Insurance for Clinical Trials
In the UK a medical device manufacturer may need to carry out a clinical investigation (clinical trial) as part of the process of obtaining a CE marking for a medical device, i.e. to demonstrate that the device complies with the essential requirements of the relevant directive. For medicinal/ pharmaceutical products a manufacturer must have marketing authorisation before they can be sold. Trials are crucial to the wider medical community. Where results are absorbed by researchers, pharmacists, doctors and regulators to aid further product development and treatments.
Whilst there is no legal requirement to insure in the UK the EU Clinical Trials Directive 2001/20/EC does state that there has to be sufficient funding to provide indemnity should there be any bodily injury or property damage to any research subject who is taking part. Insurance is used provide confirmation of indemnity.
Conducting clinical trials is a critical part of your company’s development. There are many complex regulatory issues to deal with and having the correct insurance is a big part of this. It is important to look into your insurance needs early on in the process. You may also need to consider that the availability and affordability of clinical trial insurance in various countries may have an impact on where you conduct the trial.
The protocols for a multi-national clinical trial are complex and, therefore, often misunderstood. Whilst some countries have well documented compulsory insurance requirements outlining specific terms and conditions of the policy which must be in place, others do not. Finding an Insurer that is able to accommodate overseas sites is essential.
Clinical trials insurance is available from a number of different insurers in the UK. They generally offer two types of cover being:-
1. Agreed Compensation cover – compensation agreed under the applicable Clinical Trials Compensation guidelines
2. Legal Liability cover – damages and defence and claimants costs that you are legally liable to pay.
It’s important to be aware that some insurers issue a policy for the period of the trial. While others on an annual basis. If this is the case, the policy will need to be renewed if the trial lasts longer than one year to ensure continuity of insurance.
Typically insurers require a copy of the draft study protocol document and patient consent form to be able to provide a quotation. To enable insurance to begin a signed copy of the protocol document will be required by the insurer.
ADF Insurance can arrange clinical trials liability insurance both in the UK and overseas including USA and Canada.
If you have any other questions please contact us.
Clinical Research Organisations
Where large medical device, biotech or pharmaceutical manufacturers outsource the management of a clinical trial to a CRO its important that the CRO protect themselves against claims arising from the professional services that they provide. If something goes wrong with a trial cost can be significant and if this leads to a trial patient suffering injury the repercussions can be significant. It’s important that the insurance purchased provides adequate protection and includes bodily injury.
A clear understand of the CRO’s responsibilities and ultimately potential liabilities is vital to ensure that the insurance is tailored to meet the require.