ADBC Newsletter September/October 2011
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Transcript of ADBC Newsletter September/October 2011
Head of U.S. MDA Visits Weibel in Denmark
U.S. Navy to Support Advanced Biofuels
Greening the Army: New Energy Strategy
International Project Contracts
IFC Involvement in Maritime Projects
Danish Energy Delegation at RETECH 2011
The Embassy Strengthens Relationship with FDA
Membership Update & Upcoming Events
Front page, from left: Gitte Lillelund Bech, Minister of Defense, Denmark and Leon Panette, Secretary of Defense, U.S. Copyright, R. D. Ward, Department of Defense.
This page, from left: BG. Jørgen Jacobsen, Embassy of Denmark, Gitte Lillelund Bech, Minister of Defense, Denmark and Peter Taksøe-Jensen, Ambassador. Copyright, Embassy of Denmark
On the 17th of August, I had the honor of welcoming the Danish Minister for Defense, Ms. Gitte Lillelund Bech,
to the Danish Embassy in Washington. The Defense Minister traveled to Washington to meet with her Ameri-
can colleague, Mr. Leon Panetta, who took office as Secretary of Defense on July 1st this year.
Not only was this visit a timely opportunity to discuss the future for Danish and American defense collabora-
tion, but indeed also a clear indication of the importance that the United States attaches to its relationship with
Denmark. On that note, I would like to emphasize the fact that Ms. Lillelund Bech was only the second Euro-
pean Defense Ministers to meet with Mr. Panetta since his July inauguration.
Considering the close ties between Denmark and the United States on defense cooperation, we have focused
this edition of the American-Danish Business Council newsletter on the possibilities that exist within the Ameri-
can defense sector for both Danish and American companies alike.
With energy consumption within the Department of Defense equal to that of Portugal and continued efforts to
improve military health services, it is fair to say that the American defense sector is more than just a market
place for military products and services in the traditional sense. Certainly, companies within, especially, the
energy and health sector should focus on the growing potential within the Department of Defense.
That brings me to the Renewable Energy Technology Conference & Exhibition (RETECH) that took place on Sep-
tember 20-22 here in Washington, with Invest in Denmark as a proud sponsor. From Denmark, a delegation of
seven companies lead by the Confederation of Danish Industry participated at RETECH, among them three
members of ADBC, Cowi, Danfoss and Vestas, respectively. In relation to RETECH, the Embassy organized a
seminar on greening the U.S. military and I had the pleasure of hosting a reception. Guests included the Ameri-
can Ambassador to Denmark, Ms. Laurie S. Fulton, and high ranking members of the Department of U.S. De-
fense.
In the time passed since our latest newsletter, a new Danish Government has been elected. As our first ever
female Prime Minister, Ms. Helle Thorning-Schmidt will lead a coalition of center-left parties, hereby marking a
political shift from the former two-term liberal Government. We look forward to welcoming Ms. Thorning-
Schmidt and the newly appointed Ministers to Washington. It is our ambition to ensure that these visits at Min-
isterial level will be used to the benefit of your businesses as members of ADBC.
On the membership side, I am pleased to welcome Mil-tek A/S as our newest member to the ADBC network.
Finally, I encourage you to look ahead to this year’s Christmas reception at the Embassy on the 6th of Decem-
ber. I hope to see as many of you as possible.
// Peter Taksøe-Jensen
Newsletter Sept/Oct 2011
Copyright, Weibel Scientific
Unmatched Technological Potential
When the Director of the U.S. Missile Defense Agency
(MDA) Lieutenant General Patrick J. O’Reilly’s visited
Denmark in connection with international missile de-
fense conference in early September, his busy sched-
ule allowed him to visit the company Weibel Scientific.
A company whose radars could become essential to
the European missile defense system.
It was with great pleasure that Defense Industrial Atta-
ché Lieutenant Colonel Per Lyse Rasmussen was able
to accompany the general to Weibel following the em-
bassy’s successful effort to facilitate the visit.
Lt. Gen. O’Reilly showed great interest in Weibel’s
multi-frequency Doppler radar systems.
“During my visit I got a new understanding of
the advantages of the multi-frequency Doppler
radars and I will definitely investigate the possi-
bilities for closer collaboration between Weibel
Scientific in Allerød and the MDA in USA fur-
ther. Weibel Scientific has demonstrated that its
multi-frequency Doppler radar has an un-
matched technological potential and we should
in the MDA definitely take advantage of what
has already been developed here in Denmark.”
Their unmatched technological potential is what
makes Weibel’s multi-frequency Doppler radars stand
out: According to Weibel Scientific, they are “mobile,
highly accurate and have extremely long ranges. This
means that a Weibel radar can accurately track enemy
missiles across very long distances.”
Emphasizing the potential usefulness of their radars to
the US-led effort to establish a missile defense system
in Europe, Weibel Scientific’s CEO, Peder R. Pedersen,
says: “NASA uses our technology and so does a large
part of Europe’s and U.S. defense organizations. For
us, being part of the future missile defense system is a
natural development of our multi-frequency Doppler
technology.”
