80/2021 : 12 May 2021 – Judgment of the General Court in Cases T-516/18, T-525/18
80/2021 : 12 May 2021 – Judgment of the General Court in Cases T-516/18, T-525/18

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ESMA consults on its MiFID II/MiFIR Annual Report
ESMA consults on its MiFID II/MiFIR Annual Report

The Consultation Paper provides for the Annual Assessment of the operation of the thresholds for the liquidity determination of bonds and the trade percentiles determining the pre-trade SSTI-threshold which is currently subject to a a four-stage phase-in regime under RTS 2.

The Consultation proposes to:

  • Move to stage 3 for the liquidity assessment of bonds;
  • Move to stage 3 for the SSTI percentile of bonds; and
  • Not to move to stage 2 for the SSTI percentile of non-equity instruments other than bonds.

These proposals are designed to increase the transparency available to market participants in the bond market.

Next steps

ESMA will consider the feedback and expects to publish a final report and submit, if necessary, regulatory technical standards to the European Commission for endorsement in July 2021. Following such endorsement, the RTS are then subject to a non-objection procedure by the European Parliament and the Council.

Further information:

Dan Nacu-Manole

Communications Officer

   +33 (0)1 58 36 52 06

@   press@esma.europa.eu

Consultation Paper on the RTS 2 Annual Review
Consultation Paper on the RTS 2 Annual Review

The European Securities and Markets Authority (ESMA) invites responses to the specific questions listed in the Consultation Paper on the transparency regime for non-equity instruments and the trading obligations for derivatives MiFID II/ MiFIR review report published on the ESMA website.

Responding to this paper 

ESMA invites comments on all matters in this paper and in particular on the specific questions summarised in Annex 1. Comments are most helpful if they: 

  1. respond to the question stated;
  2. indicate the specific question to which the comment relates;
  3. contain a clear rationale; and
  4. describe any alternatives ESMA should consider.

Next steps

ESMA will consider all comments received by 11 June 2021.

All contributions should be submitted online at www.esma.europa.eu under the heading ‘Your input – Consultations’.

ESMA expects to publish a final report and submit, if necessary, regulatory technical standards to the European Commission for endorsement in July 2021. Following such endorsement, the RTS are then subject to a non-objection procedure by the European Parliament and the Council.

European Union Preparing Plan That Will Allow Vaccinated Americans To Travel Once Again
European Union Preparing Plan That Will Allow Vaccinated Americans To Travel Once Again

(CBS LOCAL) – The European Union is preparing a plan to reopen to vaccinated Americans and many seniors are ready to go. Travel advisors say the older travelers are among those leading bookings.

Gale and Bob Grossman are frequent travelers. They vacation in places like Italy, Brazil, and Ireland. But international trips were no longer possible when the pandemic hit.

READ MORE: Washington County’s Little Lake Theater Set To Reopen Next Week

A year later, the senior couple is now vaccinated and eager to start flying abroad again.

“As soon as Europe opens up, we’re gone,” says Gale.

“We go to Ireland every year also and Ireland can’t give us an answer when we can get there and we keep postponing that trip as well,” says Bob.

It’s what travel advisor Hillel Spinner keeps seeing among his older clients.

“Between February and March, I’ve noticed an increase of about 110%. And the reason for that is they’ve been vaccinated, they feel safe to travel again, the world is their oyster, they’re like where can I go now?” he says.

READ MORE: Know Before You Go: Understanding The Pennsylvania Primary Ballot

A recent survey by the American Society of Travel Advisors finds 44% of those polled say being able to travel is the main reason why they’re getting vaccinated. And two-thirds of those surveyed feel the vaccine will enable them to do so.

Jim Moses is the President and CEO of Road Scholar which provides educational travel tours for older adults.

He says, “It’s been unbelievable. We’ve seen about a 50% increase in the numbers of people who are enrolling in programs. They’re so excited.”

Alisa Kauffman is in her early 60’s and planning a 60th birthday trip for her husband to Greece. It’s a much-needed getaway after losing her mother to COVID in August.

