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                              Introducing the
                              Pharma 2020
                              Series
These reports look
into the future of the
Pharmaceuticals and Life
Sciences’ value chain. And
they include an analysis of
the strategies available to
companies.
Publications in this series include:

     Pharmaceuticals
                                                Published in June 2007, this      Pharmaceuticals and Life Sciences
                                                                                                                      Published in February 2009,
                                                paper highlights a number of                                          this paper discusses the key
                                                issues that will have a major                                         forces reshaping the
     Pharma 2020: The vision                    bearing on the industry by        Pharma 2020: Marketing the future   pharmaceutical marketplace,
     Which path will you take?*                 2020. The publication outlines    Which path will you take?           including the growing power
                                                the changes we believe will                                           of healthcare payers, providers
                                                best help pharmaceutical                                              and patients, and the changes
                                                companies realise the potential                                       required to create a marketing
                                                the future holds to enhance the                                       and sales model that is fit for
                                                value they provide to                                                 the 21st century. These
                                                shareholders and society alike.                                       changes will enable the
                                                                                                                      industry to market and sell its
                                                                                                                      products more cost-effectively,
     *connectedthinking                                                                                            to create new opportunities
                                                                                                                      and to generate greater
     Pharma 2020: The vision               #

                                                                                                                      customer loyalty across the
                                                                                                                      healthcare spectrum.

     Pharmaceuticals and Life Sciences
                                                This report, published in June    Pharmaceuticals and Life Sciences
                                                                                                                      The fifth report in our series,
                                                2008, explores opportunities                                          published in December 2009,
                                                to improve the R&D process. It                                        focuses on the opportunities
     Pharma 2020: Virtual R&D                   proposes that new technologies    Pharma 2020: Taxing times ahead     and challenges from a tax
     Which path will you take?                  will enable the adoption of       Which path will you take?
                                                                                                                      perspective. It discusses how
                                                virtual R&D; and by operating                                         the political, economic,
                                                in a more connected world the                                         scientific and social trends
                                                industry, in collaboration with                                       currently shaping the
                                                researchers, governments,                                             commercial environment,
                                                healthcare payers and                                                 together with the development
                                                providers, can address the                                            of new, more collaborative
                                                changing needs of society more                                        business models, will exert
                                                effectively.                                                          increasing pressure on effective
                                                                                                                      tax rates within the industry. It
                                                                                                                      also shows how companies can
     Pharma 2020: Virtual R&D              1

                                                                                                                      adapt their tax strategies to
                                                                                                                      support the provision of
                                                                                                                      outcomes-based healthcare and
                                                                                                                      remain competitive.

     Pharmaceuticals and Life Sciences
                                                Fourth in the Pharma 2020                                             In our sixth release of the
                                                series and published in April                                         series, published in February
                                                2009, this report highlights                                          2011, PwC discusses how
     Pharma 2020: Challenging business models   how Pharma’s fully integrated                                         pharma companies must
     Which path will you take?                  business models may not be                                            develop different supply chain
                                                the best option for the pharma                                        models, learn to use supply
                                                industry in 2020; more                                                chains as a market
                                                creative collaboration models                                         differentiator and revenue
                                                may be more attractive. This                                          generator, and recognise how
                                                paper also evaluates the                                              information will drive the
                                                advantages and disadvantages                                          downstream flow of products
                                                of the alternative business                                           and services.
                                                models and how each stands
                                                up against the challenges
                                                facing the industry.

