Archive for the ‘European Union’ Category

Advancing regulatory science in the EU mid-point report published … – European Medicines Agency |

EMA has published a report summarising the mid-term achievements of itsRegulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.

The achievements highlighted in this report demonstrate that we have made considerable progress in advancing regulatory science to build a more adaptive regulatory system that encourages innovation in human and veterinary medicines, said Emer Cooke, EMAs Executive Director.

The mid-term report highlights achievements for the top five human and top three veterinary recommendations thought to deliver the most significant change over the course of the five-year strategy, according to an extensive stakeholder consultation process that took place with EMAs scientific committees, stakeholders and EU regulatory partners.

In thehumandomain, progress was made in several areas, including:

In theveterinarydomain, progress was made in several areas, including:

The report also highlights achievements for thehumanandveterinary medicines strategies. Links are included in the report to detailed information on goals, core recommendations and underlying actions in these areas.

Work will continue at pace through 2023-2025 to deliver the strategic goals to their fullest potential.

We will seek opportunities to further progress delivery of the Regulatory Science Strategy to 2025, and the broaderEuropean medicines agencies network strategy to 2025, as we emerge from a long period of business continuity. This work will be crucial to evolve the networks capability to engage with and enable innovative science and technology within the current pharmaceutical framework and pave the way for the legislative review, added Ms Cooke.

A final report on the regulatory science strategy will be published in 2026, once the strategy has been completed.

EMA published its Regulatory Science Strategy to 2025 in March 2020. The strategy was developed in 2018 and 2019 in consultation with a wide range of stakeholders and provides a plan for advancing regulatory science over a five-year period.

The motivation behind the strategy was the recognition that the pace of innovation had accelerated dramatically in recent years. As part of their mission to promote and protect human and animal health, regulators needed to be ready to support the development and assessment of ever more complex medicines that increasingly deliver healthcare solutions by converging different technologies.

Furthermore, the advent ofBig data opened up new sources of information on the use of medicines in healthcare settings. Regulators needed to take action to address the challenges arising from collecting and processing these data from patients.

The COVID-19 pandemic also underlined the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy.

Note

Regulatory sciencerefers to the range of scientific disciplines that are applied to the quality, safety and efficacyassessment of medicinal productsand that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.

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Advancing regulatory science in the EU mid-point report published ... - European Medicines Agency |

Lack of Maltese interpreters in the EU ‘totally unacceptable,’ MEPs … – Times of Malta

MEPs Alex Agius Saliba and David Casa have protested about a lack of translators of Maltese at European Union meetings, insisting that the situation is unacceptable.

Agius Saliba said the latest case happened on Wednesday at a meeting of the European Parliament's employment committee on the subject of discrimination. Soon after he started to speak, in Maltese, he was cut off and told by an official that an interpreter was not available.

Agius Saliba obliged, but not before delivering a stern rebuttal to colleagues in the committee.

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This is happening continuously in this committee we have been complaining about this for a number of weeks now, he said.

Branding the lack of interpreters as discrimination against the Maltese language, Agius Saliba told officials he would continue in English, but would not be so accommodating in the future.

[It is] totally unacceptable I cannot speak as my colleagues do in an official language of the European Union today I will be making my intervention, but Im sorry, next time he said.

Agius Saliba noted that there were other Maltese representatives present for the meeting, including the EUs Commissioner for Equality Helena Dalli.

Fellow MEP David Casa (PN) joined Agius Saliba in denouncing the lack of interpretation at the committee meeting.

It is not acceptable that my colleague was unable to speak in Maltese during the hearing in committee, he said.

Casa agreed that Maltese interpretation should be available and said he had written to the EU about the issue.

The Maltese language is an official language of the European Union, just as French or German or Slovak or Greek. Maltese interpretation should be available in such meetings, Casa said.

As an official language of the EU, Maltese is meant to be accepted and interpreted in all official meetings. With 22 commission meetings taking place, often at the same time, however, a lack of interpreters can mean that not all 24 official languages are always able to be interpreted, an MEP told Times of Malta.

This was not the first time that the EU has come under fire for not providing sufficient interpretation services in Maltese.

In 2020, Labour MEP Alfred Sant complained that many freelance interpreters had been left out in the cold during the COVID-19 pandemic due to meetings taking place virtually, branding the lack of personnel manifestly unfair and unjust.

In 2005, former Labour MEP and later Prime Minister Joseph Muscat refused to continue addressing the European Parliament (EP) after he was informed no interpreters were present to translate his speech from the Maltese language.