“Travel is the only thing that you can buy that makes you richer, and that’s the one thing that my mother taught me,” she says.

A lesson she can put to good use now that she’s vaccinated.

MORE NEWS: Pittsburgh Weather: Temperatures Begin To Climb Starting On Wednesday

The travel agency Embark Beyond is seeing strong bookings in Turkey and Greece this summer.

European Parliament to return to Strasbourg seat for June session
European Parliament to return to Strasbourg seat for June session

The European Parliament will return to its seat in Strasbourg for the June plenary session, President David Sassoli’s office said on Tuesday in a note to the secretaries-general of the political groups, according to two officials cited in Brussels Playbook.

The argument behind the move is that the improved epidemiological situation and the progress made in the vaccination campaign make it possible for MEPs to return to the Parliament’s main seat. Top EU leaders already gathered in Strasbourg this weekend for the inaugural ceremony of the Conference on the Future of Europe, the first plenary session of which will also be held in the Alsatian city in June.

The Parliament’s first plenary back in its seat since February 2020 will however still face some restrictions: in-person staff presence will be reduced, and MEPs will still be allowed to follow online if they choose to do so.

Plans to return to Strasbourg were last made for the September 2020 session, only to be cancelled a week before due to the quarantine requirement MEPs would have faced upon their return to Brussels. The closest Parliament has come to the French city was in December 2020, when Sassoli held gave a speech to a virtually empty hemicycle in Strasbourg before the plenary continued in Brussels.

Many MEPs oppose the Parliament’s seat being in a different city to the rest of the European institutions, which in pre-pandemic times meant a costly “traveling circus” between Brussels and Strasbourg several times a year. Several votes have been held in attempts to change this setup, which is provided by EU treaties. French officials and local Strasbourg businesses disagree, with President Macron having put pressure on Sassoli to come back to the city and return to normality.

The European Union should halt all developmental assistance to Guyana
The European Union should halt all developmental assistance to Guyana

Kaieteur News – I cannot recall now who said it but I recall what was said, “There is a middle finger on each hand but no middle hand.” This saying was intended to convey the idea that there are two main ideological paths – the Left and the Right, no middle way.
However, it is also said that on each hand there are four fingers and a thumb, which means that whichever way you choose – Left or Right – there are different paths to that process.
This is worth remembering when one tries to assess where the PPP/C stands on the ideological continuum. The PPP/C leadership is now ideologically fixated to the Right. While it assumes a more moderate posture than the more extremist Right wing governments, there can be little doubt that the PPP/C’s primary interest lies more with the business class than the working class.
The PPP/C has found its own route towards Right wing politics while still paying lip service to the working class.
This is best illustrated by the manner in which it has addressed the COVID-19 pandemic. There has never been a government, which has treated Guyanese, particularly the elderly, as dispensable as has the present PPP/C Government. The majority of persons who have been dying from COVID-19 have been persons beyond the age of 60.
Moreover, this catastrophe has not forced the government to consider tightening the social restrictions, even though the pandemic has exacted a huge cost to the Treasury, including $800M to procure vaccines from the United Arab Emirates. Is it because the majority of the victims are the elderly that this callous approach is being adopted?
There is a factoid, which is being advertised on social media in which there is a claim that more than 150,000 persons have been vaccinated locally and that 60 percent of these are persons over 60 years old. This would mean that 90,000 persons 60 years and over have been vaccinated. But how can this figure be correct when Guyana is estimated to have only 72,000 persons above the age of 60 years?
Vaccine hesitancy was so high that on April 21, the government was forced to open vaccinations to persons aged 40 years and over. And two weeks later, on April 3, a mere 40,468 persons had been vaccinated. If 90,000 elderly persons were vaccinated, then the deaths should not have been as high as is being reported.
The number of COVID-19 infections and deaths has also climbed appreciably since January and yet the PPP/C is stubborn to return to any form of post-August 2020 restrictions, including a closure of non-essential businesses, rotation of government workers and an extension of the curfew.
The PPP/C has opted instead to further reopen the economy. Casinos and betting shops have reopened in the midst of the most recent surge and enforcement efforts are aimed mainly at targeting entertainment spots after 10.30pm and preventing social gatherings.
But that is how Right wing governments operate. They make calculations and those calculations put profits above everything else.
The PPP/C’s Right wing approach is also evident in the recent controversy over the destruction of mangroves. The PPP/C, which has championed environmental protection, is however siding with big business when it comes to environmental destruction.
The PPP/C is justifying the destruction of the mangroves on the basis that the removal of the mangroves is necessary for development. Yet, it was this very PPP/C Government, which launched in 2009 a campaign to protect the country’s sea and river defences by mangrove reforestation.
The expansion of mangroves was intended to serve as a natural defence against rising sea levels and flooding. This was all part of the PPP/C’s much-vaunted Low Carbon Development Strategy. The PPP/C even launched Village Mangrove Action Committees as a means of adaptation to climate change. Now it is saying that development trumps the mangrove.
In light of this latest retreat by the PPP/C Government, the European Union, which had funded the Guyana Mangrove Restoration Project, should cease all climate adaptation assistance to Guyana. Also, all those environmentalists who have accepted positions on government Boards and committees should immediately tender their resignations in protest against the government’s stance on the destruction of mangroves at Versailles.
However, the government has four fingers and a thumb and so it will create a façade that it is committed to placing people’s health and environment above that of the business interests. And so it will aggressively move against persons who have established industrial facilities without the necessary permits. And it will go around boasting about how many persons it has vaccinated even though question marks remain over its protection of the elderly.
If the PPP/C were even a center-Left party, it would have long taken aggressive action to impose stricter social restrictions in light of the pandemic. And it would have been outraged over the destruction of the mangroves at Versailles. But in so far as the PPP/C is concerned, business comes first.

