ANNUAL REVIEW OF THE DECISION ON THE implementation
of paragraph 6 of the doha declaration on
the trips agreement and public health

Report to the General Council

1.  Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of 30 August 2003 (the "2003 Decision") provides that the Council for TRIPS shall review annually the functioning of the System set out in the Decision with a view to ensuring its effective operation and shall annually report on its operation to the General Council.  This review is deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement.

2.  The Council for TRIPS undertook the tenth annual review in October 2013.  The General Council took note of the report of the Council for TRIPS (IP/C/66) at its meeting on 26 November 2013 (WT/GC/M/149, paragraph 7.15).  The present report covers the period since October 2013.

3.  At its meeting of 28-29 October 2014, the Council undertook the eleventh annual review.  Annex 1 to this report records the review and the statements made by delegations.  The paragraphs below set out factual information regarding the implementation and use of the 2003 Decision and the acceptance of the Protocol Amending the TRIPS Agreement.

1  Information on implementation and use of the System established under the Decision

4.  Since the last annual review, Chinese Taipei and the Republic of Korea have notified legislation implementing the System into domestic law to the Council for TRIPS.^[1] An overview of all notified implementing laws and regulations, including hyperlinks to the legal texts, is available on a dedicated page on the WTO website at http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm.

5.  During the period covered by the present report, no notifications by importing or exporting Members pursuant to paragraphs 1(b), 2(a) and 2(c) of the 2003 Decision have been made to the Council for TRIPS. As foreseen in the 2003 Decision, the Secretariat regularly updates a page on the WTO website dedicated to this Decision, notably to ensure the public availability of notifications made pursuant to it (http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm).

6.  A trilateral study on "Promoting Access to Medical Technologies and Innovation – Intersections Between Public Health, Intellectual Property and Trade", launched by the WHO, WIPO and WTO Secretariats in February 2013, offers explanatory background material on the implementation and use of the System.^[2] In addition, a set of model notifications has been provided for illustrative purposes on the WTO's webpage dedicated to public health in order to further facilitate the use of the System.^[3]

2  Decision on the Amendment to the TRIPS Agreement

7.  As called for in paragraph 11 of the 2003 Decision, the General Council adopted a Protocol Amending the TRIPS Agreement, by a Decision of 6 December 2005 (WT/L/641). The Protocol is open for acceptance by Members until 31 December 2015 or such later date as may be decided by the Ministerial Conference (WT/L/899). In accordance with Article X:3 of the WTO Agreement, the Protocol will enter into force upon acceptance by two thirds of the WTO Members.

8.  As of 30 September 2014, the following Members have notified their acceptance:

·        United States, 17 December 2005, WT/Let/506;

·        Switzerland, 13 September 2006, WT/Let/547;

·        El Salvador,  19 September 2006, WT/Let/548;

·        Republic of Korea, 24 January 2007, WT/Let/558;

·        Norway, 5 February 2007, WT/Let/563;

·        India, 26 March 2007, WT/Let/572;

·        Philippines, 30 March 2007, WT/Let/573;

·        Israel, 10 August 2007, WT/Let/582;

·        Japan, 31 August 2007, WT/Let/592;

·        Australia, 12 September 2007, WT/Let/593;

·        Singapore, 28 September 2007, WT/Let/594;

·        Hong Kong, China, 27 November 2007, WT/Let/606;

·        China, People's Republic of, 28 November 2007, WT/Let/607;

·        European Communities^[4], 30 November 2007, WT/Let/608;

·        Mauritius, 16 April 2008, WT/Let/619;

·        Egypt, 18 April 2008, WT/Let/617;

·        Mexico, 23 May 2008, WT/Let/620;

·        Jordan, 6 August 2008,WT/Let/630;

·        Brazil, 13 November 2008, WT/Let/636;

·        Morocco, 2 December 2008, WT/Let/638;

·        Albania, 28 January 2009, WT/Let/639;

·        Macao, China, 16 June 2009, WT/Let/645;

·        Canada, 16 June 2009, WT/Let/646;

·        Bahrain, Kingdom of, 4 August 2009, WT/Let/652;

·        Colombia, 7 August 2009, WT/Let/650;

·        Zambia, 10 August 2009, WT/Let/651;

·        Nicaragua, 25 January 2010, WT/Let/663;

·        Pakistan, 8 February 2010, WT/Let/664;

·        Former Yugoslav Republic of Macedonia, 16 March 2010, WT/Let/671;

·        Uganda, 12 July 2010, WT/Let/678;

·        Mongolia, 17 September 2010, WT/Let/684;

·        Croatia, 6 December 2010, WT/Let/747;

·        Senegal, 18 January 2011, WT/Let/753;

·        Bangladesh, 15 March 2011, WT/Let/758;

·        Argentina, 20 October 2011, WT/Let/830;

·        Indonesia, 20 October 2011, WT/Let/831;

·        New Zealand, 21 October 2011, WT/Let/832;

·        Cambodia, 1 November 2011,WT/Let/833;

·        Panama, 24 November 2011, WT/Let/837;

·        Costa Rica, 8 December 2011; WT/Let/838;

·        Rwanda, 12 December 2011, WT/Let/839;

·        Honduras, 16 December 2011, WT/Let/843;

·        Togo, 13 March 2012, WT/Let/848;

·        Saudi Arabia, Kingdom of, 29 May 2012, WT/Let/855;

·        Chinese Taipei, 31 July 2012, WT/Let/870;

·        Dominican Republic, 23 May 2013, WT/Let/884;

·        Chile, 26 July 2013, WT/Let/888;

·        Montenegro, 9 September 2013, WT/Let/893;

·        Trinidad and Tobago, 19 September 2013, WT/Let/894;

·        Central African Republic, 13 January 2014, WT/Let/920;

·        Turkey, 14 May 2014, WT/Let/949;

·        Botswana, 18 June 2014, WT/Let/953; and

·        Uruguay, 31 July 2014, WT/Let/984.