Unlike many other Danish companies, Weibel Scientific
is not outsourcing, but actually doing the opposite.
Identifying this as a key reason for the company’s suc-
cess, CEO Peder R. Pedersen says that it would not be
possible to produce such advanced technology at such
a low cost if it was outsourcing parts of the production
line to the same degree that it once used to: “It is core
to our business to develop and own the most impor-
tant components ourselves, this is the only way to se-
cure our position as the technology leader – at ex-
tremely competitive prices.”
Weibel was recently awarded two contracts with the
U.S. military, worth USD 47 million combined for the
delivery of well over 2,000 radars. Additionally, Weibel
has won contracts throughout most of the world with
other customers.
For further information, please contact:
Lt. Col. Per Lyse Rasmussen, Assistant Defense, Military, Naval and
Air Attaché / [email protected]
Newsletter Sept/Oct 2011
From left: Lt. Gen. Patrick J. O’Reilly, Director MDA, Peder R. Pedersen, President and
CEO of Weibel and Lt. Col. Per Lyse Rasmussen, Assistant Defense Attaché at the
Embassy of Denmark, Washington. Copyright, Weibel Scientific.
Copyright, Department of Navy.
Agricultural Industry
Last month during his trip to the mid west states,
President Obama, along with Secretary of Agriculture
Tom Vilsack, took the opportunity to focus on the on-
going biofuels debate. From the American depart-
ments for Agriculture, Energy and Navy, respectively,
came an initiative to further the development of ad-
vanced biofuels. This came in the shape of an “Request
for Information (RFI)” calling on private companies to
draw up a rapports on the conditions needed to estab-
lish the production and development of advanced hy-
dro-carbon biofuel with “drop in” potential. Drop in
potential indicates that this new fuel should be able to
replace the current fossil fuels, without changes to the
machinery that is the Navy’s large quantity of aircraft.
The purpose of this RFI is for the government to estab-
lish programs that helps private companies break
through some of the barriers preventing them from
establishing an American market for advanced biofu-
els.
On the 16th of August the three departments decided
to earmark USD 510 million to promote private R&D
and infrastructure within the advanced biofuels area.
This is only legislatively possible because of “The De-
fense Production Act” from 1950, which allows the
president to intervene in private business if there is a
military impetus, even if it means direct government
investment in private initiatives.
There seems to be two main political reasons for this
federal involvement.
First off, security concerns. The U.S. is dependent on
fossil fuels from abroad and self-sufficiency in regard
to energy is a significant military concern.
Secondly, and perhaps most politically poignant, is job
creation. The high rate of unemployment is one of the
biggest concerns for both the President and Congress
alike, especially with the election coming up.
This sort of initiative would create jobs in some of
America’s rural states; states where the crisis has hit
hard and where jobs for returning army veterans are
sorely needed. The Department of Energy has already
supplied grants to states like Illinois, North Carolina
and Wisconsin, so that new biofuel plants could be
established. These plants were also supported finan-
cially by the respective states.
It is interesting to note that nowhere do environ-
mental concerns pose as a reason for the establish-
ment of this program.
Focus on Energy Independence
It seems that a long term effort for the production of
advanced biofuels with military application is due. Nei-
ther the fuel nor the production facilities to create it
are yet in existence, but federal funding is to make it
so. Navy secretary Mabus states that:
“Energy independence is critical to the military
and critical to national security. That is why the
Department of Navy is partnered in the effort to
create a biofuels market.”
It is emphasized at several points in the bioenergy dis-
cussion that the establishment of a competitive and
efficient market for bioenergy is never to contribute to
raising the already record high commodity prices, and
this condition also appears in the present RFI. How-
ever, nowhere is it stated how this is to be accom-
plished.
For further information, please contact:
Steen Steensen, Minister Counselor, Food and Agriculture /
Newsletter Sept/Oct 2011
Copyright, Department of Defense.
Newsletter Sept/Oct 2011
New Energy Strategy
The Department of Defense recently released a strat-
egy to meet its ambitious energy targets for the entire
US Army. To the Department this strategy is a matter
of savings, energy security and enhancing tactical secu-
rity. As one of the largest single-consumers of energy,
DoD has a potential to lead the way and be a central
driver in the energy market.
The Department of Defense, as an institution, is one of
the single largest consumers of fuel in the world. In
2010, the Department consumed nearly 5 billion gal-
lons of petroleum in military operations, costing USD
13.2 billion. This is a 255 percent increase over 1997
prices. Costs that cannot be priced are the lives lost
protecting and moving fuel across the battlefield.
In its new strategy, DoD emphasizes the importance of
assessing all risks and costs when making decisions on
its energy and equipment procurements. An example
of this is the great risks associated with transporting
fuels supplies for vehicles and generators through the
battle field in large convoys. This calls for a reduction
of the energy demand and ambitious efficiency meas-
ures in its operations, but also for exploring alternative
fuels and sources of energy in the battle field.
