Archive for the ‘European Union’ Category

Russia Belongs at the Center of Europe – Foreign Policy

The Western attempt to expel Russia from Europe has failed. That there was such an attempt was always implicit in the strategy of seeking to admit every European country but Russia into NATO and the European Union. In this context, the NATO slogan A Europe Whole and Free is an explicit statement that Russia is not part of Europe.

But as French President Emmanuel Macron has reminded us, Russia is part of Europe and is simply too big, too powerful, and too invested in its immediate neighborhood to be excluded from the European security order. A continued strategy along these lines will lead to repeated Russian attempts to force its way back in. At best, this will lead to repeated and very damaging crises; at worst, to war.

A structure needs to be created that can defend the interests of NATO and the EU while at the same time accommodating vital Russian interests and preserving peace. The solution lies in a modernized version of what was once called the Concert of Europe.

The Western attempt to expel Russia from Europe has failed. That there was such an attempt was always implicit in the strategy of seeking to admit every European country but Russia into NATO and the European Union. In this context, the NATO slogan A Europe Whole and Free is an explicit statement that Russia is not part of Europe.

But as French President Emmanuel Macron has reminded us, Russia is part of Europe and is simply too big, too powerful, and too invested in its immediate neighborhood to be excluded from the European security order. A continued strategy along these lines will lead to repeated Russian attempts to force its way back in. At best, this will lead to repeated and very damaging crises; at worst, to war.

A structure needs to be created that can defend the interests of NATO and the EU while at the same time accommodating vital Russian interests and preserving peace. The solution lies in a modernized version of what was once called the Concert of Europe.

The current security order has reached its limit. Until 2007-2008, the expansion of the EU and NATO appeared to have proceeded flawlessly, with the admission of all the former Soviet satellites in Central Europe and the Balkans, as well as the Baltic states. Russia was unhappy with NATO expansion but did not actively oppose it. Then, however, both NATO and the EU received decisive checks, through their own overreach.

At the NATO summit in Bucharest, Romania, in 2008, the United States and its allies, though denied an immediate Membership Action Plan for Ukraine and Georgia because of the opposition of France and Germany, procured a promise of those countries eventual membership. Seen from Moscow, this created the prospect that NATO would include countries with territorial disputes (and in the case of Georgia, frozen conflicts) with Russia; that (as in the Baltic states) NATO would give cover to moves to harm the position of local Russian minorities; and that NATO would expel Russia from its naval base at Sevastopol and from the southern Caucasus.

Later that year, the Russo-Georgian War should have sounded the death knell of further NATO expansion, for it demonstrated beyond doubt both the acute dangers of territorial disputes in the former USSR and that in the last resort Russia would fight to defend its vital interests in the region, and the West would not fight. This is being demonstrated again today by the repeated and categorical statements from Washington and Brussels that there is no question of sending troops to defend Ukraine; and if NATO will not fight for Ukraine, then it cannot admit Ukraine as an ally. It is as simple as that.

The rise of China is the other factor that makes the exclusion of Russia unviable. For this project was developed at a time when Russia was at its weakest in almost 400 years and when Chinas colossal growth had only just begun. This allowed the West possibilities that today have diminished enormously, if as seems likely China is prepared to strengthen Russia against Western economic sanctions.

The EU too has reached the limit of its expansion eastward. On the one hand, there is Ukraines size (44 million people), corruption, political dysfunction, and poverty (GDP per capita thats one-third of Russias). Perhaps more importantly, EU expansion to eastern Europe no longer looks like the unconditional success story that it did a decade ago.

Romania, Bulgaria, and other states remain deeply corrupt and in many ways still ex-communist. Poland and Hungary have developed dominant strains of chauvinist and quasi-authoritarian populism that place them at odds with what were supposed to be the core values of the EUand that in some respects bring them closer ideologically to the regime of Russian President Vladimir Putin. After this experience, there is no chance that the EU will admit a country like Ukraine in any foreseeable future.

An acknowledgment of these obvious truths (which are acknowledged in private by the overwhelming majority of Western officials and experts) should open the way to thinking about a new European security architecture that would incorporate NATO and the EU while reducing the hostility between these organizations and Russia. We should aim at the creation of this new system as part of the solution to the present crisis, and in order to avoid new ones.

