Breakthrough Agreement On EU HTA Regulation “Falls Short”

The European Parliament and EU Council have reached an agreement on taking forward proposals for greater cooperation on health technology assessments.

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European Parliament And Council of the EU Reach Agreement ON HTA Regulations • Source: Alamay

Following negotiations with the Council of the European Union on proposed regulations on health technology assessments, the European Parliament has conceded its position that joint clinical assessments should be mandatory for member states carrying out HTAs on medicines and medical devices. However, industry representatives doubt that safeguards secured by the parliament to prevent a bigger burden on companies go far enough.

“While the European Commission's original legislative proposal was certainly a step into the right direction, last night’s agreement falls short...

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