Medical devices are instruments, software or implants which are used for diagnosis, monitoring, treatment or replacement due to injury or disability. They cover a vast spectrum of products ranging from low-risk products such as corrective glasses, sticking plasters, etc. to high-risk products such as pacemakers and hip implants.
The existing regulatory framework for medical devices dates back to 1990 and 1993 and needs to be updated substantially to keep pace with technological and scientific progress, and to harmonise the way the rules are applied. Recent scandals such as fraudulent silicone breast implants and problems with certain metal-on-metal hip-joint replacements have shown that the approval system in place is not appropriate for high-risk devices. Under the current regime, notified bodies assess the performance and safety of medical devices, but this process is not sufficiently transparent and neither are the fees they charge to manufacturers. The S&D Group is pressing for improved patient safety and better protection of EU citizens from defective medical devices through a more effective and efficient system for granting market access.
Regulation of the European Parliament and of the Council on the production and making available on the market of plant reproductive material (plant reproductive material law)
Plant reproduction is a very important issue for both farmers and citizens, and must be carefully regulated. The agricultural committee voted in favour of rejecting the Commission's proposal and decided to table an oral question to the Commission. MEPs took this decision for several reasons: due to concerns about replacing 12 existing directives with one; because it fails to address major issues surrounding plant genetic resources and agricultural biodiversity; and due to concerns about rushing through a complex legislative issue before the imminent 2014 European elections.
Role and operations of the Troika with regard to the euro area programme countries
The S&D Group deplores the authoritarian and austerity-driven policies of the Troika, which we feel acts outside EU law. We take the view that technocrats cannot continue to give instructions to democratically elected representatives of the people. Europe needs a genuine European Monetary Fund based on EU law in order to support counties in difficulties and to involve the European Parliament in the decision-making process.
The report concludes that the Troika's decisions are unsound and undemocratic, and it must be phased out. It goes on to recommend that a European Monetary Fund should be set up under community law, with European Commission staff and a community-based European Stability Mechanism (leaving the International Monetary Fund as an optional participant and the European Central Bank as a silent observer). Moreover, in addition to medium-term reform at European level, country-specific solutions are needed more rapidly.
Mid-term review of the Stockholm Programme
The Stockholm Programme is a multi-annual (2009-2014) strategic document which aims to provide a roadmap for EU work in the area of freedom, security and justice in Europe. The European Parliament's own initiative report has now been adopted, assessing the achievements made so far and detailing the actions still to be undertaken.
The most relevant point was that follow up of the Stockholm programme should no longer be undertaken by the Council alone, but ‘in the spirit of the Lisbon Treaty, in a joint exercise of Parliament, the Council and the Commission’. Other crucial points were the inclusion of the evaluation of criminal justice in the justice scoreboard.
Employment and social aspects of the role and operations of the Troika
Europe’s social dimension has been completely ignored in recent years. Europe needs to show that it cares not only about the financial health of its member states but also about the day-to-day lives of its citizens. Europe is not only a lenders’ club but a community of values. This report focuses on those countries (Greece, Ireland, Portugal and Cyprus) that underwent the Troika's economic adjustment programmes and it offers an in-depth analysis of the social impact of the programmes.
The report calls upon the Troika and member states to put an end to these programmes as soon as possible and to create transparent crisis-management mechanisms through the EU institutions. The report asks the Commission, together with the International Labour Organisation (ILO) and the Council of Europe, to study the employment and social consequences of these adjustment programmes, including corrective measures and incentives to improve the employment and social situation in these countries. It also calls for a social and employment recovery plan to repair the damage done to individuals, communities and industry, through measures such as improving credit for small businesses and an effective European Youth Guarantee.
US NSA surveillance programme, surveillance bodies in various member states and impact on EU citizens' fundamental rights
On 4 July 2013, the European Parliament instructed the civil liberties, justice and home affairs committee to conduct an inquiry into the alleged mass surveillance of citizens by the US National Security Agency (NSA) and various EU countries, and the impact on citizens' fundamental rights.
Over 15 inquiry meetings were held with witnesses from various member states, the US, Brazil and Russia, and a delegation visited Washington in October 2013. MEPs heard from EU institutions, national parliaments, whistle-blowers, journalists, academics, lawyers, civil society respresentatives, security and technology specialists and private businesses. The extensive report gathers all the evidence and concludes with a set of recommendations, including setting out clear protections for individuals online, seven actions for protecting privacy and a roadmap for the future.
Protection of individuals with regard to the processing of personal data
The new data-protection regulation is needed primarily because the implementation and enforcement gaps between member states were too large and confusing for all involved. The regulation lays down rules relating to the protection of individuals in the processing of personal data and rules on the free movement of personal data. This will help to improve the level of protection and legal certainty, guarantee the enforcement of individuals' rights and improve factors relating to the internal market.
Successes achieved include: clear principles for processing data and clear, technologically neutral definitions that can stand the test of time; appropriate information and rights for the data subject, including a strong definition of consent; reduced bureaucracy for businesses; strong data-protection authorities; harmonised EU-wide enforcement; a clear system for international transfers of data; and strong sanctions for breaches.
Processing of personal data for the purposes of crime prevention
The directive defines the rules relating to the processing of personal data for the purposes of prevention, investigation or prosecution of criminal offences. It defines its objectives as protecting people’s fundamental rights and freedoms – particularly the protection of their personal data – while also guaranteeing a high level of public safety and ensuring the exchange of personal data between the competent authorities within the EU. The scope of the directive is not limited to cross-border data processing but also applies to all processing activities carried out by 'competent authorities'. The directive replaces the old Framework Decision 2008/977/JHA with improved, enforceable rights and a much higher level of protection for personal data.
The file is currently blocked in the Council with very slim hopes of movement any time soon. The Parliament is therefore forced to take a first-reading decision without agreement to keep the text alive.
Prevention of the use of the financial system for the purpose of money laundering and terrorist financing
This report concerns the Parliament's first-reading position on the proposed fourth Anti-Money Laundering Directive. The major positive in the report from the civil liberties, justice and home affairs, and economic and monetary affairs committees is the public register of beneficial owners – the result of a compromise between all political groups. This allows full public access to the information on beneficial ownership, subject to the identification of the person seeking the information. It also ensures that trusts and other such legal arrangements are treated as registered companies in terms of the transparency measures required. However, on the related issue of the level of shareholding which may constitute evidence of beneficial ownership, the S&D Group was unsuccessful in trying to lower this level from 25% to 10%. We may table an amendment in plenary on this point.
Freedom of movement for workers
This directive is aimed at improving the enforceability of the existing regulation on freedom of movement for workers within the EU. It will help remove existing barriers to the mobility of EU workers by making it easier to enforce their rights under EU law and providing information and legal support to mobile workers in the EU who face discrimination based on their nationality.
The purpose of the directive is to establish fair and transparent conditions for those European citizens who decide to move to another country to work and the result of the negotiations was satisfactory for us. We have succeeded in highlighting and securing the role of trade unions and employers in protecting mobile workers and preventing unequal treatment. The S&D Group also ensured that a fair balance was reached between individual rights and collective rights.