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 twelfth annual review in October 2015. The General Council took note of the report of the Council for TRIPS (IP/C/72) at its meeting on 30 November and 7 December 2015 (WT/GC/M/160, paragraph 8.12). The present report covers the period since October 2015.

3.  At its meeting of 8-9 November 2016, the Council undertook the thirteenth annual review. Annex 1 and Appendix 1 to this report record 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, Canada has notified the Council for TRIPS of an amendment to its legislation implementing the System into domestic law.^[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.  The 2013 WHO-WIPO-WTO study on "Promoting Access to Medical Technologies and Innovation – Intersections Between Public Health, Intellectual Property and Trade" offers explanatory background material on the implementation and use of the System.^[2] In addition, a set of model notifications is available 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 2017 or such later date as may be decided by the Ministerial Conference (WT/L/965). 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.  At the Council's meetings in February, June and November, the Chair of the Council for TRIPS, H.E. Ambassador Al-Otaibi from Saudi Arabia and H.E. Ambassador Mero from the United Republic of Tanzania respectively, updated Members on the state of play of acceptances that had been submitted and encouraged delegations that were yet to accept the TRIPS Amendment to take the necessary steps so that the domestic procedures could be completed as soon as possible.

9.  As of 30 September 2016, 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;

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

·         Brunei Darussalam, 10 April 2015, WT/Let/1037;

·         Moldova, 7 July 2015, WT/Let/1048;

·         Kenya, 21 July 2015, WT/Let/1052;

·         Saint Kitts and Nevis, 27 July 2015, WT/Let/1055;

·         Sri Lanka, 9 September 2015, WT/Let/1080;

·         Lao, People's Democratic Republic, 29 September 2015, WT/Let/1084;

·         Iceland, 12 October 2015, WT/Let/1088;

·         Grenada, 8 December 2015, WT/Let/1107;

·         Malaysia, 10 December 2015, WT/Let/1108;

·         Myanmar, 16 December 2015, WT/Let/1114;

·         Lesotho, 4 January 2016, WT/Let/1122;

·         Mali, 20 January 2016, WT/Let/1129;

·         Thailand, 28 January 2016, WT/Let/1132;

·         South Africa, 23 February 2016, WT/Let/1134;

·         Nepal, 11 March 2016, WT/Let/1138;

·         Tanzania, United Republic of, 14 March 2016, WT/Let/1139;

·         Ukraine, 16 March 2016, WT/Let/1142;

·         Qatar, 6 April 2016, WT/Let/1147;

·         Samoa, 21 April 2016, WT/Let/1153;

·         Saint Lucia, 2 May 2016, WT/Let/1156;

·         Tajikistan, 23 May 2016, WT/Let/1164;

·         Seychelles, Republic of, 8 June 2016, WT/Let/1168;

·         Papua New Guinea, 22 June 2016, WT/Let/1173;

·         Peru, 13 September 2016, WT/Let/1196 and

·         Belize, 15 September 2016, WT/Let/1197.

10.  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 8-9 november 2016
(to be circulated as IP/C/M/83)

6. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF TH DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

1.  The Chairman said that Paragraph 8 of the Decision required the Council to review the functioning of the System annually, with a view to ensuring its effective operation. The Council was also required to report annually on its operation to the General Council. This review was deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.

2.  He suggested that the Council start with an exchange of views between Members about the functioning of the System. He encouraged Members to engage in a constructive discussion which could usefully build on the records of earlier reviews which continued to provide a unique and valuable resource for understanding this important measure. The reviews in 2010 and 2011 had taken the form of a structured debate on the basis of lists of topics for the discussion that had been agreed in advance. The General Council's Aide Mémoire circulated on 20 February 2015 (WT/GC/W/696) was also a useful resource; it set out the expected benefits of the Paragraph 6 System and provided a model instrument of acceptance.

3.  After that discussion, the Council could then consider the report to the General Council. A draft cover note modelled on previous years' reports had been circulated as JOB/IP/18.

4.  The Chairman updated the Council on the status of acceptances of the Protocol Amending the TRIPS Amendment (WT/L/641). The current period for accepting the Protocol ran until 31 December 2017. Fifteen instruments of acceptance had been deposited in 2016, including instruments from Papua New Guinea, Peru, and Belize since the Council's meeting in June 2016. All Members that had notified their acceptance were listed in the cover note of the draft report prepared by the WTO Secretariat, as well as the dedicated WTO webpage that was regularly updated. Only five more instruments of acceptance were needed to trigger entry into force.

