Rule of Law: European Commission takes new step to protect judges in Poland against political control
Brussels, 17 July 2019
Today, the European Commission decided to take the next step in an ongoing infringement procedure against Poland, by sending a reasoned opinion regarding the new disciplinary regime for Polish judges.
On 3 April 2019, the Commission launched this infringement procedure on the grounds that the new disciplinary regime undermines the judicial independence of Polish judges and does not ensure the necessary guarantees to protect judges from political control, as required by the Court of Justice of the EU.
Specifically, the Polish law allows ordinary court judges to be subjected to disciplinary investigations, procedures and sanctions on the basis of the content of their judicial decisions, including the exercise of their right under Article 267 of the Treaty on the Functioning of the European Union (TFEU) to request preliminary rulings from the European Court of Justice. Moreover, the new disciplinary regime does not guarantee the independence and impartiality of the Disciplinary Chamber of the Supreme Court, which is composed solely of judges selected by the National Council for the Judiciary, which is itself appointed by the Polish Parliament (Sejm). Furthermore, the new disciplinary regime does not ensure that a court ‘established by law' will decide in the first instance on disciplinary proceedings against ordinary court judges. Instead, it empowers the President of the Disciplinary Chamber to determine, on an ad-hoc basis and with an almost unfettered discretion, the disciplinary court of first instance to hear a given case. The new regime no longer guarantees that cases are processed within a reasonable timeframe, allowing judges to be permanently under the threat of pending cases, and it also affects judges' right of defence.
Poland had 2 months to respond to the arguments put forward by the Commission in its letter of formal notice. Following a thorough analysis of the response from the Polish authorities, the Commission concluded that the response does not alleviate the legal concerns. The Commission has, therefore, decided to move to the next stage of the infringement procedure.
The Polish authorities now have 2 months to take the necessary measures to comply with this reasoned opinion. If Poland does not take appropriate measures, the Commission may decide to refer the case to the Court of Justice of the EU.
The rule of law is one of the common values upon which the European Union is founded and common to all Member States. It is enshrined as such in Article 2 of the Treaty on European Union. The rule of law is essential for the functioning of the EU as a whole, for example with regard to the internal market, cooperation in the area of Justice and Home Affairs, and ensuring that national judges, who are also EU judges, can fulfil their role in ensuring the application of EU law and can properly interact with the Court of Justice of the EU in the context of preliminary ruling procedures. The Commission's Communications of 3 April and 17 July 2019 on the rule of law explain the existing toolbox for enforcing the rule of law and the Commission's actions and proposals to further strengthen that toolbox.
The European Commission, together with other Union institutions and the Member States, is responsible under the Treaties for guaranteeing the rule of law as a fundamental value of our Union and making sure that EU law, values and principles are respected.
Events in Poland led the European Commission to open a dialogue with the Polish Government in January 2016 under the Rule of Law Framework and then activate the Article 7(1) TEU procedure on 20 December 2017. The process is based on a continuous dialogue between the Commission and the Member State concerned. The Commission keeps the European Parliament and Council regularly informed.
In addition, on 2 July 2018, the Commission launched an infringement procedure on the Polish law on the Supreme Court, on the grounds of its retirement provisions and their impact on the independence of the Supreme Court. On 24 September 2018, the Commission decided to refer the case to the Court of Justice of the EU, which delivered its final judgement on 24 June 2019. The Court has found that lowering the retirement age of judges of the Supreme Court is contrary to EU law and breaches the principle of the irremovability of judges and thus that of judicial independence.
On 29 July 2017, the Commission launched an infringement procedure on the Polish Law on Ordinary Courts, on the grounds of its retirement provisions and their impact on the independence of the judiciary. The Commission decided to refer this case to the Court of Justice of the EU on 20 December 2017.
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Press Release – Rule of Law: European Commission launches infringement procedure to protect judges in Poland from political control
Strengthening the rule of law through increased awareness, an annual monitoring cycle and more effective enforcement
Brussels, 17 July 2019
Building on the lessons learnt since 2014 and detailed consultations since April this year, the Commission has today decided on a series of measures to further strengthen the rule of law in Europe. Over the past five years, the European Commission has had to deal with a series of challenges to the rule of law in the European Union. The European project relies on constant respect of the rule of law. This is a prerequisite for citizens to enjoy their rights under EU law and for mutual trust among Member States. A Eurobarometer public opinion survey released today shows that more than 80% of citizens attach great importance to respect of the rule of law, and feel that it needs to be improved. 89% of citizens support the need for the rule of law to be respected in all other EU Member States.
