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CONCEPT NOTE ON A JOINT LESOTHO-UNDP-SARPAM WORKSHOP ON THE IMPLEMENTATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION FOR ENHANCING ACCESS TO MEDICINES IN

LESOTHO

Lehakoe Conference centre, Maseru, week 11 August 2014 Lawyers meeting (11 August), CSO briefing (12 August), National workshop (13-14 August)

1. Background The Southern African Regional Programme on Access to Medicines and Diagnostics (SARPAM) and the United Nations Development Programme (UNDP)1 support the Lesotho Government in its efforts to provide access to essential medicines for all Basotho. SARPAM is a DFID funded regional project that assists SADC Member States in implementing the Pharmaceutical Business Plan 2007-2013 (PBP). The Government of Lesotho together with UNDP has focused on enhancing national efforts to implement the Trade and Intellectual Property Rights (TRIPS) Flexibilities under the national IP legislation. As a result, linkages exist in the work that is being conducted by SARPAM and UNDP in Lesotho related to the PBP on pooled procurement, drug regulatory harmonization, regional collaboration and implementation of TRIPS Flexibilities. Both Organizations are supporting the Government to coordinate the implementation of TRIPS flexibilities to improve access to essential medicines within the SADC region. The primary goals of the SADC Pharmaceutical Business Plan 2007-2013 include:

(i) A regional assessment of intellectual property and medicines legislation in Countries to determine their TRIPS compliance and adaptability;

(ii) Identification of reliable and specialized legal advice resources both within and outside the SADC region and maintain a roster of legal experts who are able to offer technical assistance on TRIPS;

(iii) Collaboration with development partners to enable Countries to protect, include and take advantage of the flexibilities that exist in the TRIPS Agreement as well as to assist Countries in bilateral trade negotiations to conclude agreements that are not detrimental to public health.

To date, several achievements have been made towards the primary goals to support Lesotho and the SADC Region.

1 UNDP is temporal PR for GFTAM public health components and supports strengthening on HIV Response Coordination and Management in Lesotho.

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2. Regional Consultative Meetings On 18th September 2012, SADC Member States discussed two Papers at a Regional Consultative Meeting: (1) a concept note on “Trade, TRIPS and Access to Medicines: Challenges and Options for the SADC Region”, and (2) a paper on “Pharmaceutical Patents, TRIPS Flexibilities and Access to Medicines in Southern Africa Development Community (SADC)”. In addition, a bibliography, glossary and database of legal experts were presented who are able to support SADC Member States in adjusting their IP legislation in the interest of access to medicines. At the meeting SADC Member States’ Representatives discussed and developed Action Plans for national implementation, especially on maximizing TRIPS Flexibilities, reducing TRIPS+ and various IP issues impacting on access to medicines. The Lesotho delegation presented a list of actions to be undertaken, among them those highlighted in table 1 below. Table 1- Lesotho Action Plan presented 18th September 2012

Remarks Country action Regional action

Currently no inter-ministerial committee on TRIPS and Access

Plan to do research on Lesotho’s patents register / IP profile

Support regional strategies of SADC

No knowledge of products under patent

Immediately advocate for interministerial committee (Health, Trade, Law and Parliamentary Affairs Committee)

Concerted efforts needed for extension or permanent exemption of LDCs

Write TOR for TA to be requested

Request TA legal experts (UN Agencies, SARPAM experts – pro bono- given limited resources)

Advise Ministry of Health to write to Ministry of Trade to request ARIPO to stop granting of patents on pharmaceuticals until 2016

Incorporate TRIPS flexibilities in national legislation

Lobby for a permanent exemption to TRIPS for LDCS

Advocate local production of generics

Following the regional meeting, SARPAM received funding from DFID to support 6-8 countries with a national workshop to support with: (a) maximizing the TRIPS Flexibilities in their national IP/Patent legislation; (b) minimizing TRIPS-plus aspects in national legislation or free trade agreements; and (c) analysis of specific problems of access to medicines in the country caused by or related to Intellectual Property rights. At the September 2012 workshop, several Member States including Lesotho invited SARPAM for discussions about possible national workshops to take these matters further. SARPAM indicated that it was interested in supporting Lesotho with a workshop to discuss these elements.2 Lesotho reiterated the request for support to SARPAM at the September 2013 SADC member states consultation on the Pooled Procurement Strategy.

