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Ms. Josie Chetty: Senior Pharmacist, MOH Mr. Reginald Hoareau & Mr. Ronny Arnephy: NGO Representatives.

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Presentation on theme: "Ms. Josie Chetty: Senior Pharmacist, MOH Mr. Reginald Hoareau & Mr. Ronny Arnephy: NGO Representatives."— Presentation transcript:

1 Ms. Josie Chetty: Senior Pharmacist, MOH Mr. Reginald Hoareau & Mr. Ronny Arnephy: NGO Representatives

2  To provide a context how IP policies and the new Industrial Property legislation can impact on Access to Medicines in Seychelles.  To develop a joint understanding of how Seychelles can support future access to medicines.  To develop a stakeholder coordination mechanism to map the way forward and to coordinate the implementation of TRIPS.  To agree on TORs for a multi-stakeholder Technical Working Group on IP and Access to Medicines in Seychelles.

3  Constitution of the Republic of Seychelles 1994 Article 29: The state undertakes:  To take steps to provide free primary healthcare in state institutions for all its citizens.  Takes appropriate measures to prevent, treat and control epidemic, endemic and other diseases.  To takes steps to reduce infant mortality and promote the health development of the child

4  The Ministry of Health recognizes the importance of access to medicine and promote trust and participation in health services  The National Health Strategic Framework 2006-2016  Access to medicines is among key strategies in obtaining the objectives of six of goals out of 11. Health Care Agency (HCA) is committed to ensure :  that essential medicines are available and accessible to the citizens of Seychelles.  an annual budget is allocated for the procurement of medicines.  that patients get access to medicines that is of standard quality, safety and efficacy. (NDQCL)

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6  Agreed by Health Ministers in 2006.  Follow-up PBP 2014-2018 being developed  Objective: For everyone to have access to Medicines.

7 Program Goal:  Reduce Disease Burden in SADC by Increasing Access to Quality, Affordable and Essential Medicines  Assists SADC Secretariat & member states with the implementation of the SADC Pharmaceutical Business Plan2007-2013

8  Supports SADC PBP TRIPS activities since 2012  SADC member states adopted Sept 2012 concept note.  8 member states requested support to review their national IP/patent legislation.  Seychelles is 6 th on the list to organise workshop.

9 World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) Sets out minimum standards for IP protection which all WTO members have to comply with. Seychelles, once a WTO member needs to comply with TRIPS. PATENT: Create benefits to the society. May be used to delay generic competitors to enter the market and thus medicines prices would remain high.

10  Nature and Scope of Obligations  Objectives  Principles  REFERENCE :2001 Doha Declaration on TRIPS and Public Health  Patentability criteria  Exceptions to patent rights  Data Protection  Non-TRIPS measures-Voluntary licensing  E.g. Seychelles can benefit from recent (15 Sept.) VL agreement for hepatitis C treatment.  Seychelles can benefit from Medicines Patent Pool licenses and source medicines for the treatment of HIV (ARVs).

11  Initiated accession in 1995 to become a member of the World Trade Organization (WTO).  In 1998 Seychelles suspended its accession to the WTO. (lack of human capacity).  Re-started its accession in 2008 with the submission of its Memorandum of Foreign Trade Regime (MOFTR).

12  PRINCIPLES OF WTO  STATUS OF NEGOTIATION: 6 Working party meetings held since in February 1997. Last one was in July 2014.  BILATERAL  DOCUMENTS SUBMITTED: Seychelles has submitted further additional documents to finalize its accession process.  GOODS OFFER: As part of the negotiations, Seychelles has submitted its goods offer since June 1997. It has been revised three times, with the latest being in May 2013.  SERVICES OFFER: Services schedule offers a total of eleven sectors

13  Once a member of WTO, Seychelles will consider signing up to paragraph 6 of the Doha Declaration on TRIPS agreement WAY FORWARD IN ACCESSION PROCESS:  Final’ Working Party meeting planned for October 2014  Work to implement outstanding regulations and trade regime in compliance with WTO rules prior to accession is envisaged to be completed by the end of 2014. Conclusion:  Seychelles is amongst 22 other member States in the process of acceding to the WTO. The aim is to become a WTO member by the end of the year 2014.

14  Seychelles IP law is compliant with the trips agreement.  Several examples given:  Patent infringement, considered as a criminal offence.  Provision in section 118 (liability to imprisonment) and 120 (arrest without warrant by police officers)  Not desirable for several reasons e.g. Risk of abuse by patent holders.  Should be considered as Civil law??? (As UK).

15  Seychelles adopts restrictions to patentability of new uses/new indication.  Introduce pre-grant opposition procedures.  Adopt royalty guidelines for CL e.g. UNDP  Issue non-voluntary licenses, for public non-commercial use in standard international procurement.  Make use of parallel importation in standard international procurement procedures.  Amend IP Act to:  delete criminalisation of patent infringement.  implement WTO Decision of August 30th 2003.

16  Mechanism for compulsory license.  Registration of medicines.  Revision of medicines Act.  Deadline for the Minister to gazette the Act?  Warnings to the data protection.  Unethical drug promotion.  Quality of products.  Impact of TRIPS on medicine prices.  Regulation of traditional medicines.  Effect of WTO accession on medicines budget.

17  What actions can be recommended to ensure access to Medicines is protected after Seychelles joins WTO?

18  Similar to lawyers’ recommendations.  Seychelles to implement the WTO Aug 30 ‘03 decision.  Establishment of Pool procurement within the SADC region.  Adopt royalty guidelines.  Decriminalise patent infringement.  Revision of Seychelles law: prevention of evergreening patents.  Review medicines regulations.  Increase public and government awareness on WTO accession and consequences.  Concerns about protection of traditional knowledge against biopiracy.

19  Involvement of stakeholders in the making of regulations.  Accesiiility of patent registration to the stakeholders.  Availability of supplementary budget from Ministry Of Finance.  Affordability of medicines from both private and public sector.  Undergo a thorough research on the impact of WTO accession on Seychelles.  A focal point of enquiry for members of the public.

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