The European Health Data Space should safeguard trust between pharmacists and patients
PGEU, the European organization representing community pharmacists, published today a position paper
on the European Commission proposal for a European Health Data Space (EHDS) asking for stronger safeguards to maintain the bond of trust between health care professionals and patients.
The EHDS will support community pharmacists in providing better services and treatments to patients while promoting the safe use of medicines, but it is important that the new legislation doesn't put excessive burden on healthcare professionals with time-consuming obligations that can potentially compromise the provision of care.
It is also necessary to increase legal certainty by clarifying the uses of health data, further developing strong anonymization standards for secondary uses, and considering ethical duties of healthcare professionals set out in national regulations. PGEU also believes that Article 168 of the Treaty regarding public health should be added as legal basis because the main objective of this legislation should be to improve public health and quality of care and it should not focus only on the internal market perspective. PGEU also recommends reconsidering some parts of the impact assessment accompanying the proposal due to the significant consequences it will have on national health care systems.
PGEU also asks for the provisions on the re-use of data to be amended to guarantee a higher protection of fundamental rights and effective control mechanisms for citizens. In this regard the proposal has some loopholes to be addressed, such as the possibility for data access applications to be automatically approved if data access bodies do not review the application in two months.
PGEU President Roberto Tobia stated “Optimal data generation, gathering and interoperability can improve treatments for patients and foster personalized advice. From this perspective, we expect that the European Health Data Space will improve quality of care and promote medical research.
Enhanced interoperability will also contribute to unleashing the possibilities of e-prescriptions and support interprofessional collaboration and seamless care. However, to fully exploit its potential, it is vital to ensure that the EHDS legislation is fully in line with the EU General Data Protection Regulation, that it respects Member States competence on health care delivery and takes into account ethical professional duties".