[Pharm-policy] TRIPS: SPECIAL DISCUSSION ON INTELLECTUAL PROPERTY AND ACCESS

[James Love]

-------- Original Message --------
Subject: Fw: TRIPS: SPECIAL DISCUSSION ON INTELLECTUAL PROPERTY AND ACCESS
Date: Fri, 27 Jul 2001 13:29:09 -0500
From: "Mary Bottari" <marybottari@home.com>

>
>WORLD TRADE
>ORGANIZATION RESTRICTED
>
> IP/C/M/31
>10 July 2001
> (01-3431)
>
>Council for Trade-Related Aspects
>of Intellectual Property Rights
>
>
>
>
>
>SPECIAL DISCUSSION ON INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES
>
>Held in the Centre William Rappard
>during the meeting of the Council from 18 to 22 June 2001
>
>Chairperson:  Ambassador Boniface Chidyausiku (Zimbabwe)
>
>Table of Contents: Page Nos.
>Introduction by the Chairperson 3
>
>Statements by Members (in order of speaking) 3
>
> Zimbabwe (on behalf of the African Group) 3
> European Communities 6
> Brazil 9
> Argentina 11
> Venezuela 13
> Norway 15
> Malaysia (on behalf of ASEAN) 17
> Chile 18
> India 21
> South Africa 26
> Barbados 27
> Tanzania (on behalf of the Least-Developed Countries) 28
> Bolivia 30
> Thailand 31
> United States 33
> Egypt 41
> Switzerland 44
> Japan 46
> Cuba 50
> Kenya 51
> Table of Contents:
> Page Nos.
> Hungary 55
> Nigeria 56
> Canada 57
> Ecuador 58
> New Zealand 60
> Jamaica 60
> Dominican Republic 62
> Peru 64
> Sri Lanka 65
> Hong Kong, China 66
> Honduras 66
> Czech Republic 67
> Panama 68
> Singapore 68
> Indonesia 69
> Turkey 71
> Korea 72
> Colombia 73
> Pakistan 74
> Guinea 75
> Uruguay 76
> Australia 77
> Uganda 77
> Philippines 78
>
>Statement by observer government
>
> Holy See 79
>
>Statement by observer organization
>
> WIPO 81
>
>Council action on further work 81
>
>_______________
>
> Introduction by the Chairperson
>
>1. The Chairperson said that, at the previous meeting, the Council had
>agreed, following a request from Zimbabwe, on behalf of the African Group,
>to devote a full day to a special discussion of intellectual property
>issues relevant to access to medicines during the course of the present
>TRIPS Council meeting.  Recalling that, when this matter had been discussed
>at the Council's last meeting, two specific sub-items had been identified
>as topics on which Members would exchange their views.  One was the
>interpretation and application of the relevant provisions of the TRIPS
>Agreement with a view to clarifying the flexibility to which Members were
>entitled under that Agreement;  and the other was the relationship between
>the TRIPS Agreement and affordable access to medicines.  As also discussed
>at the informal meeting on 21 May, delegations should feel free to address
>also any aspect that they considered relevant to this item.
>2. As requested at the informal meeting of 21 May, the Secretariat had
>prepared, prior to the present meeting, an information paper listing the
>meetings relevant to intellectual property and access to medicines, whether
>organized by intergovernmental or non-governmental organizations, in which
>the Secretariat had been involved over the past couple of years;  what
>issues had been discussed at those meetings relating to TRIPS;  and where
>additional information about those meetings could be found, for example on
>web-sites or published documentation.  This paper was available in document
>JOB(01)/82.
>3. The European Communities and their member States had submitted a paper
>on the relationship between the provisions of the TRIPS Agreement and
>access to medicines.  This paper had been circulated a week prior to the
>present meeting as document IP/C/W/280.  On 19 June, Brazil had also
>submitted a paper on the matter, which was also sponsored by the African
>Group, Barbados, Bolivia, Brazil, Cuba, the Dominican Republic, Ecuador,
>Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, the Philippines,
>Peru, Sri Lanka, Thailand and Venezuela.  This paper would shortly be
>circulated as document IP/C/W/296.
>4. The following statements were then made:
>ZIMBABWE (ON BEHALF OF THE AFRICAN GROUP)
>
> Two weeks ago, world attention focused on the Heroes Acre in South Africa
>where young Nkosi Johnson was laid to rest.  In a special way, young Nkosi
>had become the personification of the plight of millions of people who have
>died and millions more waiting to die because of HIV/AIDS.  Indeed, young
>Nkosi reminded us of the plight of millions of young children orphaned by
>AIDS and of many who will not celebrate their fifth birthday;  of families
>robbed of the source of their livelihood and societies robbed of their
>future due to the scourge of HIV/AIDS and other life threatening diseases.
>
> The death toll from preventable and treatable infectious diseases is
>unacceptably high.  11 million people, most of them in developing
>countries, die each year from such diseases.  In the case of HIV/AIDS, a
>human tragedy of horrific dimensions is now at hand.  In some countries in
>Africa, more than a quarter of the adult population has HIV.  Life
>expectancy is projected to fall dramatically.  In industrialised countries
>AIDS deaths have been significantly reduced partly because of the
>availability of life-saving medicines to many patients.  Indeed, patients
>in developing countries also deserve access to medicines at affordable
>prices, to treat AIDS and other diseases.
>
> The TRIPS special discussion provides a crucial opportunity to address
>mounting public perception that implementation of the TRIPS Agreement has
>hampered people's access to affordable medicines.  Members must affirm that
>the TRIPS Agreement does not stand in the way of urgently-needed solutions
>to the deepening health crisis.  By agreeing to this discussion in the
>TRIPS Council we believe Members have taken cognisance of increasing public
>criticism and civil society campaigns against the perceived negative
>effects of the TRIPS Agreement, and are ready to respond positively.
>
> Members should reach a common understanding that asserts and confirms the
>balance in the TRIPS Agreement that recognizes the importance of patent
>protection and provides that governments may adopt all appropriate measures
>to protect the health and lives of their people.  This is the assurance and
>guarantee that governments need, to enable them to adopt such measures,
>without fear of litigation (either at national level or at the WTO) or that
>bilateral pressures will be applied on them.  The African Group is
>convinced that all Members, as a matter of right and at their discretion,
>can take advantage of the existing provisions and safeguards in the
Agreement.
