mr president let me first thank linda mcavan for the incredible intelligence with which she has tackled this very technical dossier as well as the shadow rapporteurs the commission and the council for the fruitful cooperation which has been crucial in reaching this first reading agreement paving the way towards a safer more efficient and more transparent pharmacovigilance system in europe
as shadow rapporteur for the alde group i very much welcome this agreement concluded under the spanish presidency and the fact that parliament's position remains firmly included in the final text
one may say that we are dealing today with a less exciting dossier within the pharma package but pharmacovigilance is actually crucial in ensuring observance of some of the key principles which have guided the alde position towards patients trust in pharmaceutical treatments
the development and smooth functioning of eudravigilance collecting adverse drug reactions at the larger european scale as well as the better coordination with national authorities and pharmaceutical companies are major steps towards making sure risks relating to the use of medicinal products are duly assessed in a timely manner
patient safety will also be reinforced with the possibility for authorities to request efficacy studies after a product has been authorised on the market
for the first time here we will be able to use health technology assessment in order to avoid putting patients lives at risk
transparency has been one of parliament's guiding principles during the negotiations
while avoiding any misuse of the information available more transparent communication about pharmacovigilance activities will enhance patients trust in their treatment as well in the authorities that guarantee their safety
to conclude the changes made to the pharmacovigilance system in europe should be a tool to reinforce european citizens confidence and understanding of the medicines they are taking
in this regard i very much welcome the call for a broader and complete review of the patient information leaflet
we have a public health responsibility to guarantee the highest level of safety efficiency and transparency in the future european pharmacovigilance system to be implemented
