Challenges Bringing Drugs to All EU Member States Worry Pharma

May 9, 2023

As the European Commission prepares for a major revamp to drug legislation, pharma executives and thought leaders worry that even with the new laws, rolling out new drugs to all 27 member states in a short timeframe will be a difficult task to achieve. The proposed law would offer pharma companies an additional years of data protection if new drugs reach all EU markets within 2-3 years of launch, which will be complicated if reimbursement decisions must be made in that period.

According to Sidley partner Maarten Meulenbelt, “If it is practically impossible for companies to achieve a full-scale launch in all 27 Member States, is it realistic to expect them to try, given the cost and the potential pricing impact of high-pressure reimbursement negotiations? The Commission said [on April 26] in its press conference that it would be ‘perfectly feasible’ to achieve an all-EU launch, but this seems optimistic. And if the overall degree of protection goes down compared to today, it is not realistic to expect more new products”

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