(The views expressed in this article are those of the author and do not necessarily reflect the opinions of this newspaper.)


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European Union files lawsuit against AstraZeneca
European Union files lawsuit against AstraZeneca

The European Union has filed a new lawsuit against AstraZeneca that could lead to financial sanctions against a company that the EU claims had violated a contract to supply COVID-19 vaccines, Reuters reported.

This is the second EU lawsuit against AstraZeneca after it took action in late April over delays in vaccine supplies.

AstraZeneca said the first EU lawsuit is unfounded, saying it has complied with the terms of the contract.

The Anglo-Swedish drugmaker initially pledged to deliver 300 million doses of the vaccine from December to the end of June, but delayed shipments, delivering only 50 million, which were contracted to be delivered in January.

As partial and immediate compensation for delays, the company is expected to deliver 120 million doses by the end of June – 90 million in the second quarter, in addition to the 30 million doses shipped by the end of March, an EU lawyer told the court.

Officials familiar with the case said the second trial is mostly procedural and substantive, but also allows for financial penalties to be imposed on the company.

The EU has put forward a request for preliminary compensation of € 1 while the damage assessment is being carried out. AstraZeneca’s decision to claim effective compensation for breach of contract will be considered at a later stage.

The official said the fine could be significant, but he declined to quantify the financial claim that could be approved by a judge.

Buhari lauds European Union’s support for Nigeria
Buhari lauds European Union’s support for Nigeria

President Muhammadu Buhari has appreciated the support of the European Union to Nigeria, which he said has been “in diverse ways, including humanitarian and trade relations.”

Speaking while receiving the outgoing Ambassador/ Head of the European Union delegation to Nigeria and the Economic Community of West African States (ECOWAS), Ketil Karlsen, the president appreciated the fact that the EU remains the largest trading partner with Nigeria, while members of the union equally remain the largest investors.

According to a statement by the Special Adviser to the President (Media and Publicity), Femi Adesina, President Buhari thanked the outgoing ambassador for facilitating the visits of French and German leaders during his tour of duty, noting that it was during Prime Minister Angela Merkel’s visit that the door to relationship with Siemens of Germany on power was opened.

In his response, Ambassador Karlsen, who has spent four years in Nigeria, said he enjoyed “excellent collaboration” with President Buhari, and with Nigeria.