Growing Interest in Public-Private-Partnerships
In the report, DoD clearly signals an interest in learning
from and working with other agencies and the private
sector to diversify and secure fuel and energy supplies.
The areas mostly prone to commercial interests have
recently been summarized by the Washington-based
think tank, the Pew Charitable Trust. The report
(“From Barracks to the Battlefield: Clean Energy Inno-
vation and Americas armed forces”) highlights the fol-
lowing three areas: vehicle efficiency (aircrafts, electric
ground vehicles, ships), advanced biofuels; and energy
efficiency, renewable energy technology for buildings
and energy storage.
Danish companies in the energy industry have a lot of
relevant solutions to bring to the table. But competi-
tion is fierce: Major defence contractors like Boeing,
Lockheed Martin and Raytheon are also pursuing this
as a new and emerging market. Surely, Danish compa-
nies have the advantage of many decades of experi-
ence in developing and improving smart, energy effi-
cient solutions so they will have a lot to offer in re-
gards to the integration of improved and secure en-
ergy supplies.
With these policies, the US Defense is moving forward
in becoming the driver of alternative energy and en-
ergy efficiency within the rest of the US society. Hence,
clear advantages arise for Danish companies, ready to
be part of the US Defense solutions. These solutions
are likely to create a “spill over” effect on the rest of
the emerging U.S. energy market, likely to create a
windfall for the companies involved.
For further information, please contact:
Anders Østervang, First Secretary, [email protected]
- A Bureacratic Headache or an Attractive Business Opportunity?
Copyright, World Bank Group.
370 million US dollars
In the past five years, Danish companies have won a
total of 236 contracts with the World Bank for a com-
bined value of USD 370 million. Within the European
Union, this positions Denmark at a respectable 9th
place alongside countries such as Austria and the
Netherlands. Yet, among the Nordic countries, Den-
mark continues to hold a clear lead ahead of Sweden
and Finland respectively.
Thomas Djurhuus, Minister Counselor at the Danish
Embassy and head of the department for develop-
ment, is not surprised by the success of Danish compa-
nies:
“The World Bank shares several priorities with
Denmark, among other things, our continued
focus on sustainable development, health and
education. Hence, Danish companies offer a
variety of goods and services that match spe-
cific project demands as set forth by the Bank in
order to deliver and implement the best possi-
ble solutions to support the countries’ contin-
ued growth and development and to reach the
Millennium Development Goals for 2015.”
A majority of the USD 370 million stems from projects
on clean energy, delivery of medicine, especially to
African countries, and consultant services, which are
needed by the World Bank during preparation and im-
plementation of new projects.
Unmet Potential and New Initiatives
Although Public-Private Partnerships with international
organizations such as the World Bank seldom rank
high, when looking at priorities for most companies,
there are still a number of reasons why companies
could benefit from the opportunities offered by the
World Bank.
Perhaps the Bank’s best kept secret is the fact that it is
one of the few international financial institutions
where lending has remained unaffected by economic
booms and recessions. Thus, as the financial crisis con-
tinued to affect markets during 2010, the World Bank
paid nearly USD 60 billion in loans and direct financing
to projects in developing countries – to date a new
record high.
Throughout 2011, the Danish Embassy has had a num-
ber of meetings with interested companies, who wish
to learn about the possibilities of doing project work
for the World Bank. And even though, Danish compa-
nies have performed well up until now, recent infor-
mation from the Bank shows that there is still consid-
erable unmet potential for Danish companies.
For that reason, the Danish Embassy in Washington
and the American-Danish Business Council has decided
to initiate a series of new activities to promote the po-
tential for procurement at the World Bank. A closer
collaboration with the Confederation of Danish Indus-
try is intended to coordinate domestic and interna-
tional activities that focus specifically on international
project contracts with the World Bank.
For members interested in learning more about the
possibilities for procurement at the World Bank, the
American-Danish Business Council offers to assist with
further inquiries and to facilitate contact to relevant
representatives within the World Bank organization.
For further information, please contact:
Ulrik Eversbusch, Executive Secretary / [email protected]
Kasper Meldgaard Nielsen, Assistant Secretary / [email protected]
Newsletter Sept/Oct 2011
Newsletter Sept/Oct 2011
World Bank Annual Meeting 2011
On 22-25 September 2011, Danish delegations from
the Ministry of Development Cooperation, the Ministry
of Finance and Denmark’s Central Bank, visited Wash-
ington, D.C. in order to participate in the Annual Meet-
ings of the World Bank and the IMF. Focus was on the
international economic outlook and on the Bank’s em-
phasis on jobs and growth, gender equality, and recent
reforms that have made the Bank more open and
transparent.
Focus on Gender Equality and Development
At the Annual Meetings the World Development Re-
port 2012 on Gender Equality and Development was
presented at a well-attended seminar, where the Dan-
ish State Secretary, Mr. Ib Petersen, had the privilege
of participating as a key-note speaker. Along with Mr.
