IMPACT REGIONAL CONFERENCE ON COMBATING COUNTERFEIT MEDICAL PRODUCT: 9-10

NOVEMBER 2009: KEMPTON PARK,SOUTH AFRICA:

BY DETECTIVE INSPECTOR NAMIBIA

TABLE OF CONTENTS

• GEOGRAPHICAL LOCATION• DEFINITION OF COUNTERFEIT MEDICAL

PRODUCT• NATIONAL LEGISLATION• PENALTIES• NATIONAL COORDINATION• PROPOSALS FOR ACTION

GEOGRAPHIC LOCATION

Geography

• Area : 823,145 sq. km. (320,827 sq. mi.)• Terrain : Varies from coastal desert to semi-

arid mountains and plateau.• Climate : Semi desert and high plateau. • Population : 2,1 million (2001 Population

Census)

DEFINITION OF COUNTERFEIT MEDICAL PRODUCT

• THE MEDICINES AND RELATED SUBSTANCES ACT, ACT 101 OF 1965, AMENDED TO BECOME THE MEDICINES AND RELATED SUBSTANCE CONTROL ACT NO. 13 OF 2003 DEFINES COUNTERFEIT MEDICINES AS MEDICINES IN RESPECT OF WHICH A FALSE REPRESENTATION HAS BEEN MADE WITH REGARD TO ITS CONTENT, IDENTITY, OR SOURCE BY ANY MEANS INCLUDING ITS LABELLING AND PACKAGING.

WORLD HEALTH ORGANISATION DEFINITION

• PRODUCTS WITH A FALSE REPRESENTATION OF ITS IDENTITY OR SOURCE

• THIS APPLIES TO THE PRODUCT, ITS CONTAINER, PACKAGING OR LABELLING INFORMATION

• INCLUDES PRODUCTS WITH CORRECT INGRIEDIENTS / COMPONENTS, WITH WRONG INGRIDIENTS , OR WITHOUT ACTIVE INGRIDIENTS OR WITH FAKE PACKAGING

NATIONAL LEGISLATION

• THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT 2003, ( ACT N0 13 OF 2003)

• THE PHARMACY ACT, 2004, ( ACT N0 9 OF 2004)

• OTHER LEGISLATIONS ON INTELLECTUAL PROPERTY RIGHTS ( PATENTS AND DESIGNS ACTS ETC

OFFENCES UNDER THE LEGISLATION

• A PERSON COMMITS AN OFFENCE IF HE / SHE (a) OBSTRUCTS OR HINDERS THE INSPECTOR IN

THE EXCERCISE OF HIS OR HER DUTIES SUCH AS THE ENTERING OF A PLACE ON REASONABLE GROUNDS OF SUSPICION OF MEDICINES ETC, INSPECT ANY MEDICINES OR SEIZURE OF SUCH MEDICINES.

(b) WITH FRAUDULENT INTENT TEMPERS WITH A SAMPLE OF A MEDICINE, SUBSTANCES OR ANY OTHER THING AS SPECIFIED BY THIS ACT

OFFENCES CONT

• (c) - MAKES A FALSE OR MISLEADING STATEMENT IN AN APPLICATION FOR THE REGISTRATION OF A MEDICINE OR OTHER APPLICATION

• AND OR IN THE COURSE OF THE SALE OF A MEDICINE ETC.

OFFENCES CONT

• (d) SELLS A MEDICINE OR A SCHEDULED SUBSTANCE IN A CONTAINER ON WHICH A FALSE OR MISLEADING STATEMENT IN CONNECTION WITH THE CONTENTS IS WRITTEN.

PENALTIES

• A PERSON WHO IS CONVICTED OF AN OFFENCE SPECIFIED IN THIS ACT IS LIABLE TO A FINE NOT EXCEEDING N$ 40 000,00 OR TO IMPRISONMENT FOR A PERIOD NOT EXCEEDING 10 YEARS OR TO BOTH SUCH FINE AND IMPRISONMENT

• THE COURT CONVICTING SUCH A PERSON UNDER THIS ACT MAY DECLARE SUCH A MEDICINE TO WHICH THE OFFENCE RELATES TO BE FORFEITED TO THE STATE

PENALTIES CONT

• SUCH MEDICINES SO FORFEITED MUST BE DESTROYED OR DEALT WITH IN THE PRESCRIBED MANNER OR AS MAY BE DIRECTED.

NATIONAL COORDINATION

• THIS INVOLVES THE FOLLOWING AGENCIES (a) THE NAMIBIA MEDICINE REGULATORY

COUNCIL OR DRUG REGULATORY AUTHORITY UNDER THE MINISTRY OF HEALTH AND SOCIAL SERVICES

(b) LAW ENFORCEMENT AGENCIES SUCH AS THE POLICE ( COMMERCIAL CRIME UNIT, DRUG LAW ENFORCEMENT UNIT AND CUSTOMS ).

COORDINATION CONT

• ALL PHARMACEUTICAL BODIES OR REPRESENTATIVES

PROPOSALS FOR ACTION

• WE PROPOSE THE STRENGTHENING OF THE REGULATORY AUTHORITY THROUGH INCREASED SKILLED PERSONNEL

• IMPROVE ON THE COORDINATION OF VARIOUS STAKEHOLDERS IN THE FIGHT AGAINST COUNTERFEIT OF MEDICAL PRODUCTS

• INTENSIFICATION OF AWARENESS CAMPAIGN AMONG CONSUMERS OR PATIENTS ETC

PROPOSALS FOR ACTION

• THE IDENTIFICATION AND APPOINTMENT OF A FOCAL PERSONNEL TO ASSESS AND MONITOR THE MOVEMENTS OF COUNTERFEIT MEDICAL PRODUCTS ETC