Archive for the ‘European Union’ Category

Labour must say it out loud: Brexit needs to be reversed – The Guardian

He did not want to die until Brexit was reversed. These words were spoken at the funeral last week of my dear friend and former Observer colleague Dick Leonard.

Dick died a month ago at the ripe old age of 90. The speaker was his widow, Irne Heidelberger-Leonard, before a group of mourners who included the Labour leader Keir Starmer, to whom Dick had been something of a political mentor.

Dicks devotion to the European cause was such that he jeopardised his political career he was parliamentary private secretary to the Labour cabinet minister Anthony Crosland from 1970 to 1974 when he joined 68 other Labour rebels, led by Roy Jenkins, in voting in 1971 in favour of joining the European community, against Labour policy at the time. Yes, Labours attitude towards what is now the EU has always been a rollercoaster ride, and here we go again, with prominent Labour politicians lamely accepting a Brexit that is manifestly a disaster and needs to be reversed.

Why, even that prominent culprit and architect of the lying Leave campaign appeared to be having second thoughts about it all in his BBC Two interview last week. Is Brexit a good idea? No one on Earth knows, averred the shameless Dominic Cummings. Indeed, said the prime ministers former best friend, it was perhaps perfectly reasonable to say Brexit was a mistake.

Ill say it is perfectly reasonable. Many of us here on Earth know that only too well. But Cummings almost indicating that in delivering Brexit for Johnson he was merely acting in the capacity of a hired mercenary also told us that anyone convinced that Brexit was a good thing must have a screw loose.

The media are now replete daily with disaster stories. The Northern Ireland protocol is unworkable. The egregious Brexit minister Lord Frost makes this country a laughing stock every time he says the deal that the UK signed up to for the short-term political convenience of Johnson should be renegotiated on the grounds that the EU is being wait for it unreasonable! He calls to mind the Groucho Marx quip: These are my principles. And if you dont like them well, I have others.

One begins to wonder whether Cummings now thinks that, on top of all the other well-publicised prime ministerial gaffes, the chaos of Brexit may contribute to Johnsons downfall a significant signpost being the way freedom day on 19 July swiftly turned into fiasco day in the same week that the Northern Ireland crisis became wholly manifest. In the former case it did not need footballers to embarrass the government: just the chief executive of Marks & Spencer.

But back to my late friend Dick Leonard, with whom I often worked covering European matters when he was based in Brussels. Many of the problems brought about by the Brexiters might have been avoided if they had consulted the invaluable guides to the EU he jointly wrote for the Economist and later the publishers Routledge. In the 2016 edition of The Routledge Guide to the European Union, the authors Dick and another EU expert, Robert Taylor observed of the impending UK referendum: Not everybody would accept that it would be a win-win situation for both Britain and the EU if voters choose to remain, but it will assuredly be a lose-lose one if they decide to quit.

If the Brexiters had consulted the guide, they could have discovered what the customs union and the single market actually were, and what making the crass decision to abandon the hard-won privileges of membership would entail (privileges won, in the case of the single market, not least by their ostensible political heroine Margaret Thatcher). It beggars belief that, after the deed was done and the cabinet Brexiters were faced with reality, they had to have both institutions explained to them by our former ambassador to the EU, Sir Ivan Rogers.

Alas, as that astute observer Denis MacShane a former Labour minister for Europe recently pointed out, Johnson needs a permanent war with the EU to prove that the Battle of Brexit is not over. This in the name of a country that went to war in 1939 to save Europe, and whose prime minister, Winston Churchill, even proposed, in 1940, what would have in effect been a political union of the UK and France.

Above all, says MacShane who probably coined the term Brexit and certainly forecast the result of the referendum Johnson wants the main opposition, Labour, to say nothing about Brexit.

But the time has assuredly come, and those words of our friend Dick Leonards widow he did not want to die until Brexit was reversed will, I hope, stiffen Starmers resolve.

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Labour must say it out loud: Brexit needs to be reversed - The Guardian

Mini trade war imminent? EU rejects the UK’s attempts to overhaul the Brexit deal – CNBC

LONDON, ENGLAND - JUNE 09: Cabinet Minister Lord Frost (R) chairs the first meeting of the Partnership Council followed by the eighth meeting of the withdrawal agreement joint committee with his EU counterpart Maros Sefcovic (L), Richard Szostak, Principal Adviser, Service for the EU-UK Agreements (2ndL) and Paymaster General, Penny Mordaunt (2ndR), on June 9, 2021 in London, England.