The Ombudsman Took Part in an On-Line Conference Organized by the Members of the European Parliament
The Ombudsman Took Part in an On-Line Conference Organized by the Members of the European Parliament

On May 11, the Human Rights Ombudsman of the Republic of Artsakh participated in the online conference “The situation in Nagorno-Karabakh: prisoners of war and threats to Armenian population” organized by the Friendship Group with Artsakh people in the European Parliament.

Ombudsman Gegham Stepanyan and Deputy Minister of Foreign Affairs Armine Aleksanyan delivered speeches within the framework of the conference.

The Ombudsman presented the cases of inhuman treatment, torture, mutilation and murder of Armenian prisoners of war and captives by the Azerbaijani Armed Forces during and after the 44-day war and emphasized that any captive illegally detained in Azerbaijan is under imminent threat to life and health, therefore the immediate return of Armenian captives to their homeland is urgently needed.

Speaking about the actions of the international community, the Ombudsman highlighted the need for the international community to put pressure on Azerbaijan, noting that in this way it is possible to make Azerbaijan to fulfill its international obligations and return the Armenian captives.

Gegham Stepanyan urged the partners of the European Parliament to continue the struggle for the protection of the rights of the people of Artsakh both at the level of their states and at the pan-European level.

The post-war humanitarian situation and the problems and threats facing the people of Artsakh were discussed during the conference.

Over 56 400 cultural goods seized and 67 arrests in action involving 31 countries
Over 56 400 cultural goods seized and 67 arrests in action involving 31 countries

Despite constraints imposed by the COVID-19, the 2020 edition of the Pandora operation targeting the illicit trafficking of cultural goods has been the most successful to date with over 56 400 cultural goods seized.  These objects include archaeological objects, furniture, coins, paintings, musical instruments and sculptures.

Running between 1 June and 31 October 2020, Pandora V saw the involvement of customs and law enforcement authorities from 31 countries.

During the operational phase, tens of thousands of checks and controls were carried out in various airports, ports, border crossing points, as well as in the auction houses, museums and private houses. As a result, more than 300 investigations were opened, and 67 individuals arrested.

Given the global nature of this crime, operation coordination units working 24/7 were established by Europol on one side, and the World Customs Organization and INTERPOL on the other, to support the exchange of information as well as disseminate alerts, warnings and perform cross- checks in different international and national databases.

This operation was led by the Spanish Civil Guard (Guardia Civil), with the international coordination supported by Europol, INTERPOL and the WCO. PANDORA V was carried out in the framework of the European Multidisciplinary Platform Against Criminal Threats (EMPACT).

Operational highlights

  • A total of 27 300 archaeological artefacts were seized as a result of a single investigation carried out by French Customs (Douane). A suspect was arrested, who now faces a prison sentence and a fine of several hundred thousands of euros.
  • The Spanish authorities seized more than 7 700 cultural goods including archaeological artefacts, coins, sculptures and statues, weapons, paintings and archives of sound, film and photography with a value in excess of €9 million.
  • During the operational phase, the Spanish Civil Guard (Guardia Civil) also finalised a complex investigation initiated within the framework of Pandora III. As a result, one individual was arrested and 94 objects stolen in various places of worship were recovered. A total of €165 000 in cash was seized at his home. The arrestee is suspected of trying to sell online these stolen goods, such as a 16th century silver chalice and an illuminated manuscript of the Apocalypse by Beatus of Liébana.
  • During searches on the internet, the Swedish Police (Polisen) identified a folk art item stolen in Sweden in 2019. At that same online auction, the Swedish Police discovered a pair of 17th century candlesticks stolen from a Swedish church 8 years ago.
  • The Italian Carabinieri Corps (Arma dei Carabinieri) reported more than 2 700 cultural goods seized including ceramics, archaeological goods, art and books valued at €1 155 000.
  • The Hellenic Police (Ελληνική Αστυνομία) carried out 34 arrests and recovered a total of 6 757 antiquities, including ceramic and marble objects, as well as 6 452 coins, 5 533 of which were recovered in one single investigation. In one case, two Greek nationals were arrested for trying to sell 6 marble and clay antiquities for €150 000.
  • A total of 50 metal detectors were seized, and 6 of them were seized directly in archaeological sites, clearly demonstrating that such sites are under treat.
  • Several hundreds of Word War II grenades and other explosive devices were seized by the Police Force of the Slovak Republic (Policajný zbor Slovenskej republiky). This is a worrisome development as some of these old explosive devices are still functional and may lead to numerous casualties.

