Brussels (Brussels Morning) The European Commission has welcomed yesterday’s adoption of its proposed Regulation on Health Technology Assessment (HTA, noting that it will open doors to new health technologies.
In a press release issued on Monday, Stella Kyriakidou, European Commissioner for Health and Food Safety, welcomed the fact that “after years of hard work, new rules to ensure that patients have better access to innovative medicines and medical devices will soon be a reality in the EU.” She pointed out that the new regulation is part of the EU’s pharmaceutical strategy and stressed that it will help EU authorities to provide “safe and efficient” treatments for all citizens. “The new rules will secure inclusiveness and transparency in the assessment process and increase predictability for member states’ authorities and for the industry”, she noted. “Member states will be able to take more timely and evidence-based decisions on patient access to innovative technologies within their healthcare systems”, she added
New rules are to come into effect in January 2025, but bureaucratic preparation for implementation tarts immediately, including the setting up of bureaucratic structures as well as preparation of documents and processes. Some 20 days after the regulation is published in the Official Journal of the EU, the EC will start setting up bureaucratic bodies, adopting required non-legislative delegated acts and implementing them, as well as developing methodologies, and the like. The regulation was sent to the European Parliament in February 2019 for the first reading and earlier this month for the second reading.