Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance

9.6.2017

Question for written answer E-003872-17
to the Commission
Rule 130
José Inácio Faria (PPE)

Parliament’s resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance incorporates a number of significant amendments.

These are reflected in the following paragraphs: ‘Urges the Member States to implement or develop the following measures: […] ensure that medical professionals inform patients when a medicine is used off-label and provide patients with information on the potential risks in order to enable them to give informed consent; […] Calls on Member States to investigate possible malpractice involved in the refurbishment and re-use of medical devices originally designed and labelled for single use; […] Calls on the European Medicines Agency (EMA) to develop guidelines on the off-label/unlicensed use of medicines based on medical need, as well as to compile a list of off-label medicines in use despite licensed alternatives; […] Calls on the Commission and the Member States to promote the introduction of the European logo provided for by Implementing Regulation (EU) No 699/2014 in order to identify clearly online pharmacies which offer medicines for sale to the public remotely while safeguarding consumers against the purchase of fake medicines, which are often a health hazard […]’.

Can the Commission say what progress has been made in addressing these important amendments?