2 The DFID support via SARPAM is available until December 2014.

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3. National workshops, week of 11 August 2014 3.1 Justification and rationale

Lesotho is a least developed country (LDC) with poor socio-economic indicators, particularly in public health. It has a very small pharmaceutical manufacturing base and thus depends significantly upon the importation of products from foreign-based manufacturers. As an LDC, Lesotho does not yet have an obligation to adhere to TRIPS (exempted until 1 July 2021). Despite this, Lesotho has granted a few patents for pharmaceutical products. ARIPO, the regional Patent Office, may also have granted some patents for Lesotho. More research should be conducted to identify what patented products – for which generic competition is available elsewhere – are not accessible in Lesotho because of the price of product. However, it is safe to say that at a minimum, the granting of patents is blocking the opportunity to import, produce and use generic versions of the products on which patents are applied in Lesotho. The situation is particularly difficult in the case of newer medicines, due to the fact that India, since becoming fully TRIPS-compliant in 2005, can no longer automatically make or export these pharmaceutical products. In the near future, generic versions of newly patented products will be needed in Lesotho, SADC member states and other African countries. For essential medicines that are no longer patent protected, Lesotho relies on generic manufacturers based in India and, to some extent, in China and Southern Africa. 87,352 people currently are on anti-retroviral medicines, but 150,000 would need to be on ARV treatment (http://kff.org/global-indicator/arv-need/). Another potential access to medicines problem in Lesotho is the increase of HIV/AIDS related cancers and other Non-Communicable Diseases (NCDs). Lesotho is not well equipped to deal with cancer due to the absence of specialized personnel and the high cost of cancer drugs, some of which are still under patent protection. Newer anti-cancer drugs including imatinib and sunitinib are unaffordable despite the fact that more affordable, generic versions of these drugs are produced and available in India. Imatinib is theoretically available courtesy of the Glivec International Patient Assistance programme. However, this is an unsustainable way of making the drug available to cancer patients in Lesotho. Making use of the LDC exemption (including rolling-back any existing IP legislation) under which Lesotho would not provide any patents on pharmaceutical products until 2021, would be the most important first step in ensuring sustainable supply of pharmaceuticals. Lesotho has not yet taken steps to regularize its intellectual property rights to benefit from TRIPS flexibilities for pharmaceuticals that it has granted patents for (by its own IP office or ARIPO). It has an Industrial Property Order, 1989 (Order No. 5 of 1989, last amended by Act No. 4 of 1997). A new Lesotho IP policy is being developed with support of WIPO through NEPAD3. A national workshop was held with stakeholders [data lacking]. A September 2012 report commissioned by SARPAM reviewed the status of flexibilities in SADC member states’ legislations.

Compulsory licenses can be issued on the grounds of non/insufficient working in Lesotho four years from filing date or 3 years from patent grant.

3 WIPO support to NEPAD in collaboration with other United Nations Agencies' (May 2012 - April 2013).

Available at http://www.un.org/africa/osaa/2013_un_system/WIPO.pdf

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Government use licenses can be issued in the public interest: national security, nutrition, health or the development of other vital sectors of the national economy

No Bolar clause (this delays introduction of generic medicines as they cannot be tested or offered to the Regulatory Authority before patent expiry

No specific legislative provision on data exclusivity (need to check the new Medicines Bill)

Lesotho has specific provisions for research exemption - to acts done for scientific research.

Unclear status on parallel import (international exhaustion?)

Additional issues? It is against this background that SARPAM and UNDP propose to organize a national awareness workshop to promote a better understanding by Lesotho stakeholders and decision makers of the proposed amendments of the IP legislation, and the options for the government to create an environment which is supportive of the right to health and the right of access to medicines in particular.

