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

2. 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..

3. Three foundation stones for Access to affordable, safe & effective quality medicines Audit Transparency File review Ethical promotion Efficient Regulatory system Prescribing/ Dispensing practices Balanced IP system

4. Governments many times accept restricted access to pharmaceuticals in exchange for market opportunities in other sectors

5. JUS FTA outlines Liberalization of Trade in Goods Liberalization of Trade in Services Rules of Origin Intellectual Property Rights Environment & Labour

6. 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

7. Patents Two types of provisions in FTA Scope of protection Period of protection

8. 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

9. Duration of protection Supplementary Patent Certificate (SPC) To compensate the patent owner for unreasonable delays occur at regulatory authority to grant marketing approval Cap

10. 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

11. 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

12. 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.

13. Data protection New Chemical Entities New Uses of old Chemical Entities = New indications

14. Data protection This requires issuing guidelines to Set definitions, like NCE Set the procedures; un-disclosure requirements, unfair commercial use, etc

15. Implications on affordability and availability of medicines

16. Impact of JUSFTA on affordability and availability of medicines Some indicators Access/ barriers to medicines( out of pocket) Pharmaceutical spending

17. Local products share 2006

18. Market analysis

19. 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

20. 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

21. Setting the right IP measures will make safe & effective medicines affordable, create major savings for healthcare providers and stimulate innovation

22. 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

23. Thank you for your attention www.japm.com