Activities of Laura AGEA related to 2018/0081(COD)
Plenary speeches (1)
Protection of workers from the risks related to exposure to carcinogens or mutagens at work (A8-0382/2018 - Laura Agea) (vote) IT
Reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work PDF (715 KB) DOC (115 KB)
Amendments (3)
Amendment 55 #
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
(7a) Work involving exposure to carcinogenic or mutagenic substances resulting from the preparation, administration or disposal of hazardous drugs (including cytotoxic drugs) which are carcinogenic and classified as IARC group 1, and in some cases substances that are classified as IARC group 2A and group 2B, or substances with a similar chemical structure or pharmacologic class as those described herein, should be considered for inclusion in the scope of directive 2004/34/EC 1a. Individual substances that should be evaluated for inclusion in the list of hazardous drugs (including cytotoxic drugs) in the directive include the alkylating agents Oxaliplatin, Carboplatin, Cyclophosphamide, Cisplatin, Bendamustine, Ifosfamide, Mechlorethamine, Melphalan, Busulfan, and Thiotepa. Alkylating agents are among the oldest and most prevalent drugs used to treat cancer but also widely regarded as the most hazardous class of carcinogenic drugs. Substances to be considered for inclusion should be able to comply with all provisions in the directive to ensure the occupational safety of workers handling those hazardous drugs and, in accordance with article 168(1) TFEU, access to the best available treatments for patients should not be questioned or jeopardised. __________________ 1a Relevant research, such as International Agency for Research on Cancer (IARC) Monographs Volume 100A “Pharmaceuticals” or Volume 26 “Some Antineoplastic and Immunosuppressive Agents” and published Supplements with an IARC group designation of 1, 2A, or 2B, or substances with a similar chemical structure or pharmacologic class as those described herein, shall be taken into account.
Amendment 57 #
Proposal for a directive
Recital 7 b (new)
Recital 7 b (new)
(7b) In order to protect the workers exposed to carcinogenic or mutagenic substances resulting from the preparation, administration or disposal of hazardous drugs (including cytotoxic drugs), the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annex I to Directive 2004/37/EC by inserting therein a list of hazardous drugs (including cytotoxic drugs),which are carcinogenic or mutagenic, on the basis of scientific data and consultation with the ACSH. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 80 #
Proposal for a directive
Article 1 – paragraph -1 (new)
Article 1 – paragraph -1 (new)
Directive 2004/37/EC
Article 17 a (new) and Article 17 b (new)
Article 17 a (new) and Article 17 b (new)
The following articles are inserted: "Article 17a Delegation of power By 30 September 2019, the Commission shall adopt a delegated act, in accordance with Article 17b, amending Annex I by inserting a list of hazardous drugs (including cytotoxic drugs), which are carcinogenic or mutagenic, on the basis of scientific data and consultation with the ACSH. Article 17b Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 17a shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Directive. 3. The delegation of power referred to in Article 17a may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 17a shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council."