THE CHALLENGE OF THE RESPONSIBLE REGULATION OF

NANOMEDICINE

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

What is Nano…? Novel materials, novel properties

create novel products Nanotechnology is a science of new

possibilities…

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)”

NANOTECH 101

• 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

Scanning Tunnelling Microscope

Nanoscale Chemicals

NANOSCALE CHEMICALSOPTICAL PROPERTIES EXAMPLES

* 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

Bulk gold appears yellow

12NM gold particles look

red

‘Traditional’ ZnO

sunscreen is white

Nanoscale ZnO

sunscreen is clear

BENEFITS

•Societal

•“Next industrial revolution”

•“Revolutionise individual health care in the 21st century.”

•Commercial

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

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

Studies of Particle-exposed Populations

Asbestos and Carbon Nanotube Particles

Regulating the Health and Safety Risks of NMs

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

The ‘Otago Report’

http://www.msi.govt.nz/about-us/consultations-and-reviews/nanotechnology-review/

Method Regulatory Agencies Legislative Instruments

Department of Labour Health and Safety in Employment Act. Approved Code of Practice for the Management of Substances Hazardous to Health in the Place of Work.

Ministry of Health (Medsafe) Medicines Act 1981Ministry for the Environment &ERMA

Waste Minimisation Act 2008 (MfE).Hazardous Substances and New Organisms Act 1996 (ERMA).

Ministry of Consumer Affairs Consumer Guarantees Act Fair Trading Act

New Zealand Customs Service Customs and Excise Act 1996 New Zealand Food Safety Authority &Food Standards Australia and New Zealand

Food Act 1981 Australia New Zealand Food Standards Code

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)

Examples of Nanomeds Tumour-targeted

nanomeds Caelyx

(Liposomes) Feridex (iron oxide

particles for MRI imaging)

Abraxane (Albumin-bound nanoparticles)

Rapamune (nano-crystal technology)

Nanomeds Approved by Medsafe in NZ

Medical Products Regulation in NZ & Australia Medsafe & TGA

ANZTPA

The Medicines Act 1981

The Medicines Amendment Bill 2011

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

Regulatory Gap: Combination Products

Cosmeceuticals:Cosmetics with medicinal

benefits

Combination Product:A therapeutic or

diagnostic product that combines a drug, device and/or biological product

into a single entity

“Anti-Aging Actives in Nano-Cosmeceuticals”

Regulatory Gaps

Medical devices: no pre-market approval process no human safety assessment

for medical devices (including nanomed devices)

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

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)

“Problematic Provisions”

Definition and classification challenges ‘medical device’ ‘combination products’?

“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.

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?

Questions?