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European Commission secures EU access to Remdesivir for treatment of COVID-19

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Yesterday, the European Commission has signed a contract with the pharmaceutical company Gilead to secure treatment doses of Veklury, the brand name for Remdesivir. Veklury was the first medicine authorised at EU level for treatment of COVID-19. As from early August onwards, and in order to meet immediate needs, batches of Veklury will be made available to Member States and the UK, with the coordination and support of the Commission.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “In recent weeks, the Commission has been working tirelessly with Gilead to reach an agreement to ensure that stocks of the first treatment authorised against COVID-19 are delivered to the EU. A contract has been signed yesterday, less than a month after the authorisation of Remdesivir, which will allow the delivery of treatments from early August for thousands of patients. The Commission is leaving no stone unturned in its efforts to secure access to safe and efficient treatments, and is supporting the development of vaccines against coronavirus. Yesterday’s agreement is another important step forward in our fight to overcome this disease”.

The Commission’s Emergency Support Instrument will finance the contract, worth a total of €63 million. This will ensure the treatment of approximately 30,000 patients presenting severe COVID-19 symptoms. This will help to cover the current needs over the next few months, while ensuring a fair distribution at EU level, based on an allocation key, taking into account the advice from the European Centre for Disease Prevention and Control.

The Commission is now also preparing a joint procurement for further supplies of the medicine, expected to cover additional needs and supplies as from October onwards. 

Background

On 3 July, Remdesivir became the first treatment to be authorised for a conditional marketing authorisation. This authorisation facilitates early access to medicines in public health emergency situations, such as the current pandemic.

Remdesivir is a treatment against COVID-19 for adults and adolescents as from age 12 with pneumonia who require supplemental oxygen. The application for the marketing authorisation was submitted to the European Medicines Agency (EMA) on 8 June. EMA’s recommendation was endorsed by the Member States through the Standing Committee on Medicinal Products for Human Use.

While authorised in the EU, the medicine continues to be monitored to ensure safety. Gilead has also been requested to submit the final reports of the Remdesivir studies to the EMA by December 2020 as part of the conditions to be fulfilled to move from a conditional marketing authorisation to a full marketing authorisation. Further data on the effectiveness and safety of the medicine is expected to be submitted by August 2020 in order to finalise this process.

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Fight against human trafficking must be strengthened in Ethiopia

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A group of internally displaced people due to the Tigray conflict gather in a site in Ethiopia's Afar region, Ethiopia. © UNHCR/Alessandro Pasta

Throughout Ethiopia’s Tigray, Afar and Amhar regions, women and girls are becoming increasingly vulnerable to abduction and sex trafficking as they flee ongoing armed conflict, a group of UN-appointed independent human rights experts warned on Monday.

The protracted conflict in the three northern regions have heightened risks of trafficking for sexual exploitation as a form of sexual violence in conflict, the experts said in a statement.

“We are alarmed by reports of refugee and internally displaced women and girls in the Tigray, Afar, and Amhara regions being abducted while attempting to move to safer places,” they said.

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“We are concerned at the risks of trafficking, in particular for purposes of sexual exploitation, including sexual slavery.” 

Women and children in crosshairs

Amidst abductions and displacement, the UN experts raised serious concerns over Eritrean refugee women and children being at particular risk of sex trafficking.

“Urgent action is needed to prevent trafficking, especially for purposes of sexual exploitation, and to ensure assistance and protection of all victims, without discrimination on grounds of race or ethnicity, nationality, disability, age or gender,” they said.  

Meanwhile, the hundreds of children who have been separated from their families, especially in the Tigray region, are particularly vulnerable, warned the independent experts.

“The continuing lack of humanitarian access to the region is a major concern,” the experts continued, urging immediate national, bilateral and multilateral measures to prevent all forms of trafficking of children and to ensure their protection.

Identifying victims

They added that sufficient measures were not being taken to identify victims of trafficking, or support their recovery in ways that fully takes account of the extreme trauma being suffered.

“The failure to provide accountability for these serious human rights violations and grave crimes creates a climate of impunity, allows trafficking in persons to persist and perpetrators to go free,” underscored the six UN experts.

They urged all relevant stakeholders to ensure that victims of trafficking can adequately access medical assistance, including sexual and reproductive healthcare services and psychological support.

The experts said they had made their concerns known to both the Governments of Ethiopia and neighbouring Eritrea.

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35 years of Cultural Routes: Safeguarding European Values, Heritage, and Dialogue

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A Europe rich in history, heritage, dialogue and values: the Council of Europe Cultural Routes’ programme celebrates its 35th anniversary, on the occasion of the 11th Advisory Forum in Minoa Palace Hotel, Chania, Crete (Greece) on 5-7 October, with a special event to highlight the relevance of Cultural Routes for the promotion of cultural diversity, intercultural dialogue and sustainable tourism.