9.  Information on the status of acceptances of the Protocol can be found on a dedicated webpage which is regularly updated by the WTO Secretariat.^[5]

ANNEX 1

Excerpt from the Minutes of the Council's meeting of 28-29 October 2014
to be circulated as IP/C/M/77

6.     review under paragraph 8 of the decision on the implementation of paragraph 6 of the doha declaration on the trips agreement and public health

1.  The Chairman recalled that the standard format for the review had been that, after an introduction and update on recent developments by the Chairman, the floor was opened to delegates for comments. In 2010 and 2011, the Council had held more structured debates. They had been conducted on the basis of a list of topics for the discussion that had been agreed in advance of the reviews. In light of the feedback previous Chairmen had received in their consultations prior to the subsequent reviews, the 2012 and 2013 reviews had again followed the standard format.

2.  At his informal consultations in June 2014, he had encouraged delegations to consider how the Council should conduct the present review. In light of the feedback received, the Chairman suggested that the standard format be followed this year. The records of earlier reviews, including the exchange of questions and responses, continued to provide a unique and valuable resource for understanding this important measure and might inform Members' discussions at this review. If Members felt that any questions regarding the Paragraph 6 System itself or possible alternatives to it had not been adequately addressed at past reviews, they should feel free to revert to any such questions.

3.  As regards the purpose of the review, he recalled that paragraph 8 of the waiver Decision provided that the Council for TRIPS shall review annually the functioning of the System set out in the Decision with a view to ensuring its effective operation and shall annually report on its operation to the General Council. Furthermore, the paragraph provided that this review shall be deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement.

4.  The Secretariat had prepared a draft cover note for the Council's report modelled on previous years' reports (circulated as JOB/IP/11). He suggested that the Council take up the preparation of its report to the General Council after it had exhausted its discussion. Paragraph 8 of the cover note contained a list of Members that had notified their acceptance of the Protocol. The following Members had deposited their instruments of acceptance since the Council's last meeting in June: Botswana on 18 June and Uruguay on 31 July.

5.  He recalled that the Protocol had originally been open for acceptance by Members until 1 December 2007. Upon proposals by the TRIPS Council, the General Council had four times extended this period for further two-year periods. At present, the period extended until 31 December 2015. 53 instruments of acceptance, including from the European Union, had been deposited with the WTO Director General. In order for the TRIPS amendment to enter into force, acceptance by two thirds of the membership was, however, required. He therefore strongly encouraged Members who had not yet completed their domestic procedures to do so as soon as possible.

6.  He said that, regarding how accepting the Protocol related to the implementation of the Paragraph 6 System in a Member’s domestic legal framework, these were two entirely separate acts; the Protocol could therefore be accepted independently from adopting domestic implementing legislation. By accepting the Protocol, a Member expressed its consent that other WTO Members were entitled to use the additional flexibility that the System provided. Should a WTO Member wish to take advantage itself of these additional flexibilities, it might need to domestically implement appropriate legislative measures. But since these two processes were entirely separate, a Member might choose to deposit an instrument of acceptance of the Protocol without the need to wait for any domestic implementation. Many instruments of acceptance that the WTO had received had been deposited before the Member in question had adopted any domestic implementing legislation.

7.  The representatives of Chile; Uganda on behalf of the LDC Group; India; Brazil; Cuba; China; Chinese Taipei; the United States; Australia; Canada; Japan; the European Union; Switzerland; Egypt; and the Secretariats of WTO; WIPO and WHO took the floor.

8.  Referring to the draft cover note for the Council's report to the General Council (circulated as JOB/IP/11), the Chairman said that it contained factual information on the implementation and use of the system established under the Decision, as well as on the status of acceptances of the Protocol Amending the TRIPS Agreement. In accordance with the way that the Council had prepared its reports in the previous years, the part of the minutes of the meeting that would reflect the discussions held under this agenda item might be attached to the cover note.

9.  The Council took note of statements made and agreed on the draft cover note to the report. It also agreed that the record of the discussion be attached to it.

Appendix 1

Excerpt from the Addendum to the Minutes, containing the statements made during the Council's meeting held on 28-29 October 2014, to be circulated as IP/C/M/77/Add.1

Agenda item 6: review under paragraph 8 of the decision on the implementation of paragraph 6 of the doha declaration on the trips agreement and public health

6.1       Chile

Our country gives this issue high importance. As the report states in JOB/IP/11, Chile deposited its ratification instrument during the course of 2013. We commend countries that have decided to implement the Protocol which creates a quorum for its entry into force. As the report states, this is not a panacea to resolve all issues of public health. It is part of a larger programme that includes other important aspects that have an impact on innovation and access, like infrastructure, financing mechanisms that are supporting innovation, inter alia.

However, although it is necessary to develop national programmes to make progress in this area, it is also important to emphasize that the Paragraph 6 System is the only flexibility of the TRIPS Agreement that is specifically devoted to the participation of two countries at least to enable that Members with difficulty to make effective mandatory licensing under the Agreement can effectively use them. We believe that this quality of effort is important today. Our delegation would like to stress the importance of the role of the mechanism as a political sign agreed between Members that reflects the importance that this Organization places in the promotion of access to medical technology and innovation as a key area of public health overlapping with intellectual property. Our country is happy to participate in the various initiatives, dialogue bodies that may be developed in this area.

6.2   Uganda

I make this statement on behalf of the LDC Group. It is no secret that LDCs have limited capacity to manufacture medicines. Access to affordable medicines by our people continues to remain a prominent public health concern relating to TB, HIV/AIDS and malaria. It is a matter of life and death. We have a recent eye-opener in this regard – the Ebola outbreak has given us a clear message on our capacity constraints and immense limitations. You will recall that Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health clearly recognized the gravity of the problem and instructed the Council to find an expeditious solution.

