madam president i am very pleased to have this opportunity to address parliament on this important issue of falsified medicines
the proposal before us today for an amending directive on falsified medicines will subject to parliament's approval take us into new territory
a successful conclusion of this file will mark the first time that the european union has tackled with legislation the specific threat of falsified pharmaceuticals
this text is going to make our regulatory system fit for the future making a major contribution to protecting patients from the many dangers of fake medicines
as members will know falsified medicines are different from counterfeit products
falsified medicines are about public health
i was very pleased that an early agreement on the substance of the proposal was reached between the colegislators just before christmas
let me thank all those who worked so hard to make this agreement possible especially the rapporteur of the lead committee ms matias as well as the rapporteurs of the committees giving opinions ms sartori and ms bastos
i would also like to thank all the shadow rapporteurs
the commission stands fully behind the substance of this well-balanced agreement which introduces rigid and effective measures whilst being risk proportionate and flexible
this is crucial as not all medicines are the same the likeliness of falsification varies as does the risk of public health
turning to some of the specific issues i would like to highlight the following
on safety features we saw the risk that member states might in future take divergent approaches on the packaging
this would have led to different levels of protection in the european union
it would have led to a fragmentation of the european union market for medicines
i am sure members will share my satisfaction that we have paved the way towards a european safety feature to identify and thus authenticate a medicine
the commission has always supported a european approach in this regard
on active pharmaceutical ingredients the agreed text strengthens inspections and international cooperation in this field
the commission and the network of european agencies will work more closely with international partners
only through such cooperation can we achieve a truly effective system of inspection and enforcement
the legislation once adopted will increase the transparency of actors involved in the distribution of medicines
finally parliament insisted on rules concerning online sales of medicines
i consider that parliament found a strong pragmatic solution by focusing on issues of transparency
the argument acknowledges that the rules for pharmacies in the eu vary but in future it will be easier for patients throughout the eu to distinguish legal operators from illegal online pharmacies
president members i trust i can count on your full support as regards the next step in the legislative process towards finalising this worthy and much needed initiative
