Data Exclusivity and Access to
Medicines – Empirical Evidence
Hearing European Parliament: EU-India Free
Trade Agreement: What Future for Patients in
Developing Countries
Date
Presenter
10 February 2011
Katrien Vervoort
Data exclusivity?
• Registration brand medicine: show safety and
efficacy throug submission of clinical trial data
• Registration of a generic medicine: show
bioequivalence
• DE: Forbids use of or referral to clinical trial data of
originator company => Administrative barrier to
marketing of generic drugs, even when no patent
• Two choices for generic producer:
• Repeat clinical tests: unethical + expensive
• Wait…
• Monopoly, even when not innovative.
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Consequences for Access to
Medicines: Empirical evidence
• Jordan:
• Oxfam 2007: All costs, no benefits: How TRIPS-plus rules
in the US-Jordan FTA affect access to medicines.
• Guatemala:
• Center for Policy Analysis on Trade and Health, 2009: A
trade agreement’s impact on access to generic drugs.
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TRIPS-plus rules in the US-Jordan
FTA
1) Data exclusivity
2) Restricted use of parallel importation
3) Restrictions on the use of compulsory licensing
** Study only examined consequences of data
exclusivity
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US-Jordan FTA
The US Government claimed that TRIPS plus
rules are beneficial in developing countries.
Cited the US-Jordan FTA – particularly:
• No public health deterioration
• Increased local R+D
• Numerous new, innovative product launches
• Increased foreign direct investment
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Oxfam study on US-Jordan FTA
• Oxfam hired three researchers to collect data to
either verify or rebut US government assertions.
• 2 objectives:
(1) To measure actual public health consequences of
US-Jordan FTA since 2002 (through mid-2006)
(2) To measure benefits
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Overall findings
1) Medicine prices have risen 20% since 2002 and account for
an increasing share of overall health care costs.
2) Many new medicines lacking a generic equivalent in Jordan
from 2002-2006 were due to the imposition of data exclusivity
(and not patent protection).
3) Few or no benefits due to US FTA – despite US claims.
** Only looked at data exclusivity, although the FTA restricts use
of parallel imports and compulsory licensing.
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Data exclusivity in Jordan
• Analyzed 108 medicines launched onto the Jordanian market
since 2001 (42% of all new, branded medicines launched and
more than 70% of sales).
• Only 5 medicines (of 108) had patent protection.
• Of 103 medicines without patent protection, 79% had no generic
competitor (despite the existence of generic competition
elsewhere) due solely to data exclusivity.
=> Drug companies relied upon data exclusivity to function as
patent protection.
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Public Health Consequences? –
comparison Egypt – Jordan (1)
•
Heart disease and diabetes are serious problems in Jordan and Egypt.
•
Prices for new medicines to treat cardiovascular disease and diabetes
are two to ten times higher in Jordan than in Egypt.
Country
(company)
API (dosage)
Medical use
Price per Unit (in
Jordanian dinars
at prevailing
exchange rate
Jordan price
compared to
Egyptian price
Egypt (local
generics
manufacturer)
Metformin
(850mg)
Anti-diabetic
.02
800%
.16
9
Jordan (Merck)
Metformin
(500mg)
Egypt (local
generics
manufacturer)
Atenolol (100mg)
Jordan (Kleva)
Atenolol (100mg)
Anti-hypertensive
.03
.11
367%
Public Health Consequences? –
comparison Egypt – Jordan (2)
• Must qualify that other reasons – costs of APIs,
currency shifts and surcharges could be responsible
for price increases or lack of a greater price
differential.
• These medicines had no patent in Jordan or Egypt –
only data exclusivity in Jordan prevented generic
competition.
=> Increased health-care costs and less medical
treatment, especially for poor people.
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Medicine prices and TRIPS-Plus
rules
• Medicine prices increased by 20 percent since
the country entered into an FTA in 2001: 2005
National Health Strategy: «the rise in the
pharmaceutical bill represents one of the main
challenges that face…continuation of health
programmes…and sustainability of funding for
those programmes. »
• Many factors: new economies of scale,
procurement negotiations, inflation, currency
shifts.
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Medicine prices and TRIPS-Plus
rules
• But also: Introduction of new medicines
with no generic equivalent. Many remain
unsold, some have captured a large share of
the local market.
Market share of medicines with no generic equivalent (2002-2006)
2002
2003
2004
2005
2006
3,0%
5,3%
7,2%
9,1%
9,4%
Sales
2964
(USD)
Thousands
5192
9217
13699
14296
Market
share (%)
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No benefits to TRIPS plus rules
1) Our study found local companies engage only in minimal
R&D and are not inventing new medicines;
2) Little or no FDI into Jordan since 2001 - most new
medicines are imported rather than produces locally via
licensing agreements with multinational companies. (only
5% via licensing agreements)
3) Egypt – No TRIPS implementation until 2005 yet
received 223 million USD of FDI (35% of all output due
to licensing agreements with foreign manufacturers)
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No benefits to TRIPS plus rules (2)
4) There have been new product launches in
Jordan, but only a fraction of total product
launches in US/EU.
5) Even when launched, mostly unaffordable –
IMS data indicates few or no sales of most
medicines.
6) Scientific offices: aggressive marketing methods
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New studies on consequences of
TRIPS-plus rules – Guatemala
• CPATH, 2009
• Research question: Do CAFTA IP rules affect
access to generic drugs in Guatemala?
• => 77 brand-name drugs are affected by data
exclusivity for either 5 or 15 years:
contraceptives, diabetes, hypertension, cancer,
HIV/Aids, etc.
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Main findings
• CAFTA IP rules affect the price of
medicines:
• Delayed entry of generics;
• Reduced access to some generic drugs
already on the market;
• Some data protection expires sooner in US
than in Guatemala.
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Guatemala: Brand name vs generic
versions
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Key lessons for EU-India FTA
• Data exclusivity => Significant price increases, even on
the short term.
• Jordan and Guatemala  India: Pharmacy of the
developing world: 70% of all generic medicines in DCs,
80% of ARVs
• New challenges:
• 2nd and 3rd line ARVs for HIV/Aids, rise of NCDs in
developing countries,…
• Financial and economic crisis: constrained budgets;
decrease of ODA
=> The world cannot afford the introduction of data
exclusivity
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Link to studies:
• Jordan:
http://www.oxfam.org/en/policy/bp102_jordan
_us_fta
• Guatemala:
http://www.cpath.org/sitebuildercontent/sitebu
ilderfiles/cpathhaonline8-25-09.pdf
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Katrien Vervoort
Oxfam-Solidarity Belgium
Email: kve@oxfamsol.be
Phone: 0032 (0)2 501 67 56
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