Transcript Data Exclusivity

International Max Planck Research School for Competition and Innovation
Owais Hassan Shaikh
IMPRS-CI 2010
Data Exclusivity in Free Trade Agreements and
Access to Originator (R&D Pharma) Medicine
WIPO – 31.05.2012
Owais H. Shaikh
IMPRS-CI 2010
Preliminaries
• What is data exclusivity...
• Protection of clinical trial data, submitted with a new drug application,
against usage (reliance) by either drug regulatory authorities or generic
companies for approving subsequent generic applications.
• Data exclusivity through FTAs
• Current debate focuses on availability of affordable medicines
• However, data exclusivity provisions in specific FTAs (mainly US)
may restrict total access (originator + generic)
How specific FTA provisions relating to data exclusivity
affect access to originator company’s medicine?
22
Owais H. Shaikh
Data
Exclusivity
Protection
IMPRS-CI 2010
Reliance on
Clinical Trial Data
is not allowed
Reliance on
foreign marketing
approval is not
allowed
EU FTAs
US FTAs
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Owais H. Shaikh
IMPRS-CI 2010
Reliance on prior foreign marketing approval not
allowed
If a Party requires or permits,... the submission of evidence of prior marketing approval (of
originator’s medicine) in the other territory, the Party shall not, without the consent of a
person that previously submitted the safety or efficacy information to obtain marketing
approval in the other territory, authorize another to market a same or a similar product
based on:... (ii) evidence of prior marketing approval in the other territory for at least
five years for pharmaceutical products from the date of marketing approval of the new
product in the Party.
(Art. 14.9(b) US-Bahrain FTA)
Art. 17.10(c) US-Australia FTA; Art 15.10.1(b) CAFTA-DR; Art 18.9.1(b) US-Korea; Art
15.10.1 US-Morocco; Article 15.9.1(b) US-Oman and Article 16.8.2 US-Singapore.
Reduced or no access to originator medicine
(as well as no or delayed access to generic medicine)
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Owais H. Shaikh
IMPRS-CI 2010
Two Scenarios; Four Strategies
EU FTA
Scenario:
Reliance on
foreign
marketing
approval allowed
Strategy 1:
Sequential
filing
Strategy 1:
Sequential
filing
US FTA
Scenario:
Reliance on
foreign
marketing not
allowed
Strategy 1:
Simultaneous filing
Strategy 1:
Simultaneous filing
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Owais H. Shaikh
IMPRS-CI 2010
Hypothetical
FTA between countries A, B and US/EU
Assumptions:
1. Other that data exclusivity no exclusivity (patent, orphan drug or pediatric) remaining
for the originator medicine.
2. Parallel importation is not allowed (National exhaustion);
3. Drug authorities take 1 year to approve (originator or generic) medicine;
4. Generic companies take 1 year to develop a bioequivalent generic drug;
5. Term of data exclusivity is 5 years.
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Owais H. Shaikh
IMPRS-CI 2010
No Data Exclusivity
Simultaneous filing in the absence of data exclusivity in FTA
De facto Exclusivity
(All)
0
O
Appl
(All)
Generic Competition starts from year 3 (All)
1
2
3
O
Appr
(All)
G
Appl
(All)
G
Appr
(All)
Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US/EU
12
13
14...
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Owais H. Shaikh
IMPRS-CI 2010
EU FTA Scenario: Strategy 1
Sequential filing when reliance is allowed in the presence of data
exclusivity
Data Exclusivity (EU)
0
1
2
3
O Appli O Appr G Appli G Appr
(EU)
(EU) (All – EU) (All – EU)
De facto
Exclusivity
(EU)
Generic Competition from year 7 (EU)
6
7
12
13
14...
G Appl G Appr
(EU)
(EU)
Generic Competition from year 3 (All – EU)
No
Medicine(All
– EU)
Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+EU
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Owais H. Shaikh
IMPRS-CI 2010
EU FTA Scenario: Strategy 2
Simultaneous filing when reliance is allowed in the presence of data
exclusivity
Data Exclusivity (All)
De facto
Exclusivity
(All)
Generic Competition from year 7 (All)
0
1
6
7
O
Appl.
(All)
O
Appr
(All)
G
Appl
(All)
G
Appr
(All)
Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+EU
12
13
14..
9
Owais H. Shaikh
IMPRS-CI 2010
US FTA Scenario: Strategy 1
Sequential filing when reliance is not allowed in the presence of data
exclusivity
De facto
Exclusivity
(US)
Data Exclusivity (US)
0
O
Appli
(US)
1
O
Appr
(US)
Data Exclusivity (A)
6
7
G Appl
(A)
O Appl
(A)
G Appr
(A)
O appr
(A)
No Medicine (All – US)
De facto
Exclusivity
(A)
12
G Appl
(A)
O Appl
(B)
Generic Competition from year 7
(US)
Data Exclusivity
(B)
13
14...
G Appr
(A)
O appr
(B)
Generic Competition
from year 13 (A)
No Medicine (B)!
Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US
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Owais H. Shaikh
IMPRS-CI 2010
US FTA Scenario: Strategy 2
Simultaneous filing when reliance is not allowed in the presence of data
exclusivity
Data Exclusivity (All)
De facto
Exclusivity
(All)
Generic Competition from year 7 (All)
0
1
6
7
O
Appl.
(All)
O
Appr
(A)
G
Appl
(All)
G
appr
(All)
Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US
12
13
14..
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Owais H. Shaikh
IMPRS-CI 2010
Impact on Revenue of Originator’s Medicine
EU FTA: Strategy 1: Sequential filing when
reliance is allowed
Mean Market Share for
5-year (%)
100
Mean Market Share for
5-year (%)
EU FTA: Strategy 2: Simultaneous filing when
reliance is allowed
100
Gen.
Orig.
0
A
B
C
A
1-6
B
C
A
7-12
B
C
13-18
Gen.
Orig.
0
A
B
C
A
1-6
C
A
7-12
B
C
13-18
Years
Years
US FTA: Strategy 2: Simultaneous filing when
reliance is not allowed
US FTA: Strategy 1: Sequential filing when
reliance is not allowed
100
100
Gen.
Orig.
0
A
B
1-6
C
A
B
7-12
Years
C
A
B
13-18
C
Mean Market Share for
5-year (%)
Mean Market Share for
5-year (%)
B
Gen.
Orig.
0
A
B
1-6
C
A
B
7-12
Years
C
A
B
13-18
C
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Owais H. Shaikh
IMPRS-CI 2010
Insights
•
In the presence of data exclusivity protection reliance on prior foreign
marketing approval (EU FTAs) increases access to medicine in parties to an
FTA.
•
Access to medicine is most enhanced when originator simultaneously applies
under EU and US FTA and most restricted when sequentially applies under US
FTA.
•
Originator company earns relatively more revenue when it applies
simultaneously under both EU and US FTAs.
•
A binding provision should be included in FTAs to ensure that Originator files
simultaneously in under both EU and US FTAs.
•
A centralized approval mechanism may be adopted in an FTA (EMEA).
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Thank you!
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