Commission: EU’s new blood directive to address dependency on US plasma

The ongoing revision of the European legislation on blood, tissues, and cells offers an opportunity to tackle the highly problematic dependency on plasma collected in the US for manufacturing plasma-derived medicinal products (PDMPs), according to an EU health official.

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Briefing – Mental health and the pandemic – 09-07-2021

While the pandemic is primarily a physical health crisis, it has also had widespread impact on people’s mental health, inducing, among other things, considerable levels of fear, worry, and concern. The growing burden on mental health has been referred to by some as the ‘second’ or ‘silent’ pandemic. While negative mental health consequences affect all ages, young people, in particular, have been found to be at high risk of developing poor mental health. Specific groups have been particularly hard hit, including health and care workers, people with pre-existing mental health problems, and women. The pandemic has also appeared to increase inequalities in mental health, both within the population and between social groups. To address the population’s increased psycho-social needs, the World Health Organization Regional Office for Europe established an expert group on the mental health impacts of Covid-19 in the European region. The Organisation for Economic Co-operation and Development has issued analyses and guidance on mental health in general and the pandemic’s impact on mental health in particular. At European Union level, a December 2020 European Commission communication addressed the pandemic’s impact on mental health. In May 2021, the Commission organised a major online stakeholder event, and published best practice examples of solutions presented. A July 2020 European Parliament resolution recognises mental health as a fundamental human right, calling for a 2021-2027 EU action plan on mental health. Members of the European Parliament have also called on the Commission to put mental health at the heart of EU policymaking. Stakeholders broadly rally around calls for programmes and funding to improve citizens’ mental health, not least to respond to the pandemic’s long-term implications.

Source : © European Union, 2021 – EP

Briefing – EU-UK relations: Difficulties in implementing the Northern Ireland Protocol – 09-07-2021

On 3 March 2021, the United Kingdom (UK) Secretary of State for Northern Ireland, Brandon Lewis, announced in a written statement to the UK Parliament, and without consulting the European Union (EU) in advance, that the grace period on border controls on a series of food and live products shipped from Great Britain to Northern Ireland would be extended. This meant that products of animal origin, composite products, food and feed of non-animal origin and plants and plant products could continue being shipped from Great Britain to Northern Ireland without the official certification, such as health and phytosanitary certificates, required by the Protocol on Ireland / Northern Ireland (the Protocol) of the Withdrawal Agreement (WA). In response to the UK’s decision, the EU launched legal action against the UK for breaching the provisions of the Protocol, as well as the good faith obligation under the WA. According to the Protocol, the UK must establish border controls on goods moving between Great Britain and Northern Ireland according to EU law. The application of EU law to Northern Ireland, together with the conduct of border controls within the UK, was designed to prevent the establishment of physical border controls (a ‘hard border’) on the island of Ireland, so as to safeguard the Good Friday/Belfast Agreement which brought peace in Northern Ireland, while preserving the integrity of the EU’s single market. The grace period on border controls was agreed by the EU and the UK in December 2020 as a temporary solution to problems raised by the UK. The UK government has reiterated that it intends to implement the Protocol, but that the border controls are causing trade disruption between Great Britain and Northern Ireland and require time to be resolved. It has also mentioned other issues involving areas as diverse as medicinal supplies and parcel shipments, as well as the complexity of customs systems and implementation of exchange of information between the EU and the UK. On 30 June 2021, the EU and the UK reached an agreement on some solutions, including the extension of the grace period on meat products, conditional on tight controls.

Source : © European Union, 2021 – EP

Highlights – Cross-border health, high-technology assessment, asbestos protection: committee votes – Committee on the Environment, Public Health and Food Safety

protecting citizens' health
The Committee on Environment, Public Health and Food Safety will vote on amendments to the report on serious cross-border threats to health, and to the opinion on protecting workers from asbestos, on 12 and 13 July. The provisional inter-institutional agreement on the Health Technology Assessment (HTA) will also be voted on 13 July.

Source : © European Union, 2021 – EP

Briefing – Prospectuses for investors – Simplifying equity-raising during the pandemic – 01-07-2021

A prospectus is a legally required document presenting information about a company and the securities that it offers to the public or seeks to admit to trading on a regulated market. The relevant EU legislation consists of a directive, adopted in 2003, amended in 2010, and finally replaced by a regulation in 2017. Drawing up a prospectus entails time and costs, which in the current economic context may deter issuers in distress from seeking to raise new funds, in particular equity. To remedy this, the Commission proposed to amend Regulation (EU) 2017/1129. These amendments aim at creating a temporary (18 month) regime for a short-form prospectus and to simplify the procedure for issuers (so that they can rapidly raise capital), as well as to release pressure on financial intermediaries. The Commission proposal was reviewed by the co-legislators who, among other things, increased the range of those who can benefit from the regime, added elements that must appear in the recovery prospectus and increased the minimum information in the prospectus. They further amended Directive 2004/109/EC (the ‘Transparency Directive’), thus providing Member States with the option to postpone, by one year, the requirement for listed companies.

Source : © European Union, 2021 – EP

Briefing – EU rural development policy: Impact, challenges and outlook – 08-07-2021

On 30 June 2021, the European Commission adopted a communication on its long-term vision for the EU’s rural areas. The communication identifies areas of action with a view to creating new momentum for the EU’s rural areas, while recognising their diversity. In recent decades, in many Member States rural areas have experienced depopulation. Such regions face a range of environmental and socio-economic challenges. These include, for example, lower income per capita, a higher percentage of the population at risk of poverty and social exclusion, a lack of access to basic infrastructure and services, and lower levels of access to fast broadband internet. The EU’s rural development policy has sought to help address these challenges. Evaluation evidence is emerging on the impact of the common agricultural policy (CAP) on the territorial development of the EU’s rural areas. Measures relating to village renewal and LEADER (Liaison entre Actions de Développement de l’Économie rurale) measures are considered to be well-targeted and relevant to local needs, although they represent a small proportion of CAP financing. Administrative burdens have been raised as an issue that can impact on the developmental process. Recommendations from this evaluation evidence point to the need for better integration of funding streams, the need to maintain a dialogue across the European structural funds, and all the implications this may have for the new CAP strategic plans. The Commission’s recommendations to Member States on their CAP strategic plans highlight a number of recurring themes relating to the employment, education and training needs of rural areas, including the need to address rural depopulation, promote generational renewal, improve connectivity, and address the role played by action taken at local level. The Commission’s communication on a long-term vision for rural areas includes provision for a ‘rural pact’ to engage actors at EU, national, rural and local levels and an EU rural action plan, setting out a range of initiatives and actionable projects. The vision and its supporting analyses will provide a framework for addressing the future of the EU’s rural areas.

Source : © European Union, 2021 – EP

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