THE IMPLEMENTATION OF TRADE RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (TRIPS) FLEXIBILITIES IN

THE NATIONAL INTELLECTUAL PROPERTY LEGISLATION FOR STRENGTHENING ACCESS TO MEDICINES

IN BOTSWANA

A UNDP-SARPAM-BOTSWANA GOVERNMENT WORKSHOP GABORONE 25-27 MARCH 2013

Workshop report

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Foreword

Botswana played a leading role in the background work in the resulting United Nations Political Declaration on HIV/AIDS of 2011. This document highlights the domestic and international emphasis on achieving universal HIV treatment targets, and the fact that these targets have been agreed upon at the highest political levels of the global community. The declaration also echoes past declarations made under the World Trade Organization (WTO), in particular, aspects of the Doha Declaration (2003) that emphasize the need to strike a balance between the rights of medicines patent holders and public health priorities of developing nations. The Doha Declaration deals with the public health flexibilities of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

We, in Botswana, have gone to put in place new HIV and AIDS policies, targets, treatment guidelines and have availed near universal access to treatment to those who need such treatment. Our aim is to reach Zero HIV infections by 2016 through a multi-sectoral approach as contained in Botswana’s National Operational Plan for HIV and AIDS (NOP, 2012-2016). Implementing this plan, which includes procuring and distributing critical medicines across all districts of Botswana, costs the country hundreds of millions of Pula, and weighs heavily on our national finances. As a developing nation our finances are limited. Although our efforts have been largely preoccupied with tackling communicable diseases, the scourge of non-communicable diseases is also affecting us as a developing nation, these diseases affect all of us, whether or not we are HIV positive.

It is therefore very practical that we should start to look for other means of ensuring that we continue to scale up treatment and prevention within our financial means, and identify strategies which can create meaningful savings for the public purse whilst progressing towards the Zero Infection target.

The legal and policy environment is a significant cost driver of medicines and also determines their accessibility. We therefore welcome the work on the implementation of the TRIPS flexibilities in Botswana with the emphasis on access to affordable essential medicines.

This work would not have been carried out without the invaluable partnership involving the Government of Botswana through the National AIDS Coordinating Agency (NACA), the Ministry of Health, and the Ministry of Trade and Industry on one hand, and the United Nations Development Programme (UNDP) and the Southern African Regional Programme on Access to Medicines and Diagnostics (SARPAM) on the other hand. On behalf of the Government of Botswana I thank these partners and all the workshop participants for guiding us to the strategies to be implemented so that we take full advantage of the TRIPS flexibilities and alternative production and procurement systems for medicines for a healthy Botswana.

Richard K. Matlhare (Mr) National Coordinator National AIDS Coordinating Agency 11 June 2013

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Executive Summary

The Southern African Regional Programme on Access to Medicines and Diagnostics (SARPAM) is a DFID funded regional project that assists SADC member states implement their SADC Pharmaceutical Business Plan 2007-2013 (PBP). Aspects of this pharmaceutical business plan include increasing access to essential medicines to boost public health. Complementing the regional work conducted by SARPAM, in Botswana the National AIDS Coordinating Agency (NACA) with the support of the UNDP Botswana office, conducted a rapid assessment of the laws and policies of Botswana to gauge whether the requirements on intellectual property rights were conducive to increased access to essential medicines. The findings were to be disseminated at a national workshop. SARPAM, the United Nations Development Programme (UNDP), NACA and Ministry of Health (MOH) agreed to collaborate on this workshop given that the rapid assessment and the SARPAM work complemented each other. The UNDP’s interest in this workshop was to provide a platform to share the findings of the TRIPS rapid assessment and obtain broader stakeholder input on a way forward regarding the identified gaps. SARPAM and the UNDP provided financial and technical support for the workshop which was held on the 25-27th March, 2013.

The target audience covered a wide group of stakeholders, including, but not limited to, 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.

The workshop had the following objectives:

To provide a context of the situation in Botswana by disseminating the findings of the situational analysis study and discussing the recommendations with stakeholders from government, health, trade and IP officials, academics, civil society and private sector;

To map the way forward by developing a joint understanding of future policies that support access to medicines, so that these concepts can be included in IP, trade and health/medicines policies; and

To agree to Terms of Reference (TORs) for a multi-stakeholder steering/technical Group on Intellectual Property (IP) and Access to Medicines in Botswana that will both drive and oversee the agenda. 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.

A number of key points and challenges were raised in the ensuing plenary discussions and group work as noted below. The major issues emerging from the discussions were as follows:

The cost of patented medicines is quite high in Botswana;

Not all essential medicines are available as registered products; this affects access to these unregistered products which now need to be imported under a Drug Regulatory Authority (DRA) waiver/exemption;

Delays in accessing cost effective generic pharmaceuticals to Botswana market combined with a weak regulatory system;

Botswana market is a low priority for manufacturers and there are insufficient incentives to attract pharmaceutical manufacturers which results in the absence of local pharmaceutical production.

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The fact that there currently is no real capacity amongst Civil Society Organisations (CSOs) stakeholders to deal with the Intellectual Property Rights (IPR) issues around access to medicines.

There is need to explore the potential of local medicines production, in particular through a feasibility study.

The discussions noted the complementary role which CSOs play in monitoring the use or abuse of patents, and the effect on access to medicines. CSOs recommended that technical capacity is critical to enable CSOs to play this role; and

The technical gaps in the local IP and competition legislation which hamper the effective application of the TRIPS flexibilities.

The workshop participants and the organizers emphasized the significance of the workshop in charting the course of ensuring that all policy and technical issues are addressed in order to increase access to affordable medicines in Botswana. The workshop produced a number of recommendations on specific areas as below:

A Technical Working Group should be established to coordinate the implementation of TRIPS flexibilities in Botswana.

The gaps identified in the Industrial Property Act and the Competition Act should be addressed to facilitate effective application of the TRIPS flexibilities.

Botswana should not lose the use of the TRIPS flexibilities by negotiating them away in free trade agreements.

A feasibility study should be conducted to inform the GoB on the pros and cons of local medicines production inclusive of options for regional collaborations in production.