Accordingly, Members adopted a decision in this regard (WT/L/540 and Corr. 1 of September 2003) to facilitate the legal coverage of importing medicines. However, this decision was marred by so many unnecessary burdensome conditions. Getting recourse through this decision was time-consuming. This is disconcerting in view of the life and death situation of our patients. Despite the multiple difficulties and without manufacturing capacity, only one of our members has invoked the provisions under this instrument. Failing to respond appropriately and quickly is thus a collective shame for all of us. As such we join our voice to those who have called for the review of this decision with a view to simplifying the instrument to address our concerns. Further, the adoption of the General Council Decision WT/L/641 in 2005 in order to respond to difficulties experienced by countries with no or insufficient manufacturing capacity was an important milestone.

However, we are concerned that the process of accepting the TRIPS amendment seems to be taking longer than it took to negotiate and arrive at a decision in 2005. Surely, if all are concerned about easing the difficulties faced by millions of people across the globe, with these global public health concerns the question is where is that true commitment to the cause of those who are suffering? Consultations have been held to get a sense of where the difficulties lie, for completing the formality of depositing an instrument of ratification. Seminars have been held, and continue to be held on this topic, yet progress is taking place at a snail's speed.

We cannot afford to wait any longer before the amendments are affected. All of us have a collective responsibility to ensure that the TRIPS Agreement works for those faced with a public health concern, just as much as private rightholders are enjoying the benefits of protection offered under this Agreement. We therefore call upon Members who are yet to deposit their Instrument of Acceptance to do so.

6.3       India

India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public Health, the Paragraph 6 System as established under the 2003 waiver decision and the Protocol. The Paragraph 6 System is also the first ever proposed amendment to the WTO Agreement in the form of the 2005 Protocol Amending the TRIPS Agreement. India had notified its acceptance of the Protocol in March 2007. We would like to congratulate Uruguay, Botswana, Turkey and the Central African Republic for depositing their instruments of acceptance of the Protocol during the last year.  However, in spite of the fourth extension of the period for acceptance until 31 December 2015, only 53 Members have accepted the Protocol so far. The fact that there is still a long way to go for it to enter into force, as acceptance by two thirds of the membership is required, is not a positive signal. Therefore, we urge other Members to notify their acceptance of the 2005 Protocol Amending the TRIPS Agreement for it to enter into force. We would like to appreciate the Secretariats of WTO and WIPO for providing technical assistance for the process of entry into force of the amendment, and also for the implementation and use of the Paragraph 6 System.

India has always been of the view that the Doha Declaration on the TRIPS Agreement and Public Health constituted a major landmark in the short history of the WTO because it recognized the primacy of public health needs and the preparedness of the Organization to take up the problems faced by the poor in developing countries. Along with several other Members, India had worked relentlessly on the Doha Declaration and the Decision. The Decision was expected to address the public health problems faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. It may have sounded prophetic at that time when India voiced certain apprehensions in the General Council meeting of August 2003. India sounded a word of caution and while expressing hope that "the results accruing from this mechanism should not be negated by the creation of cumbersome systems that would lead to huge delays in getting medicines across at reasonable cost to those that needed them or discourage Members from using the system for the benefit of the people. In order to make this system successful, a sincere collective effort was required on the part of all Members and the entire pharmaceutical industry." Regrettably, we have been proven right. The export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 was the first and only use of the system so far.

The trilateral study by WTO, WHO and WIPO on "Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade" (2013) has summarised the diverse observations of the WTO Members on whether the Paragraph 6 System is fulfilling its intended objectives into six points as follows:

i.      "By 2012, the System was only used once, and it took three years before the shipments in question proceeded. The System is too complex and administratively unwieldy for further use, and a multi-stakeholder workshop is needed in order to discuss the operation of the System. It is essential to clarify whether constraints on its use were built into the System, thus necessitating its reform, or whether such constraints were a consequence of how individual countries chose to implement it.

ii.     Potential users of the System may be deterred by concerns about political or trade ramifications associated with the use of compulsory licensing.

iii.   The Canada's Access to Medicines Regime (CAMR) was successfully utilized, and only a very small portion of the three-year time period was taken up with procedures associated with the System. Much of the time that elapsed between the regulatory review of the medicine in question and the actual shipments was attributable to other factors.

iv.   The limited use of the System is not an appropriate measure of its success, as no delegation demonstrated evidence of obstacles to its use when such use was required. A single case demonstrated that the System could work when necessary, and that it could play a supportive role in the wider effort to improve access to essential medicines, given that alternative ways of procuring the needed medicines are often available.

v.    The System is not a panacea to solve all public health related problems. Rather, it is part of a broader picture which includes other important aspects that have an impact on innovation and access, such as infrastructure, tariffs, innovative financing mechanisms, partnerships and cooperation (including at the regional level), and regulatory frameworks.

vi.   Implementation of full patent protection for pharmaceutical products in India, coupled with the approaching expiry of transition periods in LDCs, could make it more difficult in the future to procure generic versions of new medicines. Under such circumstances, the Paragraph 6 System might assume a greater significance."

The TRIPS Council has been reviewing the mechanism for the last several years. My delegation feels that the review mechanism has become ritualistic in nature and will not serve any purpose if we go on repeating similar questions and get similar replies as summarized by the trilateral study done by the WTO, WIPO & WHO. The implementation of the Paragraph 6 System involves several stake holders and our discussions would not be effective if we restrict the discussion to this level.

