Sub-Saharan Africa and its legislation to combat fake medicines

The Southern African Development Community (SADC)

  1. Historic

  • Heir to the SADCC (The Southern African Development Coordinating Conference ) established the 1st April 1980 by the adoption of the Lusaka Declaration:

Member States :

  • Angola

  • Botswana

  • Lesotho

  • Malawi

  • Mozambique

  • Swaziland

  • Tanzania

  • Zambia

+ Namibia in 1990 after its accession to independance

  • Missions : – Reduction of the Member States dependence

– Establish a genuine and equitable regional integration

– Mobilisation of Member States’ resources to promote the implementation of national, interstate and regional policies

– Ensure the international cooperation

  • Establishment of the SADC : Windhoek Declaration and Treaty of August 17, 1992.

?Read the Treaty establishing the SADC http://www.sadc.int/files/9113/5292/9434/SADC_Treaty.pdf

Member States:

  • Angola

  • Botswana

  • Lesotho

  • Malawi

  • Mozambique

  • Swaziland

  • Tanzania

  • Zambia

+ South Africa in 1994

+ Mauritius in 1995

+ The Democratical Republic of Congo in 1998

+ Seychelles in 1998

+ Madagascar in 2005

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  • Mission : «to promote sustainable and equitable economic growth and socio-economic development through efficient, productive systems, deeper co-operation and integration, good governance, and durable peace and security; so that the region emerges as a competitive and effective player in international relations and the world economy ».

South African Customs Union (SACU)

Member States :

  • South Africa

  • Botswana

  • Namibia

  • Swaziland

? Admission of a new Member State subject to unanimous acceptance of the current Member States

  • Southern African Customs Union (SACU) Agreement between the Member States, signed on 21 October 2002 and entered into force on 15 july 2004

?Read the SACU agreement http://www.wipo.int/edocs/lexdocs/treaties/en/sacu/trt_sacu.pdf

  • The establishment of a common custom tariff in the SACU

  • Removal of customs duties and other charges with equivalent effect and quantitative restrictions and measures with equivalent effect between member states for the products grown, produced or manufactured in the SACU or already in free circulation therein.

  • The Member States shall have the right to impose restrictions on imports or exports in accordance with national laws and regulations for the protection of health of humans, animals or plants; the environment; treasures of artistic, historic or archeological value; public morals; intellectual property rights; national security; and exhaustible natural resources

  • The right of each Member State to prohibit or restrict the import into or the export from its area of any goods for economic, social or cultural reasons

  1. The Pharmaceutical field in the SADC

  • The beginnings of the Pharmaceutical Regulation:

  • The Protocol on Health of August 18, 1999: integration in the agenda of SADC of the pharmaceutical harmonization issue.

?Read the Health Protocol of the SADC http://www.sadc.int/files/7413/5292/8365/Protocol_on_Health1999.pdf

Mission : in order to promote the cooperation between the member states on :

  • The harmonization of the registration procedures

  • The production, supply and distribution of medicines at an affordable price

  • The development of mechanisms to ensure the quality of the supply and the transport of vaccines, blood and blood derivatives

  • The research and the documentation on traditional medicine and its uses

  • The establishment of a regional database on the traditional medicine and the medicinal plants

  • The establishment of regimes on protection of industrial property rights for the genetic resources, the plant varieties and the biotechnologies

Results:

  • Establishment of two working groups:

  • One group responsible for the registration of medicines under the direction of the South Africa.

  • One group responsible for the pharmaceutical control under the direction of the Zimbabwe

  • Adoption of harmonized guidelines relating to:

  • the medicines registration

  • the Bioequivalence and Bioavailability

  • the clinical trials

  • the good manufacture practices

  • The strengthening of the pharmaceutical regulation:

  • The Pharmaceutical program (june 2004) : strengthen the capacity of Member States to prevent and cure the public health ills (HIV / AIDS, tuberculosis, malaria …)

  • The Strategic plan of the SADC 2007/2013 (June 27th 2007) : sustainably improve the availability and the access to safe, quality and affordable medicines including issued from traditional medicine

?Read the Strategic plan of the SADC for 2007 to 2013 of June 27th 2007 http://www.sadc.int/files/7413/5292/8365/Protocol_on_Health1999.pdf

  • Analysis of the Strengths, Weaknesses, Opportunities and Threats (SWOT) in SADC region

  • Priority Strategic Actions:

  • Strengthen regulatory capacity, supply and distribution of basic pharmaceutical products.

  • Reduce the dependence of medicines towards the outside

  • Strengthen research and development at a regional level

  • Promote the joint procurements of safe, effective and quality drugs

  • Implement the flexibilities opened by the TRIPS (trade-related aspects on intellectual property rights) agreement

  • Promote the patentability of drugs issued from traditional medicine

  • Develop guidelines on the standard treatments

  • The other bodies responsible for health: ECSA-HC (East, central and southern Africa health Community)

Member States : all the member states of the SADC excepted Madagascar and the Democratic Republic of the Congo

  • Resolutions adopted by the Ministers of Health of the Member States :

  • Resolution to increase access to medicines and medical supplies, february 2008