Eddie Mulholland - WPA Pool/Getty Images

The European Union rejected a call from the British government to overhaul the Northern Ireland Protocol, a key tenet of the agreement that saw the U.K. leave the EU in 2020.

U.K. Brexit Minister David Frost and Secretary of State for Northern Ireland Brandon Lewis on Wednesday set out a "command paper" urging European leaders to renegotiate the protocol, on the basis that it has turned out to be unworkable in practice.

"We are ready to continue to seek creative solutions, within the framework of the Protocol, in the interest of all communities in Northern Ireland," the European Commission said in a statement late on Wednesday. "However, we will not agree to a renegotiation of the Protocol."

The deal was negotiated and signed by the British government in 2019 and ratified by the British Parliament, but the government is now seeking to renege on its commitments due to the challenges arising from its implementation.

The protocol, in principle, helps prevent customs checks and an effective land border between Northern Ireland, which is part of the U.K., and the Republic of Ireland, which remains in the EU.

BELFAST, NORTHERN IRELAND - APRIL 07: Nationalists and Loyalists riot against one another at the Peace Wall interface gates which divide the two communities on April 7, 2021 in Belfast, Northern Ireland.

Charles McQuillan/Getty Images

However, it has led to port inspections on goods traveling between Great Britain and Northern Ireland, a development that has angered businesses and drawn criticism for effectively creating a border in the Irish Sea. This has stoked historical sectarian tensions in Northern Ireland.

Secretary of State for Business, Energy and Industrial Strategy Kwasi Kwarteng told Sky News on Thursday that "nobody could guarantee the effects of the Northern Ireland Protocol until we left the EU."

Kwarteng also claimed the agreement wasn't "written in stone," despite it being written into international law.

Christopher Granville, managing director for EMEA and global political research at TS Lombard, told CNBC Thursday that the process of kicking the can down the road on Northern Ireland has already begun, with a three-month extension in place until September of a grace period on food and other products being transported between Great Britain and Northern Ireland.

The British government said in its command paper that it believes the current situation satisfies the criteria for invoking Article 16 of the Protocol, which allows for its suspension in the case of "serious economic difficulties." However, it has expressed reluctance to trigger this clause just yet. The EU, Granville said, will take the position that a party cannot claim "serious difficulties" before the full terms of the agreement have been implemented.

A lorry passes through security at the Port of Larne in Co Antrim, Northern Ireland on December 6, 2020.

PAUL FAITH | AFP | Getty Images

"These positions point to the following kind of negotiation: the EU rejects the U.K. proposal for an 'honesty box' approach to goods shipments from GB to NI; but the EU will propose fast-track regulatory checks on shipments of foodstuffs arriving in NI from GB with additional facilitations for trusted traders," Granville explained.

"To the extent that such negotiations produce any agreements, both sides will be able to claim victory: the UK will say that it has renegotiated the Protocol, the EU will say that it has found the best way to implement the Protocol."

However, he noted that such agreements will be difficult to establish, and there will be "cliff-hangers" as the grace periods approach their expiry date and the parties come out with the "usual threats" of withdrawal and litigation.

While these disputes grab the headlines, Granville said the crucial reality unfolding beneath the surface will be a fundamental shift in supply chains.

"Essentially these will shift from east-west (i.e. GB-NI) to north-south (i.e. ROI-NI, with ROI in this context meaning both Ireland in its own right and as a channel for shipment from all of the rest of the EU)," he explained.

LONDON - Brexit minister Lord Frost making a statement to members of the House of Lords in London on the government's approach to the Northern Ireland Protocol.

House of Lords/PA Images via Getty Images

"This adjustment will mean over time (even in time for Christmas) that there will be no empty shelves in NI supermarkets on the basis of which U.K. politicians could invoke the 'serious economic difficulties' criterion of Article 16."

British businesses such as Marks & Spencer that are facing delays in fresh produce delivery from Great Britain to Northern Ireland would then have to either expand their supply chains within the Republic of Ireland, Granville suggested, or leave their Northern Irish market share to be taken up by a company operating in the Republic or the broader EU.

James Smith, developed markets economist at ING, said there are two possible ways the renewed stand-off could affect the British economy.

"A positive though seemingly unlikely outcome is that the UK government opts to align more closely to EU food standards after all, removing barriers not only for GB-NI trade, but also on exports to the EU," he told CNBC on Thursday.

"But with trust between both sides clearly low, the bigger near-term question is whether further legal steps are taken by Brussels that eventually culminate in tariffs and in a negative scenario, some form of mini trade war."

