While all EU Member States are bound by the Beijing Declaration and its requirement to provide access to safe and high-quality sexual and reproductive healthcare, this continues to be an area of concern.

EIGE has noted this development in several recent studies. The 25-year review of the Beijing Platform for Action shows that access to sexual and reproductive health services varies greatly between the Member States, with some countries introducing restrictions to services such as abortion.

In order to achieve gender equality in the European Union, this area needs close attention. EU Member States must ensure women have access to services that reflect their gendered health needs, such as hormonal contraception and abortion. Next year, EIGE’s Gender Equality Index will have a special focus in the area of health, including sexual and reproductive health. This is a priority in the EU.

Further information

25-year review of the Beijing Platform for Action

Gender Equality Index 2020

On 30 October 2020, the European Asylum Support Office (EASO) published a Country of Origin Information (COI) report entitled: Pakistan Security situation. 

The newly released report provides information on the security situation in Pakistan, which is relevant for the assessment of international protection status determination, including refugee status and subsidiary protection. 

With just over 26 500 applications in 2019 and almost 12 000 from January to September 2020, Pakistan was the sixth most important country of origin for asylum applicants in the EU+ in both years. However, compared to the same period in 2019, the number of Pakistani applications between January and September 2020 decreased by 37 % due to the COVID-19 pandemic and related emergency measures. At the end of September 2020, close to 19 200 Pakistani cases were awaiting a first-instance decision, down from almost 21 200 cases at the end of 2019. The recognition rate for Pakistani nationals has been relatively low, with just 8 % receiving some form of EU-regulated protection between January and September 2020, down from 10 % during the same period in 2019. 

The security situation in Pakistan has been influenced by both internal and external security issues. The main internal security challenges consist of political and economic instability, ethnic and sectarian conflicts, religious extremism and militancy; while external security challenges are linked to the relationship of Pakistan with neighbouring countries such as Afghanistan and India. Militant violence in the country is mainly caused by the separatist insurgency in Balochistan and the instability in the north-west of the country resulting from the 2001 toppling of the Taliban regime in Afghanistan.

The report is divided in two parts: the first part provides a general description on the security situation in Pakistan; the second part explains the security situation per province in more detail, including information on population, background of the conflict, actors active; as well as quantitative and qualitative information on recent security trends and impact of violence on the civilian population.

This report was drafted by a COI specialist from the Belgian Centre for Documentation and Research (Cedoca) in the Office of the Commissioner General for Refugees and Stateless Persons, in accordance with the EASO COI Report Methodology. It was reviewed by experts from Austria (Federal Office for Immigration and Asylum, Country of Origin Information Department), Poland (Country of Origin Information Unit, Department for Refugee Procedures, Office for Foreigners) and ACCORD, the Austrian Centre for Country of Origin and Asylum Research and Documentation.

Today, the European Asylum Support Office (EASO) published a Country of Origin Information (COI) Report on the security situation in Iraq. This report is the last of a series of Iraq reports  produced in 2020, covering – besides the security situation – also key socio-economic indicators and the targeting of individuals of different profiles. The reports provide information relevant for international protection status determination for Iraqi applicants and will be used to update the EASO Country Guidance on Iraq 2020.

The report, Iraq: Security situation, should be read in conjunction with the other reports on Iraq published in 2020.

Iraqi applications for international protection in the EU+ have been decreasing since 2016. Nevertheless, Iraqi nationals ranked fifth among the most common citizenships in the EU+ in 2019 with over 30 000 applications. In the first quarter of 2020, Iraqis lodged some 6 100 applications, fewer than in the first quarter of 2019. Subsequently, the number decreased even more as asylum authorities in EU+ countries implemented restrictive measures to halt the spread of the COVID-19 pandemic. As a result, in the first six months of 2020, Iraqi nationals lodged just under 8 500 applications in EU+ countries, almost half compared to the same period in 2019. Nevertheless, Iraq kept the fifth position among the most common countries of origin. In the first six months of 2020, approximately 11 900 first-instance decisions were issued on Iraqi applicants, with a recognition rate for EU-regulated types of protection at 38 %. The number of pending cases at first instance has gradually decreased over the last six months, so that in the end of June 2020 there were some 15 800 cases awaiting a decision.  Germany has been the main destination country for Iraqi applicants: from April 2019 to March 2020 almost half of all Iraqi applications in the EU+ were lodged in Germany.