>
> The purpose of the special discussion is to begin to identify the relevant
>provisions of the Agreement, and exchange views in order to forge a common
>understanding of the TRIPS Agreement.  As this important and vital task
>cannot be completed in one special session, Members need to agree on a work
>programme to complete this work in the shortest time possible, befitting a
>serious response to the current crisis.
>
> We believe that the Ministerial Conference in Qatar in November 2001, will
>be an opportunity to demonstrate Members' commitment and contribution to
>preventing further deaths and saving lives through facilitating easier
>access to medicines at affordable prices.  Therefore, we propose that
>Members issue a special declaration on the TRIPS Agreement and access to
>medicines at the Ministerial Conference in Qatar, affirming that nothing in
>the TRIPS Agreement should prevent Members from taking measures to protect
>public health.  The fourth WTO Ministerial Conference will provide an ideal
>opportunity for Members to affirm this common understanding.
>
> Rather than being seen as an end in itself, intellectual property rights
>protection is intended as a means to benefit society as a whole.  The mere
>existence and the protection of intellectual property rights, such as
>patents, does not necessarily result in the fulfilment of the objectives of
>the TRIPS Agreement.  The experience of the past six years since the
>Agreement was established provides clear evidence of this.
>
> In the context of public health, patent rights should be exercised
>coherently to the mutual advantage of patent holders and the users of
>patented medicines, in a manner conducive to social and economic welfare
>and to balance rights and obligations.
>
> Article 7 is a key provision with respect to interpreting the Agreement,
>as it establishes that the protection and enforcement of intellectual
>property rights does not exist in a vacuum.  The objective of the promotion
>of technological innovation and the transfer and dissemination of
>technology locates the protection and enforcement of IPRs in the wider
>interests of society.  With regard to public health, protection of
>intellectual property rights, in particular patent protection, should
>encourage the development of new medicines and the international transfer
>of technology to promote the development of manufacturing capacities of
>pharmaceuticals without restraining policies on access to medicines.
>
> Article 8 explicitly recognizes that Members may adopt measures to protect
>public health, among other overarching public policy objectives, such as
>nutrition and socio-economic and technological development.
>
> We believe that each provision of the TRIPS Agreement should be
>interpreted in the light of the objectives and principles set forth in
>Articles 7 and 8.
>
> Consequently, the Agreement does not prevent Members from taking measures
>against abuses of intellectual property rights or anti-competitive
practices.
>
> Compulsory licences are an essential tool for governments to carry out
>effective public health policies.  Such licences are a crucial element in
>the prevention of abuses of patent rights, the promotion of domestic
>manufacturing capacities in pharmaceuticals production, as well as in
>situations of national emergency and extreme urgency.  The Paris
>Convention, which is part and parcel of the TRIPS Agreement, explicitly
>provides for the grant of compulsory licences as a means of countering
>abuses of intellectual property rights.  The mere existence of a legal
>provision on compulsory licences may be enough to curb anti-competitive
>practices.  Indeed, in the use of compulsory licences we look towards the
>rich experience of our developed country partners, which have employed
>compulsory licences to great effect.
>
> In the light of Article 31, it is our understanding that Members can grant
>compulsory licenses on a range of grounds, including those based on public
>interest, including health, or to protect the environment.  We, therefore,
>affirm our understanding that nothing in the TRIPS Agreement limits the
>grounds for governments to issue compulsory licences.
>
> The Group affirms that legitimate grounds for the issuance of compulsory
>licences include:  (1) where there is non-working or insufficient working
>of a patent;  (2) for the importation of a product under patent protection;
> and (3) for the export of a product under patent protection.  It is also
>affirmed that Members should undertake to recognize and give due effect to
>a compulsory licence issued by another Member, to a manufacturer in their
>territory for the production of goods intended for the market of the Member
>issuing the licence.
>
> Parallel importation is also an important tool to ensure adequate access
>to medicines.  It should be recalled that the Preamble and Part I of the
>Agreement set out that an important goal of the Agreement is to reduce
>distortions and impediments to international trade.  In this context,
>parallel importation of a patented medicine from a country where it is sold
>at a lower price will enable more patients in the importing country to gain
>access to vitally-needed medicines.  In this regard, parallel importation
>must be regarded as a legitimate measure, which Members can adopt to
>protect public health and nutrition.  Article 6 allows each Member the
>freedom to incorporate the principle of international exhaustion of rights
>- the legal basis for parallel importation.  Members should therefore
>refrain from imposing any limitations on the right of other Members to
>apply the principle of international exhaustion, and thus allow them to
>exercise their right to parallel importation without hindrance.
>
> While the Group favours the establishment of differential pricing
>arrangements provided this is done in a fair manner within a comprehensive
>and multilateral framework, these arrangements can only be part of a
>broader set of initiatives to improve access to medicines.  Nevertheless,
>we reaffirm that such arrangements must not prejudice the rights of Members
>under the TRIPS Agreement.
>
> It is crucial that Members be given the opportunity and sufficient time to
>acquire the necessary expertise, to incorporate the best possible elements
>and principles which they deem to be in their national interests when
>formulating national laws and policies, in order to take advantage of the
>inherent flexibility in the TRIPS Agreement.  For many developing country
>Members, the implementation process requires development of capacity and
>expertise in what is a new field for them.  This will take time.  For this
>reason, developing country Members should be allowed a reasonable period of
>time to put into place legal frameworks which properly reflect their
>understanding of the TRIPS provisions, consistent with their national
>priorities and needs.  Therefore, the Group urges Members to seriously
>consider the following:
>
>· firstly, extending the transition period for the implementation of their
>TRIPS obligations by developing country Members in relation to patent
>protection (both product and process) regarding pharmaceutical drugs;
>
>· secondly, undertaking, through a Ministerial Declaration, to adopt a
>moratorium in the dispute settlement mechanism to allow Members to take
>measures to protect public health;
>
>· thirdly, observing with immediate effect a moratorium on dispute
>settlement action against developing country Members that hinder their
>ability to promote access to medicines and protect public health (including
>compulsory licences and parallel imports) measures.
>
> In addition to the above measures, improvements to the TRIPS Agreement are
>required to take into account recent developments and problems that have
>arisen in the more than six years of implementation of the TRIPS Agreement.