    All these publications are available to download at: www.pwc.com/pharma2020

2    PwC
Pharma 2020:
Executive summary

The global market for                                  Pharma’s strategy of placing big bets
                                                       on a few molecules, promoting them
                                                                                                              • governments everywhere are
                                                                                                                beginning to focus on prevention
medicines is growing                                   heavily and turning them into                            rather than treatment, although
but the industry must                                  blockbusters worked well for many
                                                       years, but its R&D productivity has
                                                                                                                they have not yet invested very
                                                                                                                much in pre-emptive measures; and
transform to capitalise                                now plummeted and the
                                                                                                              • the regulators are becoming more
opportunities                                          environment’s changing. PwC1
                                                       believes that seven major trends are
                                                                                                                cautious about approving truly
                                                                                                                innovative medicines.
                                                       reshaping the marketplace:
                                                                                                              These trends will compound the
                                                       • the burden of chronic disease is
                                                                                                              challenges Pharma already faces, but
                                                         soaring – placing even greater
                                                                                                              they’ll also provide some major
                                                         pressure on already stretched
                                                                                                              opportunities. So what must the
                                                         healthcare budgets
                                                                                                              industry do to capitalise on them? We
                                                       • healthcare policy-makers and                         think that it’ll have to improve its
                                                         payers are increasingly mandating                    understanding of disease, reduce its
                                                         what doctors can prescribe                           R&D costs significantly and spread its
                                                                                                              bets to improve its productivity. It’ll
                                                       • a growing number of healthcare
                                                                                                              also have to tap the potential of the
                                                         payers are measuring the
                                                                                                              emerging economies and switch from
                                                         pharmacoeconomic performance of
                                                                                                              selling medicines to managing
                                                         different medicines. A widespread
                                                                                                              outcomes. However, few, if any,
                                                         use of electronic medical records
                                                                                                              companies will be able to perform
                                                         will give them the data they need to
                                                                                                              these activities alone.
                                                         insist on outcomes-based pricing
                                                       • the boundaries between different
                                                         forms of healthcare are blurring, as
                                                         clinical advances render previously
                                                         fatal diseases chronic and the
                                                         self-medication sector expands
                                                       • demand for medicines is growing
                                                         more rapidly in the emerging
                                                         economies than the industrialised
                                                         economies

1 “PwC” refers to the network of member firms of PricewaterhouseCoopers International Limited (PwCIL), or, as the context requires, individual member firms of the
PwC network.
                                                                                                                                                      PwC       3
Taking R&D to the                          such a model will require a massive
                                                                                                collaborative effort far exceeding that
                                                     virtual level                              needed to complete the Human
                                                     Let’s begin with R&D. If Pharma’s to       Genome Project. Nevertheless,
                                                     develop safe, efficacious new              predictive biosimulation’s already
                                                     medicines more economically, it’ll         playing a growing role in the R&D
                                                     have to learn much more about how          process and we anticipate that, by
                                                     the human body functions at the            2020, virtual cells, organs and animals
                                                     molecular level and the                    will be widely employed in
                                                     pathophysiological changes disease         pharmaceutical research (see Figure 1).
                                                     causes. Only then will it be able to
                                                                                                Of course, even the most robustly
                                                     develop a better understanding of how
                                                                                                modelled molecules will still have to
                                                     to modify or reverse these changes.
                                                                                                be tested in real human beings. But
                                                     This is a huge task – but one that
                                                                                                here too, we expect some dramatic
                                                     several emerging technologies can
                                                                                                changes. When biomarkers for
                                                     help to facilitate.
                                                                                                diagnosing and treating patients more
                                                     Semantic technologies will, for            accurately are more widely available,
                                                     example, make it much easier to            for example, the industry will be able
                                                     identify the links between a particular    to stratify patients with different but
                                                     disease and the biological pathways it     related conditions and test new
                                                     affects, or the links between a            medicines only in patients who suffer
                                                     particular molecule and its impact on      from a specific disease subtype. That
                                                     the human body. Similarly, computer-       will allow the industry to reduce the
                                                     aided molecule design will give            number and size of the clinical studies
                                                     researchers a much better starting         required to prove efficacy. Semantic
                                                     point in the search for potent             technologies will also play a major role
                                                     molecules.                                 in improving the development process,
                                                                                                while pervasive monitoring will help
                                                     Various academic institutes and
                                                                                                Pharma track patients on a real-time
                                                     bioinformatics firms are also building
                                                                                                basis wherever they are.
                                                     computer models of different organs
                                                     and cells, with the ultimate aim of
                                                     creating a “virtual man”. Developing

    Figure 1: What the research process might look like in 2020

                                     Design &                             Further testing      Testing of
                                                          Synthesis of                                         Initial testing
                   Target ID       initial testing                         of treatment        treatment
                                                           treatment                                               in man
                                    of treatment                               in vitro          in vivo

                  Mixed computer/lab
                  Lab work
                  In silico
                  Testing in man

