Implementation of the DOHA Declaration on the TRIPS Agreement and Public Health: Technical assistance - how to get it right | Trips Agreement | Patent

Please download to get full document.

View again

of 7
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
Information Report
Category:

Documents

Published:

Views: 9 | Pages: 7

Extension: PDF | Download: 0

Share
Related documents
Description
Médecins Sans Frontières (MSF), Consumer Project on Technology (CP Tech), Health Action International (HAI) and Oxfam jointly convened a one-day conference in Geneva on the implementation of the Doha Declaration on the TRIPS Agreement and Public Health, with particular emphasis on Technical assistance -- How to get it right. The gathering came on the heels of a World Intellectual Property Organisation (WIPO) Conference on the International Patent System, at which the questions of access to medicines and the suitability of a one size fits all intellectual property model repeatedly arose. The NGO gathering convened over 200 attendees from 38 countries, including representatives from national and regional patent offices, Permanent Missions to the World Trade Organisation (WTO) and WIPO, UN agencies, academia, industry, philanthropy, and non-governmental organisations (NGOs).
Transcript
    CONFERENCE REPORT  I MPLEMENTATION OF THE   D OHA D ECLARATION ON THE TRIPS A GREEMENT AND P UBLIC H EALTH : T ECHNICAL A SSISTANCE –  H OW TO G ET IT R IGHT   28 th March 2002, International Conference Centre of Geneva (CICG)   Introduction . . . . . . 2 In the Spotlight: Assessing WIPO’s Technical Assistance.  3 Case Study: Bangui 1999  . . . . 4 Technical Assistance: What is Needed?  . . . 4 Implementing Doha Provisions  . . . . 5 Practicing Compulsory Licensing  . . . 6 Conclusion s . . . . . . 8    2   I MPLEMENTATION OF THE   D OHA D ECLARATION ON THE TRIPS A GREEMENT AND P UBLIC H EALTH : T ECHNICAL A SSISTANCE –  H OW TO G ET IT R IGHT    It has become obvious over the years that IPRs are   too important to just be left to IPR specialists. – O tto Genee, Deputy Permanent Representative, Mission of the Netherlands to the WTO   Introduction   Médecins Sans Frontières (MSF), Consumer Project on Technology (CP Tech), Health Action International (HAI) and Oxfam jointly convened a one-day conference in Geneva on the Implementation of the Doha Declaration on the TRIPS Agreement and Public Health , with particular emphasis on “Technical assistance --  How to get it right.” The gathering came on the heels of a World Intellectual Property Organisation (WIPO) Conference on the International Patent System, at which the questions of access to medicines and the suitability of a ‘one size fits all’ intellectual property model repeatedly arose. The NGO gathering convened over 200 attendees from 38 countries, including representatives from national and regional patent offices, Permanent Missions to the World Trade Organisation (WTO) and WIPO, UN agencies, academia, industry, philanthropy, and non - governmental organisations (NGOs).   The high attendance at the meeting  attested to the growing interest in implementation of the Doha Declaration in the health, trade and intellectual property (IP) policy circles. This historic declaration, made at the November 2001 WTO Ministerial Conference, strongly affirmed that the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) “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.” 1  The Declaration clearly outlines all the key flexibilities available in TRIPS, including:  - The right of countries to use compulsory licensing and to determine the grounds on which to grant them,  - The right of countries to determine what constitutes a national emergency or urgency, which can ease the granting of compulsory licenses,  - The right of countries to determine their own parallel import regimes, and - The right of least developed countries to postpone providing pharmaceutical patents until at least 2016, an d possibly longer.  As this was the first major international gathering of concerned countries and NGOs since the Doha Ministerial, many participants were eager to make progress towards implementing the Declaration, and to assess what role WIPO, as the UN body charged with developing IP systems worldwide, could play in the process. Major themes of the conference included the nature and quality of WIPO’s technical assistance to developing countries, what elements were necessary for appropriate technical assistance, how to address the ‘production - for - export’ question, and putting compulsory licensing into practice. In the Spotlight: Assessing WIPO’s Technical Assistance   A main focus of many of the conference proceedings was the role of WIPO, and the quality and emphasis of its technical assistance. In particular, participants voiced concerns that WIPO’s mandate to strengthen IP protection worldwide may not be consistent with the need for more nuanced levels of IP protection that take into account varying sta ges of economic development and local conditions in developing countries, especially in light of the crisis in access to essential medicines. Deputy Director General of WIPO Roberto Castelo gave the keynote address, outlining the organisation’s mission as mandated by its Member States and its role in providing legal and technical assistance to developing and least-developed countries under the 1995 WIPO/WTO Agreement on the implementation of the TRIPS Agreement. WIPO has now given technical assistance to 134 developing Member States in a “demystified and very transparent way,” according to Castelo. Though emphasizing that ongoing talks between WIPO and governments had to be kept confidential due to the wishes of Member States, he assured 1  Declaration on the TRIPS Agreement and Public Health, World Trade Organization, WTO/MIN(01)/DEC/W/2, 14 November 2001.    