First Vice-President Frans Timmermans said today: “The European Court of Justice has recently reaffirmed that the rule of law is essential for the functioning of the EU. Its importance is also recognised by an overwhelming majority of EU citizens. However, it has come under attack in several ways in the past five years. The European Commission has been fighting hard to resist these attacks with the tools available to us, and will continue to do so. Today we have decided to further strengthen our toolbox, to promote, protect and enforce the rule of law."
The Commission is today setting out concrete initiatives grouped around 3 pillars: promoting a rule of law culture; preventing rule of law problems; and responding effectively to breaches of the rule of law. As guardian of the Treaties, the European Commission has a unique role. However, all Union institutions and Member States are responsible for guaranteeing the respect of the rule of law as a fundamental value of our Union. Beyond that, an effective response also requires the support of civil society. The Commission is also calling on all to act.
To promote a common rule of law culture across Europe, the Commission will follow up on the idea of a dedicated annual event for dialogue with civil society. It will make full use of funding possibilities to empower stakeholders, including civil society, to promote the rule of law, and set up a dedicated communication strategy on the rule of law. The Commission will strengthen cooperation with the Council of Europe and other international organisations, as well as with judicial networks and national parliaments. The Commission calls on the European Parliament, the Council and Member States to engage fully in this process.
To prevent rule of law problems from emerging, the Commission has decided to set up a Rule of Law Review Cycle, including an annual Rule of Law Report covering all EU Member States. This additional system will assist early detection of emerging rule of law problems wherever they appear. The Commission will deepen its monitoring of rule of law developments and invite all Member States to engage in a mutual exchange of information and dialogue, including through a network of national contact persons. There should be a dedicated follow-up on the annual report with the Parliament and the Council. The Commission will also further develop the EU Justice Scoreboard and strengthen the dialogue with other EU institutions, Member States, European political parties and stakeholders.
For an effective common response to rule of law breaches, the Commission will continue to make full use of its enforcement powers, if early detection and prevention measures are not effective. The Commission will adopt a strategic approach to infringement proceedings, bringing cases to the Court of Justice of the EU as necessary. In the light of the time sensitivity of such cases, the Commission will request interim measures and expedited procedures when needed. The Commission will also constructively support Member States in de-escalation and resolution of rule of law issues for the situation to be restored in a sustainable manner. In addition, the Commission calls on the European Parliament and the Council to reflect on a collective approach to managing Article 7 TEU cases with clear procedural rules.
The rule of law: a shared value for all Europeans
The results of a Eurobarometer public opinion survey released today show that citizens attach great importance to the respect of the rule of law:
More than 8 in 10 citizens say that effective judicial protection by independent courts, equality before the law and proper investigation and prosecution of corruption, are important to them.
More than 8 in 10 citizens say that the rule of law needs to be respected in all other Member States.
Over 80% of citizens in the EU support improvements regarding key rule of law principles.
A majority of citizens (56%) do not feel sufficiently informed about the rule of law situation.
The Eurobarometer also shows strong support for the role of media and civil society in holding those in power to account, with more than 8 in 10 citizens considering it important that media and civil society can operate freely and criticise the government without risk of intimidation.
In its Communication of 3 April 2019, the Commission presented an overview of the existing rule of law toolbox and launched a consultation on the necessary reforms. Over 60 written contributions were received and debates and discussion were held within the EU institutions, with Member States, international organisations, judicial networks, civil society and academia. Today's Communication takes into account this debate.
The European Union is based on a set of shared values, including fundamental rights, democracy, and the rule of law. These are the bedrock of our societies and common identity. No democracy can thrive without independent courts guaranteeing the protection of fundamental rights and civil liberties, or without an active civil society and free media ensuring pluralism.
The rule of law has a direct impact on the life of every citizen: it is a precondition for ensuring equal treatment before the law and the defence of individual rights, for preventing abuse of power by public authorities and for decision-makers to be held accountable. The rule of law determines how accountably laws are set, how fairly they are applied, and how effectively they work. It also covers institutional issues such as independent and impartial courts, and the separation of powers.
