Today, the European Union and the United States delivered on a significant element of the Joint Statement agreed by Presidents Juncker and Trump in July 2018. The positive transatlantic trade agenda established in the Joint Statement includes a commitment from both sides to reduce barriers and increase trade in a range of sectors, including pharmaceuticals.
The recognition today by the U.S. Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, marks the full implementation of the EU-U.S. Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for human medicines in their respective territories. This can make it faster and less costly for both sides to bring medicines to the market.
Commissioner Vytenis Andriukaitis, in charge of Health and Food Safety said: “The completion of the Mutual Recognition Agreement is not only a step forward in the trade relations between the EU and the U.S., but it will also ensure high quality medicines for the benefit of patients. It means that, on both sides of the Atlantic, the authorities in charge of medicines can now rely on inspections results to replace their own inspections. Today, the U.S. Food and Drug Administration has completed the capability assessments of the 28 EU competent authorities, the result of five years of close transatlantic cooperation”.
This Mutual Recognition Agreement is underpinned by robust evidence that the EU and the U.S. have comparable procedures to carry out good manufacturing practice inspections for human medicines.
Together, Europe and the United States account for more than 80% of global sales of new medicines. As a result of the full implementation of this agreement, both the industry and public authorities on both sides will be able to free resources that could be used to inspect facilities in other large producing countries.
The pharmaceutical industry is a strategic sector in which EU-U.S. regulatory cooperation is much more advanced than in most other sectors. Since May 2014, teams from the European Commission, EU national competent authorities, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration have been auditing and assessing the respective supervisory systems. The U.S. Food and Drug Administration has now assessed positively all national competent authorities of the EU.
From now on, the batch testing waiver will also start to apply. This means that the qualified persons in the EU pharmaceutical company will be relieved of their task for carrying out the quality controls when carried out already in the United States.
The Mutual Recognition Agreement implementation work will continue with view to expanding the operational scope to veterinary medicines, human vaccines and plasma derived medicinal products.
State aid: Commission approves over €22 million of public support to promote rail transport operability in the Netherlands
The European Commission has approved, under EU State aid rules, €22.2 million of public support to upgradetraffic management equipment on freight locomotives in the Netherlands. The scheme will contribute to making railway systems more interoperable in the EU without unduly distorting competition.
Commissioner Margrethe Vestager, in charge of competition policy said: “The Dutch scheme will contribute to the deployment of the European Rail Traffic Management System and to the creation of a Single European Railway Area. It will improve the competitiveness of European railways and foster the shift of freight traffic from road to rail, in line with the EU’s environmental and transport objectives, without unduly distorting competition.”
In October 2019, the Netherlands notified the Commission of their plans to support the upgrade of 99 cross-border freight locomotives with the newest European Rail Traffic Management System (ERTMS) on-board equipment. ERTMS is a safety system that ensures the compliance by trains with speed restrictions and signalling status. This system is expected to enable the creation of a seamless European railway system, and increase the safety and competitiveness of the European rail sector.
The EU Implementing Regulation on the ERTMS European deployment plan requires that about 30% – 40% of the so-called European Core Network Corridors should be equipped with ERTMS by 2023. To meet these requirements, the Netherlands plans to deploy the latest version of ERTMS on a large share of its core national railway network, which is part of the European Core Network Corridors. Consequently, the owners of the locomotives, who invested in the retrofitting of their freight locomotives with former versions of the ERTMS on-board equipment in the past, will now need to upgrade the existing equipment to ensure interoperability with the latest version of the ERTMS and will have to face significant costs.
The public support will take the form of direct grants to the owners of the locomotives, to be used for the prototyping and serial upgrades of the equipment. The public support by the Dutch state will be complemented by grants for a total of €23.8 million financed through the Connecting Europe Facility.
The Commission’s assessment
The Commission assessed the scheme under EU State aid rules, in particular the 2008 Commission Guidelines on State aid for railway undertakings and found that:
- The Dutch scheme is beneficial for the environment and for mobility as it supports rail transport, which is less polluting than road transport, while also decreasing road congestion.
- The measure is proportionate and necessary to achieve the intended objectives, i.e. the promotion of interoperability of railway systems in the EU and supports the shift of freight transport from road to rail.
- The Dutch public funding has an “incentive effect”, as railway vehicle owners would not perform the necessary upgrade of the ERTMS equipment of their freight locomotives absent the public support.
On this basis, the Commission concluded that the measure is in line with EU State aid rules.
Antitrust: Commission opens investigation into possible collusion by two French retailers in a purchasing alliance
The European Commission has opened a formal antitrust investigation to assess whether two French groups of retailers, Casino Guichard-Perrachon (known as ‘Casino’) and Les Mousquetaires (known as ‘Intermarché’), have coordinated their conduct in the market, in breach of EU competition rules.
