Sub-Saharan Africa and its legislation to combat fake medicines

Seychelles

  1. The Industrial Property Field

  1. Standards

  • At national level

  • Patents Act, March 3, 1901 (as amended in 1991)

?Read the Patents Act as amended http://www.wipo.int/edocs/lexdocs/laws/en/sc/sc006en.pdf

  • Art.20 : protection of the invention by the patent for a period of 14years from the granting date ? TRIPS agreement (20years)

  • Trade Marks Decree, January 4, 1978 (as amended in 1991)

?Read the Trademarks Decree as amended http://www.wipo.int/edocs/lexdocs/laws/en/sc/sc007en.pdf

  • Part. II, Division 3, Art. 17 : Protection of the trade mark for a period of 7years renewable = TRIPS agreement (not less than 7years renewable)

  • Part. II, Division 7, Art. 34. 3) : Violation of the exclusive right of the trade mark’s owner by the unauthorized use by a third of an identical mark or a mark so nearly resembling the trademark, as to be likely to deceive or cause confusion in the course of business, for goods or services for which the trademark has been registered.

  • Part. III, Division 5, Art. 51 : falsely representing a trademark as registered:

  • Use a mark not being a registered trademark, to the effect that it is a registered trademark

  • Use a part of a registered trade mark as a separately registered trademark whereas she isn’t

  • Use a registered trade mark in respect of any goods or services in respect of which it is not registered

  • Use an exclusive right whereas the registration does not give that right

Sanction : fine of ?5000 rupees

  • Customs Management Act, December 2011

?Read the Customs Management Act http://www.src.gov.sc/resources/Legislations/CustomsManagementAct2011.pdf

  • Part.V, Section I, Art. 46 : An officer or police officer may without warrant arrest any person who the officer has reasonable grounds to believe is concerned in the commission or attempted Commission of importation/exportation/have in his possession/unlawful conveying of prohibited or restricted goods

  • Part. VI , Section I, Art. 63 & Part. XI, Section I, Art. 190: prohibition of the import/export of goods which are prohibited under a law into force

  • Part. XIII, Section I, Art. 246 : any goods imported, landed or unloaded contrary to any prohibition or restriction in force with accordance with this act or any other law shall be liable to forfeiture and may be seized

  • Part. XIII, Section II, Art. 256 : Fail or refuse to produce books, records or other documents and data which are required by customs for import or export of goods

Sanction : in the case of an individual: fine ?20 000 SCR & in the case of a body corporate: fine ?50 000 SCR

  • At International Level

Warning :

The Seychelles aren’t member state of the WTO but have only the observer status and therefore, are not parties to the TRIPS agreement (Trade-Related Aspects on Intellectual Property Rights ) = Accession under talks

  • Other international texts relating to industrial property :

  • Paris Convention for the Protection of Industrial Property, accesion the November 2nd, 2002

?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 November 2nd, 2002

?Read the Patent Coopération 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

  1. Competent Authorities

  • Registration Division , Department of Legal Affairs

  • Evaluation and management of the trademarks and patents registration

  • Seychelles Bureau of Standards, Ministry of National Development

  • Develop, disseminate and defend the national standards for products, the necessary processes and practices for the economy and the environment

  • Develop facilities for a monitoring and verification service of compliance with standards

  • To provide scientific and industrial metrology services and certification services

  • Manage a national information center relating to the standardization, the science, the technology and the industry

  1. The Pharmaceutical Field

A.Standards

  • National Pharmaceutical Policy, May 15th 2009

?Read the National Pharmaceutical Policy http://apps.who.int/medicinedocs/documents/s19286en/s19286en.pdf

  • 4.6 « Pharmaceuticals quality assurance» :

  • No procedures of quality assurance for medicines imported into or manufactured in the country

  • No medicine inspectorate and no medicines registration procedure

  • A quality control laboratory has been established in 2001 which carries out complete chemical analysis on all medicines imported by the Ministry of Health and also on all medicines produced locally for the public sector health facilities

  • 4.9 « rational use of medicines » :

  • No mechanisms for monitoring medicine use by health workers and the general public because of the lack of the necessary tools, staff and resources

  • Need to strengthen the role of the current Medicines and Therapeutics Committee in promoting rational use of medicines

  • 8 « policy orientations » :

  • Strengthen the national pharmaceutical services administration so as to enable it to fulfill its present and future responsibilities

  • Put in place the appropriate legislative and regulatory frameworks for the implementation of the present policy and enable effective control of the national pharmaceutical sector:

  • Establishment of a medicine regulatory authority, registration of medicines

  • Registration of medicines and of health workers

  • Monitor the import of medicines

  • Monitor Compulsory licensing in accordance with Trade Related Intellectual Property Rights (TRIPS)

  • conditions for dispensing doctors and various levels prescribers

  • Ensure efficient procurement, storage and distribution of sufficient quantities of essential medicines and other medical supplies

  • Ensure that only those medicines that are safe, effective and of assured quality are used in Seychelles:

  • Establish procedures for the registration of medicines, the inspection of pharmaceutical premises, the licensing and quality control

  • Develop mechanisms for controlling and combating substandard and counterfeit medicines

  1. Competent Authorities

  • Department of Pharmaceutical Services, which is part of the authority of health services, itself dependent on the Ministry of Health

  • Planning, regulation and management of the operation of the pharmaceutical services

  • Ensure the availability and affordability to only medicines which are safe, effective and good quality

  • Quality Control Medicines Laboratory , department of the pharmaceutical services

  • No National Medicine Regulatory Authority