Online fraud exceeding €3 million halted in Ireland and Finland
18 July 2019
An organised crime group involved in extended online fraud and money laundering in several European countries was targeted by the Irish and Finish national authorities with Eurojust’s support. A coordinated investigative and prosecutorial strategy was agreed at Eurojust, which enabled the speedy execution of mutual legal assistance requests between the countries concerned to advance their investigations, as well as the collection and exchange of evidence to ensure solid prosecution. 3 suspects were convicted in Finland for aggravated money laundering and forgery, with sentences of between 1 year and 2 years and 3 months. Another 9 suspects were arrested in Ireland. Five people were charged, one of whom pleaded guilty. The remaining four were remanded in custody pending trial. The estimated amount of the illegal proceeds laundered by the criminal group exceeds €3 million.
The members of the organised crime group (OCG) used fabricated online platforms to offer to unknowing customers non-existent goods, including luxury cars, tractors, expensive jewellery and watches, or services, such as accommodation. To receive the online payments from the victims, the criminals created numerous bank accounts in Ireland and Finland, using forged documentation, inter alia identity cards, passports, working permits, rental contracts and utility bills. When the transactions were concluded, the suspects transferred the payments to other bank accounts and withdrew the money from cashpoints in various European countries.
Following several searches by the Garda Síochána (Ireland’s National Police Service) and the Finnish Border Guard and Police in both countries, a large number of items were seized, including fake documentation, equipment for document forgery, laptops and cash. Europol assisted the national authorities in the cross-checking of data and identification of the victims of the fraud.
The OCG members are suspected of participation in a criminal organisation, fraud, money laundering, forgery of documents and registration offences. The national investigations are ongoing.
EU–Canada Summit: strengthening the rules-based international order
Montreal, 18 July 2019
At the 17th Summit between the European Union and Canada held today in Montreal, the EU and Canada reaffirmed their determination to jointly address global challenges in a manner that strengthens the rules based international order, benefits citizens, and protects the planet by delivering on climate change and ocean commitments. Leaders expressed their resolve for rapid and concerted action to address the challenges facing the multilateral trading system.
“The EU and Canada believe that global issues require multilateral solutions. Together we are sending a clear message that international cooperation is beneficial to all,” said the European Commissioner for Trade, Cecilia Malmström. “Nowhere is this more apparent than in our trade relationship. Almost two years after it entered into force, CETA is providing concrete proof of the mutual benefits of open trade. Exports on both sides are up, and our businesses and citizens are already seeing the benefits.”
The European Union was represented by the President of the European Council, Donald Tusk, with the participation of Trade Commissioner CeciliaMalmström. Canada was represented by its Prime Minister, Justin Trudeau.
Three years after the signature of the Comprehensive Economic and Trade Agreement (CETA) and the Strategic Partnership Agreement (SPA) the EU and Canada emphasised the progress they have made since.
Thanks to the EU-Canada trade agreement, which is under provisional application since September 2017, the EU-Canada trade relations keep becoming stronger. EU exports to Canada increased overall by 15% in 2018 compared to the previous 3-year average, strengthening even more the EU's positive trade balance. Most significant export growth has been registered in particular for industrial products such as combustion engines (over 100%), tramway locomotives and parts (+87%) furniture (+21%) and perfumes and cosmetics (+14%). The same trends were registered for several agricultural products, including citrus fruit (+78%), cheese (+33%), pasta (+16%), wine (+10%) and chocolate (+9%).
The Strategic Partnership Agreement (SPA) led to a further strengthening of political dialogue and cooperation between the European Union and Canada across a wide range of areas, from tackling climate change and innovation to working together in the fields of development cooperation and consular protection. The EU and Canada agreed to advance bilateral cooperation digital policy focussing on artificial intelligence, quantum computing and protecting democratic values in a digital world.
At the summit, the European Union and Canada signed an ocean partnership agreement. Ocean governance is a shared challenge and responsibility, and only international cooperation can ensure the conservation and sustainable use of oceans, their resources and ecosystems. The agreement includes clear commitments to combatting the negative effects of illegal, unreported and unregulated fisheries, marine pollution and climate change. It will also help to facilitate the sustainable development of marine and maritime sectors and the implementation of the 2030 Agenda for Sustainable Development.
Both sides also welcomed the conclusion of the negotiations on a new EU-Canada Passenger Names Record (PNR) agreement, pending its finalisation. They acknowledged the vital role of this agreement in enhancing security while ensuring privacy and the protection of personal data.
The leaders agreed to advance consultation and coordination on foreign policy issues. The Joint Statement demonstrates the European Union and Canada's consistent and firm collaboration regarding, among other examples, Ukraine, Iran, China, Syria and Venezuela. The EU and Canada will expand practical cooperation to support democracy based on a new arrangement that will facilitate Canada's participation in EU Election Observation Missions.
