Presentation on theme: "Ms. Josie Chetty: Senior Pharmacist, MOH Mr. Reginald Hoareau & Mr. Ronny Arnephy: NGO Representatives."— Presentation transcript:
Ms. Josie Chetty: Senior Pharmacist, MOH Mr. Reginald Hoareau & Mr. Ronny Arnephy: NGO Representatives
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.
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
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)
Agreed by Health Ministers in 2006. Follow-up PBP 2014-2018 being developed Objective: For everyone to have access to Medicines.
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
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.
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.
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).
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).
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
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.
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).
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.
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.
What actions can be recommended to ensure access to Medicines is protected after Seychelles joins WTO?
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.
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.