04/11/2304/11/23 11

International Politics of Intellectual International Politics of Intellectual Property Rights: An African PerspectiveProperty Rights: An African Perspective

Enga Kameni,Enga Kameni,Access to Medicines Coordinator, and Doctoral Candidate, Access to Medicines Coordinator, and Doctoral Candidate,

International Development Law Unit, Centre for Human Rights, International Development Law Unit, Centre for Human Rights, Faculty of Law, University of Pretoria, South AfricaFaculty of Law, University of Pretoria, South Africa

LL.M Student, Harvard Law SchoolLL.M Student, Harvard Law SchoolEmail: Email: kameni19@yahoo.com or ienga@llm10.law.harvard.edu or ienga@llm10.law.harvard.eduNB: Some materials sourced from Cecilia Oh and Tenu Avafia.NB: Some materials sourced from Cecilia Oh and Tenu Avafia.

OverviewOverview

August 30 DecisionAugust 30 Decision Free Trade AreasFree Trade Areas Anti Counterfeiting LegislationAnti Counterfeiting Legislation

04/11/2304/11/23 22

04/11/2304/11/23 33

OverviewOverview

FTAs and TRIPS-plus provisionsFTAs and TRIPS-plus provisions US-SACU FTA (failed) and EU-ACP EPA US-SACU FTA (failed) and EU-ACP EPA

negotiationsnegotiations How will they affect access to medicines How will they affect access to medicines

and prices?and prices? Lessons learnt and possible strategies Lessons learnt and possible strategies

04/11/2304/11/23 44

TRIPS Plus provisionsTRIPS Plus provisions

Strengthen IP rights protection beyond the Strengthen IP rights protection beyond the minimum standard of the TRIPS Agreementminimum standard of the TRIPS Agreement

TRIPS-plus provisions have the general TRIPS-plus provisions have the general effect of extending the patent life beyond effect of extending the patent life beyond that required by TRIPSthat required by TRIPS

04/11/2304/11/23 55

TRIPS plus provisionsTRIPS plus provisions

TRIPS plus provision can be found inTRIPS plus provision can be found in- Unilateral national policy makingUnilateral national policy making- WTO accession processWTO accession process- Regional and bilateral free trade agreementsRegional and bilateral free trade agreements Difference between unilateral incorporation of Difference between unilateral incorporation of

TRIPS-plus in national laws vs. obligations agreed TRIPS-plus in national laws vs. obligations agreed to under the WTO process and FTAs:to under the WTO process and FTAs:

- Unilaterally adopted national provisions may be Unilaterally adopted national provisions may be changedchanged

- But FTA provisions and WTO accession But FTA provisions and WTO accession agreements can be enforced by trading partnersagreements can be enforced by trading partners

04/11/2304/11/23 66

TRIPS-plus in AfricaTRIPS-plus in Africa

Failed US-SACU FTAFailed US-SACU FTA

- Started in 2002, but failed due to divergent Started in 2002, but failed due to divergent viewsviews

- No evidence that talks would resumeNo evidence that talks would resume EU-ACP EPA negotiationsEU-ACP EPA negotiations

- Brief background- Brief background

04/11/2304/11/23 77

Intellectual property rights in EPAsIntellectual property rights in EPAs

Cotonou Agreement does not require inclusion of Cotonou Agreement does not require inclusion of substantive IP provisions in EPAssubstantive IP provisions in EPAs

But the first full EPA – EU Cariforum EPA – includesBut the first full EPA – EU Cariforum EPA – includes- Context, objectives and principles: parties to ‘ensure Context, objectives and principles: parties to ‘ensure

increasing levels of protection’increasing levels of protection’- Absence of transition periods for LDCsAbsence of transition periods for LDCs- Harmonisation and regional patentsHarmonisation and regional patents- Requirement to join and comply with WIPO treaties; e.g. Requirement to join and comply with WIPO treaties; e.g.

