Decisions taken by regulators and health care payers, the latter informed by HTA bodies, determine which patient groups have access to new therapies and at what point in time. While these decision makers have different roles, they often rely on almost the same scientific data about new products; they also share the broad goal of enabling access for patients to beneficial therapies. Yet, formal interactions and collaboration between regulators and the HTA bodies that inform payers have only started in recent years in the European Union (EU) and are mostly in a pilot stage. This plenary session explores hitherto unrealised synergies in the work and processes of regulators and HTA bodies. Panelists will also address the roadblocks in the EU health sector ecosystem that need to be removed in order to realise the synergies while respecting their different roles.