The CMS should be assisted to identify and implement more efficient procurement strategies such as pooled procurement in collaboration with other agencies in the region.

The IPR office should create a list of patented products and enable the CMS etc to have access to the database.

Technical assistance should be availed to the IPR office to enable efficient enforcement of the Industrial Property Act including the office’ role as a patents examiner.

The technical and financial position of the Drugs Regulatory Unit should be strengthened.

Steps should be taken to harmonize the essential medicines list with the register maintained by the DRU.

The DRU should take steps to provide guidelines for parallel imports of medicines.

Specific capacity building programmes should be created to enable CSOs to better understand and monitor the implementation of TRIPS flexibilities.

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Abbreviations

ARIPO African Regional Intellectual Property Organization (www.aripo.org)

ARV Anti-Retroviral

BONASO Botswana Network of AIDS Service Organizations

BONELA Botswana Network on Ethics, Law and HIV/AIDS (www.bonela.org)

BWP Botswana Pula

CIPIH Commission on Intellectual Property Rights, Innovation and Public Health www.who.int/intellectualproperty

CMS Central Medical Stores

COHRED Council on Health Research for Development (www.cohred.org)

COMESA Common Market for Eastern and Southern Africa (www.comesa.int)

CSO Civil Society Organisation

DFID Department for International Development (www.dfid.gov.uk)

DRA Drug Regulatory Authority

DRU Drug Regulatory Unit

EAC East African Community (www.eac.int)

EQUINET Regional Network on Equity in Health in Southern Africa (www.equinetafrica.org)

FTA Free Trade Agreement

GoB Government of Botswana

ICTSD International Centre for Trade and Sustainable Development (www.ictsd.org)

IP(R) Intellectual Property (Rights)

LDC Least Developed Country

MOH Ministry of Health (www.moh.gov.bw)

NACA National AIDS Coordinating Agency (www.naca.gov.bw)

NEPAD New Partnership for Africa’s Development (www.nepad.org)

PBP [SADC] Pharmaceutical Business Plan

PEPFAR President's Emergency Plan for AIDS Relief (www.pepfar.gov)

SACU Southern African Customs Union (www.sacu.int)

SADC Southern African Development Community (www.sadc.int)

SARPAM Southern African Regional Programme for Access to Medicines and Diagnostics (www.sarpam.net)

SEATINI Southern and Eastern African Trade Information and Negotiations Institute (www.seatini.org)

TORs Terms of Reference

TRALAC Trade Law Centre (www.tralac.org)

TRIPS [Agreement on] Trade Related Aspects of Intellectual Property Rights (www.wto.int)

TTAtM Trade, TRIPS and Access to Medicines

TWG Technical Working Group

TWN Third World Network (http://twnside.org.sg)

UNAIDS United Nations AIDS programme (www.unaids.org)

UNCTAD United Nations Conference on Trade and Development (www.unctad.org)

UNDP United Nations Development Programme (www.undp.org)

WHO World Health Organization (www.who.int)

WIPO World Intellectual Property Organisation (www.wipo.int)

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Table of Contents

1. Background .................................................................................................................................................. 7

1.1 Workshop Objectives .......................................................................................................................... 7

1.2 Target audience ................................................................................................................................... 7

1.3 Preparation Day - 25 March 2013 ....................................................................................................... 8

2. Workshop Day One- 26th March 2013 ......................................................................................................... 8

2.1 Workshop expectations ....................................................................................................................... 8

2.2 Opening Remarks ................................................................................................................................ 8

2.3 Overview of SARPAM and UNDP Botswana ........................................................................................ 9

2.4 Access to Medicines Policy and Issues in Botswana ............................................................................ 9

2.5 Procurement of Patented and Other Essential Medicines ................................................................ 10

2.6 Assessment of the Status of the Implementation of the TRIPS flexibilities in Botswana ................. 10

2.7 Group Work and Plenary Discussions ................................................................................................ 11

3. Workshop Day Two- 27th March 2013 ....................................................................................................... 12

3.1 The SADC Pooled Procurement Strategy ........................................................................................... 12

3.2 Options for Regional Production of Anti-retrovirals using TRIPS article 31bis ................................. 13

3.3 Working Group Reports ..................................................................................................................... 14

3.4 Presentation of the Draft Policy Brief Framework ............................................................................ 15

4. Day Three- 28th March 2013- Senior Level Officials Briefing ..................................................................... 15

5. Workshop Recommendations ................................................................................................................... 15

6. Annexes ..................................................................................................................................................... 18

List of participants ......................................................................................................................................... 18

Bibliography ................................................................................................................................................... 21

Glossary of IP terms ....................................................................................................................................... 26

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1. Background The Southern African Regional Programme on Access to Medicines and Diagnostics (SARPAM) is a DFID funded regional project that assists SADC member states implement their SADC Pharmaceutical Business Plan 2007-2013 (PBP). With the support of SARPAM, on 18 September 2012 SADC member states discussed 2 papers at a regional consultative meeting. The papers were a concept note on “Trade, TRIPS and Access to Medicines: Challenges and Options for the SADC region”, and a paper on “Pharmaceutical Patents, TRIPS Flexibilities and Access to Medicines in Southern Africa Development Community (SADC)”. In addition, a bibliography, glossary and database were presented of legal experts that are willing to support SADC member states fixing 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 Botswana delegation presented a list of interventions to be taken in this regard. In this context one of the Botswana delegation’s requests was a workshop on TRIPS and access to medicines. The SARPAM lead consultant visited Botswana 10-12 December 2012, and met with senior Ministry of Health (MOH) staff, Drug Regulatory Unit, Central Medical Stores and the Registrar of Companies and Intellectual Property to discuss a possible workshop between Trade, IP and Health officials on the impact of TRIPS and national IP Laws on access to medicines. Around this period the Botswana National AIDS Coordinating Agency (NACA), with support from the UNDP was conducting a rapid assessment of the status of implementation of the TRIPS Flexibilities in Botswana. SARPAM, the UNDP, NACA and MOH agreed to collaborate on this workshop given that the rapid assessment and the SARPAM work complemented each other. The UNDP’s interest in this workshop was to provide a platform to share the findings of the TRIPS rapid assessment and obtain broader stakeholder input on a way forward regarding the identified gaps. SARPAM and the UNDP provided financial and technical support for the workshop which was held on the 25-27th March, 2013.