    Source: PwC

4    PwC
Companies will use virtual R&D to increase
innovation and reduce commercial deficit

We think that these scientific and          The regulatory process will change           significant organisational and
technological advances will ultimately      equally substantially over the next          behavioural changes. They’ll, for
render the current model of                 decade. First, there’ll be a common          example, have to decide whether they
development, with its four distinct         regulatory regime for all healthcare         want to focus on mass-market
phases of clinical testing, defunct. A      products and services, rather than           medicines or speciality therapies, and
company will start by administering a       separate regimes for pharmaceuticals,        whether they want to outsource most of
treatment to a single patient who has       medical devices, diagnostics and the         their research or keep it in-house.
been screened to ensure that he or she      like. Indeed, there may even be a            Those that regard R&D as an integral
has the right medical profile. Once         single global system, administered by        part of their activities may also need to
there’s evidence that the treatment         national or federal agencies                 review the way they manage their R&D
doesn’t cause any immediate adverse         responsible for ensuring that new            and remunerate their scientific staff.
events, it’ll be sequentially               treatments meet the needs of patients
administered to other patients – from       within their respective domains,
as few as 20 to as many as 100. The         although we think the latter is less
data they generate will be compared to      likely.
data from the modelling that preceded
                                            Second, the current ‘all-or-nothing’
the study and subjected to techniques
                                            approach to the approval of new
like Bayesian analysis to adapt the
                                            medicines will be replaced by a
course of the study, but the study itself
                                            cumulative process, based on the
will be conducted in a single,
                                            gradual accretion of data. In other
continuous phase (see Figure 2).
                                            words, all newly approved therapies
The development process will also           will receive “live licences” conditional
become much more iterative, with            on further in-life testing to
data on a molecule for one disease          substantiate their safety and efficacy
subtype getting fed back into the           in larger populations, different
development of new molecules for            populations or the treatment of other
other disease subtypes in the same          conditions.
cluster of related diseases. And the
                                            But, if they are to capitalise on the new
current system of conducting trials at
                                            technologies now emerging and the
multiple sites will be replaced with a
                                            creation of a nimbler, more
system based on independently
                                            collaborative regulatory regime, many
managed clinical supercentres.
                                            companies will have to make

Figure 2: What the development process might look like in 2020

                                                                     1.5 years
     Confidence in mechanism
           from research work
                                                      1 year                                 0.5 year
          Epidemiological data
                                                   First into man                          Automated                   Limited
              Disease knowledge
                                            (adaptive design) 20-100 pts               submission/approvals          clinical use
Knowledge / Data from clinical
    usage or similar products
   Proof of value requirements                                                                              Launch
                                                                              CIE
                                                                              CIS

                                                               Clinical data / Knowledge incorporated into studies
Source: PwC                                                              on future indications/populations

                                                                                                                          PwC       5
Getting the medicines                       As demand grows for more customised         outcomes; new modes of delivering
                                            products and services – and as the          healthcare where the care is pushed
to the marketplace                          nature of those products and services       into the community and where access
We’ve noted that the pharmaceutical         becomes more complex – the next             to information on patients will become
industry is experiencing major              generation of supply chains will            as important as the products
upheavals associated with the need to       become an increasingly important            themselves; the growing importance
move to more efficient models for           source of differentiation for makers of     of emerging markets; a greater public
discovery, development and selling of       medicines. It’ll also play a more           scrutiny impacting the ability to
the medicines to which many                 prominent part in the strategic             manage risk and compliance; and,
companies have responded in different       thinking of industry leaders.               tougher environmental controls and
ways. However, they’ve invested                                                         regulations will oblige companies to
                                            We believe there are numerous trends
relatively little effort in reconfiguring                                               strategically reassess their supply
                                            that are reshaping the environment in
their manufacturing and distribution                                                    chain approach. (see Figure 3)
                                            which the industry operates and
operations to date. Yet a significant
                                            which are dictating the need for a
amount of the cost base of most
                                            different way for the pharmaceutical
bio-pharmaceutical companies comes
                                            companies to make and distribute
from the supply chain. It’s the link
                                            their products.
between the laboratory and the
marketplace and includes everything         By 2020, the more diverse product
from sourcing raw materials to              types and therapies with shorter
manufacturing and packaging to              product lifecycles; new ways for
inventory warehousing, transportation       assessing, approving and monitoring
and distribution.                           medicines; increasing emphasis on

Figure 3: Numerous forces are dictating the need for a different sort of supply chain

 1     New product types                         • More complex manufacturing and distribution processes
                                                 • Different supply chains for different product types
                                                 • Shorter product lifecycles

