Available environmental information for medicinal products, award criteria
Level: Spearhead
Details
- Type:
- Award criteria
- ID:
- 11222
- Group:
- Medicinal Products
Criterion text
In order to receive [points or discounts per position], the supplier must submit information in its tender for [state relevant positions/medicinal product that shows that environmental information has been obtained and is publicly available. Publicly available environmental information refers to information that is available on a free website without requiring membership, payment etc.
The environmental information must at least include details regarding persistence, bioaccumulation, toxicity and environmental risk. It must be compiled in accordance with the European Medicines Agency's (EMA's) latest guidelines1 the most recently published FASS guidelines regarding environmental information for medicinal products,2 or another equivalent publicly available model for environmental information.
If the award criterion is met for one or more of the medicinal products included in the tender, the winning supplier must keep environmental information for the medicinal products in question available according to this requirement for the entire duration of the agreement.
The award criterion does not apply to medicinal products that are covered by the European Medicines Agency's (EMA') guidelines.1, 2 Neither does the requirement apply to medicinal products that are exempted from environmental information requirements according to the same guidelines.
1. European Medicines Agency, 2006. Committee for medicinal products for human use (CHMP). Guideline on the environmental risk assessment of medicinal products for human use. Ref EMEA/CHMP/SWP/4447/00 corr 2, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500003978.pdf.
2. Environmental classification of pharmaceuticals at www.fass.se Guidance for pharmaceutical companies 2012, https://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf.
Verification
In order to show that the requirement is met, the supplier can include together with its tender references to various websites, such as www.ema.europa.eu, www.fass.se, or show in some other way that the requirement is met.
Information about the criterion
The environmental information can be used, for example, in the work of pharmaceutical committees or as a basis for assessing the follow-up work of contracting authorities regarding contracted medicinal products.
According to article 8(3) of directive 2001/83/EC, the environmental risks of medicinal products for human use are defined as 'any risk of undesirable effects on the environment.' The European Commission's strategy for handling medicinal products in the environment highlights that there is a need for more environmental information and an improved environmental risk assessment.3
The European trade association4 is working with the Pharmaceuticals in the Environment (PiE) initiative in order to, amongst other things, assess how calculations and predictions can be used in assessing inherent environmental risks, so called iPiE. A recent study of 975 small molecule medicines indicates that chronic ecotoxicity data is lacking for 88% of medicinal products registered prior to 2006.5
It is in the interests of the contracting authorities and the general public that suppliers should make environmental information for the contracted medicinal products publicly available.
It is appropriate to use this award criterion for medicinal products registered prior to 2006 and that are considered to have a considerable negative impact on the environment. For further information, see the implementation manual. In 2006, it became mandatory to provide environmental information in connection with the approval of medicinal products.1, 2 It is important to be able to produce information about inherent environmental impacts and environmental risks for medicinal products registered for sale prior to 2006.
Publicly available environmental information refers to information that is available on a free website without any requirement for membership, payment etc.
1. European Medicines Agency, 2006. Committee for medicinal products for human use (CHMP). Guideline on the environmental risk assessment of medicinal products for human use. Ref EMEA/CHMP/SWP/4447/00 corr 2, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500003978.pdf.
2. Environmental classification of pharmaceuticals at www.fass.se Guidance for pharmaceutical companies 2012, https://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf.
3. European Union Strategic Approach to Pharmaceuticals in the Environment. Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee. Brussels, 11.3.2019 COM (2019) 128 final.
4. European Federation of Pharmaceutical Industries and Associations (EFPIA)
5. Pharmacology beyond the patient – The environmental risks of human drugs. Gunnarsson L. et al. Environmental International 129 (2019) 320-332.
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11222
- Version date
- 2019-10-23