Mediaboss Marketing

-Analysis-

PARIS Is the longest European summit in history also historic? The answer is yes.

Indeed, the European Union is now a state. Not a so-called superstate replacing the 27 member states that make it up, but a state that includes them. We could say that the EU is now 28 states: the 27 separately plus the 27 together as one. Finally, the European state represents Alexandre Dumas' famous saying from The Three Musketeers: "One for all, all for one." The novelty that allows us to recognize Europe as a state comes from the fact that the EU will issue treasury bonds to finance a brand new part of its budget, which it calls the "recovery plan," amounting to 750 billion euros.

This historic development of issuing European debt corresponds to a social demand with weak signals that have existed for several years. Even though European power and its leaders are the subject of mistrust as national powers and leaders have also been for the past 15 years Eurobarometer surveys indicate that Europeans want a European solution to the economic and geopolitical challenges that threaten us. And while the euro is the subject of permanent and legitimate debate, Europeans are now particularly attached to their common currency: In just 20 years, the euro has won the confidence of citizens and investors large and small and has established itself as the world's second reserve currency. In fact, the national recovery plans adopted in response to COVID-19, the colossal sum of which amounts to 2.3 trillion euros, are only possible because of the guarantee of the European Central Bank and its worldwide credibility.

The advent of the European state is part of the evolution of the state in Europe. This history is often reduced to the rise of European nation-states following the French Revolution. However, this story spans more than 10 centuries. It includes many forms of statehood, and a plurality of states, each with its own singularity, as specific and different as, for example, the Holy Roman Empire, the Republic of Venice, the Polish-Lithuanian Kingdom, Portugal or the United Provinces.

During the EU summit in Brussels Photo: Xinhua/ZUMA

The still-young EU could be described as a "baroque state." Baroque, the great European artistic movement, is set in opposition to classicism through its circumvention of rules and subverting of forms, mixing genres and resorting to the exception. This is the case of the EU, which escapes the traditional classification of political systems as territorial state entities and is distinguished by its novel singularity. Based on state cultures inherited from a long history and a fragmented political geography, contemporary Europeans are inventing the "mutuality" of sovereignty.

Europeans can now shelve the ideological debate on whether the existence of the EU is relevant.

Negotiations on the terms and conditions of the plan are thus not limited to discussions between heads of government at the European Council. The agreement will then have to be voted on by the 27 national parliaments, themselves networked with the European Parliament and the parliaments of local states, such as the Belgian or Spanish communities and the German Lnder. This "mutualization," or exchange of reciprocity of sovereignty, is democratic: It is deliberate, voluntary and negotiated, in contrast to the empires and conquests by kings and then nations of the past two millennia. Europeans do not form a nation but a society. For the past few decades they have been building a state that corresponds to this one: pluralist, unprecedented and forward-looking.

By this metric, the four-day, four-night series of debates are the manifestation of national governments becoming tremendously civilized in building this European state. They have become, together with the European Parliament, which is the direct expression of European society, actors of a deliberative democracy with its majority, its opposition (the so-called 'frugal' countries) and its compromises. From now on, Europeans can shelve the ideological debate on whether the existence of the EU is relevant, and focus on the citizen's debate that confronts the real issue: Are we satisfied with the political choices and public policies made by the European "government?"

*Sylvain Kahn is a historian, geographer and professor at Sciences Po. He is the author of Histoire de la construction de l'Europe depuis 1945 (PUF, 2018), winner of the Mieux comprendre l'Europe book prize.

See more from World Affairs here

All rights reserved Worldcrunch - in partnership with LE MONDE

Read the original:
Why The European Union Has Changed Forever - Worldcrunch

Since Boris Johnson became the Prime Minister, Britain has in every possible way demonstrated a lack of fear towards a tough deal with the European Union. Over the years of its presence in the European space, Britain has successfully resisted imposition of labor market standards, subordination to the economic and political institutions of the EU, and the introduction of a single currency on the territory of the United Kingdom (which the UK was quite sceptical about). In a sense, all of this softens the perfidious Albions divorce from mainland Europe. Nevertheless, at the same time, Britain is potentially losing a huge sales market. This could also be a great opportunity for the UK to agree on new preferential trade deals with countries outside of the EU. In the event a deal isnt struck, Boris Johnson already gave his consent to the possibility of trading with the European Union under the rules of the World Trade Organization

No analyst right now would be willing to predict the budget losses, especially in light of the problems due to the pandemic. Considering that global demand and trade are at their lowest, Britain's transition to WTO standards does not look catastrophic for the country's budget. In any case, the slump in trading is already taking place and it is unlikely that the economy will fully recover until December 31. This coupled with the possibilities of new trade deals creates very strong bargaining power with the EU. Against the backdrop of the pandemic, the standard of living has already dropped significantly, real wages fell by 4.5%, unemployment, according to forecasts, may reach beyond 12%, and in 2021 even hit over 13%. Compared to all of this, the impact of Brexit on the economy becomes far less prominent.

