You are on page 1of 59

Pharma and Manufacturing

Industry Overview and Recent


Updates
Karishma R. Phatarphekar
Partner,
Global Transfer Pricing Services
KPMG India
The Chamber of Tax Consultants
TP study course
22nd March 2014

Transfer Pricing A proliferation in recent times....

More and more


complex regulation

Business
restructuring and
exit charges

Dissatisfaction with
profit based
methods
Scope of rules
expanding

Increasing onus on
taxpayer

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

More audits,
disputes and
litigation

Location
advantages

Aggressive practices
by tax authorities

Indian TP environment
TP Adjustment scenario at present

Indian Revenue authorities are reckoned to be tough


globally in TP matters, with India accounting for about 70%
of all global TP disputes by volume
(Source: Financial Express newspaper 16 July 2012)
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Pharmaceutical industry - Areas of discussion..


1

Pharmaceutical Industry - Overview

Types of International Transactions

Import of APIs

Payment of Commission

Clinical Trail Support Services

Marketing Intangibles

Contract R&D

Royalty Payouts

Location Savings

Other Pharma TP Issues

Comparison of Relevant Decisions

Key Takeaways

Way Forward

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Pharmaceutical Industry - Overview

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Pharmaceutical Industry - Overview


Typical FAR of Pharma Industry
Functions
Research & Development

Procurement
Manufacturing Primary &
Secondary
Inventory Management

Assets
- Tangible Assets
(e.g Building, Plant &
Machinery, etc.)

Risks
Market risk

Product liability risk


Inventory risk

- Intangible Assets
: Technical (Know-how)
: Marketing (Brand name)

Technology risk

Advertising / Marketing

Research and development


risk

Sales

Credit risk

Ordering and distribution

Foreign exchange risk

Invoicing and collection

Manpower risk

Administrative, Financial and


Legal Matters

General business risk

Quality control

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

5
5

Pharmaceutical Industry - Overview


Transfer Pricing Methods
CUP

RPM

TNMM

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Purchase of APIs
Sale of APIs
Import / Export of Formulations
Royalty for use of technology and
trademark

Distribution of API/Formulation

Manufacture of Formulations
Contract R&D Services
Clinical Trail Services
Marketing and Promotion Services
Contract Manufacturing Services
6

Import of Active Pharmaceutical Ingredients (APIs)

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Pharmaceutical Industry International Transactions


Import of Active Pharmaceutical Ingredients
Entities Involved

Primary
manufacturing
of APIs

Functions / Risks

Overseas AE

- Manufacturing and
marketing of API
- Product liability, R&D
Risk

Outside India

Import of Actives

India
- Processing of API

Secondary
manufacturing
of FDFs

Indian AE

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

- Sale of Formulations
- Market, credit, inventory
and forex risk

Pharmaceutical Industry International Transactions


Import of Active Pharmaceutical Ingredients

Issues

Documentation
Suggestions

Comparability with generic APIs;


Secret Comparables using power u/s 133(6);
CUP analysis for import of actives / formulations. (using
CIMS data) geographic differences, quality and grade of
APIs ignored

Selection of right comparables;


Carry out analysis on Customs database;
Exclusion of companies from different geographies;
Difference in Selling Price, Pharmacopeia;
Re-iteration of high profits under TNMM, if applicable;
Analysis of the customs data / relevant industry
publications.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

9
9

Pharmaceutical Industry International Transactions

Analysis for APIs where external CUP not favourable

Whether the patents for the products have


expired

Independent reports on differentiation in quality

Meeting with markets team to understand


other competitors similar products and their
procurement strategy

Whether any licensing agreement executed


earlier

Selling price and market share analysis

Evaluate internal CUPs if any upfront

Quantify other adjustments R&D, quality and


other support

Why TNMM is the most appropriate method


make aggregation rationale more conclusive

Request for quality reports, data and


information on generic comparables proposed
to be utilized by the TPO very strongly and
explicitly

Comparison of the transfer price over the past 5


years whether increased or decreased

Understand the policy of the group to price the


API's whether standard cost plus

Imports is generally a high value item and therefore the


department is eyeing this closely so need to be extremely
proactive and detailed
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

