european union’s medical technology market by emanuel baisire
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Emanuel Baisire
G00397918
Introduction:
Globalization and the need to be competitive in the ever changing market place has
forced many forward looking businesses to either move their production process to
strategic locations or simply widening their supply-chain. Unlike traditional methods of
exporting and green-field foreign direct investment (FDI), many companies have adopted
cross boarder mergers and acquisition (M&As) and strategic alliances as a preferred form
of extending their businesses globally (OECD, 2005). It is argued that many businesses
tend to outsource their production process due to reasons ranging from skilled labor
force, technology and market capture. It has been argued that for companies to continue
growing and increase their profits, they should take advantage of available opportunities
to expand globally. When a company embarks on a strategic decision of going global, it
is always faced with uncertainties of selecting a market entry strategy. Company
executives are often faced with the task of determining which foreign market to enter,
whether to export from the home base or set up a plant in another country, to enter into a
joint-venture or making an acquisition in the foreign market (Hill, 2005). The uncertainty
is minimized by technology and easy flow of information. Company’s entry strategy to a
foreign market is driven by efficient markets, opportunity to recover costs, access human
and physical capital, research and development capabilities, technology and the
availability of capital and financial resources (IMF, 2004).
Overview of the European Union’s Medical Technology Market:
The European Union is a composition of 25 member countries that have come together under
different sets of agreements to share a common political, economical and social policy. Dinan
(2005) has acknowledged that the desire to diffuse long standing rivalry between Germany and
France became a driving force to Europe’s regional integration. After the collapse of the Soviet
Union, the European Union decided to extend its influence to the eastern and Southern boarders
of Europe to incorporate several former communist countries and others into the European Union.
The vision for expansion is attributed to European Union desire to extend its economic and
political influence to the new independent states.The expansion of the EU has created exciting
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opportunities for pharmaceutical companies to expand into new territories and take advantage of
these high growth emerging markets countries like the Czech Republic, Estonia, Hungary, Latvia,
Lithuania, Poland, Slovakia and Slovenia. European Union's (EU's) ongoing efforts to transition
to a single European market continue to present the pharmaceutical and medical technology
industry with unprecedented opportunities and challenges.
The E.U’ expansion to the East and South is estimated at tapping a pharmaceutical and medical
technology market of over U.S. $ 10.8 billion (Pharma Intelligence, 2004). Medical related
companies trying to enter the E.U market faces a lot of challenges. Due to the nature of E.U’s
health system, member countries have different methods of controlling pharmaceutical and
medical technology related costs. E.U control of pharmaceutical and medical technology
companies includes price controls, profit controls, reference pricing, medical technology approval
guidelines and marketing approvals (OECD, 2005). Member countries set medically related sale
prices or sometimes enter a deal with a manufacturer to sale at an agreed price (OECD, 2005).
Member governments indirectly determine medical related product’s price by imposing low
reimbursement prices. Another method commonly used by E.U member countries to control
pharmaceutical companies, involves the use of reference pricing. Reference pricing compares the
sale price of medical equipment to the price of the similar product in other countries (OECD,
2001). The problem with this approach is that it does not take into consideration the difference in
income levels and other factors that can not easily be compared for the purpose of price
determination.
Before determining our entry strategy to the E.U market, it is important to understand how we
can overcome the issue of profit controls for pharmaceutical products in the E.U. Several
member states limit pharmaceutical and medically related company’s profit. Member states
determine how much a medically related firm can make in profits through the sale of a specific
product at a given period of time (Foreign Government Pharmaceutical prices, 2004). In case of
violation, the Company is required to pay back the respective excess profits to the government
(OECD, 2005). E.U member’s medical industry is not influenced by free market forces, rather
each member has its own guidelines and policies as far as medical technology pricing and device
approval is concerned in each country. It is therefore crucial to analyze each entry point in our
strategy to determine which option will minimize our contact with E.U’s regulatory and
bureaucratic market barriers.
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Market Entry Strategy:
The prevailing market conditions for medical technologies and pharmaceutical companies in the
E.U are so complex and need a well thought strategy. The possibility of manufacturing in the
U.S. and export through a wholly owned subsidiary in Europe or entering into a
contractual agreement with an existing distribution system will not be effective. The
problem with the export strategy is that we will not be able to take advantage of the
relatively cheap and skilled human capital in the newer E.U member states. By exporting
bulky medical equipments from the U.S. to the E.U involves high transport costs thus
undermining the firm’s ability to compete with other medical technology producers based
in the European market. The other compelling reason not to export complete medical
equipments to the E.U is its complex tariff and non-tariff barriers imposed on foreign
products entering the European market. As clearly indicated in the over-view of the
European Union, member countries have different guidelines and regulations to manage
importation and sale of foreign medical equipments in the E.U market. These rules and
regulations tend to be time consuming and expensive to handle thus straining the
competitiveness of our firm.