5.  He strongly encouraged those Members who were yet to complete their acceptance procedures to do as soon as possible. His call upon these Members echoed the multiple efforts Director‑General Azevêdo and his predecessors had made since 2015 to secure the entry into force of the Protocol. The Director-General in his contacts regularly emphasized that this was not only a priority for the WTO, but represented a concrete contribution that WTO Members could make to global efforts to strengthen the legal framework for access to medicines. Providing the necessary legal certainty for the export of much needed medicines through the permanent incorporation of the Paragraph 6 System into the TRIPS Agreement would, in particular, also respond to many calls for its timely implementation and entry into force that emanated from the multilateral system, including most recently the Political Declaration on HIV and AIDS that had been adopted by the UN General Assembly in June 2016.

6.  He invited the WTO Secretariat to update the Council on the Paragraph 6 System, including on capacity building and on the process of acceptance.

7.  The representative of the Secretariat took the floor.

8.  The representatives of India, Brazil, Canada, Bangladesh, South Africa, the European Union, Australia, Japan, Chinese Taipei, Switzerland, the United States, and Panama took the floor.

9.  The Council took note of the statements made.

10.  Turning to the Council's report to the General Council, the Chairman said that the Secretariat had prepared a draft cover note for the report which was modelled on previous years' reports and had been circulated as JOB/IP/18. It contained factual information on the implementation and use of the System, and the status of acceptances of the amendment Protocol. As for past reports, an extract from the Council's minutes on this agenda item might be attached to the cover note.

11.  The Chairman proposed that the Council agree on the cover note to the report contained in JOB/IP/18 and also that the Council minutes containing the record of the discussion be attached to it.

12.  The Council so agreed.

_______________

Appendix 1

Excerpt from the Addendum to the Minutes, containing the statements made during the Council's meeting held on 8-9 november 2016

(to be circulated as IP/C/M/83/Add.1)

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    Secretariat

1.  We have observed a steady rise in the rate of acceptances of the Protocol Amending the TRIPS Agreement in the course of this year. As you have noted, Mr Chair, to date already 15 Members have accepted the Protocol in this year alone. It is worth observing that if it were not for the very welcome fact of new Members acceding to the WTO in this period, the Protocol would have already entered into force some time ago earlier this year.

2.  We are providing technical assistance on request to Members who are in the process of accepting the Protocol – and a number of Members have told us that they are at the final stages of their domestic processes. We are at the disposal of any delegation or Member who would need practical support in the acceptance process. As a very general observation, it often takes Members by surprise how straightforward and simple the process is. It is not a difficult procedure and we have the necessary model instruments of acceptance to facilitate the process.

3.  The other aspect of the report concerns technical assistance for implementation. Document IP/C/W/618 is the regular annual report of the Secretariat's technical assistance activities in the area of TRIPS in general. We will be introducing that report briefly under that separate item later in this meeting. However, as for previous annual reviews of the Paragraph 6 System, because this has been a matter of particular focus and particular attention for technical assistance, we give a more focused update under this agenda item.

4.  In general, TRIPS flexibilities with specific reference to public health have long formed a consistent element of our technical assistance activities. A strong impetus in this direction was given by the Doha Declaration on the TRIPS Agreement and Public Health; this flows through to the practical level of technical assistance in the TRIPS area.

5.  This element of TRIPS implementation is also extensively covered in the Trilateral Study published jointly by WHO, WIPO and the WTO in 2013, which includes specific material on flexibilities for health and in particular the System of compulsory licences for export of medicines (also known as the "Paragraph 6" System).

6.  This mechanism has also been a focus of an annual series of Workshops dealing with TRIPS and Public Health since 2005. These Workshops were conceived as cross-cutting programmes directed at a blend of health, trade and IP officials. As this series evolved over the years, it maintained coverage of the key issues concerning medicines, innovation and access to medicines from a TRIPS perspective, especially the use of TRIPS flexibilities. In addition, because of the demand received from Members, it provided an increasing focus on public health policy within a wider range of disciplines, including the human rights dimension.

7.  Specifically looking at the use of TRIPS flexibilities and the implementation of the Paragraph 6 System of compulsory licensing for export, these capacity-building Workshops have evolved in line with progress in the domestic implementation of the System in many Members. In recent years, many more Members have introduced export provisions into their laws to facilitate the System as a tool for export. Accordingly, more recently, the Workshops have turned from looking at legislative implementation towards a more detailed look at how to make effective use of this additional procurement tool in practice so that affordable medicines do reach patients.