This situation is not acceptable anymore. We either have our language as an official one with all its full rights or we have only an official language on paper, Muscat told the EP back in 2005.

According to the EUs language policy as found on the EP website, the EU has adopted a full multilingual language policy, meaning that all EU languages are equally important... every Member of the European Parliament has the right to speak in the language of his or her choice.

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Lack of Maltese interpreters in the EU 'totally unacceptable,' MEPs ... - Times of Malta

ECHA Updates Recommendations To Improve REACH … – Mondaq News Alerts

23 March 2023

Bergeson & Campbell

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On February 28, 2023, the European Chemicals Agency (ECHA) announced that it updated its recommendationsto improve Registration, Evaluation, Authorisation and Restrictionof Chemicals (REACH) registrations. According to ECHA, therecommendations are based on ECHA's findings from registrationdossier compliance checks and take recent changes to REACHinformation requirements into account. The recommendations focus onthe rules for using adaptations to assess the safety of chemicalswithout animal testing. ECHA states that they provide advice onread-across, covering considerations on structural similarity,defining substance groups, and predicting target substanceproperties. ECHA also provided information on adaptations based onexposure scenarios outlined in chemical safety reports. Accordingto ECHA, further advice addresses the requirements for mutagenicityinformation and chronic aquatic toxicity studies for poorly solublesubstances. ECHA recommends that companies review therecommendations to make sure their dossiers comply with REACH andensure the safe use of their chemicals.

ECHA also released statistics on its progress evaluatingregistered substances. In 2022, ECHA conducted 330 compliancechecks covering more than 2,300 registration dossiers andaddressing 295 substances. According to ECHA, 302 checks were fullcompliance checks, addressing all relevant endpoints of substancesof potential concern. They resulted in 277 draft decisions beingsent to companies, requesting more data to clarify long-termeffects on human health or the environment. ECHA adopted 252compliance check decisions together with European Union (EU) memberstates. ECHA states that these decisions addressed data gapsremaining after draft decisions and dossier updates. ECHA alsoadopted 169 testing proposal decisions addressing 347 informationrequirements for which testing was originally proposed byindustry.

ECHA follows up on information requests sent to companies tocheck whether the information provided by companies complies withREACH requirements. According to ECHA, in 2022, this was concludedfor 249 substances. In about 60 percent of the cases, companiesprovided the requested information. ECHA notified the remaining 40percent to EU member states for enforcement. ECHA notes that italso adopted nine substance evaluation decisions, requestingfurther information to assess the safety of substances of potentialconcern.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

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European Union – Overview, History, Membership, Insitutions

A unified organization of 27 member countries, with authority over their political, economic, and social policies

The European Union (EU) is a unified international organization that governs the economic, political, and social policies of 27 member states. Originally formed with the desire to achieve peace in Europe, current EU policies are tailored to ensure the free movement of people, goods, services, and capital among its member states.

The European Union was built with the aim of ending frequent wars among neighboring countries following the Second World War. In 1951, the European Coal and Steel Community (ECSC) started uniting nations to achieve peace.

The six founding countries of the EU are:

The Treaty of Rome was signed in 1957, creating the European Economic Community, or a common market. It was followed by a period of economic growth a result of lowering trade restrictions among member states.

The EU experienced continued expansion ever since, with the fall of communism and the Berlin Wall supporting a closer-knit Europe. In 1993, the Single Market agreement was completed, allowing four types of freedoms the movement of goods, services, people, and money.

As more members joined the EU, it grew from a community of six member states to 27 member states.

To be a part of the EU, applicant countries must meet certain conditions, known as the Copenhagen criteria. The key criteria are listed below:

Following the exit of the United Kingdom in early 2020, there are now 27 remaining member states of the EU.

The European Union oversees three main institutions that are involved in legislation:

The European Parliament is elected by the EUs citizens and is responsible for law-making, supervision, and budget establishment.

Represents the governments of each of the EUs member states, with one minister from each state. Responsible for coordinating policies, adopting EU laws, and voicing the opinion of member states.

The EUs politically independent executive arm, responsible for proposing and enforcing legislation, managing policies, allocating budgets, and representing the EU internationally.

The EU is the largest trading power and the largest single-market area in the world. In 2019, the EU posted a GDP of $15.59 trillion, only behind the United States in terms of economic size.

Free trade within the EU was one of the unions foundational rules. Trade among member states is completely free, allowing the exchange of goods and services across borders without any tariffs or quotas.

