Transcript Test data protection - MSF Access Campaign

Test data protection
TRIPS requirements & TRIPS-plus provisions
Carlos Correa
Test data
Preclinical and clinical trials
Safety
–
Efficacy
Empirical information obtained
through the application of standard
protocols
Data exclusivity
During the data exclusivity period,
national drug authorities cannot use
or rely on test data to register generic
equivalents
As long as data exclusivity lasts…
Generic manufacturers must
=> Repeat the clinical trials
=> Wait until the expiry of the data
exclusivity period
TRIPS Article 39.3
Members, when requiring, as a condition of
approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new
chemical entities, the submission of undisclosed
test or other data, the origination of which
involves a considerable effort, shall protect such
data against unfair commercial use. In addition,
Members shall protect such data against
disclosure, except where necessary to protect
the public, or unless steps are taken to ensure
that the data are protected against unfair
commercial use.
PROTECTION OF
UNDISCLOSED INFORMATION
Article 39
1. In the course of ensuring effective
protection against unfair competition as
provided in Article 10bis of the Paris
Convention (1967), Members shall protect
…data submitted to governments or
governmental agencies in accordance with
paragraph 3.
USA v Argentina: WTO settlement


-Argentina kept its system based on fair
competition law
- Argentina committed itself to change its
law if WTO established that exclusivity was
required under TRIPS
Countries without data exclusivity
for pharmaceuticals
-Brasil
- Filipinas
- Ghana
- India
- Indonesia
- Malaysia
- Pakistan
- Thailand
- Uruguay
Beyond patents
Patent
Registration;
market entry
Data exclusivity
Registration
for new
indicationEnd patent term
Data exclusivity
Colchicine : 3 years of data exclusivity
-Widely available as a generic drug for gout
pain in the USA since the 19th century:
second-line treatment for gout
-Tests with 185 patients, one week:
shortened dosing regime :
- Lawsuits to remove any other versions of
colchicine from the market
-Price increase by a factor of more than 50,
from $0.09 per
pill to $4.85 per pill.