Posts Tagged ‘EU’

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Opportunity for U.S. Manufacturers of Active Pharmaceutical Ingredients

October 22, 2013

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Farah Naim is an International Trade Specialist in the International Trade Administration’s Office of Health and Consumer Goods.

The European Union (EU) is taking action against substandard and falsified medicines, and it could present an opportunity for U.S. pharmaceutical manufacturers to increase exports to the region.

As of July 2, shipments to any EU country of active pharmaceutical ingredients (APIs) — the ingredients that make medications work — have had to be certified by the EU. Certification requires that the APIs be manufactured under standards at least equivalent to EU manufacturing practices. These standards include considerations for quality management, production reviews, and regular internal audits of manufacturing facilities.

Each individual pharmaceutical manufacturing facility now needs a compliance certificate for every API that it produces.

Countries can request assessment of their national manufacturing standards, to determine if they meet the EU’s standard. If they do, then individual manufacturers in those countries will not need a compliance certificate. As of September, Australia, Japan, Switzerland, and the United States have applied for and met the standard.

This presents an opportunity for U.S. innovative and generic pharmaceutical manufacturers. As global manufacturers apply for EU certification, and other nations apply for and strive toward EU standards, American-made pharmaceuticals can fill gaps created by the certification processes.

All of us here on ITA’s Health Team are dedicated to enhancing the global competitiveness of the U.S. health industry, and making sure it has every advantage when competing abroad.

For more information on this and other health-related trade matters, please visit ITA’s Health Industries page or contact me at Farah.Naim@trade.gov.

More information on the new rules, enacted in Directive 2011/62/EU, can be found at: http://ec.europa.eu/health/human-use/quality/index_en.htm.

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President Obama Prescribes Increase in U.S. Exports to Support Economic Growth

February 13, 2013

Francisco Sánchez serves as the Under Secretary of Commerce for International Trade. 

Archived photo showing Congress during 2011 State of the Union Address.President Obama made it clear in his State of the Union address that American exports will play a part in America’s economic success. This requires creating free access for American goods to more markets, enforcing trade laws, and ensuring a level playing field in which American companies can compete.

These initiatives have and will continue to support business and create jobs. Over the last 35 months, they’ve already contributed to the creation of 6.1 million private-sector jobs. We at the International Trade Administration are proud to be a part of that success and we know that continuing these initiatives will lead to further economic growth.

The President specifically mentioned completing the Trans-Pacific Partnership and entering into a trade agreement with the European Union. Trade agreements like these proved effective in 2012, when we set a new record for U.S. exports. Recently released data show that almost half of the growth in U.S. exports in 2012 was to countries with which we have similar agreements. In fact, U.S. exports to the 20 countries with which we have trade agreements comprised almost half of American goods exports in 2012.

We achieved record levels of exports to 11 of our trade agreement partners in 2012. Five of them – Australia, Canada, Chile, Mexico and Peru – will all be a part of the TPP and accounted for more than $550 billion in U.S. exports. Completing this partnership will further develop our trade with these countries and help our exports continue to grow.

As Deputy Secretary of Commerce Rebecca Blank explained today, a trade agreement with the EU “will support good-paying American jobs and will expand our trade and investment relations, strengthen our economy, and create new opportunities on both sides of the Atlantic.”

President Obama also mentioned the importance of enforcing trade regulations and ensuring a level playing field in which American exporters can compete. We accomplish this mission every day at ITA, and we are proud to help American exporters compete as a lead member of the President’s Interagency Trade Enforcement Center.

The President has set a clear path to use export growth to help grow the American economy. We at the International Trade Administration are ready to do what it takes to continue to support President Obama’s mission and help support a thriving American economy.

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October 2011 Trade Facts and Figures – Autos and Europe

December 9, 2011

Cory Churches is a Communication and Outreach Specialist in the Office of Public Affairs at the International Trade Administration

Today the Commerce Department announced the figures for international trade in goods and services for the month of October. Year-to-date, exports have grown nearly 16 percent. One area that has had particularly strong growth in exports is the auto sector. Exports of passenger cars in the first ten months of 2011 is nearly 25 percent over the same period last year. Those vehicles are finding homes in driveways and garages in Canada, Germany, Saudi Arabia, Mexico and the UK.