Besides free trade among member states, the EU also promotes the concept of open economies in foreign trade. The EU also signed several trade agreements with a number of countries, including:

With each trade agreement, the EU aims to either cut or remove tariffs, making the cross-border flow of goods and services easier for exporters and importers.

The EUs top 10 trading partners:

In 2019, the EUs five largest exports were:

The EUs five biggest imports were:

In addition, countries in the EU are the largest importers of cocoa beans, which explains the Netherlands and Germanys prowess in the chocolate industry and the high per-capita chocolate consumption across Europe.

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European Union - Overview, History, Membership, Insitutions

European Union – The euro-zone debt crisis | Britannica

The sovereign debt crisis that rocked the euro zone beginning in 2009 was the biggest challenge yet faced by the members of the EU and, in particular, its administrative structures. The economic downturn began in Greece and soon spread to include Portugal, Ireland, Italy, and Spain (collectively, the group came to be known informally as PIIGS), threatening the survival of the single currency and, some believed, the EU itself. As confidence in the afflicted economies continued to erode, rating agencies downgraded the countries creditworthiness. Borrowing costs soared as government bond yields rose, and the PIIGS countries found it increasingly difficult to obtain financing. A series of stopgap measures were undertaken by the EU and the International Monetary Fund in an attempt to halt the spread of the crisis, but it soon became apparent that a larger, more-organized response would be required.

Representing the two largest economies in the euro zone, German Chancellor Angela Merkel and French Pres. Nicolas Sarkozy spearheaded the effort to stabilize the eurowhich had plunged to a four-year low against the U.S. dollarand preserve the solvency of at-risk euro-zone members. A bailout package was approved for Greece in May 2010, and, over the next two years, similar rescue funds were assembled for Ireland, Portugal, Spain, and Cyprus. The economic crisis, and the austerity measures associated with it, took a staggering political toll on ruling parties across the continent. Between March 2011 and May 2012, more than half of the euro zones 17 members saw their governments collapse or change hands.

The debt crisis had revealed dangerous shortcomings within the regulatory measures that governed the euro zones shared economy, most notably the lack of any enforcement mechanism for the fiscal rules that were outlined in the Maastricht Treaty. EU leaders attempted to correct this with a new fiscal pact, signed on March 2, 2012. The treaty bound signatories to limit government deficits to 3 percent of GDP or face automatic penalties. EU leaders also created the European Stability Mechanism, a permanent bailout fund that officially replaced the EUs temporary rescue measures in October 2012. The European Commission also proposed the integration of the euro zones 6,000 financial institutions into a single banking union, with oversight provided by the European Central Bank. The system would allow for the centralized supervision of banks capital reserves, as well as the restructuring or direct recapitalization of imperiled banks without regard to national boundaries. As markets calmed and the imminent danger to the euro zone began to diminish, EU leaders focused on returning the region to a path of economic growth. The bailout of the Cypriot banking sector in March 2013 was dealt with almost as a matter of course, while lingering issues, such as endemic youth unemployment, remained a subject of concern. The EU welcomed its 28th member on July 1, 2013, when Croatia completed the accession process.

In early 2014 the EU faced what was perhaps its greatest foreign policy crisis since the collapse of Yugoslavia. In November 2013 the former Soviet republics of Georgia and Moldova signed an association agreement with the EU, pledging closer political and economic ties. Ukraine, which had been scheduled to sign the agreement, backed out at the last minute under pressure from Russia. The reversal by Ukrainian Pres. Viktor Yanukovych triggered a wave of popular protests that turned violent in February 2014. A bloody government crackdown left scores dead and hundreds wounded, and, with his political base disintegrating, Yanukovych fled to Russia. As an interim government assumed power in the Ukrainian capital of Kiev, unidentified troops fielding Russian equipment took control of key sites in Crimea, a Ukrainian autonomous republic that had a predominantly Russian population. Armed gunmen seized the regional parliament building, and a pro-Russian prime minister was installed. As the Russian troop buildup continued, the self-declared Crimean government announced its independence from Ukraine. A referendum was hastily scheduled, and 97 percent of Crimean voters stated their preference to join the Russian Federation. EU leaders called for dialogue and enacted economic sanctions against a number of high-ranking Kremlin officials, and Russian Pres. Vladimir Putin completed the formal annexation of Crimea on March 21, 2014. That same day Ukrainian interim Prime Minister Arseniy Yatsenyuk signed a portion of the EU association agreement that had originally sparked the crisis.