PCTPCT- Border measuresBorder measures- EnforcementEnforcement

04/11/2304/11/23 88

Lessons and StrategiesLessons and Strategies

JUST SAY NOJUST SAY NO For EPAs, the Cotonou Agreement does not For EPAs, the Cotonou Agreement does not

require the inclusion of IP as a substantive require the inclusion of IP as a substantive issueissue

There is no requirement under the Cotonou There is no requirement under the Cotonou Agreement to include any substantive Agreement to include any substantive provisions on IP in EPAsprovisions on IP in EPAs

04/11/2304/11/23 99

Lessons and strategiesLessons and strategies

What’s the real deal?What’s the real deal? Demand independent and critical evaluation Demand independent and critical evaluation

of economic and social implications of any of economic and social implications of any IP negotiationIP negotiation

Is there equal bargain – preferential market Is there equal bargain – preferential market access in exchange for increased IP access in exchange for increased IP protection?protection?

04/11/2304/11/23 1010

Lessons and strategiesLessons and strategies

No secretsNo secrets Many FTAs are negotiated in secret, with Many FTAs are negotiated in secret, with

the public having no access to the terms of the public having no access to the terms of negotiationsnegotiations

There should be a transparent and public There should be a transparent and public process of consultation on FTA negotiationsprocess of consultation on FTA negotiations

04/11/2304/11/23 1111

Lessons and strategiesLessons and strategies

Strength in numbersStrength in numbers TRIPS-plus provisions affect and interest a broad TRIPS-plus provisions affect and interest a broad

range of stakeholders therefore, broad-based range of stakeholders therefore, broad-based support should be canvassedsupport should be canvassed

There should be mobilization of, and collaboration There should be mobilization of, and collaboration with, civil society organisations, patient groups and with, civil society organisations, patient groups and parliamentariansparliamentarians

Technical support from appropriate UN agencies Technical support from appropriate UN agencies should be requestedshould be requested

Paragraph 6 Doha DeclarationParagraph 6 Doha Declaration

“ “We We recognizerecognize that that WTO Members with WTO Members with insufficient or no manufacturing capacities in the insufficient or no manufacturing capacities in the pharmaceutical sectorpharmaceutical sector could face difficulties in could face difficulties in making effective use of compulsory licensingmaking effective use of compulsory licensing under the TRIPS Agreement”under the TRIPS Agreement”

““We instruct the Council for TRIPS to find an We instruct the Council for TRIPS to find an expeditious solution to this problem and to report expeditious solution to this problem and to report to the General Council before the end of 2002”to the General Council before the end of 2002”

3030thth August “Solution” August “Solution”

Decision reached on 30 August 2003Decision reached on 30 August 2003

-waiver of Article 31(f) for countries producing under a CL-waiver of Article 31(f) for countries producing under a CL-entire production can be exported-entire production can be exported-BUT many procedures have to be followed by exporting and -BUT many procedures have to be followed by exporting and importing countriesimporting countries-many view the procedures as cumbersome and a -many view the procedures as cumbersome and a disincentive to use the decisiondisincentive to use the decision

Note that there is Note that there is “Chairman’s Statement”“Chairman’s Statement” with some with some clarifications and additional obligations…...the legal status of clarifications and additional obligations…...the legal status of which is unclear.which is unclear.

When does the Decision Apply ?When does the Decision Apply ?

Product is patented in Exporting countryProduct is patented in Exporting country (Supplying Country) (Supplying Country) for e.g. Indiafor e.g. India

To produce and export, India has to issue a CLTo produce and export, India has to issue a CL

Decision appliesDecision applies

100 % production100 % production >50% of production exported >50% of production exported (the predominant portion)(the predominant portion)

If less than 50%, the decision does not applyIf less than 50%, the decision does not apply

Using the Decision As An Importing Country (1)Using the Decision As An Importing Country (1)

Who can Import ?Who can Import ? : : Decision says only “eligible importing members” See Decision says only “eligible importing members” See

Sect (1) (b) defined as: Sect (1) (b) defined as: i) any LDC i) any LDC (automatically qualifies and no need (automatically qualifies and no need for notification)for notification) ii) other WTO membersii) other WTO members that has that has notifiednotified TRIPS TRIPS Council of its Council of its intention to use the system as an intention to use the system as an importerimporter

- This is a “one time” notification - This is a “one time” notification - Notification is declaratory…No need approval- Notification is declaratory…No need approval

Using the Decision As An Importing Country (2)Using the Decision As An Importing Country (2)