As Secretary Bryson said this morning,

Today’s numbers clearly show the positive impact of exports on the American economy. So far this year we have seen six months of record-breaking growth of exports. Our initiatives are working for the American people. Since the President implemented the National Export Initiative in January 2010 monthly exports have increased 25 percent.

Exports continue to be a bright spot in our still recovering economy.

Europe and the EU have been in the news constantly and it’s worth noting that in 2010, exports to the 27 members of the European Union still represented nearly 19 percent of U.S. merchandise exports. The European Union is an important market for high value U.S. goods, with the largest U.S. export categories to the EU-27 market being chemicals, transportation equipment, computer and electronic products and machinery.

Demand in the Euro-zone countries has been the slowest to recover continuing into 2011. Through the first ten months of 2011, U.S. merchandise exports to these countries increased 13.4 percent. European Union members outside the Euro-zone have grown at a more rapid 15.6 percent. Outside the Euro-zone, the United Kingdom has led growth in  2011 with U.S. merchandise exports increasing 15.1 percent or $6.1 billion in the first ten months of 2011 (compared to the same period of 2010).

You can find more facts and figures about our trade with the EU and Europe in our Export Fact Sheet and about today’s trade figure release in the Census Bureau’s full report.

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The First U.S. Certified Trade Misison to Lithuania Furthers U.S. Enthusiasm for this Small, but Important Market

September 29, 2011

Juan Verde is the Deputy Assistant Secretary for Europe in International Trade Administration’s Market Access and Compliance Unit.  In this capacity, he leads the Department of Commerce’s efforts to help solve trade policy and market access issues facing U.S. firms seeking to grow their business operations in Europe and Eurasia.

I have just returned from a two-day visit to Lithuania, where I met with the Prime Minister and other  senior government leaders. I  had the pleasure to meet with the members of the first Department of Commerce Certified Trade Mission to that country, led by Illinois Congressman John Shimkus.

Lithuania is a small nation, and many American companies are probably not familiar with it.  It is located on the Baltic Sea, bordered by Poland, Belarus and Latvia.  It is a member of the European Union and NATO.  It is providing a valuable contribution to our efforts in Afghanistan.

From left to right.  U.S. Ambassador Anne Derse,  Deputy Assistant Secretary for Europe Juan Verde, Representative John Shimkus, Lithuanian Minister of Economy Rimantas Zylius.

From left to right. U.S. Ambassador Anne Derse, Deputy Assistant Secretary for Europe Juan Verde, Representative John Shimkus, Lithuanian Minister of Economy Rimantas Zylius.

Despite its being a small nation, it is attractive to U.S. companies for a number of reasons.  It is a gateway to markets in the east, and into the wider European Union.  The government of Lithuania, from the Prime Minister on down, is committed to making the country an attractive place to do business.  Government leaders meet regularly with the foreign business community to find ways to address its concerns.  Lithuanian industry is a leader in many interesting areas, including laser technology.  Its workforce is well-educated.  The nation’s transportation sector is modern, along with its legal system.

Lithuania’s leadership has enabled it to emerge from economic crisis to becoming one of the fastest growing in the European Union.  Our trade with Lithuania is also growing rapidly, reflecting the economic recovery.  As they consider expanding their markets, I encourage American companies to look at Lithuania.   A steadfast ally, and a friend, Lithuania has much to offer.

 

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Help Make Exporting To the European Union Easier – Seeking Comments on US-EU Regulatory Cooperation

July 11, 2011

Have you experienced challenges in exporting to the European Union (EU)?  Do you have any ideas for making it easier to export to the EU by enhancing U.S.-EU regulatory cooperation?  If so, we want to hear from you.  In response to requests for additional time to provide comments, the Department of Commerce has reopened the comment period for its Federal Register Notice, “Request for Public Comments Concerning Regulatory Cooperation between the United States and the European Union That Would Help Eliminate or Reduce Unnecessary Divergences in Regulation and in Standards Used in Regulation That Impede U.S. Exports”.

The United States Department of Commerce strives to eliminate differences in regulatory measures between the U.S. and the EU, while also promoting free and open trade as well as protecting public health and safety, the environment, intellectual property, and consumers’ rights. The Federal Register Notice is a medium where all associations, business, and individuals in U.S. and EU countries can voice their challenges and recommendations regarding regulatory divergences.  Your comments are important in assisting us to increase awareness of trade impediments and improve exporting between the U.S. and EU.