> The seriousness of these problems were not anticipated at the time the
>Agreement was negotiated and concluded.  With the benefit of hindsight,
>Members are now in a position to improve on the Agreement and thus be able
>to contribute more effectively to dealing with the crisis of AIDS and other
>infectious diseases.
>
> The issues raised in this paper are not exhaustive.  According to the
>developments in this exercise of interpreting the TRIPS Agreement, we may
>wish to bring (collectively or individually) further clarifications and
>complements to this document.  All elements and views presented in the
>document are without prejudice to individual positions that Members may
>take in further discussions in the TRIPS Council or in other WTO bodies,
>including the dispute settlement procedures.
>
> Finally, the African Group, together with a number of delegations, have
>tabled the paper which appears in unrestricted document IP/C/W/296, which
>we fully endorse and commend to Members for their consideration.
>
>EUROPEAN COMMUNITIES
>
> Let me first say how much the European Communities and their Member States
>(EC/MS) welcome the very fact that we have this special discussion of the
>TRIPS Council for the very first time - and I hope it is not for the last
>time - on the link between intellectual property and health policy.
>
> Secondly, I would wish to thank my colleague of the delegation of Zimbabwe
>for a very illuminating and appealing statement.  I think it sets the tone
>for a constructive and open discussion today and, I hope, on other
>occasions between now and the Doha Ministerial Conference.  I also would
>wish to welcome the papers which have been co-sponsored by the African
>Group, Brazil and quite a number of other countries.
>
> I think that all these papers, including the paper we have tabled, have
>one thing in common:  all of them stress that the TRIPS Agreement and
>especially its application, and if need be the clarifications to it, should
>be part of the solution and not part of the problem.  And I think that it
>is in this spirit that we have to work together.  It is a complex matter
>but we are dealing with vital issues in this area, so we should try to
>tackle this complexity and to find the solutions that we collectively need.
>
> Let me also stress that the EC/MS are fully committed to finding solutions
>to the problem of access to affordable medicines in developing countries.
>You are certainly aware that we have been, for quite some time now, in the
>forefront of all kinds of initiatives, be it in the context of the G-7, be
>it in the context of our Round Table and the Action Plan that we tabled in
>September 2000, be it in the context of very intense discussions which we
>have had with the World Health Organization (WHO), or together with the
>WHO, with the pharmaceutical industry, and be it in the context of the
>Resolution of 14 May 2001 by the Council of Ministers, which endorsed the
>Commission's comprehensive Programme for Action which was tabled at the
>beginning of this year and which targeted the combat of the major
>communicable diseases.
>
> The Resolution of 14 May 2001 focuses on three main goals:  maximizing the
>impact of existing interventions (and that deals notably with what we are
>doing in the context of developing cooperation and focusing on health
>education and other matters);  increasing the affordability of key
>pharmaceuticals;  and increasing investment in research and development of
>specific global public goods.
>
> One of the key points of our approach is to encourage the pharmaceutical
>industry to commit itself to a global tiered pricing (TP) system, which is,
>in our view, the most effective way to ensure sustainable supply of
>affordable medicines to the poorest.  Although we recognize that the
>establishment of such a global system is not directly linked to
>intellectual property protection, we believe that the latter has an
>important role to play to make the system work.  The objective of a TP
>system is certainly not to deny Members the right to grant compulsory
>licences or to authorize parallel imports.  Our objective is to render
>recourse to such measures unnecessary.
>
> Let me turn more specifically to the link between TRIPS and health.  The
>EC/MS have, on several occasions, declared their willingness to promote
>discussions, within the WTO, WIPO and WHO, to address the link between the
>TRIPS Agreement and public health protection issues.  At the same time we
>have always insisted, and continue to insist, that intellectual property
>aspects are only one among many aspects to be considered and cannot be
>dissociated from the global problem of access to health.
>
>The EC/MS welcome that, today, the TRIPS Council will for the first time
>address the link between intellectual property and health.  We remain
>strongly committed to the TRIPS Agreement, because we consider that
>intellectual property rights provide an essential stimulus for creativity
>and innovation.  These rights need to be adequately protected in order to
>encourage investment in research and development into new medicines, and we
>need the R&D-based pharmaceutical industry to have those new medicines.
>But they should be more particularly targeted at the major communicable
>diseases, as recently also stressed by the WHO.
>
> The TRIPS Agreement has, however, sometimes been criticized as limiting
>policy options in relation to public health concerns.  In our view, the
>Agreement's objectives and principles, as set out in Articles 7 and 8,
>special transitional arrangements and other broadly drafted provisions give
>countries a sufficiently wide margin of discretion in implementing it.
>This margin enables them to set up an intellectual property regime that
>meets their policy needs and is capable of responding to public health
>concerns, while preserving an adequate level of intellectual property
>protection.  Downgrading the level of current IP protection should
>certainly not be the aim of the exercise.  In that context, we welcome the
>constructive contributions by other delegations.  We have to look at the
>different solutions with an open mind, but also have to put a notion of
>caution:  each and every proposal requires careful examination as to its
>potential positive effects and downsides.
>
>To stimulate substantial and result-oriented work in the TRIPS Council, the
>EC/MS Communication on TRIPS and access to medicines examines a number of
>provisions that are relevant  in this debate.
> One of the TRIPS provisions most cited in this context is Article 31 on
>compulsory licensing.  The lack of any explicit reference to public health
>in it is said to make some Members wary of using the Article for fear of
>provoking expensive litigation.
>
> Our view is that, in fact, compulsory licences can be issued for any
>reason, including of course public health, as long as the procedural
>safeguards contained in Article 31, as well as other relevant
>TRIPS-provisions, are respected.
>
> Let me remind you in this context that Article 7 of the TRIPS Agreement -
>and this has also been stressed in other documents - refers to "social and
>economic welfare" as an objective of the Agreement, while Article 8 allows
>Members to take measures necessary to protect public health, provided such
>measures are consistent with the provisions of the Agreement.  Articles 7
>and 8 were clearly not drafted as general exception clauses, but they are
>important for interpreting other provisions of the Agreement, including
>where measures, such as compulsory licences, are taken by Members to meet
>public health objectives.
>
> It is important also to note that the requirement under Article 31 to
>first try to obtain a voluntary licence can be waived in cases of public
>non-commercial use, a national emergency, or other circumstances of extreme
>urgency.  As for the level of HIV/AIDS infection reported in regrettably
>quite a number of countries, there would, in our view, appear to be very
>good reasons for describing it as a "national emergency" or as a
>"circumstance of extreme urgency".  I am sure that all of us can agree on
>that interpretation.
