EuropaBio position on the proposal for the directive on the application of patients' rights in cross-border healthcare

06.03.2009
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. 

• The current INN system, whereby drugs with the same molecular structure (irrespective of their production processes) are given the same name, could easily lead to inadvertent substitution without the prescribing clinician being aware. It might therefore have clinical consequences and jeopardize patient safety and health outcomes. Therefore, inadvertent substitutions as abetted by amendments calling for  compulsory INN prescription pose a potential risk to the patients’ health, and interfere with the  freedom of prescription of physicians.
 
As a result, EuropaBio urges the honourable MEP to vote against amendments 630, 631 and 633, or support the inclusion of an exception clause for biological products