Monday, May 1, 2023

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From Lab to Launch: Risk Management and Insurance for Life Science and Biotech Innovators

Australia has emerged as a thriving hub for research and development (R&D) and clinical trials, beckoning researchers with its attractive tax offsets and generous funding opportunities. Featuring a top-notch healthcare system, cutting-edge research infrastructure, strong Intellectual Property safeguards, a highly skilled workforce, and strategic proximity to Asia, Australia presents an irresistible draw for clinical trials.

Each Life Science and Biotech company is unique and a nimble start-up will have different needs, challenges and legal requirements to a listed company bringing in revenue from overseas. As a company’s capabilities and technologies evolve, so do their risk exposures. Below are some of the key insurance considerations to help you limit your risk exposures at each phase, allowing you to focus on what you do best.

MANAGING RISKS AT EACH STAGE OF THE LIFE CYCLE

 

1.  START-UP, EARLY & PRE-CLINICAL PHASES

Life Science Liability policies can be tailored to cater for early R&D activities to provide a basic level of protection during this non-revenue producing phase.

Protection of Intellectual Property and the interests of Directors and Officers via an affordable Management Liability policy is critical in the start-up phase.  Depending on your company’s strategic objectives, coverage for private capital raising or initial public offerings (IPOs) may be appropriate.

 

Additional insurance to support you in this phase:

  • Public Liability
  • Cyber & Privacy

 

Workers’ Compensation is a mandatory class of insurance once employees have been engaged.

 

2. HUMAN CLINICAL TRIALS PHASE

When you are ready to sponsor a human clinical trial, a comprehensive Clinical Trials Liability program will need to be placed.  These policies can be purchased on a standalone basis or incorporated into your company’s existing Liability Insurance program. 

 

Coverage limits and conditions will depend on the trial location and jurisdictional requirements, so it is important to seek guidance from an insurance advisor who is a specialist in this field.    

 

Additional insurance to support you in this phase:

  • Intellectual Property
  • Management Liability (private limited companies)
  • Directors & Officers Liability (public companies)
  • Public Liability
  • Cyber & Privacy

 

Workers’ Compensation is a mandatory class of insurance once employees have been engaged.

 

3.  PRODUCT LAUNCH/COMMERCIALISATION PHASE

Companies in this phase have an increased level of exposure to third party liability claims and damage to their physical assets.

 

Life Science Liability policies have multiple coverage sections so they can be tailored to your business’s needs. These policies include Product Liability, Product Recall, Errors & Omission / Professional Indemnity and Clinical Trials Liability.

 

Insurers are now adapting to Medtech exposures by including additional coverage clauses such as IT Liability Errors & Omissions and Cyber Liability to respond to new and emerging threats.

 

Supply chain challenges have increased in recent years, which can lead to business disruptions. Stock Throughput insurance offers a solution by providing comprehensive coverage for the movement of stock globally and static coverage for goods stored at third-party logistic sites. This insurance can help your business mitigate its risk exposures and minimise losses in the event of unexpected disruptions.

 

Additional insurance to support you in this phase:

  • Clinical Trials Liability Insurance
  • Public Liability
  • Professional Indemnity / Product Errors & Omissions
  • Directors & Officers / Management Liability
  • Property


Workers’ Compensation is a mandatory class of insurance once employees have been engaged.

 

NEXT STEPS

We help businesses identify and limit their risks, from the start-up phase through to product launch, and beyond. No matter where you are in the life cycle, we understand your contractual obligations and work with global insurers to secure the cover you need - as you grow and evolve. Feel free to reach out at any time to discover how we can help your business.

 

Daniel Reid

Client Manager | Industry Leader – Life Science & Biotech

daniel.reid@honan.com.au

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