International International

Medical Products Medical Products

Anti-Counterfeiting Anti-Counterfeiting

TaskforceTaskforce

INSPECTOR OF DRUGSNATIONAL DRUG AUTHORITY-

UGANDA

MAP OF UGANDAMAP OF UGANDA

Kempton Park, South Africa9th -10th November 2009

Kempton Park, South Africa9th -10th November 2009

Definition of “Definition of “counterfeit medical counterfeit medical

productproduct” used in our Uganda” 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 LegislationOur 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.

National Legislation cont…National Legislation cont…Section 30 of cap 206, states“Any person who-a)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; orb)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 Africa9th -10th November 2009

Kempton Park, South Africa

9th -10th November 2009

Penalties 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 coordinationNational 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 NCB- Uganda and this has greatly energized the fight against counterfeits (Mamba I & II)

National coordination cont..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 casesSuspected Confirmed Imported / Domestic Vital Medicines

2009 36 14 Only 2 domestic Antimalarials &

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 All cases

Routine checks

Reported by affected manufacturer/importer

Other

Kempton Park, South Africa9th -10th November 2009

Number of prosecutions, Number of prosecutions, convictions & pending casesconvictions & pending cases

Operation Mamba II

Prosecutions Convictions Pending Cases

19 05 14

Kempton Park, South Africa

9th -10th November 2009

Our proposals for actionOur 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

proposals for action cont…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 YOUTHANK YOU