The clash of the titans: The relation between the European water and medicines legislation

Common Market Law Review

Volumn 47, Issue 5, 2010, Pages 1429-1454

  Keessen, Andrea ^a   Freriks, Annelies ^a   Van Rijswick, Marleen ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

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EID: 78049364463     PISSN: 01650750     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (102)

1. Dhondt, Integration of Environmental Protection into other EC Policies. Theory and Practice, (Europa Law Publishing, 2003).
2. See on the integration of environmental concerns into other policies, such as the CAP.
3. More recently, concerning fisheries, Wakefield, "Fisheries: A failure of values", (2009) CML Rev., 431-470.
4. Medicines include both medicines for human use and veterinary medicines. Veterinary medicines may also be used and authorized as feed additives, but the risks posed by these feed additives will not be extensively addressed in this article, because many medicines that were administered as feed additives are being phased out. The deadline for the last antibiotics thus administered is set in 2012.
5. Fent, Weston and Caminada, "Ecotoxicology of human pharmaceuticals", (2006) Aquatic Toxicology, 122-159.
6. Halling-Sorensen, Nielsen, Lanzky, Ingerslev, Lutzhoft and Jorgensen, "Occurrence, fate and effects of pharmaceutical substances in the environment - A review", 36 Chemosphere (1998), 357-394.
7. Houtman, Van der Aa and ter Laak, "Relatie tussen gebruik geneesmiddelen in Rijnstroomgebied en concentraties in de Rijn", (2010) H2O, 33.
8. Versteegh, Van der Aa, Dijkman, Geneesmiddelen in drinkwater en drinkwaterbronnen, (2007) RIVM report 703719016/2007. (RIVM is the Dutch National Institute for Public Health and the Environment) Available at .
9. See on knowledge gaps and future research needs, Daughton, "PPCPs in the Environment: Future Research - Beginning with the end always in mind", in Kummerer (Ed.), Pharmaceuticals in the Environment, 2nd ed (Springer, 2004), pp. 463-495.
10. Johnson, Jurgens, Williams, Kummerer, Kortenkamp and Sumpter, "Do cyotoxic chemotherapy drugs discharged into rivers pose a risk to the environment and human health? An overview and UK case study", (2008) Journal of Hydrology, 167-175.
11. Van Vlaardingen and Montforts, Geneesmiddelen in het milieu. Twee verkennende studies samengevat, (1999) RIVM report 734301017/1999.
12. Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for Community action in the field of water policy (WFD), OJ 2000 L 327/1.
13. See e.g. Van Rijswick, "EC Water Law in Transition: The challenge of integration", in Somsen et al. (Eds), (2003) Yearbook of European Environmental Law, pp. 249-304.
14. Lee, "Law and Governance of Water Protection Policy", in Scott (Ed.), Environmental Protection: European Law and Governance (OUP, 2009) pp. 27-55.
15. See Howarth, "The progression towards ecological quality standards", (2006) Journal of Environmental Law, 3-35.
16. Directive 2008/105/EC of the European Parliament and of the Council of 16 Dec. 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/167/EEC, 83/153/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council, OJ 2006 L 64/52 and Directive 2006/118/EC of the European Parliament and of the Council on the protection of groundwater against pollution and deterioration, O.J. 2008, L 348/84.
17. Art. 16 (2) WFD.
18. Cf. Montforts, Van Rijswick, Freriks, Keessen and Wuijts, The relationship between product registration and water quality legislation, medicines, veterinary medicines and feed additives, (in Dutch, English summary) (2006) RIVM Report 601500003/2006.
19. Art. 3 Directive 2006/118 and Art. 3 Directive 2006/11.
20. The difference between point source pollution and diffuse pollution is whether the discharge comes from a single source, e.g. a factory, or from many different sources, e.g. runoff from agricultural areas.
21. Art. 10 WFD.
22. E.g. Case C-231/97, Van Rooij, [1999] ECR I-6355; Case C-232/97 Nederhoff en Zn, [1999] ECR I-6385.
23. As occurs in the regulation of plant protection products and biocides.
24. See Van Rijswick and Vogelezang-Stoute, 'The Water Framework Directive and pesticides legislation. The influence of environmental quality standards and the river basin approach taken in the Water Framework Directive on the authorization of plant protection products', (2008) European Energy and Environmental Law Review, 78-89.
25. Cf Joined cases C-211/03, C-299/03 and C-316-319/03, HLH Warenvertriebs Orthica v. Deutschland, [2005] ECR I-5141 and Case T-70/99, Alpharma v. Council [2002] ECR II-3945.
26. As stated in several cases, e.g. Case C-142/05 Mickelson and Roos, [2009] ECR I-4293 (and see Horsley op. cit. infra note 91, for comments on these cases), national rules on use fall within the ambit of Art 34 TFEU (ex 28 EC), but can be justified under Art. 36 TFEU (ex 30 EC).
27. Case C-32/05 Commission v. Luxembourg [2006] ECR I-11323.