>
>Article 31 has been further criticized for requiring that goods
>manufactured under a compulsory licence be "predominantly for the supply of
>the domestic market of the Member authorizing such use".  This provision is
>sometimes said to prevent a small country that has no production facilities
>of its own from obtaining cheap medicines from abroad under a compulsory
>licence.  This is an important argument, as the Agreement does not appear
>to offer any legal certainty on the issue.  I think that all of us should
>be ready to examine this issue with an open mind in order to find solutions
>that could meet the consensus among all WTO Members.  The EC/MS do have
>that open mind.
> Another important provision is Article 39.3 on data protection.  Concern
>has been expressed in some quarters that certain interpretations of this
>Article could render compulsory licensing ineffective.  Let me reassure you
>that the EC/MS consider that Article 39.3 should certainly not be
>interpreted in such a way as to weaken or nullify Members' rights under
>other Articles of the Agreement, such as the "fast-track" procedure in case
>of emergency foreseen under Article 31(b).
>
> Let me turn now to parallel imports, an issue which has also been
>addressed by the delegation of Zimbabwe.  Much importance will also be
>attached to Article 6, which enables Members to allow for parallel imports
>of patent protected goods which have been put on a third market by the
>right holder or with its consent.  While we do not want to put Article 6
>into question, we would like to emphasize that the introduction of a global
>TP scheme will call eventually for measures to avoid for re-importation of
>TP medicines.  This problem should not be ignored.  Certain aspects may
>need to be addressed by the TRIPS Council as a complementary measure to a
>global TP system.  You will all agree that it is in the interest of all
>that TP medicines remain in the countries to which they were destined, and
>do not pop up in rich country markets, where customers can afford to pay
>much more for their medicines.
>
> To conclude, we acknowledge that intellectual property rights play an
>important role with regard to access to medicines.  However, we want to
>emphasize that the TRIPS Agreement cannot be held responsible for the
>health crisis in developing countries, while it must not stand in the way
>for action to combat this crisis.  As I said at the beginning of my
>intervention, the TRIPS Agreement should be part of the solution and not
>part of the problem.  The EC/MS will therefore continue to actively take
>part in the expanding global effort to develop a strong global response to
>the health problems of the developing world.
>
> In this context, the EC/MS are also ready to discuss to what extent
>technical assistance can take into account health concerns.  To make this
>work, an interactive dialogue is clearly required with the participation of
>all developing and least-developed countries concerned.  We also plead for
>closer coordination in that respect with other organizations like WIPO and
>the WHO.
>
> While we remain convinced that the TRIPS Agreement represents a delicate
>balance between the interests of right holders and consumers, the EC/MS
>stand ready to contribute in an open way and constructively to any
>discussion in the TRIPS Council or in other WTO bodies, which should lead,
>where necessary, to the clarification of certain of the Agreement's
>provisions.  We will see to it that we work together in the coming months
>also to have a clear indication to this effect in the Doha Ministerial
>Declaration.
>
>BRAZIL
>
> It is an auspicious sign that the exercise of discussions on "TRIPS and
>Access to Medicines" takes place under the chairmanship of a representative
>from an African country, a continent that has been particularly affected by
>health problems.  We trust that discussions under your guidance will be
>productive and results-oriented.
>
> I also wish to congratulate the African Group for taking the lead in this
>process.  While the question of access to medication concerns the whole WTO
>membership - and developing countries are particularly interested in
>achieving results from this process - the African continent deserves
>special attention in light of the grave situation of AIDS, tuberculosis and
>malaria pandemics in that continent.  We all have a great debt to you and
>the African Group in this respect.
>
> Brazil is proud to be one of the co-sponsors of a document circulated in
>this Council on the issue of "TRIPS and Public Health" (document
>"unrestricted" IP/C/W/296).  I will not go into detail on the paper but
>will make some reference to it.  The document reflects the reading of at
>least 50 developing country Members - and hopefully more as we go along in
>this debate - on the relevant provisions of the TRIPS Agreement related to
>public health.  In the drafting process of this document, all delegations
>contributed actively to bring meaningful elements to the discussion.  Such
>a "team work" was largely facilitated by the fact that the participants
>shared the same goals of ensuring that TRIPS should not - and, indeed, in
>our view, does not - prevent protection of public health.  In the
>substantive debate, we hope that other delegations may support the elements
>contained in this paper.  Confirmation that the TRIPS Agreement should not
>run counter to the protection of public health will be crucial to provide
>clear guidance for Members, avoiding the explicit or implicit threats of
>using the dispute settlement mechanism to enforce restrictive, unbalanced
>and, indeed, incorrect interpretations of the TRIPS Agreement.
>
> The Members that subscribe to this paper consider that the special
>discussion on TRIPS and Public Health at the TRIPS Council is not a one-off
>event.  It should be part of a process to ensure that narrow readings of
>the TRIPS Agreement do not in any way undermine the legitimate right of WTO
>Members to formulate and implement their own public health policies.  In
>this regard, and without prejudice to other possible actions, we believe
>that the Ministerial Conference in Qatar in November this year will be an
>excellent opportunity to confirm this understanding in an unambiguous and
>unconditional way.  This should go a long way to build the required
>confidence between developed and developing countries for any future
>negotiations we may embark on, not only on this subject.  It would also
>send a powerful message to all those growing sectors of civil society, both
>in the North and in the South, that see the WTO as a soulless organization
>at the service of the rich and the powerful.