3   the audience that WIPO’s legal advice took into consideration all the flexibilities available in TRIPS. Furthermore, in response to concerns that many developing countries lacked in-depth IP expertise and therefore relied heavily on WIPO advice, Castelo remarked that participants should not underestimate the capacity of national IP offices, and reminded the audience that sovereign states – not WIPO – made final legislative decisions, in accordance with their own political and legal considerations. However, Professor Frederick Abbott, international IP expert and arbitrator for WIPO, underscored the critical role that WIPO plays when he responded that “it is of course no doubt true that WIPO member governments are sovereign states….however, when we provide technical guidance to least developed countries, most of the government officials in those countries are only vaguely familiar with some of the very technical elements of intellectual property law; and WIPO, of course, has an enormous expertise in this area.…the process of providing technical assistance is a give and take, which involves many subtleties and many different levels and layers of communication.” Victor van Spengler, a legal advisor with MSF in Cambodia, asserted that in his experience, WIPO’s draft legisla tion had not in fact taken into account all the flexibilities available in TRIPS. Cambodia does not yet have a patent law, but WIPO is helping them to draft one as a condition of entry to the WTO. van Spengler found that WIPO had not yet informed Cambodia of the Doha Declaration, nor was the government aware that they are not required to grant patents on pharmaceuticals until 2016. van Spengler also read to the audience an example of text given by WIPO to Cambodia, which disallowed parallel importation completely. In response to an inquiry about a model law for TRIPS implementation in developing countries, Castelo stated that “we cannot have and we do not have a model law” because “our Member States have different legal basics, according to their cultural structures.” Castelo explained that WIPO provided working drafts of legislation on an individual basis instead. Nevertheless, there was strong backing among many participants for WIPO to provide something like a model law that would include all the flexibilities available under TRIPS. Later in the conference, William Haddad, a representative from the generic pharmaceutical industry, suggested that “we did have a model compulsory licensing law,” referring to Canadian legislation that had been “acceptable for decades to brands and generic” before being dismantled under the North American Free Trade Agreement.   Case Study: Bangui 1999   Catherine Gavin, legal advisor to MSF, presented the Bangui Agreement of the African Organisation of Industrial Property (OAPI) as a case study of WIPO technical assistance. The srcinal 1977 Bangui Agreement, which is binding on all 16 West African Member States of OAPI, was revised in 1999 with the participation of WIPO and the French IP office. This process resulted in what Gavin termed “TRIPS plus plus plus” – that is, IP protection that was much stronger than the minimum level required by TRIPS. For example, Bangui ’99 allows parallel importing only among Member States, despite the fact that medicines can often be found at lower prices outside the OAPI region. Gavin presented data showing that one tablet of GlaxoSmithKline’s Combivir, a one- pill combination of the two antiretrovirals AZT and 3TC, costs US$1.96 in Togo and US$0.94 in Senegal (lowest price within OAPI region), but only US$0.65 in India. TRIPS does not govern countries’ use of parallel importation, as was clarified in Paragraph 5(d) of the Doha Declaration. Therefore, Togo should be allowed to import Combivir from India; however, under Bangui ’99 it i s restricted to importing from Senegal – at a price that is 45% higher than in India. In addition, Bangui ‘99 does not allow compulsory licensing for imports and has extended patent protection on pharmaceuticals from 10 to 20 years. In this way, it pushed 12 Member States that are considered least-developed countries (LDCs) to comply with TRIPS many years before it is required. 2 At the time Bangui was revised, LDCs had until 2006 to become TRIPS - compliant; Doha granted them a further extension until at least 2016.  