040824_miljouppdraget-rapport

directives. Considering current legislation, environmental protection interests, and the internal market, the
most suitable approach is to work actively at the EU level for a discussion of environmental classification
of pharmaceutical products. Developing a common European environmental classification system is preferable
to having different regional systems being developed separately.
EU legislation places requirements for submitting data and hindrances for a number of classification models.
A Swedish national environmental classification, based on environmental risk assessments included
in marketing applications, cannot be regarded as being in conflict with the legislation. However, at present,
environmental classification of pharmaceuticals is associated with several qualitative and quantitative deficiencies.
Environmental classification of pharmaceutical products should be based on knowledge of longterm
toxicity of low concentrations, persistence and bioaccumulation and less on acute toxicity. Additionally,
to obtain a complete picture of the total potential for environmental effects of a pharmaceutical product,
both active substances, excipients, formulation and packaging should be considered.
While awaiting a possible European system of environmental classification, a voluntary national system
might be introduced. The lack of scientific data will, however, lead to practical problems and a risk of arriving
at erroneous conclusions is apparent. Thus, the Medical Products Agency is of the opinion that the
benefit of a national system is doubtful.
If a voluntary Swedish classification system is introduced, the responsibility for obtaining and providing
the necessary data should lie with the pharmaceutical industry. A voluntary classification system should
rely on selfregulation by the pharmaceutical industry as civic governance could be percieved as indirect
regulation skewing competitiveness. The review of published environmental information should be the
responsibility of the Medical Products Agency. This additional workload would require additional funding.
Packaging
Packaging could also be of interest from an environmental viewpoint as packaging materials make up large
volumes. However, the volume of pharmaceutical packaging (excluding glass packaging) comprises only
about 1,6 % of the total amount of packaging in Sweden. Pharmaceuticals packaging generally differs little
from other types of packaging circulating in society as regards materials. Plastics are the most common
packaging material, followed by corrugated cardboard and cardboard. Various metals and glass are also
used. None of the materials used for pharmaceutical products is considered to cause any particular environmental
problems.
Packaging that contains visible residues of pharmaceutical products is today classified as pharmaceutical
waste and is handled in accordance with specific routines. Packaging without visible residues is not expected
to cause any environmental problems.
Proposed measures
The Medical Products Agency is of the opinion that environmental aspects of pharmaceutical products
should be given greater attention and that this attention should encompass the entire life cycle of the product.
Measures to reduce the potential effects of pharmaceutical products on the environment must be based
on knowledge of, foremost, possible long-term effects. Correct use, i.e. improved consideration and
application of approved indications and follow-up of pharmacological treatments is of course, fundamental
in reducing the exposure of the environment to pharmaceuticals.
There is an urgent need to increase our knowledge of the environmental effects of pharmaceutical products
and this need for research should be recognised and given priority within the area of environmentally directed
research.
The Medical Products Agency proposes the following measures:
• Increased basic knowledge
• Increased consideration of environmental aspects in the EU legislation on pharmaceutical products
• More and improved environmental risk assessments
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