Results of the Cyber Patrol

Within the framework of the Operation Pandora V, the Dutch National Police (Politie) organised a five-day cyber patrol week focusing on online markets. Law enforcement from 15 countries, with the support of Europol, INTERPOL and WCO, identified suspicious sales online, as a result of which 15 new investigations were opened. 

International coordination

Europol, as co-leader of this action, played a key role in implementing the entire operation by facilitating information exchange, and providing analytical and operational support. The WCO also facilitated intelligence exchange among different agencies through a special user group created on its CENComm communication platform.

INTERPOL connected Balkan and European participating countries, facilitating the exchange of information through its secure communications system. A dedicated expert supported the entire operation by double checking searches against INTERPOL’s Stolen Works of Art database to locate and identify stolen and missing items.


Participating countries: Albania, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Latvia, Luxemburg, Malta, the Netherlands, North Macedonia, Montenegro, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey and the United Kingdom

EMPACT
In 2010 the European Union set up a four-year Policy Cycle to ensure greater continuity in the fight against serious international and organised crime. In 2017 the Council of the EU decided to continue the EU Policy Cycle for the 2018 – 2021 period. It aims to tackle the most significant threats posed by organised and serious international crime to the EU. This is achieved by improving and strengthening cooperation between the relevant services of EU Member States, institutions and agencies, as well as non-EU countries and organisations, including the private sector where relevant. Organised property crime is one of the priorities for the Policy Cycle.

European Union one step closer to Green Passports
European Union one step closer to Green Passports
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    <figure class="">&#13;
        <a href="/data/cache/noticias/81258/0x0/green-passport.jpg" class="gallery" title="Europe plans to launch this digital health card in June with which to save the summer vacation season" rel="nofollow"> </a>&#13;
        <span>Europe plans to launch this digital health card in June with which to save the summer vacation season</span>        </figure>


    The European Commission Monday took decisive steps towards the creation of a “green” or “vaccine passport” through a pilot test for what is viewed as the new normal.

“The testing phase of the digital green pass begins today in 18 member states plus Iceland,“ a spokesperson for the EU announced, who added that ”as of today, we are testing the interoperability of the facilities that will produce the passes, uploading and downloading data. Until now we do not use real data, but test data, but, as of June 1, member states will be able to upload real data. real.“

The European Commission is developing a unified data centre platform that allows different national applications to ”communicate“ with each other, thus making travel between EU countries. It is the testing of this unified database that started Monday.

The Digital Green Pass ”is on the right track, construction is on schedule and will be ready this summer,“ the spokesperson quoted by the Italian news agency ANSA added.

The source added that “we are confident that we will finish the works in the period of time we have always talked about,” meaning by the end of May.

Europe plans to launch this digital health card system in June with which to save the summer vacation season, by allowing travellers to prove that they have been vaccinated against Covid-19 or have tested negative.

The pass, issued by a doctor or health centre, would contain a QR code with pre-authenticated information that the traveller has been vaccinated against the virus or has had a negative result in the PCR test.

The QR code, printed on a piece of paper, would serve as proof of immunity. It would also be possible to scan the code into a smartphone app.

The apps are being created by the EU member states. France, for example, has already been testing its application for a couple of weeks for airline flights. And in Germany, a team led by IBM is creating one application for users and a second “verification” application for officials, such as airline personnel or border guards: a “green” result means that the health card is authentic; “red” it is not.

