for human and veterinary use factor in environmental aspects to a greater extent”. Under the EQO, the government may adopt Milestone targets that define steps on the way, in priority areas, to achieving the environmental quality objectives and the generational goal. There are currently 8 milestone targets related to hazardous substances, covering, inter alia, information on hazardous substances in products and reducing the exposure of children. And since autumn 2013 there is also a new MT on pharmaceuticals and “increased environmental consideration” [läsa upp vad som står I PP-bilden] A major achievement through this MT is that the Ministry of the Environment and the Ministry of Health and Social affairs share an overall position on the subject. This facilitates Swedish input to various EU and international processes.

Swedish Proposals for increased environmental considerations Regulatory instrument setting minimum requirements for manufacturing conditions More appropriate and better environmental tests, revising the ERA guideline Make the information on environmental impact of medicinal products accessible Consider environmental risk in risk-benefit to manage risk mitigation C D A In The Milestone Target decision and a Government Bill on Chemicals Safety from 2013, four measures to attain the MT are identified. These are: 1.To require more appropriate an better environmental tests , and 2. To make this information accessible to stakeholders through a database at the European Medicines Agency . 3. To factor in environmental risk into the assessment of benefit and risks of medicinal products, and 4. To create a regulatory instrument that would set minimum requirements on environmental performance, for medicinal products that are produced outside the EU but aimed at the EU market For the context of today’s meeting, the testing requirements and the making available of information are the most relevant, so I will focus on them.

A database containing information on assessments of environmental risk should be created at EU-level - There is no collated information at present on environmental data for active substances, either at the Swedish Medical Products Agency or at the European Medicines Agency (EMA). - Such information would facilitate updates of voluntary information systems as well as establishing relevant limit values based on the effect levels of the substances in various contexts. - A database at EU level would also make it easier to find information on environmental risk assessments etc. A database is needed, we believe, for the authorities as well as various voluntary initiatives. You could compare to the European Chemicals Agency database for industrial and consumer chemicals or the Pesticides database

A regulatory instrument should be introduced at EU level setting minimum requirements for production conditions for the sale of products on the EU market. - Requirements for an environmental certification of the production facilities could be introduced in the legislation on Good Manufacturing Practice. - Regulation of the minimum requirements for production conditions for the marketing of products in the EU can eliminate the shortcomings in treatment of residues that occur today. - A regulatory instrument will competitively benefit those companies that have already invested in sufficient wastewater treatment equipment.

Swedish proposals in the review of Regulation on veterinary medicinal products (Working Party of Veterinary Experts - Animal Health) Antimicrobial resistance Minimize environmental pollution from the manufacturing of pharmaceuticals; New regulation setting emission limits Restrictions on persistent, bio-accumulating and toxic (PBT) chemicals Access to collated information from Environmental Risk Assessment (ERA) The environmental effects of veterinary medicinal products is one important dimension in the on-going negotiations on a new regulation ( of the European Parliament and of the Council ) on veterinary medicinal products. Negotiations in Council takes place in the Working Party of Veterinary Experts - Animal Health. These negotiations are important also because they may influence the foreseen review of the Human Medicinal products legislation. Sweden has proposed a couple of amendments to improve the protection of the environment. [The preventive use of antimicrobials should not be allowed. No economic incentive for prescribers Allow stricter national legislation] [Setting active substance emission limits at the manufacturing of pharmaceuticals is important The competent authority shall ascertain that the manufacturers are able to minimize env pollution and/or Carrie out the control tests required.] [For environmental protection the Commission should establish restrictions on the use of pharmaceutical substances with PBT properties in veterinary medical products] [Access to collated information such as ERA is important for authorities, research institutions and operators within the waters sector]

Eliminating pharmaceutical residues by advanced waste water treatment Already implemented in Switzerland. Swedish government is sponsoring pilot projects 2014-2017. Government commission to the Swedish EPA to analyse needs, technical solutions, advantages and drawbacks by May 2017.

Swedish experiences and recommendations in summary Co-operation with ministries and authorities of health and social affairs is key Precautionary measures could and should be taken within EU regulations on human and veterinary medicinal products and/or internationally End-of-pipe solutions, e.g. advanced waste water treatment, may also be necessary to develop at national level