10

Payment of Commission

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

11

Pharmaceutical Industry International Transactions


Payment of Commission
Entities Involved

Overseas AE

Outside India
India

- Marketing outside
India of products
manufactured by
Indian AE canvasser

Payment of
Commission
- Manufacturing of
formulations

Indian AE

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Functions

- Distribution of products in
and outside India directly
to the customer

12

Pharmaceutical Industry International Transactions


Payment of Commission

Issues

Documentary
Suggestions

Evaluation of commission transaction separately required


as the same is not closely connected to other transactions;
If no direct documentary evidence to demonstrate, services
rendered could be disallowed;
Commission percentage more than 3-5% scrutinized;
Documentary evidences like copy of agreement, marketing
material, letters from overseas AE, CA Certificate / Bank
Realization Certificates, etc. should be maintained;
Demonstrate tangible benefits;
Demonstrate that marketing in India is routine and not nonroutine

Documentary evidence very crucial


2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

13

Clinical Trial Support Services

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

14

Pharmaceutical Industry International Transactions


Clinical Trial Support Services
Entities Involved

Functions / Risks

Overseas AE

Outside India

Clinical trail
services

India

Hospitals /
CROs

Indian AE

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

- Manufacturing

- Marketing
- Primary R&D
including clinical
trials

- Co-ordinates with
hospital and CROs

- payment to hospitals /
CROs

15

Pharmaceutical Industry International Transactions


Clinical Trial Support Services

Issues

Documentary
Suggestions

High mark up comparables selected by TPO without carrying


out appropriate FAR as to whether Indian AE does actual
clinical trials or only acts as coordinator;
Difficulties arise in identifying appropriate comparable
companies
Charges mark-up even on pass through cost
Role may vary from mere facilitation/co-ordination v/s
responsibility for the completion of the trials;
Risk associated with failure of product development primarily
assumed by AE;
Service being procured from a third party pass through
cost;
Demonstrate pass through cost is pure reimbursement

Demonstrate the functional dissimilarity of comparables


2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

16

Marketing Intangibles

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

17

Pharmaceutical Industry International Transactions


Marketing Intangibles

Trade Intangibles

Trade intangibles are all commercial intangibles (other than


marketing intangibles)
Created through R&D activities and expenditure that the
developer seeks to recover over the life of the IP
Include patents, know-how, designs, and models that are used for
the production of a good or provision of a service, as well as
intangible rights that are themselves business assets transferred
to customers or used in the operation of a business

V/s

Marketing Intangibles

These are typically created through marketing activities or


developed over time through customer relationships (goodwill)
Include trademarks and trade names that aid in the commercial
exploitation of a product or service, customer lists, distribution
channels, and unique names, symbols, or pictures that have a
promotional value for the product concerned

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

18

Pharmaceutical Industry International Transactions


Marketing Intangibles

Issues

Documentary
Suggestions

Determining the ALP


More than 1 party contribute to the IP what should be the arms
length share of each party
Advertisement, Marketing and Promotion expenses (AMP)
construed as marketing intangible
Indian distributor, even if not the legal owner, held to be the local
developer of trademark and hence should not pay royalty and /
or recover the AMP
TPOs adopt cost plus mark-up assuming more than normal AMP
to be reimbursed at mark-up of 10-15%
Well drafted agreements and documenting business strategy;
Demonstrate the tangible benefits and economic substance;
Demonstrate that marketing in India is routine and not towards
promoting the brand;
Policy to recover non routine expenditure as reimbursement

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

19

Brand
Creation /
Marketing
Intangible

Judicial Precedent
Indian Company

LG Electronics : Special Bench decision to deal


with legal issues not factual issues
Indian company, engaged in manufacturing of Electronic
goods in India , is a subsidiary of a Foreign Company

Excessive
AMP
Expenses

Indian Company incurs AMP expenses for marketing the


goods produced in India

In India

Indian company has incurred AMP expenses which


exceeds the Bright Line limit

Outside
India

Excess AMP expenses incurred by the Indian Company


is perceived to enhance the brand value of Foreign
Company
Indian tax authorities have contended that
AMP
expenditure incurred by a taxpayer at a level that exceeds
the bright line is to be reimbursed by the foreign AE with
a mark-up

