New Psychoactive Substances


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Presentation by Des Corrigan (School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin) on the occasion of the EESC hearing on New Psychoactive Substances (Brussels, 27 November 2013)

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New Psychoactive Substances

  1. 1. European Economic and Social Committee Public Hearing on proposed Regulation COM(2013) 619 Presentation By Dr Des Corrigan Trinity College Dublin
  2. 2. EU Commission Assessment of the functioning of CD 2005/387/JHA (COM (2011)430 ∗ Unable to tackle groups of similar substances- Not adequately addressed by COM(2013)619 ∗ Reactive- Still not Proactive ∗ Lengthy process – Welcome Article 9 ∗ Lacks options for regulatory & control measures- Better alignment of laws in the field of drug control, product & food safety, medicines & consumer protection.
  3. 3. Groups of Similar Substances ∗ Article 6.2(b) refers to “other NPS with a similar chemical structure that have emerged.” ∗ Should read “ that have emerged or which might reasonably be expected to emerge, based on scientific assessment & Judgement.”
  4. 4. Article 11 ∗ Art. 11 in conjunction with Art. 3 implies legal availability & free movement of certain NPS within the EU. This is based on an assessment process which is not adequately aligned with the public health protection standards applied to all other consumer chemicals.
  5. 5. Article 11 (contd) ∗ No requirement for any manufacturer etc of a NPS to have a legal presence in EU. ∗ No requirement to adhere to any Code of Manufacturing Practice. ∗ No onus to report adverse events to a Competent Authority. ∗ No restriction on sale to under-18s or on advertising. ∗ Onus on EMCDDA & COM to show evidence of low risk ∗ Onus SHOULD be on promoters to prove safety.
  6. 6. CD 92/414/EEC concerning the placing 0f plant protection products on the market. ∗ Dossier to be supplied by applicant must include inter alia: ∗ Oral cumulative toxicity involving one rodent & one nonrodent species- usually 90 day study ∗ Mutagenicity- gene mutations, chromosomal aberrations & DNA perturbances. ∗ Reproductive Toxicity – Teratogenicity studies in rabbit & one rodent species; multigenerational studies in mammals ( at least two generations). ∗ Neurotoxicity studies including delayed neurotoxicity tests ∗ NOAEL, NOEL & ADI
  7. 7. Comment ∗ NPS which cannot be shown , by those profiting from their sale, to be safe for human use, using standard toxicity tests including Carcinogenicity, Mutagenicity & Reproductive Toxicity as well as Neurotoxicity, should NOT BE PERMITTED on the market. ∗ This applies whether the NPS is consumed on its own or in combination with other NPS , controlled drugs, medicines, caffeine, alcohol or tobacco. ∗ Articles 10-13 should be redrafted to reflect this approach.