Transcript UGANDA

International
Medical Products
Anti-Counterfeiting
Taskforce
INSPECTOR OF DRUGS
NATIONAL DRUG AUTHORITYUGANDA
MAP OF UGANDA
Kempton Park, South Africa
9th -10th November 2009
Definition of “counterfeit medical
product” used in our Uganda
Uganda has adopted the WHO definition of a counterfeit
medicine which states;
“А counterfeit medicine is one which is deliberately and
fraudulently mislabeled with respect to identity and/or
source. Counterfeiting can apply to both branded and
generic products and counterfeit products may include
products with the correct ingredients or with the wrong
ingredients, without active ingredients, with insufficient
active ingredients or with fake packaging.”
Kempton Park, South Africa
9th -10th November 2009
Our National Legislation
There is currently no specific legislation regarding
counterfeit medicines in Uganda.
A bill on counterfeits (generally) is however currently
in Parliament, and it will soon be passed into law.
The bill addresses the aspect of intellectual property
protection, including sections regarding medical products.
There are however a few inadequacies in this bill in
regard to medicines and efforts have been taken by NDA
to streamline this.
We currently however invoke section 30 of the NDP/A
Act which essentially prohibits the supply of impure drugs.
Kempton Park, South Africa
9th -10th November 2009
National Legislation cont…
Section 30 of cap 206, states
“Any person whoa) Sells any drug, medical appliance or similar article
which is not of the nature, substance and quality
demanded or which, unless otherwise agreed at the time
of demand, does not conform to standards laid down in
the authorized pharmacopoeia; or
b) Supplies any drug which is unwholesome or adulterated
or which does not conform to the prescription under
which it is supplied, commits an offence and is liable to
a fine not exceeding five million shillings or to
imprisonment for a term not exceeding ten years or
both.”
In regard to the above section we address all cases of
counterfeits as “impure drugs” in order to build a case
against the culprit.
Kempton Park, South Africa
9th -10th November 2009
Penalties
As stated above in section 30 of cap 206,
• A fine not exceeding 5 million shillings (2500 USD) or,
• Imprisonment for a term not exceeding 10 years or,
• Both.
The judiciary has however consistently given light
sentences to individuals convicted under the above section.
The record highest in fines ever given, for instance, is
one million shillings (approx. 500USD)
Kempton Park, South Africa
9th -10th November 2009
National coordination
We (NDA) have a memorandum of understanding with the
police esp. the Anti- Narcotics department with which we
work jointly in combating this vice.
We also work closely with the Customs institution (URA)
which mans all border points. They forward all medical
products (imports & exports) to NDA for authorization and
they also report to us any suspected cases of illicit drug
dealing.
We have also lately developed collaborations with NCBUganda and this has greatly energized the fight against
counterfeits (Mamba I & II)
Kempton Park, South Africa
9th -10th November 2009
National coordination cont..
We currently have a faint collaboration with the
National Bureau of Standards and we are working
towards strengthening it.
Our dream is the formulation of National task force
of membership from core stakeholders, ready to take
action whenever a counterfeit is detected.
Number of cases
Suspected
Confirmed
Imported / Domestic
Vital Medicines
36
14
Only 2 domestic
Antimalarials &
2009
antibiotics,
2008
34
02
Only 1 domestic
Antimalarials
2007
2006
How were these cases detected?
number of cases
Patients complaints
Health professionals reports
Enforcement/investigation work
Routine checks
Reported by affected manufacturer/importer
Other
All cases
Number of prosecutions,
convictions & pending cases
Operation Mamba II
Prosecutions
19
Convictions
05
Kempton Park, South Africa
9th -10th November 2009
Pending Cases
14
Our proposals for action
Formation of a National task force comprising all
core stakeholders
Regional integration of medical product
regulation (East African Harmonization)
Formulation of tough laws with punitive
punishments against counterfeiters (NDP/A Act is
under review, Counterfeits Bill is also underway)
Increasing human resource & capacity building
in DRA’s and other partner institutions
Kempton Park, South Africa
9th -10th November 2009
proposals for action cont…
Ensuring access to & affordability of essential drugs
Massive sensitization and education of public
regarding counterfeits
DRA’s should put in place measures that prevent
the existence of counterfeits
Empowering and facilitation of anti-counterfeiting
programs (Government commitment)
THANK YOU