1.1 Workshop Objectives

The workshop had the following objectives:

To provide a context of the situation in Botswana by disseminating the findings of the situational analysis study and discussing the recommendations with stakeholders from government, health, trade and IP officials, academics, civil society and private sector;

To map the way forward by developing a joint understanding of future policies that support access to medicines, so that these concepts can be included in IP, trade and health/medicines policies; and

To agree to TORs for a multi-stakeholder steering/technical Group on IP and Access to Medicines in Botswana that will both drive and oversee the agenda. 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.

1.2 Target audience

The target audience covered a wide group of stakeholders, including, but not limited to, public officials, civil society, industry, academia, patient and professional groups from a variety of sectors, including the public

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health, science, education, economic, industrial and innovation policy and practice sectors. A full list of the participants and officials who were consulted in this context is attached hereto. The report below captures the deliberations as well as the recommendations arising from each specific session/discussion.

1.3 Preparation Day - 25 March 2013

The workshop organisers held a series of planning session on the 25th of March 2013.

The major event on this date was a special TRIPS and access to medicines briefing for representatives of civil society in Botswana. This special briefing was designed to give enough space for civil society to be updated on the major issues regarding TRIPS and access to medicines and public health in general, and to enable civil society to articulate their concerns, including specific needs with respect to the subject matter. The main civil society organisations offering support and coordination in the context of HIV and AIDS were represented at this briefing.

A key outcome of this briefing session was the need to address knowledge and capacity gap in civil society understanding of the TRIPS and public health issues if civil society in Botswana is to be able to make a contribution to the implementation of TRIPS flexibilities in the country.

2. Workshop Day One- 26th March 2013

2.1 Workshop expectations

Mr. Peter Chibatamoto of NACA explained the workshop objectives to the participants and invited them to state their expectations. The following expectations were identified by the participants:

That there will be dialogue on how government will continue helping the poor to access essential

medicines;

That the role of Civil Society Organisations (CSOs) will be well defined and CSO capacity on dealing

with the TRIPS flexibilities will be enhanced, so that CSOs can conduct proper advocacy on the

issues;

The creation of a platform for networking amongst key stakeholders such as CSOs, academics, UN

and government agencies;

To gain more knowledge on the TRIPS flexibilities and what laws need to be changed or introduced

and also to identify training opportunities for lawyers;

That the issue of patents will be unpacked and simplified;

To understand what the government commitment is on legal reforms; and

To understand the government’s long term strategy on TRIPS.

2.2 Opening Remarks

In his opening remarks the Coordinator for NACA, Mr. Richard Matlhare noted the significance of the 2011 UN Political Declaration on HIV/AIDS, and the leading role which Botswana played in getting the UN members to agree on a number of commitments contained in that policy document. He highlighted the following key points:

o The domestic and international emphasis on achieving universal HIV treatment targets;

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o The importance of sensitive TRIPS laws;

o The need to promote generic drugs competition in the quest for cheaper medicines; and

o The need to sustain gains already made on HIV/AIDS access to treatment in light of the

increased CD4 threshold (from 250 to 350) for eligibility to the Botswana national ARV

treatment programme.

He noted the national response strategy is largely supported by public funds although international development partners also make a contribution and stressed that implementing TRIPS flexibilities and the options therein may assist the country in terms of cost measures and requested the workshop participants to reflect on this critical development problem and identify appropriate solutions.

2.3 Overview of SARPAM and UNDP Botswana

Dr. Wilbert Bannenberg and Ms. Tinaye Mmusi gave a brief overview of the work programmes of SARPAM

and the UNDP Botswana respectively. Dr. Bannenberg noted that 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 SARPAM work programme include:

A regional assessment of intellectual property and medicines legislation in countries to

determine their TRIPS compliance and adaptability;

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;

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.

Ms. Mmusi noted that as part of the UN family Botswana also benefits from technical and financial support for its public health interventions, notably the national HIV/AIDS response strategy where the UNDP has been supporting various strategies coordinated by NACA. She noted that one of the recent interventions was support for NACA to conduct a rapid assessment of the implementation of the TRIPS flexibilities in Botswana.

2.4 Access to Medicines Policy and Issues in Botswana

Mr. Botsang John explained the regulatory role played by the Ministry with respect to access, quality, production and distribution of medicines in Botswana. He noted that it is the Ministry’s role to ensure a safe, secure, cost effective and efficient drug distribution system to enhance accessibility and availability of essential medicines at all health facilities. He observed that patented medicines are expensive especially drugs for oncology (cancer), cardiovascular diseases, second and third antiretroviral medicines and stressed that the harmonization of medicines and intellectual property legislation with the TRIPS is necessary for improving access to medicines. He raised the following issues as requiring intervention to enable the country to achieve a sustainable medicines provisions system:

• Ensuring Bilateral Trade Agreements do not hinder full exploitation of TRIPS flexibilities; • Implementing the SADC Pooled Procurement Strategy to increase access; and • Strengthening Medicines Supply Chain System and Medicines Regulatory Authority.

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2.5 Procurement of Patented and Other Essential Medicines

(Ms. Merapelo Baruti, Central Medical Stores (CMS))

The presentation by the CMS covered the following issues: Drug Supply Chain Management, Product Sourcing, Contract Management, and challenges facing the procurement and distribution system. The presenter noted that there are over 1,500 products on the CMS catalogue including Special Orders (non-

stockable items) with a budget (2012-13) of BWP700m ( USD 95m) broken down as follows:

• BWP 408 million for Essential Meds and Dressings; • BWP 238 million for ARVs and Lab commodities (NACA) + Merck Donation; and • BWP17 million for ARVs (PEPFAR) & Training.