Gavin’s presentation prompted several audience responses, including a comment from J.N. Mono Ndjana of the IP office in Cameroon, who insisted that her country had been obliged to instate 20-year patents for medicines by the year 2000 – not 2006 or later – and that the OAPI countries themselves, not WIPO, had made the final decisions on Bangui ‘99. Furthermore, when asked if WIPO would help to adapt Bangui in light of the Doha Declaration, Castelo responded “in my opinion, this is not necessary….It is totally in line with the Doha Declaration. We should not mix the role of the NGO, where you have a different mandate, a 2  Of the 16 countries of OAPI, Cameroon, the Republic of Congo, Cote d’Ivoire, and Gabon are considered developing countries, and the re maining 12 (Benin, Burkina Faso, Central African Republic, Chad, Guinea - Bissau, Guinea, Equatorial - Guinea, Mali, Mauritania, Niger, Senegal, Togo) are considered LDCs.    4   different mission – with an international organization, where all Member States are represented…We cannot –  we do not have the m andate –  to go along with what the Secretariat thinks.”  Nevertheless, Falou Samb, of the Senegal Mission to the WTO, made a clear request for assistance at the end of the day when he noted that in OAPI countries “we do face legal challenges in our Bangui agreement, revised in ‘99 and modified to take into account the TRIPS Agreement….What we need to have, first thing, is sample legislation. What we have was drafted before Doha, now we have to shift from a TRIPS- compliant legislation in our countries to a Doha - compliant legislation. That is what we need from technical assistance.”   Technical Assistance: What is Needed?   Several other speakers echoed Samb’s call for appropriate technical assistance. For example, Ambassador B.G. Chidyausiku of Zimbabwe stated , “the technical assistance that we have received both from the WTO and from WIPO, has been to developing countries: how do you change your legislation, how do you comply with the TRIPS Agreement? But the question we have never asked ourselves is, how can developing countries benefit from the TRIPS Agreement? At this phase, this is what we should be focusing on.” Martin Khor, Director of the Third World Network (TWN), asserted that “we need that kind of technical assistance that is honest, in favor of the poor and for developing countries,” and recommended the publication  Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options , by Carlos Correa, which he called “a response to the wrong kind of technical assistance that was going on.” 3   Cecilia Oh, also of TWN, perhaps best summarized the concern of many participants when she said, “at the moment, the emphasis of technical assistance is possibly too much on the legal solutions and possibly too much on the obligations of the TRIPS Agreement.” Reacting to these types of concerns, Castelo noted that “WIPO has not received one complaint from a Member State that it has received wrong technical assistance.” However, speaking in a personal capacity, Otto Genee of the Netherlands Permanent Mission to the WTO told the audience, “it doesn’t surprise me at all. If he gives technical assistance to the patent offices, of course he will not hear complaints –  certainly not if he brings computers with him, and hardware, and other nice goodies. Then, of course, you will not bite the hand that feeds you –  that is not so strange.”  Overall, serious concerns were raised as to whether WIPO’s technical assistance was balanced and appropriate. Nevertheless, at the end of the day Mr. James Quashie- Idun, Director of Cooperation for Development at WIPO, affirmed his organisation’s commitment to its Member States and declared that “we are going to take fully into account the Doha Declaration in our technical cooperation.” Castelo a lso informed the conference that WIPO was convening a meeting of LDCs in Dar es Salaam in April, where WTO and WHO would be participating, and at which the Doha Declaration and IP would be discussed.   Implementing Doha Provisions   Later discussions focused mainly on the specifics of the Declaration, including how to resolve the ‘production - for - export’ issue and put compulsory licensing into practice.   Professor Carlos Correa of the University of Buenos Aires, a pre - eminent world expert on IP, pointed out that the 2016 extension for LDCs was in fact a rather negligible concession, since LDCs represent very small markets and the majority of them already offer patent protection for pharmaceuticals. For example, out of the 30 LDCs in sub - Saharan Africa, only Eritrea and Angola do not currently grant such protection.  Not only did LDCs gain little from the 2016 extension, according to Correa, they also face a serious practical hurdle: Article 31.f of the TRIPS Agreement requires compulsory licenses to be used “predominantly for the supply of the domestic market.” This clause may restrict developing countries that do have domestic drug production capacity (e.g. India) from exporting sufficient quantities of medicines to those that do not (e.g. Togo), making compulsory licensing a meaningless measure for many LDCs. Correa also pointed out that very little capacity exists in developing countries to produce active ingredients (only a few countries, such as China, India, Brazil, and Thailand, have this capacity.) While many more countries have formulation capacity (i.e. producing pills from active ingredients), a 1992 United Nations Industrial Development Organization study indicated that 60 countries do not have the capacity for either active ingredients or 3 Correa, Carlos.  Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options . (London: Zed Books and Penang: Third World Network, 2000).
Recommended
View more...
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks