On the eve of voting on its negotiating position on the draft revision of the European Medicines Agency’s mandate, the European Parliament held a final debate on the subject on Wednesday 7 July in the presence of Commissioner for Health Stella Kyriakides. The latter welcomed the fact that the amendments tabled by the Parliament “maintain the level of ambition” of the initial proposal. However, she called for some of them to be “reconsidered”.
In particular, one of the main innovations that the rapporteur, Nicolás González Casares (S&D, Spain), would have liked to introduce is the creation of a European database on the supply of medicines (see EUROPE 12752/15).
According to Ms Kyriakides, this proposal “goes far beyond the scope of the proposal and would result in substantial additional obligations and costs”.
“Instead, we need to maximise synergies with existing national systems so that our efforts are as effective and efficient as possible”, she insisted.
A position shared by Cristian-Silviu Buşoi, shadow rapporteur on the dossier for the EPP: the creation of such a database would be a “very useful” additional measure to help deal with shortages of medicines, he acknowledged, although he in turn regretted that it was outside the scope of the initial proposal.
“A common central repository based on standardised data could be the first step in monitoring shortages”, the MEP suggested in his speech.
Amendments to this effect, drafted by Mr Buşoi, were put to the vote in plenary on Wednesday evening. They propose that the European Medicines Agency should maintain and manage such a register in collaboration with the European Commission and the Member States.
The latter would operate “on the basis of a common set of data from national electronic systems” and would be limited to “prescription-only medicines and the list of critical medicines, especially during public health emergencies”, Mr Buşoi suggests. However, the outcome of the vote on these amendments was not yet known at press time.
The Commissioner, alone this time, expressed concerns about a second point: the postponement by one year, suggested by the Parliament, of the implementation of the future steering group on medical device shortages - a group which should therefore be created within the Agency.
Postponing these rules would also “risk deferring the enhanced level of protection for citizens”, Ms Kyriakides said.
The Parliament will therefore adopt its negotiating position on Thursday 8 July, which will then pave the way for interinstitutional discussions on the final text, as the EU Council adopted its position on the text last month (see EUROPE 12741/7). (Original version in French by Agathe Cherki)