Archive for the ‘European Union’ Category

ECDC and EMA update recommendations on additional booster doses of COVID-19 vaccines – European Centre for Disease

In April 2022, both agencies recommended that people over 80 years of age be considered for a second booster. However, the agencies noted at the time that it might be necessary to consider second boosters in people between 60 and 79 years old and vulnerable persons of any age if there was a resurgence of infections.

As a new wave is currently underway in Europe, with increasing rates of hospital and intensive care unit (ICU) admissions, it is critical that public health authorities now consider people between 60 and 79 as well as vulnerable persons of any age for a second booster. These could be administered at least four months after the previous one, with a focus on people who have received a previous booster more than 6 months ago. Currently authorised vaccines continue to be highly effective in reducing COVID-19 hospitalisations, severe disease and deaths in the context of emerging SARS-CoV-2 variants.

Stella Kyriakides, the European Commissioner for Health and Food Safety said that Our COVID-19 vaccines work, and offer good levels of protection against severe illness and hospitalisation. With cases and hospitalisations rising again as we enter the summer period, I urge everybody to get vaccinated and boosted as quickly as possible. There is no time to lose.

I call on Member States to roll-out second boosters for everyone over the age of 60 as well as all vulnerable persons immediately and urge everyone eligible to come forth and get vaccinated. This is how we protect ourselves, our loved ones and our vulnerable populations.

We are currently seeing increasing COVID-19 case notification rates and an increasing trend in hospital and ICU admissions and occupancy in several countries mainly driven by the BA 5 sublineage of Omicron, said Dr Andrea Ammon, the Director of ECDC.

This signals the start of a new, widespread COVID-19 wave across the European Union. There are still too many individuals at risk of severe COVID-19 infection whom we need to protect as soon as possible. We need to remind people of the importance of vaccination from the very first shot to the second booster. We have to start today.

We expect that adults 60 years and older and medically vulnerable populations will need a second booster dose. These are the groups most at risk of severe disease and giving a second booster to those groups now will avert a significant number of hospitalisations and deaths from COVID-19.

I am aware that it requires a significant effort from public health authorities and society at large to achieve this goal. But now at the beginning of a new wave is the time to make the extra effort. We have several safe and effective vaccines available, and every single COVID-19 infection prevented now is a potential life saved.

At the moment, there is no clear evidence to support giving a second booster dose to people below 60 years of age who are not at higher risk severe disease. Neither is there clear evidence to support giving early second boosters to healthcare workers or those working in long-term care homes unless they are at high risk.

However, residents at long-term care homes are likely to be at risk of severe disease and should be considered for booster doses in line with national recommendations.

ECDC and EMA have called on public health authorities across the EU to plan for additional boosters during the autumn and winter seasons for people with highest risk of severe disease, possibly combining COVID-19 vaccinations with those for influenza.

National Immunisation Technical Advisory Groups (NITAGs) will ultimately make national decisions on who should get second boosters, taking into account the situation in their countries.

The latest ECDC/EMA advice comes amid work to adapt vaccines for the Omicron variants of concern.

We are working towards possible approvals of adapted vaccines in September, said EMAs Executive Director, Emer Cooke, noting that our human medicines committee is currently reviewing data for two adapted vaccines.

In the meantime, it is important to consider using currently authorised vaccines as second boosters in people who are most vulnerable. Authorised vaccines in the EU continue to be effective at preventing hospitalisations, severe disease and deaths from COVID-19, even as new variants and subvariants continue to emerge.

She added that Authorities in the EU are working closely with the World Health Organization and international partners on policies concerning adapted vaccines.

ECDC and EMA will continue to closely evaluate emerging vaccine effectiveness and epidemiological data and will update their recommendations accordingly. Further details about the latest advice on second booster doses is available in the ECDC/EMA joint statement.

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ECDC and EMA update recommendations on additional booster doses of COVID-19 vaccines - European Centre for Disease

Free trade agreement between Australia and the European Union back on the table – with some caveats – Lexology

The AU-EU FTA would cover goods, services and business investment, but the EU has set some new demands which link trade liberalisation to climate.

The free trade agreement between Australia and the European Union (AU-EU FTA) which aims to drive Australian exports, economic growth and job creation appears to be back on the table with negotiations restarting later this year, albeit with some hard lines on climate targets set by the European Union (EU).