Mr Lefu Manyokole, PS/MOH and Dr. McPherson, then DG/MOH, were briefed by SARPAM on 25 March 2014 about this initiative for a national multi-stakeholder workshop. They gave their principle support, and asked a team of MOH to work with SARPAM on an updated Concept Note. The PS Health has since formally approved the workshop plan, and invited his colleagues at the Ministries of Law, Trade, Police and Agriculture, as well as the IP office, to send representatives to the national workshop.

3.2 Objectives

To provide a context on how IP policy and legislation impact on Access to Medicines by: o Disseminating the findings of the situational analysis by the lawyers meeting on IP

and Patent legislation, and its impact on access to medicines o Present the international legal environment and Lesotho’s options within that to

protect public health and manufacture, supply and distribute new generic medicines to the SADC region and beyond

To develop a joint understanding of how Lesotho can support future access to medicines, so that these principles can be included in national IP, trade, health and medicines policies.

To develop the strategy for taking full advantage of TRIPS flexibilities for existing patented medicines, and for making us of the LDC exemption until 2021.

To develop a 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

4 It is envisaged that such a group would consist of a wide range of voices, including, but not limited to, elected

and public officials, civil society, industry, academia, patient and professional groups from a variety of sectors, including the public health, science, education, economic, industrial and innovation policy and practice sectors. Improving the channels for communication amongst these diverse groups will result in development of IP laws and policies which are more inclusive and public health-orientated.

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Specific objectives

To enhance knowledge and understanding of TRIPS flexibilities, and their implications for access to medicines, and their relevance for the development of local/regional pharmaceutical production.

To generate awareness, and enhance knowledge and understanding of the possible impact of TRIPS-plus provisions in Free Trade Agreements and other IP enforcement initiatives on access to medicines.

To equip policy makers with knowledge and skills relating to how they can reform the Patent laws while safeguarding public health objectives.

To equip participants with necessary knowledge and skills to advocate for the use of TRIPS flexibilities in the Industrial Property Order 1989, in order to promote access to medicines in Lesotho

To identify areas of support from development partners and agree on roles and responsibilities in providing that support.

To facilitate the development of a country coordination mechanism to develop and implement roadmaps for securing and expanding full use of TRIPS Flexibilities by 2021

3.3 Expected Outcomes

Participants will have an enhanced understanding of: o The TRIPS agreement and its impact on access to essential medicines, and the

relative advantages/disadvantages of utilizing TRIPS flexibilities to promote access to essential medicines.

o The impact of TRIPS-plus provisions in free trade agreements on access to essential medicines.

o The dangers of overreaching anti-counterfeit legislation which may harm access to generic medicines.

Participants will have an enhanced understanding of how regional production and pooled procurement strategies may enhance access to essential medicines.

Participants will have agreed on mechanisms for cooperation, collaboration, and coordination towards developing an agenda for using TRIPS flexibilities to strengthen local/regional production of new essential medicines.

Development partners will have identified possible areas of technical and financial support 3.4 Expected Outputs

Workshop report

Roadmap for adopting and optimizing the use of TRIPS flexibilities in order to promote access to medicines

Outline for a policy brief for MPs and senior officials

TORs for a Technical Working Group, including capacity building & support

3.5 Participants Up to 50 people have been invited by the PS Health for the national multi-stakeholder workhsop from the following organisations:

Ministries of Health and Social Welfare; Trade & Industry, Cooperatives & Marketing; Law, Human Rights and Constitutional Affairs;

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Relevant government institutions involved in procurement and regulation of medicines, such as the National Drug Service Organisation (NDSO) and the Medicines Regulatory Authority (being established)

Chairpersons or members of parliamentary Committees on Health, Commerce, Trade & Industry, Legal

Private non-profit medicines importers/wholesalers, CHAL and other NGOs

Human Rights Commission

IP Lawyers, Law Commission, Law Association of Lesotho

UN and development agencies (UNDP, UNAIDS, WHO, UNICEF, DFID, EU, USAID/PEPFAR)

Academics, civil society, local manufacturers, private sector and other stakeholders The main conference is to be held 13-14 August 2014. This meeting is prepared by an organising committee consisting of Ministries of Health, Trade and Justice, UNDP and SARPAM. The main meeting will be preceded by:

A separate briefing for 30 participants of civil society and NGOs on 12 August. This meeting is co-organised with Lesotho civil society and SARPAM.

