The European Council has given its final go-ahead for the adoption of a regulation on health technology assessment (HTA). 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. Janez Poklukar, the , said: “The adoption of this law is another demonstration of how EU countries, when acting together, can achieve very practical results for their citizens. This new law will benefit patients, producers of health technologies and our health systems.”
The new rules foresee that member states co-operate 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.
The vote means that the Council has adopted its position at first reading. The regulation still needs to be adopted by the European Parliament before it will be published in the EU Official Journal. It will start to apply three years after its entry into force (which happens on the twentieth day following its publication).