European Union provides €500,000 to WFP for Covid-19 recovery in Rwanda
European Union provides €500,000 to WFP for Covid-19 recovery in Rwanda

KIGALI – The United Nations World Food Programme (WFP) welcomes €500,000 from the European Union (EU) to provide technical support to Rwanda’s COVID-19 recovery efforts.

With this contribution, WFP will support Government efforts to ensure that social protection is expanded to the most vulnerable and food insecure Rwandans and responds to the unique challenges presented by the pandemic.
With this contribution, WFP will support Government efforts to ensure that social protection is expanded to the most vulnerable and food insecure Rwandans and responds to the unique challenges presented by the pandemic.

The new funding will also support evidence generation on food security, markets, and supply chains to inform the Government and partners in their investments in COVID-19 recovery.

“To ensure an effective COVID-19 recovery, it is vital for Rwanda to harness strategic technical expertise that will strengthen its social protection and food security systems to efficiently support national economic recovery,” said Ambassador Nicola Bellomo, Head of the EU Delegation in Rwanda.

WFP has widely recognized expertise in food security analysis and a close partnership with the Government in social protection. WFP will work to assist the Local Administrative Entities Development Agency on national systems for social protection targeting, monitoring and evaluation and feedback to support the response to vulnerabilities associated with COVID-19.

“The Government’s response to mobilizing the social protection system as a key platform for the COVID-19 response has been impressive to date,” said Edith Heines, WFP Rwanda Representative and Country Director.

“With this generous support, WFP will help the Government make the national social protection system even more shock-responsive, building on the lessons learned from the pandemic.”

This support is a contribution to the ongoing food security and vulnerability analysis as well as to food market and supply chain monitoring and their recovery from COVID-19.

This contribution is 100 percent funded by the EU under the Sector Reform Contract to enhance the agriculture sector’s sustainable use of land and water resources, value creation and contribution to nutrition security through its budget support action in response to the COVID-19 crisis.

  #    #      #

Follow us on Twitter: @wfp_africa, @EdithHeinesWFP @EUinRW, @nicolabellomo

Contact
For more information please contact:

Emily Fredenberg, WFP/Kigali,
emilyjean.fredenberg@wfp.org,
Mobile: +250 789 451 347

How easy would it be for Scotland to rejoin the European Union?
How easy would it be for Scotland to rejoin the European Union?

Scotland’s separatist parties won a majority of seats at last Thursday’s election, meaning leaving the United Kingdom is once again being talked about.

First Minister Nicola Sturgeon’s Scottish National Party (SNP) and the Scottish Greens, both stood on a platform of independence and rejoining the European Union, winning more than 50% of the vote.

The UK government is currently ruling out another referendum, but if the moment does arrive, how easy would it actually be for the Scots to rejoin the EU?

Kirsty Hughes, director of the Scottish Centre on European Relations said there wouldn’t be too much difficulty, given the country’s recent history within the bloc.

“If there is a yes vote in a referendum, then I think if it’s in the next five years, Scotland is going to still be very close to EU laws and legislation that’s got almost half a century experience being within the European Union,” Hughes told Euronews. “So I think there is a fairly clear path to accession.”

“An independent Scotland is going to have to realise though that there’s a process to go through, criteria to meet,” she added. “There’s no sort of nice wishful thinking and the wave of a wand and you’re just back in because you were in once before.”

Right now, the UK is in almost complete alignment with EU law, but this could change over the next few years, depending on how far the UK decides to go in its own post-Brexit direction.

Scotland would also have to establish various new institutions that EU membership requires.

“If it’s applying to join the EU, is going to be a new state,” Hughes explained. “it hasn’t been a state for the past 300 years. So it will have a lot of different institutions and regulatory bodies, laws to set up things that were previously done from London or at a UK level.

“So, although in one way it looks fairly simple for Scotland to meet the so-called Copenhagen criteria, to show that it’s a properly functioning democracy, to show that it’s a market economy.”

There would also be the issue of the border between Scotland and England, one country inside the EU, the other out. But Hughes says the experience of the Irish border difficulties that are currently going on would make this process slightly easier.

