Early access in early launch markets France and Germany

Pharma and biotech companies wanting to bring a new product to patients in the EU go first to France and Germany. The reason, besides the size of these markets, is local reimbursement schemes. Both countries allow companies to commercially launch a product and generate revenue – and only then negotiate the price – thus making France and Germany very attractive early launch markets. 

In addition, many companies enter Europe by way of early access programs in France and Germany. These programs allow for pre-launch access to drugs in advance of marketing authorization. The overarching European law only provides a rudimentary framework for early access such as by offering a product for compassionate reasons. Local laws differ widely and determine the early access pathway.

In France, a major reform of early access came into force on 1 July 2021. The basic principles of early access remain, such as delivery to health care providers (HCPs) under a free price subject to repayment in exchange for immediate financing by the health insurance. However, the decision-making system and criteria have been clarified. 

In particular, two health authorities will be involved to decide on the presumption of innovation and benefit/risk, depending on whether the request for early access is made before or after MA. The financial regulation system has also been made more complex. Also, to compensate for its deficit in terms of time to market for innovations compared to other European countries, the French government introduced a system of “direct market access” for innovative products that cannot benefit from early access, following the example of the German model.

Germany, likewise, is an attractive early launch market. Germany allows companies to fully commercially launch a pharma product and to determine the price for the product. The commercially launched product can be sold to the entire German population at that price. Only one year after the first commercial sale does a negotiated reimbursement price kick in. 

Even before such commercial launch, many companies bring their product to German HCPs and patients by way of early access, either by way of allowing importing product, which is authorized elsewhere, or under an official compassionate use program.

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Authored by Charlotte Damiano and Joerg Schickert.