Nonetheless, some investors are already beginning to shift their investments from pounds to euros, suggesting that the UK's growth rate could slow significantly in the long term. There is a concept that Europes financial center, which London was informally considered to be, will potentially move to Germany. I personally do not believe in this shift taking place to a significant extent due to multiple organisational and cultural reasons. In the meantime, both the euro and the pound are near local maximums. Market participants will likely wait for a decision within the framework of the autumn round of negotiations, during which the EU might make concessions, but the likelihood of this is low. In the event of a tough divorce, the pound quotes might face a downward movement to 1.2000 against the US dollar, while the euro during the same time period will be positioned quite comfortably in the range of 1.15 - 1.17.

Link:
Britain and the European Union can't agree. How will this affect investors? - Finextra

On July 16, 2020, Blackbaud, a U.S. based cloud computing provider and one of the worlds largest providers of education administration, fundraising, and financial management software, notified users of its services that it had suffered a ransomware attack in May 2020 in relation to personal data stored on their servers. Numerous colleges, universities, foundations, and other non-profits across the U.K., U.S. and Canada were affected.

Blackbauds handling of the attack has raised some questions. Blackbaud has confirmed in a statement on its website that they paid the cyber-criminals ransom demand in return for confirmation that the stolen data had been destroyed. Paying ransom demands is not unlawful, but it goes against the official advice issued by many law enforcement agencies, including the FBI. In addition, Blackbaud has faced criticism for taking many weeks to inform its customers of the breach.

Much of the affected data was of a nature that would not trigger notice requirements in the United States, because the elements that constitute sensitive data in the U.S. (such as usernames, passwords and social security numbers) were encrypted. However, there are a handful of states (notably Washington and North Dakota) that have notification statutes requiring notice to affected individuals if other kinds of information is accessed, such as names together with dates of birth, and was the case for many of Blackbauds customers.

The bigger issue, however, is for those U.S.-based entities who actively target individuals in the European Union. For example, many colleges and universities in the United States actively recruit prospective students or donors in the European Union. These types of recruitment activities are likely to bring them in scope of the EUs General Data Protection Regulation (GDPR).

The GDPR is a far-reaching piece of European legislation which applies to organizations outside the EU and includes draconian financial sanctions for non-compliance. Moreover, the standard for notification to individuals and data protection authorities in the EU is much lower than in most U.S. states. The GDPR requires that data breaches are reported to European data protection supervisory authorities unless the breach is unlikely to result in a risk to the rights and freedoms of individuals. This requires the affected institution to perform a thorough, documented risk assessment in each case.

Larger institutions may have already analyzed the need to comply with the GDPR and will therefore be aware that, if they are in scope of the GDPR, they may be required to report the breach both to the individuals concerned and to the relevant data protection supervisory authority in the EU. However, many smaller institutions may not have performed that analysis. This situation may find them needing to report the breach, but in doing so perhaps also alerting the data protection authorities to the fact that they may be subject to GDPR and may not be compliant in other ways. For instance, the GDPR requires specific contractual terms (including terms relating to the handling of data breaches) to be in place between customers and vendors where vendors process personal data on behalf of the customer.

The attack on Blackbaud is a major data breach. It may serve as a catalyst for U.S. non-profits to take a longer look at the GDPR and analyze their own need to comply.

Affected organizations both in and outside the EU should be working to determine what data has been compromised and whether they need to notify the local supervisory authority. The breach should also prompt all organizations to review any vendor contracts where personal data is involved, with a particular focus on ensuring that (a) the responsibility for data breach falls on the vendor and (b) strict notification timescales are imposed on the vendor (with the aim of preventing the lengthy delay in informing customers that has occurred in the Blackbaud case). Organizations that are subject to GDPR should also ensure that they implement GDPR-compliant vendor contracts.

See more here:
Blackbaud Data Breach: Do You Need to Notify Affected Individuals or EU Data Protection Authorities? - Lexology

A bevy of seafood products from the European Union could be the target of new tariffs by the United States, stemming from a dispute over European subsidies for Airbus.

Starting in October, several mainly premium goods from the E.U. such as Scotch whisky, cashmere, cheeses, and others have carried a 25 percent tariff, with salmon and other seafood products barely avoiding a tariff in the trade spat. The tariffs stem from U.S. criticisms of what it calls over-subsidization of Airbus by European governments, with the World Trade Organization (WTO) allowing the U.S. to take USD 7.5 billion (EUR 6.3 billion) in retaliatory tariffs, BBC news reported.

The tariffs have already been impacting certain seafood products from Europe from other regions prepared or preserved mussels, clams, cockles, razor claims, and molluscs have all been hit with the 25 percent tariffs, according toa list released by the USTR.

For years, Europe has been providing massive subsidies to Airbus that have seriously injured the U.S. aerospace industry and our workers. Finally, after 15 years of litigation, the WTO has confirmed that the United States is entitled to impose countermeasures in response to the EUs illegal subsidies, U.S. Trade Representative Robert Lighthizer said at the time.

Now, the WTO has agreed to even more U.S. claims about Airbus subsidies, opening the door for more potential tariffs. That means more seafood products could be on the chopping block. In June, the U.S. Trade Representative put out a notice that it is considering expanding the potential items being tariffed. The majority of the seafood items were considered for tariffs in the first round implemented in October, but were subsequently excluded from tariffs.