On the European side, any agreement between Edinburgh and Brussels would require the blessing of all member states, with some countries, particularly Spain, having their own separatist problems to consider.

Spain would be fine about [a] membership application as long as the independence process had been legal and constitutional, and what that will especially mean from Spain’s point of view and from other EU member states point of view is essentially that London and Edinburgh agreed it,” Hughes told Euronews.

“If London isn’t internationally recognised in Scotland and if Scotland is somehow leaving the UK without a negotiated divorce, then that will be very messy indeed.”

But the SNP leader has previously said that this is not a process she even wants to contemplate.

She did say that an advisory referendum could be held if the UK government blocks any legal referendum, but the preference is for a legitimate vote.

One area which might be of major concern though is public finances.

An independent Scotland could risk beginning its new life with a much higher deficit than EU rules normally allow.

Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulations
Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulations
Chalfont Saint Peter, UK – May 10, 2021 – A research report from RWS, the world’s leading provider of technology-enabled language, content management and intellectual property services, highlights the impact of COVID-19 on medical device manufacturers, and their readiness to meet the European Union’s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) deadline.

The research, involving leading medical device organizations operating in Europe, looks at how the pandemic has affected their preparations to meet the 26 May 2021 deadline for the EU MDR, and EU IVDR deadline of 26 May 2022. The research paints an optimistic picture: almost three-quarters (70%) of organizations are positive about meeting the MDR deadline, while 69% remain positive about meeting the IVDR deadline in 2022.

Research highlights:
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· 44% of organizations admit the MDR and IVDR regulations are their top priority, and over half (53%) say they will be impacted by both requirements.

· 42% say their technology stack evolution is the most important transformation initiative they have put in place to complete EU MDR/EU IVDR compliance.

· 56% of organizations felt that COVID-19 had a “significant” impact on supply chain management. Meanwhile 45% of respondents said COVID-19 had the most impact on their strategic planning for 2021.

· When asked what specific challenges the respondents faced during the COVID-19 crisis, 50% said increased or decreased product manufacturing demand had the most impact on their business.

“While it’s a positive sign that organizations feel optimistic about meeting their MDR and IVDR commitments, there’s clearly a lot of work to do post-pandemic,” explains Jon Hart, President of RWS Regulated Industries. “The decisions that medical manufacturing organizations make now won’t just affect their ability to comply with these two regulations, they will also play a continuing role in how quickly and effectively they can meet compliance standards in years to come. Introducing automation into the content management and translation process is a good first step, but a more visionary end-to-end solution that spans the manufacturing organization and the supply chain will better prepare organizations for the inevitable introduction of future regulations.”

Meeting the May deadline

Based on the survey results, organizations are advised to explore the following approaches to meet short and long-term commitments:

· Automation will be necessary to quickly meet compliance standards during and beyond EU MDR and EU IVDR implementation.

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Detention of EU nationals in UK ‘source of concern’, says EU Commission
Detention of EU nationals in UK ‘source of concern’, says EU Commission

The EU Commission has said the detention of EU nationals in the UK is a “source of concern” after it emerged people from the bloc were being held in removal centres after entering the country.

The commission is “closely following” what it describes as a “consular issue” whereby a number of EU citizens are reported to have been detained after entering the country for work without visas or residence status – treatment non-EU nationals in the same situation have long faced.

A statement released by the commission on Monday said it was particularly concerned about the conditions of and the duration for which these individuals were being held.

It comes after Politico reported that 30 EU nationals, including those from Germany, Greece and Italy, had been held in removal centres since the end of the Brexit transition period on 31 December 2020.

European embassies in London are said to be offering legal advice and intervening to try to shorten the period of detention, although not all EU citizens are seeking consular support.

EU nationals who were resident in the UK before the end of the transition period have until 30 June to apply for the EU settled status, which will grant them residency rights in the country.

Those who were not can enter Britain visa-free for tourism and stay for up to 90 days, but Home Office border officers are entitled to reject entry if they have reasonable grounds to suspect they intend to work in the country but cannot produce the necessary documentation.