8.  The most recent session of these series of Workshops, the WTO Workshop on Trade and Public Health, was held here in Geneva in October. The Workshop included updated capacity-building material on making effective use of special compulsory licences for export as a procurement tool for medicines. This material was tailored exactly for the mix of public health, trade and intellectual property officials that took part in the Workshop. The feedback and practical guidance provided by those officials will, as ever, guide us in updating and improving our technical assistance activities and programmes to enhance its practical relevance.

9.  Some of the general points that we have made in the Workshop are touched upon in an annex to the Secretariat report (IP/C/W/618). This notes as an important recent development that the significant increase in pharmaceutical exporting countries that are putting in place the necessary legislation to use the System for export. This has gone literally from one Member, at the time of the first use of the System, to over 52 today. By informal estimates, the System now covers about 80% of current global medicines export capacity. It also mentions that the practical context of the System is such that it applies when the best option for access to a medicine is production especially for export under a compulsory licence in a foreign country. It need not apply for instance when lower cost medicines are available by other means through regular generic production, voluntary licensing or when some of the production under regular compulsory licences could be exported. For example, if a compulsory licence is applied to serve a relatively large home market this could, in principle, be used to serve also a smaller export market.

10.  A key element in the use of the System concerns notifying expected demands for medicines. It was noted that this could be done early in the procurement process, so as to open up a wider range of potential suppliers and potentially enable the pooling of demand by different Members with similar needs. Notification under the System could also be used at this early stage to identify all possible sources of supply so as to ensure the most competitive and sustainable range of options for access to medicines.

11.  The important point of economies of scale has been considered and discussed. The need for economies of scale was foreseen in the design of the System and would clearly be a factor when the needs of relatively small populations are concerned. On that note, it was observed that the System makes it clear that an export compulsory licence can serve the needs of multiple Members. When countries do share the same needs and the same constraints, for example, in the same region, this could be an opportunity to pool demand so as to use the System more effectively. This would be especially effective if their regulatory requirements were similar or compatible, for example, through the WHO prequalification programme.

12.  Discussion has also covered how the System could be used as part of efforts to build local production capacity, especially when this would enable one country's production to serve several countries in the same region, enabling economies of scale and thus lower cost, and to support more sustainable production of medicines.

13.  The Workshop on Trade and Public Health also considered the human rights dimension of access to medicines with a participation of a range of international organizations, including the Office of the United Nations High Commissioner for Human Rights. The Secretariat of the UN Secretary General's High-Level Panel on Access to Medicines presented the Panel Report which will be the subject of a separate agenda item in this session of the Council. We would like to record our warm gratitude to our colleagues from across the multilateral system for their invaluable contributions to this essential capacity-building dialogue.

14.  Participating experts in the procurement field and other related fields explored a range of practical questions in the course of the Workshop discussion on the use of the System. They mentioned the need for awareness-raising of the practical possibilities of use of this mechanism within domestic agencies and other programmes responsible for medicines procurement. More generally, they also looked at the practicalities of situating the System as an integral part of procedures for access to medicines, including procurement processes and other processes such as needs identification, procurement policies and the regulation of medicines for safety and efficacy. Other points raised by the experts included the possible choices for effective implementation of the System at the domestic and regional levels and, in particular, how to make the System more streamlined in its practical use in those countries that are most likely to be producers and exporters under the System. Further points discussed concerned the information needs of potential importing countries about potential sources of supply and how to facilitate the forecasting of expected needs which in turn would enable early notification under the System and more capacity to aggregate demand of similar needs.

15.  A final point that has come up in a range of our activities concerning this matter is a question of economic viability, or commercial sustainability, given the significance recognized in the System of boosting economies of scale, how to use the System for greater predictability for potential suppliers, and the pooling and aggregation of demand so as to ensure that its use is commercially sustainable for producers seeking to export under this System.

16.  We look forward to continuing cooperation with multilateral partners on our capacity building work in this area and again warmly thank our colleagues for their invaluable contributions to this work.

