Pharmaceutical Executive Europe - September 2008 - (Page 22)

Joining the parallel lines The US and the EU are set to intensify their co-operation in the pharmaceutical arena by pushing forward a joint facilities inspection initiative. However, will the weaknesses of the similar Parallel Scientific Advice Programme, which failed to garner successful results, come back to haunt them? Fabien Roy reports. A long with the scientific uncertainty inherent in developing new drugs, companies seeking approval for their products must deal with the worry of navigating the diverse regulatory systems around the world. However, the establishment of the Transatlantic Economic Council (TEC) by European Commission President José Manuel Barroso, German Chancellor Angela Merkel and US President George W. Bush at the EU/US Summit in April 2007 aimed to combat some of these problems, at least between the US and Europe, by fostering transatlantic economic integration, and allowing companies to express their concerns and to push for more transparent cooperation. On 13 May 2008, US Cabinet members and European Commissioners met for a second session of TEC and decided to intensify the co-operation between the US and the European Union in the pharmaceutical arena. In theory, this can be regarded as an important date for pharmaceutical companies engaged in the marketing of products on both sides of the Atlantic. In practice, however, it might not be quite the milestone it could be. Pharma objectives of TEC TEC aims to achieve better regulation, barrier-free and secure trade, protection of intellectual property rights and integration of financial markets. To achieve these objectives, it has several permanent members, comprising the EU Commissioners for External Relations, Trade, and Internal Market and Services, and, from the US, the Secretaries of the Treasury and Commerce and the Trade Representative. A group of advisers has been tasked to articulate the views of manufacturers, as well as citizens and consumers, on both sides of the Atlantic, on the priorities that should be pursued. During the high-level meeting in May, it was announced that, among other things, the EU and the US had agreed to strengthen collaboration on medicine regulation, and to conduct joint inspections of pharmaceutical manufacturing facilities. The intention is to simplify and harmonise administrative procedures in the pharmaceutical area, as well as to ensure the safety of products manufactured in third countries. The European Commission (EC), the European Agency for the Evaluation of Medicinal Products (EMEA) 25 Last Words The month’s key events from the industry’s mouth. 4 News A round-up of the last four weeks in pharma. 7 Calendar Upcoming conferences and exhibitions. 10 Brussels Report Competition between the bioindustry associations. Andrew Holt/Getty Images

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - September 2008

Pharmaceutical Executive Europe 9/08
Contents
From the Editor
News and Analysis
Calendar
The Battle for Bio
The Value of VRIO
Russian Pharma 2015
Pharma’s New Winners and Losers
Into the Lake
Joining the Parallel Lines
Last Words

Pharmaceutical Executive Europe - September 2008