Summary

This week was the last plenary session of this Parliament. The Parliament finalized most of its pending initiatives before the elections in May.

We highlight some of these files below.

On Tuesday, April 16, the Members of the European Parliament (“MEPs”) debated a report on a proposal for a Regulation amending Regulation No. 469/2009 concerning the supplementary protection certificates (“SPC”) for medicinal products. The proposed Regulation is intended to benefit EU producers of generic medicine and biosimilar products, and increase access to high quality and affordable medicines in the EU. The proposed Regulation would introduce an exception by which EU-based manufacturers of generics and biosimilars may manufacture a generic or biosimilar version of an SPC-protected medicine during the term of validity of the SPC, provided that this is done solely for the purpose of export to a non-EU market where intellectual property protection has expired or never existed. See the draft report here and the proposed Regulation here.

On Wednesday, April 17, the Parliament adopted its position at first reading on the proposed Regulation on Transparency and Sustainability of the EU Risk Assessment in the Food Chain. The Regulation amends the General Food Law Regulation as well as eight legislative acts focused on specific sectors of the food chain. Among other things, the Regulation calls for ensuring more transparency by providing citizens with access to studies and information that industries submit in the risk assessment process. It would also bolster the role of the European Food Safety Authority (“EFSA”). Member States will be required to nominate a number of experts to the EFSA Scientific Panels. The Authority will also be notified of all studies commissioned so that it can ensure that companies submit all relevant information. The Council of the EU still needs to agree the position for the Regulation to become law. See the Parliament’s position at first reading here.

On the same day, the Parliament also adopted its position at first reading on a proposal for a Directive on Better Enforcement and Modernisation of EU Consumer Protection Rules. The proposed Directive amends four Directives dealing with the protection of the economic interests of consumers. Among other things, it bans ‘dual quality’ products, i.e., the marketing of a product as being identical in different Member States, where those products have different characteristics or composition. The Council of the EU will also have to agree its stance on the proposal. See the Parliament’s position here.

As the Parliament will now enter into recess, your Week in the European Parliament will return in July 2019.

Meetings and Agenda

  • No meetings scheduled before July 2019.