Republic of Mozambique

Country Indicator Disease Indicator

Population (2016): 28,83 m

GDP Per Capita (2016): 382 USD

Health Expenditure of GDP (2014): 7%

Human Development Index (2016): 181

LDC Status: Yes.

Malaria New Cases per 1000295 (2016)

TB Estimated Cases per 100,000 551 (2015)

HIV Prevalence aged 14-4912.3 (2016)

Non-Communicable Diseases23% of total deaths (2014)

The Industrial Property Code Decree No. 47/2015. It came into effect on 31 March 2016. The new Act is a great leap forward in terms of incorporating TRIPS flexibilities. Mozambique adopted an Intellectual Property Strategy 2008–2018. The strategy

mainly addresses issues of innovation, industrial development and scientific advancement, but does not touch on the use of TRIPS flexibilities.

Policy Recommendations

1. Amend certain articles of Industrial Property Code Decree No. 47/2015 to expressly provide for:- A definition which excludes secondary patents.

- A section to include international exhaustion (parallel importation) and provide guidance around an accessible process for parallel importation. - To include post grant opposition procedures.

2. Commission a review of the Intellectual Property Strategy 2008–2018.

3. Ensure updated Intellectual Property Strategy include policy on TRIPS flexibilities.

MEDICAL REPORT

NOTES

Harnessing Trade Related aspects of Intellectual Property Rights (TRIPS)

Flexibilities

Member of World Trade Organisation (WTO): Yes. August 26, 1995.

Acceded to TRIPS Agreement: Yes. August 26, 1995.

Voluntary Licenses: Yes. [Refer to Medicines Patent Pool (MPP)].

Past Use of TRIPS Flexibilities: Yes. 2004, compulsory license. 2005, government use. 2005, government use. ARV’s, HIV/AIDS.

Research Exception: Yes. Article 75(a), (IPC decree No. 47/2015).

Early Working (Bolar) Exception: No.

Compulsory Licenses / Government Use: Yes. Article 92, (IPC 47/2015).

Parallel Importation (International exhaustion): National only. Article 68, (IPC 47/2015).

Patentability Criteria: Yes. Article 32, 38, (IPC 47/2015).

Pre and Post patent Grant Opposition Procedures: Pre only. Article 68, (IPC 47/2015).

Importation of HIV, TB and Malaria drugs from SADC member states: No.

Pharmaceutical Act: Yes. Law 4/98.

Regulatory Authority: Yes. Ministry of Health Pharmaceutical Department.

Generic Brand Name

$25

$82

Prescription drug cost comparison

Mozambique IP Timeline

03

Member of World Intellectual Property Organization (wipo)

WIpo

Lusaka Agreement on the Creation of the African Regional Intellectual Property Organization (ARIPO)

lusaka agreement

Filed with Medicines Patent pool (Mpp). It is used in combination, for the treatment of HIV INFECTIONS.

Cobicistat compound

Harare Protocol and Implementing Regulations on Patents and Industrial Designs Within the Framework of the African Regional Industrial Property Organization (ARIPO) as amended on November 25, 2013.

Harare Protocol

Deputy Minister of Industry and Commerce issued Compulsory License no. 01/MIC/04 for lamivudine, tavudine And nevirapine. Citing the HIV/AIDS pandemic.

compulsory license

1998

2000

2007

2000

2004

World Trade Organization (WTO) - Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (1994)

trips agreement1995

01

02

04

05

Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor and a prodrug of tenofovir. It was developed by Gilead Sciences for use in the treatment of HIV infection and chronic hepatitis B.

Tenofovir2012

07

06

Competition, Enforcement of IP and Related Laws, Geographical Indications, IP Regulatory Body, Industrial Designs, Industrial Property, Layout Designs of Integrated Circuits, Patents (Inventions), Trade Names, Trademarks, Undisclosed Information (Trade Secrets), Utility Models.

national ip law2015

08

A wide range of medicines can be profitably manufactured at very low cost and /or through the procurement of generic medicines. Should voluntary license options not be available, then governments could consider the use of other TRIPS flexibilities. This is especially urgent as newer and less toxic essential medicines are now needed for diseases such as HIV-Tuberculosis co-epidemics (and their drug-resistant strains), Hepatitis C and other Non-Communicable Diseases (NCD’s)such as cancer and diabetes.It is estimated that on average generics medicines are 20-80% cheaper than originator drugs and often push down price of originator drugs.

Cost Saving Mechanism

Intellectual Property Policy Environment

IP/Patent Act: Industrial Property Code (approved by Decree No. 47/2015 of December 31, 2015) Date of entry into force: March 31, 2016

Competition Act: Yes. Law No. 20/2013. Regulates activities related to competition in the exercise of economic activities.

Regional IP Member: Yes. African Regional Intellectual Property Organization (ARIPO)

Regional/ Multilateral Legislation: TRIPS/Paris/Harare/Lusaka

IP Policy Status update: Yes. Intellectual Property Strategy 2008-2018

Online searchable patent database: No. ARIPO online database only.