Foreign Company

Owner of
Brand

Incurring of AMP expenses by the assessee towards brand legally owned by the foreign AE
constituted a 'transaction' subject to TP provisions;
Upholds use of Bright Line Test for determining cost / value of such transactions:
Under IT Act, it is legal ownership of brand that is recognized - Special Bench Majority View
Matter on the quantification set aside to re-look at comparables and appropriate cost base

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

20

Judicial Precedent
BMW India Pvt. Ltd.- Delhi Tribunal
The Delhi Tribunal observed that:
BMW India though not a licensed manufacturer is fully responsible for sales promotion, full utilization of market
potential, providing customer service and for establishment of efficient distribution network and therefore the
functions far exceed the functions performed by a routine distributor.

The ITAT held that it was necessary for the assessee as a distributor to incur expenditure on sales promotion
and advertising but rejected assessees stand that incurring AMP expenditure is not an international
transaction by relying on LGs ruling.
The ITAT observed that when the margins earned by the assessee were compared to those earned by the
comparables, it could be concluded that the assessee was sufficiently compensated for excess AMP
expenditure in terms of high profit margin,
The ITAT further observed that rewarding a distributor by way of price adjustment is well recognized and

well accepted remuneration model and that the department cannot insist in the absence of any
provision under the Act that the mode of compensation to the assessee by the foreign AE necessarily
be in the form of direct compensation.
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

21

Judicial Precedent
Casio India Co. Pvt Ltd Delhi Tribunal
The Indian co. is a wholly owned subsidiary of Casio
Japan. The Indian company is a full fledged distributor of
Indian Company
watches and consumer information and other related
products in India.
The TPO made an adjustment for excess AMP expense
relying on SB ruling in case of LG.
The CIT(A) deleted the addition holding that AMP
Import of Goods
expense have been incurred as part of its distribution
function and the benefit accruing to the AE was only
Outside
incidental.
India
The revenue was in appeal before the ITAT. While the
India
assessee relied on ruling in case of BMW, since it was a
distributor and the margins earned by the company
higher than that of comparables.
However the ITAT in this case, held that SB ruling in LG
Indian co.
Distribution
not only applies to a manufacturer, but also extends to a
distributor whether he is bearing full risk or least risk.
ITAT thus set aside CIT(A) order and restored the matter
to the AO/TPO to decide afresh in conformity with LG SB
Consumer
ruling
Almost similar facts to BMW but set aside for deciding the matter afresh
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

22

Contract R&D

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

23

Pharmaceutical Industry International Transactions


Contract R&D

Issues

Documentary
Suggestions

High mark up comparables selected by TPO without carrying out


appropriate FAR as to whether Indian AE does actual R&D
activities or only acts as facilitator;
Indian R&D Centre considered to be the economic Owner of IP use of high cost plus mark ups or profit split method
TPOs allege that majority of valuable & Unique IP are generated
due to work undertaken in India
Prone to high litigation due to lack of clarity prone to subjective
interpretation;
Robust FAR to justify captive R&D activities
Primary onus on taxpayer to demonstrate remuneration on cost
plus mark-up
Reliance can be placed on clarification by CBDT vide Circular
No.06 /2013 dated 29th June, 2013 stating 3 broad categories
based on FAR i.e. Entrepreneurial, Contract R&D and Costsharing arrangements

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

24

Pharmaceutical Industry International Transactions

Favourable
Analysis

Contract Research
Services
Guidelines for
identifying the
characterization
of R&D Centre

Foreign Entity

Indian Entity

Performs Economically Significant Functions


Economically significant functions to
include critical functions such as
conceptualization and design of the product
and providing strategic direction and
framework

Performs work assigned


by foreign entity

Funding/ Assets

Provides funds/ capital


Significant assets & intangibles

Receives remuneration
for the services
performed

Supervision &
Control

Strategic decisions for Core


Functions & Monitoring on regular
basis

Operates under direct


supervision and actual
control

Risk Profile

Economically Significant Risks

No Economically
Significant realised Risks

Outcome of
Research

Legal & economic owner of


resultant IP

No ownership of resultant
IP

Parameters

Functions

Unfavourable Analysis
Contract R&D

Entrepreneurial R&D

Cost Sharing Arrangements of R&D

Note: In the case of a foreign principal being located in a country/ territory widely perceived as a low or no tax jurisdiction, it
will be presumed that the foreign principal is not controlling the risk. However, the Indian Development Centre may rebut
this presumption to the satisfaction of the revenue authorities.
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

