The Emergence of Anti-Counterfeiting Legislation in East Africa: Implications for Generic Supply and Treatment Access Mandeep Dhaliwal Tenu Avafia With assistance from Boyan Konstantinov HIV/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 ) 2

3 The Broader Enforcement Agenda (Source: Viviana Munoz Tellez, South Centre) The TRIPS Agreement Mandatory 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 , 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 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.

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