Life Sciences

Life Sciences

Protecting your passion

through certainty

Protecting your passion

through certainty

Remove the uncertainty

Your passion is to develop lifesaving or life extending products to prevent, treat or cure disease. Our passion is to provide certainty by delivering specialised insurance and risk management solutions that minimise loss potential and protect your bottom line.

Your passion is to develop lifesaving or life extending products to prevent, treat or cure disease. Our passion is to provide certainty by delivering specialised insurance and risk management solutions that minimise loss potential and protect your bottom line.

Remove the uncertainty

You need a broker that can keep up

Life sciences companies face specific challenges throughout the discovery, development, and commercialisation processes, including a range of unique property and liability exposures (such as research and development costs, clinical trials, product contamination and class action litigation).

Increasingly stringent global regulations mean compliance must remain at the forefront of daily activities, and the penalty for violations goes beyond finances. Because life sciences companies’ work largely involves human beings, trust and reputation management are critical aspects of their risk management plan.

Risk for life sciences companies comes from a number of angles. Whether it’s litigation regarding regulatory actions or intellectual property disputes, product liability claims, cyber theft, or supply chain disruptions, life sciences companies require a strong strategy for minimising risk as well as a solid plan for addressing situations that might arise.

HDL understands the unique exposures a life sciences company faces and can help develop solutions relevant to your business and to your risks, whether you are in the pharmaceutical, biotechnology, medical device and supply, or contract research sector. 

Importantly, we have the ability to keep up with your needs in the complex and fast paced life sciences industry.

Protection you need

HDL can deliver property and liability solutions for companies operating in all areas of pharmaceutical and medical technology development and manufacture, including covers for:

  • Property damage / business interruption (including research and development operations);
  • Premises / operations liability;
  • Products and services liability;
  • Clinical trials liability (including access to clinical trials certification systems);
  • Product recall expense and crisis response expense;
  • Errors or omissions (E&O) liability.

HDL, the right partner for you.

Seek advice from HDL

In an industry based on innovation, life sciences companies face ever-evolving risks with emerging exposures from cyber vulnerabilities to supply chain and regulatory risks all amplified by the increasingly global nature of the life sciences industry.

HDL offers life sciences businesses valuable support when it comes to assessing, quantifying, and mitigating risk exposure through strategic risk consulting, supply chain management, clinical trials risk management, and business continuity or crisis management plans.

Because the work of different life sciences companies tends to be diverse and highly nuanced, it can help to have the insight of not only internal and external stakeholders, but also advisors, such as HDL, who can add perspective from an industry-wide stance.

Taking a comprehensive approach to developing tailored solutions, from insurance broking to advisory and risk management services, HDL can position your company for stability and success and allow you to focus on safety and profitability.

Loss Scenarios for Life Science Companies

Whether you’re a biotech, medical device or service organisation, your complex products and devices have volatile financial and liability risks that could put you out of business.

In a competitive commercial environment, Life Science firms are increasingly challenged to meet customers’ expectations, regulatory requirements and the pressures of bringing product to market in a timely and cost-efficient manner. Companies are faced with a diverse range of loss scenarios ranging from errors or flaws in the product design causing bodily injury to contamination arising during production.

No matter how stringent a company is with their quality control procedures, these errors are often not discovered until the end-product has been distributed. Rectification expenses, damages, compensation and of course legal costs along with reputational damage, are just some of the ramifications of these errors that manufacturers can face. The costs can be significant.

Consider the following loss scenarios and then ask yourself whether you have adequate insurance protection in place.

Product Liability

Manufacturing error

Potential Cost: $8M

A Contract Manufacturing Organisation (CMO) manufactured orthopaedic implants to a customer’s specifications. After the product began causing bodily injury, the CMO and their customer were involved in litigation relating to the injuries caused by the quality of the implants. Both parties were found to be liable

Class action alleging drug company failed to warn of neurological risks

Potential Cost: $5M

Frequent long-term use of a generic product was linked to a disorder that causes uncontrollable repetitive body movements. The pharmaceutical manufacturer was sued by a consumer who allegedly suffered those side effects, and who claimed that the manufacturer failed to warn of those side effects. The case resulted insignificant defence expenses and a negotiated settlement for the alleged injuries.  Subsequently, a “black box” label was issued for the product that explicitly warned of this potential side effect.

Financial Loss (E&O) Liability

Failure to keep enrolment promises results in claim from sponsor

Potential Cost: $4.5M

A contract research organisation (CRO) was contracted by a large pharmaceutical company to handle clinical trial activities, including patient enrolment. The CRO failed to meet recruitment goals, made numerous data errors, and the business model they set up for the sponsor’s trial was allegedly awed in multiple ways. The sponsor charged the CRO with negligence and breach of contract that caused them to lose millions of dollars in potential revenue due to delays.

Software glitch invalidates clinical trial data

Potential Cost: $8.2M

A contract research organisation (CRO) was contracted to provide clinical trial services in Europe. An error in the CRO’s software program failed to properly randomise participants in one of the trials. As a result, the trial deviated from its intended design, rendering the data unusable and costing their customer millions of dollars to repeat the trial.

Clinical Trials Liability

Failure to fully disclose bodily injury risks

Potential Cost: $1.3M

The plaintiffwas part of a clinical trial for a new drug, and experienced liver toxicity. He alleged the pharmaceutical manufacturer did not fully disclose the risks of the study drug in the informed consent document. Although there was a general warning of potential adverse effects, this specific effect was not addressed, despite some animal studies showing the potential for liver toxicity.

Clinical trial patient suffers nerve damage

Potential Cost: $175,000

A healthy volunteer developed facial nerve damage during participation in a trial to test the safety of the pharmaceutical company’s investigational drug.

The scenarios have been provided by Chubb and serve only as examples.

Complimentary Review

Complimentary Review

Securing optimal insurance protection is becoming more challenging.

Having a fresh set of eyes can make a dramatic difference.  HDL welcomes the opportunity to evaluate and challenge your current risk and insurance program in a confidential manner that avoids disrupting existing relationships.

Insurance Broker

Our Global Insurance Network

Over 150 Insurers across the globe.

Our Global Insurance Network

Over 150 Insurers across the globe.