All stocked products (642 product lines) are planned to be on 2-years framework contracts. Commonly used methods of procurement are Open domestic tender (which is the default method of procurement), Restricted tendering, Direct procurement, Quotations proposal method and the Micro-procurement method. The CMS faces the following significant challenges in procuring essential medicines:

• High cost of drugs; • Lack of local manufacturers that may assist in shortening turn-around times for delivery; • Some products on the list are not registered by the Drug Regulatory Authority (DRA) • Lack of knowledge about which products on the essential drugs list are protected by valid patent • Lack of access to patent data base.

2.6 Assessment of the Status of the Implementation of the TRIPS flexibilities in Botswana

Ms. Catherine Kirk

Ms. Catherine Kirk presented an overview of the key aspects of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in the context their implications for public health. She gave an outline of why patents are filed and what purpose they are meant to serve.

The presenter also identified the public health related TRIPS flexibilities and put them in the context of Botswana’ status as a middle-income country. An outline with specific examples was also presented with respect to the nature of public finance savings the implementation of TRIPS flexibilities can achieve with examples drawn from the leading developing countries that have implemented these flexibilities. She stressed that using the flexibilities can make medicines affordable and noted that countries should be mindful of not imposing more onerous Intellectual Property Rights (IPR) requirements than the TRIPS agreement requires.

Mr. Elijah Munyuki

Mr. Munyuki presented the results of the rapid assessment of the status of the implementation of the TRIPS flexibilities in Botswana. The study assessed the local policy context for IPRs and public health, the legal environment, linkages with Botswana’s international trade obligations/negotiations, the gaps and challenges, and made a number of recommendations for the country to better exploit the TRIPS flexibilities for public health gains. The presenter noted that by passing the Industrial Property Act (2010) and the Industrial Property Act Regulations which came into effect in 2012 the country has domesticated the key

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TRIPS flexibilities including compulsory licensing, parallel importation, pre- and post-patent challenges, patent examination and a list of exclusions from patentability. The key challenges noted were:

Some inconsistent legal provisions, particularly the complete exclusion of IPRs issues from the competition legislation resulting in the prospect of anti-competitive practices going unchecked in the medical drugs industry and services.

Botswana has also legislated an unnecessary TRIPS-plus by criminalising patent infringements which goes against accepted international practice and dissuades innovation and flexible procurement since the fear of criminal law is real in this case.

The fact that the regulator can conduct patent examinations in a scientific manner but that this process can also be circumvented through the use of ministerial powers that permit the minister to designate certain applications for patents as unexaminable by the regulator. Further the powers granted to the regulator in the context of patent examination require the office of the regulator to be capacitated technically and financially in order for these powers to be fully implemented.

The omission (possibly a mere oversight by the drafters of the regulations) of a procedure for filing patent grant oppositions by interested persons.

In the context of Free Trade Agreements the presenter noted that Botswana is a party to the European Free Trade Area (EFTA) - Southern African Customs Union (SACU) FTA (the EFTA-SACU FTA). He observed that the agreement commits the SACU and EFTA countries to continuing trade liberalization negotiations which include the objective of harmonizing intellectual property rules between the SACU and EFTA blocs. He highlighted the fact that the gains made under the legislation will be reversed drastically if Botswana goes ahead to harmonise its IPR laws and policies with those of the EFTA countries as these countries apply IPR laws that incorporate a range of TRIPS-plus commitments and hence which reflect higher conditions than those under the TRIPS flexibilities.

The presenter highlighted some options for cheaper access to medicines such as pooled procurement, local production, shared use of existing manufacturing facilities in the region, and other potential options. He stressed the need for a feasibility study which explores these possibilities, particularly local production as this requires careful legal, economic and market assessments before manufacturing is done.

Registrar of Intellectual Property

A presentation on the structure, focus, and content of the office of the Registrar of Intellectual Property of Botswana was also made. The presentation focused on key operational issues as follows:

The office is now expected to implement the new legislation in the context of the Industrial Property Act and with all new laws some period for adjustment and learning is necessary.

Enforcing the legislation requires additional skills and extra resources as new responsibilities have been added to the office.

Though provisions such as compulsory licensing have always been part of Botswana IPR laws patent examination is a new area which the office is expected to conduct and that this requires capacity building in the area of patent examination as well as financial resources.

2.7 Group Work and Plenary Discussions

A number of key points and challenges were raised in the ensuing plenary discussions and group work as noted below. The report combines the issues raised in the plenary session with the group reports as there was considerable overlap of issues. The major issues emerging from the discussions were as follows:

The Pharmaceuticals Group raised a number of priority issues that require immediate, short and medium term attention as follows:

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The cost of patented medicines is quite high in Botswana;

Not all essential medicines are available as registered products; this affects access to these unregistered products which now need to be imported under a DRA waiver/exemption;

Delays in accessing cost effective generic pharmaceuticals to Botswana market combined with a weak regulatory system;

Botswana market is a low priority for manufacturers and there are insufficient incentives to attract pharmaceutical manufacturers which results in the absence of local pharmaceutical production,

Limited efforts in coordinating and implementation of TRIPS flexibilities;

Lack of understanding of various statutes by health technocrats on the impact of TRIPS flexibilities;

Lack of harmonisation of different legal instruments with respect to the TRIPS flexibilities, this requires harmony between the Industrial Property Act and the relevant sector specific legislation such as the drugs laws; and

Poor information exchanges between the private and public medicines’ sectors.

The Civil Society Group emphasised the following challenges:

The fact that there currently is no real capacity amongst CSO stakeholders to deal with the IPR issues around access to medicines.

The group noted the complementary role which CSOs play in monitoring the use or abuse of patents, and the effect on access to medicines. CSOs recommended that technical capacity is critical to enable CSOs to play this role.

The group stressed that the absence of technical capacity in CSOs made it very difficult for CSOs to engage with the Industrial Property Act or the relevant World Trade Organisation modalities such as the TRIPS agreement.

