Countries have being implementing cost containment measures since at least 2000. What is ‘new’, since the ‘financial crisis’ of 2008, is the pace and the severity with which budget controls are applied. Politicians are influencing the entire product development and commercialization more and more closely and there is little doubt that a share of Healthcare costs will have to be borne by the Industry. Pharma companies, especially small and medium sized companies, remain focused on commercialization and promotion, without a clear long-term strategic planning and in most cases a total lack of any integrative and multidisciplinary approach.

There is only one way out of the troubled path and that is for Pharma companies to understand that they are no longer seen as ‘pill sellers’, but need to show the capacity to address public health necessities and to provide value to the payer. This is the main principle of the highly anticipated Value-based and evidence-based pricing which has been shaped by the Department of Health and will constitute the pillar of the new Pricing and Reimbursement Scheme from 2014.

It is hard for a company to assume at the beginning of the development stage, that the product will have a fair price, once on the market. Even more so when you take into consideration the enormous variety of price assessments methods across Europe and the ever changing influence that Regional bodies and Patient or Healthcare organizations on the process.

Pharma Design (www.pharma-design.co.uk) has always stressed on the importance of producing a good strategy at a very early stage with the integration of clinical development and other functions including early market and health system analyses. Once there is a good understanding of the of the clinical compound, a company should immediately start considering which Regions are potentially interested in the value added brought on by their product and how their healthcare systems are potentially affected by its introduction.