EuropaBio position on the proposal for the directive on the application of patients' rights in cross-border healthcare
EuropaBio’s position paper on amendments 630, 631 and 633
Amendments 630, 631 and 633 (reproduced in Annex 1) have been tabled on Article 14 of the Cross-Border Healthcare Proposal, arguing for the introduction of identification of medical products on the basis of International Nonproprietary Names (INNs). Although this proposal could appear to represent a safe way to ensure that patients receive the correct product no matter what EU-member state their medications are dispensed in, EuropaBio is concerned that for biotechnology-derived medicines it could potentially have the opposite effect.
• Biotech medicines are different from traditional small molecule medicines for example in their complexity molecular structure and weight. One major difference is that it is impossible to make exact copies – while with small molecule drugs one can make exact, generic copies. As a result, the “similar, but not identical” nature of biosimilars raises questions about the INN prescription of biological products. Even small distinctions in any step from the cell line stage through to administration may cause different immunogenic responses in patients. These responses can be very acute and require a very prudent approach under medical control.