Medical products

Our policy is designed for manufacturers and distributors of medicines, medical devices, laboratory instruments & equipment and ophthalmic products. 

Manufacturing or distributing medicines or medical devices comes with huge responsibility – organisations face a complex set of risks including defective manufacturing, device failure, injury or product recalls. 

Many of the risks may not be covered under a general liability insurance, but would be covered under the specialist policy we offer.

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  • Research and development
  • Producers of medicinal products
  • Producers of medical devices
  • Contract research organisations
  • Contract manufacturing organisations
  • Sponsors of UK clinical trials
  • Importers / wholesalers / distributors

 

Examples of risks we would write:

  • A new therapeutic drug in clinical trial
  • Contract manufacturing of drugs
  • Orthopaedic implant manufacturer
  • Contact lens manufacturer
  • Contract manufacturer of dental implants
  • Distributor of medical devices
  • Raw ingredient manufacturer / processo

Legal liabilities

  • Liability - injury and property damage
  • Liability - financial loss
  • Clinical trials
  • Employers’ liability

Management risks

  • Entity defence
  • Directors’ and officers’ liability

Protection of assets

  • Property damage
  • Business interruption
  • Specified all risks
  • Money and personal assault
  • Transit

Extensions available

  • Public utilities
  • Denial of access
  • Restrictions to premises
  • Customers extension
  • Suppliers extension
  • Product withdrawal expense

Medical Device Manufacturer - Risk example

The policyholder is a large medical device manufacturer, established in 2006, producing a variety of single use instruments for use in general surgery. Based in the United Kingdom the company has built up a strong client base including the NHS and a number of overseas contracts.

The issues

Whilst the organisation is experienced and well-managed there was one issue that required further investigation before we could agree terms. In its early days the company had been involved in the development and sales of an orthopaedic implant.

As such the company needed retroactive cover for these products. There had been no safety issues, but the company found it difficult to find an insurance carrier that would agree to cover the more onerous implant exposure together with the relatively straight forward instrument product they were now involved with.

The solution

In this sector we are used to seeing new and challenging technologies so we find comfort in understanding how our potential clients manage the associated risks.

  • We undertook research into the safety profile of the orthopaedic product and similar products to determine if there was any current or potential litigation being talked about.
  • We met with the client to understand their business and discuss their demands and needs going forward.
  • The client demonstrated to us a high level of competence in their field and we demonstrated to them our commitment and expertise to providing insurance in this sector.
  • We provided cover on a worldwide basis including retroactive cover for the orthopaedic products.

Medicines - Claim example

Specialist cover for a pharmaceutical company

The policyholder is a pharmaceutical company, established in 1995, they have a range of oncology products both in development and also on the market. Based in the United Kingdom the company had built up a strong client base including NHS and a number of overseas contracts.

The Issues: 

The company planned to begin recruiting for a UK clinical trial during the policy period, and the research and development of the new products was funded from existing product sales and third party investment. The products were also manufactured by a third party company in Swansea and then stored and distributed to customers by a specialist distribution company. 38% of the income is generated from sales in the US.

The solution: 

As with all the risks that we review, we underwrite the policyholder as much as the product itself. In this sector we are used to seeing new and challenging technologies so we find comfort in understanding how potential clients manage the associated risks.

Alongside insurance solutions, we can also assist your clients with tax and funding services such as R&D tax relief, tax funding and patent box through our partner Abbey Tax. 

Download the service brochures below: 

For more information about any of these specialist tax and funding services, please contact your local Markel underwriter.