IMPACT Regional Conference on Combacting Counterfeit Medical

Products

9-10 November 2009Kempton Park – South Africa

Mozambique Experience

Mozambique

Definition of counterfeit medical product

• A counterfeit product is a product bearing a mark that is "identical with or substantially indistinguishable from" a genuine trademark;

• Doesn’t follow the quality, safety and efficacy requisites for a medical product;

• Dangerous for the Public Health• Crime

Mozambique

Our National Legislation

• None specific legislation about counterfeit medicines or medical products

• Law 4/98 from 14th January - Medicines Law– it legislates the manufacture, importation,

comerce and dispense of medicines and ensures that the medicines that arrive to the population have quality, safety and eficacy and correspond to the needs of the population.

Mozambique

• Decrete 21/99 from 4th May – Regulates the Farmacist conduct in his act– Defines the conditions, rules and the procedures

for the exercise of the farmaceutical practice, in form to assure the tecnical, ectical, moral and deontologic principals

• Decrete 22/99 from 4th May – Regulates de registration of medicines

• Penal Code of Mozambique

Our National Legislation

Mozambique

Penalties• Law 4/98, Cap. VII, Secção II, Art. 45:1. Constitute, in the terms of the Law, a breach of the

Law that can be punished with the fine between 80.000,00Mt and 200.000,00Mt:

c. The robbery and the ilicit sale of medicines; d. The manufacture, importation, exportation and

distribution of medicines without the respective quality control– without the comprovative of quality;

e. The comerce or distribution of alterados ou adulterados medicines;

f. The falsification of laboratorial and quality control certificates of medicines.

Mozambique

Penalties

Penal Code• Art. 216 – Falsification of documents (includes

certificates of quality)–2 to 8 years of prison

• Art. 222 – Using false documents– The same as the autor (2 to 8 years)

Mozambique

Penalties

Penal Code• Art. 228 – Falsification of stamps or trademaks– 2 to 8 years of prison

• Art. 248 – Crimes against Public Health – Selling or exposing poisoning or abortive substances – Not less 3 months of prison and a tax/fine

• Art. 249 – Crimes against Public Health – Substitute or change a perscription giving a deteriorated medicine.– Not less 1 months of prison and a tax/fine

Mozambique

Number of cases

• Unknown

Mozambique

Our proposal of action

• Create or adopt a regional specific legislation about counterfeit medical products;

• Create a specific unit inside the Inspective body of the MRA;

• Establish cooperation with Customs and Police• Create a cooperation with the private sector

to promote the fight against counterfeit products;

Mozambique

Our proposal of action

• Create cooperation with industries;• Create a cooperation with OMS, Interpol and

Impact to receive information and participate in debates about this matter, acknowledging the experience of other countries;

• Receive training on detecting and investigating counterfeit medicines;

• Educate the population where to buy the medicines

Mozambique

Thank youThank you

ObrigadoObrigado

Mozambique