In 2016, due to the Brexit fallout, the Turnbull Government announced that it had commenced work towards negotiations with the EU for an AU-EU FTA, with the first round of negotiations occurring in early July 2018.

The most recent round of negotiations for the AU-EU FTA took place virtually on 7-18 February 2022, but further negotiations have been on pause since France placed a block on further progress following the Morrison Government's cancellation of the French contract to supply diesel-powered submarines. Australia's relations with France had been on ice until this May, when newly elected Anthony Albanese made efforts to reinvigorate a spirit of co-operation between the nations, with there now being clear signs from the EU about proceeding with the negotiations.

The shape of those negotiations is a bit clearer, with reports that the EU will include sanctions for failure to reach Paris Agreement targets for emissions reductions (Australia has already satisfied a requirement to make a commitment on carbon neutrality). Some members of the EU Parliament have also called for more sustainability commitments in trade agreements as well, which could be a factor as the EU Parliament must approve any FTA.

Apart from climate issues, the EU is also looking for new laws on geographic indicators, which would bring rules already in place for wine to foodstuffs, while pushing back on the size of beef, lamb and dairy quotas.

Why does Australia need a free trade agreement with the EU?

The AU-EU FTA intends to leverage the partnership between Australia and the EU, given that they both share a commitment to the rule of law, global norms and free and open markets. According to Department of Foreign Affairs and Trade (DFAT), Australia exported goods and services to the value of $18.7 billion in 2019-20, and imported $59.9 billion in the same period.

As a bloc, the EU is a high-income market with a population of just under 450 million people and a GDP of around US$15 trillion. In 2020, it was Australias second largest trading partner, as well as our seventh largest export destination, fourth largest services export market and second largest source of foreign investment.

>Similar to the Australia-United Kingdom Free Trade Agreement that was signed on 17 December 2021, an agreement with the EU will provide new opportunities for Australian goods and services in a highly significant market, which in turn will assist Australia with its post-pandemic economic recovery. The AU-EU FTA also has the ability to afford Australian exporters with a competitive edge and more choice about where they do business, while granting Australian consumers greater choice in goods and services at lower prices.

Potential benefits of the AU-EU FTA

The AU-EU FTA has, like most FTAs, the potential to create significant benefits to Australia, such as:

What could the AU-EU FTA deliver?

Australia has been at the forefront of concluding modern, comprehensive FTAs which aim to maximise tariff reductions for Australian exporters, open up services markets, and set rules to enhance trade and investment, reduce regulatory risk and support further liberalisation.

The AU-EU FTA would cover goods, services and business investment and is considered key if Australia is to reduce its trade dependency on China. According to an impact assessment, trade in goods and services between the two partners could increase by around a third.

For example, the AU-EU FTA has the potential to deliver:

Timeline and next steps for the AU-EU FTA

Currently, the Australian Government is aiming to accelerate negotiations and progress the AU-EU FTA, with the next formal round of negotiation in October.

Throughout the negotiation period, DFAT indicates that it would be interested to receive submissions from interested individuals and groups on the potential opportunities and impacts of the AU-EU FTA. In your submission, it would be worthwhile considering how the AU-EU FTA may impact your business and the opportunities that will likely arise from a partnership with the EU to assist the Government in determining Australia's key priorities for further negotiations of the FTA.

In addition, as the AU-EU FTA is likely to have significant implications for Australian business and might open up various opportunities that will be worth taking advantage of, Australian businesses involved in trade and foreign investment, or those who are seeking to attract foreign capital, should prepare for the changing landscape and continue to stay abreast of the changes yet to come.

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Free trade agreement between Australia and the European Union back on the table - with some caveats - Lexology

European Union – Data Privacy and Protection | Privacy Shield

The EU General Data Protection Regulation (GDPR), which governs how personal data of individuals in the EU may be processed and transferred, went into effect on May 25, 2018. GDPR is a comprehensive privacy legislation that applies across sectors and to companies of all sizes. It replaces the Data Protection Directive 1995/46. The overall objectives of the measures are the same laying down the rules for the protection of personal data and for the movement of data.