6.2   India

17.  India attaches high importance to the Doha Declaration on Public Health, the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol Amending the TRIPS Agreement. India had notified its acceptance of the Protocol in March 2007. We would like to congratulate Papua New Guinea, Peru and Belize who have deposited their instruments of acceptance of the Protocol since the last TRIPS Council meeting held in June 2016. So far, over 64% of WTO Members have submitted their instruments of acceptance for the TRIPS Protocol and five more Members have to submit their instruments of acceptance for entry into force of the 2005 Protocol Amending the TRIPS Agreement.

18.  We have always been of the view that the Doha Declaration on TRIPS 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 established a framework for special compulsory licences, which is an additional flexibility aimed at enabling exports of medicines to WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector. However, the export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of the System so far.

19.  The side event which was held today to discuss the challenges and problems associated with this Paragraph 6 Mechanism and the comments by experts has broadened our understanding on aspects related to the Paragraph 6 System, especially as regards its implementation so far, the challenges and opportunities involved, as well as the ways of improving the System to make it effective and meaningful.

20.  Ms. Yuanqiong Hu from Medicines Sans Frontiers said that her organization had requested the HIV/AIDS medicines from Canada to supply Rwanda, but it had taken three years for the whole process to deliver because there were delays associated with regulatory approval, as well as discussions with patent holders which took a lot of time. At the same time, the HIV/AIDS medicines were available and supplied by Indian generic companies before Rwanda accorded supplies from the Canadian company Apotex.

21.  The representative from Canada who spoke at the side event confirmed that the regulatory approval had taken close to six months, as compared to one year under the normal procedure, to ensure the quality, safety and efficacy of the drugs. The company had made losses and had supplied the tablets at a very cheap rate. He was also informed by some companies that they would never venture into providing medicines under this special compulsory licensing scheme.

22.  Mr. Denis Broun, the representative of CIPLA, shared the experiences of a generic producer to manufacture under the System. There was no way to achieve economies of scale because of the limited quantities of medicines to be procured by the importing countries. He also noted requirements like special labelling and markings and the need for the generic company to host a special website and to pay remuneration to the patent holder. According to him, there was so much red tape built into the System that it was difficult for the Paragraph 6 Mechanism to achieve its intended purpose. Unless the procedures were simplified, his company would never use the System.

23.  Ms. Suerie Moon, Director of Research, Global Health Centre, Graduate Institute of International and Development Studies opined that this was not a good System. It should be renegotiated before it entered into force as it was not workable. She also said that patenting in exporting countries like India was on the rise. In her view, the Paragraph 6 System needed to be made more workable for it to be used by countries.

24.  Based on the experts opinion at the side event held today, we reiterate our concern that the Paragraph 6 System is too complex, cumbersome and administratively unwieldy for further use. I conclude by quoting the recommendation on the special compulsory license mechanism by the UN Secretary General's High-Level Panel on Access to Medicines in its report released in September. The recommendation was also endorsed by many experts at the side event. Recognizing the Paragraph 6 System as complex and cumbersome, the UNSG High-Level Panel on Access to Medicines has recommended that "WTO Members should revise the Paragraph 6 Decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory licence. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform."

6.3   Brazil

25.  The Paragraph 6 System represents the recognition of the importance of international solutions for public health emergencies. In the Doha Declaration, Members of the WTO recognize that countries with insufficient or non-manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licences under the TRIPS Agreement. The System that implements the Decision has only been used once in 13 years. According to the Report of the UN Secretary General's High-Level Panel on Access to Medicines, "some note that multilateral health financing has removed the need for resource constraint countries to use it. Others argue that it is too complex to be used. The only time the mechanism was used it proved to be complex and cumbersome and serious questions remain as to its effectiveness. More than ten years after WTO Members agreed to transform the temporary waiver into an amendment of the TRIPS Agreement, the amendment is yet to be accepted by two-thirds of the WTO Members. At a time of increased political commitments to enhance local pharmaceutical production in developing countries, attention should be paid to incorporating an efficient easy-to-use compulsory licensing provision into domestic legislation".

26.  We would like to highlight the importance of this periodic review of the implementation of the Paragraph 6 Mechanism which will become even more necessary after the entry into force of the TRIPS Amendment. We were glad to be co-sponsors of the South Centre initiative to host a side event to the TRIPS Council on the subject. We had the opportunity to hear from representatives from industry, government, non-governmental organizations and academia their assessment of the System. We will continue to contribute constructively to discussions on the improvement of the System.

