Agreement on TRIPS & access to medicines Presentation by Dr Zafar Mirza PILdAT Briefing session for Parliamentarians on “The WTO Regime and Implications for Pakistan” 18 th August 2003, Islamabad

The emergence of TRIPS One of the new areas in the multilateral trade regime Three industries pushed it: pharmaceutical; software; motion pictures IPR scene before the TRIPS agreement

Pre-TRIPS era Countries used to decide about patent protection according to their level of industrial development and according to societal needs: Germany:1967 France:1967 Japan:1976 Italy:1979 Spain:1992 In 1995 around 40 countries had exempted pharmaceuticals from patent protection Developed countries of today developed their industries by extensive copying

German example In 1876 when the German industry was in its infancy and the patent law was yet to be evolved, Bismarck appointed a committee to study the likely impact of the patent system on the industry. Committee members also included founders of Siemens and Hoechst. Their observations made interesting reading: " Today industry is developing rapidly monopolization and abuse of patent rights will inevitably expose large segments of the industry to serious injury. The government must protect industry against these dangers..."

TRIPS standards Set-up a minimal criteria for patent protection – implementation through national legislation - Patent Ordinance Patent Ordinance 2002 and Super 301, watch list In case of pharmaceuticals it meant: more stronger (both process and product) and more longer patent protection (20 years) Reverse engineering is no more possible:

Time lag between introduction of a new drug in the world market and its availability in India DrugsYear of introduction in International market Year of introduction in India Time lag (Years) 1. Salbutamol 2. Mebendazole 3. Rifampacin 4. Naproxen 5. Bromhexin 6. Ranitidine 7. Captopril 8. Norfloxacin

TRIPS Controversies It has become a flashpoint of globalization In 7 years of WTO and 55 years of GATT nothing has become more controversial than the TRIPS agreement In the last 7 years more has been written and debated on the TRIPS agreement than on any other WTO agreement

TRIPS in last 7 years Drug price debates World Health Assemblies Treatment Access Campaigns The role of international civil society – MSF, CPT, HAI, OXFAM, ActionAid, etc. South African Case HIV/AIDS and prices of ARV’s UN Commission on Human Rights, HDR G7, Davos, US Congress From Seattle to Doha

Doha Declaration on TRIPS & Public Health A separate declaration A political declaration, reaffirmed the TRIPS agreement Considered as a triumph of developing countries Enters the debate on “Para 6” -

Doha Declaration on the TRIPS Agreement and Public Health 1. We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.

Doha Declaration on the TRIPS Agreement and Public Health 2. We stress the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of the wider national and international action to address these problems.

Doha Declaration on the TRIPS Agreement and Public Health 3. …We also recognize the concerns about its (IPR) effects on prices.

Doha Declaration on the TRIPS Agreement and Public Health 4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

Doha Declaration on the TRIPS Agreement and Public Health 5 (b) Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted. (c) Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

Doha Declaration on the TRIPS Agreement and Public Health 6. We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.

From Doha to Cancun Deadline of 31 st December 2002 has not been met in the areas of interest to developing countries: Implementation issues Special and Differential treatment Solution of Para 6 Backtracking has started which is actually undermining the flexibilities already provided in the TRIPS agreement

Backtracking and reneging Effective use of Compulsory licensing by countries not having manufacturing capacity List of diseases issue – 5(C) Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

Backtracking and reneging EU, USA, Japan and Canada has come up with the list of 22 diseases On 14 January the US has come up with a gracious offer of moratorium on disputes! Chairman of the TRIPS Council has come up with a “Statement of Understanding” on 16 December text which says that: "Secondly, delegations have made it clear that they see the system that we are establishing under para 6 of that Declaration as being essentially designed to address national emergencies or other circumstances of extreme urgency.

Scope of Diseases issue The EC compromise, floated by the EC Commissioner, Pascal Lamy, in January, says in a footnote, that "this (public health problems recognized in para 1 of the Doha declaration) covers at least HIV/AIDS, malaria, tuberculosis, yellow fever, plague, cholera, meningococcal disease, African trypanosomiasis, dengue, influenza, leishmaniasis, typhoid fever, typhus, measles, shigellosis, haemorrhagic fevers, and arboviruses. When requested, by a Member, the World Health Organization, 'shall give' its advice as to the occurrence in an importing Member, or the likelihood thereof, of any other public health problem."

Scope of diseases issue The Director-General of the World Health Organization, Dr. Gro Harlem Brundtland insisted 0n 14 January that one should be careful about excluding some diseases from the scope of the Doha Declaration on TRIPS and Public Health, and not limit the scope (for compulsory licensing and imports) to a few very prominent ones like HIV/AIDS, TB or Malaria.

Why Pakistan should not accept any list of diseases? Restrictive interpretation of Para 1. We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. Problems in declaring a national emergency Sovereignty issue Even TRIPS does not require such restriction Double burden of diseases in developing countries (Pakistan: 47% of BoD is that of non-communicable diseases)

Why there should be no list of diseases? Three kinds of Problems: 1. Non-existence of drugs for existing problems. 2. New drugs required to replace the drugs which are increasingly becoming ineffective 3. Drugs are required to be developed for new emerging diseases

Why this backtracking? PhARMA is directly involved Meetings in DEVOS US $ 14 million contributed to the Republican Party in the mid term elections Power holders in the WTO

Current Political Scenario in the WTO Current General Council Chair is from NAFTA country – Canada TRIPS Chair, Singapore - US FTA PhARMA is getting directly involved – WEF

What next? Would developing countries stick to their guns? We are heading towards troubles? Cancun can be other Seattle – or may be worse IPR under TRIPS would be further questioned. Already there are two very important developments: 1. UK Commission report on IPRs 2. UNDP report released earlier this year: “Making Trade Work for the Poor”