Sub-Saharan Africa and its legislation to combat fake medicines

Zimbabwe

  1. The Industrial Property Field

  1. Standards

  • At National Level

  • Patents Act, February 1st, 1972 as amended in 2002

?Read the Patents Act http://www.wipo.int/edocs/lexdocs/laws/en/zw/zw031en.pdf

  • Part. IV, Art. 25 : protection of the invention by the patent for a period of 20years from the filing date = TRIPS agreement (20years)

  • Part. IV, Art. 24, 4) : Exclusive right of the patentee to make, use, offer for sale, sell or import for one of these purposes the machine, manufacture or composition of matter which is subject of a patent or directly obtained by the patented process or to use the patented process

  • Part. VI : Description of the judicial action procedure for infringement of the patentee’s right according to the patented object

  • Trade Marks Act, January 1st, 1975 as amended in 2001

?Read the Trade Marks Act http://www.wipo.int/edocs/lexdocs/laws/en/zw/zw016en.pdf

  • Part. IV, Art. 24 : Protection of the trademark for a period of 10years renewable = TRIPS agreement (not less than 7years renewable)

  • Part. III, Art. 8 : Infringement of the right of the trademark's owner by a third who uses, in the course of trade, without the authorization of the trademark’s owner:

  • a trade mark in relation to goods or services in respect of which the trade mark is registered, of a mark identical with it or so nearly resembling it as to be likely to deceive or cause confusion

  • otherwise than as a trade mark, of a mark identical with it or so nearly resembling it as to be likely to deceive or cause confusion if such use is in relation to or in connection with goods or services in respect of which the trade mark is registered and likely to cause injury or prejudice to the proprietor of the trade mark

  • Part. XIII, Art. 83 : Forgery of registered trademark: Make, without authorization, a registered trade mark or a mark so nearly resembling that trademark is likely to deceive or cause confusion or falsify a registered trade mark, whether by alteration, addition, effacement or otherwise

  • Part. XIII, Art. 84 : Prohibition of forgery of registered trade marks and other acts :

  • Forge a registered trade mark or falsely apply to goods or in relation to services a registered trade mark

  • Make, dispose or have in its possession a die, block, machine or other instrument for the purpose of forging, or of being used for forging, a registered trade mark

  • Without the consent of the proprietor of a registered trade mark: make, import or have in its possession, any device for applying that registered trade mark to goods or in relation to services; or make any reproductions, replicas or representations of that trade mark; or import any reproductions, replicas or representations of that trade mark otherwise than on goods to which they have been applied

  • Make, Import or have in its possession, any device for applying of, or any reproductions, replicas or representations of, or any covering which bearing, a mark so nearly resembling a registered trade mark as to be likely to deceive or cause confusion, for the purpose of applying them to goods or in relation to services contrary to the provisions of this Part

Sanction : Fine of ? level 7 (800 000$) And/or Imprisonment to ? 2years

& The proprietor of the trademark may give notice in writing to the Director of Customs and Excise to request that these goods be treated as prohibited goods

  • Act To amend the Trade Marks Act, 2001

?Read the Act to amend the Trade Marks Act http://www.wipo.int/edocs/lexdocs/laws/en/zw/zw005en.pdf

  • Amendment of Part. XIII, Art. 86, (1) of the Trade Marks Act:counterfeit trade mark goods: any goods which bear without authorization a trade mark which is identical to a registered trade mark or cannot be distinguished in its essential aspects from a registered trade mark and thereby infringes the rights of the proprietor of the registered trade mark

& (2) : If the proprietor of a registered trade mark, by written notice:

  • informs the Director of the Customs and Excise that he is the proprietor of the trade mark;

  • satisfies the Director that there are reasonable grounds to suspect that counterfeit trade mark goods have been or may be imported into or exported from Zimbabwe;

  • requests the Director to treat the counterfeit trade mark goods as prohibited goods & describes the goods concerned with sufficient particularity to make them readily identifiable;

