Data Exclusivity in Free Trade Agreements and Access to Originator (R&D Pharma) Medicine

International Max Planck Research School for Competition and Innovation

WIPO – 31.05.2012

Owais Hassan Shaikh IMPRS-CI 2010

Data Exclusivity in Free Trade Agreements and Access to Originator (R&D Pharma) Medicine

Owais H. Shaikh IMPRS-CI 2010

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• 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)

Preliminaries

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How specific FTA provisions relating to data exclusivity affect access to originator company’s medicine?


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Data Exclusivity Protection

Reliance on Clinical Trial Data

is not allowed

Reliance on foreign marketing

approval is not allowed

EU FTAs

US FTAs


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)

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Reliance on prior foreign marketing approval not allowed

Reduced or no access to originator medicine (as well as no or delayed access to generic medicine)

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.


Two Scenarios; Four Strategies

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EU FTA Scenario:

Reliance on foreign

marketing approval allowed

US FTA Scenario:

Reliance on foreign

marketing not allowed


Hypothetical

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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.


No Data ExclusivitySimultaneous filing in the absence of data exclusivity in FTA

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0 1 2 3 12 13 14...

Generic Competition starts from year 3 (All)De facto Exclusivity

(All)

O Appl (All)

O Appr (All)

G Appl (All)

G Appr (All)

Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US/EU


EU FTA Scenario: Strategy 1Sequential filing when reliance is allowed in the presence of data exclusivity

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0 1 2 3 6 7 12 13 14...

O Appli (EU)

G Appli (All – EU)

G Appr (All – EU)

O Appr (EU)

Data Exclusivity (EU)

De facto Exclusivity

(EU) Generic Competition from year 7 (EU)

Generic Competition from year 3 (All – EU)

No Medicine(All

– EU)

G Appl (EU)

G Appr (EU)

Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+EU


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0 1 6 7 12 13 14..O

Appl. (All)

O Appr (All)

G Appl (All)

G Appr (All)

EU FTA Scenario: Strategy 2Simultaneous filing when reliance is allowed in the presence of data

exclusivity

Data Exclusivity (All)


(All) Generic Competition from year 7 (All)

Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+EU


US FTA Scenario: Strategy 1Sequential filing when reliance is not allowed in the presence of data

exclusivity

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0 1 6 7 12 13 14...

Data Exclusivity (US)


(US)

G Appl (A)

O Appl (A)

G Appr (A)

O appr (A)

Generic Competition from year 7 (US)

Data Exclusivity (A)


(A)

Generic Competition from year 13 (A)

No Medicine (All – US)

Data Exclusivity (B)

O Appli (US)

O Appr (US)

G Appl (A)

O Appl (B)

G Appr (A)

O appr (B)

No Medicine (B)!

Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US


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0 1 6 7 12 13 14..O

Appl. (All)

O Appr (A)

G Appl (All)

G appr (All)

Data Exclusivity (All)


(All) Generic Competition from year 7 (All)

Simultaneous filing when reliance is not allowed in the presence of data exclusivity

US FTA Scenario: Strategy 2

Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US


Impact on Revenue of Originator’s Medicine

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EU FTA: Strategy 1: Sequential filing when reliance is allowed

Mea

n M

arke

t Sha

re fo

r 5-

year

(%)

Years Years

EU FTA: Strategy 2: Simultaneous filing when reliance is allowed

US FTA: Strategy 1: Sequential filing when reliance is not allowed

Years Years

US FTA: Strategy 2: Simultaneous filing when reliance is not allowed

Mea

n M

arke

t Sha

re fo

r 5-

year

(%)

Mea

n M

arke

t Sha

re fo

r 5-

year

(%)

Mea

n M

arke

t Sha

re fo

r 5-

year

(%)


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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Documents

Data Exclusivity in Free Trade Agreements and Access to Originator (R&D Pharma) Medicine