impact of jusfta on affordability and availability of medicines from perspective of local generic...

Impact of JUSFTA on affordability and availability of medicines

from perspective of local generic manufacturers

Towards equitable and affordable medicine prices policyin Jordan

Mövenpick Hotel, Dead Sea, Jordan4 - 5 December 2007

Hanan SboulSecretary 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

Audit Transparency

File review Ethical promotion

Efficient Regulatory

system

Prescribing /Dispensingpractices

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

• Rules of Origin

• Intellectual Property Rights

• Environment & Labour

IPR Environment in Jordan Jordan has joined the WTO Dec. 1999; TRIPS Agreement

& signed Jordan-US Free Trade Agreement, Dec. 2001

Patents

Patent Law, Amended 1999 & 2001,

Product Process

Patent term: 20 years from filing

SPC Bolar exception

Notification

Data protection

New Chemical Entities

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 protectionMeasures related to Certain Regulated Products

Jordan – U.S. Free Trade Agreement

• Article 4-22pursuant 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

0

10

20

30

40

50

60

70

by value by volume

Originators

Local Generics

Market analysis

0

20

40

60

80

100

120

140

160

millionunit

million JD price ratio

Originators

Local Generics

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