The Forum is organised by the Enlarged Partial Agreement on Cultural Routes of the Council of Europe and the European Institute of Cultural Routes, in co-operation with the Hellenic Ministry of Culture and Sports, the Hellenic Ministry of Tourism, the Greek National Tourism Organization, the Region of Crete, the Municipality of Chania, the Chamber of Industry and Commerce of Chania, and the Historic Cafes Route. The 2022 edition will be the opportunity to underline the growing relevance of the Cultural Routes methodology and practices in promoting Europe’s shared cultural heritage while fostering viable local development.

Deputy Secretary General Bjørn Berge will participate in the high-level dialogue, together with Minister of Culture and Sports of Greece Lina Mendoni, Minister of Tourism of Greece Vassilis Kikilias, Parliamentary Assembly (PACE) Vice-President and Chairperson of the Greek Delegation Dora Bakoyannis and Chair of the Statutory Committee of Cultural Routes Ambassador Patrick Engelberg (Luxembourg). 

Over three days of workshops and interactive debates, three main general sessions will be explored:

  1. Promoting European Values and Intercultural Dialogue;
  2. Safeguarding Heritage in Times of Crisis;
  3. Fostering Creative Industries, Cultural Tourism, Innovative Technologies for Sustainable Communities.

The Forum will discuss trends and challenges in relation to Cultural Routes, providing a platform for sharing experiences, reviewing progress, analysing professional practices, launching new initiatives and developing partnerships across Europe and beyond. Participants range from managers among the 48 cultural routes to representatives of national ministries, International Organisations, academics, experts and tourism professionals.

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Little progress combating systemic racism against people of African descent

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More than two years since the murder of George Floyd by a police officer in the United States sparked the global Black Lives Matter movement, there’s been only “piecemeal progress” in addressing systemic racism, the UN human rights office (OHCHR) said on Friday, in a new report.While more people have been made aware of systemic racism and concrete steps have been taken in some countries, the Acting High Commissioner for Human Rights called on States to demonstrate greater political will to accelerate action.

“There have been some initiatives in different countries to address racism, but for the most part they are piecemeal. They fall short of the comprehensive evidence-based approaches needed to dismantle the entrenched structural, institutional and societal racism that has existed for centuries, and continues to inflict deep harm today,” said Nada Al-Nashif, who will present the report to the UN Human Rights Council on Monday.

Triggering change

The report describes international, national and local initiatives that have been taken, towards ending the scourge of racism.

These include an Executive Order from the White House on advancing effective, accountable policing and criminal justice practices in federal law enforcement agencies; an Anti-Racism Data Act in British Columbia, Canada; measures to evaluate ethnic profiling by police in Sweden; and census data collection to self-identify people of African descent in Argentina.

The European Commission has issued guidance on collecting and using data based on racial or ethnic origin; formal apologies issued, memorialization, revisiting public spaces, and research, to assess links to enslavement and colonialism in several countries.

‘Barometer for success’

The report notes that poor outcomes continue for people of African descent in many countries, notably in accessing health and adequate food, education, social protection, and justice – while poverty, enforced disappearance and violence continues.

It highlights “continuing…allegations of discriminatory treatment, unlawful deportations, excessive use of force, and deaths of African migrants and migrants of African descent by law enforcement officials”

The barometer for success must be positive change in the lived experiences of people of African descent,” continued Ms. Al-Nashif.

“States need to listen to people of African descent, meaningfully involve them and take genuine steps to act upon their concerns.”

Higher death rates

Where available, recent data still points to disproportionately high death rates faced by people of African descent, at the hands of law enforcement, in different countries.

“Families of African descent continued to report the immense challenges, barriers and protracted processes they faced in their pursuit of truth and justice for the deaths of their relatives”, the report says.

It details seven cases of police-related deaths of people of African descent, namely George Floyd and Breonna Taylor (US); Adama Traoré (France); Luana Barbosa dos Reis Santos and João Pedro Matos Pinto (Brazil); Kevin Clarke (UK) and Janner [Hanner] García Palomino (Colombia).

While noting some progress towards accountability in a few of these emblematic cases, “unfortunately, not a single case has yet been brought to a full conclusion, with those families still seeking truth, justice and guarantees of non-repetition, and the prosecution and sanction of all those responsible,” the report says.

Ms. Al-Nashif called on States to “redouble efforts to ensure accountability and redress wherever deaths of Africans and people of African descent have occurred in the context of law enforcement, and take measures to confront legacies that perpetuate and sustain systemic racism”.

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