Petersen, Ministers and senior government represen-
tatives from around the world gave their perspective
on gender and development issues relating to – among
others – women in the Middle East and North Africa in
the aftermath of the Arab Spring, Rwanda’s impressive
success on gender equality performance, specific gen-
der equality challenges in a large and heterogeneous
country like India, and lastly the view of the donor –
represented by Denmark.
The Danish delegation met throughout the weekend
with key senior staff of the World Bank as well as with
bilateral and multilateral development partners. Apart
from gender, focus was on the current global financial
crisis and its potential impact on developing countries,
as well as the critical issue of rising food prices. More-
over, important discussions where held on how to as-
sist fragile states, including how to create jobs in North
Africa and elsewhere. Finally, the Danish delegation
had the opportunity to address the humanitarian crisis
on the Horn of Africa.
For further information, please contact:
Thomas Djurhuus, Minister Counselor, [email protected]
From left: Nalia Chowdhury, CEO Grameen Solutions, Bangladesh, John Rwangombwa, Minister of Finance, Rwanda, Ib Petersen, State Secretary of Development Coor-
peration, Denmark. Copyright, World Bank Group
Copyright, World Bank Group.
IFC Involvement in Maritime Projects
The Danish embassy in Washington has initiated a dia-
logue with the private sector window under the World
Bank Group, the International Finance Corporation
(IFC). Leading officials from the Global Infrastructure
Department of the IFC express clear interest in team-
ing up with Danish companies within the transporta-
tion sector.
In a number of projects, the IFC has co-financed the
building of new ships. This includes projects for off
shore supply vessels, Ro-Ro vessels, handymax tankers,
and barges to be used for internal waterways.
The IFC is also looking at infrastructure projects in rela-
tion to dredging and sea ports. And earlier this year,
the IFC signed on to provide long-term project financ-
ing to develop a new container terminal within the
Port of Santos to serve Sao Paulo and surrounding ar-
eas in the Brazilian metropolis. APM Terminals is a ma-
jor shareholder in the project company.
The financing for the Sao Paulo project will be pro-
vided at a maturity necessary for the project's comple-
tion, but unavailable in the commercial market. It will
help the project company better manage the startup
risk inherent in a greenfield project. The proposed IFC
financing is expected to include an investment of up to
USD 140 million from IFC’s own account and up to USD
535 million in the form of a B Loan. IFC's involvement
will also help raise additional financing.
The Sao Paulo – APM project illustrates how the IFC
sees its role in creating venues for the private sector to
engage in projects with a development prospect. The
anticipated development impact is a strengthening of
the port sector in Brazil by increasing container han-
dling capacity, which again will help ease the existing
congestion at the Port of Santos. The accompanied
remediation of a site formerly used for waste disposal
will benefit the Santos community and avoid further
contamination of the soil and water. The Project will
also create direct and indirect employment opportuni-
ties and increase revenues for the Government of Bra-
zil through increased economic activity.
Looking to Partner with Danish Companies
For most projects in the maritime sector, the bank’s
involvement will make up around USD 30-40 million.
The process for evaluation of potential projects and
negotiating terms and conditions on average runs for a
period of 6 months, although this of course depends
on the concrete case. The IFC’s Infrastructure Depart-
ment last year signed on to about 20 projects making
up a total sum of close to USD 700 million. The bank
typically requires 20%. ownership of a project.
The IFC wishes to engage with Danish companies inter-
ested in maritime infrastructure projects in Asia, Africa
and Latin America. The Danish embassy in Washington
is in a key position to facilitate dialogues.
For further information, please contact:
Henrik Juhl Madsen, Maritime Advisor / [email protected]
Newsletter Sept/Oct 2011
Copyright, Renewable Energy Law Blog.
Newsletter Sept/Oct 2011
Danish Energy Delegation meets with key U.S.
Stakeholders and Leaders
On September 20-22, 2011 the annual Renewable En-
ergy Technology Conference & Exhibition, RETECH,
took place in Washington, D.C. RETECH 2011 gathered
government, utility, technology and finance profes-
sionals from over 50 countries, and it covered all of the
cleantech industry’s key technologies, such as wind,
solar, biomass, biofuels and waste energy.
In conjunction with RETECH, the Danish Green Partner-
ships delegation visited Washington from September
19-23. The visit was organized by the Confederation of
Danish Industry and the American Embassy in Copen-
hagen, both of which had representatives in the dele-
gation. Members of the delegation also included lead-
ing Danish companies and American-Danish Business
Council members Cowi, Danfoss, and Vestas along with
the companies ABB, Grundfos, Solardrive, TK Energy,
and Invest in the Faroes.
As part of the visit, the Danish Embassy in Washington
hosted a well-attended reception on September 20.
This gave the participating companies an opportunity
to meet and connect with relevant U.S. business lead-
ers and decision makers, such as Bob Simon, the De-
mocratic Staff Director on the Senate Energy and Natu-
ral Resources Committee, and Katherine Hammack,
Assistant Secretary of the Army for Installations, En-
ergy, & the Environment.