The Group on Legislation and Trade identified challenges hampering implementation of TRIPS flexibilities in Botswana. In view of the sector specific nature of this group the challenges identified were basically the same as those reported under the NACA-UNDP rapid assessment study that are reflected under paragraph 2.1.6.2. of this report. However the group highlighted the need for capacity building to be a core intervention to enable key private and public legal professionals and trade negotiators to be adept at utilising the TRIPS flexibilities and to enforce IPR laws for local development purposes.

3. Workshop Day Two- 27th March 2013

3.1 The SADC Pooled Procurement Strategy

Mrs. Aarti Patel of SARPAM presented an overview of the SADC Pooled Procurement Strategy for Essential Medicines and Health Commodities (2013-2017). She highlighted:

The key points, objectives and issues related to this strategy as one of the options for reducing the costs of medicines by creating economies of scale through collaboration in procurement by the SADC member states.

That there are opportunities for increasing market efficiencies through regional approaches to procurement such as pooled procurement including applying ‘good practices’ in the pharmaceutical procurement and supply management systems.

That with pooled procurement, savings can be made through information and work sharing by procurement agencies in Member States. With the savings more funds become available for

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procurement, which will increase availability of and access to essential medicines and Health Commodities.

Market regulation is also expected to be improved through information sharing on product quality and supplier performance.

3.2 Options for Regional Production of Anti-retrovirals using TRIPS article 31bis

(Mr. Wilbert Bannenberg, SARPAM and Mr. Elijah Munyuki, Consultant)

Mr. Wilbert Bannenberg explained the options available for Botswana in the context of the possibilities for local production under compulsory license and export under article 31bis of the TRIPS Agreement. He emphasised that domestic production, for example, through compulsory licences was fraught with legal and economic difficulties which make it very difficult for the country to attempt to implement this option owing to the small size of the market and Botswana’ status as a TRIPS compliant country. The following key points were raised as challenges to local production:

Botswana is a small market and this does not justify the investment necessary for local production.

Central Medical Stores and importers buy from SADC, India, etc whilst local production can play a role, it still has to compete with imported medicines from established manufacturers who have pricing advantages.

Not all essential medicines are registered and this is a problematic information gap.

Raw materials (active pharmaceutical ingredients which are 80% of value) still need to be imported.

Generics are mostly off-patent; but new ARVs which are critical for the second and third lines of treatment are patented and this creates problems such as having to negotiate and pay for expensive licences for local production to happen.

He stressed the point that Botswana is better off collaborating with other SADC member states, particularly the least-developed countries (LDCs) to make use of existing or planned pharmaceutical production facilities in a regional context as envisaged by the SADC Pharmaceutical Manufacturing Business Plan. He noted that exporting medical drugs produced in the context of the WTO August 30th Decision was a theoretical possibility but added that it is very unlikely that Botswana could do this better than Canada, EU, India etc, which found this not economically feasible. He noted that the procedure has too many administrative hurdles and has only been attempted once in the context of Rwanda and Canada collaboration. As an alternative to local or regional production, the presenter stressed that the use of pooled procurement information systems can also achieve cost savings.

Mr. Elijah Munyuki analysed the background, meaning and intention of article 31bis of the TRIPS Agreement and noted that:

One of its clear aims is to achieve economies of scale for developing countries through the implementation of options such as scaling up local production and circulation in the regional economic community.

Local production has been identified as an option worth assessing in Botswana’s Revised National Health Policy and that the conditions in the SADC region are such that the region qualifies to utilise article 31bis of the TRIPS agreement.

The operation of this provision at a regional level requires combined policy cohesion and coherence amongst the SADC member states at a WTO level, and that such cohesion has not been evident particularly in the context of extending the development friendly TRIPS flexibilities.

He further noted that the key point for Botswana is not to dismiss the possibility of local production as an option, but to invest resources into a thorough feasibility study that also learns from the

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experiences of other countries such as Tanzania and Uganda and produce evidence-based recommendations.

Participants noted the challenges that affect local production. The ensuing discussion agreed that there are economic and technology issues to consider before the country can adopt local production, but equally that there could be gains to be realized from the context of economic diversification. Participants also noted that the country may not necessarily be interested in manufacturing branded medicines which are still patented in which case the patent fees and licence hurdles would not apply.

The recommendation was that it is important that a feasibility study should be conducted to assess the potential of local production as one of the options available to Botswana in the case of affordable medicines.

3.3 Working Group Reports

The participants were further presented with specific issues to discuss and produce recommendations thereon. Key issues arising from this exercise were:

The Group on Trade, Industry and Legal aspects considered the TRIPS Flexibilities implementation in the context of addressing shortcomings in the Industrial Property Act. A debate on whether or not the Industrial Act is right to criminalise patent infringements ensued; most delegates agreed that it is not appropriate and it is self-defeating to keep this provision in the legislation, and that it should be repealed.

The Group on Access to medicines made a number of observations and recommendations on the systems applicable to medicines procurement and production. These were on:

o Lack of procedures for assessing quality of parallel imported medicines. Drugs authority to produce guidelines for such imports.

o Weak medicine supply chain systems which need to be improved. Need for CMS to outsource medicines distribution.

o Addressing capacity problems at the Drug Regulation Authority, the group urged semi-autonomy for this regulator since this may allow the authority to increase staff and improve staff conditions; at the moment the authority is a unit within the government which depends on state handouts. An autonomous authority can self sustain by charging drug registration fees plus strategies like 1-2% fee on quality assurance tests; and

o The necessity for a Feasibility study for local production.

The Group on Terms of Reference for the Technical Working Group on TRIPS Flexibilities produced very detailed guidelines on this working group whose purpose is to create a coordinated trade and public health operational environment with the objective of monitoring the implementation of the flexibilities. Very detailed TORs were produced with an organisational structure and procedural guidelines. The major outstanding issue was where this Group will be housed and its reporting modalities. NACA was deemed ideal but the problem is that this agency deals only with HIV and AIDS. The Ministry of Health was also recommended as it deals with broader health issues. It was recommended that the Law Society of Botswana should be brought in as a member of this group and that the Legislative Drafting Division of the Attorney General’s Office should also be included.