25

Royalty payouts

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

26

Pharmaceutical Industry International Transactions


Royalty Payouts
Charging a royalty or licensing fee within a MNE for the use of valuable
know-how, technology processes, trade names, or other intangible property,

have faced stringent tax scrutiny in pharma industry.


Tax authorities are challenging the royalty rate, comparables and arms
length price as determined by the taxpayer.
Historically India has been a technology importing country.
With the advent of MNCs, royalties were increasingly viewed as cash

repatriation tools tax shield on royalty payments plus credit of withholding


tax in receiving country.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

27

Pharmaceutical Industry International Transactions


Royalty Payouts

Issues

Documentary
Suggestions

Satisfy Benefits test, justify royalty in a loss situation


Need to establish direct correlation with sales/ profitability
Whether royalty is embedded in price paid
Approvals received by RBI not acceptable as external CUP
Aggregation approach under TNMM Challenged and general lack
of availability of comparables.
Transaction specific approach has been adopted by revenue
Outright rejection of rationale for payment. ALP held to be NIL.
Non acceptance of foreign comparable / databases.
Tangible/Strategic benefits received and quantification
Demonstrate dependence of business on the intangibles
License agreement, quotations of comparable independent recipient
Uniqueness of intangible, market where it is used, rights of taxpayer
to receive upgrades
geographic restrictions - export based on the licensed technology.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

28

Pharmaceutical Industry International Transactions


Royalty Payouts
Various payment models
Normal Royalty streams

Percentage on sales or profit, per unit royalty, lump sum payment etc.

Package Pricing

Amount included in transfer price of goods, no separate royalty payment.

Industrial franchise arrangements

Franchise fee paid by licensee to licensor for entire business format including
production process, marketing strategies, etc.

Others

Separate royalty fees for trademark / trade name and technology.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

29

EKL Appliances Ltd. Delhi High Court (2012)


(ITA Nos. 1068/2011 & ITA Nos. 1070/2011)]
Taxpayer engaged in the business of manufacturing and trading of refrigerators, washing
machines etc.

For FYs 2001-02 and 2002-03 the TPO disallowed the transaction of payment of royalty to
AE, whereas accepting all other international transactions to be at arms length.
Revenues Allegations

Taxpayers arguments

Taxpayer has been incurring


losses year after year. Royalty
payments did not result in
profits from operations

The allowance of royalty depends on the utility of the brand


name and the technical knowhow in respect of which the
payment is made and not on the profitability of the paying
entity.

Increase in turnover did not


result in any profit to the
taxpayer.

Royalty payment is a legitimate expenditure and nonpayment of the same would have had serious implications
for the taxpayers business.

The continuous losses incurred


showed that the taxpayer did not
benefit in any way from the
royalty payment. Thus payment
of royalty to the AE is not
justified.

There were profits at the gross level and the losses at the
net level were due to significant increases in the operating
expenses.

Due to availability of the brand name there was substantial


increase in the turnover otherwise there would have been
more losses.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

30

EKL Appliances Ltd. continued

CIT(A) Ruling
It was imperative for the taxpayer to upgrade its technology due to market dynamics.
There were profits at the gross level and the losses at the net level were due to increase in
operating costs. The losses show significant reduction after technical up gradation.
The TPO disregarded the business and commercial realities of the business of the
taxpayer and acted in a mechanical manner ignoring the economic circumstances
surrounding the transaction. TPO cannot question the judgment of the taxpayer as to how it
should conduct its business.

