Innovation and patients at the core of EU orphan drugs law review

Around 30 million people suffer from such diseases across the EU. [Shutterstock/ Shidlovski]

The EU’s Orphan Regulation was introduced in 2000 and its main objective was to address the challenge of regulating medicines which treat an estimated 30 million patients with rare diseases across the EU.

The regulation introduced some incentives for the pharma industry to invest in the area of rare diseases, resulting in more than 160 new medicines. However, the Commission now wants to re-visit and amend the regulation as part of a new Pharmaceutical Strategy.

For its part, the pharma industry warns that if incentives are changed, this would negatively impact investments in innovation in this sensitive public health field.

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