>
> As it became known to the world public opinion since the beginning of this
>year, Brazil has a successful Programme for Universal Distribution of
>HIV/AIDS Medicines.  As you know, these medicaments are available free of
>charge to anyone who requires them.  The Programme clearly demonstrates
>that, important as they are, prevention policies alone are not sufficient
>to control the AIDS pandemics:  indeed prevention and cure are
>intrinsically linked.  I was glad to read in the Herald Tribune today an
>article by an American medical scientist, which says that experts have
>agreed that prevention and treatment are inseparable, or in the
>authoritative words of the UNAIDS expert committee, "their effectiveness is
>immensely increased when they are used together".  So let's not be fooled
>by the latest attempt to say that the whole question of AIDS relates to
>prevention and not to treatment.  The two go together.  Treatment based on
>access of patients to AIDS drugs plays an essential role in achieving
>concrete results.  In Brazil, the benefits of access to drugs have been
>concrete:  in the last four years, the number of deaths related to AIDS has
>decreased by half (although in some hospitals in Sao Paulo, where the
>incidence of HIV-infected patients is the highest in the country, the
>number of deaths was decreased by 71 per cent).  This was obtained by the
>use of drugs, not by prevention alone.  While such an aggressive policy to
>fight AIDS justifies itself on the ethical ground, as it saves human lives
>and alleviates suffering of patients, it also brings concrete benefits for
>the better allocation of scarce resources in developing countries:  the
>dramatic decrease in opportunistic infections resulting from drugs-based
>treatment has reduced up to 80 per cent the number of admissions in
>hospitals.  This has brought an economy of US$422 million dollars in
>hospital admissions.  Not an insignificant figure for a country like
Brazil.
>
> Two elements are absolutely necessary for the success of the Brazilian
>Programme for Universal Distribution of HIV/AIDS Medicines (and indeed to
>make it affordable to the Government):  the local production of medicines
>and negotiations with the pharmaceutical industry.  The two elements are
>closely linked to each other and directly related to our discussions here.
>In the case of drugs used in Brazil in the treatment of AIDS, local
>manufacturing has been utilized so far for products that were already in
>the public domain, without any infringement of patents.  But the
>possibility of issuing compulsory licenses is also an essential element of
>the negotiation between the Government and the pharmaceutical industries.
>Besides that, local production of pharmaceutical products may be crucial to
>ensure that medications are readily available at affordable prices.  Local
>manufacturing of pharmaceutical products also encourages sustainable access
>to medications by insulating the price of patented medicines against
>currency devaluations, as well as supporting the development of local
>expertise, which is vital in addressing local needs.
>
> The Brazilian AIDS Programme is strictly consistent with the TRIPS
>Agreement.  The Brazilian Law on Industrial Property provides strong patent
>protection for pharmaceutical products, and efficient mechanisms to fulfill
>the objectives of the TRIPS Agreement in a coherent way with our public
>health policy.  While Brazil has not as yet resorted to compulsory licences
>under the current law, a recent experience of our Ministry of Health in
>negotiations with one pharmaceutical company has demonstrated that the very
>existence of a compulsory licensing mechanism - together with the political
>will of the Government to use it is essential to persuade patent holders
>not to abuse their rights to the detriment of public health objectives.  In
>this case, a pharmaceutical company, which was refusing to bring its
>unreasonably high prices on two patented antiretrovirals down, has agreed
>to cut its prices by 64 per cent and 59 per cent respectively, when the
>Government gave unambiguous signs of its intention to issue a compulsory
>licence.  So this remains an essential element in our policy and we intend
>to keep it.
>
> As regards the issue of parallel imports, Brazil believes that Members
>should confirm their right of applying regimes of exhaustion of rights in
>their jurisdiction.  For developing countries, in particular
>least-developed countries and smaller economies, parallel importation can
>be a significant way of increasing access to medications, where the prices
>charged by patent holders for their products are unaffordable.
>
> In this respect, we favour discussions on differential prices as a means
>to improve access to affordable medicines, although the issue may be best
>discussed in other fora with a mandate to address public health policies,
>such as UNAIDS, UNICEF and the WHO, for instance.  At the same time,
>discussions on differential pricing should in no way result in restriction
>to or modification of the rights ensured to Members by the TRIPS Agreement
>to make use of provisions such as those on parallel imports and compulsory
>licences, as may be necessary.
>
> The beginning of special discussions on the issue of "TRIPS and Access to
>Medicines" in the TRIPS Council is a momentous occasion for Members to
>ensure that nothing in the TRIPS Agreement will prevent, should prevent or
>can prevent governments from taking measures to protect public health.  We
>hope that the debate here will confirm this understanding.
>
> Economic theory has for a long time established a link between price and
>value.  The nature of such a link, however, has never been fully resolved.
>In the end, our discussion today is also about the relation between price
>and value, i.e. the price of medicines seen as profit-bringing commodities
>and the value of human life.  We understand that, as any other industry,
>the pharmaceutical producers have to remunerate their activity.  We are not
>against them, but we hope that, with our help, they will find ways of doing
>it without beating what should be the very purpose of their activity:  to
>save lives and to alleviate suffering.
>
>ARGENTINA
>
> We consider these discussions to be particularly important in that they
>help to ensure that we, the WTO, face up to some of the negative effects of
>globalization.  I think we owe special thanks to the African Group for
>taking the initiative to propose this special debate, as well as the group
>of countries like the European Union on the one hand, and Brazil, India and
>the African Group on the other, whose significant contributions have helped
>to launch serious discussions.
>
> One way to ensure that negotiations produce an imbalanced result is to
>confront, at the negotiating table, those who have very specific knowledge,
>objectives and interests with those who do not.  Another way is to fail to
>implement properly what has been agreed.  This is where the problem lies
>between the TRIPS Agreement and public health objectives.
>
> As the  European Union states in its proposal, "it will be the first time
>that the TRIPS Council discusses intellectual property issues in the
>context of public health".
>
> Imbalanced negotiations or implementation will obviously lead to the
>interests and rights of one of the parties being ignored.  Some will
>exaggerate their demands.  In extreme conditions, this, in its turn, will
>lead others to react in a way that could jeopardize the global system of
>rules as a whole.
>
> It should be made clear before it is too late that excessive demands are
>not sustainable and that the destruction of the global system of rules is
>in no one's interest.
>
> This is exactly why we must tackle the problems by reaching a consensus
>interpretation, a common understanding of the current text of the TRIPS
>Agreement as regards the issue of public health.
>
> Without going into technical details for the moment, my Government would
>like to make clear its basic position in these discussions, which we see as
>the initial stage in a process that will assume importance at the Qatar
>meeting, by highlighting the following fundamental principles:
>
>(1) Articles 7 and 8 of the Agreement recognize that a private right cannot
>be made to prevail over a social benefit such as health.  Specific
>provisions were therefore included to prevent:
>
> - abuse of intellectual property rights by their holders;
>
> - recourse to practices which unjustifiably limit trade or are detrimental
>to the international transfer of technology.
>
> At the same time, the Agreement also provides for:
>
> - promotion of technological innovation;
>
> - transfer and dissemination of technology;
>
> - measures to protect public health and nutrition.