 2     Live licensing                            • Incremental launch of new medicines
                                                 • Ability to scale up and down very rapidly
                                                 • Step changes in the revenue curve

 3     Increasing emphasis on outsources         • Expansion into health management services
                                                 • Leaner and more adaptable cost structure that preserves gross margins at
                                                   every stage of the product lifecycle

 4     New modes of healthcare delivery          • Blurring of the boundaries between primary and acute care
                                                 • Much wider distribution network
                                                 • Demand-driven manufacturing and distribution processes

 5     Growing importance of emerging
       markets
                                                 • Offerings designed for patients in emerging markets
                                                 • More widely dispersed and more robust supply chain

 6     Greater public scrutiny                   • Heavier regulation
                                                 • Robust risk assessment and risk-management capabilities across the
                                                   extended supply chain
Source: PwC

                                                                                                                     PwC      6
By 2020, the most successful companies will be those that seize the
initiative and start building agile, efficient supply chains which bring
them closer to the patient

We believe that timely access to           The successful pharmaceutical            Alternatively, they might position
various emerging technologies will         companies of the future will be those    themselves as service innovators,
help to increase the efficiency of the     that integrate all these opportunities   building supply chains that are
manufacturing and distribution             and build supply chains with new         capable of manufacturing and
functions. It will also redefine the       manufacturing, distribution and          distributing complex treatments as
interface with the patient bringing        service-management techniques. We        well as managing multiple suppliers of
pharma companies even closer to            outline four potential scenarios.        integrated, valued-added health
patients.                                  Depending on their product and           management services.
                                           channel portfolio, most companies
Additionally, more collaboration                                                    Mass-market manufacturers, such as
                                           will have to manage more than one
between the parties involved in                                                     the makers of generics, might position
                                           scenario simultaneously.
healthcare provision will contribute to                                             themselves as high-volume, low-cost
make the industry more efficient. The      Companies that concentrate on            providers, borrowing lessons in lean
supply chains for designing,               specialist therapies might exit from     manufacturing, strategic pricing and
manufacturing and distributing             manufacturing altogether and, instead,   inventory management from the
pharmaceuticals and medical devices        become a virtual manufacturer. They’ll   consumer products industry. Another
plus those providing healthcare            outsource the entire supply from         option for mass mass-market
services will integrate. The aim is that   production of the earliest clinical      manufacturers is to turn their supply
all partners can see the full picture      batches to full-scale manufacturing,     chains into profit centres that combine
and can plan ahead more accurately         packaging and distribution through a     economic manufacturing and
and cost-effectively.                      network of integrated supply partners    distribution of satellite services, such as
                                           (see Figure 6).                          direct-to-patient delivery, secondary
                                                                                    packaging or distribution to hospitals
                                                                                    and pharmacies. They’ll then franchise
                                                                                    those profit centres as a stand-alone
                                                                                    offering for both internal and external
                                                                                    customers.

                                                                                                                     PwC     7
Figure 4: Four options exist for restructuring the pharmaceutical supply chain

                                                       Operations strategy

                       Specialist Therapies                                           Mass-market medicines

        Virtual manufacturer             Service innovator              Low-cost provider                   Profit centre

     Create a virtual network        Build a service-oriented       Build a reliable, ‘no-frills’     Combine agile,
     of integrated supply            supply chain to enhance        supply chain to deliver           economic manufacturing
     partners                        brands and differentiate       products as                       and distribution with the
                                     company from its               economically as                   provision of satellite
                                     competitors                    possible                          service to generate
                                                                                                      profits

    Source: PwC

                                                                                          In all four cases, the supply chain of
                                                                                          the future will need to be much more
                                                                                          patient-focused. In a world where
                                                                                          outcomes count for everything, it’s not
                                                                                          molecules that create value but,
                                                                                          rather, the ability to integrate data,
                                                                                          products and services in a coherent
                                                                                          care package. Understanding this shift
                                                                                          of emphasis from products to patient
                                                                                          outcomes is key. Those organisations
                                                                                          that recognise the shift will be able to
                                                                                          deliver significant benefits to every
                                                                                          stakeholder in the healthcare value
                                                                                          chain: payers, providers, patients and
                                                                                          shareholders.

