Do I need to Insure my “property”?

What is Employers Liability and why buy it?

This is insurance to protect you from claims made against you by employees who suffer injury or illness as a result of their employment by you

• Typically you get cover automatically for €13m limit when you purchase this
• Your wage roll and the activities / occupations of the people on your payroll is what determines the premium . In many countries this is obligatory insurance and you do not have a choice
• Currently this in not obligatory in the Republic of Ireland but virtually all Employers have it as it makes economic sense !

You will need purchase Public Liability Insurance

In your business you have a duty of care to the public (as indeed to employees) to ensure that they are not injured or their property damaged as a result of your activities.

A person could be injured when on your premises as a visitor or you could cause damage to property or injure someone when you are working away from your premises

Public Liability is intended to cover these scenarios.

Typical public liability limits for cover start at €2.600,000 and for many businesses this limit is increased to €6,500,000 due to requirement of a customer or client of the business . It’s the first €1m that costs the most and typically the higher the incremental limit you require the lower the premium for the incremental cover. We could talk all day on the subject but that will give you an idea for now!

What is Products Liability insurance and why do I need it?

You might buy Products liability.  This is kind of like an extension on the Public liability insurance – If you make, alter, repair, supply product then you have a common law duty and statutory duty of care to ensure that these products cause no injury or harm to persons or property. If they do then you can be sued – So to protect yourself here you should arrange Products liability insurance . The basic cover will give you legal defence cover to defend claims brought against you for your product causing harm and will pay the award to the injured party if you are held responsible – Like the public liability you get a basic policy limit of maybe €2.6m and you can top up from there.

In the Medical Device area you should note a couple of things

Often in the Medical Device industry the insurers will issue their polices on a Claims Made basis –as distinct from a claims occurring basis (as for example you’d have if you made calculators )

What this means essentially is that it is the policy that is in force at the time a claim is presented that deals with a claim and not the one in force when the incident occurred – Best to give you an example

Company makes needles and has insurance since 2004 – The company changed insurers in 2009.

A claim is presented in 2012 to the needle manufacturers for defective product for injury that was caused in 2007 – It is the policy from the 2012 year and new insurers that will deal with the claim , not the policy from 2007 – important to note in this example also is , if the clients had let their insurance lapse ( lets’ say they let it lapse in 2012) – then they would have no cover for the incident being claimed for as there was no policy in place at the time the claim was presented !! – Cruel isn’t it!

What about Uncle Sam?

Other bits we often find in the Medical Device world for Product liability – Everyone wants to sell product to the US for the higher margins, bigger markets etc… The regular products liability policies are intended to cover you selling to worldwide Excluding USA or Canada – So make sure you get the US and Canada jurisdictions covered if you sell to these countries.

But I do lots of consultancy?

The technology/medical device area has a lot of work that involves consultancy – Often a firm that manufactures something discovers that they can make as much money again charging other firms for their expertise that has been built up in a given area – If you provide advice for a fee you will not be covered under your public or products liability insurance – So you need Errors and omissions Insurance.

What is Professional Indemnity and why buy it? What is Errors & Omissions Insurance and why buy it?

Errors and Omissions Insurance

So what is this one for?  Well, if you provide advice to someone and that person in turn relies on your advice and ends up suffering some financial loss as a result of poor or incorrect advice – then like our injured friend under the public liability scenario they have a right to make a claim off you for the loss they have suffered – Professional Indemnity or errors and omissions insurance provides cover to you for the legal defence costs in defending these type claims and will pay the award if you are found to be liable – Like the Public or products liability cover you have to choose what level of cover / protection you want and this is known as your Limit of Indemnity . The type business and contracts you are involved in will have a bearing on the limits/exposure .

Remember like the Products liability example above – these policies are “Claims Made and Reported ” wordings – So basically you need to ensure you have insurance in place

We have a separate site which deals with Professional indemnity – so if you would like more information on this area follow this link – Professional Indemnity terms etc.