A separate lawyers meeting of up to 10 lawyers from different Ministries and organisations on 11 August. This meeting will co-organised by the lawyers from Ministries of Health and Law, UNDP and SARPAM legal consultants.

4. Venue All meetings will be held at the Lehakoe Club conference centre, Maseru. Tel: 22232310. 5. Timetable

Lawyers’ meeting, 11 August 2014

Monday, 11 August 2014, 09:00-16:00 - Lawyers’ meeting Chair: Masello Sello Facilitators: Ms Dinah Mandaza (SARPAM legal consultant), Catherine Kirk and Cailin Morrison (UNDP legal consultants) Participants: national, regional and international lawyers (10 in total) Venue: Lehakoe Club Board room, Maseru

Programme:

Introductions

Meeting objectives

Update on the current IP legal framework and IP Policy (process)

International perspective of maximizing Access to Medicines – what can be done to national IP laws?

Discuss specific clauses of the current IP Order 1989, especially the ”flexibilities”

Formulate main conclusions

Agree how the conclusions shall be presented at the main workshop on 13 August

Discuss the possibility of a Technical Working Group to take the law amendments forward after the workshop

Any other matter

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Lesotho Civil Society Consultation Meeting, 12 August 2014

Tuesday, 12 August 2014, 09:00-16:30 Venue: Lehakoe Club, Executive Games room Chair: Mamathule Makhotla (LCN) Facilitators: Wilbert Bannenberg (SARPAM)

Time Content Responsible

09:00 – 10:00

Registration LCN

10:00 – 10:15

Introductions and Welcome Remarks LCN

10:15 – 10:30

Opening Remarks SARPAM, UNDP

10:30 – 10:45

Health Break All

10:45 – 11:15

Session 1: Access to Medicines problems in Lesotho and Plenary Discussion

Ms Thakane Kotelo

11:15 – 12:00

Session 2: Patents, TRIPS, Flexibilities & Access to Medicines – public health view and Plenary Discussion

Wilbert Bannenberg (SARPAM)

12:00 – 12:30

Session 3: Patents, TRIPS, Flexibilities & Access to Medicines – legal perspective

Cailin Morrison (UNDP legal Consultant)

12:30 – 13:00

Session 4: MSF experiences on fix the Patent Law! campaign Julia Hill (MSF)

13:00-14:00

Networking and Lunch Break All

14:00-14:30

Session 6: Lesotho TRIPS and Access to medicine Plenary Discussion

14:30 – 15:00

Session 7: Group Discussions on Key Trade, TRIPS and Access to Medicines Issues in Lesotho and Plenary Discussion

15:00 – 15:30

Session 8: Plenary Presentations/Open Discussion

15:30 – 15:45

Health Break All

15:45 – 16:15

Session 9: Adoption of Resolutions CSO Health Forum

Planning Committee

16:15 -16:25

Closing Remarks LCN

16:25 – 16:30

Vote of Thanks, Announcements and End of Meeting Wilbert Bannenberg (SARPAM)

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NATIONAL WORKSHOP, 13-14 AUGUST

DOMESTICATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION FOR STRENGTHENING ACCESS TO MEDICINES IN LESOTHO

Day 1: Wednesday 13 August 2014 Venue: Lehakoe Club Conference Centre, Executive Games room, Maseru Chair: Mrs. Germina Mphoso, MOH - Pharmaceuticals Director Rapporteurs: Botha Tiheli, Masello Sello

Time Content Responsible

08:30 – 09:00

Registration Phiny Hanson

(SARPAM)