This requires a return to a more traditional way of thinking about international politics. For a key problem of the Wests approach to Russia since the end of the Cold War is that it has demanded that Russia observe the internal rules of behavior of the EU and NATO without offering EU and NATO membership (something that is in any case impossible for multiple reasons).

In recent years and in the wider world, the U.S. establishment by contrast has loudly announced the return of great-power politicsand this is true enough as far as it goes. Certainly the idea of a monolithic rules-based global order, in which liberal internationalism acts as a thin cover for U.S. primacy, is now dead.

The problem is that most members of the U.S. establishment have become so wedded to belief in both the necessity and the righteousness of U.S. global primacy that they can see relations with other great powers only in confrontational and zero-sum terms. Rivalry, of course, there will inevitably be; but if we are to avoid future disasters, we need to find a way of managing relations so as to keep this rivalry within bounds, establish certain genuine common rules, prevent conflict, and work toward the solution of common problems. To achieve this, we need to seek lessons further back in diplomatic history.

The essential elements of a new, reasonably consensual pan-European order should be the following: a traditional nonaggression treaty between NATO and the Russian-led Collective Security Treaty Organization (CSTO), by which both sides pledge not to attack the other militarily. As a matter of fact, neither side has any intention of doing so, and to put this on paper would reduce mutual paranoia and the ability of establishments on both sides to feed this paranoia for their own domestic purposes.

Full diplomatic relations should be established or reestablished between NATO and the CSTO and between the EU and the Russian-led Eurasian Economic Union. On the basis of this, intensive negotiations should be launched to achieve two goals: new arms control agreements in Europe, starting with nuclear missiles, and economic arrangements that would allow nonmembers of the EU and the Eurasian Economic Union to trade freely with both blocs, rather than forcing on them a mutually exclusive choice of trading partners.

When it comes to the avoidance and solution of conflicts, however, institutions involving all European countries are too large and too rigid to be of much use. The Russian establishment has also decidednot without reasonthat these are simply excuses for Western countries to agree to a common position and then present it to Russia as a fait accompli. The need is for a regular, frequent, but much smaller and less formal meeting place for the countries that really count in European security: the United States, France, Germany, and Russia (plus the United Kingdom, if it survives as one state and emerges from its post-Brexit bewilderment).

Such a European security council would have three goals: firstly, the avoidance of new conflicts through early consultation about impending crises; secondly, the solution of existing conflicts on the basis of common standards of realismin other words, who actually controls the territory in question and will continue to do so; and thirdly, democracythe will of the majority of the local population, expressed through internationally supervised referendums (a proposal put forward by Thomas Graham).

Finally, a European security council could lay the basis for security cooperation outside Europe. Here, the present situation is nothing short of tragicomic. In Afghanistan, the United States, NATO, the EU, Russia, and the CSTO have an identical vital interest: to prevent that country from becoming a base for international Islamist terrorism and revolution. And for all the greater complexity of the situation, this is also true in the end of the fight against the Islamic State and its allies in the Middle East and western Africa.

Among the other benefits of such a new consultative institution would therefore be to remind both the West and Russia that while Russian and NATO soldiers have never killed each other and do not want to, there are other forces out there that have killed many thousands of Americans, Russians, and West Europeans, would gladly kill us all if they could find the means to do so, and see no moral difference whatsoever between what they see as Western and Eastern infidel imperialism.

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Russia Belongs at the Center of Europe - Foreign Policy

What the SNP’s independence White Paper said about the European Union – HeraldScotland

THE Scottish Governments 650-page White Paper on Independence, published in late 2013, contained just eight pages on Scotland in the European Union, a sign that Brexit was yet to be taken seriously by either side of the constitutional debate.

The paper assumed the UK would still be part of the EU when Scotland became independent.

Although it flagged up the idea of Brexit, noting an in-out referendum was expected in 2017, there was no discussion of its implications, only the statement that independence offered a way to avoidbeing taken out of the EU against our will.

The prospectus assumed, again perfectly reasonably for the time, that an independent Scotland and the rest of the UK would be in the EU single market and customs union, with continued free trade across the Anglo-Scottish border.