The Summit took stock of the successful cooperation between EU and Canada in the framework of the EU's Common Security and Defence Policy and welcomed Canadian deployments to EU civilian missions in Ukraine (EUAM Ukraine), the West Bank (EUPOL COPPS), Mali (EUCAP Sahel Mali) and Iraq (EUAM Iraq).
Commission opens investigation into possible anti-competitive conduct of Amazon
The European Commission has opened a formal antitrust investigation to assess whether Amazon's use of sensitive data from independent retailers who sell on its marketplace is in breach of EU competition rules.
Commissioner Margrethe Vestager, in charge of competition policy, said: "European consumers are increasingly shopping online. E-commerce has boosted retail competition and brought more choice and better prices. We need to ensure that large online platforms don't eliminate these benefits through anti-competitive behaviour. I have therefore decided to take a very close look at Amazon's business practices and its dual role as marketplace and retailer, to assess its compliance with EU competition rules.”
Amazon has a dual role as a platform: (i) it sells products on its website as a retailer; and (ii) it provides a marketplace where independent sellers can sell products directly to consumers.
When providing a marketplace for independent sellers, Amazon continuously collects data about the activity on its platform. Based on the Commission's preliminary fact-finding, Amazon appears to use competitively sensitive information – about marketplace sellers, their products and transactions on the marketplace.
As part of its in-depth investigation the Commission will look into:
the standard agreements between Amazon and marketplace sellers, which allow Amazon's retail business to analyse and use third party seller data. In particular, the Commission will focus on whether and how the use of accumulated marketplace seller data by Amazon as a retailer affects competition.
the role of data in the selection of the winners of the “Buy Box” andthe impact of Amazon's potential use of competitively sensitive marketplace seller information on that selection. The “Buy Box” is displayed prominently on Amazon and allows customers to add items from a specific retailer directly into their shopping carts. Winning the “Buy Box” seems key for marketplace sellers as a vast majority of transactions are done through it.
If proven, the practices under investigation may breach EU competition rules on anticompetitive agreements between companies (Article 101 of the Treaty on the Functioning of the European Union (TFEU)) and/or on the abuse of a dominant position (Articles 102 TFEU).
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.
Article 101 of the TFEU prohibits anticompetitive agreements and decisions of associations of undertakings that prevent, restrict or distort competition within the EU's Single Market. Article 102 of the TFEU prohibits the abuse of a dominant position. The implementation of these provisions is defined in the Antitrust Regulation (Council Regulation No 1/2003), which can also be applied by the national competition authorities.
Article 11(6) of the Antitrust Regulation provides that the opening of proceedings by the Commission relieves the competition authorities of the Member States of their competence to apply EU competition rules to the practices concerned. Article 16(1) further provides that national courts must avoid adopting decisions that would conflict with a decision contemplated by the Commission in proceedings it has initiated.
The Commission has informed Amazon and the competition authorities of the Member States that it has opened proceedings in this case.
There is no legal deadline for bringing an antitrust investigation to an end. The duration of an antitrust investigation depends on a number of factors, including the complexity of the case, the extent to which the undertakings concerned cooperate with the Commission and the exercise of the rights of defence.
Guidance on bees and pesticides: work plan published
EFSA has outlined how it plans to review its guidance on the risk assessment of pesticides and bees in the EU. As the outline shows, stakeholders and pesticide experts from Member States will be consulted regularly throughout the process.
The first consultation begins later this month, when stakeholders and Member State representatives will be asked for their views on the current guidance document.
Stakeholder feedback will be provided by a consultation group, comprising representatives of EFSA’s different stakeholder communities, that has been set up to support the revision of the guidance. Member States will be consulted through EFSA’s existing Pesticides Steering Network.
2019 EU budget: Council adopts contingency measures for a no-deal Brexit
The Council today adopted contingency measures on the implementation and financing of the 2019 EU budget in the event of a no-deal Brexit.
The aim of the measures is to mitigate the impact of a no-deal scenario for funding in a wide range of areas such as research and agriculture.
They will enable the EU to continue making payments to UK beneficiaries for contracts signed and decisions made before the withdrawal date, as long as the UK continues paying its contribution agreed in the EU budget for 2019.
The European Parliament gave its consent to this contingency framework on 17 April 2019.
A no-deal scenario does not affect the basic principle that the EU27 and the UK should honour the financial commitments they have both made together. The measures agreed today will help ensure this. They will benefit UK individuals and entities, and avoid possible disruptions to other beneficiaries of EU funding.
