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Burson-Marsteller is able to provide evidence-based communications because of the people we hire, the breadth of our market coverage, our specialist practices and our proprietary research. Our markets and practices regularly develop their own reports, tools and thought pieces based on original research and analysis in areas ranging from EU affairs to Web Rep and the Environment. More
Looking ahead: assessing the revision of EU medical devices legislation
by isabelle.merillet on 26th April 2013
The keenly anticipated revision of the EU medical devices legislation is perhaps one of the most controversial, technical and topical pieces of health legislation to be discussed in Brussels in recent years.
Medical devices cover a wide range of products, from simple bandages to the most sophisticated life-supporting products. These devices play a crucial role in the diagnosis, prevention, monitoring, and treatment of diseases and in the improvement of the quality of life of people suffering from disabilities.
Innovation in this particularly dynamic sector is considered fundamental to ensuring access to quality and cost-efficient healthcare. The new regulatory framework will undoubtedly affect the ability and capacity of the medical device industry to deliver this.
It will also impact upon national public authorities, the healthcare community and patients by ensuring access to safe and high-quality devices across the EU through robust surveillance, assessment and monitoring mechanisms.
Kenyan Presidential Election Insight
by isabelle.merillet on 26th March 2013
The Kenyan general election, held on 4 March, saw Uhuru Kenyatta of The National Alliance (TNA – part of the Jubilee Coalition) declared winner, defeating Raila Odinga of the Coalition for Reforms and Democracy (CORD).
However, his victory may be short-lived if a petition filed with the Supreme Court to nullify his victory stands. Mr Odinga challenged the
election of Mr Kenyatta as the fourth president of the Republic of Kenya, deeming the vote to be ‘tainted’. This may delay the swearing in of the President-elect.
Ghanaian General Election insght
by isabelle.merillet on 18th December 2012
Ghana’s ‘caretaker’ president John Dramani Mahama has won his first full four-year term in an closely-contested vote. The leader of the centre-left National Democratic Congress (NDC), who became President in July following the death of John Atta Mills, won 50.7 per cent of the vote in the election on 7 December.
The NDC also increased its representation in parliament, and is projected to win an absolute majority in the 275-seat assembly.
The Observer Mission from Ecowas (the Economic Community of West African States), led by a former President of Nigeria, Olusegun Obasanjo, described the electoral process as generally free, fair and peaceful. Ghana was described as being ’the vanguard of democracy’. However, the centre-right opposition New Patriotic Party (NPP) alleged that the election was fraudulent and indicated that it will contest the polls in court.
Global Public Affairs: Hot Issues
by isabelle.merillet on 17th December 2012
“Hot Issues” from Burson-Marsteller’s Global Public Affairs Practice will focus on new forthcoming legislative or policy issues that will impact business from around our global network of 130+ offices in Latin America, Asia-Pacific, Europe, Middle East, Africa and North America.
The public policy dynamics in each country, let alone a particular region can be very different, demonstrated by the different experts we utilize in the countries where we operate. Conversely, there are similarities and you can see this in some of the issues we have picked out: labour/union policy in the US and China; gambling legislation for the EU and Japan; and environmental law in Brazil and China.
Hot Issues are designed to give you a flavor of our global perspective and should any of the items raise particular interest with you please contact the designated person listed with that issue.
Romanian parliamentary elections
by isabelle.merillet on 17th December 2012
The Social-Liberal Union (USL), a broad coalition headed by the Prime Minister, Victor Ponta (right), has won a landslide victory in Romania’s parliamentary election. The USL, a centrist grouping that includes social democratic, liberal and conservative parties, won 395 of the 577 seats available in Romania’s parliament, giving it a strong majority in both the lower house, the Chamber of Deputies, and the upper house, the Senate. The main opposition, the centre-right Just Romania Alliance (ARD), won only 80 seats in Parliament. Mr Ponta, the leader of the Social Democrats and co-leader of the USL, is almost certain to be re-appointed as Prime Minister, although the President of Romania, Traian Bascescu is likely to wait the maximum 20 days before reappointing his political rival.
Slovenian presidential election
by isabelle.merillet on 17th December 2012
Borut Pahor, the left-wing former Prime Minister of Slovenia, has won the country’s presidential election. Mr Pahor took more than double the number of votes of his rival, the outgoing independent President, Danilo Türk, in the run-off on Sunday 2 December. The campaign had been marked by demonstrations and increasing public dissatisfaction with the current right-wing government and politics in general.
The 2010-2014 European Commission Mid-Term Review
by paul.schuchhard on 13th November 2012
To mark the mid–term of the Barroso II Commission, we asked actors from across the world of EU policy-making to tell us how they thought they did. More than 811 respondents from all corners of the EU policy making world took part in our online survey, which asked questions about achievements of the European Commission as a body, as well as for each of the 27 individual Commissioners.
The Review of EU Medical Devices Legislation
by isabelle.merillet on 28th September 2012
Brussels, 27 September 2012
On 26 September 2012 the European Commission published its proposals for the review of the medical devices legislation, consisting of a:
Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
The Commission also published its ‘Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals’. The Communication was adopted as a response to the Council Conclusions on innovation in the medical device sector, from 6 June 2011 and to the European Parliament Resolution on defective silicone breast implants from 14 June 2012.
The adoption of the above documents was announced in a press release. The key elements of the revision are summarised in a Citizens’ summary and in a questions and answers document.
Dutch General Election
by isabelle.merillet on 17th September 2012
Dutch voters send mixed message: stay the course and change direction.
The right-wing Liberals of Prime Minister Mark Rutte and Diederik Samsom’s Labour Party made strong gains in the Dutch general election on 12 September. It now seems likely that these two parties, from opposite ends of the political spectrum, will come together to form a coalition, with negotiations already underway.
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