Burson-Marsteller Brussels » Insights and reports

Looking ahead: assessing the revision of EU medical devices legislation

isabelle.merillet — Fri, 26 Apr 2013 15:39:04 +0000

Looking ahead: assessing the revision of EU medical devices legislation

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.

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Arab Youth Survey 2013

isabelle.merillet — Fri, 12 Apr 2013 15:21:20 +0000

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Kenyan Presidential Election Insight

isabelle.merillet — Tue, 26 Mar 2013 09:09:42 +0000

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.

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Ghanaian General Election insght

isabelle.merillet — Tue, 18 Dec 2012 14:33:22 +0000

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.

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Global Public Affairs: Hot Issues

isabelle.merillet — Mon, 17 Dec 2012 10:51:27 +0000

“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.

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Romanian parliamentary elections

isabelle.merillet — Mon, 17 Dec 2012 09:28:56 +0000

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.

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Slovenian presidential election

isabelle.merillet — Mon, 17 Dec 2012 09:25:06 +0000

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.

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The 2010-2014 European Commission Mid-Term Review

paul.schuchhard — Tue, 13 Nov 2012 05:03:20 +0000

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 results are presented on 13 November in Brussels by a panel composed of John Wyles (Senior Advisor, EPC), David Harley (Chairman, Burson-Marsteller Brussels), David Earnshaw (CEO, Burson-Marsteller) and moderated by Daniela Vincenti (Editor-in-Chief,EurActiv).

The full report

Full Results – Commission as a Whole (pdf)

Full Results – 27 Commissioners (pdf)

Commissioners Overall Results Table (pdf)

Methodology

Comments from Respondents

Poster Commitments Barroso II

The Review of EU Medical Devices Legislation

isabelle.merillet — Fri, 28 Sep 2012 11:43:04 +0000

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:

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.

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Dutch General Election

isabelle.merillet — Mon, 17 Sep 2012 14:37:59 +0000

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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