  • The Director shall forthwith comply with the request and ensure that no such goods are imported into or exported from Zimbabwe, and that any such goods that have been imported but not yet entered are not released to the importer

  • Penal Code, June 3, 2005

?Read the Penal Code, Part. IV, Art. 137 http://www.iracm.com/wp-content/uploads/2013/01/code-pénal-2004-1440.pdf

  • Forgery :

– Forge any documents or item (including a mark) by using without authorization this document or by making some material alteration, erasure or obliteration

Sanction : forgery of a document or item other than a public document or item: Fine of ? level 13 (4 000 000$) and/or imprisonment to ? 15years

  • Customs Act

?Read the Customs Act http://www.zimra.co.zw/index.php?option=com_phocadownload&view=category&id=23:legislation&download=199:customs-and-excise-act&Itemid=112

  • Part. III, Art. 47 : Prohibited importations: The importation into Zimbabwe of any goods the importation of which is prohibited by or under the authority of any enactment is totally prohibited

Art. 48: Restricted importations: Goods the importation of which is restricted or controlled by this Act or any other enactment shall only be imported in conformity with the provisions of this Act or such other enactment, as the case may be

Sanction: Fine of ? level 12 (3 000 000$) or the duty-paid value of the goods, whichever is the greater and/or ? 5years imprisonment (Part. XIII, Art. 187)

  • At International Level

  • The agreement on TRIPS :

  • The agreement on TRIPS (Trade-Related Aspects on Intellectual Property Rights ), accession the March 5th, 1995

?Read the TRIPS agreement http://www.wipo.int/edocs/lexdocs/treaties/en/wto01/trt_wto01_001en.pdf

  • Trademark : Uniform conditions of the protection by the trademark and of the rights conferred by it

  • Patentability : Duty to confer a patent protection for any invention, whether products or processes, provided that it is new, involve an inventive step and is capable of industrial application

  • Non-discrimination : Identical treatment whatever the technological field or the origin of the invention

  • Compulsory Licence : Possibility under certain conditions to manufacture or use the patented product without authorization of the patentee (prior request for voluntary licence unless emergency conditions; adequate remuneration of the patentee)

? Patents Act Part. IV, Art. 32 « Inventions relating to food or certain other commodities »

  • Part III « Enforcement of intellectual property rights » :

    • Establish judicial and criminal procedures which be effective, fair, equitable and not unnecessarily costly in order to fight infringements to the intellectual property rights

    • Establish procedures to enable the owner of the right to file a written request to the judicial authorities with the view to suspend the circulation of goods by customs authorities, at least in cases of suspicion of counterfeited or pirated trademark

    • The competent judicial authorities are empowered to take provisional measures to prevent the commission of the offense

    • The competent judicial authorities are empowered to order the adduction of proof, the cessation of the infringement, the removal of the infringing goods and their destruction, the payment of damages

    • Establish proportional and sufficiently dissuasive procedures and criminal penalties (imprisonment and fine) at least in cases of willful counterfeiting of trademark or willful infringement of copyright

  • Doha Declaration on the agreement on TRIPS and public health, November 14, 2001

?Read the Doha Declaration adopted on November 14 2001 http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf

+ Decision of the TRIPS Council, June 27, 2002

  • Extension of the deadline for implementing the provisions relating to the patentability of pharmaceutical products for the least developed countries until the January 1st, 2016

+ Decision of the General Council, August 30, 2003

  • Management of the flexibilities opened by the compulsory licence in case of inability of production by the recipient country

  • Decision of the TRIPS Council, June 11, 2013

?Read the Decision of the Council for TRIPS of 11june 2013 http://www.wto.org/english/tratop_e/trips_e/ta_docs_e/7_1_ipc64_e.pdf

  • New extension of the deadline for implementing the provisions relating to the agreement on TRIPS (excepted article 3, 4 &5) given to the least developed countries until the 1st July 2021 or at the time where the country will cease to be a least developed country if this one is earlier

