26 Amendments of Marco SCURRIA related to 2013/0305(COD)
Amendment 29 #
Proposal for a regulation
Recital 14
Recital 14
(14) No risk assessment should be conducted under this Regulation on a new psychoactive substance if it is subject to an assessment under international law, or if it is an active substance in a medicinal product or in a veterinary medicinal product.
Amendment 31 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 34 #
Proposal for a regulation
Recital 19
Recital 19
(19) Those new psychoactive substances which pose moderate health, social and safety risks should not be made available to consumers.
Amendment 40 #
Proposal for a regulation
Recital 24
Recital 24
(24) The mechanism for rapid exchange of information on new psychoactive substances (the 'European Union Early Warning System on New Psychoactive Substances' (hereafter 'EWS')) has proved to be a useful channel for sharing information on new psychoactive substances, on new trends in the use of controlled psychoactive substances and on related public health warnings. That mechanism should be further strengthened to enable a more effective response to the rapid emergence and spread of new psychoactive substances across the Union, the mechanism should be maintained and further developed, in particular as regards to the collection and management of data on the detection and identification of new psychoactive substances, adverse events associated with their use, and the involvement of criminal groups in the market through the Union new psychoactive substances database (the 'European Database on New Drugs'). The media, particularly the scientific and medical literature, can be an important source of information on adverse event case reports. In order to enhance the efficiency of reporting, the EMCDDA should monitor all new psychoactive substances and enter this information into the European Database on New Drugs. Data sets essential to the functioning of this Regulation include data on the detection and identification of new psychoactive substances, across the Union. dverse events associated with their use, and the involvement of criminal groups in the market. A core data set should be defined. The core data set should be reviewed on a regular basis to ensure it reflects the information required in order for the effective functioning of the Regulation. Suspected serious adverse events, including fatal adverse events, should be subject to expedited reporting.
Amendment 41 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) In order to allow Member States to receive, access simultaneously and share information on new psychoactive substances in the Union, the European Database on New Drugs should be fully and permanently accessible to the Member States, the EMCDDA, Europol and the Commission
Amendment 43 #
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24b) In order to protect public health the EWS activities of EMCDDA and Europol should be adequately funded.
Amendment 44 #
Proposal for a regulation
Recital 25
Recital 25
(25) Information from Member States is crucessential for the effective functioning of the procedures leading to decision on market restriction of new psychoactive substancesis Regulation. Therefore, Member States should collect, on a regular basis, data on the use of new psychoactive substances, related health, safety and social problems and policy responses, in accordance with the EMCDDA framework for data collection for the key epidemiological indicators and other relevant data. They should share this data.
Amendment 47 #
Proposal for a regulation
Recital 26
Recital 26
(26) A lack of capacity to identify and anticipate the emergence and spread of new psychoactive substances and a lack of evidence about their health, social and safety risks hamper the provision of an effective response. Therefore, support should be provided, including at Union level, in order for the EMCDDA to lead a network of forensic laboratories and to facilitate cooperation between the EMCDDA, research institutes and forensic laboratories with relevant expertise, in order to increase the capacity to assess and address effectively new psychoactive substances.
Amendment 52 #
Proposal for a regulation
Recital 33
Recital 33
(33) In the application of this Regulation, the Commission should consult Member States' experts, relevant Union agencies, in particular the EMCDDA, civil society and economic operators.
Amendment 55 #
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
Each Member State shall set up an on- line register of wholesalers and retailers of such substances. The register shall be kept by the health ministry of the Member State or by delegated authorities. The sale of such substances shall be subject to inclusion in the register. Producers and vendors shall be required to declare the quantities bought, sold and produced, whether for industrial, scientific or commercial purposes.
Amendment 56 #
Proposal for a regulation
Article 4 – paragraph 2 b (new)
Article 4 – paragraph 2 b (new)
Under no circumstances may such substances be sold to children under 18 years of age.
Amendment 59 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
National Focal Points within the European Information Network on Drugs and Drug Addiction (‘Reitox’) and Europol National Units shall provide to the EMCDDA and Europol the available information on the consumption, possible risks, manufacture, extraction, importation, trade, distribution, trafficking, commercial and scientific use of substances that appear to be new psychoactive substances or mixtures.
Amendment 60 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
The national authorities which keep the registers, National Focal Points within the European Information Network on Drugs and Drug Addiction ("Reitox") and Europol National Units shall provide to the EMCDDA and Europol the available information on the consumption, possible risks, manufacture, extraction, importation, trade, distribution, trafficking, commercial and scientific use of substances that appear to be new psychoactive substances or mixtures.
Amendment 61 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
The EMCDDA and Europol shall communicate that information immediately to Reitox and, the Europol National Units and the European Medicines Agency.
Amendment 62 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
To enable a more effective response to the rapid emergence and spread of new psychoactive substances across the Union, the information exchange mechanism (the 'Early Warning System') should be maintained and further developed, in particular as regards to the collection and management of data on the detection and identification of new psychoactive substances, adverse events associated with their use, and the involvement of criminal groups in the market through the Union new psychoactive substances database. The Union shall adequately support the EMCDDA, Europol and the Member States activities to develop and maintain the early warning systems capable of achieving high standards of public health protection in relation to the emergence and use of new psychoactive substances.
Amendment 74 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Scientific Committee of the EMCDDA shall assess the risks during a special meeting. The Committee may be extended by not more than five experts, including a psychologist specialising in addiction and psychological disorders in children and adolescents, representing the scientific fields relevant for ensuring a balanced assessment of the risks of the new psychoactive substance. The Director of the EMCDDA shall designate them from a list of experts. The Management Board of the EMCDDA shall approve the list of experts every three years. The Commission, the EMCDDA, Europol and the European Medicines Agency shall each have the right to nominate two observers.
Amendment 78 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 80 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 87 #
Proposal for a regulation
Article 11 – title
Article 11 – title
Amendment 88 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
The Commission shall not adopt restriction measures on a new psychoactive substance if, based on existing evidence, it poses, overall, low health, social and safety risks, in particular:
Amendment 90 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity, abuse liability and dependence-producing potential, is limited, as it provokes minor injury and disease, and minor physical or mental impairmentdoes not represent imminent harm to health;
Amendment 92 #
Proposal for a regulation
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) the social harm caused to individuals and to society is limited, in particular regarding its impact on social functioning and public order, criminal activities associated with the new psychoactive substance is low, illicit profits generated by the production, trade and distribution of the new psychoactive substance and associated economic costs are non- existent or negligibleor social harm;
Amendment 94 #
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
(c) the risks to safety are limited, in particular low risk of spread of diseases, including transmission of blood borne viruses, non-existent or low consequences of physical and mental impairment on the ability to drive, and the impact of the manufacture, transport and disposal of the new psychoactive substance and associated waste materials on the environment is lowor risks to safety.
Amendment 108 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The Commission shall adopt the Decision referred to in paragraph 1 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(2). The Commission shall notify the Union and Member State judicial authorities, so that proceedings may be brought against anyone selling or using such substances illegally.
Amendment 114 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3a. For all of authorised uses, each substance shall be sold with a package leaflet providing information on the molecules and active ingredients it contains and the short-, medium- and long-term effects it will have if taken by humans (a use other than that for which it is intended).
Amendment 120 #
Proposal for a regulation
Article 20
Article 20