6.4   Canada

27.  Providing access to medicines to populations in need is one of the key priorities of our Government. Canada is a global leader in supporting partnerships such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Global Drug Facility, and Gavi, the Vaccine Alliance, which strengthen health systems and provide targeted programming to increase access to medicines and vaccines.

28.  Canada hosted the Fifth Replenishment Conference of the Global Fund to Fight AIDS, Tuberculosis and Malaria in Montreal on 16-17 September 2016. Canada pledged $804 million, for 2017 to 2019, to the Global Fund, an increase of 23% over its previous commitment of $650 million for 2014-2016. Canada is the 6^th largest donor to Gavi, the Vaccine Alliance, having pledged $520 million for the 2016-2020 period bringing Canada's contribution to over $1 billion since 2002.

29.  In addition, Canada has introduced tax incentives for donations of medicines to developing countries. The Government of Canada's Donations of Medicine Eligibility Program ensures that only Canadian charities with sufficient expertise can participate in this scheme.

30.  Canada's Access to Medicines Regime (CAMR), which implements Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, is another measure Canada uses to promote access to medicines. Canada continues to believe that CAMR is a useful and effective tool to enhance access to medicines in the specific circumstances the System was designed to address. Last year, Canada amended the list of medications covered by CAMR to add three new antiretroviral drugs. Canada notified this amendment to the TRIPS Council in June 2016.

31.  I mention all of these programmes to illustrate that the Government of Canada takes a holistic approach to promoting access to medicines. Our view is that only by addressing all of the factors affecting access to medicines can we end the tragedy of people suffering from treatable illnesses.

32.  To this end, Canada is open to having a discussion of how best to promote access to medicines that considers all relevant factors. We would caution against treating certain factors, such as IP rights, in isolation, as doing so would risk overlooking effective tools to promote access. Canada looks forward learning more about the views of other Members on this issue, including with respect to Member experiences, challenges, and other considerations.

33.  We consider it essential that the Protocol Amending the TRJPS Agreement be brought into force as soon as possible. We are only a handful of countries away from that goal and Canada urges all Members who have not already done so to accept the Protocol without delay.

6.5   Bangladesh

34.  We thank the WTO Membership for this historic decision; they deserve every accolade for this. The intention to help developing countries which lack the necessary capacity to produce medicines is both honest and genuine. We thank Members who have recently accepted the amendment and hope that the remaining five ratifications that are needed for the entry into force of this amendment of the TRIPS Agreement will soon be deposited.

35.  During the side event today, we have learnt about different limitations which hinder the widespread use of the System. After the entry into force, we may find suitable ways to overcome the administrative and supply side constraints so that this wonderful mechanism is utilized and not wasted. This would pave the way for future necessary amendments of the TRIPS Agreement that our Members advocate for other important issues.

6.6   South Africa

36.  The Doha Declaration stresses that TRIPS can and should be interpreted and implemented to support the right to health and promote access to medicines for all. The Sustainable Development Goal target of achieving universal health coverage by 2030, requires strong government and international leadership to effectively implement access to essential medicines.

37.  South Africa notes that the number of notifications required for the entry into force of the Protocol Amending the TRIPS Agreement is now fewer than ever. We would encourage all Members who have not yet done so to deposit their notifications in order for the Protocol to enter into force. This will mark a significant landmark toward the realization of access to essential medicines.

38.  As the sources of generic drugs are substantially depleted over time, the most effective method by which a country with insufficient or no manufacturing capacity may obtain certain medicines at competitive prices is through the use of the Paragraph 6 System. In addition, the Paragraph 6 System may prove to be increasingly important for HIV/AIDS patients who need to shift to second-line or third-line treatments. Studies indicate that at least 22% of people on treatment would have to switch over to second-line treatment within a five-year period. Second‑ and third-line treatments are substantially more expensive, costing up to four to eleven times as much as first-line treatments. For these treatments and other widely patent protected treatments, the Paragraph 6 System may prove to be an important mechanism for obtaining a bulk of the medicine at a competitive price.

39.  Having said this, it is indeed not the end of the story since the Paragraph 6 System has been reviewed since 2004. During this time a rich debate has emerged between Members regarding their experiences of the use of the System. This review mechanism continues to provide Members with an opportunity to exchange their views and to devise ways to make the System more effective. As already mentioned by India and Brazil, the side event hosted this afternoon (of which South Africa is a co-sponsor), clearly outlined many criticisms associated with the Paragraph 6 System including the length of time it takes to use it. Procedural and other substantive complexities make it difficult to effectively use the System, while many developing countries face severe political pressures when they consider using it. Raising these criticisms is not an attempt to undermine the System, but is indeed an attempt to fully understand the challenges that countries face when they want to use it.

