04/12/2017

Deadline for applications is 20 December 2017

The European Commission’s Directorate-General for Health and Food Safety has launched a call for expressions of interest to represent patient organisations in the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP).

The call aims to fill three positions for COMP members nominated by the European Commission to represent patient organisations. These members participate in the meetings of the Committee alongside the members nominated by each Member State, Iceland and Norway, as well as an additional three members nominated by the European Commission based on a recommendation from the EMA.

The three members representing patient organisations will be appointed for a term of three years from 1 July 2018, which can be renewed. The deadline for the submission of applications to the European Commission is 20 December 2017. Further information on the application procedure and the assessment criteria is available on the Commission’s website.

The COMP has a strong tradition of involving patient representatives in its work. Its main task is to examine applications sent by companies and decide whether their medicines can be designated as ‘orphan’. An orphan medicine is used in the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that is rare, which means it affects no more than five in 10,000 people in the European Union (EU).

The role of a patient organisation representative in the COMP is to give a voice to patients and ensure their needs are taken into account in the Committee’s decision-making process. Although a medical background is not required, candidates may benefit from a sound knowledge of medical and, to a certain extent, regulatory issues related to medicines in the EU.

Representatives of patient organisations participate in the COMP procedures in the same way as other Committee members. They are expected to attend monthly Committee meetings at EMA and to actively contribute to scientific discussions, examine documents and make comments with a specific focus on the target group they represent.

Representatives of patient organisations are also members of the EMA’s Pharmacovigilance Risk Assessment Committee, Paediatric Committee and Committee for Advanced Therapies.

The European Commission will appoint the patient organisation members after consultation with the European Parliament.

The Europe 2020 Strategy is soon coming to an end at a time when Europe is facing major challenges. Civil society should provide contribution to the shaping of the new post-2020 participatory long term strategy, as well as to its governance and implementation, was the event’s message. Key priority for the future strategy should be to respond more effectively to rising inequality, to create trust and confidence across Europe and to ensure a fair transition for all.

The conference, which took place on 27-28 November 2017 in Budapest, was organised by the European Economic and Social Committee (EESC), with the support of the Hungarian Economic Association and the Hungarian Ministry for Human Resources.

The event gathered members of the EESC and national Economic and Social Councils, European Union institutions, representatives of the Hungarian government and representatives of Hungarian civil society.

Opening the conference, president of the EESC’s Europe 2020 Steering Committee Etele Baráth underlined the importance of continuity and the still relevant objectives of the EU 2020 strategy in choosing the best scenario for 2030. The aim must be to improve governance and to further strengthen the objectives for a smart, inclusive and sustainable Europe.

Juca Jahier, President of the Various Interests Group of the EESC said “The post 2020 Europe will have to be designed and delivered through a new governance, working transparently and in partnership, driven by bottom-up initiatives. Sustainability should be at the very heart of the new strategy.”

Philippe Lamberts, Member of the European Parliament, Péter Balázs, Professor at Central European University and former European Commissioner for Regional Policy highlighted the need to invest in long term projects and avoid impact from more short term economic and political interests as well as to define the EU position in the world and what future EU we want. Gyula Pleschinger, President of the Hungarian Economic Association mentioned the Juncker five scenarios are a good starting point to trigger the debate. Gábor Zupkó, EC Representation in Hungary, added that building the capital markets union is more challenging now with the challenges Brexit brought about.

Brenda King, President of the Sustainable Development Observatory at the EESC, called for the European Commission to “focus more on integrating the SDGs and the Paris Agreement fully into the European policy framework with the objective of setting out a vision for a fair and competitive Europe to the year 2050″. Moreover, “The EU must succeed in getting the best out of the digital revolution to build a new, competitive and sustainable economy; shifting towards a low-carbon, circular and eco-friendly economy while ensuring a fair transition for all”.

Anne Demelenne, EESC Member and Pavel Trantina, President of the Section for Employment, Social Affairs and Citizenship of the EESC highlighted consequences of technological changes on the quantity and quality of jobs (referring to the recently proclaimed ‘pillar’ of social rights), the need for an extended eurozone and the need to realise the benefits that migrants can contribute especially considering the European demographic situation.

The importance of striking the proper future balance concerning division of labour between EU institutions and member states, in order to create the flexibility needed to respond and adapt to future shocks, was highlighted by Enrico Giovannini, (Italian Alliance for Sustainable Development). Csaba Kőrösi, Director of Environmental Sustainability at the Office of the President of Hungary added the importance of an integrated approach and to avoid silo thinking.