It is pertinent to mention here that the WTO, WHO and WIPO are holding a technical symposium on "Innovation and access to medical technologies: challenges and opportunities for middle income countries" on 5 November 2014 at the WTO in Geneva. As part of the trilateral cooperation between the WHO, WIPO and the WTO on innovation and access to medicines, we request these Organizations to organize a dedicated workshop involving all stakeholders to expand the scope of the discussion on the question of making effective use of the Paragraph 6 System, including alternatives to it.

6.4   Brazil

We associate ourselves to the statements delivered by Chile, Uganda and India. In 2001, all Members recognized 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. In response to this challenge, the Council for TRIPS developed the Paragraph 6 System to implement one solution to access to medicines. Since the System was established, only one country benefited directly from it.

In light of the fact that we have not witnessed any usage of the System in the last six years, it is valid to raise the question of whether Members feel entitled to use the System as an instrument of public policies towards universal access to health.  Uganda, on behalf of the LDC Group, reminded us all of the high stakes present at the full implementation of the System.

We should not deny the fact that there is a relationship between IP and access to medicines. In this sense we would like to support the proposal by the delegation of India to expand the discussion on the subject of the effectiveness of the Paragraph 6 System to a broader public of stakeholders. A workshop would be a good initiative in this direction.

6.5       Cuba

Cuba is in favour of an open‑ended workshop on the Paragraph 6 System, to which all interested parties would be invited; the time has come to review the problems of the System, as the delegations of Uganda and India have requested.

This is independent from the acceptance of the Protocol, which does not in itself resolve the problem of ineffectiveness of the system.

6.6       China

By waiving Members' obligations under Article 31(f) of the TRIPS Agreement, the System aimed to address the public health problems faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector.

Unfortunately, the System has been used only once so far, and it is not easy to assess whether it has achieved its objectives. The very limited use does not mean that the developing country Members do not face public health problems anymore. According to the trilateral study on "Promoting Access and Medical Innovation - Intersections between Public Health, Intellectual Property and Trade" prepared by WTO, WHO and WIPO, tuberculosis and HIV/AIDS are among the leading causes of death in middle-income countries, and people in low-income countries predominantly die of infectious diseases. This indicates that the problem of public health and access to medicines is still a big challenge for many Members.

Therefore, the review is necessary. It is important to carefully examine the reasons behind the limited use, identify the difficulties faced by Members in using the System, and find possible ways of improving it. We support the proposal to hold an open-ended workshop. The inputs from all stakeholders, including experts, non-governmental and intergovernmental organizations, would contribute to achieve greater transparency, promote a holistic understanding of the issues, and identify the possible solutions to the current situation. We take note that these kinds of workshop took place from time to time in other WTO committees, and we do not see any rational for some Members to oppose such a workshop.

6.7       Chinese Taipei

On behalf of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu, I would like to thank you for the informative briefing on the current development of the Paragraph 6 System.

I would like to draw your attention to the fact that the elements contained in the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, and the draft amendment of TRIPS Article 31bis have already been introduced in our 2011 Patent Act.

Public health problems afflict many developing and least-developed countries, especially those resulting from Ebola and other new and serious epidemics. We would like to highlight the need for the TRIPS Agreement to be part of the wider national and international action to address these problems. It should be also emphasized that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health and, in particular, to promote access to medicines for all. My delegation supports the Paragraph 6 System and encourages other Members to notify their acceptance of the amendment so that it can enter into force.

6.8   United States of America

The United States strongly supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol. The United States was the first WTO Member to accept the amendment in 2005. We also welcome the latest General Council decision of 26 November 2013 which extended the deadline for acceptance of the amendment to 31 December 2015. We also welcome and congratulate Botswana, the Central African Republic, Turkey and Uruguay who have formally accepted the amendment this year. We welcome and encourage the Secretariat's efforts with respect to depositing instruments of acceptance of the Amendment as well. We join Uganda in encouraging other Members to notify their acceptance of the Amendment so that it can enter into force. Finally, we wanted to highlight the Secretariat's good efforts in this regard, and draw delegates' attention to the WTO TRIPS webpage where Members can find a link to an illustrative guide to notifying under the Paragraph 6 System which we find to be quite helpful. As we have explained, there are multiple avenues available for promoting access to medicines, the Paragraph 6 System is important of course, but it is not alone.

There are many mechanisms to overcome barriers, and such barriers of course include tariffs and non-tariff barriers. Measures including those that are discriminatory, non-transparent or otherwise trade-restrictive have the potential to hinder access to pharmaceuticals and medical devices and potentially result in reduced access to healthcare due to higher healthcare costs. For example, taxes or tariffs may be levied often in a non-transparent manner on imported medicines and the increased expense associated with those levies is then passed directly to health-care institutions and to patients. Moreover unreasonable regulatory approval delays and non-transparent reimbursement policies can create uncertainty or ambiguity about when a new drug or medical product can enter into the market and thereby discourage the development and marketing of such new drugs and other medical products. The criteria, rational and operation of such measures are often non-transparent and not fully disclosed, contributing to this uncertainty. Appropriate mechanisms for transparency, procedural and due process protections and opportunities for public engagement are important in the context of health care systems. We continue to believe that the access to medicines issue is multidimensional; making life-saving medicines available requires transparency and a commitment to address measures that unduly delay patients from getting the treatments they need.

Finally, to the extent that a delegation has requested a TRIPS Council decision today on a workshop, as this is a new proposal and on which we have received no advance notice, including at yesterday's informal meeting, we will need to revert this request, if it is a request, back to capital.

