Download Six Scenarios

International Max Planck Research School for Competition and Innovation
Owais Hassan Shaikh
IMPRS-CI 2010
Data Exclusivity Provisions in Selected Free Trade
Agreements:
Do They Allow Originator Pharmaceutical Companies to Delay
Entry in Different National Markets as Part of Life Cycle
Management of Specific Pharmaceuticals?
WIPO – 31.05.2012
Owais H. Shaikh
IMPRS-CI 2010
What is Data exclusivity?
A period where a submitter of clinical trial data, submitted as part of an approval
application of a new drug can preclude generics as well as national drug regulatory
authority from using it to approve subsequent generic applications
Why are FTAs important?
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Negotiated between two or more (regional) countries
Avoid problems of ‘negative consensus’ at WTO
Circumvent the impasse in WTO Ministerial Rounds
Address the issues where TRIPS or other IP treaties are silent or ambiguous
MFN makes FTA provisions applicable to all trading partners of an FTA country
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Owais H. Shaikh
IMPRS-CI 2010
The other side of the coin: Access to
Originator Medicine
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)
If a Party permit, ... third persons to submit evidence of prior marketing approval (of
originator medicine from another territory) ... the Party shall not permit third persons, without
the consent of the person who previously submitted information ..., to market the same or a
similar product on the basis of ..., for at least five years, ..., from the date of marketing
approval by the Party, or the other territory, whichever is late.
(Art. 17.10(c) US-Australia FTA)
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.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Assumptions for the scenarios:
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2.
3.
4.
5.
6.
7.
8.
9.
Originator company only considers data exclusivity for making market entry;
No patent or other exclusivities are pending;
For originator there are no costs and revenues equal profits;
‘National exhaustion’;
Once generic competition starts, increase/decrease in the market is distributed
according to existing market shares;
Identical market size in all parties;
Drug Authorities take one year (period) to approve both medicines;
Generic companies take one year (period) to come up with a bio-equivalent
pharmaceutical; and
Period of data exclusivity is five years in all parties.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Scenario 0: No Data Exclusivity
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No data exclusivity protection in the FTA.
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Simultaneous filing of originator Marketing Approval (MA) application in all parties.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Scenario 1:
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Data exclusivity in the FTA including preclusion on reliance on prior foreign
marketing approval.
Filing of originator MA application in country A first.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Scenario 2:
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Data exclusivity in the FTA including preclusion on reliance on prior foreign marketing
approval.
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Simultaneous filing of originator MA application in all parties.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Scenario 3:
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Data exclusivity protection in the FTA but no preclusion on reliance on prior marketing
approval.
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Filing of originator MA application in country A first.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Scenario 4: CAFTA-DR model
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Data exclusivity in the FTA including preclusion on reliance on prior foreign marketing
approval.
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Subsequent filings within 5 years of the earlier approval to get protection.
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Filing of originator MA application in country A first.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Scenario 5: NAFTA model
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Data exclusivity in the FTA including preclusion on reliance on prior foreign marketing
approval.
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Where approval granted on the basis of prior approval, data exclusivity periods in starts
from the date of first approval.
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Owais H. Shaikh
IMPRS-CI 2010
Six Scenarios
Scenario 6: Panama-Colombia-Peru model
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If a party grants approval in a specific time period, say in six or twelve months, the data
exclusivity period in that party starts from the date of prior foreign marketing approval.
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Where the Drug Authority takes longer, the period of data exclusivity starts a fresh in
that party.
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However, where the originator files after the end of its exclusivity period in the earlier
party and the subsequent party’s DRA approves the application within time, data
exclusivity in not available.
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Owais H. Shaikh
IMPRS-CI 2010
Impact on Originator Medicines Revenues
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Owais H. Shaikh
IMPRS-CI 2010
Findings
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Scenario 2 is best for access to medicine in the presence of general
data exclusivity provisions and provisions precluding reliance on foreign
marketing approvals.
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Scenario 2 is the most profitable as it allows originator company to enjoy
periods of monopoly in all parties.
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Owais H. Shaikh
IMPRS-CI 2010
Conclusion & Recommendations
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No preclusion on reliance on foreign marketing approval.
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If no reliance allowed then a limiting period must be adopted in FTAs
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In the presence of data exclusivity periods, it is optimal for the originator
and for access to medicine that originator applies in all parties at the
same time.
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If possible, NAFTA-style pegging period be introduced for increased
access to affordable medicine.
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Centralized approval mechanism may be adopted in an FTA.
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Generic pharmaceutical applications should be allowed with in the data
exclusivity period and not after it ends.
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Thank you for your attention!
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