1. DOMESTICATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION FOR STRENGTHENING ACCESS TO MEDICINES IN LESOTHO REPORT OF DAY 1 Botha Tiheli, Masello Sello (rapporteurs)

2. Objectives Of The Workshop To provide a context on how IP policy and legislation impact Access to Medicines Develop a joint understanding of how Lesotho can support future access to medicines- so that these principles can be included in the national IP, trade, health and medicines policies To develop strategies for taking full advantage of TRIPS flexibilities for existing patented medicines, considering the fact that Lesotho is a LDC

3. Objectives (cont.) To develop stakeholder coordination mechanism to map the way forward and coordinate the implementation of the agreed strategies To agree on TORs for a multi-stakeholder Technical Working Group on IP and Access to Medicines in Lesotho that will both drive the process and oversee the agenda.

4. Presenters Agi Veres, UNDP Deputy Resident Representative, Lesotho Mr. Lefu Manyokole, Principal Secretary of MOH Mrs. Rona Matsoara - National Medicines Policy Catherine Kirk (UNDP) – what are the flexibilities, and how will their incorporation in patent legislation promote access to essential medicines Dinah Mandaza (SARPAM)- assessment of the status of implementation of the TRIPS flexibilities Cailin Morrison (UNDP)- Patents, TRIPS, Flexibilities & Access to Medicines Ms. ‘Mampoi Taoana (Deputy Registrar General)- IP Policy Situation Update in Lesotho

5. Participants

6. GENERAL PROBLEMS with regards to TRIPS Flexibilities Lesotho uses a national exhaustion principle for buying medicines - expensive Difficulty to access medicine in the future due to IP protection Lesotho has not been responding to letters from ARIPO hence faces 20 patents (on HIV/AIDS alone) Insufficient knowledge on how to exploit TRIPS flexibilities and Doha declaration for access to medicine No implementation of compulsory licensing for access to medicine

7. GENERAL PROPLEMS with regard to Access to Medicines No regulation of drugs that enter the country Herbal/traditional medicines advertised without control The country is still in the process of developing legislation that would establish the development of Medicines and Related Substances Authority The country does not have a lab to test drugs before putting them on the counter- still relies on South Africa for registration of drugs

8. TRIPS FLEXIBILITIES with relevance to Lesotho The right of the country to issue compulsory licenses at their discretion and not only in cases of emergencies The right to issue Government licenses Bolar exception LDCs extension of transitional period (2016, now 2021) Lesotho can adopt the International Exhaustion (parallel import) principle of buying medicines - cheaper

9. RECOMMENDATIONS IP should not hinder access to medicine in Lesotho since very few of the drugs are protected in the country Most of the drugs should be exploited without authorization by the owner since they are in public domain in Lesotho Lesotho should build local capacity to exploit this opportunity Under Doha Declaration, Lesotho may request other countries to produce these drugs for the supply of domestic market

10. RECOMMENDATIONS cont. Lesotho should stop protecting pharmaceutical products which were in the first place not protected in the country There is a need to encourage compulsory licensing for access to medicines Registrar General should provide a list of the pharmaceutical products protected by ARIPO on behalf of Lesotho

11. RECOMMENDATIONS cont. Lesotho should write a letter to ARIPO stating that because of the its status as a LDC, it should not be granted patents Develop mechanisms which enhance utilization of TRIPS flexibilities to take advantage of the extension period of TRIPS compliance to 2021 for LDCs Advocate for shifting of the period of TRIPS Compliance by LDCs to beyond 2021 Sensitize parliamentarians and the health sector on available opportunities for access to medicines

12. RECOMMENDATIONS cont. Develop the mechanism for regulating the use and practice of traditional medicine Develop structures to encourage establishment of manufacturing companies locally Establish a quality control laboratory that will test drugs before being sold