Alex Salmond and Nicola Sturgeon at the launch of the White Paper on independence

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The paper also said that Scotland would not have to apply to join the EU as an outside country, but would enjoy a smooth and timely transition to independent membership of the EU based on the principle of continuity of effect, as it was already inside it.

The paper said this membership process would be achieved in the 18 months after a Yes vote, while Scotland was still part of the UK and, therefore, part of the EU.

The paper did not propose a referendum on EU membership.

It said Scotland would retain the pound and not adopt the Euro.

Some key White Paper quotes:

It is the current Scottish Governments policy that Scotland remains part of the European Union. Between a Yes vote in 2014 and independence day, Scotland will agree the terms of our continuing membership of the EU. This will happen while we are still part of the UK and part of the EU, ensuring a smooth transition to independent membership.

The advantage of independence is that the people of Scotland will have the sole and final say. We will not be taken out of the EU against our wishes as may turn out to be the case if we are not independent.

An independent Scottish Government will, for the first time, be able to promote Scottish economic interests directly, protect Scottish citizens and participate on equal terms as all other member states in EU affairs.

The Scottish Government does not wish Scotland to leave the EU and does not support the Prime Ministers plans to hold an in-out referendum on EU membership.

Following a vote for independence, Scotland will become an independent EU member state before the planned in-out referendum on the EU in 2017. However, if we do not become independent, we risk being taken out of the EU against our will.

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What the SNP's independence White Paper said about the European Union - HeraldScotland

EU not closing diplomatic missions in Kyiv amid threat of Russian invasion | TheHill – The Hill

The Council of the European Union said on Saturday that diplomatic missions are not closing in Kyiv, Ukraine, despite what U.S. officials signal is an increasingly likely possibility that Russia will invadetheneighboringcountry.

The EU and its member states are coordinating their actions in view of the current threats on Ukraine,the council said in astatement. Our diplomatic missions are not closing. They remain in Kyiv and continue to operate in support to EU citizens and in cooperation with the Ukrainian authorities. Staff presence and travel advice to EU citizens are being adjusted as necessary to take into account security circumstances.

We reaffirm our continued support to Ukraines territorial integrity and sovereignty and diplomatic efforts towards de-escalation. We recall that any further military aggression against Ukraine will have massive consequences and severe cost in response, the statement continued.

The development comes as the U.S. State Department issued a travel advisory on Saturday morning saying that it had ordered most U.S. direct hire staff from the American Embassy in Kyiv to evacuate. A senior State Department official said on Saturday that some employeeswould remain in Kyiv, while otherswouldmoveto Lviv, located in the western part of Ukraine.

The German Foreign Office also announced on Saturday thatit would be reducingits diplomatic presence in the Ukrainian capital.

We will keep our embassy in #Kiew open but reduce our diplomatic staff. Our Consulate General Donetsk, based in Dnipro since 2014, is temporarily being relocated to Lviv, German Foreign Minister Annalena Baerbock said.

More than 100,000Russian troops have been amassed near the Ukrainian border as the international communityis concerned that Russia is preparing to invade Ukraine. U.S. officials have suggested that an invasion is increasingly likely from Russia and that it could happen any day now, according to White House national security adviser Jake SullivanJake SullivanEU not closing diplomatic missions in Kyiv amid threat of Russian invasion Sunday shows preview: White House says Russia could invade 'any day'; RNC censure resolution receives backlash Biden warns Putin of 'swift and severe costs' if Russia invades Ukraine MORE.

When I appeared on the Sunday shows last weekend, I made the point that we were in the window, that Russian military action could begin any day now. And that remains true. It could begin any day now. And it could occur before the Olympics have ended, Sullivan told reporters during a White House press briefing on Friday.

We are not saying that a decision has been taken a final decision has been taken by [Russian] President [Vladimir] Putin, he later added. What we are saying is that we have a sufficient level of concern, based on what we are seeing on the ground and what our intelligence analysts have picked up, that we are sending this clear message. And it remains a message that we have now been sending for some time.

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EU not closing diplomatic missions in Kyiv amid threat of Russian invasion | TheHill - The Hill

EU brings relief to victims of Iran floods – European Commission

In response to the widespread floods that ravaged most parts of Iran last month, the EU is providing 100,000 (over 4,75 billion Iranian rial) in humanitarian funding to assist the most affected communities.