8    PwC
Smaller, refocused sales                 A new approach to                                management services. Most
                                                                                          treatments perform much better in
forces will enable                       marketing and sales                              clinical trials than they do in everyday
pharma companies to                      The industry’s marketing and sales               life, partly because the level of
                                                                                          compliance is much higher. Any
                                         model will likewise have to undergo
create greater value for                 major alterations, as pay-for-                   pharmaceutical company that wants
patients                                 performance becomes the norm in                  to command premium prices for its
                                                                                          therapies will have to provide a range
                                         many countries and the opportunities
                                         for generating value from pure                   of products and services from which
                                         product offerings diminish. Many                 patients can choose all but the core
                                         companies will have to analyse their             prescription. They will need to help
                                         own value chains to identify                     patients manage their health.
                                         opportunities for working more
                                                                                          This route has several significant
                                         closely with healthcare payers and
                                                                                          advantages. It’ll enable companies to
                                         providers. They will, for instance,
                                                                                          generate new sources of revenue,
                                         have to consult payers, providers and
                                                                                          differentiate their offerings more
                                         patients when deciding which
                                                                                          effectively and protect the value of the
                                         compounds to progress through their
                                                                                          medicines they make. But it’ll also
                                         pipelines. Some companies now look
                                                                                          entail the formation of numerous
                                         at whether the products they’re
                                                                                          alliances with local service providers
                                         developing are more effective than
                                                                                          and even rival manufacturers; the
                                         other existing therapies. Very few
                                                                                          development of a secure, interoperable
                                         focus on understanding the payer’s
                                                                                          technological infrastructure; the
                                         perspective. We believe that all
                                                                                          management of new intellectual rights
                                         companies should extend the concept
                                                                                          issues; the creation of much stronger
                                         of “de-risking” from the clinical to the
                                                                                          brands; and the redefinition of the
                                         commercial sphere to ensure that
                                                                                          industry’s role. Instead of trying to
                                         they’re making medicines the market
                                                                                          stimulate prescription sales, its task
                                         really wants to buy (see Figure 5).
                                                                                          will be to help patients manage the
                                         Similarly, many companies will have              disease lifecycle.
                                         to supplement the therapies they
                                                                                          The shift to performance-based
                                         develop with a wide range of health
                                                                                          pricing will dictate other changes, too,

Figure 5: Pharma needs to use a price de-risking strategy in early development

                 Percentage of spending in each phase of R&D. 11.3% of spending uncategorised

                 Preclinical     Phase I        Phase II          Phase III      Regulatory        Phase IV
                    25.7           5.8           11.7              25.5             6.9              13.3

                                              Point at which          Point at which
                                              pharmaceutical          pharmaceutical
                                                companies               companies
                                                 should be              typically start
                                              thinking about           thinking about
                                             pricing to de-risk            pricing
                                              their portfolios
Source: PwC

                                                                                                                         PwC     9
including the need for a more flexible     liaise with secondary-care specialists;
         approach to pricing. The introduction      and communicate with patients.
         of live licences and increasing
         importance of the emerging markets         The need for new
         will reinforce this trend. Any company     business models
         that launches a new healthcare
         package will have to negotiate price       The changes we’ve outlined above will
         rises in line with the extension of the    all necessitate the development of
         terms on which that package can be         multinational, multi-disciplinary
         marketed. And if it wants to establish a   networks drawing on a much wider
         stronger footing in the emerging           range of skills than Pharma alone can
         world, it’ll have to use differential      provide. Most companies will therefore
         pricing – both within and between          need to adopt new business models.
         countries.                                 We believe that two principal models
         Increasing payer pressure on pricing       – federated and fully diversified – will
         and outcomes is forcing companies to       emerge. The federated model
         increase its efforts to improve patient    comprises a network of separate
         compliance. Improved patient               organisations linked by a shared
         compliance provides numerous               purpose and infrastructure. The fully
         benefits, not least, individual health     diversified model comprises a network
         outcomes, but it also helps to drive       of entities owned by a single parent
         healthcare cost and improved revenues      company. We’ve also identified two
         for companies. With performance            variants of the federated model. In the
         based pricing becoming more                virtual version, a company outsources
         common, a focus on patient                 most or all of its activities; in the
         compliance through education and           venture version, it manages a portfolio
         technology will be a necessity.            of investments (see Figure 6).