Another notification to TRIPS Council (S. 2 (a)Another notification to TRIPS Council (S. 2 (a)(notification is declaratory need to be (notification is declaratory need to be approved)approved)

(i)(i) specify names and expected quantities of products (not the exact specify names and expected quantities of products (not the exact quantities)quantities)

(ii)(ii) confirm establishment of insufficient or no manufacturing capacities confirm establishment of insufficient or no manufacturing capacities for the products specified (self – assessment)for the products specified (self – assessment)***This requirement does not apply to LDCs. Assumed not to have ***This requirement does not apply to LDCs. Assumed not to have manufacturing capacitymanufacturing capacity

(iii)(iii) confirm grant or intention to grant a CL if product is patented in that confirm grant or intention to grant a CL if product is patented in that country (in accordance with Art. 31 TRIPS Ag.)country (in accordance with Art. 31 TRIPS Ag.)

Using the Decision As An Exporting Country (1)Using the Decision As An Exporting Country (1)

Grant of CL and conditions attached to it (S. 2(b)Grant of CL and conditions attached to it (S. 2(b) To produce only amounts necessary to meet the needs of the eligible To produce only amounts necessary to meet the needs of the eligible

importing member andimporting member and Entire production must be exportedEntire production must be exported Clear identification of products through specific labelling or marking.Clear identification of products through specific labelling or marking. Distinguishing products through special packaging and/or special Distinguishing products through special packaging and/or special

colouring/shaping of products themselvescolouring/shaping of products themselves Notification to TRIPS Council of: (S. 2 © )Notification to TRIPS Council of: (S. 2 © )

Grant of CL and the conditions including:Grant of CL and the conditions including: name and address of licenseename and address of licensee products for which licence grantedproducts for which licence granted quantity for which licence grantedquantity for which licence granted countries to which product to be suppliedcountries to which product to be supplied duration of licenceduration of licence

To post on Website (before shipment) details of: (S 2 © )To post on Website (before shipment) details of: (S 2 © ) Quantities being supplied to each destinationQuantities being supplied to each destination Distinguishing features of products as requiredDistinguishing features of products as required

Other Relevant ProvisionsOther Relevant Provisions

S. 6(i) in the 30 August Decision S. 6(i) in the 30 August Decision - with a view to harness economies of scale for the with a view to harness economies of scale for the

purposes of enhancing purchasing power for, and purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical productsfacilitating the local production of, pharmaceutical products

another system is established…for where a regional another system is established…for where a regional

trade agreement exist and at least half of the current trade agreement exist and at least half of the current membership are LDCs e.g. SADC, etc….membership are LDCs e.g. SADC, etc….

e.g: Tanzania imports from India under this e.g: Tanzania imports from India under this Decision and re exports to Swaziland ….under Decision and re exports to Swaziland ….under SADC FTA arrangementSADC FTA arrangement

Rwanda’s paragraph 6 notificationRwanda’s paragraph 6 notification

• No country had used 30 August 2003 Mechanism for almost No country had used 30 August 2003 Mechanism for almost 4 years4 years

• Rwanda in Document Rwanda in Document www.wto org IP/N/9/RWA/1 on 19 July IP/N/9/RWA/1 on 19 July 2007 changed this2007 changed this

• Initiated by Rwanda Centre for Treatment and Research on Initiated by Rwanda Centre for Treatment and Research on Aids (TRAC)Aids (TRAC)

• Intention to import 260 000 packets of combination therapy of Intention to import 260 000 packets of combination therapy of AZT, 3TC & NVP from Apotex, (generic company) in CanadaAZT, 3TC & NVP from Apotex, (generic company) in Canada

• LDC status precludes notification as eligible importing countryLDC status precludes notification as eligible importing country• Some stakeholders puzzled because Canada was not Some stakeholders puzzled because Canada was not

cheapest sourcecheapest source• MSF has been importing the same generic product from IndiaMSF has been importing the same generic product from India

Rwanda’s paragraph 6 notificationRwanda’s paragraph 6 notification

• Apotex obtained CL to export in September 2007 1 Apotex obtained CL to export in September 2007 1 year after Health Canada approved the drugyear after Health Canada approved the drug

