Brussels: the ball game on health data and electronic prescriptions

The European Union has published a proposal which will have an impact on e-pharmacies: SAE expects a positive impact from the initiated European Health Data Space (EHDS), since it enables healthcare actors across the EU to make full use of the potential offered by a safe and secured exchange, use or reuse of health data, including e-prescriptions.

As one of the leading e-pharmacies, our company has to deal with different sets of national policies and legislation which determine in which framework we can act, albeit the extent to which vouchers can be awarded and the way in which we have to label medication. Next to the national systems, we´re bound by the ´Brussels´ system too, since a great deal of legislation is initiated and implemented in Brussels. But the way laws are being determined in the EU, is not just about finger pointing at ´those civil servants in the bubble´. In fact, next to the European Commission and the European Parliament, the member states of the EU always sit at the table as well, with either their heads of state (European Council) and/or their Ministers (Council of Ministers) involved. 

The proposal on the EHDS presents us with a legislative framework called a ´regulation´, which is a binding piece of legislation of immediate applicability in its entirety in all EU member states and it overrules national laws.

The EHDS is of such great interest to us, because it provides a framework of rules, common standards and practices, infrastructures and governance in which the following is arranged:

• Most importantly, online pharmacies have been mentioned specifically throughout the document:
  1. Member States need to “ensure that pharmacies operating on their territories, including online pharmacies, are enabled to dispense electronic prescriptions issued by other Member States”. All EU member states must by 2025 be equipped to process electronic prescriptions.
  2. “different reimbursement policies should…not constitute barriers to the free movement of digital health services such as telemedicine, including online pharmacy services”.
• The document focuses on primary and secondary health data, of which to us the use of primary health data is most important, since it entails the use of health data for the provision of health services to individuals to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices.
• A couple of pillars have been defined which are important for SAE to define upfront how data is being dealt with and who is effectively in charge:
  1. Empowerment of the right of patients’ control over their health data in electronic format.
  2. Mandatory requirements for interoperability, security, safety, access to data in electronic health records.
  3. Mandatory deployment of cross-border digital infrastructure for the exchange of health data.
  4. Common European purposes for reuse (public and private re-users and data holders) with safeguards
  5. Designation of national competent bodies for digital health and national competent bodies for Health Data Access;
  6. Creation of the EHDS Board as a governance mechanism, which is composed of national authorities and relevant institutions/agencies

Now, the document is up for discussion by the Parliament and Council. It is being viewed as a watershed moment since the EC goes pretty far in initiating a proposal in the domain of healthcare, which ultimately remains a competence of the member states. The European Association of E-Pharmacies (EAEP), which represents our interest, is actively involved in the process. If negotiations unfold following perfect planning, an agreement could be reached by the European institutions by the end of 2023.