The new deadline for comments is August 8, 2011.

Comments may be submitted electronically via Regulations.gov.  You may also access the Docket Folder, where you can read comments that have already been submitted (check the box labeled “Public Submission”). While we appreciate and encourage discussion here on our blog, the only way to ensure consideration of your input is to submit comments through the form on Regulations.gov.

Please direct any questions to TransatlanticRegulatoryCooperation@trade.gov

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U.S. Firms Shining Bright (Green) in Copenhagen

December 14, 2009

(This post contains external links.  Please review our external linking policy.)

Frank Carrico is the Regional Senior Commercial Officer at the U.S. Embassy in Stockholm, Sweden. He has also served the U.S. Commercial Service in Iraq, Brazil, Ukraine, Japan, and Germany.

Following Secretary Gary Locke’s whirlwind schedule on December 11th – featuring a breakfast for Bright Green companies hosted by the American Chamber of Commerce in Denmark; a bilat with Sweden’s Trade Minister Ewa Björling to discuss the EU Presidency and cleantech cooperation; and a long evening with the World Business Council for Sustainable Development – the “Bright Green” program began very early Saturday morning long before the trade show doors opened.  The Commercial Service’s (CS) Bright Green team helped the Secretary meet U.S. exhibitors, give remarks at a morning reception hosted by GE, visit with CS staff at the “Commerce/FedEx Meeting Place”, and formally open Bright Green with remarks focused squarely on the value of U.S. technology for mitigating climate change and for increasing jobs in the cleantech sector.

After the morning departure of the Secretary and his team, CS personnel turned full attention to the business of helping U.S. firms make the most of their time in Copenhagen, spending two hectic days coordinating matchmaking for our 40 U.S participants and partner companies with visiting Governors, foreign companies, officials, and royalty.  CS staff based in Copenhagen and colleagues from Stockholm, San Francisco, Lisbon, Oslo, the Hague, Helsinki, and Washington, DC, worked together to provide dynamic networking for all participants.  A detailed Cleantech Program Guide was widely circulated to COP15 delegates and the press to highlight the many exciting U.S. companies offering cleantech solutions.  The Governor of Washington, Chris Gregoire, was introduced to her State’s companies and updated on a May 2010 Swedish trade mission which will visit her State.  U.S. Ambassador to Denmark, Laurie Fulton, followed with a reception on Saturday evening for U.S. firms participating in Bright Green and their special guests.  Networking continued in full force throughout Sunday on the event floor at Bright Green, featuring special visits by NOAA Administrator Jane Lubchenco; Director of White House Science and Technology Office, John Holdren; and Energy Secretary Steven Chu.  Throughout the event, FedEx and CS personnel worked with U.S. companies and visitors to explore additional ways these companies could succeed in the European market, especially by participating in a planned April cleantech trade mission.  U.S. Ambassadors Matthew Barzun (Sweden) and Bruce Oreck (Finland) were also able to meet with the U.S. Green Building Council and GE executives to explore expanding cleantech programs for U.S. companies active in the European Union.

Finally, it was Sunday evening – at last the Bright Green team relaxed for a late meal together.  The mood was positive and the conversation still focused on how to help the companies who had participated at Bright Green; we all agreed to correspond at length on contacts and results.  Our hope is that many of these firms had concrete results, and we certainly intend to stay in touch and follow up.

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Green Building Takes Root in Copenhagen

December 14, 2009

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Keith Curtis is a senior Foreign Service Officer currently based in the U.S. Commercial Service’s Office of International Operations. He is the Commercial Service’s senior advisor on energy efficiency and renewable energy.

The atmosphere in Copenhagen is charged with activity.  Nobody is saving on personal energy – and everyone seems to be filled with a passion to make their point and make things happen.  At the U.S. Presence Center at Bright Green, the International Trade Administration (ITA) was making its point bright and early at the 9:00 Green Building Seminar and the 10:15 Bright Green, “Solutions at Your Doorstep” panel discussion.  Bringing the momentum of the Green Build Road Show to Copenhagen, we laid out for the delegates, NGOs, and students the wide and deep variety of everything going on in the States on Green Buildings.  The audience seemed to especially like the story of the Greening of the Empire State Building as told first hand by Clay Nesler, VP of  Johnson Controls (did you know Johnson Controls produced the first commercial thermostat?).  He described how the tens of thousands of windows would be replaced and lighting and installation changed office by office in the ¼ mile high icon of the American Industrial Age so that when done, they would be using 37% less electricity.  Roger Platt, VP of the US Green Building Council talked about how Green Building was spreading around the world, and the Department of Energy talked about how it was creating the first net-zero (uses no electricity from the Grid overall) large scale commercial building for their National Renewable Energy Laboratory, in Golden, Colorado.

