Louise Cantrill - Henry Davis York - Nano-Medicine - A Macro Medico-Legal Risk?
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Transcript of Louise Cantrill - Henry Davis York - Nano-Medicine - A Macro Medico-Legal Risk?
Nanomedicine:
A Macro Medical Legal Risk?
Medico Legal Congress
25 – 26 February 2016
Louise Cantrill, Partner
Henry Davis York
Purpose
To consider the effect that the law of negligence will have on the use of
nanomedicine by medical practitioners
Structure
Introduction to nanomedicine focusing on its benefits and risks
Overview of the regulatory framework in Australia
The medico-legal implications of using nanomedicine
Practical suggestions to help manage the risks
Nanomedicine: A Macro Legal Risk?
Nanotechnology in Medical Applications
Overview
What is nanomedicine
Examples of its use in practice
Benefits of Nanomedicine
Risks of Nanomedicine
Nanotechnology involves the manipulation and manufacture of matter at
the nanoscale
Nanomedicine refers to the application of nanotechnology to medicine
aims to benefit human health through improved diagnostics and treatment
Examples of its use in practice
Diagnosis and imaging
Treatment
What is Nanomedicine?
Change the properties of substances
Many materials are different at the nanoscale than in their bulk state
Extremely small size means they are more easily taken up by the human body
Reformulate existing medicines to improve administration and absorption
Improve efficacy and decrease toxicity
Enhanced drug delivery processes have been used in cancer treatment
Toxicity of the treatment and negative side-effects are reduced
Benefits of Nanomedicine
Direct risks to human health
Materials in their bulk form may not remain safe when broken down into nanoparticles
Nanoparticles have the potential to cross biological barriers
Environmental risks and indirect risks to human health
Concerns that nanoparticles may enter the food chain impacting the ecosystem and
human health
Risks are not settled
Risks compared with conventional medicine
Whilst the risks of many conventional treatment methods may be well known, they may
nevertheless be high
Nanomedicine is potentially safer than other conventional treatments
Risks of Nanomedicine
The Regulatory Framework Governing the Supply
of Nanomedicines
Overview
The framework governing the supply of nanomedicines in Australia
Therapeutic Goods Administration (TGA)
Pharmaceutical Benefits Scheme (PBS)
Medical Research Future Fund Act 2015 (Cth)
Australian Guidelines
International Guidelines
How it works
Therapeutic Goods Act 1989 (Cth)
Assessment of quality, safety and efficacy based on risk
No specific regulatory controls for medicines or devices encompassing
nanomaterials
Therapeutic goods are regulated as an end product
Nanomaterials are considered in the risk assessment conducted by the TGA
Sunscreen
Therapeutic Goods Administration (TGA)
The register lists two nanoparticle treatments as registered and approved
for use
SentiMag Probe
A magnetic tracer device used in cancer treatment
Abraxane
Used in cancer treatment
Clinical trials have shown that it is effective in slowing the growth of cancerous
cells
Australian Register of Therapeutic Goods
National Health Act 1953 (Cth)
Listing on the PBS is critically dependent on a recommendation by the
Pharmaceutical Benefits Advisory Committee
Effectiveness
Cost of therapy
Listing on the PBS can have a significant effect on the prescribing habits
of practitioners
Abraxane is the only nanoparticle drug listed on the PBS
Pharmaceutical Benefits Scheme (PBS)
To improve the health and wellbeing of Australians by providing grants of
financial assistance to support medical research and medical innovation
Australian Medical Research Advisory Board
Australian Medical Research and Innovation Strategy
Australian Medical Research and Innovation Priorities
Help to inform the medico legal understanding of the uses and risks
associated with nanomedicine
Medical Research Future Fund Act 2015
Ethical guidelines governing clinical trials in Australia
National Statement of Ethical Conduct in Researching Involving Humans
– Integrity
– Respect for persons
– Beneficent and justice
– Informed Consent
– Hippocratic Oath
Australian Standards
Australian Guidelines
Council of the European Commission recommendations (2009)
Potential risks managed through measures such as proportionality, non-
discrimination and consistency
Precautionary principle
Food and Drug Administration in the United States
Strong preference for monitoring products at pre-market stage and when they
are in the market
International Guidelines
The Medico-Legal Implications of Using Innovative
Technology
Overview
Negligence – general requirements
The standard of care
Interaction between technology and standard of care
Causation
Damage
Negligence means a failure to exercise care and skill
To prove negligence the plaintiff must establish:
Duty of care
Breach
Causation
Foreseeability
Negligence General Requirements
Peer professional opinion
Common law requires reasonable care and skill of the ordinary skilled
practitioner
Duty to warn
Duty to warn of a material risk inherent in the proposed treatment
Duty to warn of a treatment’s experimental nature goes beyond the normal
duty to warn a patient of material risk.