6.9   Australia

We welcome this opportunity to discuss the Paragraph 6 System, which we strongly support. We agree with others who have pointed out that the TRIPS Protocol is not a panacea to improve public health, and Australia, in that regard supports many international measures to improve access to medicines, including through the WHO Pandemic Influzena Preparedness Framework for sharing of influenza viruses and access to vaccines and other benefits. We also support other things like the efforts to increase access to quality medicines and other technologies in our region through co-chairing the Asia Pacific Leaders Malaria Alliance. The Australian aid programme will also invest AUS$30 million per year in health and medical research, including product development partnerships for medical technologies. We were pleased to accept the TRIPS Protocol in 2007 and would like to join those who congratulate Trinidad and Tobago, the Central African Republic, Turkey, Botswana and Uruguay on their acceptance of the Protocol since this issue was last discussed in the Council, and we certainly join in encouraging others who have not yet accepted the Protocol to do so. Legislation to implement the TRIPS Protocol is currently before the Australian parliament. On the question of a workshop on access to medicines, we would welcome a workshop on the effectiveness of the Paragraph 6 System that is sufficiently broad to allow a meaningful and frank discussion of access to medicines issues by including participants from industry and NGO stakeholders, and by covering related issues, other than intellectual property, such as government procurement, supply chains and the role of gender.

6.10        Canada

As Canada has previously said, while the Paragraph 6 System is a useful tool, it should not be regarded as a panacea for the complex problem of access to medicines. Indeed, medicines are one of the many components of health systems, the price of medicines is one of the many factors affecting access to those medicines, and intellectual property is one of the numerous factors influencing the price of medicines. The impact of intellectual property rights on access to medicines, on the price of those medicines and on health care in general is proportionate to the role played by intellectual property in relation to other factors affecting the price and availability of medicines, including infrastructure, health systems, regulations, distribution and administration of medicines, in addition to customs tariffs and other taxes applicable to them.

Indeed, it is our understanding that a quarter of Members eligible for the Paragraph 6 System without notification under paragraph 1(b) of the Decision of 30 August 2003 continue to impose import tariffs on medicines at rates of up to 15%, or even 25%. The situation is comparable for other eligible Members. Moreover, a 2011 study by the WHO and the Dutch NGO Health Action International shows that many Members that are eligible for the Paragraph 6 System apply different taxes on medicines in addition to port, customs clearance, transport and/or inspection charges, at rates ranging from 5 to 34%, on top of customs tariffs where they exist. Another study by the same two organizations, published in 2014, reveals that increased distribution charges can push up the price of medicines by another 17 to 84% in relation to the manufacturer's price in low- and middle-income countries, regardless of the patent status.

In other words, we think that tariffs, taxes and charges on medicines can neutralize, at least in part, the beneficial effects of the flexibilities we have given ourselves, which is tantamount to lifting a barrier to exportation and availability on the one hand while erecting barriers to access to medicines on the other.

This being the case, we cannot examine either the Paragraph 6 System or intellectual property in isolation from the other issues affecting access to medicines. Canada would like to note that according to a United Nations report published in 2014, even essential generic medicines are available in only 55% of public sector health facilities in low- and middle‑income countries. In other words, the absence of a patent on a particular medicine is no guarantee of its availability; hence the need to examine all of the factors that impact access to medicines, as well as all of the supply mechanisms. In this connection, Canada would like to underscore the importance of voluntary licences, including those obtained through the Medicines Patent Pool, as well as pooled supply systems such as those used by the East African Community. We would be happy to discuss the experiences of importing Members eligible for the Paragraph 6 System in this respect, and more generally, the supply mechanisms they advocate and the challenges those mechanisms would involve.

We reiterate that Canada's Access to Medicines Regime that implements the Paragraph 6 System, clearly functions well in its current form, and meets the requirements and parameters laid down in the Doha Declaration on the TRIPS Agreement and Public Health. The Canadian Access to Medicines Regime is just one of many aspects of Canada's firm commitment and leadership when it comes to access to medicines and public health for the least‑developed and developing countries.

Let me conclude by calling upon all Members that have not already done so to deposit their instruments of acceptance of the Protocol Amending the TRIPS Agreement.

6.11        Japan

Firstly, this delegation would like to reiterate the importance of access to Medicines, which needs to be discussed in a manner so that not only the Paragraph 6 System but also various other elements are taken into consideration, such as procurement and tariffs. The very objective of the System is to support WTO Members in obtaining greater access to medicines, specifically Members who have either insufficient or no pharmaceutical manufacturing capacity. Compulsory licenses are just one of the means available to achieve this objective; and therefore, the Paragraph 6 System should not be considered as the only solution, but rather as an option we could consider.

Secondly, we need to understand and analyse the specific concerns of potential importing Members who would or who might use the Paragraph 6 System. We hope that these Members will share their concerns and experiences with us. We believe that it would be beneficial for this Council to hear specific comments by potential importing Members.

Therefore, this delegation is of the view that it is premature to hold any workshop at this moment, as proposed by some Members. Instead, this delegation believes that we should take full advantage of this annual review to collect concrete practical examples, particularly based on the list of topics for discussion prepared by the WTO Secretariat in 2011.

6.12        European Union

I will be very brief on this point, because I think it is a subject that has been discussed many times here, and there is not a lot of novelty. Furthermore, I think that our Canadian colleagues just captured exactly what we wanted to say, so for the sake of making of a short intervention, I would reiterate what Canada mentioned. Intellectual property is only one of the items that have an impact on access to medicines. We spend an excessive amount of time discussing this, while overlooking other trade-related issues that have an enormous impact on access to medicines. I think by doing we are not rendering a service to this very important issue of getting medicines to people who need it.

6.13        Switzerland

I would like to react to some of the criticism that we have heard in the discussion in the Council this morning on the Paragraph 6 System. Some Members have said that the System has not fulfilled its objective of addressing the access to medicines problem of potential beneficiary countries. It is important to recall in this context that the mandate in the Doha Declaration on the TRIPS Agreement and Public Health as well as the solution eventually found was not, and could not have been, to solve the access to medicines problem for countries without manufacturing capacity. The mandate was merely - but importantly - to put all WTO Members on a level playing field with regard to the use of of compulsory licences as a policy tool provided under the TRIPS Agreement. The Paragraph 6 System has achieved this objective, as is evidenced by the Rwanda-Canada case.