>
>(2) By adhering to the Marrakesh Agreement, WTO Members not only took on
>obligations, but also acquired rights, the implementation and respect of
>which are hierarchically just as important as the obligations.
>
> The TRIPS Agreement laid down minimum standards for protection through a
>basic system of rights and obligations.  The wording of the Agreement,
>which is the fruit of complex negotiations, provided considerable
>"flexibility" or "margin of manoeuvre" in many of the provisions to enable
>Members to incorporate them in their domestic legislations.
>
> This margin of flexibility in fact constitutes one of the rights acquired
>by the signatories to the Agreement.  Thus, the Agreement enables Members
>to develop a legal system that strikes a balance between the protection of
>intellectual property and their public policies.
>
> In our view, these margins do not need to be "interpreted", since some
>interpretations would merely be imposed at the expense of others, which is
>exactly what the authors of the Agreement were trying to avoid during the
>Uruguay Round.
>
> These margins take the form of different options which the States may use
>in implementing their obligations in a way that is in keeping both with the
>TRIPS Agreement and their domestic needs or policies.
>
>(3) There is a general understanding, to which Argentina subscribes, that
>the system of patents plays an important role in research and development
>of new medicines.
>
> There are two parallel objectives of the TRIPS Agreement whose fulfilment
>calls for a uniform understanding of its provisions:
>
> (i) due consideration for the rights of those who invest considerable sums
>in the development of new medicines;  and
>
> (ii) public health needs.
>
> We understand the second of these two objectives basically to mean fair
>prices, availability of quality medicines when and in the form in which
>they are needed, and dissemination of know-how.
>
>4. To try to limit the field to a series of specific issues that need to be
>resolved, such as "differential prices", would be to ignore the true
>dimension of the problem.
>
> The negotiation of differential prices falls outside the scope of
>intellectual property rights, and hence is not within the competence of
>this Council.  It is merely a tool to which countries and/or enterprises
>may resort if they so wish, and if they think that this will enable them to
>resolve an aspect of the problem.
>
> As stated by the Ambassador of Brazil and the Ambassador of the European
>Communities, it should in no way interfere with the legitimate right of
>States under the TRIPS Agreement.
>
>5. Finally, we think it is important to take advantage of the experience of
>the World Health Organization (WHO) in this area and encourage the Council
>for TRIPS to work on the basis of aspects of intellectual property - public
>health - access to medicines already identified by that organization.
>
> Fortunately, the Council is not beginning its work today in a void.  At
>the international level, much has been done over the past years to
>identify, study and seriously assess, from the public health point of view,
>the provisions of the TRIPS Agreement which directly or indirectly affect
>accessibility to medicines.
>
> Alongside the respectable studies by experts in the field and recognized
>NGOs, and the documents submitted by various countries to this meeting, the
>WHO has conducted numerous studies in this area.
>
> Any experience that the WHO could transmit to the Council on this subject
>would be of value for its future work, which we have defined as the search
>for a consensus interpretation, a common understanding of the TRIPS
>Agreement seen as a balance between rights and obligations.
>
>VENEZUELA
>
> Venezuela is fully committed to promoting health as a fundamental social
>right guaranteed by the State on the grounds that it pertains to the right
>to life.  Our Constitution gives priority to the promotion of health and
>prevention of disease, and pledges appropriate treatment.  We reaffirm our
>Government's interest in monitoring public health and assuring fair and
>equal access to medicines.  Health is a guarantee for development.
>
> We are aware that health problems affect mainly the low-income sectors of
>the population and that poor health hampers domestic, and ultimately
>international, economic growth.  The health problems which beset developing
>countries, coupled with economic crises such as that currently affecting
>the African continent, make protecting intellectual property rights less
>viable since upholding these rights may adversely affect economic
well-being.
>
> The problem of access to medicines in general has taken on structural
>dimensions in developing countries.  These countries are at a disadvantage,
>since health problems are closely related to survival itself.  It is
>therefore crucial for our countries to overcome the difficulties relating
>to services, health care and access to medicines.  And indeed, any proper
>approach to the health problem must go well beyond the mere need to protect
>intellectual property.
>
> AIDS is a scourge which needs to be dealt with as a matter of urgency, as
>do the other infectious, contagious and endemic diseases which afflict the
>developing countries in particular, such as dengue fever, tuberculosis,
>malaria, meningitis and diarrhoeal diseases.  We back international
>community action designed to guarantee access to medicines and hope that
>the outcome gives impetus to the strategy of granting access at affordable
>prices to the medicines which help to combat such diseases.
>
> Venezuela attaches considerable importance to intellectual property
>protection in relation to both the development of research and growth.
>Such rights are neither incompatible with, nor restrictive of health
>policies if interpreted in the light of the objectives and principles of
>the TRIPS Agreement.  The Venezuelan State is deeply committed to
>protecting the public interest when implementing the TRIPS Agreement.
>
> The Council for TRIPS has only recently begun to discuss the implications
>of the Agreement for the implementation of public health policies.
>Nevertheless, Venezuela's understanding of this issue has been that the
>very foundation of the multilateral system is the fairness in allowing
>countries which meet their commitments a degree of flexibility in
>implementing development policies, in this particular case public health
>policies.  This is the very spirit and rationale of the paper which has
>been submitted on behalf of developing countries and endorsed by Venezuela.
> This paper was well summed up by the delegation of Zimbabwe.
>
> We shall touch but briefly on a few aspects which have already been
>extensively dealt with in the proposal.  Firstly, any interpretation of the
>Agreement must be based on Articles 7 and 8.  We are certain that reducing
>government options with regard to promoting and protecting health or
>applying other related public policies is not in the spirit of the
Agreement.
>
> When some countries' interpretation of a failure to observe patent rights
>leads them to claim violation of the TRIPS Agreement, they are not taking
>into consideration the fact that developing countries are entitled to take
>the necessary measures to promote and protect health pursuant to Articles 2
>and 12 of the International Covenant on Economic, Social and Cultural
>Rights and the Declaration of Human Rights.
>
> We wish to highlight the importance of compulsory licensing and parallel
>imports as mechanisms for protecting public health and making medicines
>available at affordable prices to people with low incomes.  Mention should
>also be made of the use of non-discriminatory price controls, since this
>does not constitute a breach of the TRIPS Agreement.  Such instruments
>should be studied in the light of the general principles of law, the
>Preamble to the Marrakesh Agreement and the objectives and principles of
>the TRIPS Agreement.
