Health Action International’s (HAI) 2019 European workplan builds on previous successes supported by CHAFEA. It provides a response to persistent shortcomings in European medicines policy and regulation. HAI’s workplan is aligned with the objectives of the Third Health Programme and with HAI’s organisational goals: (1) Access to Affordable Medicines, (2) Medicines Safety, Added Therapeutic Value and Responsible Use, (3) Democratisation of Medicines Policy. In 2019, HAI will continue to address factors affecting access to medicines, including Intellectual Property Rights (IPR) while campaigning to broaden public and policy support in the European Union for alternative models of biomedical innovation that prioritise unmet medical needs, contribute to medicines affordability and ensure public return on public investment. Through the ‘Our Medicines, Our Right’ Campaign, we will seek to broaden policy support to medicines price transparency and R&D costs, as well as needs driven R&D modelling. We will roll-out campaign activities in Germany and thereby build bridges between policy discussions at the EU and Member State level. HAI will, furthermore, implement initiatives to promote responsible use of medicines, including antibiotics, by healthcare professionals. As a member of the Health Technology Assessment (HTA) Network Stakeholders Pool, HAI will contribute to the work programme of the network and advocate for strengthened EU collaboration on HTA. We will advocate specifically for joint HTA to be driven by high evaluation standards, transparency and independence from commercial interests. HAI will also seek policy and regulatory support for a more robust EU framework for medicines market authorization, in particular for cancer medicines. As a member of the European Medicines Agency (EMA) Patients’ and Consumers’ Working Party (PCWP), HAI will bring an independent consumers’ voice to EMA’s discussions and public consultations.