Royalty payment was incurred for genuine business purposes and should have been
allowed even if the taxpayer had suffered continuous losses in the business.
Tribunal Ruling
Tribunal agreed with CIT(A) that the royalty payment was justified and the TPO was wrong
in disallowing the same.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

31

EKL Appliances Ltd. continued


High court ruling
It is not for the Revenue authorities to dictate to the taxpayer as to how he should conduct his
business and what expenditure should be incurred.
It is not necessary for the taxpayer to show that any legitimate expenditure incurred by him

was also incurred out of necessity or

that the expenditure incurred by him for the purpose of business has actually resulted in profit
or income.

Taxpayer only needs to show that the expenditure should have been incurred wholly and
exclusively for the purpose of business.
Whether or not to enter into the transaction is for the taxpayer to decide. Quantum of expenditure
can be examined by the TPO but he has no authority to disallow the expenditure on the ground
that the taxpayer has suffered continuous losses.
High Court also relied on the OECD Guidelines - Tax administrations should not disregard and
restructure the transactions as actually undertaken by the taxpayer except

where the economic substance of a transaction differs from its form; and

where the form and substance of the transaction are the same but arrangements made in
relation to the transaction, differ from those which would have been adopted by independent
enterprises behaving in a commercially rational manner.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

32

Location Savings

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

33

Pharmaceutical Industry International Transactions


Location Savings - Meaning

General Parlance

OECD

UN

Net Cost savings realized by an MNC as a result of relocating


manufacturing functions / production / operation sites from a high
cost to low cost jurisdiction to obtain competitive advantage

Location Savings (LS) derived by an MNE group that relocates


activities to a place where costs are lower than in location where
activities were initially performed

LS are net costs savings that an MNE realizes as a result of relocation


of operations from a high cost jurisdiction to a low-cost jurisdiction

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

34

Pharmaceutical Industry International Transactions


Location Savings
Typical cost savings include savings pertaining to:

Labour costs;
Raw material costs;
Rent and property taxes;
Training costs
Infrastructure costs and
Incentives including tax exemptions

Most low cost locations are in the Developing World (e.g.- India, China,

Malaysia etc.)
Location savings = Input cost in a high cost region Input cost in a low cost region

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

35

Pharmaceutical Industry International Transactions


Location Savings

Issues

Documentary
Suggestions

Quantification and allocation of location savings


Attribution i.e. who is the rightful owner of additional profits from
location savings, the parent company or the overseas subsidiary
(AE) or both
Existence and allocation of location savings depends upon the
bargaining power of the parties
Bargaining Power highly subjective - depends upon factors like
economic or beneficial ownership, uniqueness and monopoly power
Benchmark industry cost structure changes rapidly due to shift of
manufacturing activity to low cost locations

Approaches to allocation of location savings :


- Facts and circumstances based approach
- Indirect approach considering location dis-savings
LS advantage passed onto end customers to survive stiff
competition

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

36

Pharmaceutical Industry International Transactions


Location Savings Recent Case Law

GAP Intl Sourcing


(India) Pvt. Ltd

Location savings is reflected in the profitability earned by


comparables
News Paper report cannot partake the character of
comparable data
Location savings arise to industry as a whole
LS advantage could be passed to end-customers to survive
stiff competition

GAP International Sourcing has rejected the applicability of Location Savings to the
particular case in a competitive situation (where the location advantages are passed onto
customers), however, it has not rejected the concept of Location Savings.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

37

Other Pharma TP Issues

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

38

Pharmaceutical Industry Other Pharma TP issues


Other Issues
Product Analysis vis--vis basket of products approach

Most Enterprises in Pharma Industry use basket of product approach for TP


analysis and benchmarking using TNMM

Product portfolio is a mix of established products and the products with future
potential

Parent companies invest significant time and resources to generate new product
lines

General Industry trend to promote complete mixture of products across different


therapeutic segments

Tax authorities ignore the business rationale to aggregate the transactions and
require each international transaction to be benchmarked separately.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

39

Pharmaceutical Industry Other Pharma TP issues


Other Issues
Drugs Prices Control Order (DPCO)

In India, end consumer prices of several drugs are governed by DPCO

Price control under the DPCO may cause product margins of pharmaceutical
companies to come under pressure

Where the pricing of raw material inputs procured from AEs is sought to be
reviewed by the application of profit based transfer pricing methods, the
identification of comparable companies entails challenges