The Standard of Care
Technological innovation is associated with a spike in medical
negligence litigation
Types of claims
Changed expectations of the standard of care influences the number of
claims made
Standard of care then becomes measured by the new technology
Interaction Between Technology and the Standard
of Care
Innovative technology can mean errors result in more visible and severe
outcomes
‘Point of difference’ between practitioners
New technology may also be useful in reducing litigation in some
situations e.g. cerebral palsy
Interaction Between Technology and the Standard
of Care
A plaintiff must prove, on the balance of probabilities, that the harm
sustained was caused or materially contributed to by the defendant.
Two stage approach set up by civil liability legislation
Factual causation
Normative causation: ‘scope of liability’
Evidentiary gaps
Causation
The defendant is liable for the plaintiff’s injuries and damages that are
reasonably foreseeable
Damages
Other Types of Claims
Overview
Other types of Civil Liability
Disciplinary Exposure
Toxic Torts
Nanotechnology can have far reaching implications given its unique
properties
Environmental liability
Employer liability
Product liability
Other Types of Civil Liability
If doctors use innovative technology inappropriately or fail to use
technology, this may give rise to disciplinary action
Example (Medical Board of Australia)
Doctors are required to provide treatment options based on the best available
information and any human research must be approved by a human research
ethics committed
Disciplinary Exposure
Potential risks of nanotechnology have been liked to asbestos
Mass tort litigation instigated in relation to asbestos claims may also occur to
deal with nanomedicine claims
Especially as health risks may not manifest for a latent period
In toxic tort cases causation is proven by establishing a causal nexus
between the hazardous substance and disease which it caused
Little research to suggest exposure to nanoparticles gives rise to a specific disease
Standard of proof required for causation remains unchanged for toxic tort
claims
Toxic Torts
How Can the Risks of Using Nanomedicine Be
Managed?
Overview
The Precautionary Principle
Managing Risk
What is it?
Precautionary principle as a risk management strategy
However it is only used in the context of the environment
The Precautionary Principle
Keep up to date with available knowledge
Undertake adequate training and ensure adequate training of staff
Ensure adequate protocols and procedures are in place and there is a
process for updating them
Ensure sufficient information is provided to patients to obtain informed
consent
Maintain good rapport with patients
Managing Risk
If litigation does ensue, consider the following:
Ensure the actions of the practitioner are measured by the standards of care
in place at the time of the incident
The standard is measured by reference to ‘a’ manner widely accepted in
Australia by peer professional opinion
Justification on the basis that the new technology should not have been
employed should also be explored
The alleged negligence must have caused the damage complained of
Using an appropriate expert to comment will be critical
Managing Risk
United Kingdom: The Access to Medical
Treatments (Innovation) Bill 2015-2016
Overview
What is it?
Debate regarding the Bill
Changes to the Bill
Likelihood of a similar Bill in Australia
Conclusion regarding status of legislation in the UK
Until recently, the Bill aimed to promote access to innovative medical
treatments through:
The creation of a database of innovative medicine
Enabling doctors to carry out innovative treatment by attempting to clarify
when innovation is responsible
The Bill sought to clarify the steps doctors needed to take into order to
demonstrate that the decision to innovate was taken responsibly
What Is It?
Established on the belief that fear of litigation inhibits innovation
Critics pointed to a lack of evidence that this occurred
British Medical Association
Royal College of Surgeons
Cancer Research UK
Undermine clinical trials
Quacks charter
Debate Regarding the Bill
Significant changes were made to the bill on 29 January 2016 following
debate surrounding the ‘responsible innovative’ provision
Emphasis directed away from the standard of care
Focus is now on
Database to store and access information about innovative treatment
Regulations which govern the registration of innovative medical treatments
Changes to the Bill
Lack of legislative guidance on how to use nanomedicine in Australia
legally and responsibly
Practitioners must rely on ethical guidelines
UK has attempted to alter the standard of care
Australia has increased funding
Likelihood of a Similar Bill in Australia
The Bill represents an attempt in the UK to alter the standard of care
Likely influence on Australian law makers
Practitioners should continue to act in accordance with the existing
framework
Conclusion Regarding Status of Legislation in the
UK