Europe is not a single entity. It sounds so obvious but this is the single and fundamentally most important point for any company to understand, whether US-based or elsewhere, when considering whether to establish themselves in Europe. The regulatory and licensing process conducted by the European Medicines Agency (still referred to as the EMEA) continues to move Europe towards total regulatory harmonisation. A product approved via the centralised procedure will have a single licence for all 27 member states. National licences for a product for which the intention is to promote it across the whole of Europe are now unheard of, and this can lull one into a false sense that Europe is unified in terms of healthcare provision. However, once a product is licenced, harmonisation ends. After that, each country in which you want to market your product has its own healthcare system, authorities and institutes, and pricing and reimbursement system. In short, it is a highly complex region and any new company considering an expansion into Europe will require a detailed strategic approach.

WHY EUROPE?

For a US company, Europe is the obvious region to consider for expansion after their home continent. As a territory, it is second only to the US in terms of market value, and typically accounts for approximately 30 per cent of global pharmaceutical sales in any particular therapeutic area. In 2005, total pharmaceutical sales in the region were approximately $170 billion, with seven per cent growth (1).