Paul OgendiAccess to Essential Medicines Initiative (AEMI) Fellow, 2011

LLM (Human Rights and Democratisation in Africa) 2012

candidate, Centre for Human Rights, University of Pretoria

Friday 25 May 2012

ANTI-COUNTERFEITING IN EAST AFRICA: CIVIL

SOCIETY PERSPECTIVE

OutlineObjectivesBackgroundEAC and anti-counterfeiting: Policy and BillTanzania and anti-counterfeiting: Merchandise

Marks Regulation, 2008, TFDA, 2003Uganda and anti-counterfeiting: BillKenya and anti-counterfeiting: 2008 Act,

Patricia Osero CaseKey lessonsRecent developmentsConclusion and way forward

Civil society march in Nairobi during the 10 year DOHA Anniversary

ObjectivesThe following are the objectives of this session:To highlight the situation in East Africa with

regard to anti-counterfeit laws and access to medicines

To discuss the concerns of civil society organizations in the region

To discuss the strategies employed to address the concerns

To discuss key lessons from the experience in East Africa and Kenya

To list some recent developments that may require CSOs attention

BackgroundEAC Treaty signed: 30 November 1999 Entry into force: 7 July 2000Pioneer members: Kenya, Uganda and Tanzania. Rwanda and Burundi: Acceded to the Treaty on 18 June

2007 and became full members with effect since 1 July 2007.

Steps to be taken (Custom Union – 2005; Common Market - 2010; Monetary Union – 2012; Political Federation – 2013.

Regional cooperation on health is one of the priorities enshrined in the Treaty for the Establishment of the EAC.

EAC and Anti-CounterfeitingEAC Common Market: Include implementation

of policies and legislations on trade in counterfeit and pirated goods as common standards in the region.

Currently: EAC Policy on Anti-Counterfeiting, Piracy and Other Intellectual Property Rights Violations; and EAC Anti-Counterfeiting Bill.

Rationale: To improve business and investment climate in EAC. However, research shows no co-relation.

EAC Policy on Anti-Counterfeiting, Piracy and Other Intellectual Property Rights ViolationsAccording to the policy, counterfeiting and

piracy are serious criminal offences that often leads to:

1.Significant health and safety risks which may result in loss of life;

2.Loss of revenue to companies and governments leading to economic decline; and

3.Channeling of proceeds to criminal networks, organised crime and other groups that disrupt and corrupt society, and ought to be treated as such. (p.40)

EAC Policy cont….Counterfeit/pirated products have no

guarantee as to ‘quality and safety checks normally imposed by public standards authorities and by the brand proprietor.’ (p.25)

Areas of concern: a) counterfeiting offenses are not clearly defined under the EAC Policy; and b) Supports stiff criminal sanctions IPR infringement instead of strengthening medicines regulatory and registration nationally and regionally. (p.45)

The EAC Anti-Counterfeit BillDrafted in 2010 Funded by Climate Investment Fund.

Emphasis on trade and investment as opposed to human rights and public health

Areas of concern:Provisions takes precedence over national

laws (s.1(4)Establishes mandatory national anti-

counterfeit boards within three months upon its entry into force in all the countries (s.3). Catch: anti-counterfeit laws!!!

Establishment of an authority to coordinate performance of national boards (s.9)

Up to 10 years imprisonment for third and subsequent offenders (S.14(C))

 

EAC Bill cont….Lower thresh-hold for de-minis goods for non-

commercial and private use – reasonableness test

Parallel enforcement regime: Special anti-counterfeiting courts, prosecutors, judges and magistrates

Seizures and detentions including by customs officials – Capacity??? (s.32)

Establishment of Counterfeit Goods Depot (s. 11)Compensation (s.28)Interim ex parte orders – Potential for abuse if

full disclosure of material facts are withheld

Overview of anti-counterfeit-related laws in EAC partner states• Burundi ( No law on counterfeiting) • Kenya (The Anti Counterfeit Act, 2008) • Rwanda (IP Code)• Tanzania (the 2008 Merchandise Marks

Act & Regulations; Tanzania Food, Drugs and Cosmetics Act)

• Uganda (The Anti-Counterfeiting Goods Bill 2010) – No patent jurisdiction.

• Zanzibar (No law on counterfeiting)

Tanzania Merchandise Marks Act Cap. 85 (2005)Understands counterfeiting as trademark

infringement, therefore offences include:S. 3: forging or falsely applying a trademark or

descriptionMaking a trademark or a mark which deceptively

resembles another S.4: Falsifying a genuine trademark by alteration,

addition, effacement or otherwiseS.6: Selling using false trademark or descriptionFound not comprehensive to deal with

counterfeiting and therefore enactment of Merchandise Marks Regulation, 2008.