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The Ukraine crisis expanded as pro-Russian militants occupied government buildings in eastern Ukraine. An existing EU sanctions package against Russian individuals and businesses was expanded, and in April 2014 the EU, the International Monetary Fund, and the World Bank negotiated a $17 billion bailout deal to bolster the flagging Ukrainian economy.

Attention was soon focused closer to home, however, as Brussels struggled with the emergence of Euroskepticism as a popular movement. Elections for the European Parliament in May 2014 saw unprecedented wins by the U.K. Independence Party (UKIP) in Britain and the National Front in France as voters across Europe turned to antiestablishment parties. While the main centre-right and centre-left coalitions retained a majority in the European Parliament, EU leaders were forced to address a strong electoral performance by parties whose stated goals were the radical restructuring or outright elimination of the defining characteristics of the EU.

In 2015 Euroskeptic parties capitalized on the ongoing migrant crisis in Europe as hundreds of thousands of refugees from the Middle East and Africa sought asylum in the EU. Thousands perished while attempting the treacherous Mediterranean crossing, and thousands more found themselves interred in makeshift camps as countries suspended their participation in the Schengen Agreement and reimposed internal border controls. Euroskeptic leaders such as UKIPs Nigel Farage and the National Fronts Marine Le Pen drew a direct link between the influx of migrants and deadly terrorist attacks in Paris and Brussels.

Facing pressure from UKIP as well as Euroskeptic members of his own Conservative Party, British Prime Minister David Cameron undertook a renegotiation of the relationship between the EU and the United Kingdom. Those talks were concluded in February 2016, prompting Cameron to schedule a long-promised referendum on Britains continued membership in the EU for June 2016. Despite Camerons relative success at achieving a special status for Britain within the EU, on June 23 some 52 percent of British voters elected to leave the EU. EU leaders pledged solidarity in the face of the Brexit, and they urged Britain to begin separation proceedings as soon as possible to restore stability to the EU. The following day, Cameron announced that he would resign as prime minister, and in July he was succeeded by Theresa May.

May had pledged to carry the Brexit to its conclusion, but in November 2016 Britains High Court ruled that she could not trigger Article 50the Lisbon Treatys mechanism for withdrawing a country from the EUwithout parliamentary approval. After months of wrangling between Mays government, the courts, and both houses of Parliament, on March 29, 2017, May presented a letter to EU president Donald Tusk formally invoking Article 50. That act opened a two-year window of negotiations between London and Brussels, and it soon became clear that the divorce between the parties would be neither clean nor easy. In Scotland, where voters had overwhelmingly elected to remain within the EU, First Minister Nicola Sturgeon voiced her support for a second Scottish independence referendum.

Voters in Northern Ireland had also opted to remain within the EU, and perhaps the most pressing issue of the Brexit negotiations was the border between Ireland (an EU member) and Northern Ireland (a constituent unit of the United Kingdom whose devolved government was not empowered to act independently with regard to Article 50). The May government framed the issue largely as a matter of trade, but a joint EU-U.K. study found that nearly 150 cross-border activities would be negatively affected by the reimposition of border controls. In addition, there were some 275 land border crossings between Northern Ireland and Ireland, more than twice as many crossings as there were along the EUs entire 3,700-mile (6,000-km) eastern frontier, which stretched from Finland to Greece. Finally, the terms of the Good Friday Agreement, which had enabled the creation of a devolved government in Northern Ireland and had done much to defuse the sectarian violence there, were negotiated with the assumption that both Ireland and the United Kingdom would remain within the EU. A hardening of the border would potentially jeopardize the underpinnings of that historic agreement.

In an effort to bolster her slim parliamentary majority and strengthen her hand in Brexit negotiations, May called for a snap election to be held on June 8, 2017. The ploy backfired dramatically: Mays Conservative Party lost its majority entirely, and she faced calls for her resignation as prime minister. After weeks of negotiations, May was able to craft a minority government with the support of Northern Irelands Democratic Unionist Party (DUP). As the DUP were strict unionists who opposed any special status for Northern Ireland within the United Kingdom, May found her room to maneuver on the Irish border issue even more restricted. She would spend the next two years trying to forge a deal that would be acceptable to both Brussels and Westminster. In the end, she faced a series of embarrassing rejections from her own party, and her Brexit plan was voted down on three separate occasions by Parliament. Britains departure from the EU, originally scheduled for March 2019, was postponed until May and then again until October. May, having exhausted her options, resigned as prime minister, and she was succeeded by Boris Johnson, her former foreign secretary and one of the most visible faces of the pro-Brexit campaign.