From left: Peter Taksøe-Jensen, Danish Ambassador to the U.S and Laurie S. Fulton,
American Ambassador to Denmark. Copyright, Embassy of Denmark.
From left: Lt. Col. Per Lyse Rasmussen, Assistant Defense Attaché, Embassy of Den-
mark, Washington, Katrine Hammack, Assistant Secretary of the Army for Installa-
tions, Energy, & the Environment, BG. Jørgen Jacobsen, Embassy of Denmark and
Kristine Kingery, Acting Director, Army Sustainability Policy. Copyright, Embassy of
Denmark.
From Left: Anne Mette Vester, Minister, Deputy Chief of Mission, Embassy of Den-
mark, Bob Simon, Democratic Staff Director on the Senate Energy and Natural Re-
sources Committee and Ulrik Eversbusch, First Secretary, Embassy. Copyright,
Embassy of Denmark.
Newsletter Sept/Oct 2011
Green Partnerships Delegation Attends Energy
& Defense Seminar at the Danish Embassy in
Washington
On the occasion of the visit of the Green Partnerships
delegation in Washington, the Danish Embassy held a
seminar on energy efficiency in a defense context on
September 22. Within the U.S. Department of Defense
(DoD) there is increasing focus on the energy issue
and, in particular, on solutions that can help reduce
energy consumption. The DoD thus has a stated goal
that 25 percent of all energy consumed by 2025 must
be supplied from renewable sources. The potential for
energy savings is enormous, considering that the DoD
is America’s largest energy consumer, representing
about 80% of federal sector energy consumption.
The seminar included networking opportunities as well
as presentations by relevant representatives from the
public and private sector. The first speaker was Tarak
Shah, Special Assistant to the Assistant Secretary of
Defense for Operational Energy, who outlined the
DoD’s newly released Operational Energy Strategy and
provided insight into how the DoD aims to lower its
energy consumption.
Next, the participating Danish companies learned how
the U.S. Army, the U.S. Navy, and the General Services
Administration (GSA) plan to implement this strategy
and what role Danish energy companies may have in
this regard. Rick Ballard, Director for Energy Strategy &
Policy at the Office of the Deputy Assistant Secretary
of the Army (Energy & Sustainability), represented the
Army, while Captain (select) James Goudreau, Director
at the Navy Energy Coordination Office at the Office of
the Chief of Naval Operations, spoke on behalf of the
Navy.
Bryan Steverson, Sustainability and Green Buildings
Program Advisor at GSA, then explained how his or-
ganization implements energy efficiency, before Wes
Stith and Marston Smith from Clark Construction
Group concluded the seminar, providing first-hand ex-
perience on how a major U.S. building contractor
works with the DoD.
For further information, please contact:
Ulrik Eversbusch, Executive Secretary / [email protected]
James Goudreau, Captain (select), Director at the Navy Energy Coordination Office at the Office of the Chief of Naval Operations. Copyright, Embassy of Denmark.
Copyright, Jacob Ehrbahn.
Life Sciences & Healthcare Update
The U.S. and Danish regulatory policies are not only in
place to ensure safe and efficacious medical products.
They are more than ever important components of the
larger framework conditions needed to retain and bol-
ster a medical industry, capitalize on product develop-
ment, ensure economic growth and job creation.
The FDA Commissioner Margaret Hamburg has lately
intensified public outreach promoting FDA as an inno-
vation agency. This is an important component of the
current politics and advocacy between sponsors and
FDA user-fee negotiations, surely to affect revenue,
research and regulatory oversight.
In recent articles, for example in the Wall Street Jour-
nal Aug. 1st titled “America’s Innovation Agency: The
FDA, “Hamburg reiterated points made at a Senate
HELP Committee hearing. Noting FDA approved 21
new drugs so far in 2011, equaling the total for all
2010, Hamburg further wrote “we hope this signals a
larger trend in industry and at the FDA.” She added
that “when presented with high-quality applications
that are based on strong science, we work quickly and
efficiently.”
According to FDA the review stage is the fastest
and most predictable part of drug develop-
ment. Referring to FDA’s failure rate analysis,
Phase I has a 38% failure rate, Phase II has a
68% failure rate, and Phase III has a 45% failure
rate all related to scientific issues. Regarding
the FDA review there is a failure rate of 22%
related to regulatory issues.
However, Hamburg also acknowledges that medical
devices raise problems, but blamed approval delays on
poor quality applications that require FDA reviewers to
ask manufacturers for additional data not found in the
original filing.
These are important arguments for a commissioner to
be making at this time. The negotiation between FDA
and the drug and device industry over PDUFA and
MDUFA reauthorization is ongoing, and much critique
has been said about the agency’s ability to communi-
cate, meet deadlines, and basically stay on course.
The Embassy of Denmark is aware of the unease with
the agency and work closely with the International Of-
fice of FDA to facilitate international collaboration on
innovative technologies, aiming at enhancing transpar-
ency, clearer approval paths and generally enhance
communication between the agency and sponsor.