         Lastly, the industry leaders will have     These models are not mutually
         to develop comprehensive strategies        exclusive. A fully diversified company
         for marketing and selling specialist       might choose to use a federated model
         healthcare packages, a process that        for certain aspects of its business, and
         will require the development of new        vice versa. But we think that the
         skills and routes to market; and they’ll   federated model will ultimately
         have to revolutionise their marketing      dominate, primarily because it’s
         and sales functions. By 2020, the role     quicker and more economic to
         of the traditional sales representative    implement.
         will be largely obsolete. Conversely,      The transition will not be easy,
         the industry will have a much greater      because collaborative business models
         need of people with the expertise to       are far more complex than the
         build brands; manage a network of          integrated model that’s previously
         external alliances; negotiate with         prevailed.
         governments and health insurers;

10 PwC
Challenging times require bold moves
if pharma companies are to survive the immediate storm

Disrupting the existing order can also             Yet there are many opportunities to
have a major impact on a company’s                 generate revenues by improving the
short-term performance. We anticipate              way in which the remaining 85-90% is
that many companies which choose                   spent. It’s these opportunities the
the federated model will adopt a                   industry will need to address in the
progressive approach. They’ll start                brave new world of 2020.
with opportunistic alliances; use the
most successful alliances as building
blocks to create more strategic,
longer-lasting coalitions; and, finally,
use the most successful coalitions to
create a fully federated network of
long-term partners.
The prospects for any pharmaceutical
company that can make the switch are
very promising. To date, Pharma has
focused on the profits it can earn from
the estimated 10-15% of the health
budget that goes on medicines.

Figure 6: The different business models

                             Collaborative: Federated model                                            Owned: Fully Diversified model
                            • Network of separate entities                                             • Network of entities owned by one
                                                                                                         parent company
                            • Based on shared goals and infrastructure
                                                                                                       • Based on provision of internally integrated
                            • Draws on in-house and/or external assets
                                                                                                         product-service mix
                            • Combines size with flexibility
                                                                                                       • Spreads risk across business units

 Virtual variant                                               Venture variant
 • Network of contractors                                      • Portfolio of investments
 • Activities coordinated by one company                       • Based on sharing of intellectual property/
   acting as hub                                                 capital growth
 • Operates on project-by-project basis                        • Stimulates entrepreneurialism and innovation
 • Fee-for-service financial structure                         • Spreads risk across portfolio

Source: PwC

                                                                                                                                              PwC 11
A heavier tax burden                        will increase. Demand for such services
                                                     initially is likely to be greatest in the
         The collaborative business models will      industrialised world, where corporate
         enable Pharma to deliver healthcare         income tax rates are often higher. That
         packages that comprise medicines and        will make it more difficult for
         supporting services supplied locally        companies to assign profits legitimately
         (such as drug administration training,      from high- to low-tax jurisdictions.
         home delivery, physiotherapy, health
         screening and exercise facilities). This    Undertaking or managing more
         new way of doing business, combined         business activities in end markets will
         with the political and economic trends      also make it harder to prove that a
         already shaping the general commercial      company has not created a permanent
         environment, will have major tax            business establishment in countries
         repercussions. We anticipate that the       where services are delivered. This may
         industry’s corporate tax burden will rise   increase the risk of failing to obtain
         significantly over the next 10 years        double tax relief, as allowed under
         — unless it undertakes various              international tax treaties, and of being
         strategies to mitigate the impact.          taxed on the same earnings in the
                                                     home country and the country where
         Governments of the industrialised           the services have been delivered.
         world will struggle to repair public
         finances damaged by debts accrued in        The provision of direct-to-patient
         managing the global recession. They’ll      services will additionally make it even
         decrease the opportunities that have        more difficult for the industry to
         allowed the industry to reduce              negotiate its way through the maze of
         corporate taxes by moving profits from      withholding tax regulations. Countries
         higher-tax to lower-tax territories.        have traditionally adopted a more
                                                     diverse approach to the application of
         Along with imposing more stringent          withholding taxes to payments for
         tax regulations, the major powers           services than they have for goods.
         could place trading restrictions on         These variations can produce more
         traditional tax havens that refuse to       material for tax disputes.
         cooperate. The tax authorities in most
         countries will work more closely with
         their counterparties in other
         territories to control multinationals’
         tax-reducing practices.
         As Big Pharma moves toward the
         provision of integrated healthcare
         packages, the proportion of income
         generated in the industry’s end markets