Included on that list of new products that could be tariffed are:

A decision on the products is expected to take place some time after 12 August, when a U.S. consultation ends.

Photo courtesy of barmalini/Shutterstock

Read the original:
Proposed US tariffs on EU seafood products nearing end of consultation period - SeafoodSource

By: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs and Mark Abdoo, Associate Commissioner for Global Policy and Strategy

The European Union (EU) is one of the U.S. Food and Drug Administrations most important collaborators in tackling public heath challenges. The FDA and the European Commission (EC) and its European Medicines Agency (EMA) have long leveraged each others expertise and experience to promote the safety, effectiveness, and quality of medical products to advance the health of our citizens. Now, our work, built together over more than a decade, has paved the way for a multitude of critical collaborations on many scientific and regulatory fronts as part of our COVID-19 response.

What has helped drive this collaboration are the 30 technical expert groups, or clusters that the FDA and the EMA have established since 2003. These clusters meet regularly for regulatory discussions held under confidentiality commitments and were well positioned to pivot to focus on COVID-19 because of our ongoing work together. Since the start of the pandemic, many of these groups which often also include regulatory authorities from Japan, Canada, Australia, and other countries have shifted their work priorities to focus on COVID-19. For example, our expert group on vaccines has expanded into a multilateral forum to discuss regulatory issues related to the development of SARS-CoV-2 vaccines, whereas the pharmacovigilance group has begun to identify opportunities for collaboration on observational studies related to COVID-19 natural history and interventions. Similarly, our standing meetings on blood products are now focusing on developments related to COVID-19 convalescent plasma. The drug shortages discussions revolve around information sharing on strategies for COVID-19 related shortages and supply disruptions of medicines.

In these expert group discussions, the FDA and the EMA have been exchanging information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions. For example, two days after the release of results from a clinical trial that the National Institute of Allergies and Infectious Diseases (NIAID-ACTT study) conducted, the FDA authorized the emergency use of the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The FDA subsequently hosted a virtual meeting of key regulatory partners, including from Europe, Canada, and Japan, to discuss the safety and efficacy of remdesivir as a treatment for COVID-19. At the time, Japan had announced their version of early access to the drug and most of the other participating authorities were about to begin their own reviews for making such a decision, with EMA issuing a recommendation to expand remdesivir compassionate use shortly thereafter.

Against this backdrop of robust collaboration, on June 18-19, the FDA hosted virtual bilateral meetings with the EC and EMA to review progress on ongoing activities and share horizon scanning across high-priority areas. For example, public and private sector entities are proactively exploring strategic partnerships to address the anticipated challenges related to manufacturing and rapid scale-up of potential COVID-19 vaccines or therapeutics. As two-prominent international regulatory bodies, the FDA and the EC/EMA can help inform global regulatory strategies to accelerate production and global access of products. In addition, the application of real-world data to understand the natural history of COVID-19, treatment patterns, and the performance of diagnostics is of keen interest for both the FDA and the EU.

The FDA and the EU are also promoting engagement with global regulators, under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe. For example, in March, as vaccine candidates began to be identified, the FDA and the EMA jointly chaired the first global regulators meeting to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines. Subsequent ICMRA workshops that are focused on COVID-19 therapeutic development, observational studies, and real-world data as well as policy approaches are helping to support mutual awareness and consideration of potential guidance alignment. Such vigorous efforts are reflected in the ICMRA joint statement, which was issued in April 2020, with global regulatory authorities expressing their collective support in countering COVID-19.

To maintain strong oversight of foreign-manufactured medical products, the FDA is leveraging inspection reports completed by the EU and United Kingdom under the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement (MRA). The MRA creates an environment in which FDA and the EU may rely on inspections performed by each others regulatory authorities to inform our regulatory decisions, such as drug approvals or addressing drug shortages.

We are also leveraging our international collaborations in our medical device work. The FDA and global partners (including the EC and other European partners) regularly exchange information on medical device safety issues and regulatory developments. These international relationships have never been more important as we work to maintain critical supplies of medical devices such as personal protective equipment, ventilators and ventilator accessories, as well as diagnostic testing supplies and test kits for COVID-19. Our interactions have included working through our embassies and European contacts to address supply chain disruptions, medical device shortages, and removal of fraudulent and poor-quality products from the market. Moving forward, shared learnings about antibody tests, otherwise known as serology tests their validation, results of ongoing epidemiological studies, and potential use in broader testing programs will inform our continued efforts to confront this pandemic.

Our work in these endeavors is, as always, rooted in the FDAs unwavering commitment to helping to foster the development of safe and effective medical products. We recognize the shared challenges of public health authorities across the world in fighting this pandemic as well as the tremendous opportunities to accelerate our mission critical work through robust scientific collaboration. We will continue to collaborate with our global regulatory counterparts as we seek to bring safe and effective COVID-19 vaccines and treatments to our citizens as quickly as possible and as part of advancing our vital mission to protect and promote public health.

Follow this link:
Partnering with the European Union and Global Regulators on COVID-19 - FDA.gov