Ensuring access of patients to appropriate diagnostics and treatment is a key issue for patient advocacy groups, as treatments can only work if patients are able to access therapies and related diagnostics and healthcare services. To be effective advocates in the area of access, an understanding of the regulatory system and where and how decisions are being made is essential. Advocates should know the system to avoid to “bark up the wrong trees”.
In terms of medicines approval and patient access, patient advocates in Europe need to understand regulatory pathways including the difference between the competencies of the EU and national national regulators: medicines authorization is mostly done at a European level, while reimbursement decisions are being taken on a Member State level. However, there are many more access barriers, as described e.g. by the Access Atlas of Myeloma Patients Europe.
Presentation at the WECAN Academy 2019:
Regulatory system: Overview of access pathways, and why is access to treatment, care and diagnostics an issue
Presenter: David Haerry, EUPATI
The following presentation held at the WECAN Academy 2019 will help you to understand:
- Why is access to treatment, care and diagnostics an issue, and is more complex than the “easy messages”?
- Overview of the regulatory system – difference between EU and national regulation
- The basics where approval and access decisions are taken (EMA/MAA then HTA/reimbursement)
- How to monitor access in Europe?
Additional resources and lins
- EMA Patients’ and consumers portal
- EUPATI Toolbox on medicines research and development (9 languages)
- Myeloma Patients Europe’s Access Atlas – as an example of evidence on access barriers gathered by a patient umbrella organisation