The aid will benefit over 22,000 people in some of the hardest hit areas in the provinces of Hormozgan, Kerman, Sistan Baluchestan and Fars.

EU funding supports the Iranian Red Crescent Society (IRCS) in providing the most vulnerable communities with food packages and essential household items.

Iran has one of the worlds highest numbers of COVID-19 cases and all necessary measures will be in place to minimise the transmission of the virus during the operation.

The funding is part of the EUs overall contribution to the Disaster Relief Emergency Fund (DREF) of the International Federation of Red Cross and Red Crescent Societies (IFRC).

More than 80,000 people in 20 provinces have been affected by the floods, triggered by days of heavy rainfall that started on 1 January. The floods have killed 10 people, and damaged homes and agricultural landsthe main livelihood for many.

The floods, which also caused widespread destruction of the drinking supply system, vital facilities, and other infrastructure, have brought transportation to a halt. They have forced relief teams to bring critical supplies to flood-ravaged communities by air.

Affected people have been evacuated to safe areas and medical care has been provided to those injured.

The European Union together with its Member States is the world's leading donor of humanitarian aid. Relief assistance is an expression of European solidarity towards people in need around the world.

It aims to save lives, prevent, and alleviate human suffering, and safeguard the integrity and human dignity of populations affected by natural hazards and human-induced disasters.

Through its European Civil Protection and Humanitarian Aid Operations, the European Union helps millions of victims of conflicts and disasters every year.

The European Commission has signed a 3 million humanitarian contribution agreement with the International Federation of Red Cross and Red Crescent Societies (IFRC) to support the Federation's Disaster Relief Emergency Fund (DREF). Funds from the DREF are mainly allocated to small-scale disasters those that do not give rise to a formal international appeal.

The Disaster Relief Emergency Fund was established in 1985 and is supported by contributions from donors. Each time a National Red Cross or Red Crescent Society needs immediate financial support to respond to a disaster, it can request funds from the DREF.

For small-scale disasters, the IFRC allocates grants from the Fund, which can then be replenished by the donors. The contribution agreement between the IFRC and ECHO enables the latter to replenish the DREF for agreed operations (that fit in with its humanitarian mandate up to a total of 3 million.

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EU brings relief to victims of Iran floods - European Commission

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 February 2022 | European Medicines Agency – European Medicines…

PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market

EMAs safety committee (PRAC) has recommended that marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union (EU). These products were authorised as an addition to other treatments for plasma volume replacements following acute (sudden) blood loss.

The safety of HES solutions for infusion was reviewed in two separate procedures in 2013, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, i.e. a bacterial infection in the blood) were put in place at the time.

As a result of a third review conducted in 2018, the use of HES solutions for infusion was further restricted to accredited hospitals, and healthcare professionals prescribing or administering the medicines had to be trained in their appropriate use. Companies marketing HES solutions for infusion were also requested to conduct a drug utilisation study to check that the restrictions were adhered to in clinical practice, and to submit the results of this study to EMA.

The PRAC has now reviewed the results from this study, which show that HES solutions for infusion are still being used outside the recommendations included in the product information. In view of the serious risks that certain patient populations are still exposed to, the PRAC has therefore recommended the suspension of the marketing authorisations for HES solutions for infusion in the EU.

More information is available inEMAspublic health communication.

The PRAC has started a review of the safety of Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis).

The review was prompted by the final results from a clinical trial (study A3921133) of the JAK inhibitor Xeljanz (tofacitinib). The results showed that patients taking Xeljanz for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem (such as heart attack, stroke or death due to cardiovascular disease) and had a higher risk of developing cancer than those treated with medicines belonging to the class of TNF-alpha inhibitors. The study also showed that compared with TNF-alpha inhibitors, Xeljanz was associated with a higher risk of death due to any cause, serious infections and blood clots in the lungs and in deep veins (venous thromboembolism VTE).

In addition, preliminary findings from an observational study involving another JAK inhibitor, Olumiant (baricitinib), also suggest an increased risk of major cardiovascular problems and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors.

In the treatment of inflammatory disorders, Olumiant and other JAK inhibitors work in a similar way to Xeljanz. PRAC will therefore carry out a review to determine whether these risks are associated with all JAK inhibitors authorised in the EU for the treatment of inflammatory disorders1 and whether the marketing authorisations for these medicines should be amended.

