Transcript Jordan Food and Drug Administration

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
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.
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 2
0
Exports accounted for 210 million JD. 0
6
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 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 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.
Regulatory
Local
authority
manufacturers
JFDA
GENERICS
are made
available in
Jordan
Public
sector
Generic
importers
In JORDAN high quality affordable
Generic drugs are made available
through joint force between the
following:-
1. Local manufacturers
Manufacture quality medicines to patients who
can not afford high co-payments
2. Generic importers
Synergistic source of generics more when are
not produced locally with affordable prices.
Public 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
3.
4. 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…
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