• In May 08, announcement that Apotex would In May 08, announcement that Apotex would produce combination for produce combination for US$0.195 per tabletUS$0.195 per tablet

• Cheapest previous source was India at US$0.246 Cheapest previous source was India at US$0.246 per tabletper tablet

• Delay caused both by process of getting CL issued Delay caused both by process of getting CL issued as well as internal government procurement as well as internal government procurement proceduresprocedures

• Shipment arrived in Kigali 1Shipment arrived in Kigali 1stst week of October 2008 week of October 2008• Apotex publically stated that it would be hard Apotex publically stated that it would be hard

pressed to repeat the endeavorpressed to repeat the endeavor

Reflections on 30 August AgreementReflections on 30 August Agreement

• Only 1 country has used Decision in more than 5 yearsOnly 1 country has used Decision in more than 5 years• Process of obtaining medicines through Decision slowProcess of obtaining medicines through Decision slow• 15 months from notification to delivery in Rwanda15 months from notification to delivery in Rwanda• Would this solution work for public health emergency Would this solution work for public health emergency

e.g. Swine flu?e.g. Swine flu?• If decision ratified by 2/3rds of WTO membership, it If decision ratified by 2/3rds of WTO membership, it

becomes permanentbecomes permanent• About 30 ratifications at presentAbout 30 ratifications at present• Is this something that African countries should ratify?Is this something that African countries should ratify?

Definition of Counterfeit, Section 2Definition of Counterfeit, Section 2

(a) the manufacturing, producing, packaging, re-packaging, (a) the manufacturing, producing, packaging, re-packaging, labelling orlabelling or making, whether in Uganda or outside Uganda, making, whether in Uganda or outside Uganda, of any goods by whichof any goods by which those protected goods are imitated those protected goods are imitated in such manner and to such a degreein such manner and to such a degree that those other that those other goods are identical to or substantially similar to protectedgoods are identical to or substantially similar to protected goods;goods;

04/11/2304/11/23 2222

Definition of CounterfeitsDefinition of Counterfeits

(b) the manufacturing, producing or making, whether in (b) the manufacturing, producing or making, whether in Uganda or outsideUganda or outside Uganda, of the subject matter of that Uganda, of the subject matter of that intellectual property, or a colourableintellectual property, or a colourable imitation of it so that imitation of it so that the other goods are likely to be confused with or tothe other goods are likely to be confused with or to be be taken as being the protected goods of the owner or any taken as being the protected goods of the owner or any goodsgoods manufactured, produced or made under his or her manufactured, produced or made under his or her licence;licence;

04/11/2304/11/23 2323

(b) the manufacturing, producing, or making of copies, in (b) the manufacturing, producing, or making of copies, in Uganda or outside Uganda, in violation of the author s Uganda or outside Uganda, in violation of the author s rights or related rights;rights or related rights;

(c) in the case of medicines, includes the deliberate and (c) in the case of medicines, includes the deliberate and fraudulentfraudulent mislabeling of medicines with respect to identity mislabeling of medicines with respect to identity or source, whether or notor source, whether or not such products have correct such products have correct ingredients, wrong ingredients, have sufficientingredients, wrong ingredients, have sufficient active active ingredients or have fake packagingingredients or have fake packaging

04/11/2304/11/23 2424

CritiqueCritique

Why another law when Uganda has an IP law?Why another law when Uganda has an IP law? any person manufacturing say a drug under a compulsory any person manufacturing say a drug under a compulsory

licensing scheme through appropriate Patent law licensing scheme through appropriate Patent law provisions given without the authority of the owner would provisions given without the authority of the owner would be involved in counterfeiting. The implication of such an be involved in counterfeiting. The implication of such an interpretation is clearly grave to manufactures of generic interpretation is clearly grave to manufactures of generic medicines who do so through necessary limitations on the medicines who do so through necessary limitations on the owner’s IPR’sowner’s IPR’s

Confusion on the definition of generics, fake and Confusion on the definition of generics, fake and substandard medicinessubstandard medicines

Pressure from EU and big pharmaPressure from EU and big pharma

04/11/2304/11/23 2525

Thank youThank you

04/11/2304/11/23 2626