Tanzania’s Merchandise Marks Regulation, 2008S. 2: Trips-plus definition of

counterfeiting:Without authority of IPR owner (compulsory licenses??... generics??)

a)The manufacturing, producing, repackaging, labeling or making, whether in Tanzania or elsewhere, of any goods whereby those protected goods are imitated….

b)The manufacturing, producing or making, whether in Tanzania or elsewhere, the subject matter of that intellectual property, or a colourable imitation thereof so that the other goods are calculated to be confused….

Tanzania Food, Drugs and Cosmetics Act, 2003S.76 provides for counterfeit drugs as follows:

It is an imitation of, or substitute for, another drug, resembles another drug likely to deceive or bears upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true characteristics and its lack of identity with such other drug;

If it has been submitted wholly or in part by another drug substances;

Uganda Anti-Counterfeit BillModel for the region for the following

reasons:Intellectual property is limited to‘counterfeit trademark goods’ or ‘pirated copyright goods’.

Court reviews (warrants) before an inspector can exercise the power to seize and detain

Offence must be commited ‘willfully’ and on a commercial scale

Uganda cont….Seizure and detention of all suspected

counterfeit goods in customs control until final disposal or order of court. However, where the IPRs in question has expired, the goods seized and detained will be released (early working).

The Ugandan National Drug Authority will be in charge of dealing with any matter of alleged counterfeiting of medicines and other pharmaceutical products.

Kenya Anti-counterfeit Act, 2008Has attracted CSOs opposition for the

following reasons:Definition of counterfeiting:

‘medicines’ does not include vaccines; Patent infringements and counterfeiting are still confused. This is the basis for generics being confused with counterfeits!

Extra-territorial application of IPRs – negation of sovereignty, burden on Kenyans and the Kenyan legal system.

Kenyan Act cont….Section 32: Counterfeit offenses Section 34: Seizure and detention. The

section also allows the holder of IPRs accrued elsewhere to enforce rights in Kenya, notwithstanding the existing laws in Kenya do not recognize those IPRs.

Powers exercised by Kenya Revenue Authority (KRA) customs officials instead of the Pharmacy and Poisons Board (PPB)

CSO’s concernsThe following are the desired changes:Generic medicines should clearly be distinguished from counterfeit medicines. In addition, any measures to combat counterfeiting should not extend to patents and generics.

No enforcement of extra-territorial, expired and/or un-renewed IPRs.

Counterfeiting must include mental element -‘willful’ infringement (on a commercial scale’).

CSO’s concernsCourt reviews (warrants before seizures

and detentions)No barrier to goods in-transitCompensation for negligence,

carelessness, corruption or bad faith resulting into the loss or damage to goods seized or detained.

The Kenya Pharmacy and Poisons Board (PPB) should be in charge of any allegations of counterfeiting in medicines and pharmaceutical products

Case study: Patricia OchiengTook more than 2 yearsCase filed by 3 PLWHIVs;PLWHIVs and activists attend court sessions in t-

shirtsInterested parties: Aids Law Project (supported by

Kelin, Health Gap, NEPHAK, MSF and CBOs)Regular meetings and updates Amicus curie: UN Rapporteur for Rights to HealthArguments: based on the Constitution, TRIPs

Agreement, international human rights, and HAPCA

Supported by OSIEA, Akiba Uhaki etc

Key lessonsTiming: the new constitution with justiciable

socio-economic rightsUse of individualsCommunity mobilisation: numbers in courtNetworking and coordination: Grass-root,

national, regional and international stakeholders

Media strategy and engagementResources: time and financesTechnical expertise: IP lawyers and expertsExpect delay tactics by the state

Latest developments in the regionImplementation of Ochieng: lobbyingThe launch of the East African Community

Medicines Registration Harmonization Initiative (EAC-MRH) in Tanzania on 30 March 2012 under the AU-NEPAD AMRH.

Implementation of a 5-year Regional Pharmaceutical Manufacturing Plan of Action (2012-2016).

Research and Development Treaty at WHO

Conclusion and way forwardAnti-counterfeiting and access to generic

medicines struggle is far from over in the regionCSOs mobilisation is crucial to achieving successPatricia Osero confirms the supremacy of human

rights over intellectual property rights protectionThere is need for an access to essential

medicines policy and legislation in the regionFocus should also be on the East African

Community Medicines Registration Harmonization Initiative (EAC-MRH) under AU-NEPAD AMRH.