Manage Expectations and Meet Requirements
Following years of heated debate over the risk-benefit
balance for drug approvals, many arguing the FDA had
become too conservative and stifled innovation, pre-
sent scrutiny falls within approval of medical devices.
Recent statistics suggests that the average clearance
and approval process for 510(k) products and PMAs
has risen by 45 and 75 percent, respectively, since
2007 (3-6 months and 12-24 months).
This is further complicated by the user-fee negotia-
tions for medical devices and in vitro diagnostics, as
FDA is under review and evaluation of the agency’s
device approval pathway called 510(k) for lower risk
devices, which cause much industry anxiety. This fol-
lows a recent Institute of Medicine report advising the
agency to explore better ways to assess the safety and
efficacy of medical devices, potentially ending with a
sub-classification of the approval pathway.
The Embassy of Denmark follows the U.S. and Danish
medical industry close, including policy and framework
conditions. Regular meetings between the U.S. Depart-
ment of Health and Human Services (HHS), the Danish
Ministry of Health and embassy staff ensure close dia-
logue and exchange of ideas and best practices, ac-
knowledging the importance of the medical industry
ensuring new innovative solutions to health and medi-
cal problems, as well as a broader societal and eco-
nomic value creator.
U.S. an Important Science and Trade Partner for
Denmark – And Vice Versa
Danish exports to the United States increased to 35.6
billion DKK in 2010 which was an increase of 15% com-
pared with 2009, and the largest industry was the
medical device and pharmaceutical industry, contribut-
ing with 29% of the total export to the U.S. The export
of medical device and pharmaceutical products to the
US was 10.3 billion DKK in 2010, an increase of 36%
Newsletter Sept/Oct 2011
Newsletter
compared with 2009.
The U.S. market for medical devices is the biggest in
the world, and it is a key export market for Danish
medical device companies as approximately 20% of the
Danish exports go to the U.S., exceeding 3 billion DKK
in 2010.
FDA CDRH Seminar in Copenhagen
November 15-16, 2011
To facilitate current knowledge about regulations,
health policies and agency guidance the Embassy of
Denmark has teamed up with the FDA Center for De-
vices and Radiological Health (CDRH) and a regulatory
consultancy group, Beaufort, to host a unique FDA
CDRH Seminar focusing on International Regulatory
IVD/Medical Device regulations.
The initiative follows from increased collaboration be-
tween the FDA and the Embassy of Denmark, and the
need to update Danish industry on current regulatory
requirements. This is a win-win, as the seminar aims at
facilitating sponsors submitting complete submissions,
enabling FDA to clear or approve devices within ex-
pected deadlines.
Further, U.S. FDA regulations are different to European
(EMA) regulations in so far the U.S. FDA issues legisla-
tion on both safety and efficacy, whereas the Euro-
pean medical authorities only legislate on the safety of
medical device. This constitutes an important differ-
ence for Danish medical device companies entering
the U.S., as they need to consider another dimension
of legislation.
The FDA Seminar provides four leading official
FDA CDRH staff and several advisory and indus-
try experts, leading the industry to navigate
step-by-step through the regulatory guidelines,
practical steps, and strategic considerations for
determining a product’s regulatory route to
market in the most cost and time efficient way.
Further the seminar will address key insights on new
guidelines, innovation regulations, clinical develop-
ment strategies, compliance and submission priorities,
best practices, agency policy discussions and includes
real life cases and examples followed by plenary de-
bate with the experts. Most important the seminar
offers a rare opportunity for individual face-to-face
consultations with the FDA regulators and regulatory
executives.
The FDA Seminar is supported by Medicoindustrien,
Medico Innovation, Danish-American Business Forum,
The Trade Council of Denmark, and the American-
Danish Business Council.
For information on the seminar, please contact:
Joakim Steen Mikkelsen, Life Sciences & Helathcare Attaché /
Sept/Oct 2011
FDA Seminar 2011
Supported By
Following a successful visit by His Royal Highness
(H.R.H.) The Prince Consort of Denmark in June this
year, organized by American-Danish Business Council
and the Royal Danish Embassy at the company’s
American headquarters in Virgina, Mil-tek has decided
to join our expanding network as the company con-
tinue to promote their activities throughout the US.
Founder of Mil-tek, Mr. Kristian Skannerup and CEO,
Mr. Bryan Wingflied, both praised the participation by
H.R.H. The Prince Consort of Denmark, which they be-
lieved has had a considerable impact on the way they
are now perceived by their American business net-
work.
Progressive and impressive is probably the best way to
describe how Mil-tek has grown from a small start-up
company in Denmark, with a bright idea, to a global
venture with operations in 27 countries.
Mil-tek is one the world’s leading suppliers on waste
disposal solutions. The company offers a varied selec-
tion of air-operated waste balers and compacters for
recycling cardboard, plastic and paper.
American-Danish Business Council will continue to as-
sist Mil-tek in their ambitions to expand into the
American market.
American-Danish Business Council would like to welcome Mil-tek A/S as our newest member to the
organization.
Newsletter Sept/Oct 2011
This page and next: copyright, David Galen.