The EU Commission said the EU delegation in London had met with the Home Office about the issue and remained in contact with their team, and that it “stands ready to support member states in so far as possible”.

“This does not seem to be a generalised trend as a small number of EU citizens are concerned. Nevertheless, the EU Delegation is following this case closely, in particular the conditions and the duration of retention, which are a source of concern,” the commission added in a statement.

A Home Office spokesperson said EU nationals who were not resident in the UK prior to 31 December 2020 were required to evidence their right to live and work in the country upon entry, “as the public expects”.

“If an EU citizen is considering moving to the UK for work or study, we encourage them to check the requirements for applying for a visa – we have communicated this requirement in every EU country, translated information into EU languages, and have worked closely with the Foreign Office and EU consulates to encourage EU member states to also communicate this to their citizens,” they added.

Monsanto's Roundup remains banned in European Union as court rejects Bayer's appeal
Monsanto’s Roundup remains banned in European Union as court rejects Bayer’s appeal


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                By <a href="stlouis/bio/6841/Greg+Edwards" class="u-link u-link-color" data-ct="APT: Reporter byline name" rel="author">Greg Edwards</a>
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                    Reporter, St. Louis Business Journal            </div>

            <time class="js-relative-time" data-relative-time="2021-05-10T11:47:00-05:00">May 10, 2021</time>

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<p class="content__segment combx paywall__content">The top court in the European Union rejected an appeal by Bayer to lift a ban on weed killers, including Monsanto's Roundup.</p>

The European Court of Justice dismissed Bayer’s appeal of a lower E.U. court’s 2018 decision upholding the ban, saying there were no legal errors, Seeking Alpha reported.

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    <p class="content__segment combx paywall__content">The ban dates to 2013, when the E.U. placed limits on the use of three pesticides, saying they were “harmful” to Europe’s honeybee population when used to treat flowering plants with nectar that attracts the insects.</p>

Last month, a Mexico court sided with Bayer in a government attempt to ban Roundup. Mexican President Andres Manuel Lopez Obrador issued a decree late last year that seeks to completely ban glyphosate, the active ingredient in Roundup, by 2024, even as the company always has insisted the product is safe and has been used safely in Mexico for more than 40 years.

Tens of thousands of lawsuits have been filed against Monsanto and Bayer claiming the weed killer caused non-Hodgkin’s lymphoma. Bayer, which acquired Roundup with its $63 billion purchase of St. Louis-based Monsanto in 2018, has said it would pay up to $10.9 billion to settle existing Roundup lawsuits, as well as litigation involving several other Monsanto products. Bayer said it had reached a $2 billion deal to resolve future lawsuits over Roundup claims. A U.S. federal court hearing on that deal has been postponed by one week until May 19, following previous delays.

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Commission makes €11 million available to strengthen cybersecurity capabilities and cooperation
Commission makes €11 million available to strengthen cybersecurity capabilities and cooperation

The European Commission will make €11 million of funding available for 22 new projects seeking to strengthen the European Union’s capacity to deter and mitigate cyber-threats and incidents, by employing the latest technologies. The projects, which have been selected following a recent call for proposals under the Connecting Europe Facility programme, will support various cybersecurity organisations in 18 Member States. The beneficiaries of the funding include Computer Security Incident Response teams, operators of essential services in the health, energy, transport and other sectors, as well as bodies dealing with the cybersecurity certification and testing, as defined in the EU Cybersecurity Act. They will start working after the summer on tools and skills necessary to comply with the requirements set by the NIS Directive and the Cybersecurity Act, while at the same time they will engage in activities aimed to enhance cooperation at the EU level. So far the EU has funded almost €47.5 million to reinforce EU cybersecurity between 2014 and 2020, through the Connecting Europe Facility programme. Furthermore, over €1 billion under the Digital Europe Programme will be directed towards the areas of focus of the new EU Cybersecurity Strategy. More information is available here. More information about Europe’s actions to strengthen cybersecurity capacities is available here and EU-funded cybersecurity projects can be found here.