Although things may not get that far in reality, Smith said, such a scenario would reintroduce disruption to U.K. exports which have partially recovered from the sharp decline in January, after the U.K.'s formal separation from the bloc.

BELFAST, Northern Ireland: A Loyalist holds a placard with words 'Stormont Or The Protocol?' during a protest against the Northern Ireland Protocol at the entrance to Belfast Harbour.

Artur Widak/NurPhoto via Getty Images

"At a bigger macro level however, the effects of Covid-19 are still likely to dominate the outlook over coming months, with the impact of Brexit likely to have a less noticeable impact on GDP in the short-term," Smith added.

TS Lombard's Granville suggested that the main opposition Labour party in the U.K. may push for the "easy and instant solution" of aligning with the EU's food standards, which Prime Minister Boris Johnson's pro-Brexit Conservative government will be reluctant to do as it undermines the "sovereignty" at the core of its electoral platform.

He anticipates that if the process of kicking the can down the road lasts until the Northern Irish elections next May, and present polling remains consistent, pro-Irish republican party Sinn Fein will emerge as the largest single party in the devolved Northern Irish Assembly.

"I haven't yet got a clear view for now on exactly how this might change the political dynamic over the Protocol dispute, but it will surely do so," Granville said.

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Mini trade war imminent? EU rejects the UK's attempts to overhaul the Brexit deal - CNBC

Pegasus row: United Nations to European Union, here is how the world reacted – India Today

Revelations by a consortium of media agencies that politicians, journalists and activists were potential targets of surveillance through Pegasus software of Israeli surveillance company NSO Group have triggered outrage around the globe.

While the world went into a tizzy, Israel has ordered a probe to review the allegations against NSO. However, NSO has claimed the list in public domain wasn't theirs.

NSO Group has maintained that the software was only sold to governments and not to private players. Ariela Ben Avraham, Global Communications Director, NSO Group told India Today, "We only sell to governments and law enforcement agencies. List of countries mentioned in the reports was not accurate."

Although NSO refused to reveal names of countries contracted with the company, they welcomed any kind of probe.

"We will welcome any probe initiated by the Israeli government. NSO is not related to the list published by Forbidden Stories; it never was an NSO list - it is fabricated information; a possible list of targets/potential targets is false information. NSO does not have access to data of people mentioned in the list," Avraham said.

It has been reported widely that the software sold by the Israeli surveillance company has been used by governments to snoop on individuals and entities having a divergent position from that of that country.

ALSO READ | Pegasus updated guide: How it infects phones, what it does, how to detect and get rid of it

WHAT UN, EU SAID ON PEGASUS SNOOPING ROW

The United Nations and the European Union are among a list of international organisations and countries that have condemned the acts by governments.

The UN Human Rights chief said the apparent widespread use of Pegasus spyware to illegally undermine the rights of those under surveillance was "extremely alarming" and confirmed "some of the worst fears" surrounding the potential misuse of such technology.

"Various parts of the UN Human Rights system, including my own Office, have repeatedly raised serious concerns about the dangers of authorities using surveillance tools from a variety of sources supposed to promote public safety in order to hack the phones and computers of people conducting legitimate journalistic activities, monitoring human rights or expressing dissent or political opposition," High Commissioner Michelle Bachelet said in a statement.

The UN Human Rights High Commissioner said that a "red line" was crossed by the use of the Pegasus spyware by state actors and termed it "completely unacceptable".

"Freedom of media, free press is one of the core values of the EU. It is completely unacceptable if this (hacking) were to be the case," said European Commission president Ursula von der Leyen in Prague.

"What we could read so far, and this has to be verified, but if it is the case, it is completely unacceptable. Against any kind of rules we have in the European Union," Urusula von der Leyen said.

While most affected nations have been cautious with their response, saying they do not discuss security protocols, this could impact bilateral relations between nations if the forensic reports prove snooping.

ALSO READ | Rahul Gandhi, Prashant Kishor, 2 Union ministers targeted by Pegasus: Report

WHICH COUNTRIES ARE ON PEGASUS SPYWARE LIST

According to the consortium's analysis of the leaked data, at least 10 governments are believed to be NSO customers who were entering numbers into a system: Azerbaijan, Bahrain, Kazakhstan, Mexico, Morocco, Rwanda, Saudi Arabia, Hungary, India, and the United Arab Emirates (UAE).

Analysis of the data suggests the phone numbers that were selected, possibly ahead of a surveillance attack, spanned more than 45 countries across four continents.

WHAT DID AMNESTY INTERNATIONAL SAY ON PEGASUS ROW

While the NSO Group has rejected the list, Amnesty International said it stood by the Pegasus spyware list contrary to inaccurate media stories in relation to the project.

