The Directive paves the way for patients to receive medical treatment in any of the EU-27 member states. It provides clarity and legal certainty on important issues such as reimbursement of treatments abroad, but also supports cooperation between national healthcare systems. Eucomed's main focus in the Directive is Article 14, which creates a new legal basis for HTA cooperation between member states.
"We are very pleased with the compromise on HTA. When used appropriately, HTA can be an effective tool to support decision-making and to make innovative technologies available to more people. Article 14 establishes the principles of good governance and appropriate stakeholder consultations, which is a significant step forward. Transparency in both the objectives and work of the HTA network, as well as an open dialogue with all stakeholders are key elements to develop adequate policies and methodologies for HTA and it is now up to member states to implement these principles. The medical technology industry favours strong stakeholder participation in HTA and very much looks forward to providing extensive relevant expertise" , says John Wilkinson, Chief Executive of Eucomed.
A broad range of medical technology products and services are already being impacted by HTA. Prerequisite for performing an accurate HTA is the use of adequate methodologies, taking into account parameters such as the learning curve for healthcare professionals when using new technologies, the right timing for performing an HTA or the predictability of data requirements. These elements may differ widely between medical technologies, but are also used differently within the member states. The Cross-border Healthcare Directive now provides a legal basis for an improved exchange of HTA-related information between member states. Eucomed will continue to be a constructive partner in the stakeholder dialogue.
After adoption of the text by the European Parliament today, it will be formally adopted by the Council in the coming weeks. The Directive foresees an implementation period of 30 months and will therefore be fully applied in 2013.
• EU Cross-border Healthcare Directive - Compromise text