GDPR is broad in scope and uses broad definitions. Personal data is any information that relates to an identified or identifiable living individual (data subject) such as a name, email address, tax ID number, online identifier, etc. Processing data includes actions such as collecting, recording, storing and transferring data.

A company that is not established in the Union may have to comply with the Regulation when processing personal data of EU and EEA residents (EEA countries are Norway, Lichtenstein and Switzerland):a) If the company offers goods or services to data subjects in the EU; or,b) If the company is monitoring data subjects behavior taking place within the EU.

The mere accessibility of a companys website in the EU is insufficient to subject a company to GDPR, but other evidence of the intent to offer goods or services in the EU would be relevant.

As a general rule, companies that are not established in the EU but that are subject to GDPR must designate in writing an EU representative for purposes of GDPR compliance. There is an exception to this requirement for small scale, occasional processing of non-sensitive data.

Fines in case of non-compliance can reach up to 4% of the annual worldwide revenue or 20 million euros whichever is higher. Companies of all sizes and sectors should consider GDPR as part of their overall compliance effort with assistance of legal counsel.

The European Commission and Data Protection Authorities are releasing official guidelines to help companies with their compliance process. These documents relate, for instance, to the role of the data protection officer, personal data breach notification, data protection impact assessment.

Note: the EU is currently updating its e-privacy legislation governing confidentiality of communications. This legislative instrument once enacted will add several requirements in addition to the GDPR. We encourage U.S. exporters to monitor this situation as it evolves through the EU legislative process.

For more information: Full GDPR textOfficial Press Release

European Commission guidance:https://ec.europa.eu/info/law/law-topic/data-protection_enhttps://ec.europa.eu/commission/priorities/justice-and-fundamental-rights/data-protection/2018-reform-eu-data-protection-rules_en https://edpb.europa.eu/edpb_enhttps://edpb.europa.eu/our-work-tools/general-guidance/gdpr-guidelines-recommendations-best-practices_en

Transferring Customer Data to Countries outside the EUThe General Data Protection Regulation (GDPR) provides for the free flow of personal data within the EU but also for its protection when it leaves the regions borders.GDPR sets out obligations on data controllers (those in charge of deciding what personal data is collected and how/why it is processed), on data processors (those who act on behalf of the controller) and gives rights to data subjects (the individuals to whom the data relates). These rules were designed to provide a high level of privacy protection for personal data and were complemented by measures to ensure the protection is maintained when data leaves the region, whether it is transferred to controllers, processors or to third parties (e.g. subcontractors). EU legislators put restrictions on transfers of personal data outside of the EU, specifying that such data could only be exported if adequate protection is provided.

The European Commission (EC) is responsible for assessing whether a country outside the EU has a legal framework that provides enough protection for it to issue an adequacy finding to that country. The U.S. has never sought to be found adequate by the EC. This means that U.S. companies can only receive personal data from the EU if they:

For more information, consult the European Commissions webpage on data transfers outside the EU https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection_en

Important note:The legal environment for data transfers to the United States continues to evolve. Companies that transfer EU citizen data to the United States as part of a commercial transaction should consult with an attorney, who specializes in EU data privacy law, to determine what options may be available for a transaction.

About the EU-U.S. Privacy Shield The EU-U.S. Privacy Shield Framework was designed by the U.S. Department of Commerce and theEuropean Commission to provide companies on both sides of the Atlantic with a mechanism to comply with EU data protection requirements when transferring personal data from the European Union to the United States in support of transatlantic commerce.For more information on the EU-U.S. Privacy ShieldFor more information about other mechanisms of transfer, please refer to:https://www.export.gov/article?id=European-Union-Transferring-Personal-Data-From-the-EU-to-the-UShttps://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection_en

European Union 28 Information Management Market Access

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European Union - Data Privacy and Protection | Privacy Shield

Anti-Speeding Technology Is Now Mandatory in European Union – autoweek.com

Construction Photography/AvalonGetty Images

The European Union's intelligent speed assistance program took effect on Wednesday, starting a new era of enhanced safety regulations brought forward by the cluster of European nations. The program is focused on limiting speeding through four different warning systems installed in all new chassis introduced in the EU. Manufacturers are only required to pick one system and will be able to choose which of the four warning systems to install, though some have already elected to install multiple.