Ignoring the effect of DPCO on pricing of drugs, tax authorities have been
attributing the lower profits /losses to poor transfer pricing policies of the
taxpayers.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

40

Pharmaceutical Industry Other Pharma TP issues


Other Issues
Distribution start-up losses
TP Documentation to take into account the following :
Loss analysis stating demonstrating factors triggering losses i.e. unfavourable
business decision, external / extraordinary causes,
Variance analysis between budgeted and actual figures with regards prices and
volumes
Countermeasures taken to cope with the loss situation
Documentary evidence in defending losses stating not only profits of the taxpayer
but overall profitability (including other related parties in the supply chain of the
business decreased
Consider applying for Mutual Agreement Procedure (MAP) based on taxpayers
position

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

41

Pharmaceutical Industry Other Pharma TP issues


Other Issues
Entity level Comparison v/s Segment Comparison

Rule10B(1)(e)(i) net profit margin realised by the enterprise from an international


transaction entered into with an associated enterprise

Taxpayer to maintain segmental accounts separately for transactions with AEs and
Non-AEs

Expenses to be allocated between AE and Non-AE Segment using appropriate basis /


allocation keys :
- Direct Expenses : On actual basis
- Indirect Expenses : Based on allocation keys such as turnover, employee
headcount, time spent, area occupied, number of computers etc

Adoption of segmental data upheld in the decision of UCB India Pvt Ltd v/s ACIT
(Mumbai) and Iljin Electronics India Pvt Ltd v/s ACIT (Delhi).
Real time audited segmental data preferred over unaudited segmental data by the
authorities during assessment

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

42

Pharma Industry Comparison of Relevant Decisions

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

43

Pharmaceutical Industry Comparison of Relevant Decisions

Issue

Branded V/s
Generic API

Quality Differences

UCB India
Branded products
cannot be
compared with
generics

Even a minor
difference in quality
will affect price,
efficacy and safety
of product.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

GlaxoSmitkLine Inc

Serdia India

Tax Court - Price of generic


API constitutes CUP

After the patent


expiry branded
product can be
compared to generic
products.

Federal Court of Appeal


Overruled tax court,
importance should also be
given to commercial factors
such as the agreement
Quality difference cited in
granulation. GMP, HSE
practices bear no
significance on import
prices.

Allowed adjustment
based on
pharmacopeia
standards.
Requirement for
authoritative quality
grading systems.

44

Pharmaceutical Industry Comparison of Relevant Decisions


(contd.)
Issue

Priority of Methods

UCB India

Hierarchy of methods
citing CUP as the most
preferred methods. Also in
OECD hierarchy taken into
consideration.

Transactional methods
to be preferred over
profit based methods

NA

License and royalty


agreement are separate.
Need to be considered for
ALP calculation

Hidden Technical fees


needs to be supported
by agreement.

Fresh adjudication
with rejection of
TNMM and CUP
method. New TP
documentation study
to be undertaken.

Extra amount above ALP


treated as dividend.
Additional evidence
required and referred back
for fresh adjudication to
take into account the
licensing agreement

Upheld the CIT(A)


order.

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Serdia India

Rational judgment
needs to be adopted
for CUP method.
Rejection of TNMM
based on entity level
margins.

Importance of
Agreement

Final Decision

GlaxoSmitkLine Inc

45

Manufacturing - Areas of discussion..

Manufacturing Industry- Types of Manufacturer

FAR Analysis

Compensation Model

Typical Transfer Pricing Issues

Specific Transfer Pricing Issues

Challenges for Contract Manufacturers

Management Payouts

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

46

Manufacturing Industry

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

47

Manufacturing Industry Types of Manufacturer

Functions
and risks

Toll
Manufacturer

Contract
Manufacturer

Licensed
Manufacturer

Intangibles

Sales

Inventory

Manufacturing

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Entrepreneur

48

Manufacturing Industry FAR Analysis

Risks

Functions

Characterization

Products
and entities

Transactions

Forecasts/
business
plan

Business
process

Asset

Organization/
staff

Internal
comparables

Agreements/
terms

Basis to
search for
external
comparables

FAR
Analysis

Risk
opportunity
assessment

Forecasts/
business
plan

Financial
results
Documentation

Inputs
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

Planning
possibilities

Understanding
of business

Outputs
49

Manufacturing Industry Compensation Model

Functions

Typical Compensation model

Contract / Toll
manufacturing operations

Full cost plus mark up (or)

Routine manufacture /
assembly activity with
licensed technology from
Group.

