SPEECH/07/292
Günter
Verheugen
Vice-President of the European Commission responsible for Enterprise and
Industry
Closing speech Transatlantic Business
Dialogue
TABD Innovation Conference Healthcare
Berlin, 8th May
2007
Introduction
I am very pleased to have the opportunity, together with Deputy Secretary Sampson, to make a few concluding remarks at the end of this important Transatlantic Business Dialogue conference on healthcare innovation. This conference is particularly important because of:
- Its timing so soon after the historic EU-US summit at which the new 'Framework for advancing Transatlantic Economic Integration' was adopted,
- Its location in Berlin, given the crucial role of Chancellor Merkel and the German Presidency in catalysing the new EU-US Framework,
- Its organiser, the Transatlantic Business Dialogue which has been central in making the case for transatlantic economic integration,
- Its focus on healthcare, as this sector offers such challenges but also opportunities for society and business, innovation in this sector offering a win for growth and employment and also a win for health and the wellbeing of society.
The April 2007 EU-US Summit
There has been extensive discussion during this conference about last week's EU-US Summit and its main outcome: the 'Framework for advancing Transatlantic Economic Integration'. The Framework provides a clear outline of how we will work together in future and on what we have agreed to work together. On a number of items, we now have a clear timetable for implementation. And we have also established a new political structure to drive transatlantic economic integration forward with vigour and determination.
I would like to emphasise a few points:
- The newly created Transatlantic Economic Council, which I am privileged to co-chair with Alan Hubbard, Director of the US National Economic Council, will give new momentum and political visibility to transatlantic cooperation and regulatory convergence.
- The Framework will enhance transatlantic economic integration and growth, will reduce barriers to transatlantic trade and investment and will boost growth and create jobs in the transatlantic economy.
- I believe the summit outcome will also promote public health by promoting trade, investment, cooperation and innovation in healthcare and healthcare products.
- It is noteworthy for healthcare that amongst the 'Lighthouse Priority Projects' are:
- cooperation on Radio Frequency Identification technologies which could be important in combating healthcare product counterfeiting, and
- projects on nanotechnology, clearly relevant to healthcare products
- Furthermore, the Framework concentrates on fostering cooperation and reducing regulatory burden:
- to remove barriers to transatlantic commerce;
- to rationalise, reform, and, where appropriate, reduce regulations
- to empower the private sector;
- to reduce costs associated with regulation to consumers and producers;
- to remove unnecessary differences between our regulations
- to foster economic integration;
- Finally, many of the areas for cooperation in the work program are directly relevant to healthcare, including:
- Interoperability of electronic health record systems
- Cooperation on eAccessibility
- New bilateral cooperation on medical devices
- Promotion of administrative simplification in the application of regulation of pharmaceuticals
In sum, I am convinced that the 2007 EU-US Summit and the adoption of the 'Framework for advancing Transatlantic Economic Integration' will accelerate transatlantic integration to the benefit of all our citizens and to the world beyond by stimulating trade and innovation.
TABD
The business community in general and TABD in particular should congratulate itself on having supported and promoted transatlantic integration over the past years.
The TABD has been particularly instrumental in setting the agenda and in bringing business leaders together with law and policy makers. The March 2007 report 'Establishing the Barrier Free Transatlantic Market' in particular contributed to the EU-US Framework.
I have always made it a point to seek close consultation with our transatlantic stakeholders, and the new “Framework” provides for stronger involvement of legislators and stakeholders in our government-to-government efforts. With a stronger role for stakeholders comes also greater responsibility, and I have no doubt you will take these responsibilities seriously.
We have always been open and grateful for the business community’s guidance as to where to focus our cooperation efforts. I firmly believe that you, the leaders of the most important healthcare companies doing business across the Atlantic, are well positioned to inform us of the barriers to trade and investment you encounter in your daily operations.
Regulatory cooperation – pharmaceuticals as an example
Today's conference has covered healthcare and healthcare products in the widest sense. While acknowledging this I would like to take the regulation of pharmaceuticals as an example to emphasise some points of best practice which, although not all unique, I consider should be applied more widely:
- Firstly, good regulation is critical to innovation stimulation including in emerging areas; an example: in the last few weeks the European Parliament has voted to support a new European regulation on 'advanced therapies'. These are healthcare products including those based on cells, tissues and gene therapy. The European Commission proposed this regulation because a lack of a robust Europe-wide regulatory system is reducing investment in this sector by creating uncertainly on how to reach the market. The new regulation will stimulate healthcare innovation in both the EU and the US by creating a clear, robust, Europe-wide route to market for this group of new therapies which hold so much promise.
- Secondly, upstream regulatory cooperation prevents divergences and ensures best use of resources – a couple of examples: intense dialogue took place between the European Commission and United States Food and Drug Administration before the European Commission proposed regulations on medicines for children, medicines for rare diseases, and most recently advanced therapies. As a result the EU and US regulatory frameworks are complimentary, research and development programmes can be combined and return on investment can be maximised.
- Thirdly, creating the right conditions for close dialogue at the level of the regulatory bodies brings concrete results – example, since the European Commission with the European Medicines Agency agreed confidentiality arrangements with the United States Food and Drug Administration (FDA) in 2003, the level of regulatory cooperation, including upstream cooperation on future legislation has intensified dramatically. The interactions between my services and the European Medicines Agency and the US FDA are now occurring multiple times every day through e-mail, teleconferences, face to face meetings and secondments. These interactions are now the norm for regulation in the area of pharmaceuticals and this is down to the creation of 'safe conditions' within which the regulators and experts can work.
- Lastly, effective use of the transatlantic relationship can support and advance multilateral cooperation – example, the International Conference on Harmonisation – ICH, originally proposed by the European Commission, is the multilateral forum for harmonising the rules governing pharmaceuticals. It brings together regulators from the US, EU and Japan with the innovative pharmaceutical industry from those regions and the regulators have committed to implement the outcome in the form of harmonised regulatory guidelines. The ICH process has been particularly successful and sustained because of the strong EU-US relationship. Another critical factor has been having the industry at the negotiating table, thereby able to highlight differences in regulation between the regions and to bring its expertise. The format for a marketing authorisation application is now fully harmonised between the three largest pharmaceutical markets, this is, in my view, a remarkable success. By having a single set of rules covering the EU, US and Japan costs are reduced, duplication of studies is minimised and innovation and competitiveness are stimulated.
Conclusions and moving forward
Despite the globally unparalleled integration of transatlantic markets, for too long we have left some of this marketplace’s full potential untapped.
So how do we move forward?
Let us take the 'Framework for advancing Transatlantic Economic Integration' agreed at last week's EU-US Summit as a point of departure for getting down to the business of reducing and avoiding unnecessary barriers in the healthcare markets.
At the same time, let us build on and reinforce the successful collaboration and integration of the past, including our close regulatory cooperation and convergence.
Healthcare businesses have a critical role to play in progressing this agenda: we need your valuable input in the form of robust data on the barriers you encounter and we need your valuable expertise in finding ways to break down those barriers.
Working together I believe we can achieve concrete results in advancing transatlantic economic integration which will benefit our citizens, through:
- Stimulation of innovation,
- Creation of employment,
- Creation of wealth, and above all,
- Promotion and protection of health
Thank you.