Access to Medicines, Session I (Sat., August 26, 9:30 – 11:30 am)

 

Agenda – Peter Maybarduk and Brook Baker

Item One:  Free Trade Agreements (45 minutes)

Moderator:  Brook Baker

  • EU: India Discussants:  (Judit Rius)
  • US: TPPA Discussants:  (Peter Maybarduk, Krista Cox, Claudio Lara)
  • Other: EU-Mercosur / Canada

The US and EU have engaged in a tag-team strategy of using free trade agreement and economic partnership agreement negotiations to ratchet up the strength, breadth, and duration of intellectual property protections, to consolidate a hyperbolic IP enforcement agenda, and increase investor protections.  More recently, the US in particular is also attacking price controls, state-owned enterprises, and government procurement policies.

To accomplish their substantive agenda, the US and EU have forum shifted away from multilateral forums at the WTO and WIPO and attempted to negotiate strategically with individual countries and regions to isolate or convert IP holdouts – India in particular – and to establish country and regional beachfronts.  They are also trying to bundle advanced and developing economies together in the same negotiations.  The TPP is a perfect example of an effort to isolate India and China, to gain a regional foothold, and to bundle diverse economies.  The EU/India EPA was an intense effort to tackle India head on, which fortunately has met both local and global resistance from activists and some Indian officials. On-going trade negotiations between the EU and other countries / blocs (Mercosur, Andean Community, etc.) present some of the same risks.

This session will discuss the particular threats of the EU/India FTA and US TPP negotiations and strategies to counteract them.  In terms of access to medicines, it will be important to assess the on-going risks of data exclusivity, patent term extensions, utility models, and investment clauses in India.  In addition to these issues and with respect to the TPP,   it will be important to assess:  eased patent standards (new form, new uses, limited exclusions), elimination of pre-grant opposition, elimination of pre-grant opposition, patent-registration-linkage, restrictions on price controls and therapeutic formularies, liberalization of government procurement, and opposition to state-owned enterprises.

In preparation for the discussion, participants should consider:

  • What are some effective strategies for strengthening global and national coalitions of trade/health activists who oppose the US/EU IP & trade agenda?
  • What mechanisms are available to strengthen developing country capacity to negotiate more effectively and cooperatively to preserve TRIPS- and Doha-flexibilities?
  • What issues should be prioritized?
  • What avenues are there in the US Congress and the European Council to scape back the IP objectives of trade representatives?

Item Two:  Enforcement (45 minutes):

Moderators: Peter Maybarkuk and Brook Baker

  • ACTA, EU-India accord, EC reg Discussant
  • Anti-counterfeiting politics discussants

The US and EU have also been spearheading a multi-pronged IPR enforcement agenda engaging multiple fora.  Not content to rely on increased substantive protections and private enforcement, IP industries, including Big Pharma, have been prioritizing a campaign clamping down on trademark counterfeits and copyright pirated goods, but sweeping other IPRs in their net as well.  Their most wide ranging effort is codified in the proposed Anti-Counterfeiting Trade Agreement (ACTA), which still faces some opposition in Mexico, Europe, and even the US.  Activists, including many at this Congress, intensively engaged in critiques of the ACTA process and interim drafts, resulting in a final document that contained fewer threats to access to medicines.  However, ACTA’s potential application to patent disputes, its provisions on third-party liability, its rules on provisional measures, injunctions, and damages, and its lack of due process safeguard, particularly with respect to provisional measures and seizures by customs officials, remain deeply problematic.

In the medicines context, there has been a concerted effort to confuse the issue of medicine safety, quality, and efficacy with the false label of “counterfeits” and to urge border measures and judicial procedures that allow seizures of goods in transit and seizures of so-called “identical” goods, both of which can be misapplied to interfere with the legitimate trans-border trade in generic medicines.  Following the infamous seizure of nearly 20 shipments of in-transit medicines by Dutch and other European officials, India and Brazil filed a WTO complaint demanding reform of EC Reg. 1383/2003 and cessation of seizures.  Europe has recently proposed an Amended Border Regulation, which still contains many of the same flaws.

The US and EU have also been imposing ACTA-plus enforcement measures in FTAs and EPAs and seeking to promote enactment of anti-counterfeiting legislation in developing countries.  Kenya was the first developing country to fall prey to this tactic and passed a dangerous anti-counterfeiting act that extends to “identical” products – exactly what generics medicines are intended to be.  Fortunately, that Act is now being challenged by health activists.  Unfortunately, similar bills are pending (or perhaps even approved) in Uganda, Zambia, Tanzania, and the East African Community.

Declaration points & further strategy discussion.  (1/2 hour)

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