EU moving forward on HTA and access to medicines?

Council green lights new rules on health technology assessment, improving access to medicines and simplifying procedures


Things are stirring up on the HTA and access to medicines front in Europe. A news first brought to our attention by leading world specialist and friend of Decide Dr Dan Ollendorf from Tufts CEVR (click here to contact Dan).


On the somewhat arduous path towards more co-operation and co-ordination in Health Technology Assessment as well as access to medicines, it seems that the European Union made a recent leap! With health a subsidiary competence, i.e. remaining within the primary jurisdiction of Member States, extended co-ordination can prove challenging.


Against this backdrop, the Council of Europe’s encouragement for better co-operation between Member States is strongly encouraging:


The Council today gave its final go-ahead for the adoption of a regulation on health technology assessment. Thanks to the new rules, innovative, safe and effective health technologies will be more quickly available for patients. Producers of medicines and medical devices will benefit because submission procedures will be simplified.


The new rules foresee that member states cooperate to conduct joint clinical assessments and joint scientific consultations. They will also join forces when it comes to the identification of emerging health technologies.


In order to reduce the administrative burden especially for smaller companies, developers of health technologies should only have to submit information, data and other evidence required for the joint clinical assessment once at EU-level.


Joint clinical assessments at EU level ? it looks as though a pan-EU HTA mechanism may be sketched out. However, the European Parliament will need to vote on this regulation before it comes into force. We will make sure to update you!


Click here to access the full EU press release.




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