Deputy State Secretary Balázs Molnár reminded the audience that higher social standards must not negatively impact on EU competitiveness. The Christian roots of Europe should be taken into account when shaping the future strategy was the opinion of Attila Szücs, President of the National Economic and Social Council of Hungary.

Several speakers touched upon the issue of funding. The next multiannual financial framework should be geared towards the new strategy, the EU own resource budget should be increased, an organisation responsible for sustainability should be set up and there should be civil society funding.

Etele Baráth, closed the event by concluding that the next strategy must be horizontal, geared towards the long term (2030, 2050) and should build on the concept for an enhanced participative European development-oriented governance.  The conference conclusions will be factored into future work by the EESC.

More information is available at: http://bit.ly/2AkGUPR   –  For more information, please contact: EESC Press Unit
E-mail: presseesc [dot] europa [dot] eu  –  Tel: +32 2 546 8141  –  @EESC_PRESS  –  VIDEO: How has the EESC made a difference

EFSA took part in a high-level ministerial conference on Xylella fastidiosa on 1 December 2017. The meeting in Paris was organised jointly by the EU Commissioner for Health and Food Safety, Vytenis Andriukaitis, and the French Minister for Agriculture and Food, Stéphane Travert.

EU ministers, risk managers and plant health experts met to assess the current situation in Europe regarding Xylella and to reinforce co-operation between Member States to combat the disease.

EFSA presented an outline of the discussions from a scientific meeting it organised on Xylella in Palma de Mallorca on 13-15 November 2017.

Conclusions from the ministerial conference recommend that EFSA updates its 2015 scientific opinion on Xylella to account for recent scientific developments. It was also proposed that European Commission Working Groups be established to share best practice among experts and to enhance stakeholder awareness of measures to tackle the disease.

The full conclusions are available on the website of the European Commission.

The European Investment Bank (EIB) is granting Raiffeisenverband Salzburg eGen (RVS) a loan of EUR 38m. This transaction is the first tranche of an overall EIB envelope of up to EUR 100m, which will provide RVS – a member of the Austrian cooperative Raiffeisen Bank Group – with long-term funding resources for SMEs and midcaps, in particular for the financing of small and medium-scale infrastructure, construction and renewable energy projects. Under the operation RVS undertakes to match EIB’s resources with the same amount. Allocations to final beneficiaries located in Germany would be allowed, subject to a limit of 15% of the total loan amount.

EIB Vice-President Andrew McDowell, responsible for operations in Austria, stressed: “The operation will provide RVS with fresh money mainly for the benefit of SMEs and midcaps, thus contributing to private sector development. It will help create and sustain employment in the economy and encourage growth in the Federal State of Salzburg and the neighbouring region of southern Bavaria in Germany.”  And he added: “Supporting long-term financing on very favourable terms for SMEs and midcaps is a top priority for the EU bank. We are therefore delighted to sign this first transaction with RVS, which also demonstrates our very successful relationship with Raiffeisen in Austria.”

Member of the RVS management board Heinz Konrad said: “As local SMEs remain the backbone of the Salzburg economy, Raiffeisen Salzburg sees it as a priority to support their planned projects with medium to long-term loans granted on favourable terms and with minimal red tape. We are delighted to be partnering with the EIB to provide further funding for the pioneering projects and initiatives of local companies, thereby strengthening their competitive financial standing.”

Boosting the economy in the Federal State of Salzburg and southern Bavaria

As a company with deep local roots, RVS has been providing high-quality services for more than 100 years in the fields of banking, audit and warehouse operation, supporting and promoting the economic development of its members and customers. RVS is legally incorporated as a cooperative and is the Salzburg regional division of the Raiffeisen banking institution. With 56 independent cooperative banks and 125 of its own branches as well as 11 self-service locations throughout the region, it is by far the biggest banking group in Salzburg.

EFSA has launched a public consultation on its draft guidance on the assessment of the efficacy of feed additives.

The guidance document is intended to assist the applicant in the preparation and presentation of an application for the authorisation of a feed additive. It specifies what kind of information and data applicants need to include in their dossiers to allow EFSA to assess the efficacy of feed additives.

EFSA invites interested parties to submit written comments by 28 January 2018.