They said that the rumours were false and intended to distract from the widespread unlawful targeting.

"Amnesty International categorically stands by the findings of the Pegasus Project, and that the data is irrefutably linked to potential targets of NSO Group's Pegasus spyware. The false rumours being pushed on social media are intended to distract from the widespread unlawful targeting of journalists, activists and others that the Pegasus Project has revealed," Amnesty International said in a statement.

ALSO READ | Pegasus controversy, a legal viewpoint | Expert Opinion

HOW AFFECTED COUNTRIES REACTED TO PEGASUS ROW

France has already ordered an investigation and said it would sue countries actively involved in spying on their nationals. French President Macron convened an emergency meeting on Thursday to discuss reports that his cellphone and those of top officials might have been targeted by the spyware.

Some others like Hungary and India have already denied these allegations.

Peter Szijjarto, Hungarian Foreign Minister said, "I am unaware of any such data collection, and I have never been aware of it."

Speaking to the media he added, "The technical tool, let's call it software, is not used by the Information Office and the agency did not make any agreement of using it."

Reports said the leak contained a list of more than 50,000 phone numbers which, it is believed, have been identified as those of people of interest by clients of NSO since 2016.

ALSO READ | Amit Shah invokes 'aap chronology samajhiye' in response to Pegasus spyware allegations

ALSO READ | Pegasus a weapon used against terrorists, says Rahul Gandhi, demands Amit Shah's resignation

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Pegasus row: United Nations to European Union, here is how the world reacted - India Today

More than half of adults in European Union countries fully vaccinated against Covid – WION

The European Union on Thursday said that 200 million Europeans had been fully vaccinated against coronavirus. This translates to more than half of the adult population in European Union. However the bloc still short of 70 per cent target it had set for the summer.

European Commission spokeswoman Dana Spinant told reporters that based on the latest data of the European Centre for Disease Control "54.7 percent of the adult population is fully vaccinated with either two doses or one dose in the case of the Johnson and Johnson vaccine".

"We have 68.4 per cent of adults in the EU who have already had their first dose," she added.

"We are now among the regions of the world that have vaccinated the most, but it is important that this progress is distributed in a more balanced way so that there are no pockets where the virus can spread and mutate," she added.

Rollout of vaccines was slower in Europe than in the UK or US due to supply shortages. This had drawn heavy criticism earlier this year.

The European Commission, which coordinated vaccine orders for the 27 member states, was the subject of many of the complaints.

European Commission chief Ursula von der Leyen had announced on July 10 that the EU had enough doses to vaccinate "at least 70 percent of the adult population this month".

According to official data compiled by AFP, just over 440 million doses have been administered in the European Union. That is 98.4 doses per 100 inhabitants, while the United States are at 102.4 per 100 inhabitants.

(With inputs from agencies)

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More than half of adults in European Union countries fully vaccinated against Covid - WION

VERQUVO (vericiguat) Approved in the European Union – Business Wire

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO (vericiguat). In the EU, VERQUVO (2.5 mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. VERQUVO is being jointly developed by Merck and Bayer AG. Merck has the commercial rights to VERQUVO in the United States and Bayer has the exclusive commercial rights in the rest of world. Bayer also issued a news release earlier today announcing the EC approval.

In January of this year, the U.S. Food and Drug Administration (FDA) approved VERQUVO in the U.S. to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. In the U.S., the product label for VERQUVO contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. For more information, see Selected Safety Information below. In June, the medicine was approved by the Ministry of Health, Labour, and Welfare (MHLW) in Japan. Bayer has also submitted applications for marketing authorization of the medicine in China as well as multiple other countries worldwide.

This announcement reflects another important regulatory milestone in the development of this medicine, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.

About VERQUVO (vericiguat) tablets for once daily oral use (2.5 mg, 5 mg and 10 mg)

VERQUVO is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

Selected Safety Information for VERQUVO in the United States

WARNING: EMBRYO-FETAL TOXICITY

Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.

VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. VERQUVO is contraindicated in pregnancy. Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.

In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency greater than or equal to 5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).

Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension.

There are no data on the presence of VERQUVO in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.

About the Worldwide Collaboration Between Bayer and Merck

Since October 2014, Bayer and Merck have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and Merck. Merck has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.

About Merck

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the worlds most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the companys ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the companys patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2020 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov).

Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_pi.pdf and Medication Guide at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_mg.pdf.

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VERQUVO (vericiguat) Approved in the European Union - Business Wire