>
> We are concerned over restrictive interpretations of the Agreement's
>provisions which seek to reduce Members' flexibility with regard to the use
>of compulsory licensing.  The patent rights of pharmaceuticals should be
>managed in such a way as to both protect the interests of the patent owner
>and safeguard the basic principles of public health.
>
> Likewise, the international principle of exhaustion of rights must be
>worked into domestic legislation.  In particular, it has come to our
>attention that some proposals do not refer to parallel imports as a way of
>improving access to medicines.  We wish to stress the need to confirm
>Members' right to apply the principle of exhaustion in their jurisdiction.
>
> It should be noted that some interpretations of Article 39.3 could
>conflict with the public interest.  Venezuela is of the opinion that a
>request for authorization for a product which has been initially approved
>by an authority cannot, under any circumstances, be construed as illegal
>use of data.  Should this provision be inappropriately interpreted, it
>would - by preventing pharmaceuticals from being marketed - be
>unjustifiably restricting access to medicines.
>
> It is also important to recognize the decisive role played by intellectual
>property in the development of research and the transfer of technology, and
>to understand the conditional nature of this relationship and, in
>particular, the overwhelming importance of development objectives.
>
> Finally, the Council for TRIPS must request that these considerations and
>precisions be included in the Qatar Ministerial Declaration as a core
>element of the development dimension.  As we have said on previous
>occasions, we are referring to provisions, interpretations and forms of
>implementation which enable the State to promote technical progress and
>stimulate dynamic economic growth with a view to achieving more
>far-reaching objectives.
>
>NORWAY
>
>During the past century, medical science and technology have made enormous
>progress.  For millions of people in developing countries, however,
>medicines are largely unavailable, unaffordable, unsafe, of poor quality or
>improperly used.  Over the past two years or so, unprecedented efforts to
>dismantle these obstacles have been undertaken by governments, various
>organizations, and industry.
>
>It is important to keep in mind that access to essential medicines depends
>on several factors.  I will mention some of these factors briefly:
>
>(1) rational selection and use of medicines;
>(2) sustainable adequate financing;
>(3) reliable health and supply systems;  and
>(4) affordable prices.
>
>Each of these issues is important if developing countries are to have
>proper access to medicines.  For the purpose of our discussion today, let
>me make a few comments on the issue of affordable prices.
>
>While prices are not the only issue, price does make a difference.  This is
>partly because most poor people in developing countries must pay for health
>care, including drugs, out of their own pockets.  During the last year,
>industry has started, although in a modest way, to sell antiretroviral and
>other medicines to several developing countries at preferential prices.
>The issue of how industry could practice differential pricing in a
>systematic way, was indeed the theme of a joint WTO/WHO workshop at
>Høsbjør, Norway earlier this year.
>
>Differential pricing may be one way of increasing availability and
>affordability of medicines in developing countries.  In addition, there are
>other ways whereby many of the same objectives could be pursued.  I would
>just like to underline that neither differential pricing nor such other
>methods should be used as an argument for not interpreting the TRIPS
>Agreement as flexible as possible in the area of public health.
>
>Today the TRIPS Council - at the request of the African Group - has
>embarked upon a first discussion on intellectual property and access to
>medicines.  It is a very complex issue and therefore in our view not a
>one-off event, but merely the beginning of a larger process.
>
>One aim of this first discussion is to try to seek more legal clarity in
>the interpretation and application of the relevant provisions of the TRIPS
>Agreement.  In doing so, the TRIPS Council must examine closely relevant
>provisions taking into account the fundamental principles and objectives of
>the Agreement.  We hope this would contribute to clarifying some of the
>provisions, including the flexibility to which Members are entitled under
>the Agreement.
>
>It is important to note that intellectual property standards, including
>those specified in the TRIPS Agreement, take the protection of public
>health into account.  Moreover, the Agreement contains several provisions
>which illustrate its flexibility.  These provisions, if interpreted in a
>constructive manner, should enable developing countries, struggling to meet
>health and development needs of their populations, to make proper use of
>the public health safeguards built into the Agreement.  I agree very much
>with the Ambassador of Brazil when he underlined that nothing in the TRIPS
>Agreement should hinder developing countries to take action.
>
>At the same time, we should keep in mind that the main purpose of the
>patent system is to provide incentives by stimulating research in and
>development of new technology, inter alia, in the medical field.  Industry
>would generally not be prepared to take the risks involved in investing
>heavily into the development of new medicines, unless it could expect to
>recoup these investments.  I have noted that in the discussions so far this
>point has been recognized by speakers.
>
>A number of provisions of the Agreement are particularly relevant when
>examining the issue of public health.
>
>The objectives and principles in Articles 7 and 8 point to the need to
>strike a balance between intellectual property rights and other interests
>including those of the users.  Moreover, the protection of intellectual
>property rights should contribute, amongst other, to the promotion of
>technological innovation in a manner conducive to social and economic
>welfare and to a balance of rights and obligations.  The need for
>flexibility is also taken into account and Members may adopt measures
>necessary to protect public health and nutrition and promote the public
>interest in sectors of vital importance to their socio-economic and
>technological development.
>
>Article 31 of the Agreement is particularly important in the context of our
>discussion and must be read in light of the objectives and principles of
>Articles 7 and 8.  The provision allows for the use of a patent without the
>patent holders' consent, under certain conditions.  Article 31 is complex
>and we will only offer some preliminary observations on a few points.
>
>First, however, it should be underlined that, in principle, patented
>medicines should be produced or marketed through voluntary licensing
>agreements, in more or less the same ways as other patented products.  It
>is therefore important that the research based industry seeks to conclude
>with applicants licensing agreements for the production or distribution on
>a voluntary basis.
>
>We are therefore of the opinion that Article 31 of the TRIPS Agreement
>should in general only be a last resort.  Article 31 is, however, an
>extremely important provision, and the mere fact that compulsory licensing
>remains an option could in fact increase the likelihood of concluding
>voluntary agreements.
>
>An important function of Article 31 is to set the standard terms under
>which a patented product must be offered to third parties.  Under
>subparagraph (b) the applicant must, within a reasonable period of time,
>have made prior unsuccessful efforts to obtain authorisation from the
>patent holder on "reasonable commercial terms and conditions".  The concept
>of "reasonable commercial terms and conditions" should be understood to
>require both the interests of the patent holder as well as those of the
>applicant and the consumer to be taken into consideration.