Iraq: Security situation provides information about relevant security trends at national and governorate levels for the period 1 January 2019 – 31 July 2020. It covers the recent conflicts in Iraq, including a short overview of existing political tensions, as well as the international context that the political and security situation has unfolded in. It also includes the presence and capacity of the armed forces and the role they play in the security situation. Recent security trends are described, including the number of casualties and security incidents, examples of representative security incidents, and the impact of the security situation on the civilian population including remaining explosives in former conflict areas, and road security. An account is given of IDP and returnee movements in the period, as well as the state of mobility within the country.

The report was co-drafted by EASO and Belgium, Office of the Commissioner General for Refugees and Stateless Persons, Cedoca (Centre for Documentation and Research), in accordance with the EASO COI Report Methodology. Respective parts of this report were reviewed by Denmark, Ministry of Immigration and Integration, The Danish Immigration Service; Finland, Finnish Immigration Service; and France, Office for the Protection of Refugees and Stateless Persons (OFPRA), Information, Documentation and Research Division; ACCORD, the Austrian Centre for Country of Origin and Asylum Research and Documentation, and ARC, the Asylum Research Centre.

The report can be downloaded from the EASO COI Portal on the following link. 

• EIB support to develop breakthrough treatments to address orphan neurodegenerative diseases with high unmet medical needs
• Focus on Minoryx’s lead asset, leriglitazone, a novel, disease-modifying PPAR-γ agonist
• Venture debt operation supported by the Investment Plan for Europe

The European Investment Bank (EIB) today announced that it has approved €25 million financing for Minoryx Therapeutics, a Phase 3 clinical stage biotech company focused on the development of differentiating treatment options for orphan central nervous system (CNS) disorders.

The EU bank will grant long-term financing to Minoryx to drive the company’s research activities in orphan genetic diseases for which there are currently no approved drugs available. The EIB investments will specifically support the development of Minoryx’s leriglitazone, a disease-modifying treatment (PPAR-γ agonist) currently being evaluated in three late-stage clinical trials:

• Pivotal Phase 2/3 ADVANCE study in adrenomyeloneuropathy (AMN), a disease that constitutes the chronic form of X-ALD (X-linked adrenoleukodystrophy) with onset in adulthood and characterised by progressive neurodegeneration of the spinal cord, resulting in progressive motor dysfunction.
• Phase 2 NEXUS study in cerebral adrenoleukodystrophy (cALD), the most aggressive form of X-ALD, typically affecting children between 2 and 12 years of age and characterised by brain inflammation, leading to rapid cognitive decline and death.
• Phase 2 FRAMES study in Friedreich’s Ataxia (FRDA), a life threatening disease characterised by neurodegeneration resulting in loss of coordination, muscle strength, and cardiomyopathy.

Estimates indicate that the investment in this research, development and innovation (RDI) project will help create over 50 jobs during the implementation phase.

EIB Vice-President Ricardo Mourinho Félix, who is responsible for the Bank’s operations in Spain, said: “We are very happy to sign an agreement that reaffirms the EIB’s commitment to fostering innovation in the healthcare sector by driving the development of new treatments that will have a positive impact on the quality of life of people affected by rare diseases of the central nervous system. Our support for the research programme of Minoryx, a Spanish biotech company, will also help to improve the competitiveness of the European pharmaceutical industry and create highly skilled jobs.”

European Commissioner for the Economy, Paolo Gentiloni, said: “This EU support will help Minoryx to develop breakthrough therapies for genetic diseases and treatments for diseases of the central nervous system. The coronavirus pandemic has shown how important it is to continue to push scientific boundaries and deliver medication for rare diseases. The European Commission will continue to support companies’ efforts in this sense at every opportunity.”

“The EIB brings Minoryx valuable non-dilutive financial resources, alongside our strong and supportive shareholder base, which, we believe, is a clear endorsement of the potential of leriglitazone to improve the lives of patients living with debilitating neurodegenerative disorders”, said Didier Le Normand, Group CFO and General Manager Belgium. “The current clinical studies with leriglitazone continue to advance as planned and we remain on track to report top line data from the pivotal ADVANCE study before the end of the year.”    

