The following Life Sciences guidance note provides comprehensive and up to date legal information covering:
The pricing and reimbursement of medicinal products and medical devices is not harmonised across the EU. This means that the national authorities of each Member State are free to decide how to set the price of medicinal products and the amount that will be reimbursed under their respective social security systems.
This lack of harmonisation has resulted in the EU Member States developing different schemes and policies, adapted to their own economic and healthcare needs. For example, in some EU Member States, a specific price or level of reimbursement must be approved, while in other Member States a system of direct or indirect controls on the profitability of the company responsible for placing a medicinal product on the market has been adopted.
It is therefore important that companies planning to place a medicinal product on the market in the EU consider the pricing and reimbursement rules in all of the EU Member States in which they intend to sell that product and engage in pricing discussions and negotiations with the pricing authorities where it is necessary to do so. It is important to start this process as soon as possible because failure to get the necessary pricing arrangements in place can delay the launch of the product, which can be extremely
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