Mika Lintilä, Minister for Finance of Finland, which currently holds the Council presidency
Under the agreed contingency framework, the UK would have to confirm in writing that it will contribute to the financing of the 2019 EU budget as adopted. It would also have to accept the necessary controls and audits for the EU programmes and actions, and make the first payment to the EU budget for the period after its withdrawal. Only if these conditions are met would the eligibility for financing by the EU budget in 2019 of the UK and UK-entities be maintained.
As the UK makes its contribution for the entire year of 2019, the UK and UK entities would also be eligible in 2019 for the purposes of conditions set in any calls, tenders, contests or other procedures which may lead to financing from the EU budget, except in specific cases related to security and to the loss of the UK's membership of the European Investment Bank.
In addition, the contingency measures would allow for the continued financing of beneficiaries in EU member states where their eligibility depends on the UK's membership of the EU, provided that the relevant legal contracts and decisions have been signed or adopted before the UK's withdrawal.
This contingency framework would cease to apply if the UK discontinues the payments or where significant deficiencies have been observed in the execution of the controls and audits.
It is without prejudice to an agreement to be negotiated in a no-deal scenario on a financial settlement between the EU and the UK, which would have to cover the entirety of mutual obligations resulting from the UK's EU membership.
The measures agreed today are intended to keep the relative shares of the EU27 member states in financing the 2019 EU budget unaffected.
Since the UK notified its intention to withdraw from the EU, the EU has consistently stated that both the EU and the UK should respect the financial obligations resulting from the whole period of the UK's membership in the EU. This principle was recalled in the European Council (Article 50) guidelines of 29 April 2017 for the Brexit negotiations and reflected in the draft withdrawal agreement agreed by the 27 member states and the UK government in November 2018. The absence of a withdrawal agreement at the withdrawal date would not affect that guiding principle.
Pimping and money laundering network dismantled with Eurojust’s support
Eurojust actively supported the national authorities of 15 countries in taking down an organised crime group (OCG) involved in pimping and money laundering. Eurojust swiftly set up a joint investigation team (JIT) with Spain, Finland and Sweden to speed up the criminal investigations into the OCG. 11 EU Member States and 4 third countries participated in a joint action, coordinated by Eurojust, which resulted in the arrest of the main suspects of the OCG in Malta, Romania and Finland. Almost €0.5 million in cash, as well as equipment, illegal assets, such as luxury items, false documentation, and cryptocurrencies were seized, and several web domains were confiscated. Companies’ shares and bank accounts worth €1.5 million were frozen and 17 house searches were carried out.
Criminal activities of the OCG
In April 2016, the Spanish authorities initiated an investigation into an OCG, suspected of money laundering of illegal proceeds, which were obtained through aggravated pimping in Nordic countries. Due to the cross-border dimension of the investigation, a Eurojust case was opened in 2016, which targeted the Finnish leader of the OCG. From his base in Marbella, Spain, the alleged main suspect managed websites advertising sexual services offered by women of predominantly Nigerian origin, who worked as prostitutes in Finland and Sweden. A number of similar OCGs in various countries used those websites to also profit from advertising their victims’ services.
The OCG leader owned several companies and bank accounts and performed his illicit activities in more than 15 countries. Some companies were registered abroad to disguise the criminal activities. The illegally obtained assets were channeled through intermediaries to international bank accounts and multi-currency IBAN accounts for the purpose of money laundering. The OCG also invested its criminal proceeds in cryptocurrency.
Eurojust’s crucial role
During the joint action day, Eurojust set up a coordination centre at its premises in The Hague to coordinate simultaneous operations in 15 countries, allowing for real-time exchange of information. Eurojust enabled the quick issuance of several European Investigation Orders towards Bulgaria, Germany, Estonia, Malta, the Netherlands, Romania and the UK. Eurojust also assisted in swiftly submitting mutual legal assistance (MLA) requests to the USA, Russia, Hong Kong, Panama and Colombia.
Through the JIT, Eurojust financed the deployment of 9 Spanish police officers to Malta, Romania and Finland. Europol supported the joint operations by deploying mobile offices in Spain, Malta and Finland and by participating in the coordination centre set up at Eurojust.