This is not to say that my delegation considers the grant of a compulsory licence as a good or even easy-to-use tool to be applied and implemented to facilitate access to medicines in a specific situation of a health need. In practice, the grant and implementation of a compulsory licence may pose a number of problems and challenges which can render it burdensome and inefficient as a tool, not allowing for the quick access to medicines required. But this may be true for any compulsory licence, whether granted under the Paragraph 6 System or not.

Having said this, what the Paragraph 6 System did achieve is that it allows all WTO Members to make use of this policy tool. The mere possibility of doing so may be the biggest benefit of the System, as it improves a Member's negotiating position vis-à-vis manufacturers in the case of a public health situation where a particular medicine is required and still under patent protection. This may be one of the very reasons why, in practice, the Paragraph 6 System has not been used more often.

Regarding the criticism that the mechanism is burdensome and complicated, in our annual reviews since 2003, we have not heard from potential beneficiary countries any specific and real case evidence of problems they have encountered when they wanted to make use of the System. In this context it is also recalled that the safeguards under the Paragraph 6 System are mainly geared to avoid diversion of medicines produced under a special compulsory licence. They shall make sure that these medicines actually reach the beneficiary country rather than being diverted for commercial purposes to other, more affluent markets.

My delegation does therefore not agree with others who said that our annual review has become ritualistic, nor do we see any merit of inviting external stakeholders to the Council's discussion before we have heard from potential beneficiary Members what difficulties they may have encountered when they actually had wanted to make use of the Paragraph 6 System.

6.14 Egypt

Egypt does support India's proposal that a workshop be organized to discuss this subject. Such a workshop would be useful in helping us to identify the real problems in this System and what hinders developing countries and least developed countries in using it.

6.15        WTO Secretariat

As in the past, we are taking the opportunity to update Members on the work done by the Secretariat in the field of technical cooperation dealing specifically with the Paragraph 6 System, but also more broadly concerning intellectual property and public health, in view of the way in which technical cooperation in this field is undertaken.

The three partner organizations, the Secretariats of the WHO, WIPO and the WTO, have continued their trilateral cooperation in the field of intellectual property, trade and public health with a view to fostering a better understanding of the linkage between those three policy domains and to enhance the mutually supportive implementation of policies in those areas. This means that we increasingly work together to coordinate, design and carry out capacity building activities in this area. This work is undertaken on the foundation of the trilateral study which has already been referred to by delegations.

The study, "Promoting Access to Medical Technologies and Innovation", was launched last year as a shared platform for technical assistance and capacity building for policy makers in those areas of policy spanning the intersections of public health, trade and intellectual property. It includes specific material on the background and implementation of the Paragraph 6 System of special export licences for medicines. The System has been continuously addressed at almost all of our major technical cooperation activities in the past period under the review. In particular, it was covered by the 11^th Joint WIPO-WTO Colloquium for Teachers of Intellectual Property and the 6^th Joint WIPO-WTO Advanced Course on Intellectual Property for government officials; it was covered in more detail in the 9^th Annual Workshop on Intellectual Property and Public Health organized by the WTO itself.

This workshop was held in December 2013, in close collaboration with our colleagues in WHO and WIPO. The goal was to draw together each organization's particular expertise in a complementary manner and to put into practice the comprehensive coordinated approach outlined in the trilateral study. The workshop was accordingly a direct follow-up to the study and followed its content in practice. The study itself often served as starting point for the presentation and discussions at the workshop. Further, as with past workshops, the emphasis was on hearing a diversity of views, practical experience, and policy perspectives. This workshop covered a wide range of issues, including the intellectual property and TRIPS issues specifically relating to the Paragraph 6 System, but also other areas of intellectual property law and the provisions and the flexibilities within the TRIPS Agreement. The breadth of stakeholders taking part as experts and speakers included a range of officials from the three partner organizations, but also experts from elsewhere in the international system and the United Nations system, as well as representatives of industry, the philanthropic sector and civil society organizations, with a view to providing a rounded view of the issues at the crossroads between intellectual property and public health.

Building on the series of joint policy symposia that the three organizations have held, the most recent hosted by WIPO in July last year on medical innovation and changing business models, the three organizations will be convening the fourth in this series of trilateral technical symposia on 5 November 2014. It will focus on "Innovation and Access to Medical Technologies - Challenges and Opportunities for Middle-Income Countries". The idea is to focus on the concept of middle income countries. The chief economists of WIPO and WTO will be joined by the Director of Health Systems Governance from WHO for a discussion on the policy significance of middle income countries in general in relation to innovation and access issues. The following session will turn to the innovation dimension, concerning how to measure the innovative capacity in the medical sector in middle income countries and looking at the factors that are behind the success in innovation in those countries, as well as at overall trends. Discussions will then turn to the challenge of ensuring access to medical technologies and the kind of policies, initiatives, measures that have been explored in those areas by middle income countries. The emphasis as in the past is to draw on practical experience, a breadth of perspectives from those working in the field who can bring to the Geneva policy community a broader understanding of their practical activities and programmes, as well as on the policies and the initiatives in middle income countries.

The series of workshops on Intellectual Property and Public Health has proceeded for 10 years and has been progressively broadening in scope from a specific focus on TRIPS and intellectual property issues to address the broader trade and health aspects as well. The eleventh workshop in this series will be held in Geneva from 24-28 November, once again in close collaboration with the Secretariats of the WHO and WIPO. It will closely track the trilateral study as a foundation for inclusive, comprehensive and holistic capacity building in this area.