The Group on the Options for Regional Cooperation noted that there already is a regional platform on this in the context of the SADC Pharmaceutical Manufacturing Business Plan. The group recommended that the SADC member states should concentrate on strategies for regional selection of medicines before pooled procurement is implemented. The group also recommended the pooling of pharmaceutical experts within the region.

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3.4 Presentation of the Draft Policy Brief Framework

(Mr. E. Munyuki)

The workshop recommended that a technical policy brief should be produced as a tool to guide Botswana towards a more enhanced implementation of the TRIPS flexibilities. As such Mr. E. Munyuki was tasked with presenting the outline/framework of the proposed policy brief. The presenter highlighted the general purpose behind policy briefs and outlined the essential issues that would be addressed therein. These issues were:

The problem statement: what general problem is the policy brief addressing? In this case access to cheap medicines in the context of the TRIPS flexibilities.

What are the specific policy problems? These include the cost to the country of financing the medicines component of the public health policy objectives, the laws in place and policy issues.

What are the gaps and challenges related to the resolution of the specific problems?

How can these be addressed at policy level? What needs to be done, by whom and when.

4. Day Three- 28th March 2013- Senior Level Officials Briefing

The facilitators and the workshop secretariat met with senior government, private, CSO and international development partners at the UNDP to brief them on the outcome of the workshop. The meeting was hosted by UNDP Resident Coordinator Mr. Anders Pedersen, and chaired by the UNAIDS Country Coordinator Mr. Gang Sun. In his welcoming remarks the UNDP Resident Coordinator stressed the need for the project to produce clear recommendations which identify the public finance and health benefits of implementing the TRIPS flexibilities. Such recommendations should ideally be in the form of a roadmap towards a tangible outcome on implementation of the TRIPS Flexibilities. He added that such assessments should also be reflected in the policy brief which was recommended by the workshop as a key deliverable of the deliberations and noted that the assessments should be shared with the Botswana public finance authorities.

The meeting was briefed on the workshop proceedings and outcomes by Mr. Wilbert Bannenberg and Mr. Elijah Munyuki. The recommendations from the workshop deliberations were outlined. It was noted that the recommendations were practical and should be implemented in a manner that shows that some prioritisation has been made, in particular, that immediate, short, medium and long term objectives have been identified. The Coordinator for NACA also stressed that the recommendations contained issues that can also be addressed in the short term and that do not require protracted debate.

With respect to the creation of a technical working group on the implementation of the TRIPS flexibilities it was noted that there already is in existence a technical committee on the enforcement of IPRs in Botswana and that this is a multi-stakeholder group served by the Ministry of Industry and International Trade. The meeting recommended that there should not be any duplication of efforts and that the proposed terms of reference for the proposed working group should be streamlined to ensure that it complements rather than competes with the existing technical committee.

5. Workshop Recommendations The table below identifies the recommendations derived from the workshop. The recommendations are grouped according to specific topics for ease of reference.

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Subject Matter

Action Items Timeframe Responsibility

1. Implementation Arrangements.

A Technical Working Group (TWG) should be formed which will coordinate and monitor the implementation of TRIPS flexibilities in Botswana.

Draft Terms of Reference should be produced for the TWG.

TWG work programme should focus on the next 6-18 months to deliver on its objectives.

The TWG is to be formed after careful assessment of the objectives of the existing committee on Intellectual Property Rights as formed under the aegis of the Ministry of Industry & Trade.

The assessment should consider how to the TWG is to complement rather than compete with this committee.

Immediate

Immediate

Short-term

Short-term

NACA, MOH, MOT with support from UNDP, SARPAM

2. The Enabling Environment 2.1. Legal Reform (Industrial

Property Act and Competition Act)

2.2. Trade Relations

Ensure that patent examiners develop stringent criteria for the application of s8 in the context of applications for secondary patents by developing operational guidelines.

Amend the Regulations by providing for a section along the lines of s41 to cover the process for the filing of objections to applications for patents.

Repeal Section 22(2) of the Act as it gives ministerial powers to interfere in the scientific examination of patent applications.

Repeal s134(4) which criminalises patent infringements.

Section 3 (a) of the Competition Act should be amended to create a more holistic approach to dealing with anti-competitive practices in the IPR system in general.

Harmonise the IPR legislation with other relevant health sector laws e.g. drugs and medicines laws.

Create training programmes to enable public health, trade, CSOs and IPR officials to better understand the legal and trade context of TRIPS flexibilities.

Botswana should not agree to the harmonisation of IPR laws in the context of the EFTA-SACU-FTA or any trade agreement that erodes the TRIPS flexibilities.

Short-to-medium

By 2014

TWG

TWG

MOT as facilitator, UNDP, MOH as advocates.

TWG/MOH, MOT

3. Production & Procurement 3.1. Local Production 3.2. Regional Production 3.3. Options for Procurement 3.4. The CMS

A feasibility study should be conducted to inform the GoB on the pros and cons of local medicines production inclusive of options for regional collaborations in production.

The CMS should be assisted to identify and implement more efficient procurement strategies such as pooled procurement in

Medium term

TWG

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collaboration with other agencies in the region.

Create and maintain a list of products which are subject to patents.

The CMS should have access to the patents database.

The CMS should collaborate with other medicines procurement agencies in the SADC region to produce a regional list of essential medicines before implementing the regional pooled procurement strategy.

The CMS should collaborate with other medicines procurement agencies in the SADC region to exchange operational information and expertise.

CMS should take steps with the MOH to advance the SADC Pooled Procurement Strategy and achieve cost savings.

Medium Term

TWG/CMS

4. Capacity of the IPR Regulator The IPR office should create a list of patented products and enable the CMS etc to have access to the database.

Technical assistance should be availed to the IPR office to enable efficient enforcement of the Industrial Property Act including the office’ role as a patents examiner.

Officers should be assisted with training, including study visits to equip them with the necessary experience.

Short-Medium Term

TWG/IPR/MOT with support from UNDP

5. Medicines Regulator The technical and financial position of the Drugs Regulatory Unit should be strengthened.

Assist the GoB in the process of granting the DRU autonomous status as a drugs regulatory authority which can then raise its own income.

