Protecting those who help others

We understand your passion for improving patients’ lives and the specialist work undertaken by organisations in the healthcare and medical technology sectors.

We also know that businesses in these sectors are exposed to significant risks. Our role is to help you understand these risks and the options you have for protecting yourselves so you can get back to doing what you do best.

For more information, please contact

Neal Lumb 

at neal.lumb@finchib.co.uk

or call 0161 242 4304.

Your needs / Our solutions

A broker who understands my business

We’ve spent many years building long term relationships and detailed knowledge of our clients’ businesses which enables us to provide you with the right help and advice to create a clear and cost effective insurance programme that protects your business and your employees properly.

We want to be the trusted advisors to trusted advisors.

Experience and expertise in your industry

We’re glad to work with businesses at all stages of their development, from start ups to global plcs and we’ve already been able to help clients in the following specialist areas:

• Medical Device and Consumable manufacturers

• UK and global clinical trials

• Clinical Research organisations

• Medical Technology developers

• Private hospitals

• Biotech

• Pharmaceutical manufacturers

Clear solutions and long term support

Our aim is simple – we want to simplify the complex insurance solutions that exist and help you create the most practical and cost effective solution for your business.

When claims occur, we will be there to provide support and guidance to ensure your interests and reputation are properly protected.

We can help you to understand and place cover for the following classes of insurance which are particularly relevant for businesses operating in the Healthcare and Medical Technologies sectors.

We insure corporate health providers and medical establishments against claims arising from errors and omissions in the course of their professional duties. Cover includes injury, misdiagnosis, delays in referral and physical or mental harm to a patient.

The majority of research which requires human volunteers involves a degree of risk, and so it is essential that specialist insurance arrangements are in place.

The review board or ethics committee will often require proof of insurance before allowing a trial to start and, if trials are being conducted overseas, it’s often necessary to produce insurance certificates in the local language. Failure to arrange the insurance in time can cause costly delays.

 

Events which can lead to claims include:

• Trial participants being harmed – sometimes seriously

• Participants (or their dependants) demanding compensation

• Participants rejecting the compensation ‘rulebook’ and suing independently for increased damages

 

How we can help you

We have extensive expertise in arranging Clinical Trials insurance in the UK and around the world and we have access to a specialist panel of expert insurers.

We will conduct all the negotiations on your behalf to get you the best possible solution.

 

What will we need from you?

• The Protocol Document, which acts as the trial plan, and includes details such as:

Trial participants – how many, ages, genders etc. Trials involving vulnerable groups such as children and women of child-bearing age will come under particular scrutiny.

Location(s) of the trial

Informed consent documents – description of the purpose of the trial, its potential risks and benefits, procedures and duration etc.

• The indemnity limit required for liability insurance – often set by the ethics committee (also known as “institutional review boards” in the USA).

• Details of the Investigator or CRO who will conduct the trial

 

What cover does clinical trial insurance provide?

Clinical Trial Liability Insurance provides protection in two ways:

1 . Negligent harm to trial participants: caused as a result of lack of due diligence/care or negligence by the sponsor, investigator or CRO. The policy pays for legal costs & expenses and compensation or “damages” awarded to the participant.

2 . Non-negligent harm / “no-fault” compensation: harm to participants of clinical trials with no identified cause, but likely to have arisen from their involvement in the research. The policy pays compensation in line with guidelines set out by competent authorities, such as the Association of British Pharmaceutical Industries.

  

How can I reduce my clinical trials risk exposure?

Whilst having specialist insurance solutions in place is a key element of your risk management arrangements, you can also protect yourself from liability by focussing on:

• Avoiding conflicts of interest – such as by reviewing any financial interests the clinical investigators or CRO may have in the drug or device being trialled.

• The qualifications of the investigators and the make-up of ethics committees or institutional review boards

• The ethics of participant recruitment techniques

• The informed consent process

• Trial monitoring

Product liability insurance is crucial for any organisation supplying any products to the healthcare sector such as medical device or medical consumable manufacturers, suppliers and distributors. The cover is designed to pay defence costs and damages as a result of injury or property damage caused by the products supplied.

If you are providing any “advice for a fee” then you could be held liable if that advice is incorrect and your clients suffer financial loss as a result. Even the cost of proving your innocence could be ruinous.

Professional indemnity cover is there to protect your business against claims for professional negligence, errors and omissions or breaches of duty. This type of cover is often a contractual requirement when providing services to the NHS.

Intellectual Property (IP) can often be a healthcare business’s most valuable asset and, like your other assets, there are insurance options available to help you protect it.

Most IP insurance (but not all) is aimed at businesses who have already secured IP rights. However, you can also protect yourself against inadvertently infringing the rights of others.

IP insurance is bought as a “before the event” cover and broadly falls into 4 categories:

• opinion only: covers legal costs of you obtaining an opinion on the likelihood of successfully enforcing or defending an IP claim.

• enforcement and defence: covers legal costs of you taking action to stop others infringing IP rights and defending allegations of infringement. Can cover enforcement and defence either separately or together

• damages: covers any damages payable if you lost an infringement action

• validity: covers legal costs of defending challenges to validity of your rights

Traditional policies do not accurately reflect the value of R&D or the impact to your business if key experiments or prototypes are lost. For example, the loss of key experiments may mean a delay in your project which may mean key milestones to trigger further funding are missed. We can arrange cover to ensure your business can carry on operating without impairment until your R&D work can be reconstructed.

Product recall insurance covers the cost of recalling a potentially dangerous product that has been tampered with, has a fault or has been contaminated. Our policies will cover the costs of recalling the product, replacing the product, lost profit and PR and brand recovery.

Having a product recalled, through no fault of your own, can be devastating to a business. Insurance is essential to helping a healthcare business react and recover quickly, and limit brand damage and adverse publicity.

The voice of an expert

 

Jason Brannan, Director, Medilink, said, “Medilink has a core role in developing the Health sector in supporting patient care and we are excited to have Finch as part of the Medilink family offering specialist support in areas such as clinical trials insurance.  We look forward to a long relationship for our members and the wider sector.”

Proud to work in partnership with MEDILINK

For more information