The pursuit of this strategy will increase our vulnerability to local marketing and
distribution partners in the E.U market. According to Hill (2005), the local marketing or
distribution agents usually sell other competitor’s products and the partner may not
commit the needed effort in promoting our products due to differences in sales
commissions and other interests. The source of financing under this initiative will also be
relatively expensive. Since most of our operations will be based in the U.S, our cost of
capital will range between 8-9% compared to the Euro bond market of about 6%. Since
our presence will be limited in the E.U market under the export strategy, financial
institutions in Europe may be reluctant to provide us with favorable loans to finance our
expansion in Europe. The only advantage we may have under the export strategy is the
depreciation of the U.S. dollar against the Euro. The depreciation of the U.S. dollars
would provide us with a competitive edge against medical equipments produced within
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the EURO zone. However, this will be advantageous only if E.U governments did not
determine sale prices of medical equipments and other pharmaceutical products. Given
the nature of E.U’s nationalized health system, member governments are the primary
buyers of medical equipment and pharmaceutical products. In case of no price
intervention by EU member states, a weaker U.S dollar would have made our exports
more competitive and affordable in the EU market.
Due to the pitfall of the above entry strategies in the E.U market for medical equipments,
strategic alliance with a European firm to manufacture medical equipment seem to be the
most effective strategy. According to Hill (2005), strategic alliance refers to competing
firms agreeing to cooperate on specific tasks in order to achieve their respective strategic
goals. Strategic alliances involves a variety of inter-firm linkages that covers joint
research and development (R&D), joint manufacturing, joint marketing and long term
sourcing agreements (OECD, 2001). For the case of the E.U, probable alliance with a
European firm may cover marketing, research and development, distribution and
production agreement. The terms of the agreement will press special attention to
distribution and production costs.
Due to the complexity of the E.U medical technology and pharmaceutical market, it is
evident that we will need a local partner who is familiar with the E.U.’s business and
government environment and who has an established marketing and distributional
channel. By entering an alliance with a European firm we will avoid going through E.U’s
rigorous approval process for foreign manufactured medical equipments. The approval
process of foreign medical equipment in the European Union sometimes takes years
before being approved for the E.U market, thus an alliance with an established E.U firm
will save our product from undergoing such delays. We will also take advantage of the
already established distribution and marketing channels for medical equipments thus
avoiding duplication of resources in the E.U and U.S market. The alliance agreement will
include a clause stating that our European partner will provide us with unlimited access to
its marketing and distribution within the E.U in return we will also guarantee the use of
our distribution channels in the U.S. for differentiated products.
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The strategic alliance with a European firm will help us share costs associated with
setting up a plant in Europe and will spread our risks of developing new medical
equipments. A joint venture with a European firm will ensure that our European partner
will access financial resources from the E.U banking institutions with lower interest rate
compared to the U.S rates. By accessing favorable loans from E.U financial institutions
will reduce our cost of capital. The joint venture will reduce our cost of capital by
accessing favorable loans to be used in the manufacturing process. Med-Tech Inc, will
maintain the core competence of research and development and design of medical
equipments in the United States, and the E.U partner company will be responsible for
manufacturing the equipments and marketing in the entire E.U market. The depreciation
of the U.S. dollar will be an advantage to Med-Tech Inc, if most of our sales are in the
E.U market. The strategic alliance will mean that our revenues will be reflected in the
Euro currency of which when converted to the U.S. dollars show a positive financial gain
to both out our company and shareholders. Therefore, if the U.S .dollar continues to
weaken in relation to the Euro our medical equipments manufactured in the E.U will not
be profitable if exported to the U.S. or any other country because they will appear
expensive. The appreciation of the Euro will be significant to the alliance if most of our
inputs are sourced from non-Euro zones and all our products sold in the Euro-zone.
Another important reason we should form a strategic alliance with a European firm is
that we will consider an alliance as learning process of the European medical equipment
market. The alliance will help us learn European Union’s business and government
environment. The gained skills and market knowledge may be crucial for our future
projects in Europe. After acquiring sufficient knowledge and understanding the
marketing dynamics and the distributional channels of medical technologies in Europe
we may decide to break away from the alliance and undertake the market solely.
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Conclusions:
When firms start developing entry market strategy to foreign markets, there are usually
faced several challenging options. The challenges range deciding whether to manufacture
in the home and export through contractual arrangements with existing distribution
systems, export through a wholly owned subsidiary in another country, enter into a
strategic alliance or setting up a Greenfield. In the analysis, I considered the complexity
of the E.U’s market place for medical equipments and pharmaceutical products, access to
financial resources and the penetration of E.U’s marketing and distribution channels for
medical equipments. Strategic alliance seemed to be the most favorable entry strategy in
the E.U’s pharmaceutical and medical equipment market.
Reference:
Dinan, D. (2005). Ever Closer Union : An Introduction to European Integration, 3rd Ed. Boulder: CO: Lynne Rienner Publishers.
Hill, C. (2005). International Business: Competing in the Global Market Place, 6th Ed. New York: NY: McGraw-Hill/Irwin.
IMF.(2004) Mergers and Acquisitions: Balance of Payment and International Investment Statistics, Paper 4, Washington DC.
Pharmaceutical Research Association and Manufacturer’s Association, Foreign Government Price and Access Control, Federal Registry Notice Submission, FR Doc. 04-12205 (July 1, 2004), P.11.
OECD.(2005). New Patterns of Industrial Globalization: Cross-boarder Mergers and Acquisitions and Strategic Alliances, OECD, Paris.
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