Intellectual property, TRIPS and public health, as well as the Paragraph 6 System have also been regular items at other training activities such as regional and advanced trade policy courses, the Geneva Week programme for non-resident delegations, as well as a number of national workshops. The WTO Secretariat has also offered ad hoc advice to Members upon request. This information has included specific advice on the Paragraph 6 System, including the process for acceptance of the Protocol of Amendment of the TRIPS Agreement. Here, we have been able to assist along the lines of previous discussions in the TRIPS Council identifying the specific steps that are needed for acceptance of the Protocol. A number of Members have taken the step of accepting the Protocol without any domestic implementing legislation. It is clearly not a prerequisite for acceptance to pass domestic legislation: the instrument of acceptance of the protocol entirely focuses on signalling legal agreement that other Members are entitled to use the System if they so wish. We see different experiences in terms of accepting the TRIPS amendment on the one hand, and practical steps to implement the System in domestic law on the other hand, with Members treating these generally as distinct steps. This distinction has been usefully clarified in conversation with a number of Members. This agenda item also has links to the first agenda item, on notifications under the TRIPS Agreement: there has been significant amount of legislative activity among Members to implement, but we are aware that not all of this legislation has been notified.  Up to date notification of such implementing legislation is one element that could help inform our work on the System.

Finally, concerning the acceptance process, as directed at a previous session of the TRIPS Council the Secretariat has prepared a model notification of acceptance: this is available online, and we can share a copy with any interested delegation. The key point is that this is a very straightforward and simple document, and the procedure is not complex. The instrument of acceptance simply has to be executed by someone with the requisite authority in the government, such as the minister for foreign affairs.

6.16        WIPO Secretariat

During the period from November 2013 to September 2014, WIPO provided legislative and policy advice on patents that referred to or included considerations regarding paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health as follows:

·        At the request of eight Member States, the WIPO Secretariat prepared comments on draft laws which included reference to, or implemented, paragraph 6 of the Doha Declaration.

·        In the framework of legislative assistance on patents, matters related to health policies, including paragraph 6 of the Doha Declaration, were also addressed in the context of two missions that were undertaken to capitals and two consultations that took place in WIPO headquarters in Geneva.

·        Legislative implementation of patent law matters, including the international legal framework provided by the TRIPS Agreement, was addressed in the following seminars or meetings:

i.        WIPO Sub-Regional Workshop on Patent Law and Policy, Santiago, Chile, 3-4 December 2013;

ii.       WIPO National Workshop on Patent Policy and its Legislative Implementation, Santo Domingo, Dominican Republic, 29-30 April 2014; and

iii.     WIPO Regional Seminar on Issues of Patent Protection for Medicines, Bishkek, Kyrgyz Republic, 28-29 May 2014

·        WIPO staff participated in WTO Seminars, where the topic of patent-related flexibilities, including paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health has been dealt with, as follows:

i.        National Seminar on the WTO TRIPS Agreement, Addis Ababa, Ethiopia, 12-13 November 2013;

ii.       WTO National Workshop on the TRIPS Agreement, Naypyidaw, Myanmar, 20-21 November 2013;

iii.     WTO National Seminar on Public Policies concerning the TRIPS Agreement, El Salvador, San Salvador, 21-23 January 2014;

iv.     WTO Workshop on the TRIPS Agreement and IP related matters, Port Louis, Mauritius, 5-7 March 2014;

v.      WTO Annual Workshop on IP and Public Health, Geneva, 10-13 December 2013; and

vi.     WIPO-WTO Colloquium for Teachers of IP, Geneva, Switzerland, 16-27 June 2014.

WIPO's legislative assistance is consistently based on the multilateral legal framework. More recently, a number of national authorities in charge of drafting laws have sought advice from WIPO regarding how to use the available multilateral flexibilities so as to accommodate particular national interests that are specific to their countries. Since Paragraph 6 of the Doha Declaration is part of those flexibilities which are considered by several countries as part of their access-to-medicine policies, this issue is regularly covered by WIPO legislative and policy assistance.

The following is an update on WIPO Re:Search:

·        As reported to the TRIPS Council in October 2013, WIPO Re:Search is a platform launched by WIPO with the participation of the public and private sector. Its purpose is to catalyze more research for Neglected Tropical Diseases (NTDs), malaria, and TB through the sharing of IP assets between researchers in this field. NTDs, malaria and TB affect more than one billion people globally, and usually affect the most disadvantaged populations in developing countries. To generate more investment in innovation directed at these diseases, WIPO worked with public and private sector partners and created WIPO Re:Search in 2011. Its purpose is to create a new mechanism to facilitate the sharing of IP assets between public and private sector partners. For example, private sector companies have large libraries of pharmaceutical compounds and related information, but they are not generally investing substantially in NTD research. Yet, this information could be valuable to researchers that are focusing on these diseases. WIPO Re:Search was launched on 26 October 2011, with about 30 members, including pharmaceutical companies, research institutions and a range of public and private entities as members. 

·        To date, WIPO Re:Search has more than tripled its membership, with 92 members currently.

·        Importantly, WIPO Re:Search has more than 17 members from the African continent, representing the public and private sectors, and academia.

·        14 new Members, including a major private sector company, have joined since our report to the TRIPS Council in 2013.

·        Over 79 collaborations have been initiated, and more are in development. There were approximately 30 in October 2013.

·        Four scientists, from Egypt, South Africa, Nigeria, and Cameroon have completed research sabbaticals at WIPO Re:Search Members in Switzerland, India, and the United States. A fifth scientist, from Ghana, will return to the University of California, San Francisco, USA, to complete the second half of his sabbatical. This programme, funded by the Government of Australia, has become one of the most successful examples of capacity building and knowledge transfer facilitated by WIPO Re:Search.  The programme is likely to be extended in 2015.