Risk free assured return in line with industry benchmarks

As a variant of the above


with significant local
marketing efforts

Receipt of compensation for marketing intangible in addition


to the above

Full fledged manufacturer


and contributing to the R&D
effort of the Group

Profit Split Method (PSM) to determine the contribution


towards routine functions and towards intangibles

Return for value added services plus appropriate return on


capital investments in material and finished goods inventory

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

50

Manufacturing Industry Typical Transfer Pricing Issues


Start up phase challenges
Application of the TNMM method Dealing with losses
Application of CUP Comparability issues
Aggregation of transactions Trading, Sourcing, Product Bundling
Payment towards Technical Know - How
IPR Valuation
TP Vs. Customs

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

51

Manufacturing Industry Specific Transfer Pricing Issues


Business Restructuring
Challenges for Contract Manufacturers
Comparability Adjustments Specific focus working capital
Payouts - Specific focus on Royalty
Imports V/s Local
Apparent transfer pricing risk
Global effective high tax rate
Potential need for ongoing capital contributions
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

52

Manufacturing Industry Challenges for Contract


Manufacturers
Functional profile of Contract Manufacturers - Risk-free operations
Remuneration model - remunerated with a Cost Plus Mark-up with reference to third party
manufacturers
Challenge
Third parties available as benchmarks are Entrepreneurial manufacturers
Undertake full gamut of risks
Not remunerated on Cost Plus basis
Solutions
Adjustments for better comparability
Possible adjustments for working capital and Risk differential
Alternate PLIs
Use of Return on Assets (ROA) as PLI
Use of Return on Capital Employed (ROCE) as PLI
Safe Harbours
As a percent of return on value of assets employed/return on total costs
Recent safer harbours announced in India for auto manufacturing industry
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

53

Manufacturing Industry Management Payouts


Typical forms of payouts - Royalty, Technical fee, Management fee, Guarantee fee
Primary challenge Payouts through having economic substance are challenged in the start up
phase due to existing losses
Benchmarking - Is a challenge due to inadequate comparable data in public domain
Documentation - Under the transaction specific approach it is necessary to analyze potential
cost-benefit and maintain appropriate documentation to substantiate arms length nature of
payouts

Cost- Benchmarking payouts of comparable companies, Basis of arriving at the value of


payouts ( Direct / Indirect Method) by the Group

Potential Benefits - Need for obtaining service from the Group, Analysis of potential benefit
obtained by the Company and value attributable to the service

Other Regulatory Considerations - The recent relaxation of the statutory RBI / FEMA limits on
royalty and technical fee payouts increases the challenge of defending the arms length nature of
such transactions.
2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

54

Key Takeaways
Need for proactive and robust CUP analysis.
Mere reliance on the reason of difference in quality not
sufficient for rejection of CUP
Commercial justification to be built on to source APIs
from AEs vis--vis third parties
Need to have a detailed licensing agreement where

trademark/brand is involved taking care of possible


imputation of royalty
Appropriate documentation of business rationale
FAR very crucial to defend the transaction and
determination of value and non-value additions

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

55

Key Takeaways
Strong and robust economic analysis with supporting
documentation along with business rationale
Cost-benefit analysis vital
Internal CUPs preferred over external CUPs
Important to characterize value added and non-value
added activities for tested party and attribution of profits

Segmented financials play key role

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

56

Way Forward

Be Proactive not reactive - consider APA?


Adopt Coordinated and centralized approach.

Involve operational teams in tax and TP


planning and documentation process
Holistic solutions not fragmented responses
Global awareness and vision not myopic
Harmonize TP documentation with

other

regulatory requirements

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

57

Questions & Answers

Answers

&
Questions

2014 KPMG, an Indian Partnership and a member firm of the KPMG network of independent member firms affiliated with
KPMG International Cooperative (KPMG International), a Swiss entity.
All rights reserved.

58

You might also like