Each warning system functions differently with some being progressively more invasive than others. On the light end of the spectrum, some cars will note speed limits through sign-recognition cameras or GPS data and audibly alert the driver if they are exceeding them. Using the same technology, other cars will produce a vibration throughout the driver's cockpit alerting them of their speed. Alternatively, the other two warning systems rely on the tension of the accelerator pedal, known as haptic feedback and speed control function.

Haptic feedback requires the car to recognize speed signs and, if the driver is in fact speeding, automatically push back against the driver's accelerator pedal pressure. The speed control function goes one step further by cutting power input from the pedal once the speed limit is reached. It's important to note that drivers can override all four of these systems, either by acknowledging the audible or vibrating warnings or by pushing harder on the accelerator in the case of the haptic feedback or speed control function.

For many enthusiasts reading this, these technologies sound like a nightmare to the analog purists inside of us. The EU doesn't want these technologies to take human decision-making out of driving, however; these ISA systems are meant to be reminders, not restrictors.

"It should be possible to switch off intelligent speed assistance, for instance, when a driver experiences false warnings or inappropriate feedback as a result of inclement weather conditions, temporarily conflicting road markings in construction zones, or misleading, defective or missing road signs," the text of the General Vehicle Safety Regulation reads. Additionally, the regulatory requirements of the ISA system explicitly states that, "it shall not affect the possibility, for the drivers, of exceeding the systems prompted vehicle speed."

As with all new technologies, the likelihood of real-world errors and future troubleshooting is high. Beyond technological faults, driver annoyance with auditory warnings was also considered, seeing as it may lead operators to turn the system off completely. As the program is tested, the focus on maintaining some degree of driver autonomy will be imperative to its success. The legislation was adopted by the European Commission, though it is currently under two-month scrutiny from the European Parliament and Council.

All things considered, the technology is a good-faith effort to reduce fatal crashes at a time of soaring traffic deaths. Analysis of trial runs by the European Transport Safety Council suggests that this technology will reduce speeding by 30% and traffic deaths by 20%. Manufacturers like Ford and Renault are already experimenting with the technology across the European Union and even in the United Kingdom. And while the current rule only applies to all-new models, ISA systems will become mandatory for all new cars sold starting July 2024.

Do you think anti-speed technology would work on this side of the pond? Share your thoughts on in the comments below.

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Anti-Speeding Technology Is Now Mandatory in European Union - autoweek.com

Russia lost its influence in European Union – Zelensky – Ukrinform

Russia tried in every possible way to disrupt the addresses of the President of Ukraine to the peoples and parliaments of European countries, but it has lost its influence in the European Union.

President of Ukraine Volodymyr Zelensky said this in his address to the Slovenian parliament, Ukrinform reports.

I am grateful to all the countries of the European Union in which such appeals of mine took place. We know that Russia tried to disrupt them, tried to use its various connections - political, diplomatic, even business. In Moscow they understand that they have nothing to oppose such trust between the people of Ukraine and Europe and such communication activity with. Therefore, they threatened Europeans, manipulated those who depend on them. But this is already the twenty-fourth parliament of the twenty-seven countries of the European Union, and I want to congratulate you on this obvious evidence that Russia has lost its influence in the European Union. The fact remains the following: most of the countries of the European Union cannot be ruled by Russia. And this is a new political reality in Europe, which we achieved together - every country that stood up for the defense of our common freedom, Zelensky said.

He added that the words about freedom are not just words, but a key goal of the anti-war coalition. Now, according to the President of Ukraine, new and strong security, political and economic steps are being taken on the basis of a new unity.

And legal steps are next, namely: bringing Russian war criminals to justice. Most importantly, by going through this terrible challenge of the Russian war together, we prove that European values do not remain just a reference to old treaties and conventions, do not serve as formal criteria only at the level of rhetoric, but are the real basis of life on the continent here and now. And every country of the united Europe made its contribution to this, he said.

On February 24, 2022, Russia launched a full-scale invasion of Ukraine. Russian troops are shelling and destroying the key infrastructure facilities in Ukraine, firing at Ukrainian cities and villages with artillery, multiple launch rocket systems and ballistic missiles.

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Russia lost its influence in European Union - Zelensky - Ukrinform