Enhance the DRU’s collaboration with other regulators on the harmonisation of regulations at regional and continental levels.

Take steps to harmonise the essential medicines list with the register maintained by the DRU.

The DRU should take steps to provide guidelines for parallel imports of medicines.

Short-Medium Term

TWG/MOH

6. Civil Society Organisations Create specific capacity building programme to enable CSOs to better understand and monitor the implementation of TRIPS flexibilities.

Short-Medium-Long Term CSO Forum/TWG/MOT with support from UNDP, SARPAM, NACA, CSO Forum, Law Society

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6. Annexes

List of participants

First name Surname Official Designation Organisation Office phone Email address

Wilbert Bannenberg TTAtM Pact Lead SARPAM +27(11)8806993 wilbert@sarpam.net

Aarti Patel TA: SADC Pharmaceutical Programme SARPAM 3641838 aarti@sarpam.net

Merapelo Barugi Deputy Manager - Procurement CMS (MOH - Botswana) 3904035 mbbaruti@gov.bw

Muhammad Farooq Chohan Manager CMS (MOH - Botswana) 3903823 mchohan@gov.bw

Nkaelang Modutlwa Principal Pharmacist MOH - Botswana 3632830 nmodutlwa@gov.bw

Keatlaretse Dintle Principal Trade Officer International Trade Department 3190243 kedintle@gov.bw

Wema Isa- Molwane Deputy Executive Secretary Law society of Botswana 3900200 wmolwana@lawsociety.org.bw

Nesredin Jami Oumer PHS MOH - Botswana 3632397 nesredin@gmail.com

Botsang John Deputy Director Clinical services, MOH 3632085 jbotsang@gov.bw

Bathusi Kgosietsile Pharmacy Manager Botswana Medical Aid society 3633275 bathusix@yahoo.com

Catherine Kirk Consultant UNDP +1(212)9066611 catherine.kirk@undp.org

Tinaye Mmusi Programme Analyst UNDP 3633700 tinaye.mmusi@undp.org

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Heston Phillips Strategic Intervention Advisor UNAIDS phillipsh@unaids.org

Gang Sun UNAIDS Country Coordinator UNAIDS sung@unaids.org

Tebogo Madidimalo Programme Officer WHO 3905593 madidimalot@who.int

Nametso Makepe Commercial Officer Registrar of Companies and Intellectual Property 3673700 maxxmillan@yahoo.com

Malebogo Selemogo Commercial Officer Registrar of Companies and Intellectual Property 3673700/40 mselemogo@gmail.com

Richard Matlhare National Coordinator NACA 3710314 rmatlhare@gov.bw

Lefetogile Bogosing Chief Programme Planning Officer NACA 3710314 lbogosing@gov.bw; lbogosing@yahoo.com

Peter P. Chibatamoto Policy Advisor NACA 3710314 pchibatamoto@gov.bw; pchibatamoto@yahoo.com

Bonnet Mkhweli Development Assistance Coordination Advisor NACA 3710314 bmkhweli@gov.bw

Matshediso Matome Manager Associated Fund Administrators 3650570 matshedisom@afa.co.bw

Kesego Modongo Legal and Enforcement Officer Competition Authority 3712013 kesego.modongo@competitionauthority.co.bw

Emmanuel Narona Mokgano Journalist Broadcast Radio Botswana 3653232 rbnews@gov.bw

Refilwe Sarona Mosarwa State Counsel Attorney General Chambers 3613963 rmosarwa@gov.bw

Nametso Mothoka Principal Legislative Attorney General Chambers 3613676 nmothoka@gov.bw

Felistus Motimedi Programme Coordinator BONELA 3932516 felistusm@bonela.org

Keikantse Elizabeth Phele Legal Officer BONELA 3932516 phelek@bonela.org

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Thato Motlotlegi Trade Officer DIT 3190243 tmotlotlegi@gov.bw

Oscar Motsumi Executive Director BONASO 3908450 oscar.motsumi@gmail.com

Thabo Mphothwe Information Management officer Botswana Business Coalition on Aids 3164926 thabo@bbca.org.bw; mphothweta@yahoo.com

Elijah Munyuki Consultant Tri - African Advisory services 71960518 elijahmunjuki@yahoo.com

David Chizalo Ngele Executive Director BOHEPWAF 3906224 davidngele@yahoo.co.uk

Una Ngwenya Chief Executive Officer Botswana Family welfare Association 3900486 unangwenya@bofwa.org.bw

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Velasquez, G., and P. Boulet. “Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement.” Revised. DAP 7, WHO/DAP/98.9, WHO, Geneva, 1999. (also in French and Spanish) http://apps.who.int/medicinedocs/en/d/Jwhozip35e/

World Intellectual Property Organization (WIPO) 2010. Patent related flexibilities in the multilateral legal framework and their legislative implementation at the national and regional levels. CDIP/5/4. Geneva, WIPO. http://www.wipo.int/meetings/en/details.jsp?meeting_id=19686

World Health Organization (WHO) 2006. Report of the Commission on Intellectual Property Rights, Innovation and Public Health, 131. Geneva, WHO. http://www.who.int/intellectualproperty/report/en/index.html

World Health Organization (WHO) 2008a. Global strategy and plan of action on public health, innovation and intellectual property, World Health Assembly Resolution 61.21. Geneva, WHO. http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf

World Health Organization (WHO) 2008b. Improving access to medicines in Thailand: the use of TRIPS flexibilities: report of a WHO mission, Bangkok, 31 January to 6 February 2008. Geneva, WHO. http://www.moph.go.th/hot/THAIMissionReport%20FINAL15feb08.pdf

WEBSITES

http://www.wipo.int/ip-development/en/agenda/flexibilities/resources/who.html

http://www.wipo.int/ip-development/en/agenda/flexibilities/resources/unctad.html

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Report of a workshop in Gaborone, 25-27 March 2013 26

Glossary of IP terms

Glossary of Intellectual Property Rights’ terms1

Bolar (early working) exception: An exception to patent rights allowing a third party to undertake, without the

authorization of the patentee, acts in respect of a patented product necessary for the purpose of obtaining marketing approval for the sale of a product. Compulsory Licence: A licence to exploit a patented invention granted by the state upon request to a third party, for

instance in order to remedy an abuse of rights by the patentee.