Some measures to minimise these risks are already in place for Xeljanz as a result of a review finalised in 2020, which analysed the interim results of study A3921133. In addition, the product information for Xeljanz was further updated in 2021 to reflect the increased risk of major cardiovascular problems and cancer observed after the release of additional data from this study.

More information is available inEMAspublic health communication.

The PRAC is assessing reported cases of heavy menstrual bleeding (heavy periods) and absence of menstruation (amenorrhea) with the COVID-19 vaccines Comirnaty and Spikevax.

The Committee had previously analysed reports of menstrual (period) disorders in the context of the safety summary reports for COVID-19 vaccines approved in the EU and concluded at the time that the evidence did not support a causal link between these vaccines and menstrual disorders.

In view of spontaneous reports of menstrual disorders with both vaccines and of findings from the literature, the PRAC decided to further assess occurrences of heavy periods or amenorrhea following vaccination.

Menstrual disorders are very common and can occur with a wide range of underlying medical conditions as well as from stress and tiredness. Cases of these disorders have also been reported following COVID-19 infection.

Heavy periods may be defined as bleeding characterised by a volume, which may interfere with the persons physical, social, emotional and material quality of life. Amenorrhea may be defined as the absence of menstrual bleeding for three or more months in a row.

After reviewing the available evidence, thePRACdecided to request an in-depth evaluation of all available data, including reports fromspontaneous reporting systems,clinical trialsand the published literature.

At this stage, it is not yet clear whether there is a causal link between the COVID-19 vaccines and the reports of heavy periods or amenorrhea. There is also no evidence to suggest that COVID-19 vaccines affect fertility.

EMA will communicate further when more information becomes available.

The PRAC has adopted updated guidance on core requirements for risk management plans (RMPs) of COVID-19 vaccines.

As for any medicinal product that is authorised in the EU, companies need to submit their RMP when applying for a marketing authorisation to detail their plan for the post-marketing surveillance and what measures they must put in place to further characterise and manage risks. In the context of the pandemic, EMA adopted specific RMP guidance for COVID-19 vaccines, which complements theexisting guidelines on the RMP format in the EUand guidance ongood pharmacovigilance practices.

Following discussion at the PRAC, this guidance has been updated in light of the experience accrued during the pandemic to include specific considerations on:

The new version of the guidance is available on EMAs website.

As part of its advice on safety-related aspects to other EMA committees, thePRACdiscussed a direct healthcare professional communication (DHPC) containing important safety information for infliximab.

Advice to postpone use of live vaccines in infants exposed to infliximab during pregnancy or via breastfeeding

This DHPC informs healthcare professionals on the need to postpone the use of live vaccines in infants who are exposed to infliximab during pregnancy or via breastfeeding.

Infliximab is an anti-inflammatory medicine authorised for the treatment of adults with rheumatoid arthritis (an immune system disease causing inflammation of the joints), Crohns disease (a disease causing inflammation of the digestive tract), ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut), ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine), psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) or psoriasis (a disease causing red, scaly patches on the skin). Infliximab is also authorised in patients aged between 6 and 17 years with severe, active Crohns disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.

Following treatment during pregnancy, it has been reported that infliximab crosses the placenta and it has been detected in infants up to 12 months after birth. Live vaccines should not be given to infants for 12 months after birth if they have been exposed to infliximab during pregnancy. If infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier time point if there is a clear clinical benefit for the individual infant.

Infliximab has also been detected at low levels in breast milk, therefore, administration of a live vaccine to a breastfed infant while the mother is receiving the medicine is not recommended unless infant infliximab serum levels are undetectable.

It is important that women treated with infliximab who become pregnant or who breastfeed their infant inform the healthcare professional responsible for vaccination of their infant about their treatment with infliximab.

The DHPC for infliximab will be forwarded to EMAs human medicines committee, theCHMP.

Following theCHMP decision, the DHPC will be disseminated to healthcare professionals by themarketing authorisation holders according to an agreed communication plan, and published on theDirect healthcare professional communicationspage and innational registersin the EU Member States.

1 Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib) and Xeljanz (tofacitinib).

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022 | European Medicines Agency - European Medicines...