The European Union (EU) is experiencing a growing trend towards amalgamating national bodies to a single supranational authority. The pharmaceutical industry is no exception, with one of the key areas of discussion being the development of a unified approach to the Health Technology Assessment (HTA) of medicines and other treatments and medical devices. It may be particularly useful in the case of highly effective treatments for rare diseases, given the rarity of orphan diseases and the absence of real-world evidence in many cases. A joint clinical assessment, produced by a collaboration of top EU experts, aims to assess the added value of the product and enable quicker access to these innovative medicines. In 2018, the European Commission (EC) published a proposal for a regulation on the EU cooperation on HTA which highlights the need for joint clinical assessments and scientific consultations at the EU level. The proposal has received mixed reviews but is now being formalised in the form of an EU HTA regulation, to be introduced for many treatments from 2024, and for all treatments by 2029.
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