Transcript Slide 1

Impact of JUSFTA on affordability
and availability of medicines
from perspective of local generic
manufacturers
Towards equitable and affordable medicine prices policy
in Jordan
Mövenpick Hotel, Dead Sea, Jordan
4 - 5 December 2007
Hanan Sboul
Secretary General/ JAPM
Background of the Jordanian
Pharmaceutical Industry
• 17 pharmaceutical companies
• Branded Generic Industry
• Export to 66 markets, major markets are Saudi
Arabia, Iraq, Algeria, Libya and the Gulf
• 45% in volume, 35% in value of the medicines
consumed in Jordan are manufactured locally
• Essential for Jordan economy; export,
employment..
Three foundation stones for Access
to affordable, safe & effective
quality medicines
Efficient
Regulatory
system
Audit
File review
Prescribing/
Dispensing
practices
Transparency
Ethical promotion
Balanced
IP
system
Governments many times accept restricted
access to pharmaceuticals in exchange for
market opportunities in other sectors
JUS FTA outlines
• Liberalization of Trade
in Goods
• Liberalization of Trade
in Services
• Intellectual
Property
Rights
• Rules of Origin
• Environment
& Labour
IPR Environment in Jordan
Jordan has joined the WTO Dec. 1999; TRIPS Agreement
& signed Jordan-US Free Trade Agreement, Dec. 2001
Patents
Data protection
Patent Law, Amended 1999 &
2001,
 New Chemical Entities
 Product
 Process
 Patent term: 20 years from
filing
 SPC
 Bolar exception
 Notification
 New Uses of old Chemical
Entities = New indications
 TRIPS - plus
 US laws - Plus
Patents
Two types of provisions in FTA
• Scope of protection
• Period of protection
Scope of protection
• These provisions focus on relaxing the
patentability requirements: novelty,
inventive step, and industrial application.
 more products can be patented.
 Patents for minor modifications to already
existing products/ new uses of medicines
Duration of protection
Supplementary Patent Certificate (SPC)
To compensate the patent owner for
unreasonable delays occur at regulatory
authority to grant marketing approval
 Cap
Compulsory license/ FTA
• To enable a country to allow generic
production/ importation of a product
protected by a patent without authorization
of the patent holder when it deems
necessary
 FTA restrictions
Data protection
Measures related to Certain Regulated Products
Jordan – U.S. Free Trade Agreement
• Article 4-22
pursuant to article 39.3 of TRIPS, each party , when
requiring, as a condition of approving the marketing of
pharmaceutical or of agricultural chemical products
that utilize new chemical entities 10, the submission
of undisclosed test or other data, or evidence of
approval in another country 11, the origination of
which involves considerable effort, shall protect such
information against unfair commercial use. In
addition, each party shall protect such information
against disclosure, except where necessary to protect
the public, or unless steps are taken to ensure that
the information is protected against unfair commercial
use
Footnotes in Article 4-22
10. It is understood that protection for “new chemical
entities” shall also include protection for new uses for old
chemical entities for a period of 3 years.
(Implemented 17 Dec. 2004)
11. It is understood that, in situation where there is reliance
on evidence of approval in another country, Jordan shall
at a min. protect such information against unfair
commercial use for the same period of time the other
country is protecting such information against unfair
commercial use.
Data protection
New Chemical Entities
New Uses of old Chemical Entities = New
indications
Data protection
This requires issuing guidelines to
• Set definitions, like NCE
• Set the procedures; un-disclosure
requirements, unfair commercial use, etc
Implications on affordability and
availability of medicines
Impact of JUSFTA on affordability
and availability of medicines
Some indicators
• Access/ barriers to medicines( out of
pocket)
• Pharmaceutical spending
Local products share 2006
70
60
50
40
Originators
Local Generics
30
20
10
0
by value by volume
Market analysis
160
140
120
100
80
Originators
Local Generics
60
40
20
0
million million JD price ratio
unit
What does that tell us
• Late or no generic could cause around 50%
increase in medicine prices which could
generate an impact of more than 80 million JD/
year
To buy the 40 million units originators, this could
cost 133.5 million JD instead of 73.45 million JD.
If
No increase in spending
• This is equivalent to around expenditures
of 2.1 million person on pharmaceuticals
(38JD), or … reduction in consumption;
people deprived of medicines
• The national industry could lose around
80% of its sales, as marketing approval in
country of origin is a condition for export
markets
Setting the right IP measures will make safe
& effective medicines affordable, create
major savings for healthcare providers and
stimulate innovation
Would the government retain flexibilities in
terms of implementing the agreements,
benefiting from safeguard mechanisms?
We aim for the best and plan for the worst
Thank you for your attention
www.japm.com