Life Sciences and Chemicals

Yesterday Andrew Tait (of Core Risks) and I presented, via audio conference, to a group of life science companies on Supply Chain Risks and what an Integrated Approach to Managing Supply Chain Risk should look like. The session itself actually touched on a number of other issues such as some of the emerging issues, and potential starting points for supply chain risk management but the session looked at the cycle of risk management starting with risk identification and moving through the qualification/quantification stages to prioritisation, mitigation and transfer.

Click here to view the presentation

As many of our clients know, JLT keeps their clients up to date with legal and regulation changes on a regular basis. The latest 6 monthly update focuses on countries such as Argentina, Australia, Austria, Belgium, Denmark, Germany and Spain. Some of this directly affects insurance whereas other areas directly affect the submission process.

As an example, Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on Good Clinical Practice, which set out the regulatory and legal basis for planning, developing and following up on clinical research, on the one part, and a regulation that mainly deals with the functions and activities of ethics committees and the rights, safety and integrity of experimental subjects, on the one part, the regulatory agency ANMAT reinforced the process regarding information and consent within the Clinical Trial Protocol submission.

Many of you are aware of the issues that have come about in recent years following the EU Clinical Trials Directive of 2001 (see my September blog posting). There is some faint cause for hope however that things might change for the better in the future. The EU is currently assessing the functioning of the Clinical Trials Directive and how it can be improved.

In this context, they will also look at insurance issues, cf. point 5.2.1. (pg 22) of their public consultation document found at: http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/clinicaltrials_en.htm

I have been invited to meet the EU's Enterprise and Industry Directorate-General for Pharmaceuticals to discuss some of these insurance issues. My hope would be to raise some of the concerns JLT clients have expressed and some of the issues that they come up against including the increasing request for limits not easily supported by insurance and other requests such as risk assessments to prove insurance limits are adequate.

Whilst it may be too optimistic to expect legislative change it would be worthwhile if the only outcome was that the EU have a greater appreciation of how some of these issues may affect the use of EU territories in trials and I have a greater appreciation of why they make the decisions on the Directive that they do!

If any companies wish me to raise specific country issues or would like, in principle, to help form an industry lobbying group, then please contact me on my details below;

Last week saw Neil Campbell and I host our annual Life Science & Chemical conference in Barcelona. It's always a challenge for us to keep the debates and topics fresh, topical and challenging but we've already had extremely positive feedback from many of the 100 attendees. The popularity of our event continues to rise and many clients and non-clients chose to attend the JLT conference instead of other industry events such as FERMA and RIMS due to the very focussed and educational agenda alongside the ability to debate the issues with peers, experts and insurers. For 5 years now it has been an excellent forum to meet senior individuals within the insurance and risk management world but also has proved the catalyst to real industry change and product innovation.

This year the conference was opened by experts in the field of Federal Pre-emption and also the US Political Environment who gave a background then focused on what this meant to the Life Science world. These sessions were followed by an insurer round table discussion chaired by Adrian Ladbury.

Subsequent sessions covered product security and counterfeiting as well as business continuity/new insurance related cover in the area of clinical trials (did you know that Hurricane Katrina forced the cancellation of or interruption to hundreds of trials?!).

The following day brought separate workshop sessions on trade disruption and structuring product liability programs, which looked at how triggers operate and what to be aware of when combining them in a program.

We then had a demonstration of an IT tool that automates the required analysis of contractual reviews, thereby reducing the amount of time the risk manager needs to devote to a huge percentage of contract reviews and also ensuring a consistent approach.

The closing session looked at what the future holds and the changing business models of the life science world and how insurance and risk management could respond.

Presentations will be made available to attendees shortly but those who missed the event can still obtain an insight into the conference by contacting me.

This afternoon I presented, via audio conference, to a large group of life science companies and CROs on Understanding, Managing and Avoiding Common Problems and Pitfalls. The session itself actually touched on a number of other issues such as some basic risk management and mitigation and how the future might look. I also explored some of the basic parts of an insurance contract that need some focus when examining terms and conditions.

Watch the presentation with audio here

 

The session covered not just how approaches to clinical trial insurance differs between territories and how ethics committees within the same country can have different approaches but how to manage some of these issues and construct an efficient buying platform and programme. We explored admitted versus non-admitted clinical trial insurance and I had some specific questions relating to this and a few specific territories.

One of the questions asked by a participant was where she could go to get information on the requirements by each territory. This was an excellent question and only goes to show the lack of knowledge centres out there. This is a common complaint of a lot of companies I have talked to in the past. As a broker heavily involved in this arena we keep a constantly updated master sheet of legal, practical and informational requirements by territory alongside knowledge of the typical lead-in times to obtain insurance in these territories.

I also endorsed the virtues of speaking to peers to share experiences and aid the learning process. For example I participate in a working group with risk managers of leading global pharmaceutical and CRO companies where we explore industry issues relevant to clinical trial insurance and also explore the nuances and approaches to issues within specific territories. Where one party has had success in dealing with a specific problem it gets shared and becomes a form of best practice for all of us. This really provides added value!

The audio presentation can be found by clicking the link at the top of this blog post, please contact me (james_bird@jltgroup.com) and I'll be glad to discuss further.