There is a big difference between the political positioning of the early access to medicines scheme and the reality; as always, the devil is in the detail. However, it underlines the fact that regulatory and payer approval for new products is too slow, and perhaps this should be addressed instead.
This would certainly have helped biotech and smaller pharma companies, which as pointed out in the accompanying article (which you can access here), are financially discriminated against in EAMS – although, arguably, they might have the most suitable products.
Companies that want to benefit from EAMS not only need good clinical data from trials etc, they also require input from clinicians about "clinical need" and the benefit of introducing new products early. Pharma needs to develop more ways to quantify this need in order to provide compelling arguments to MHRA, NICE and commissioners.
While conventional pharma advisory boards can provide some of the necessary insights, clinical networks are highly respected for their independent stance. They also provide a powerful route to research and quantify clinical need. For example, it is important to understand the pool of patients who have yet to be referred to secondary care or formally diagnosed with a condition that has never had an effective treatment.
For more information on M3, the global provider of technology services in healthcare, and its new European division which includes www.doctors.net.uk, www.mdlinx.com, and www.networksinhealth.com, please call Tim Ringrose on +44 (0)1235 828400, or email email@example.com
You can read the full article on the early access to medicines scheme from the May issue that this comment appeared beside here.