Newsletter Sept/Oct 2011
Newsletter Sept/Oct 2011
The Crown Prince Couple of Denmark
visits New York from October 20 – 24
From October 20 – 24, the Crown Prince and Crown
Princess of Denmark will present the official promo-
tional project “Creative and Healthy for Life” in New
York. The Crown Prince Couple will participate in sev-
eral activities, promoting a healthy and active lifestyle
as well as sustainability in the areas of design, architec-
ture and gastronomy.
Denmark - Frontrunner in Digital Care
HRH the Crown Prince will give a key note at the Con-
nected Health Symposium in Boston, where the top
tier of Danish Health IT competences and solutions will
be presented. As one of the leading countries in
healthcare technology, Denmark offers a wide range of
solutions within health-IT, incl. electronic health re-
cords, telemedicine, data handling, devices etc.. Stud-
ies have shown that the US healthcare system could
save more than $81 bn. annually, better utilize health-
care resources and improve the quality of patient care,
if it were to widely adopt digital healthcare solutions.
Denmark currently spends approx. 9 pct. of its annual
GDP on the national healthcare sector. The US spends
approx. 17 pct.
Visit to Ground Zero and the UN
In New York, the Crown Prince Couple will visit the Na-
tional September 11 Memorial and pay their respects
by participating in a memorial ceremony together with
the heads of state from the other Nordic coun-
tries. Furthermore, HRH the Crown Princess will meet
with the Deputy Executive Director of the United Na-
tions Population Fund, UNFPA. The Crown Princess is a
patron for the UNFPA that works to promote maternal
health and safe motherhood in more than 150 devel-
oping nations. In these developing countries, 1 out of 7
women risk maternal death, compared to 1 in 17,800
in Denmark.
Design, Architecture and Gastronomy
The renowned Danish furniture manufacturer ‘Carl
Hansen & Son’ is to officially open a new showroom in
Soho with the event “Danish Fusion” that will be at-
tended by the Danish Crown Prince Couple. At the
event, Danish interiors, jewellery, music and food will
Copyright, Steen Evald.
Newsletter Sept/Oct 2011
merge into an American context. Original craftsman-
ship of classics and masterpieces will be showcased as
part of an educational program for architects and inte-
rior designers.
Good health begins with good food! Lead by René
Redzepi, head chef of the world’s best restaurant,
Noma, three Danish chefs will present the best of New
Nordic Cuisine at the Union Sq. Greenmarket in New
York. “New Nordic Cookout” focuses on local, sustain-
able ingredients, the heart of New Nordic Cuisine. The
Danish chefs will present dishes created with green-
market ingredients.
BIG opening!
TRH the Crown Prince and Princess of Denmark will
participate in the official opening of BIG New York
(Bjarke Ingels Group) on October 21. The office is es-
tablished in order to oversee the development and
upcoming construction of West 57th on Manhat-
tan and better service the growing work in North-,
South-, and Latin-America. At the event, the Danish
musical wonder duo the Raveonettes will perform.
Danish open-faced sandwiches coming to
New York
The Danish chef Adam Aamann-Christensen, owner of
the Copenhagen lunch restaurant Aamann's, is well-
reputed among food critics both nationally and inter-
nationally. This October, he is creating a piece of Co-
penhagen in Manhattan with the opening
of Aamanns/Copenhagen - the city’s first Danish res-
taurant and cultural center located in the TriBeCa Film
Center building. The opening will be attended by the
Royal Couple and Consul General Jarl Frijs-Madsen.
The restaurant will offer an authentically Danish ex-
perience with a culinary focus on ‘smørrebrød’, the
traditional Danish dish of select ingredients atop a slice
of fresh rye bread, year-round cultural events and dis-
tinct Danish design.
To find out more about the visit, go to www.royalvisitnyc.com
Copyright, BIG.
Newsletter Sept/Oct 2011
Invitation and Sponsorship Opportunity The Embassy is – for the sixth year running – hosting its annual Public Diplomacy event: Creative Christmas. The
event draws 700+ of the most influential decisions makers in Washington and the US in general and is an ideal
opportunity for an unforgettable evening of networking at the Embassy of Denmark hosted by the Ambassador
in his residence.
This year the event takes place on the 6th of December from 7:00pm – 9:00pm
The Creative Christmas concept aims to present the best Denmark has to offer within the fields of business, art,
gastronomy and culture. Over the past years we have been able to strengthen the Creative Christmas brand to
such an extent that the event is mentioned in national and Danish media.
Companies wishing to sponsor the Creative Christmas and join an ever growing group of partners may contact
Pernille Florin Elbech at [email protected] or at 202 320 0098 to discuss the sponsorship package or a personalized
package for your company. For sponsoring companies this is an perfect occasion to invite your own valuable
customers to the event.
This year’s standard sponsorship package looks as follows:
Sponsor Fee: USD 3,000
4 invitations to the event (2 guests pr. invitation)
Company name on Embassy website
Company name of electronic invitation
Company name in printed program
Company name in electronic newsletter to American Danish Business Council
Copyright, Embassy of Denmark.