WARNING

Zimbabwe isn’t listed as LDC, therefore the provisions of the TRIPS agreement are enforceable against it

  • Other international texts relating to industrial property :

  • Paris Convention for the Protection of Industrial Property, accession the April 18th, 1980

?Read the Paris Convention

http://www.wipo.int/edocs/lexdocs/treaties/en/paris/trt_paris_001en.pdf

  • National Treatment : The same protection regime for the industrial property rights between the nationals and the nationals of any country of the Union

  • Priority Right : A regular registration of a patent, a trademark or an industrial design gives a deadline to proceed to registration in any other contracting state with a retroactive date of registration to the date of the first filing

  • Patent Cooperation Treaty , accession the June 11th, 1997

?Read the Patent Cooperation Treaty http://www.wipo.int/edocs/lexdocs/treaties/en/pct/trt_pct_005en.pdf

  • International Patent Application : application for patent protection simultaneously in several Contracting States

  • National effect : in each designated State, the same protection that a national patent

  • Advantages : international filing format, international research services to evaluate the patentability

? Patents Act, Part. XI « international arrangements»

  1. Competent Authorities

  • At National Level

  • Zimbabwe Intellectual Property Office, Ministry of Justice, Legal and Parliamentary Affairs

  • Registration of patents and trademarks and their monitoring

  • At Regional Level

  • ARIPO (African Regional Intellectual Property Organization), Lusaka agreement of December 9, 1976 & adopted by Zimbabwe the October 11th, 1980

?Read the Lusaka Agreement http://www.wipo.int/edocs/lexdocs/treaties/en/ap001/trt_ap001_002en.pdf

  • Establishment of the African Regional intellectual Property Organization

  • No development about its powers and functions as a intellectual property office

? Annexed to the patent law

+ Harare Protocol on patents and industrial designs within the framework of the ARIPO, December 10 ,1982 & adopted by Zimbabwe the April 25th, 1984

?Read the Harare Protocol http://www.wipo.int/edocs/lexdocs/treaties/en/ap006/trt_ap006.pdf

  • Competence of the ARIPO to grant patents, to register industrial models and designs and to administer them on behalf of the Member States (patent, section 3)

  • Application filed directly with the ARIPO or at the registration office of a Member State

  • A designated State may make a written communication against the effect of a patent/ industrial designs in its territory in accordance with the protocol

+ Banjul Protocol on marks within the framework of the ARIPO, November 19, 1993 & adopted by Zimbabwe March 6th, 1997

?Read the Banjul Protocol http://www.wipo.int/edocs/lexdocs/treaties/en/ap004/trt_ap004_001en.pdf

  • Competence of the ARIPO to register trademarks and to administer them on behalf of the Member States

  • Application filed directly with the ARIPO or at the registration office of a Member State

  • A designated State may make a written communication against the effect of a trademark in its territory in accordance with the protocol

? Act To amend the Trade Marks Act, Art. 19 which adds Art. 97A = Any trade mark which has been registered by the ARIPO Office in accordance with the Protocol and in respect of which Zimbabwe has been designated shall have the same effect and shall be accorded the same protection , mutatis mutandis, as a trade mark registered under this Act

  1. The Pharmaceutical Field

A.Standards

  • Medicines and Allied Substances Control Act, September 1st, 1969 (as amended in 2002)

?Read the Medicines and Allied substances Control Act http://www.parlzim.gov.zw/attachments/article/101/MEDICINES_AND_ALLIED_SUBSTANCES_CONTROL_ACT1_15_03.pdf

  • Establishment of the Medicines Control Authority of Zimbabwe, its composition, its functions and its powers

  • Transfers of the Zimbabwe Regional Medicines Control Laboratory under the responsibility of the Medicines Control Authority & its composition, its functions and its powers

  • Regulation of the medicines registration according to their class

  • Part. IV, Art. 39 :