Johnson initially fared little better than May, and he was forced to ask for a third extension of the Brexit deadline. Wagering that he could succeed where May had failed, Johnson called a snap election in December 2019. Johnson campaigned on the slogan Get Brexit Done. His gamble proved wildly successful, and the Conservatives won a commanding parliamentary majority. Having already purged the party ranks of dissenters who had blocked his proposed no-deal Brexit, and no longer beholden to the DUP on matters of the Irish border, Johnson now found himself in a position to realize his vision of Brexit. On December 20, 2019, Parliament passed Johnsons Brexit bill, and the European Parliament gave its approval to the agreement a month later. On January 31, 2020, the United Kingdom formally left the European Union, and an 11-month implementation and transition period began.

As the Brexit process was finally reaching its conclusion, there was a changing of the guard within the EU leadership. German defense minister Ursula von der Leyen replaced Jean-Claude Juncker as president of the European Commission, Belgian Prime Minister Charles Michel succeeded Donald Tusk as president of the European Council, Spanish foreign minister Josep Borrell took over the foreign policy portfolio from Federica Mogherini, and International Monetary Fund chief Christine Lagarde was tapped to follow Mario Draghi as the head of the European Central Bank. This new team would be faced with the greatest global public health challenge since the influenza pandemic of 191819.

In March 2020 Italy became the epicentre of the coronavirus SARS-CoV-2 pandemic, and countries across the EU reintroduced border controls in an effort to stop the spread of COVID-19, the potentially deadly disease caused by the virus. Across the Schengen area, free movement of peopleone of the foundational pillars of the EUwas suspended as governments raced to develop and distribute an effective vaccine. National and local authorities enacted lockdowns, closed schools, shuttered nonessential businesses, and restricted internal travel in an attempt to head off outbreaks of disease from the mutating virus. Evidence suggested that these mitigation efforts saved countless lives, but the social and economic cost was enormous. Unemployment rates soared, and the EU economy contracted by more than 6 percent. As vaccines against SARS-CoV-2 became widely available in 2021, free movement within the Schengen area was restored on a conditional basis, many countries requiring proof of vaccination or a negative COVID-19 test for entry. By the end of 2021 nearly three-fourths of EU citizens had received at least one dose of a SARS-CoV-2 vaccine. Many restrictions were rolled back, and the economies of the EU returned to growth, but the human cost of the pandemic had been staggering. Within the 27 countries of the EU, more than 100 million people had contracted COVID-19 by January 2022 and more than 1 million had died of causes associated with the disease.

Just as the immediate danger of COVID-19 was beginning to recede, the greatest threat to European security since the end of the Cold War was taking shape on the borders of Ukraine. In late 2021 Russia began a massive deployment of troops and military equipment to western Russia, Russian-occupied Crimea, Belarus, and the Russian-backed separatist enclave of Transdniestria in Moldova. Although Western governments characterized the action as a prelude to invasion, Russian Pres. Vladimir Putin insisted that he was merely conducting exercises to guard against NATO aggression. Leaders of EU governments shuttled between Moscow and Kyiv in an attempt to head off what appeared to be an inevitable Russian attack. On February 21, 2022, Putin recognized the independence of self-proclaimed peoples republics in Donetsk and Luhansk, two regions in eastern Ukraine where Russian-backed separatists had been fighting Ukrainian security forces since 2014.

In the early morning hours of February 24, Putin announced the beginning of a special military operation to demilitarize and denazify Ukraine. Putins stated casus belli was widely ridiculed, as Ukraines military posture was entirely defensive and its president, Volodymyr Zelensky, was Jewish and had lost several family members in the Holocaust. Nevertheless, within minutes of Putins televised address, cruise missiles began striking cities across Ukraine, and Russia launched a wholesale invasion of Ukrainian territory. The EU immediately condemned the unprovoked attack and levied rounds of increasingly destructive sanctions against Russia and Putins inner circle. As Ukraines army and national guard mounted a spirited and largely effective defense, individual EU countries sent packages of humanitarian and military aid. On February 28 Zelensky signed a document formally requesting that Ukraine be granted candidate status for admission to the EU, and the following day he received a prolonged standing ovation after giving a video address to the European Parliament. As Russia continued its indiscriminate shelling of Ukrainian cities, more than a million people fled Ukraine, presenting the EU with a new refugee crisis on its eastern frontier.

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European Union - The euro-zone debt crisis | Britannica