12 PwC
Tax strategy will be the crux, not an
afterthought, of long-term business plans

The provision of services also may       duties and other trade-related tariffs       Some might choose to move their
affect the way the income of             pharmaceutical companies incur.              entire operations to a low-tax location.
controlled foreign corporations (CFCs)   Some countries levy significant import
                                                                                      On the positive side, the competition
is taxed. In many developed countries,   duties on key active pharmaceutical
                                                                                      to attract companies engaging in R&D
tax laws provide that CFC profits may    ingredients and finished products, and
                                                                                      will intensify. Some countries will
be attributed to the holding company     the valuation of combined product-
                                                                                      offer generous tax incentives and
and taxed immediately, rather than       service offerings for customs purposes
                                                                                      credits — and several will be new
being taxed only when (and if) they      could prove complicated.
                                                                                      competitors keen to build knowledge-
are repatriated. However, CFC
                                         Finally, because of more complex             based economies. Tax departments
legislation often distinguishes
                                         supply chains, it may become more            will need to keep abreast of these
between ‘passive’ income (i.e.,
                                         difficult to use transfer pricing — i.e.,    incentives so they can advise
interest, dividends, annuities, rents
                                         the allocation of income among               leadership on how to take advantage
and royalties), which is taxed, and
                                         related business entities via the            of tax-reduction opportunities.
‘active’ income (i.e., income from
                                         pricing of intellectual property,
commercial activities), which is not                                                  Tax departments will also have to
                                         tangible goods, services, and loans or
taxed. Some of the new healthcare                                                     build much closer relationships with
                                         other financial transactions — to
services pharmaceutical                                                               the operational parts of the business
                                         avoid double taxation. Many tax
multinationals will provide may fall                                                  and acquire a much more detailed
                                         authorities already are clamping down
into the taxable category.                                                            understanding of the complexities of
                                         on abusive transfer pricing practices,
                                                                                      supply chain arrangements. Those tax
Providing integrated packages also       such as shifting profits artificially from
                                                                                      departments that combine a strong
could increase compliance costs and      a high- to a low-tax jurisdiction, by
                                                                                      grasp of long-term strategy and
risks associated with indirect taxes,    maximising expenses in the former
                                                                                      effective lobbying with a detailed
such as value-added tax (VAT). Some      and income in the latter.
                                                                                      tactical understanding of the way in
VAT regimes may apply the
                                         To deal with these multiple pressures,       which products are distributed and
appropriate rate of VAT to each
                                         companies will need to rethink their         value is created will be best placed to
component of a package, while others
                                         tax strategies. The choice of legal          help pilot their companies along the
may treat the package as a composite
                                         entity and structure of commercial           path to future prosperity.
and apply the rate of the principal
                                         arrangements, for example, will have
element to the entire bundle.
                                         a significant impact on taxation. One
The increasing importance of             solution for multinationals might be to
emerging markets, an evolving supply     locate more business activities, such as
chain, and a shift to services could     R&D, manufacturing, and marketing,
also have a major bearing on customs     in regional hubs in low-tax countries.

                                                                                                                    PwC 13
Territory contacts

Argentina                 Czech Republic         Indonesia
Diego Niebuhr             Radmila Fortova        Eddy Rintis
[54] 11 4850 4705         [420] 2 5115 2521      [62] 21 5212901

Australia                 Denmark                Ireland
John Cannings             Torben TOJ Jensen      John M Kelly
[61] 2 826 66410          [45] 3 945 9243        [353] 1 792 6307

