There is a role for cross-border alignment, but what is it?
Speakers looked to collaboration across Europe to overcome some of the barriers to gene therapies. Allowing patients to travel for treatment, EU data standard setting, as well as collaboration to remove European-level barriers to gene therapies.
For specialised technologies like gene therapies, it may not be plausible or necessary for every country to deliver them within their health system. Patients may be able to travel across borders for care in a similar way that they do within countries for other forms of specialist care.
There are many practical challenges to cross-border care. For example, the European Directive for cross-border care is not well suited for gene therapies because it requires patients to pay the upfront cost which is not practical for many patients.
Countries are looking for European standards in terms of regulatory standards , data collection and (clinical) value assessment.
Some promising initiatives have already been developed. The European Health Data Space was mentioned as a promising step in the right direction that could be leveraged or piloted for gene therapies given the immediate need and clear application in the context of gene therapies.
Individual member states want to keep their autonomy in relation to health spending. Where European collaboration is valuable is likely to be in mechanisms to reduce uncertainty and to reduce the risk for payers.
The speakers discussed a number of examples of barriers that exist at the European level. For example the Directive on cross-border healthcare, which is not working well for gene therapies, or the European system of accounts (ESA) that make annuity payments (split payments) difficult or impossible.
For that reason, dialogue at the European level will be important to ensure that legislation doesn't have an unintended impact on limiting the adoption of gene therapies in Europe.
Simone Boselli- Patient perspective
