The Emergence of Anti-Counterfeiting Legislation in East Africa: Implications for Generic Supply and Treatment Access

Mandeep Dhaliwal Tenu Avafia

With assistance from Boyan KonstantinovHIV/AIDS Practice, UNDP BDP

Key Provisions on IP Enforcement in TRIPS

• TRIPS contains checks and balances on the application of procedures and defining remedies

• Infringement to be determined in each jurisdiction

• Procedures for border measures, criminal procedures and penalties must be provided required only for cases of willful trademark counterfeit or copyright piracy on a commercial scale

• “Proportionality of the measure to the seriousness of the infringement.” (Art.46 )

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The Broader Enforcement Agenda(Source: Viviana Munoz Tellez, South Centre)

The TRIPS AgreementMandatory obligations on IPR

enforcement for WTO member states

Room for flexibilities for implementation

The World Intellectual Property Organization

Advisory Committee on IP Enforcement (ACE)

WTO

TRIPS Council

Dispute Settlement

Accession Protocols

Anti-Counterfeiting Trade Agreement (ACTA)

OECD

Studies on Economic Impact of Counterfeiting and Piracy

US Special 301 Report

EU strategy on IPR enforcement in third countries

Bilateral/Bilateral FTAs - EPAs

TRIPS-Plus enforcement obligations

World Customs Organization

Standards and model law to strengthen IPR enforcement via border measures

Group of Eight

Coordinated IP enforcement strategy

World Health Organization

IMPACT Working Group on Counterfeit Medicines

Global Congress on Anti- Counterfeiting and Piracy

WCO, Interpol, WIPO and Iidustry

Technical Assistance

WIPO-WTO agreement

Model laws

Interpol

fight IPR crime, links to terrorism

Universal Postal Union

Increase involvement of postal administrations in IPR enforcement

Impact of IP Enforcement on Access to Medicines

• Problem with substandard /spurious medicines pose a real threat to patients

• Attempts to address problem by adopting IP enforcement measures raise serious concerns because they:

– conflate intellectual property concerns with medicine quality which is different;

– delegate enforcement to authorities with no adequate competency to determine IP infringement or medicines’ quality and efficacy;

– divert substantial public resources to defend private rights.

Impact of IP Enforcement on Access to Medicines

• No evidence that IP enforcement provides sustainable protection against substandard medicines

• Growing evidence that enforcement of IP border measures by European Union impacting negatively on public health

• In 2008-2009, at customs in Europe: about 17 seizures of legitimate generics (including ARVs), for developing countries, as “counterfeit”

• This has led to a request for consultations filed before the WTO by Brazil and India

Proliferation of Anti-Counterfeiting Legislation in the EAC

• EAC comprises of 5 countries , 4 of which are LDCs• EAC countries could and should benefit from the l TRIPS flexibilities

for such countries• Instead, we see developing of “anti-counterfeit” legislation, which

could prevent them from utilizing TRIPS flexibilities• Tanzania, Subsidiary Merchandise Marks Act, 2008; • Kenya , Anti-Counterfeiting Act ,2008; • Uganda, discussing a Counterfeit Goods Bill since 2008• Draft EAC Anti-counterfeit and Bill are being discussed• UN Special Rapporteur on the Right to Health has expressed

concerns about public health impact of draft Policy and Bill in letters to the governments of all EAC countries

Kenya’s Anti-counterfeit Act of 2008• Adopted in 2008• Conflates quality and IPR issues; legitimate

generics fall under definition of “counterfeits”• Up to 90% of medicines in Kenya are generics

(Source: HAI-Africa)• Act was challenged before the High Court in July

2009 by three petitioners living with HIV. • Court passed preliminary judgment in favor of

petitioners on 23 April, 2010• Court suspended powers of Anti-Counterfeit

Agency to interfere with importation and distribution of generics pending ruling on the substance (Source: HAI-Africa)

• In June 2010, unnamed Health Ministry officials conceded that Act was promoted by Kenya’s Industry Ministry without public health considerations (Source: Economic Times of India)

Uganda’s Counterfeit Goods Bill

• About 85-90% of medicines in Uganda are imported, up to 93% are generics (Sources: IPS, HEPS-Uganda)

• As a LDC, Uganda does not have to protect IPRs until July 2013 (2016 for pharmaceuticals)

• Counterfeit Goods Bill – discussed since 2008. Initial definition of “counterfeit” very similar to Kenya’s law, TRIPS-plus. Included patents, covered generics

• Civil society concerns: Bill trades away TRIPS public health flexibilities, hampers access to essential medicines , obstructs local production capacity development

Uganda’s Counterfeit Goods Bill

• UNDP: co-sponsored an expert discussion on the Bill (Entebbe, September 2009). International experts and domestic policy makers examined Bill from public health perspective: TRIPS-plus definition of “counterfeit”, contradiction with other laws, border measures, criminal sanctions

• Government decided to exclude patents from Bill• Question whether it is at all needed remains. Uganda has

comprehensive IP and medicine quality control legislation• In March 2010, Industry Minister admitted that the EU has

supported Bill’s development , as part of the Economic Partnership Agreement (Sources: IPS, PIJIP)

Draft EAC Anti-Counterfeiting Policy and Bill on Access to Essential Medicines

• Definition problems – what is “counterfeit”?

• Danger of IP enforcement abuse

• Efficiency concerns – does IP enforcement actually prevent spread of substandard medicines?

• Cost-benefit dilemma – enforcement at all cost?

Determining a Constructive Agenda• Develop adequate measures to show no tolerance for substandard

medicines.• IPR enforcement : not an adequate approach. IPRs are private rights

that regulate use of protected objects. Not suitable to ensure safety and efficacy of medicines. Likely to hamper access to generics.

• National drug regulatory authorities should implement safety and efficacy measures for medicines.

• Countries should create legal and policy environment that enables implementation of the MDGs, including Goals 4, 5, and 6.

• Developing and least developed WTO members should utilize TRIPS public health flexibilities and avoid TRIPS-plus measures.

http://www.undp.org/hiv/

tenu.avafia@undp.org

mandeep.dhaliwal@undp.org

Photos have been provided by HAI-Africa

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