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