40.  The review should not be an opportunity for delegations to repeat longstanding arguments. Our focus should be to ensure that the System does not remain a flexibility that is consigned to a piece of paper, but to move forward to a substantive review of the System and its functioning, including through the more systematic collection and sharing of information. The world has changed since the System was first introduced. Many more factors now influence its operation, including the introduction of many so-called access initiatives that are likely to limit the need to use the System; the steady increase in the number of voluntary licences that can make its use redundant; while developments under RTAs may further erode the actual use of the System.

41.  In concluding, we further note that the Report of the United Nations Secretary-General's High‑Level Panel on Access to Medicines, recommends that WTO Members should revise the Paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under special compulsory license. South Africa looks forward to hear other Members' views in this respect and remains available for any further discussion on the points raised in the High-Level Panel Report.

6.7   European Union

42.  The European Union believes that the entry into force of the Protocol will be an important signal that will ensure a legally secure, predictable, effective and sustainable solution for those countries wishing to use the TRIPS flexibilities to get affordable medicines.

43.  Therefore, the European Commission will continue to encourage and work with the remaining WTO Members so that they accept this Protocol and allow the amendment of the TRIPS Agreement to enter into force as soon as possible.

44.  We have much appreciated a series of side events regarding this issue, including the one we assisted today. We are pleased to note that, as we pointed out a number of times, these events are extremely useful to have discussions about the issues that are addressed more formally here in the TRIPS Council. They are very valuable and allow good debates with people from the outside, with other stakeholders, and to hear different opinions.

45.  We certainly appreciate clarifications that were presented today according to which the Paragraph 6 System is very much a last resort option which is most useful at the end of a long list of alternatives. Alternatives like the ones that were mentioned by my colleague of South Africa a few minutes ago, but also negotiating alternatives.

46.  That takes us to another event that we consider extremely valuable for the debate, i.e. the Workshop that was organized by the Secretariat. We participated with pleasure and a lot of interest. The part of the Workshop that I assisted was very valuable. We saw presentations of issues that have not been raised today and that are rarely raised in this venue, including how countries use the Paragraph 6 System as a negotiating mechanism. This takes us back to the fact that it is a last resort mechanism. We heard experiences of officials saying how in the discussion process with a right holder the possible use of this mechanism was there as an additional strong negotiating tool and how in most cases, and increasingly so in recent years, this had led to a good agreement with the right holder without necessarily triggering the formal steps of the mechanism.

47.  This being said, in Europe we have put in place legislation for this already in 2007. It has never been used so it is very difficult to assess. I see with some surprise how people are so certain that the System does not work based on only one case of use. In Europe, as far as we are aware because compulsory licences are managed at Member State level, there was never any attempt to use this System. We therefore wonder how people can state that it is burdensome and impossible to use. This debate is maybe a little bit more complex than it is sometimes presented and certainly proposals to review the Paragraph 6 System are way too premature at this stage.

6.8   Australia

48.  Australia supports the TRIPS Protocol's entry into force as soon as possible. This will benefit Members by providing a permanent legal basis for countries to import medicines to address their public health needs if they have limited capacity to produce those medicines. The Protocol's entry into force will reinforce the WTO's ability to deliver practical development-oriented outcomes.

49.  Australia commends Members from every region and at every stage of development that have already accepted it. We welcome the recent acceptances of the Protocol since the previous TRIPS Council meeting by Papua New Guinea, Belize and Peru.

6.9   Japan

50.  The delegation of Japan would like to reiterate the importance of access to medicine, which needs to be discussed in a broader context, taking into account not only the Paragraph 6 System but also various other relevant measures and factors such as procurement and tariffs.

51.  Japan supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol Amending the TRIPS Agreement. The very objective of the System is to support WTO Members in obtaining greater access to medicines, specifically Members that have either insufficient or no pharmaceutical manufacturing capacity. Compulsory licenses, whether granted under the Paragraph 6 System or otherwise, are just one of the potential policy tools that can be utilized for this objective. Therefore, the Paragraph 6 System should not be considered as the only solution, but rather as just an option we could consider.