Sell or produce medicines which aren’t comply with the requirements of the Minister after the opinion of the Medicines Control Authority, including requirements as to the composition, therapeutic suitability and effect, purity or other properties and the conditions under which any medicine shall be prepared

Sanction : Fine of ? level 12 (3 000 000$) and/or ? 2years imprisonment

  • Regulation of medicines advertising and regulation of clinical trials

  • Prohibition of the distribution and the possession of drugs and power of referral and sanctions authorities

  • Part. VI, Art. 54 :

No person shall practice as or carry on the business of a pharmacist, manufacture any medicine or dispense any medicine on any premises unless the premises are licensed in respect of that business and the premises are under the continuous personal supervision of a person who is licensed

Sanction : Fine of ? level 12 (3 000 000$) and/or ? 2years imprisonment

  • Powers of inspection, seizure and analysis of the inspectors, the police or customs officers in case of medicines suspected to not comply with the provisions required

  • Medicines and Allied Substances Control (Import and Export of Medicines) Regulations, 2008

?Read the Art. 4 of the Medicines and Allied Substances Control (Import and Export of Medicines) Regulations http://www.mcaz.co.zw/index.php/downloads/category/7-guidelines?download=2:import-and-export-of-medicines-registration-2008

  • The import or the export of registered medicines which not respect the terms and conditions of a permit

  • The import and the export of registered medicines as wholesaler without being duly appointed as authorized importer or exporter

  • The import of medicines by any pharmacist, veterinary surgeon, dental practitioner or medical practitioner for an other purpose than for resale, in authorized premises, to his or her customers, patients, or clientele, as the case may be

Sanction : Fine of ? level 7 (800 000$) and/or ? 6months imprisonment

  • National Pharmaceutical Policy, June 2011

?Read the National Pharmaceutical Policy http://apps.who.int/medicinedocs/documents/s20163en/s20163en.pdf

  • 3.2 « Legislation and regulation on medicines and medical supplies»

  • Ensure that only authorized medical products of adequate quality, safety and efficacy circulate in Zimbabwe

  • Strengthen and enforce the medicines legislation and regulations at all levels

  • Establish procedures and policies for sampling, testing and evaluating medicines and registration of those that conform to the prescribed standards

  • Amendment of the relevant laws to take advantage of the flexibilities offered under the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in order to promote local production of essential medicines

  • 3.5 « Assuring the quality, safety and efficacy of medicines»

  • Ensure that effective quality assurance and the appropriate legal basis be in place to ensure that only medicines of acceptable quality, safety and efficacy are allowed to be produced, imported, distributed and used

  • Ensure the monitoring of the registered medicines and withdraw them from the market and cancel their registration when medicines are subsequently found unsafe, ineffective, or of insufficient quality

  • 3.9 « Medicines supply: procurement, distribution and storage»

  • Ensure the procurement of both medicines and raw materials of consistently good quality, at the lowest possible price and in appropriate quantities

  • Ensure that these medicines are maintained in good condition throughout the chain of supply

  • Minimize wastage and loss

  1. Competent Authorities

  • Medicines Control Authority of Zimbabwe (MCAZ), Ministry of Health

?Read Part II of the Medicines and Allied substances Control Act http://www.parlzim.gov.zw/attachments/article/101/MEDICINES_AND_ALLIED_SUBSTANCES_CONTROL_ACT1_15_03.pdf

  • Registration of medicines for human and veterinary use

  • Granting licenses for all persons related to pharmaceutical activities

  • Authorization, control and evaluation of clinical trials

  • control and analysis of medicines through the medicines control laboratory

  • Management of the pharmacovigilance system for the medicines in the market

  • Under the responsibility of the Medicines Control Authority of Zimbabwe

  • Verifying the quality, safety and efficacy of any medicines and allied substances referred to it

  • Verifying the standards of specifications of any medicines and allied substances referred to it

  • Training persons in the analysis of medicines and allied substances