Newsletter Sept/Oct 2011
The annual board meeting of the American-Danish Business Council will take place on December 6
2011 at the Embassy of Denmark in Washington, D.C.
All of our Sponsoring members are automatically members of the board as part of their membership and are
thus invited to the meeting for a discussion on the year that has past and the opportunities to come.
A separate invitation will be sent out with specified information and a proposed agenda.
Sponsoring members:
Lockheed Martin Scandinavian Airlines
Bavarian Nordic Torm
Vestas Novo Nordisk
Biogen Idec Raytheon
Novozymes Weibel Scientific
Mil-tek GN
Rupari Terma
Leo Pharma Pratt & Whitney
Systematic
In conjunction with the ADBC board meeting, you are cordially invited to participate in the Embassy’s 6th annual
Christmas event – Creative Christmas – which is expected to gather more than 700 of the most influential deci-
sions makers in Washington and the US in general.
Newsletter Sept/Oct 2011
Houston is the headquarter for newly formed DANISH
AMERICAN CHAMBER OF COMMERCE SOUTHWEST.
The newly formed Chamber of Commerce with the
mission of promoting trade and good-will between
Denmark and U.S. will operate primarily in the South-
western part of the USA .
The Chamber will be a resource and a forum for ex-
change of information and networking for companies
doing business in both Denmark and the US. Houston
is home to a number of companies that are either sub-
sidiaries of large Danish companies or independent
companies with Danish roots. Among the founding
members of the Danish American Chamber Southwest
are such well known names as:
Maersk Oil and Gas, Grundfos, Haldor Topsoe, Hempel
USA, Vestas Technologies, Scandic Foods and Nordana
Line along with Ocean Projects and Danish Inspira-
tions.
The founding Board of Directors are: Anna Thomsen
Holliday, Founding Chair, Robin Ann Johansen, Found-
ing Vice Chair, Founding Secretary Thomas Damsgaard
and Founding Treasurer Sten Svendsen.
Danish Ambassador to join first official event
The first official event of the Danish American Com-
merce Southwest will be a luncheon meeting with Dan-
ish Ambassador to the United States of America, Peter
Taksoe-Jensen as keynote speaker. The luncheon will
be held on Tuesday, October 18th at the Hilton Ameri-
cas Hotel, Skyline Ballroom, 1600 Lamar Street.
For more information including membership, please visit our
website: www.daccsw.org
Copyright, Temporary Housing Blog.
Newsletter Sept/Oct 2011
October 10-12: Association of the United States Army Conference
and Exhibition (AUSA) In connection with the annual Association of the United States
Army Conference and Exhibition (AUSA) during 10-12 October
2011 we will have the pleasure of the company of Major
General Agner Rokos, Commander Army Operational Command,
Denmark. The general will be spending time on the exhibit floor
at AUSA. For the first time at AUSA, Danish companies will
participate with a joint Danish pavilion.
October 18: The Ambassador visits new Chamber of
Commerce in Houston
October 18: Bjarke Ingels from BIG speaks at National Building
Museum in Washington
October 20-24: Royal visit New York TRH the Crown Prince and Crown Princess of Denmark Present
Danish Healthcare, Architecture and Gastronomy in New York.
October 27: Concert at the Danish Embassy The band Suspicious Package will perform at the Danish
embassy. Besides great music, this event will also feature Danish
cooking by the renowned chef, Trine Hahnemann and
sponsored by Danish Crown.
October 27: Upcoming meeting in the maritime network Members of the maritime network will meet at the embassy to
discuss issues of common interest, including a presentation of
the economic outlook and a session on relevant shipping policy
issues.
November 15-16: FDA seminar in Copenhagen
December 6: Board meeting ADBC
December 6: Creative Christmas 700+ of the most influential decisions makers in Washington and
the US in general are expected to participate at the Embassy of
Denmark for our annual Christmas event.
Sponsoring Members
Corporate Members
Associate Members
Beaufort Advisors
AmCham Denmark
Danish-American Chamber of Commerce, Midtwest
Danish-American Chamber of Commerce, Northern Carolina
Danish-American Chamber of Commerce, Southern Carolina-
Northwest Danish Foundation
COWI
Danish-American Business Forum
Danish-American Chamber of Commerce, New York
Danish-American Chamber of Commerce, South East USA
Danish Information Systems Professionals
The American-Danish Business Council promotes Danish companies in the US, and American companies in Denmark. It
is engaged in a range of activities aiming at obtaining an even more thriving American-Danish market place with in-
creased trade and investment. The Council has 40 Danish and American companies and organizations as members.
A number of sector-specific committees are being formed, including on Health & Life Science, Defense, Finance, Mari-
time, Food & Agriculture and Energy. By using the Danish Embassy's contacts and access to American as well as to
Danish Authorities, the committees work to enhance business opportunities and to create network synergies and cor-
poration.
To read about membership benefits, please visit our homepage, www.usadk.org, or contact Kasper Meldgaard Nielsen, [email protected]