JPM2023 Trendspotting: successful early access in the EU

As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared a series of updates that we hope will help strategically guide your 2023 partnering and investment decisions.

Caution remains a strong theme in the current market downturn. Now more than ever, companies must think strategically and be more nimble about attracting investments and/or strategic partnerships, pathways to regulatory approval, and product commercialization.

In a challenging investment environment, life sciences and health care emerging companies may need to take a longer view than simply planning a “classical” pricing and reimbursement launch after the marketing authorization (MA). This requires strategic thinking on early access programs available in the European Union (EU), which can position your product for success even at an early stage and subject to further favorable health technology assessment.

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.

Why Hogan Lovells?

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From corporate formation to patent protection and a consistent strategy through initial financing rounds to regulatory and reimbursement approvals to market revenue or an exit, we help your company lay a strong foundation, with a life sciences and health care industry specialization at the forefront of everything we do. As your business grows and your needs evolve, so does our team of lawyers who can support your company’s strategic business needs relative to your product’s development stage, including regulatory approval planning and execution, clinical trial design and implementation, pricing and reimbursement strategy, licensing, collaborations and other commercial transactions (sales and marketing and distribution agreements, manufacturing agreements and relationships, CRO arrangements and more), and commercialization and product launch planning. Hogan Lovells is a global law firm with over 40 offices worldwide and importantly in all the major global life sciences and innovation hubs. Accordingly, we can strategically assist you with our industry experts in markets across the globe. 

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Authored by Charlotte Damiano and Joerg Schickert.


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