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 RawashdehDirector 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 FactsHospitals 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.

2006

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?Why Generics?

Generics promoteGenerics promote1.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 it’s country of origin (ITALY) to compete with the generics introduced into the market & that was reflected on Jordan’s drug prices of both Amaryl® and it’s generics.

Generics promoteGenerics 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 promoteGenerics 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.

Local Local manufacturersmanufacturers

GenericGeneric importersimporters

Public Public sectorsector

RegulatoryRegulatory authority authority

JFDAJFDAGENERICSare made

available in Jordan

In JORDAN high quality affordable In JORDAN high quality affordable GenericGeneric drugs are made available drugs are made available through joint force between the through joint force between the

following:-following:-

1.1. Local manufacturersLocal manufacturersManufacture quality medicines to patients who can not afford high co-payments

2.2. Generic importersGeneric importersSynergistic source of generics more when are not produced locally with affordable prices.

3.3. Public sectorPublic 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. Regulatory authority JFDA ….Regulatory authority JFDA ….

Provides a more efficient system for the registration of generic medicines http://www.jfda.jo/custom/law/registration/1.doc

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…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