Eurojust’s involvement was instrumental in coordinating the actions of all countries in this multinational case. The setting up of a JIT allowed for swift evidence gathering and information sharing. Eurojust assisted in overcoming legal obstacles by advising on a jurisdictional issue and reaching an agreement on the best place to prosecute. In this way, Eurojust helped to bring the prosecution against the main suspects in Spain. Without Eurojust in the lead, the success of the criminal investigation and the joint operation, as well as the immediate judicial follow-up to the case, would have been impossible.
The Judge of the Investigative Court n. 4 in Torrevieja, Spain, the Anti-Trafficking in Human Beings Brigade n. IX of the Spanish National Police, the Central Unit against Illegal Immigration Networks (Unidad Central de Redes de Inmigración Ilegal y Falsedades Documentales — UCRIF CENTRAL) and the Anti-Money Laundering Brigade of the Provincial Squad of the Judicial Police in Alicante (Brigada Provincial de Policía Judicial de Alicante — BPPJ de Alicante) were the Spanish authorities involved in the national and joint investigations in the context of the JIT, as well as the joint action day. The actions were also supported by 9 Spanish local police units and law enforcement authorities from 15 countries.
Arrests: 3 European Arrest Warrants executed
House searches: 6 in Spain, 2 in Malta, 3 in Romania, 4 in Finland, 2 in Hong Kong
Seizures: Almost €0.5 million in cash, computers, tablets, mobile phones and other encrypted devices, 9 luxury vehicles, expensive jewellery and watches, documentation from tax havens, documentation on companies and bank accounts, contracts and falsified passports
Confiscations: 16 web domains in the USA
Freezings: Bank accounts opened and shares in 6 companies based in Bulgaria, Estonia, Spain Romania, Finland, Sweden and Hong Kong
EU-U.S. trade talks: milestone reached in mutual recognition on pharmaceuticals
Brussels, 11 July 2019
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.
In 1998, the EU and the U.S. signed a broad Mutual Recognition Agreement, which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other's Good Manufacturing Practices (GMP) inspections.
2017 marked the entry into operation of the agreement between the EU and the U.S. to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement strengthens reliance upon each other's inspection expertise and resources. Initially it applied between the U.S. Food and Drug Administration and those EU Member States that the U.S. Food and Drug Administration had assessed. This has been gradually extended to all EU countries and now the regulatory authorities in all 28 EU Member States were recognised by the U.S. Food and Drug Administration. Meanwhile, the EU made the same determination about U.S. Food and Drug Administration in June 2017.
Airbnb brings its practices in line with EU consumer law
The European Commission announced today that, as a result of negotiations with Airbnb, the platform has improved and fully clarified the way it presents accommodation offers to consumers, which is now in line with the standards set in EU consumer law. This follows the call from the European Commission and EU consumer authorities in July 2018.
Věra Jourová, Commissioner for Justice, Consumers and Gender Equality said: “For these summer holidays, Europeans will simply get what they see when they book their holidays. Comparing and booking online hotel or accommodation has made it fast and easy for consumers. Now consumers can also trust that the price they see on the first page will be the price to pay in the end. I am very satisfied that Airbnb stood ready to cooperate with the European Commission and national consumer protection authorities to improve the way its platform works. I expect other platforms to follow suit.”
Airbnb addressed all the demands made by theEuropean Commission and national consumer protection authorities, led by the Norwegian Consumer Authority, to bring their practices and terms fully in line with EU consumer rules.
The main improvements and changes are as follows:
In accommodation searches with selected dates, users see the total price in the results page, including all the applicable mandatory charges and fees (such as service, cleaning charges and local taxes). There are now no surprise mandatory fees appearing on later pages;
Airbnb clearly distinguishes if an accommodation offer is put on the market by a private host or a professional;
Airbnb provides an easily accessible link to the Online Dispute Resolution platform on its website and all the necessary information related to dispute resolution.
Airbnb also revised its terms of service in which it:
makes clear that users can bring a case against Airbnb before the courts of their country of residence;
respects users' basic legal rights to sue a host in case of personal harm or other damages;
commits not to unilaterally change the terms and conditionswithout clearly informing users in advance and without giving them the possibility to cancel the contract.
The Consumer Protection Cooperation Network carried out a joint assessment of Airbnb's practices and terms of service, under the facilitation of the European Commission and the lead of the Norwegian Consumer Authority (Forbrukertilsynet). The action was launched in July 2018
The EU Consumer Protection Cooperation Regulation links national consumer authorities in a pan-European enforcement network. On that basis, a national authority in one EU country can request the assistance of other authorities in another EU country to stop a cross-border infringement of EU consumer law.