Austria                   Erik Todbjerg          Enda McDonagh
Doris Bramo-Hackel        [45] 3 945 9433        [353] 1 792 8728
[43] 1 501 88 3232
                          Ecuador                Israel
Belgium                   Carlos Cruz            Assaf Shemer
Thierry Vanwelkenhuyzen   [593] 2 2562 288 130   [972] 3 795 4681
[32] 2 710 7422
                          Estonia                Italy
Bolivia                   Peep Kalamäe           Nicola Nicoletti
Cesar Lora                [372] 6141 976         [39] 026 6720504
[591] 721 47235
                          Finland                Japan
Brazil                    Janne Rajalahti        Kenichiro Abe
Eliane Kihara             [358] 3 3138 8016      [81] 80 3158 5929
[55] 11 3674 2455
                          France                 Eimei Shu
Bulgaria                  Anne-Christine Marie   [81] 3 5293 1032
Irina Tsvetkova           [33] 1 5657 1342
[359] 2 9355 126                                 Kazakhstan
                          Germany                Richard Bregonje
Canada                    Georg Kämpfer          [77] 27 298 448
Gord Jans                 [49] 69 9585 1333
[1] 905 897 4527                                 Korea
                          Greece                 Henry An
China                     Nick Papadopoulos      [82] 2 3781 2594
Mark Gilbraith            [30] 210 687 4740
[86] 21 2323 2898                                Latvia
                          Hungary                Vita Sakne
Jia Xu                    Eva Barsi              [371] 67094425
[86] 10 6533 7734         [36] 1 461 9169
                                                 Lithuania
Colombia                  India                  Kristina Krisciunaite
María Helena Díaz         Sujay Shetty           [370] 5 239 7365
[57] 1 634 0320           [91] 22 6669 1305

                                                                         PwC 14
Luxembourg                      Singapore                 United Kingdom
Laurent Probst                  Abhijit Ghosh             Andrew Packman
[352] 0 494 848 2522            [65] 6236 3888            [44] 1895 522104

Malta                           Slovakia                  United States
Adrian Spiteri                  Rastislava Krajcovicova   Michael Swanick
[356] 2564 7038                 [421] 2 5935 06 16        [1] 267 330 6060

Mexico                          South Africa              Uruguay
Jorge Luis Hernández Baptista   Denis von Hoesslin        Richard Moreira
[52] 55 5263 6106               [27] 117 974 285          [598] 2916 0463

Netherlands                     Spain                     Venezuela
Arwin van der Linden            Rafael Rodríguez Alonso   Luis Freites
[31] 20 5684712                 [34] 91 568 4287          [58] 212 700 6966

Norway                          Sweden
Fredrik Melle                   Mikael Scheja
[47] 95 26 00 13                [46] 8 555 33 038

Peru                            Switzerland
Felix Horna                     Clive Bellingham
[511] 211 6500                  [41] 58 792 2822

Philippines                     Taiwan
Che Javier                      Elliot Liao
[63] 2 845 2728                 [886] 3 5780205 26217

Poland                          Thailand
Mariusz Ignatowicz              Zoya Vassilieva
[48] 22 523 4795                [66] 2 344 1115

Portugal                        Turkey
Ana Lopes                       Zeki Gunduz
[351] 213 599 159               [90] 212 326 64 100

Romania                         Ukraine
Mihaela Mitroi                  Ron Barden
[40] 21 225 3717                [380] 44 490 6777

Russia                          United Arab Emirates
Alina Lavrentieva               Sally Jeffery
[7] 495 967 6250                [971] 4 304 3154

                                                                              PwC 15
About Global Pharmaceuticals and Life Sciences Industry Group
PwC firms provide industry-focused assurance, tax and advisory services to enhance value for their clients. More than 161,000
people in 154 countries in firms across the PwC network share their thinking, experience and solutions to develop fresh
perspectives and practical advice.
Our Global Pharmaceuticals and Life Sciences Industry Group has experience working with companies on industry-specific
strategic, operational, and financial issues. As well as assurance, tax and advisory services, we also have specialised capabilities
in regulatory compliance, risk management, performance improvement and transaction support.

Simon Friend                                                                         Attila Karacsony
Partner, Global Pharmaceuticals and Life Sciences                                    Director, US Pharmaceuticals and Life Sciences Marketing
Industry Leader
simon.d.friend@uk.pwc.com                                                            attila.karacsony@us.pwc.com
[44] 20 7213 4875                                                                    [1] 973 236 5640

Dr. Steve Arlington                                                                  Marina Bello Valcarce
Partner, Global Pharmaceuticals and Life Sciences                                    Global Pharmaceuticals and Life Sciences Marketing
Advisory Services Leader                                                             and Knowledge Management
steve.arlington@uk.pwc.com                                                           marina.bello.valcarce@uk.pwc.com
[44] 20 7804 3997                                                                    [44] 20 7212 8642

Michael Swanick
Partner, Global Pharmaceuticals and Life Sciences
Tax Leader PwC (US)
michael.f.swanick@us.pwc.com
[1] 267 330 6060

www.pwc.com/pharma

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HB8684
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