28. See Keessen et al. "European River Basin Districts: Are They Swimming in the Same Implementation Pool?", Journal of Environmental Law, forthcoming.
29. Uitenboogaart et al, Dealing with Complexity and Policy Discretion. A Comparison of the Implementation Process of the European Water Framework Directive in Five Member States, (SDU, 2009).
30. Art. 2 (35) WFD.
31. E.g. Case C-121/03 Commission v. Spain [2005] ECR I-7569, Case C-268/00 Commission v. the Netherlands [2002] ECR I-2995, Case C-316/00 Commission v. Ireland [2002] ECR I-10527, Case C-266/99 Commission v. France, [2001] ECR I-1981, Case C-198/97, Commission v. Germany [1999] ECR I-3257.
32. See Van Rijswick, "De betekenis en vormgeving van waterkwaliteitseisen", (2007) Milieu & Recht, 395-407.
33. Rec. 51 Preamble to Directive 2000/60.
34. Art 11 (5) WFD.
35. Art. 12 WFD.
36. Art. 4, 6 and 7 WFD.
37. See Keessen and Van Rijswick, "Drinkwaterwinning in een Natura 2000 gebied: het juridische regime voor beschermde gebieden", (2008) Milieu & Recht, 557-566.
38. Veltman, "Reactie op drinkwaterwinning in een Natura 2000 gebied: het juridische regime voor beschermde gebieden", (2009) Milieu & Recht, 151-153.
39. The European standards for the product drinking water (after treatment) are set in Council Directive 98/83 on the quality of water intended for human consumption, O.J. 1998, L 330/32.
40. Regulation 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, O.J. 2004, L 136/1; Directive 2001/83 of the European Parliament and of the Council on the Community code relating to medicinal products for human use, O.J. 2001, L 311/67; and Directive 2001/82 of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, O.J. 2001 L 82/1.
41. Art. 6 Directive 2001/83/EC. The decentralized or mutual recognition procedure, established by Directive 2001/83 and Directive 2001/82, applies to most medicines. The centralized procedure, established by Regulation 726/2004, applies to biotechnology medicines and other high tech, innovative medicines. See for an overview of the functioning of these and the other two regulatory procedures (single licence and national decisions).
42. Keessen, European Administrative Decisions. How the EU regulates products on the internal market, (Europa Law Publishing, 2009).
43. Directive 2001/83; Notice to the Applicants Vol. 2A Chapter 1, p.2.
44. Art. 8(3) and 10 Directive 2001/83, Art. 12 (3) and 13 Directive 2001/82, Art. 6 and 31Regulation 726/2004.
45. See for an example .
46. It is argued that the environmental assessment could be improved. These improvements include chronic effect testing as a general approach, the use of invertebrate tests including sexual reproduction, the application of endpoints reflecting the mode of action of the medicine or known side effects and the simulation of more realistic exposure conditions in terrestrial laboratory tests.
47. See Schmitt, Boucard, Garric, Jensen, Parrot, Péry, Römbke, Straub, Hutchinson, Sánchez-Argüello, Wennmalm and Duis, 'Recommendations on the Environmental Risk Assessment of Pharmaceuticals: Effect Characterization', (2009) Integrated Environmental Assessment and Management, 588-602.
48. This omission runs counter to the trend to include environmental protection as an objective of product regulation, e.g. Regulation 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (the REACH Regulation) O.J. 2006, L396/1.
49. Art. 1(28) Directive 2001/83.
50. Art. 8(ca) and Annex I Directive 2001/83. This is further elaborated in Guidance Document at .
51. Genetically modified medicines in Guidance document According to the Guidance documents, this obligation may also apply to variations or extensions.
52. As follows from Directive 2001/83 and the Guidance documents (see footnotes above).
53. Art. 8(ca) and 8(3) (g) Directive 2001/83.
54. This may also apply to applications for variations (e.g. a new indication) or extensions.
55. Arts. 10 and 8 Directive 2001/83.
56. Directive 2004/28 of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, O.J. 2004, L 311/1.
57. E.g. Fenflor case, see .
58. Art. 30 Directive 2001/82.
59. Environmental Impact Assessment (EIAs) for veterinary medicinal products (VMPs) Phase 1 VICH GL6 (Ecotoxicity - Phase 1) and Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products (VMPs) - Phase II, VICH GL38 (Ecotoxicity Phase II). VICH is a trilateral (EU-Japan-USA) programme aimed at harmonizing technical requirements for veterinary products.
60. CVMP, Guideline Environmental Impact Assessment for Veterinary Medicinal Products Phase II, 2004. CVMP is the Committee for Medicinal Products for Veterinary Use. It is part of the European Medicines Agency (EMA, formerly called EMEA).
61. Montforts, Van Rijswick and Udo de Haes, "Legal constraints in EU product labeling to mitigate the environmental risks of veterinary medicines at use", (2004) Regulatory Toxicology and Pharmacology, 327-335.
62. See previous footnote.
63. Art. 25 Directive 2001/82; Art. 21 Directive 2001/83; Art 10(6) and 35(6) Regulation726/2004.
