JFDA & HAI Workshop Towards equitable and affordable medicine prices policy in Jordan 4-5 December 2007 Strategies to aid market entry and competition generics Professor M Rawashdeh Director General, JFDA

JFDA JFDA enjoys judicial person financial and administrative independence, by this capacity, it is entitled to exercise all legal actions that are deemed necessary to achieve its goals or purposes

JFDA: aims to guarantee: The safety of food stuffs, their quality and their suitability for human consumption through out their use. The safety of Drugs and their quality control. The safety of other stuffs specified in the Drug and Pharmacy law which is in effect.

JFDA: Mission

Supervision and inspection of the quality and suitability of food stuffs in accordance with technical rules, specifications and standards stipulated in the legislations in force. JFDA Mission

To achieve the requirements and take measures in connection with drug and pharmacy law To guarantee and supervise the safety and quality of medications in accordance with the rules and standards specified in the legislations in effect. JFDA Mission

Health & Drug Facts

Health Facts Hospitals in Jordan is 102 Hospital bed ratio 1:539 people Registered pharmacies are 1615 A ratio of 1:3389 people.

Drug Facts:2004 Spent 9% of GNP on health (35% drugs) The public sector contribution was 46% The annual expenditure on health per individual was 132 JD. Imported drugs reached191 million JD Exports accounted for 210 million JD

Drug Facts Jordan has 17 drug factories that produce branded generic drugs of around 3000 different dosage forms and concentrations & of a wide variety of drugs. 60 drug stores in addition to many institutions for health consumables (medical devices, cosmetics and herbal products).

Why Generics?

Generics promote 1.Price competition Reduces prices through a cost effective way since generics are effective alternatives to higher priced originator pharmaceuticals. Competition between generics and even originators with generics Ex. : Amaryl® price was reduced in its country of origin (ITALY) to compete with the generics introduced into the market & that was reflected on Jordans drug prices of both Amaryl® and its generics.

Generics promote 2.Innovation Since there is no permanent monopoly on pharmaceutical products this would enhance the originator companies to discover new medicines GENERICS in return develop new generic equivalents, new formulations, new dosage regimes, methods of delivery and some may develop their own NEW CHEMICAL ENTITIES so as the case in JORDAN.

Generics promote 3. Employment Competition and innovation made generic companies strive to find new market places Jordan expanded from only Jordan in 1963 to 65 countries around the world in year 2006 Encourages new pharmaceutical companies and the demand for medium skilled personnel and highly qualified scientists.

Localmanufacturers Generic importers importersPublicsector Regulatory authority authorityJFDA GENERICS are made available in Jordan

In JORDAN high quality affordable Generic drugs are made available through joint force between the following:-

1.L ocal manufacturers Manufacture quality medicines to patients who can not afford high co-payments 2.G eneric importers Synergistic source of generics more when are not produced locally with affordable prices. 3. P ublic sector Establishing generic-oriented reimbursement and health insurance systems Increasing pharmaco-economic evaluation of new products for procurements Measures to encourage doctors to prescribe generic medicines

4. R RR Regulatory authority JFDA …. Provides a more efficient system for the registration of generic medicines Ensures greater harmony between newly approved generic medicines and older approved originator equivalents. Encourages generic R&D before patent or data protection term expiry Improves consumer awareness of generic quality and availability through different meetings.

JFDA… Differential registration prices in place Originator has 1200 JD registration fee Generic has 200 JD registration fee Maximum 180 days from date of complete documentation submission- no difference from innovator…but in practice faster than innovator as much less documentation needed- mainly bioequivalence studies. Competitive pricing criteria are also being established to promote generics.

JFDA… JFDA provides the rational drug list & National Drug Formulary on line. Provides drug information & prices (Bar Code Project) accessible to the public Both sites allow health practitioners and patients to practice the generic substitution.

Conclusion JFDA aims to increase the number and variety of generic drug products available

Thank You