What is Clinical Trials Insurance?

Clinical trials are studies that are carried out to test how well new medical devices / drugs etc work.  Development work in labs and lab environment is one thing but until a device /drug is tested in a human then we can’t say with any certainty its efficacy, its safety, it’s properties etc.

The trials are to:

• Determine the Safety of the product
• Evaluate the effectiveness and look for any side effects
• Verify effectiveness, monitor adverse reactions from long-term use
• And lastly to..
• Compare product or drug with other products /drugs already in the market
• Monitor a product’s/drug’s long-term effectiveness and impact on a patient’s quality of life
• Determine cost effectiveness of a product / drug therapy relative to other traditional and new therapies.

So why would you need Clinical Trials insurance anyhow?

Well if a patient that agrees to partake in your trial is injured they will have a right to claim from you the sponsor. You can appreciate that if you are that patient you will want to know that there is insurance in place should the trails be unsuccessful and you suffer an adverse reaction to the product or drug.

Clinical Trials insurance is like a once off (although this can be extended or blended into a longer term programme) insurance to cover the sponsor against legal liability arising out of lack of care, negligence resulting in injury or death of the patient partaking in the clinical trial .  The cover is bought for the duration of the trial

Things to note when buying Clinical Trial covers

The policies are Claims Made – so like in the examples above on the Errors and Omissions Insurance you need be careful that you actually have cover in case a claim is presented in the future ( after your trials are over !). There are extensions available on notification period and these are possible to address when taking out the covers.

The Limit of indemnity you choose on the policy is an Aggregate Limit – So if you have a number of patients these all dilute your limit.  So make sure you insure for enough.

If you carry out the trials in countries outside Ireland or the UK then there are local regulations in a lot of those countries that set minimum limits of cover per patient – You do not have a option on what limits to choose so beware of this.

Many countries require you to produce an insurance certificate in their language and not all insurers can produce locally admitted insurance policies and certificates in a local language.

So what matters to insurers when they look at these risks to determine what to charge and if they want to take the risk on at all?

• Product type and characteristics
• Typical User profile
• User population
• Intended use of product
• Potential misuse of product
• Extent of regulation governing the particular area
• Legal environment

And How do Insurers view you and your proposition?

Insurance companies in this area are not only cognisant of the above – they also take into account how you as a company present yourself and your proposition – It’s like they interview you without meeting you! What they want to see is.

• Quality of your regulatory documents (you protocols, your master informed consent documentation, what your advertising and promotional materials are like etc.)
• Your financial situation
• Your Experience & Expertise in the areas you are looking to undertake trials in.
• Have you a commitment to superior risk management?
• Are you in business for the long haul and can they potentially develop long term relationship with you?

What is product recall Insurance

So if you “re successful and have lots of product in the marketplace you may find that it would be some financial headache if you were faced with having to recall product

Product recalls can be voluntary or involuntary and very costly.

Products Recall Insurance is designed to give protection in the event of a recall of your product. This protection includes coverage for your own product recall expenses and liability to third parties for both finished and component goods. A recall may involve many expenses not limited to:

Costs associated with notifying customers

The cost of shipping and disposal of the product

Extra warehouse expenses

The cost of extra personnel required to conduct the recall

The cost to refund, repair or replace and ship the product back to the customer.

Rebranding following the product recall

This insurance is generally very expensive and not commonly available and we rarely get asked for this!

So who are we?

We are Burke Insurances Ltd. We are commercial insurance brokers with some fifty years of commercial broking experience.

Based in  Galway City Ireland we are located in a hub region for Medical Devices and so have gained lots of valuable experience in handling placing and advising on insurance programmes for Medical Device manufacturers.

We understand the business and we are quite happy to provide you with some help and advice on your queries as some day we might need your device! – but before that we would like to know you better as a client!

Give Ann,Sean, or Paul a call today

091 563518