Commissioner Margrethe Vestager, in charge of competition policy, said “Buying alliances between retailers have become a key component of grocery supply chains. They can bring lower prices to consumers for food and personal care brands that they purchase on a daily basis. Such benefits can however disappear quickly if retailers use these alliances to collude on their sales activities. The Commission will therefore investigate if Casino and Intermarché have coordinated their activities in an anticompetitive way.”
Casino and Intermarché are two of the largest chains of groceries retail shops active in France. In November 2014, they set up a joint venture for the joint procurement alliance of their branded products, INCA.
The Commission is concerned that Casino and Intermarché went beyond the purpose of their alliance and engaged in an anticompetitive conduct. In particular, the Commission will investigate whether Casino and Intermarché coordinated their activities on the development of their shop networks and their pricing policy towards consumers.
If proven, this coordination may breach EU competition rules on anticompetitive agreements between companies (Article 101 of the Treaty on the Functioning of the European Union).
The Commission will now carry out its in-depth investigation as a matter of priority. The opening of a formal investigation does not prejudge its outcome.
Speech by President Juncker in the Plenary of the European Parliament at the debate on the conclusions of the European Council meeting of 17 and 18 October 2019
Mille grazie Signor Presidente,
Mr President of the European Council,
It was an emotional moment for me last week when I attended my last European Council together with my good friend Donald. We are today debating the 147th European Council of my political career. And it is today the 105th time that I speak to you in this Plenary, the beating heart of European democracy.
In many of these 105 debates, I had to discuss the UK’s departure from the European Union with you. In truth, it has pained me to spend so much of this mandate dealing with Brexit, when I have thought of nothing less than how this Union could do better for its citizens – a waste of time and a waste of energy.
The Commission has worked tirelessly to negotiate and renegotiate an agreement with the United Kingdom, to respect the UK’s decision to leave the European Union. We now have a new agreement, which – again – creates the legal certainty for an orderly withdrawal of the UK from the European Union.
It took a huge amount of work to arrive at this point. I listened to Prime Minister Johnson in the same way as I listened to Prime Minister May. Our negotiators – mainly Michel Barnier – have once again worked around the clock. And once again, they have shown creativity and determination.
The agreement we reached with the United Kingdom’s government addresses this Parliament’s demands – all Parliaments’ demands.
I will always regret the United Kingdom’s decision to leave the Union. But at least we can look ourselves in the eye and say that we have done all in our power to make sure that this departure is orderly.
In this same spirit, we have done everything in our power to prepare the European Union for all eventualities, irrespective of what is happening on the other side of the Channel.
We need now to watch events in Westminster very closely. But it is not possible, not imaginable that this Parliament would ratify the agreement before Westminster will have ratified the agreement – first London, then Brussels and Strasbourg.
Wir haben uns, Herr Präsident, auch ausführlich mit dem Finanziellen Rahmen für die nächste 7-Jahres-Periode anlässlich des Europäischen Rates beschäftigt. Ich möchte hier noch einmal zu Protokoll geben, dass ich der Auffassung bin, dass die Zeit abläuft, die gebraucht werden wird, um zu einer Einigung im Rat und später anderswo zu kommen. Wenn wir weiter Zeit verlieren, werden wir in finanzielle Engpässe in den ersten zwei Jahren des Finanziellen Rahmens kommen.
Wichtig ist aber, dass Mitgliedstaaten und andere Akteure wissen, welcher Finanzrahmen für die nächste 7-Jahres-Periode gilt. Das brauchen junge Erasmus-Studenten, das brauchen Forscher, das brauchen viele andere und wir haben eigentlich nicht das Recht, diese wichtigen Partner für das Gelingen des Europäischen Projektes vor den Kopf zu stoßen – nur, weil wir unfähig sind, uns zu einigen.
Aber ich möchte ganz klar sagen: Das von der Kommission vorgeschlagene Haushaltsvolumen ist ein Minimum – ein Minimum! Und die Vorschläge, die jetzt auf dem Tisch liegen, auch die jüngsten Vorschläge des finnischen Ratsvorsitzes, sind nicht akzeptabel. Man kann Europa und seine Zukunft nicht mit 1% des Bruttosozialproduktes gestalten, dies wird nicht möglich sein.
Et puis, Monsieur le Président, nous avons parlé de l’élargissement. Je suis très déçu de la décision ou de la non-décision du Conseil européen. La Macédoine du Nord et l’Albanie étaient en droit d’attendre qu’on ouvre les négociations avec ces pays-là, qui ont fait de grands efforts. C’est une lourde erreur de ne pas avoir ouvert les négociations avec ces deux pays.
C’est une lourde erreur parce qu’elle frappe deux pays. Au cœur, c’est une lourde erreur parce que si l’Union européenne donne l’impression de faire des promesses et de ne pas les respecter, personne ne nous respectera à travers le monde.
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