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the potential to affect our cash flows and
earnings per share. Claims, regardless of
their merits or their outcome, are costly, divert
management attention, and may adversely
affect our reputation.
The majority of the jurisdictions in which we
operate have double tax treaties with other
foreign jurisdictions, which enable us to
ensure that our revenues and capital gains do
not incur a double tax charge. If any of these
double tax treaties should be withdrawn or
amended, especially in a territory where a
member of the Group is involved in a taxation
dispute with a tax authority in relation to
cross-border transactions, such withdrawal or
amendment could have a materially adverse
effect on our financial condition and results of
operations, as could a negative outcome of a
tax dispute or failure of tax authorities to agree
through competent authority proceedings.
See the Financial Risk Management Policies
on pages 41 to 42 for further details of risk
mitigation. The Group is currently managing
a number of tax disputes detailed in Note 25
to the Financial Statements.
Substantial product liability claims
Given the widespread impact that prescription
drugs may have on the health of large
patient populations, pharmaceutical,
biopharmaceutical and medical device
companies have, historically, been subject
to large product liability damages claims,
settlements and awards for injuries allegedly
caused by the use of their products. Product
liability claims, regardless of their merits or
their outcome, are costly, divert management
attention, and may adversely affect our
reputation and demand for our products.
Adverse publicity relating to the safety of a
product or of other competing products may
increase the risk of product liability claims.
Litigation, particularly in the US, is inherently
unpredictable and verdicts and/or unexpectedly
high awards of damages can result. Substantial
product liability claims that result in court
decisions against us or in the settlement
of proceedings could have a materially
adverse effect on our financial condition and
results of operations, particularly where such
circumstances are not covered by insurance.
We are currently subject to extensive product
liability litigation in relation to Seroquel, and
further details about this and all material legal
proceedings in which we are involved are set
out in Note 25 to the Financial Statements.
Information about our approach to patient
safety is set out in the Medicines section on
page 16.
In the US realised prices are being depressed
through limited lists, or formularies, that
may force manufacturers either to reduce
prices or be excluded from the list, and as a
consequence lose sales revenue from patients
covered by that formulary. In addition, private
health insurance companies and employers
that self-insure increasingly require co-payments
from beneficiaries, particularly for branded
pharmaceuticals and biotechnology products,
among other reasons, to encourage
beneficiaries to use generic products.
The increased use of strict formularies by
institutional customers in response to the
current cost-containment environment and
increasingly restrictive reimbursement policies
could result in a materially adverse effect on
our financial condition and results of operations.
In the EU, efforts by the European Commission
to reduce inconsistencies and improve
standards and best practice in the disparate
national regulatory systems have met with little
immediate success. The industry is, therefore,
exposed to greater application of reference
pricing mechanisms and ad hoc national
cost-containment measures on prices and
the consequent cross-border movement of
products. The importation of pharmaceutical
products from countries where prices are low
due to government price controls or other
market dynamics, to countries where prices
for those products are higher, may increase.
The accession of additional countries from
Central and Eastern Europe to the EU as well
as economic changes within EU countries may
result in significant increases in the parallel
trading of pharmaceutical products. In the
US, new legislation is possible that may allow
the commercial importation of drugs into the
US from selected countries. The adoption of
such legislation could result in an increase in
volume of cross-border product movements
which could result in a materially adverse
effect on our financial condition and results
of operations.
We expect that pressures on pricing will
continue and may increase. Because of
these pressures, there can be no certainty
that we will be able to charge prices for a
product that, in a particular country or in the
aggregate, enable us to earn an adequate
return on our investment in that product.
Taxation
The integrated nature of our worldwide
operations can produce conflicting claims
from revenue authorities as to the profits to be
taxed in individual territories. The resolution of
these disputes can result in a reallocation of
profits between jurisdictions and an increase
or decrease in related tax costs, and has
The methods of distributing and marketing >
biological products could have a material
impact on the revenue we are able to
generate from the sales of products
such as Synagis and FluMist.
The commercialisation of biologic
products is often more complex than
for traditional pharmaceutical products.
This is primarily due to differences in
mode of administration, technical
aspects of the product, and the rapidly
changing distribution and reimbursement
environments. The tools available to the
commercial team can be more limited
and time-consuming in that the target
physicians who prescribe biologics are
often hospital-based specialists who treat
patients with rare diseases. Biologics sales
forces are usually smaller, more targeted
and typically are required to make a more
detailed, data-driven sales call. Patient
education and awareness also requires
a more personalised approach in that
broad-based awareness campaigns, such
as direct-to-consumer advertising in the
US, is often not an efficient means by which
to reach a smaller target population.
Competition, price controls
and price reductions
Some of our most valuable products compete
directly with other products marketed either by
major R&D based prescription pharmaceutical
companies or by generic pharmaceutical
manufacturers. These competitors may
invest greater resources to the marketing of
their products than we do depending on the
relative priority of these competitor products
within their company’s portfolio. Generic
versions of products are often sold at lower
prices because they do not have to recoup
the significant cost of R&D investment, nor
do they generally invest the same amounts in
education services for healthcare professionals.
Industry consolidation has resulted in a small
number of very large companies, some of
which have acquired generic businesses.
This trend, if it continued, could adversely
affect our competitive position, whilst
consolidation among our customers may
increase price pressures. Some of our
patented products, including Nexium, Crestor,
Seroquel and Symbicort are subject to price
pressure from competition from generic
products in the same product class.
In most of our key markets there is continued
economic, regulatory and political pressure
to limit or reduce the cost of pharmaceutical
products. A summary of the principal aspects
of price regulation and how price pressures are
affecting our business in our most important
markets is set out in the Geographical Review
from page 48.