The Green Building panel was followed by a second discussion organized by ITA to explain the wide range of bio-fuels, energy efficient manufacturing, and renewable energy technologies that the U.S. is delivering to the world. Kirsty Mac Donald of Intel talked about the modernization of the grid and all the intelligent hardware that will go into homes and vehicles.  Did you know that every wind turbine has a half a dozen IT chips in it?  Honeywell told how their bio-fuels are now being tested in regular commercial airlines for trans-Atlantic flights.  The audience was curious and impressed, but the students, who sported T-shirts saying, “How old will you be in 2050?” added a special sense of urgency to the challenges we were all talking about, although the industry presentations pointed them to ways that U.S. technology is already creating real change and reducing our reliance on fossil fuels.

And we heard our second Cabinet official, Secretary of the Interior Ken Salazar, speak to a full house as we looked forward to hearing our own Secretary Gary Locke speak tomorrow.  There is certainly a lot going on already at the COP15 even before the 100 Heads of State arrive.

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Thinking About Europe From San Francisco on the Green Build Road Show

November 10, 2009

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Dorothy Lutter is a Senior Foreign Service Officer currently serving as the Minister Counselor for Commercial Affairs at the U.S. Embassy in London.  She has previously been posted in over half a dozen other countries and has served as the U.S. Commercial Service‘s Regional Director for the Western Hemisphere.

Green Build Roadshow Stop Four – Today’s event was held in beautiful San Francisco, appropriately enough in the LEED-certified green offices of local sponsoring partner, Nixon Peabody.  Completed in 2007, the office cost 1.75% more to create a green space, but according to one of the senior partners already created energy savings and savings in terms of increased efficiency, effectiveness, and worker productivity.  David Gensler, Executive Director of the architectural firm that designed the space, noted that sustainability now permeates 100% of their business in the U.S. and around the globe.

One of the common themes along the way has been that the green building market is here to stay in Europe and will only continue to grow with increased EU initiatives and regulation.  Barry Lynham of Knauf Insulations reinforced this message today.   He noted that the EU’s Energy Performance of Buildings Directive (EPBD) is under review with stronger measures expected to be adopted by December.  Key drivers are governmental concerns over climate security, energy security and fuel poverty.  Key features will be more ambitious standards, renovation standards for all buildings, a low energy strategy, increased certification and increased inspection and enforcement.

Our “quotable quote” of the day came from my colleague Dan Harris, SCO Paris, who noted that with this momentum in Europe, not only are European companies leading the way there, but are also increasingly looking at the growing green building market in America.  U.S. companies need to think offensively, positioning themselves not only in the U.S., but in Europe as well.  “A U.S. company that operates only in the U.S. is like a football team that is playing the game with only defense.”

As we now head to the GreenBuild Show in Phoenix, our hopes are high that we will be able to encourage and assist more U.S. companies to strategically position themselves in the dynamic and growing European green building space.

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Green Build Road Show – Moving on to Denver

November 5, 2009

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Thomas Moore is Counselor for Commercial Affairs at the U.S. Embassy in Rome, Italy. Mr. Moore has previously served as the U.S. Commercial Service’s Deputy Director General, overseeing 2,000 employees in more than 80 countries.

After two successful days in Pittsburgh, the U.S. Commercial Service’s Green Build Road Show landed in an unseasonably sunny and warm Denver, Colorado, for another two-day program touting the unparalleled export opportunities in Europe’s green build and renewable energy sectors.

During the morning program, an audience member posed an interesting question:  Did we have any optimism that the United States would follow and match Europe’s current lead in the domestic deployment of these technologies?  As it turned out, the questioner had arrived late and missed most of the morning presentations.  Otherwise, he would have known that he was addressing a roomful of green entrepreneurs with strong confidence in an inevitable low-carbon future.