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

6.10        Chinese Taipei

53.  My delegation thanks the WTO Secretariat for the excellent work done on the draft report on this subject.

54.  My delegation strongly supports the System provided for under Paragraph 6 as it was established by the 2003 Waiver Decision and the 2005 Protocol. We would like to congratulate Peru, the Republic of Tajikistan and other Members who formally accepted the amendment this year. We would also like to say how much we welcome the Secretariat's efforts aimed at ensuring that instruments of acceptance of the amendment are deposited.

55.  Finally, we wish to take the opportunity to highlight the positive efforts made by the Secretariat in this respect. We would draw delegates' attention to the WTO webpage which is devoted to the TRIPS Agreement where Members can find a link to a guide on notifications under the System laid down in Paragraph 6. We certainly found that guide very useful.

56.  We would like to stress how important it is that we ensure that the TRIPS Agreement fits into the broader framework which exists nationally and internationally and which is aimed at dealing with public health problems. We should also underline the fact that the Agreement does not stop Members from taking measures which are aimed at protecting public health and in particular taking measures which would promote access to medicines for everyone.

6.11        Switzerland

57.  I would like to add the thanks from my delegation to my neighbour who has just intervened and to the Director-General and to yourself and the WTO Secretariat for all your efforts to secure the necessary number of acceptances of the Protocol during this year. We certainly commend those 15 WTO Members who have completed their acceptance procedure so far this year.

58.  We also thank the WTO Secretariat for holding its 12^th Workshop on Trade and Public Health, as noted in its annual report in document IP/C/W/618, as a capacity-building Workshop to raise awareness about the System and to help Members make effective use of it.

59.  Switzerland was among the first WTO Members to put in place the necessary legislation to enable the System at the national level and use of the mechanism for export. According to information available from the WTO Secretariat, more than 52 WTO Members have done so by today covering about 80% of current medicines export capacity. This was done on the basis of the waiver solutions agreed in 2003, and in spite of the fact that the TRIPS Amendment has not yet entered into force. This demonstrates the commitment and the support of WTO Members for the use of the Paragraph 6 System. In the Paragraph 6 Review in the TRIPS Council, Members have confirmed this political support and encouragement for use of the System.

60.  I would like to refer to two points that have been mentioned by preceding speakers. One was the complexity and cumbersomeness of the System that was claimed. However, in our recollection, in past reviews in this Council of the Paragraph 6 System, we have not heard, at least not from potential beneficiary Members, of cases where the System needed to be used, but was not used or dropped because it was too complex, or that the process of making it proved to be not workable at any specific stage of the System.

61.  When we look at the System it seems quite straightforward. The WTO Secretariat is assisting Members who may want to use the Paragraph 6 System very helpfully through all the information and the special dedicated website on the WTO site. Notifications certainly should not pose a problem.

62.  Concerns were raised with regard to the need of having to mark medicines that are produced under special compulsory licence. Switzerland has argued in earlier reviews that such special marking of medicines is in the very interest of the potential beneficiary country because it will ensure that the medicines produced under such a special licence reach the people who need these medicines.

63.  Also, the requirement for the generic producer under such a licence to put up a website has been described as cumbersome. However, I believe hosting a website for a generic manufacture capable of actually assisting under this System should not pose an unsurmountable hurdle nowadays.

64.  Having said this, compulsory licences are as such not an easy and quick-fix solution to address the broader problem of sustainable access to affordable medicines – whether in developing countries or any other WTO Member. Implementing a compulsory licence, and again I refer to normal or special compulsory licences even once granted, pose their own challenges. A generic manufacturer needs to be found who is ready, willing and available to produce the medicine needed and the quantities needed within a short time-period at an affordable and competitive price and at the required quality and safety standards. This demonstrates that a compulsory licence is never a quick-fix solution and this cannot be remedied by the Paragraph 6 System or by revising it for that matter.

65.  Also, the fact that the System has only been used once so far was taken as evidence that the System is not workable. However, I believe it is important to note, as stated by the EU, that the Paragraph 6 System does not have result in the grant of an export licence. One of its key benefits is to give all WTO Members, including those without manufacturing capacity in the pharmaceutical market, the negotiation leverage when they need to address a specific public health problem and to negotiate with potential manufacturers the price and any delivery conditions for receiving the needed medicine. That was the very basis of the mandate that Ministers gave the TRIPS Council in the Doha Declaration on the TRIPS Agreement and Public Health. Their intention was to ensure that this policy flexibility that was identified and confirmed in the Doha Declaration would be available to all WTO Members equally.

