CLINICAL TRIAL DATA
A CULTURE OF TRANSPARENCY
A new EU policy will require
pharmaceutical companies to
provide clinical trial data when seeking marketing approval for their drugs. But how will they ensure adequate IP
protection while embracing the new culture of transparency? LSIPR reports.
I
t’s becoming clear that some of healthcare’s biggest challenges, including the continuing battle against antibiotic resistance, are going to require a collaborative approach in the industry.
T e recent trend of mergers and acquisitions in pharmaceuticals highlights the industry’s newfound appetite for cross-licensing and sharing knowledge. Just two decades ago, when rivalry between the big pharma companies was at its peak, this would have been unheard of.
But in the last 12 months we’ve seen some of the largest pharmaceutical companies demonstrating their openness to change as they engage in patent licensing agreements and deals to meet their goals.
Much of a company’s commercial clout is seated in its patents, which are published for all to see, but there’s also a great deal of valuable information in the data yielded by clinical trials.
T is information is usually kept secret, but aſt er growing concerns about drug safety and effi cacy, and in order to promote a culture of transparency and trust in the industry, the European Medicines Agency (EMA) announced in October that, from next year, pharma companies will be required to release the clinical trial data used to support the marketing authorisation (MA) applications for their drugs.
On the one hand, this transparency looks as though it will make the pharma industry far more effi cient. T ere’s less chance of the same costly trials being carried out by diff erent companies and, by examining the data in existing trials, companies can learn from the mistakes of others and redesign their trials accordingly.
In fact, a handful of companies have already embraced this culture of transparency. In the last couple of years, some of the world’s largest pharma companies, including Pfi zer, Johnson & Johnson and GlaxoSmithKline, have announced that they will make their clinical trial data available to researchers.
But the move appears to be counterintuitive—in an industry where recouping the huge costs of drug development is paramount, the confi dential information contained within clinical trial data is what gives companies their competitive edge.
www.lifesciencesipreview.com Life Sciences Intellectual Property Review Volume 2, Issue 1 11
PUSITGURU /
SHUTTERSTOCK.COM
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