09:00 – 09:30

Goodwill message by UNDP Deputy Resident Representative

Official opening by the Permanent Secretary, Ministry of Health (UNDP & MOH)

09:30 – 10:00

Session 1: Workshop Objectives followed by a group picture Organizing Committee

10:00 – 10:30

Health Break All

10:30 – 11:00

Session 2: Health Policy: Access to Essential Medicines in Lesotho and Plenary Discussion

Mrs. Germina Mphoso (MOH Pharmaceutical

dept)

11:00 – 11:30

Session 3: What are the TRIPS flexibilities? How will their incorporation in patent legislation promote access to essential medicines?

Catherine Kirk (UNDP)

11:30 – 13:00

Session 4: TRIPS, flexibilities and access to medicines – Assessment of the IP law and status of implementation of the TRIPS Flexibilities in Lesotho and Plenary Discussion

Lawyers’ team

13:00-14:00

Lunch Break All

14:00-14:30

Session 5: IP Policy Situation Update in Lesotho and Plenary Discussion Ms. 'Mampoi Taoana (Deputy Registrar General)

14:30 – 15:30

Session 6: Panel Discussion on matters arising from Sections 2-5 followed by Plenary Discussion

Members from MOH, Drug regulatory, NDSO, SARPAM, UNDP

15:30 Health Break All

16:00 – 16:45

Session 7: Group discussion and stakeholders feedback on how to improve Access to Medicines in Lesotho

All to divide over 4 subgroups

16:45 – 17:30

Session 8: Plenary feedback of subgroups

Subgroup rapporteurs

17:30 End of Day 1, Logistics and Announcements SARPAM

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Day 2: Thursday 14 August 2014 Venue: Lehakoe Club Conference Centre, Executive Games room, Maseru Chair: Ms. 'Mampoi Taoana, Registrar General's Office - Deputy General Registrar Rapporteurs: Botha Tiheli, Masello Sello

Time Content Responsible

08:30 – 09:00

Session 9: Recap on proceedings of Day 1 Botha Tiheli, Masello Sello (rapporteurs)

09:00 – 09:45

Session 10: National procurement policies and access to medicines and Plenary Discussion

Matebele Sefali (NDSO)

09:45 – 10:30

Session 11: Procurement of patented and other essential medicines: challenges, opportunities and lessons learned in other SADC countries and Plenary Discussion

Wilbert Bannenberg (SARPAM)

10:30-11:00

Health Break All

11:00-11:30

Session 12: Past, current and future production capacity of generic medicines in Lesotho and Plenary Discussion

Gertrude Mothibe (NUL)

11:30 – 12:00

Session 13: Options for national/regional production of generic medicines and Plenary Discussion

Wilbert Bannenberg (SARPAM)

12:00-13:00

Session 14: Plenary Discussion

13:00-14:00

Lunch Break All

14:00-15:00

Session 15: Plenary Discussion on Key Recommendations and Roadmap to utilization of TRIPS Flexibilities related to Public Health

15:00 – 15:30

Workshop Closure Wrap up by Rapporteurs

Official Closure

Final Announcement and Logistics

Health Break

6. Contact details organising committee:

Germina Mphoso, Director Pharmaceuticals, MOH, +266 2222 6226, + 266 57 02 3400, gmphoso@yahoo.com

Masello Agnes Sello, principal legal officer, MOH, M 62874600, masello_sello@yahoo.com

Elia Masilo, Medicines Regulator, eliamasilo@yahoo.com

Representative(s) of Ministry of Law, Registrar General office, and Ministry of Trade

Seona Dillon McLoughlin, HIV & AIDS and Gender Officer, Office: +266 2231 3790, Fax: +266 2231 0042, Cell: +266 57757644, seona.dillon.mcloughlin@undp.org

Phiny Hanson, local SARPAM consultant, M 58772790, Home Tel:+27 51 924 2729, Phiny.hanson@gmail.com

Wilbert Bannenberg, SARPAM, Wilbert@sarpam.net, Tel +27 724762697, skype: wilbertb1