Scientific Research & Development

If you’re in the scientific research and development sector, then you will most likely be a biotechnology firm that’s developing a medicine or medical device, or a service organisation that’s helping to bring the product to market.

The risk exposures that you face throughout the research and development process will evolve as you move through the various stages of the journey and can take anywhere from a few months to a few years.

Using data from one of our insurer partners CFC, we explain the insurance covers that you should consider at each stage of the R&D process, to protect against your key exposures as you discover, develop and test your new products.

At this early stage your insurance requirements are usually limited to liabilities cover, as well as basic property insurance. This is because you are only likely to have a small number of employees and limited tangible assets. In the discovery stage you will have a limited reliance on supply chain partners but may use external consultants or you may license technology from a third party.

Using external providers means that you should think about protecting your professional liability, unintentional breaches of contract and use of intellectual property.

Recommended insurance covers for the discovery stage are:

• Management Liability (Directors’ and Officers’)
• Public Liability
• Employers’ Liability
• Property

This stage may be carried out by you as the biotechnology company, or by a third-party supply chain partner that you might engage and include the hiring of expertise from consultants. Naturally, by involving a third party you are increasing your exposure to risk, which may give rise to claims for property losses and business interruption. You will also need to consider your stock, which you may need to transport and could be stored at another location where it’s out of your control. This could include biological materials that need to be stored in certain conditions to remain viable.

Recommended insurance covers for the development stage are:

• Property
• Business Interruption
• Goods in Transit

The third party will also need their own indemnity insurance.

As a biotechnology firm you will most likely use a variety of models to test products for safety before you can move on to seeking approval for human trials.

This crucial stage of the R&D process is often carried out by a Contract Research Service (CRS). Testing is expensive and the failure rate can be high; any errors during this phase may lead to substantial financial loss, so CRS firms will have a significant risk exposure. A robust professional indemnity insurance policy will protect against these unforeseen risks.

You might engage a Contract Manufacturing Organisation (CMO) at this stage, who will manufacture stock for use in your clinical trials. The exposure to risk is high for any CMO assisting at this stage. Quality control is key, because any errors in production, contamination, damage to stock, or delays in production could impact the trial, causing bodily injury to participants, or financial loss to the biotech. Professional Indemnity insurance is therefore vital for the organisation tasked with manufacturing the product at this stage.

This final stage before product approval determines the efficacy and safety of your new product and is where, as a biotech firm, your exposure to the risk of causing actual bodily injury or harm increases. You will be testing the product on humans for the first time and don’t know what the outcome will be. Your liability exposure increases significantly because participants in the trials may suffer adverse reactions to the product.

You will also still be exposed to property damage and business interruption risks, but at a reduced extent because your stock may be split over several locations and will continue to diminish with use.

If you enlist the services of a Clinical Research Organisation during this stage, they will be exposed to public and employer liability losses because of facilitating the testing. They may be exposed to financial loss claims if the trial is mismanaged and can also be liable for bodily injury claims.

Recommended insurance covers for the clinical trials stage are:

• Clinical Trials Liability
• Public Liability
• Employers’ Liability
• Professional Indemnity
• Property
• Business Interruption
• Goods in Transit

Whether you are a biotechnology company, a CRS or a CMO, at any stages of the research and development process we can help you to arrange a comprehensive portfolio of covers that will protect your business from risk exposure.

We are an independent specialist broker with excellent knowledge of the scientific research sector, and partner with some of the market-leading providers of insurance for the covers that will be vital to protect your project.

We’ll work closely with you to assess the risks that you are facing and create a solution that will bring you complete peace of mind.

Contact us today about your research and development project by calling to speak to an expert adviser on 01480 272727 or emailing enquiries@barnesinsurancebroker.co.uk.