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The challenge of the responsible regulation of nanomedicine

AABHL Conference, 12 th – 14 th July 2012 Dr Jennifer Moore Centre for Law and Policy in Emerging Technologies Faculty of Law, University of Otago j ennifer.moore@otago.ac.nz. The challenge of the responsible regulation of nanomedicine. What is Nano…?.

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The challenge of the responsible regulation of nanomedicine

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  1. AABHL Conference, 12th – 14th July 2012 Dr Jennifer Moore Centre for Law and Policy in Emerging Technologies Faculty of Law, University of Otago jennifer.moore@otago.ac.nz The challenge of the responsible regulation of nanomedicine

  2. What is Nano…? • Novel materials, novel properties create novel products • Nanotechnology is a science of new possibilities…

  3. Nanotech: Contested Definitions • Nanotechnology (NT): • Manipulation of matter at atomic and molecular scales to produce new structures, materials and devices. • Nanomaterial (NM): “An insoluble or biopersistent & intentionally manufactured material with one or more external dimensions, or an internal structure from 1-100 nanometres (nms)”

  4. Nano’: dwarf Nanotech and nanoscience defined by scale:10-9 of a metre Manufactured NMs: at least 1 dimension at 1-100nms or 1-1000nms Nanotech 101

  5. Scanning Tunnelling Microscope

  6. Nanoscale Chemicals

  7. * Blurring of physiochemical rules at this scale • * NMs have large surface area to volume ratio • * Consequence: many materials behave differently at nanoscale • *Nanosized particles exhibit properties different from larger particles of the same substance 12NM gold particles look red Bulk gold appears yellow Nanoscale ChemicalsOptical Properties Examples NanoscaleZnO sunscreen is clear ‘Traditional’ ZnO sunscreen is white

  8. Societal “Next industrial revolution” “Revolutionise individual health care in the 21st century.” Commercial Benefits

  9. Risks Nano-Risks Examples of risk • risk = hazard x exposure/dose • Not all NMs are dangerous • But some may pose risks to health (human and animal) and the environment • Novel properties can cause unpredictability • Some nanoparticles appear to damage skin, brain, and lung tissue • As the particle size shrinks, there is a tendency for pulmonary toxicity to increase • Certain nanoparticles move easily into sensitive lung tissues after inhalation and cause damage that can lead to chronic breathing problems

  10. http://www.nanotechproject.org/news/archive/the_twinkie_guide_to_nanotechnologyhttp://www.nanotechproject.org/news/archive/the_twinkie_guide_to_nanotechnology

  11. Studies of Particle-exposed Populations Asbestos and Carbon Nanotube Particles

  12. Regulating the Health and Safety Risks of NMs

  13. Review of Adequacy of NZ’s Regulatory Systems to Manage the Possible Impacts of mNMs • Assess NZ’s existing regulatory framework to determine if potential risks of manufactured NMs are covered by existing frameworks • Identify where NMs may not be adequately covered by any existing regulatory framework • Review may be used by regulators and policy makers

  14. http://www.msi.govt.nz/about-us/consultations-and-reviews/nanotechnology-review/http://www.msi.govt.nz/about-us/consultations-and-reviews/nanotechnology-review/ The ‘Otago Report’

  15. Method

  16. Nanomedicine…. • “The science and technology of diagnosing, treating and preventing disease and traumatic injury, of relieving pain, and of preserving and improving human health, using molecular tools and molecular knowledge of the body.” (European Science Foundation, 2005)

  17. Examples of Nanomeds • Tumour-targeted nanomeds • Caelyx (Liposomes) • Feridex (iron oxide particles for MRI imaging) • Abraxane (Albumin-bound nanoparticles) • Rapamune (nano-crystal technology)

  18. Nanomeds Approved by Medsafe in NZ

  19. Medical Products Regulation in NZ & Australia • Medsafe & TGA • ANZTPA • The Medicines Act 1981 • The Medicines Amendment Bill 2011

  20. NZ Medicines Act 1981 • Concerned with the law relating to the manufacture, sale, and supply of medicines, medical devices, and related products. • S 3(1)(a) ‘medicine’: any substance or article, other than a medical device, that is manufactured, imported, sold or supplied wholly or principally for administering to one or more human beings for a therapeutic purpose

  21. Regulatory Gap: Combination Products Combination Product: A therapeutic or diagnostic product that combines a drug, device and/or biological product into a single entity Cosmeceuticals: Cosmetics with medicinal benefits “Anti-Aging Actives in Nano-Cosmeceuticals”

  22. Regulatory Gaps • Medical devices: • no pre-market approval process • no human safety assessment for medical devices (including nanomed devices)

  23. The Medicines Amendment Bill • Introduced Oct 2011 • Passed first reading late Feb 2012; referred to Health Committee • Will amend the Medicines Act 1981 • “Will address some of the problematic provisions of the Medicines Act” • Eg definitions • Eg the approval process for new medicines

  24. Future Work • “A more comprehensive overhaul of the Medicines Act will be required in the future to modernise and recast the medicines legislation and to address issues such as the regulation of medical devices…” (RIS)

  25. “Problematic Provisions” • Definition and classification challenges • ‘medical device’ • ‘combination products’?

  26. “Problematic Provisions” • “Principal intended action” *Moore, J "Proposed Changes to New Zealand's Medicines Legislation in the Medicines Amendment Bill 2011“ (2012) Journal of Bioethical Inquiry. * Moore, J “Is New Zealand’s Regulation of Nanomedical Products Adequate?” (2011) 19 Journal of Law And Medicine 112-127.

  27. Conclusions • Regulatory Gaps • ‘New’ or ‘Existing’? • Responsibility for approval and notification? • No regulatory definition of nanomed in Australasia • ‘medicine’, ‘medical device’, ‘combination product’ • Nanomeds illuminate legislative imperfections • Meds A Bill? • Opportunity to address the regulatory weaknesses? • Opportunity to move towards the responsible regulation of nanomedicine?

  28. Questions?

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