64. The absence of a transparency clause concerning environmental information of medicines renders it different from the transparency regimes concerning environmental information present in genetically modified organisms, plant protection products and biocides legislation. Consequently, case law such as Case C-552/07, Commune de Sausheim v. Pierre Azelvandre [2009]ECR I-0000, where the transparency regime of Directive 2001/18 supersedes the general environmental information transparency regime, does not apply to this situation.
65. Montforts and Keessen, The public nature of environmental information acquired at the registration of (veterinary) medicines (in Dutch, with English summary), (2007) RIVM report 601500006/2007.
66. See previous footnote.
67. The UNECE Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, done at Aarhus on 25 June 1998 (Aarhus Convention), available at: .
68. Directive 2003/4 of the European Parliament and of the Council on the access of the public to environmental information O.J. 2003, L 41/26 and Regulation 1367/2006 of the European Parliament and of the Council on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies, O.J. 2006, L 264/13.
69. Art. 4 Aarhus Convention, Art. 6 Reg.1367/2006 and Art. 4 Directive 2003/4.
70. Eight years is the average period. Under circumstances it can be longer. See: Art. 10 Directive 2001/83, Art. 13 Directive 2001/82 and Arts. 14(11) and 39(10) Regulation 726/2004.
71. See Adamski, "How wide is 'the widest possible'? Judicial interpretation of the exceptions to the right of access to official documents revisited", (2009) CML Rev., 521-549.
72. Note that this article is on the general regime on access to information.
73. See de Abreu Ferreira, "The Fundamental Right of Access to Environmental Information in the EC: A Critical Analysis of WWF-EPO v. Council", (2007) Journal of Environmental Law, 1-10.
74. See on integration of environmental concerns into other policy fields, such as the CAP and the common transport policy.
75. Even in that case there is not a formal ranking, as daughter directives remain separate directives.
76. For instance Art. 2(2) of Directive 2002/96/EC of the European Parliament and the Council of 27 Jan. 2003 on waste electrical and electronic equipment (WEEE), O.J. 2003, L 37, states that it applies without prejudice to specific Community waste management legislation.
77. Beijen, De kwaliteit van milieurichtlijnen. Europese wetgeving als oorzaak van implementatieproblemen (Boom Juridische Uitgevers, 2010).
78. See above.
79. Vos and Janssen, Options for emission control in European legislation in response to the requirements of the Water Framework Directive, (2005) RIVM report 601300003.
80. Case C-232/97, Nederhoff en Zn [1999] ECR I-6385.
81. Van Rijswick, De kwaliteit van water (Kluwer, 2001).
82. Art. 2 Reg. 1907/2006.
83. Case C-405/07 P, Netherlands v. Commission (Dutch Diesel Vehicles) [2008] ECR I-8301.
84. Cf. Weatherill, "Pre-emption, harmonisation and the distribution of competence to regulate the internal market" in Barnard and Scott (Eds), The Law of the Single European Market, Unpacking the Premises, (Hart Publishing, 2002) pp. 41-76.
85. See Wenneras, "Towards an Ever Greener Union? Competence in the Field of Environment and Beyond", (2008) CML Rev., 1645-1685.
86. Case C-512/99 Germany v. Commission [2003] ECR I-845 and Joined Cases C-439/05 P & C-454/05 P Land Oberösterreich and Austria v. Commission [2007] ECR I-7141.
87. It is important to note that the Water Framework Directive already contains several provisions which link it to other policy fields. However, inclusion of the suggested provisions could strengthen their effect.
88. It could become an example of the use of not so new governance instruments in European law. See Scott, "Governing without law or governing without government? New-ish governance and the legitimacy of the EU", (2009) ELJ, 160-173.
89. Governance is here used in the sense of how the government interacts with society.
90. See Kjaer, Governance (Polity Press, 2004).
91. This is called community control. See Scott, "The governance of the European Union: The potential for multi-level control", (2002) ELJ, 59-79.
92. See .
93. Thus creating a hybrid of regulation and governance.
94. The absence of information exchange duties between officials of different policy fields seems to be a common omission in European legislation.
95. E.g. Dougan, "Minimum harmonization and the Internal Market", (2000) CML Rev., 853-885.
96. Horsley, annotation of Case C-110/05, Commission v. Italy, Case C-142/05, Aklagaren v. Percy Mickelson and Joakim Roos, and Case C-265/06, Commission v. Portugal, (2009) CML Rev., 2001-2019. See also Case C-473/98 Kemikalieninspektionen v. Toolex Alpha, [2000] ECR I-5681.
97. Art. 12 WFD.
98. Art. 16 WFD.
99. Art. 16 (9) WFD.
100. See the paragraphs on access to information and participation for suggested improvements.
101. Case C-284/95, Safety Hi-Tech v. S&T, [1998] ECR I-4301.
102. Krämer, EC Environmental Law (Sweet & Maxwell, 2000), pp. 14-15.