The EIB will provide funds for this RDI project by way of a venture debt operation under the European Fund for Strategic Investments (EFSI), a financing instrument used by the EU bank to assist leading companies in innovative research sectors. Since it was launched by the EIB under the Juncker Plan in 2016, this initiative has granted over €2 billion in financing for projects in sectors such as robotics, artificial intelligence and biomedicine. EIB venture debt financing targets European companies with up to 3 000 employees in the fields of biotechnology and health sciences, software and ICT, engineering and automation, and renewable energy and clean technology.

Backgrund information

About EIB venture debt and Investment Plan for Europe

The EIB’s venture debt product is a financing instrument that supports startup and fast-growing innovative companies in cutting-edge technology sectors. It combines the advantages of a long-term loan with a remuneration model based on the company’s performance. Venture debt transactions help strengthen the borrower’s economic capital without diluting the shares of existing investors. The product, developed four years ago in response to market needs, is backed by the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe. The European Fund for Strategic Investments (EFSI) is the main pillar of the Investment Plan for Europe. It provides first-loss guarantees enabling the EIB to invest in more and often riskier projects. The projects and agreements approved for financing under EFSI have mobilised €535.4 billion in investment so far, a quarter of which is supporting research, development and innovation projects.

About Minoryx

Minoryx is a clinical stage biotech company focusing on the development of novel therapies for orphan CNS diseases with high unmet medical needs. The company’s lead programme, leriglitazone (MIN-102), a novel, selective PPARγ agonist, is currently being evaluated in X-ALD and Friedreich’s Ataxia. The company is backed by a syndicate of experienced investors, which includes Caixa Capital Risc, Roche Venture Fund, Ysios Capital, Kurma Partners, Fund+, Chiesi Ventures, S.R.I.W, Idinvest, SFPI-FPIM, HealthEquity and Sambrinvest, and has support from a network of other organisations. Minoryx was founded in 2011, has operations in Spain and Belgium and has so far raised more than €60 million.

About leriglitazone

Leriglitazone (MIN-102) is a novel bioavailable and selective PPAR-γ agonist with a potential best-in-class profile indicated for CNS diseases. It has a demonstrated sufficient brain penetration and favourable safety profile. It showed robust preclinical proof-of-concept in animal models of multiple diseases by modulating pathways leading to mitochondrial dysfunction, oxidative stress, neuroinflammation, demyelination and axonal degeneration. Leriglitazone has successfully completed a phase 1 clinical trial showing good safety, tolerability and CNS engagement of PPAR-γ receptors at levels equivalent to those required for efficacy in preclinical models. Leriglitazone has the potential to treat several CNS disorders, including orphan diseases, and is currently being evaluated in a registration enabling Phase 2/3 study in AMN, a registration enabling Phase 2 in cALD and in a Phase 2 in Friedreich’s Ataxia.

About X-ALD

X-ALD (X-linked adrenoleukodystrophy) is an orphan neurodegenerative disease. AMN and cALD are the two most common phenotypes of X-ALD, which account for 45% and 35% respectively. The global incidence of X-ALD is approximately 6.2/100 000 live births.

The age of onset of cALD patients is typically 4-8 years old. Untreated patients progress quickly, as severe neurological function impairment appears 6-24 months after disease onset, leading to early death in 2-4 years.

AMN is characterised by progressive spastic paraparesis, sensory dysfunction and incontinence. This form progresses chronically with onset of symptoms typically in adulthood and poor prognosis.

There is currently no therapeutic treatment available for X-ALD. Several observational studies have demonstrated that hematopoietic stem cell transplantation (HSCT) may improve the five-year overall survival for cALD patients. However, there is no evidence that HSCT improves clinical outcomes of patients with AMN.

October 30, 2020 About the EUIPO

New interactive interface for EUIPO’s Service Charter

The Service Charter has a more user-friendly design and new interactive features.

In line with the 2025 Strategic Plan’s objective of improving user experience and evolving with the digital era, the Office has revamped the Service Charter web page. The Service Charter has a new visualisation that features simpler graphics, interactive categories and a quick summary.

Third quarter results

The results of the third quarter of 2020 continue showing the recovery resulting from the measures taken by the Office to improve the performance of the indicators and help customers cope with the difficult situation due to the COVID-19 pandemic (including the publication of two time limit extension decisions by the Executive Director).

Currently all the indicators are in the Excellence or Compliance categories. This also includes the Cancellation timeliness indicator which is now back in Compliance after a long period in Action Needed. All in all, 98.9% of the total amount of files processed by the Office were completed without any delay.

See the new Service Charter page

Tag: #ipexcellence