Life Sciences and Chemicals

An Integrated Approach to Managing Supply Chain Risk

2010-03-11T16:27:40Z

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

]]> Supply chain integrity has never been a bigger or more complex challenge for today's global businesses. Increased pressure for improved financial performance, combined with the need to optimise assets and resources, has resulted in a growing reliance on out-sourcing and off-shoring,often to developing countries. But with the benefits of reduced costs comes the increased and more complex threat of supply chain interruption. Increasing numbers of company financial reports now make mention of supply chain risks as being one of the key business exposures - but many do not seem to have an integrated model to identify, quantify and manage risk.

Efficient supply chains are by definition lean, stretched and fragile, resulting in an ever present threat of breakdown. While most organisations prepare themselves for the more obvious areas of weakness, breakdown can come from unanticipated causes. And all too often, traditional insurance products fail to provide any or sufficient financial help in these situations.

Managing supply chain integrity is about acknowledging the connections from threat through to interruption. To properly do this, companies have to develop an integrated approach covering identification, quantification, mitigation, financing and acceptance of supply chain risk. Many companies fail to appraise the full extent of supply chain vulnerabilities and as a result are not totally confident that risks are managed within acceptable financial targets.

Andrew and I explained how an integrated model for the identification, treatment and acceptance of Risk can address these concerns. Finally we touched on the management of risk through contracts and how insurance should be considered as the end point of the risk management process plus some new approaches.

The audio presentation and slides can be found by clicking the link at the top of this blog post, please contact me and I'll be glad to discuss how we can help your company further.

JLT keeps industry abreast of legal changes affecting clinical trials

2010-02-10T10:23:03Z

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.]]> Argentina
Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on GCP, 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 (contact me for a copy of the exhibit).

Australia
Pursuing the implementation of enforcement guidelines in the Clinical trials area, the Australian government implemented Therapeutic Goods Amendment Regulations 2009 (No.5) enabling issuing of infringement notices.

The Therapeutic Goods Amendment Regulations (the Regulations) were registered on the Federal Register of Legislative Instruments on 10 September 2009, and commenced on 11 September 2009.

The said Regulations allow an issuing officer (the National Manager of the Therapeutic Goods Administration (TGA), or an Assistant Secretary of a Branch or Office of the TGA) to give a person alleged to have committed a strict liability offence or contravened a civil penalty provision of the Act, and in relation to whom legal proceedings will otherwise be brought by the Commonwealth, the option of addressing that matter by paying a penalty specified in an infringement notice, as an alternative to being taken to court.

A person issued with an infringement notice is under no compulsion to pay the penalty stated in the notice, and may elect instead to have the matter dealt with by a court. If a person issued with a notice does pay the penalty in accordance with the Regulations, the person's liability for the offence or contravention will be discharged in full, and no further action may be taken against the person for the offence or contravention.

Austria
The Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH / AGES) published guidance for Clinical Trial Applications (CTAs) for the conduct of a clinical trial according to Austrian Medicinal product Act (contact me for a copy of the exhibit). This publication was the occasion to obtain current and precise information on regulatory and practice concerning clinical trials implemented in Austria, in particular about the sponsor's obligations.

In particular, on the basis of the AGES checklist of the Information required by the Austrian Competent Authority (CA) for the request for authorisation of a clinical trial on a medicinal product for human use, the sponsor must provide provision for indemnity or compensation in the event of injury or death attributable to the clinical trial as well as for any insurance or indemnity to cover the liability of the sponsor or investigator (contact me for a copy of the exhibit).

Belgium
The Belgian Federal Agency for Medicines and Health Products has published a special Guidance to the Conduct of Exploratory Trials in Belgium (contact me for a copy of the exhibit). As precised in this guidance, this is a working document concerning the conduct of clinical exploratory trials in Belgium, while awaiting the development of guidelines at the European level.

Denmark
As it has received many enquiries about amendments to clinical trials, the Danish Medicines Agency has drawn up a form containing a list of significant changes for which it is necessary to apply for an authorisation. The form also indicates which changes are only to be provided to the regional ethics committee (contact me for a copy of the exhibit).

This was the occasion to the Danish Medicines Agency to publish forms regarding the authorisation to make changes/amendments to the clinical investigation, the notification of completion of the clinical investigation of medical devices and the notification for serious adverse events or near-incidents with medical devices during the clinical investigation (contact me for a copy of the exhibit)

Germany
The German Federal Drug Law has implemented a specific procedure for variations (national, MRP and DCP) based on the assessment of paediatric clinical trials with authorised medicinal products in accordance with Article 45 of Regulation (EC) No1901/2006 (Paediatric Worksharing).

Spain
The Spanish Ministry of Health took a "resolucion" dated October 26, 2009 as regards the Clinical Trials electronic register, describing all clinical trials realised in Spain (contact me for a copy of the exhibit).

Regarding European regulation, the last version of the "Guidance Documents Applying to Clinical Trials" in the European Union is available - please contact me for a copy. As far as insurance is concerned, this version states that:

According to Article 3(2) (f) of Directive 2001/20/EC, a clinical trial may be undertaken only, if provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.

There are no specific Community provisions on when this insurance coverage can stop. However, the purpose of Article 3(2)(f) of Directive 2001/20/EC is to ensure that a clinical trial subject can obtain compensation for damages caused by the clinical trial- independently of the financial capacity of the investigator/sponsor. In view of this purpose of the provision, and in the absence of specific Community rules, the insurance should provide coverage for the period in which such damages can arise and lawfully be claimed by the clinical trials subject.

As a Community Directive by definition is binding to the result to be achieved while leaving open to EU Member States the choice of form and methods, it is up to the Member State to establish specific rules, if any. If no such rules are established at Member States level, it is up to the sponsor to assess, on the basis of the principle set out above and the clinical trial in question (in particular in view of the risk it implies for the clinical trials subject), the necessary period of coverage. Note, that, in accordance with Article 6(3)(i) of Directive 2001/20/EC, aspects of insurance or indemnity to cover the liability of the investigator and sponsor are considered by the Ethics Committee or, in accordance with Article 6(4) of Directive 2001/20/EC, by the national competent authority of the Member State concerned.

EU review their Clinical Trial Directive - opinion sought

2009-11-25T15:41:59Z

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;

JLT 5th Annual Life Science & Chemical Forum

2009-10-20T09:45:48Z

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.

Managing Clinical Trial Insurance

2009-09-29T17:13:22Z

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.