·        An additional example of technical assistance and capacity building provided by WIPO Re:Search is the upcoming Intellectual Property Management Workshop organized by WIPO with the financial support of the Government of Australia in November 2014.  Fifteen scientists from a range of African countries will benefit from this programme, which is one of the 'supporting services' of WIPO Re:Search.

The WIPO Re:Search website (http://www.wiporesearch.org/)  provides further information.

6.17    WHO Secretariat

We seize the opportunity to present under this health-related agenda item a number of the WHO's technical cooperation activities that took place since our last report to the TRIPS Council.

The overall objective of WHO's technical cooperation in the area of public health and intellectual property is to strengthen the capacity of developing countries in health innovation, access to medicines and management of intellectual property. Countries should prioritize public health interests in the formulation of national policies and legislation on trade and intellectual property.

WHO's technical cooperation is based on its mandate derived from the Global strategy and plan of action on public health, innovation and intellectual property, as well as from other relevant WHO resolutions. For example, Resolution WHA67.6 on the prevention, diagnosis and treatment of viral hepatitis requested the Director-General "to assist Member States to ensure equitable access to quality, effective, affordable and safe hepatitis B and HCV treatments and diagnostics, in particular in developing countries". In 2014, contributing to the implementation of this resolution was one of the main activities in the area of public health and intellectual property.

The WHO's 2014 Guidelines for the screening, care and treatment of persons with hepatitis C infection state that more than 185 million people are infected with the hepatitis C virus worldwide. Of these people, 350 000 to 500 000 die each year. HCV infection can be cured, but most people infected with the virus are unaware of their infection and thus do not seek timely treatment. Several medicines are available to treat hepatitis C, but treatment duration is long, involves weekly injections, and side effects are considerable. With the development of new direct-acting antiviral medicines, the treatment landscape is rapidly changing. These new antivirals are expected to reach cure rates of more than 90% in persons with hepatitis C virus infection across different genotypes, with fewer side effects and a shorter duration of treatment. Prices for these new treatments however are extremely high, in particular in developed countries, but remain out of reach for many patients in developing countries as well. WHO has advised a number of Member States on how to establish national hepatitis programmes that cover all aspects reaching from prevention, to diagnosis and treatment, including on how to access the new treatments at affordable prices. Options include local production where patents have not been filed or granted, license agreements, price negotiations and compulsory licenses.

To identify their best options to increase access to and affordability of these new antiviral treatments, countries need clarity about the patent status of the medicines. Therefore, in September 2014 the WHO Secretariat published an analysis of the patent situation of seven new hepatitis treatments. This corresponds to the mandate provided by the WHO Global strategy and plan of action on public health, innovation and intellectual property that requests WHO to support efforts to determine the patent status of health products. The patent working papers identify the most relevant patents with respect to the seven medicines and list the countries in which these patents have been filed and granted.

Generic competition is the single most effective means to drive prices down. In this respect the UN/WHO programme on prequalification has played a key role in ensuring the quality of mostly generic products, in particular for international procurement programmes for HIV. The prequalification programme ensures the quality and safety of all prequalified medicines, vaccines, diagnostics, and active pharmaceutical ingredients, in particular for international procurement programmes. Its mission is to make quality priority medicines available for all those in need. Given that many generic manufacturers from developing countries are not submitted to stringent regulatory control, prequalification is essential to allow for the widespread export of generic products from these manufacturers. WHO has thus decided to expand the programme to include hepatitis C and B treatments and, in September 2014, has issued the first call for expressions of interest for hepatitis C and B treatments.

In the area of HIV, the new WHO Technical Report on Access to antiretroviral drugs in low and middle-income countries examines global trends in prices of antiretroviral treatment and assesses how WHO treatment guidelines have influenced the uptake of different formulations. It describes the current constraints limiting the use of second-line, third-line and pediatric treatment, and explores how the quality of antiretroviral treatment can be secured and in-country distribution can be improved. The report includes chapters on the role of intellectual property in access to treatment, on prices, quality assurance, increasing global demand as well as on supply chain management.

Developed from the consultation on access to HIV medicines in middle-income countries held from 10 to 12 June 2013 in Brasilia, Brazil, WHO published the report "Increasing access to HIV treatment in middle-income countries: Key data on prices, regulatory status, tariffs and the intellectual property situation". The paper provides information on the prices paid by 20 middle-income countries for adult and pediatric formulations of antiretroviral treatments recommended by WHO. It links pricing information with an analysis of the intellectual property situation of the selected medicines taking into account existing license agreements as well as compulsory licenses. It also includes data and general information on a number of other determinants of prices and availability of ARVs, including tariffs, mark-ups and taxes as well as the regulatory status. The data shows that middle-income countries are a heterogeneous group and that procurement prices vary widely. Middle-income countries supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria pay low prices for first-line and many second-line treatment regimens, comparable to those paid by low-income countries. Other middle-income countries pay higher prices, especially for newer second-line and third-line treatments sourced from originator producers.

More ample information on technical cooperation activities under the WHO programme on public health and intellectual property can be found in document IP/C/W/603/Add.1. We would be glad to answer any questions delegations might have regarding these activities and send you the reports mentioned by email.

6.18    Chairman

Let me thank the three Secretariats of WIPO, WHO and WTO for the information they have shared with the Council. They clearly enrich the knowledge and the discussions in the Council. As we wrap up this part of the discussion, let us recognize the fact that there has been a diversity of views expressed on this matter so far, and that clearly there is still a divergence of views, especially in relation to some of the proposals that have been made, such as the organization of a workshop. Clearly we have not been able to reach agreement on that issue and may therefore have to continue to discuss amongst ourselves and explore the issue further in order to see whether any progress can be made in that area. So we leave that part with the understanding that we don't have an agreement on that particular proposal.

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