Copyright: Exclusive rights of the creators of original literary, scientific and artistic works, which are created, without

formalities, with the creation of the work, and last (as a general rule) for the life of the creator plus 50 years (70 years in the US and EU). It prevents unauthorised reproduction, public performance, recording, broadcasting, translation, or adaptation, and allows the collection of royalties for authorised use.

Counterfeit medicines: Medicines which are deliberately and fraudulently mislabelled with respect to identity or source.

Counterfeiting can apply to both branded and generic products. Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging. Cross-licensing: The mutual exchange of licences between patent holders. Data exclusivity: A legal provision that data collected (e.g. the results of clinical trials) for the purpose of obtaining

marketing approval may not be used for a specified period by the regulatory authorities to grant approval to a generic equivalent. Data protection: An obligation imposed on third parties to protect test data (e.g. the results of clinical trials) – usually

collected in order to comply with government regulations on the safety, efficacy and quality of a broad range of products (e.g. medicines, pesticides, medical devices). For example, TRIPS provides for the protection of such data against unfair commercial use. Differential pricing: The practice of setting different prices for different markets, typically higher prices in richer markets

and lower prices in poorer markets. Disclosure of origin: Requirement on patent applicants to disclose in patent applications the geographical origin of

biological material on which the invention is based. Doha Declaration (on TRIPS and Public Health): Declaration, agreed at the Doha WTO Ministerial Meeting in 2001,

which states that to the TRIPS agreement should be interpreted and implemented in a way that supports public health and clarifies some flexibilities allowed by the Agreement for that purpose.

Evergreening: Evergreening is a term popularly used to describe patenting strategies that are intended to extend the

patent term on the same compound. Examination: The examination of the patent application, undertaken by a patent examiner, to determine whether the

application complies with all the legal requirements for patentability set out in the legislation. Examination, Substantive: A full examination of the patent application, undertaken by a patent examiner, to determine

whether the application complies with all the legal requirements for patentability set out in the legislation. The examination takes into account any documents found during the search.

Exhaustion of rights: Principle whereby the right holders’ intellectual property rights in respect of a product are

considered exhausted (i.e. he or she can no longer exercise any rights) when that product has been put on the market by the right holder, or by an authorized party. Fair Use or Fair Dealing: An exception to copyright allowing third parties to use the copyrighted material in certain

circumstances. National copyright laws in most countries incorporate exceptions for copying for personal use, research, education, archival copying, library use and news reporting, based on principles of ‘fair dealing’, or ‘fair use’ (US).

Incremental innovation: Innovation which builds incrementally on previous innovation, as compared with “breakthrough”

innovation, a completely novel means to prevent, treat or cure a particular disease.

1 Extracted from the WHO/CIPIH report on public health, innovation and intellectual property rights 2006, and from the UK

Commission on Intellectual Property Rights, 2nd

edition, 2002.

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Report of a workshop in Gaborone, 25-27 March 2013 27

Intellectual property rights: Rights awarded by society to individuals or organizations over inventions, literary and artistic

works, symbols, names, images, and designs used in commerce. They give the titleholder the right to prevent others from making unauthorized use of their property for a limited period. Multisource: Multisource pharmaceutical products are pharmaceutically equivalent products that may or may not be

therapeutically equivalent. Multisource pharmaceutical products that are therapeutically equivalent are interchangeable.2

Parallel Imports: The import of a patented product from another country once it has been put on the latter’s market by the

titleholder, or other authorised party. For instance, in the EU it is legal to buy a product from a wholesaler in Portugal to retail in the UK, although the product is patented in both countries. The legal status of parallel imports is a matter for national decision, and is related to the issue of the Exhaustion of Rights.

Patent: An exclusive right awarded to an inventor to prevent others from making, selling, distributing, importing or using

the invention, without licence or authorization, for a fixed period of time. In return, the patentee discloses the invention to the public. There are usually three requirements for patentability: novelty (new characteristics which are not “prior art”); inventive step or non-obviousness (knowledge not obvious to one skilled in the field); and industrial applicability or utility. Patent pools: An agreement between two or more patent owners to license one or more of their patents to one another or

third parties. Prior art: Publications or other public disclosures made before the filing (or priority) date of a patent application against

which the novelty and inventiveness of the invention in the patent application is judged. Registration: A formal procedure for obtaining an IP right typically requiring an application and examination of that

application. Certain IP rights such as copyright are available automatically without the need for registration. Patent applications in some countries may simply be registered after a basic check.

Regulation: Typically refers to the process by which a governmental authority reviews medical interventions for marketing

authorization. Although methods vary, this normally involves determination of product safety, quality and efficacy. Regulation also involves ongoing monitoring and evaluation of safety, efficacy and quality of products that have already obtained marketing authorization. Reverse Engineering: Process of evaluating something to understand how it works in order to duplicate or enhance it.

Particularly relevant in the copyright field where reverse engineering of software may be necessary to ensure interoperability with other programs. Also relevant, for example, to semiconductors and the production of generic medicines.

Search: A search of the prior art by a patent examiner, which brings to the patent applicant’s attention documents which

are thought by the patent examiner to establish whether the invention in the patent application is novel and inventive. Primary search material is the disclosures in other patent applications, but all forms of prior art in principle should be covered.

Sui generis: Latin expression meaning “of its own kind”. Data exclusivity is a sui generis form of intellectual property protection. 'Swiss claims': Claim for the use of a substance or composition that has already been used for medical purpose for a

'specified new medical purpose'.3

Trade secret: Commercially valuable information about production methods, business plans, clientele, etc. They are

protected as long as they remain secret by laws which prevent acquisition by commercially unfair means and unauthorized disclosure.

2 WHO prefers the term “multisource” rather than “generic” which can be multi-interpretable.

3 http://www.iponz.govt.nz/cms/patents/patent-topic-guidelines/2004-business-updates/guidelines-for-the-examination-of-swiss-

type-claims