EuropaBio believes tendering is an inappropriate process for selecting and reimbursing biological medicines. This is due to the fact that whilst biosimilars are similar, they are not identical. Significant differences exist between any two biologic medicines, also between biosimilars and the originator biologic that the medicine ‘copies’, which in turn demands certain precautions:
• One size does NOT suit all – Exclusionary population-based procurement may result in wholesale switching of a patient population from one biologic treatment to a different biologic provided by the winning tender
• Patient safety and treatment efficacy – Due to the specific nature of biotech products, the decision to switch a patient to a new product should only be taken by the prescribing doctor and not be based on the results of a tendering process. This is particularly the case for a patient stabilised on a long-term treatment. If a change of treatment is made, the patient must be fully informed.
• Investing in innovation - It is important that procurement practises keep up with the emerging reality of personalised medicine and do not stifle innovation - by purchasing non-identical biotech medicines via a single tender (e.g. off patent biosimilars, newer patented innovations, etc), authorities run the risk that further investment in innovation of biotech medicines will be dramatically reduced.
Vaccines are designed to protect populations from disease, not to treat individual patients. Tenders might therefore be an acceptable purchasing mechanism for vaccines.