Aon helps pharma firms get to grips with insurance needs

As biotechnology, pharmaceutical and medical device companies increasingly move clinical trials beyond their own borders to other parts of the world, such as Asia, Eastern Europe and South America, complicated regulatory environments challenge those firms' efforts to do business, according to an analysis by Aon Risk Services.

Aon's 2008 Clinical Trials Risk Map provides those companies with a visual representation of the complex insurance requirements and risk management needs that exist for companies conducting clinical trials internationally.

A robust research and development pipeline is essential to bringing new drugs or medical products to market, with clinical trials being an important step in the process of regulatory approval and marketing. While companies find benefits to conducting trials abroad, insurance and risk management requirements vary. Missteps in the placement of insurance can delay or disrupt clinical trials, resulting in costly financial implications for the life sciences company.

In 53% of the countries included in Aon's analysis, businesses must include a certificate of insurance in their regulatory filing package.

Certificates issued by locally licensed insurance companies are generally required for regulatory filings, and most countries' regulatory authorities have specific requirements for insurance certifications.

Turnaround time for certification issuance is often longer, particularly when local admitted insurance companies must be used.

Delays or errors in certification can result in delays in regulatory filings and approvals by ethics committees, ministries of health and other oversight authorities.

"Our analysis provides an overview of the constantly changing clinical trials landscape," said James Walters, managing director of Aon Risk Services" Life Sciences practice group. "Conducting clinical trials globally is an increasingly popular practice for firms seeking to bring better medicines and therapies to market, and insurance is the last thing that should stand in the way of the life sciences research so critical to human health and disease management."

To enable companies to better monitor clinical trials worldwide, Aon has developed a new clinical trials module as part of its risk management information system, RiskConsole. To date, companies used paper-based processes and spreadsheets to track clinical trials and coordinate coverage. RiskConsole offers a Web-based platform to manage the clinical trials process and ensure necessary insurance is secured.

Aon's report found that China, Estonia, Russia, Peru and Malaysia have been experiencing the most growth in the number of clinical trial sites. In China alone, the number of clinical trials grew by 47% in 2006 1. And with the exception of Peru, each of these countries requires locally admitted insurance. Russia has a limited local market for clinical trials insurance, which presents an even greater challenge to the life sciences company seeking to expand their clinical trials into this country.

Reference

1. Berndt, E.R., Sinskeyy, A.J., Theirs, F.A. Trends in Globalization of Clinical Trials. Nature Reviews: Drug Discovery [online]. November 2007.