66.  The case of Canada-Rwanda was the first one and was not an easy one. Always when you do a thing for the first time, you learn lessons. Therefore, we do believe that the Paragraph 6 Review, within this Council, is extremely beneficial for Members to exchange and share experiences made, raise concerns so that all can learn for any next use of the Paragraph 6 System.

67.  We have also heard that in many cases the Paragraph 6 System might not have been needed since medicine was available from a country or manufacturer in a country where this medicine was still available off patent. It has also been mentioned in that context that in the future this might be less often the case. In my delegation's view, this only raises the importance of the Paragraph 6 System in the future. Therefore, we very much welcome the discussions in this Council under the Paragraph 6 Review so that we can learn how to make this System and its application in practice more useful to potential beneficiary countries.

6.12        United States of America

68.  The United States fully associates ourselves with the delegation and the intervention from Switzerland. We also want to thank the Secretariat for the update regarding the status of acceptances of the 2005 Protocol Amending the TRIPS Agreement.

69.  The United States strongly supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol.

70.  The United States congratulates the significant number of countries who have formally accepted the amendment since last year's review. This is a significant achievement. We encourage other Members to notify their acceptance of the amendment so that it can enter into force.

71.  Finally, again, we want to welcome the Secretariat's efforts, I think Chinese Taipei also referred to it, and draw delegations' attention to the WTO TRIPS webpage where Members can find an "Illustrative guide to notifying under the Paragraph 6 System." This is quite a helpful document. We have taken a look at it. It is easy and it is very understandable so we commend the Secretariat's work in this regard and join Chinese Taipei in that respect.

72.  There are multiple avenues available for promoting access to medicines. The Paragraph 6 System is of course important, but it is not alone. As raised through the Trilateral Public Health Workshop held at the WTO the week of 17 October as referenced by the European Union, there are many mechanisms that governments can use to promote access. Such improvements are the building blocks for a sustainable healthcare system. These include, as cited in the October Workshop:

·        strong and effective procurement systems and processes;

·        supply chain management, including reliable data regarding actual demand;

·        improvements in notification systems and coordination with producers;

·        strong and efficient regulatory control of assured quality of medicines;

·        eliminating retail mark-ups through more efficient distribution and dispensing systems;

·        advance policies that combat substandard and spurious, falsely labelled, falsified; or

·        counterfeit (SSFFC) medicinal products that displace innovative and generic drugs; and

·        eliminating taxes and tariffs.

73.  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 healthcare institutions and patients. For example, in a review of tariffs as applied and bound on medicinal products, we see ranges of 25% to 40% on tariffs at the border with respect to pharmaceutical products. We see applied levels of 10% or 7.5% but that is not the end of the analysis. We see an additional 13% by some Members added as other duties and taxes creating an applied rate of 21% on pharmaceuticals.

74.  We continue to believe that the access to medicines issue is multidimensional. Making lifesaving medicines available requires transparency and a commitment to address measures that unduly delay patients from getting the treatments they need.

6.13        Panama

75.  As one of your predecessors, Chair, who has had many opportunities to speak with on this matter, I would like to urge Members just as the Director-General has to ratify this Amendment. The map that you showed on the screen is very revealing and is very interesting in the sense that if we look at the countries which still have to ratify we see that most of them are in fact developing countries. The other countries are economies in transition if I am not mistaken. This was a measure that was promoted by developing countries to the benefit of developing countries. I believe that we as developing countries need to make a big effort to achieve this as soon as possible to ensure that we reach the necessary number of ratifications so that the measure can come into force. We will spare no efforts just as those who came before us did not either. This is an important measure as has been said by many. To be honest I have never understood the reason behind the delays other than perhaps a lack of understanding regarding what the ratification process involved.

76.  The Secretariat has made a lot of effort providing technical assistance and I would like to congratulate the Secretariat for all these efforts. Perhaps the most important detail that a government can take into consideration and which can inform the decisions made by delegations and authorities is that acceptance of the Protocol does not mean a change to national legislation. What it does is accept that other Members of the WTO can use this mechanism. In other words, this could be a very simple decision, a very simple instrument because there is always the possibility of drafting a more complex national law within domestic legislation in order to apply it, but this is not necessary. This could be a subsequent step after acceptance.

77.  Once again, I would like to thank the Secretariat and I would like to thank all our predecessors who have fought very much for this measure. I hope that we will achieve the necessary number of acceptances.

__________