The Road Show had touched down in exactly the right place:  Denver is a hotbed of green technology development.  While the Road Show was conceived to educate U.S. companies on the European green build market, it has also been an eye-opening learning experience for the U.S. Commercial Service’s European officers and industry specialists.  We have found exactly what we were looking for:  A rich vein of new and innovative products and specialized expertise that should find an attentive market in Europe.

Pam Reichert, the State of Colorado’s Director of International Trade, opened the program with a description of Colorado’s strong commitment to what they have creatively coined the “New Energy Economy.”   “We’ve become a template for the rest of the nation for creating jobs, diversifying our energy portfolio, increasing energy security, and reducing our carbon footprint,” she said, citing the State’s success in attracting European investment in green technologies and in exporting nearly $2 billion last year to Europe.

The morning program featured presentations by two Colorado entrepreneurs who epitomize this success and should serve as encouraging role models – and mentors – for others to follow.

Dan Kigar, CEO of The Colorado Yurt Company, described his experiences in exporting 25 tent-like yurts for a major cultural exhibition in Paris.  Dan plans to conquer the world with his tent structures based upon the famous design of Genghis Khan, updated to the 21st century and pushing the envelope in use of sustainable technologies and recycled products.  He also cautioned exporters to beware of “bumps in the road” such as EU standards conformity issues, and he thanked the Commercial Service in France for helping him overcome these obstacles when they arose.

Mark Chen, Marketing Director for Abound Solar, discussed his company’s success selling thin-film solar photovoltaic modules in Germany, the world’s largest solar market with 50 percent annual growth in recent years.  Mark elicited laughs from the audience when he compared the bureaucratic paperwork required by Germany for a solar installation – two pages – versus the tabletop full of paper required by California.  But he did caution companies that they would face difficulties, albeit surmountable, in dealing with the European Union’s regulatory regimes for chemicals and electronic products.  (FYI:  The Commercial Service can help!)

The keynote speaker at lunch was David Hiller, Executive Director of the Colorado Renewable Energy Collaboratory, a joint venture of four premier public research universities in partnership with the private sector, and an important element in the infrastructure that has attracted foreign investment to Colorado.  David highlighted the strong public support and commitment among Coloradans for clean energy solutions.

Will this public commitment be replicated nationally, as one audience member wondered?  We had a room full of people betting their sweat and financial equity that it would!  On a personal note, it was wonderful to renew acquaintances with our top-notch U.S. Commercial Service colleagues in the Denver Export Assistance Center.  Kudos for a fantastic job organizing this event!

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From Inside a Greenbuild Enivronment, Day Two of the Greenbuild Road Show!

November 4, 2009

(This post contains external links.  Please review our external linking policy.)

Slyvia Mohr is the Standards Specialist for the U.S. Commercial Service at the U.S. Mission to the European Union.  She has been with the Mission since 1986 and been a part of the U.S. Commercial Service since 1991.

Day Two of the Greenbuild roadshow:  another sunny day in Pittsburgh, which we were able to appreciate from inside a perfect greenbuild environment – Carnegie Mellon’s Intelligent Workspace – the greenbuild state-of-the-art home of the Faculty of Architecture, with special shading, ventilation system and lighting.  At the invitation of Professor Volker Hartkopf, Director of the Center, the Commercial Service team participated in a greenbuilding conference attended by approximately 35 representatives from government, academia, industry, and service providers.

A series of presentations from selected speakers, among others, Kevin Kampschroer from the General Services Administration, and William Sanders from the Environmental Protection Agency, set the scene for a lively discussion on how the U.S. and EU can work together to speed up the process in addressing climate change.   It was interesting to hear that participants felt a need for government to set green building target – it struck as me as so European!

We heard that promoting awareness of the benefits of green building to the general public – especially the incentives to stimulate going green and enabling green technologies – is key to making the program a success.    While ambitious energy performance targets now have to be met, and preferably exceeded, for public buildings, it is often a challenge to balance budget realities and green build opportunities.

Our own mission – to reach out to U.S. greenbuild firms who are new to exporting – was expressed most eloquently by George Ruffner, the Senior Commercial Officer at the U.S. Embassy in Germany: “Where are you?!” asked George, adding, “We in the Commercial Service are ready to help American companies succeed in European markets, but we need your help to find those companies and encourage them to export.”    After highlighting the individual markets in Europe, we left the participants with some food for thought for future projects, outreach, and more…  Hopefully, it is the beginning of more to come!

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