>
>In the case of, inter alia, a "national emergency", the subparagraph
>provides a waiver from the requirement to make prior efforts to obtain
>authorisation through voluntary arrangements.  What constitutes a "national
>emergency" must be considered on a case-by-case basis.  In our opinion,
>however, a "national emergency" does not have to be limited to sudden or
>unforeseen events, but could also encompass a continuous crisis like the
>AIDS epidemic in certain Sub-Saharan countries.
>
>Article 31(f) states that "any such use shall be authorised predominantly
>for the supply of the domestic market of the Member".  This subparagraph
>raises many important questions, most of which cannot be dealt with
>in-depth at this stage.  To which extent the manufacturing of products
>covered by a compulsory licence may take place outside the country issuing
>the licence is one of the important questions, particularly for smaller
>developing countries.  This is because production abroad may be the only
>way these countries may use the compulsory licensing provision.
>
>Under subparagraph (h), the patent holder must be paid "adequate
>remuneration" "taking into account the economic value of the
>authorization".  It is difficult to give any exact guidance on the
>interpretation of this provision.  Depending on the circumstances of the
>case, the remuneration which must be paid under (h) may however be less
>than the minimum amount which the patent holder could have requested under
>the concept of "reasonable commercial terms and conditions" in subparagraph
>(b).  Moreover, if the compulsory licensed products are lifesaving
>medicines which are urgently needed, this might also have an influence upon
>the level of remuneration.
>
>Subparagraph (i) provides for the review - in one instance - at the
>national level of the decision to authorize a compulsory licence, in order
>to take into consideration the interests of all parties.  It should be
>noted that, in order not to delay the application of a decision to grant
>authorization, national law might, under certain conditions, implement
>subparagraph (i) by, inter alia, providing for the provisional application
>of such an authorisation, even though it has been appealed.
>
>In conclusion, it is our view that the rights of developing countries to
>use the public health safeguards provided for in the TRIPS Agreement must
>be fully respected.  It will be up to each Member in the first place to
>determine the grounds for granting a compulsory licence under Article 31,
>taking into account other relevant provisions as well as the principles and
>objectives of the Agreement.  We would in this context urge developed
>country Members to show due restraint with regard to invoking the dispute
>settlement procedures under the DSU in matters regarding TRIPS and public
>health.
>
> Finally, we are open as to how this issue should be pursued, as long as
>the objective of securing a flexible interpretation of the Agreement as
>regards access to medicines is achieved.  I have noted the statement made
>by the delegation of Zimbabwe on behalf of the Africa Group for action to
>be taken at the fourth Ministerial Conference in Doha.  We would certainly
>not rule out the possibility of an authoritative interpretation at the
>Ministerial Conference if our discussions identify a need for such action.
>
>MALAYSIA (ON BEHALF OF ASEAN)
>
> At the outset, ASEAN would like to thank the African Group for initiating

>the holding of this special session on intellectual property and access to
>medicines.  The discussion on this subject in the TRIPS Council is both
>timely and very important for Members to advance our collective
>understanding of the provisions under the TRIPS Agreement that allow
>measures to be taken to fulfill public health objectives and the exercise
>of these rights.
>
> We would like to take this opportunity to thank the European Communities
>and the group of developing countries that have provided papers to further
>our discussions in this area.  In particular, ASEAN welcomes the paper as
>presented by Zimbabwe on behalf of almost 50 developing countries, and
>support the need, as outlined in the paper, to address Members' concerns
>over the relationship between TRIPS and health and in order to provide
>certainties as regards Members' rights to fulfill health objectives under
>the TRIPS Agreement.
>
> In negotiating the TRIPS Agreement, it was recognized that intellectual
>property rights are private rights.  Yet at the same time, the Agreement
>acknowledged that the protection and enforcement of intellectual property
>rights should be done in a manner conducive to social and economic welfare
>and that Members may adopt measures to protect public health.
>
> Indeed, Articles 7 and 8 are key provisions in implementing the TRIPS
>Agreement, ensuring a balance between rights and obligations and the
>prevention of abuse of intellectual property rights.
>
> In particular, we note that the TRIPS Agreement provides for:
>
> (i) the non-authorized use of a patent or otherwise known as the issue of
>a compulsory licence.  The TRIPS Agreement allows Members to issue a
>compulsory licence, but the grounds for the issue of such a licence are not
>stated in the TRIPS Agreement.  Hence, Members are free to determine the
>grounds for granting compulsory licences.
>
> (ii) Further, it is noted that the TRIPS Agreement also does not specify
>whether the compulsory licence can only be issued to a manufacturer in its
>own territory.  We have the provision of Article 31(f) that such use should
>be predominantly for the supply of the domestic market of the member
>authorizing such use.  Could this mean that Members have the right to
>confer compulsory licences to a third country manufacturer provided the
>procedures under Article 31 are met?
>
> (iii) The provisions of Article 31 themselves are meant to be used
>flexibly to meet public interest objectives.  The choice of the words
>"predominantly" in Article 31(f), and the word "adequate" in Article 31(h)
>are not specific and hence should lend themselves to a broad interpretation
>towards meeting public health objectives.  The use of the word
>"predominantly" should also be taken to mean that some portion of the
>production could be used for exports.
>
> (iv) Members also have the freedom to provide for the principle of the
>international exhaustion of rights in their legislation.  We note that,
>since the TRIPS Agreement does not address the issue of exhaustion of
>rights, as stated in Article 6, this provides the right of import from
>third countries.
>
> We believe that it is important that Members recognize these rights and
>respect their application.  In this context, the language for a common
>understanding of these rights should be worked out for Ministers'
>endorsement in Doha.
>
> Members have an excellent opportunity in Doha to inform that the TRIPS
>Agreement is not against affordable access to medicines.  On the contrary,
>the TRIPS Agreement has a number of provisions that contribute to the
>achievement of public interest objectives.  They should be accorded full
>recognition in their implementation and application.
>
>CHILE
>
> Today's discussions on intellectual property and access to medicines are
>absolutely crucial and highly topical and come in answer to a concerted
>appeal by the international community.  The actual issue of access to
>medicines clearly goes well beyond the mandate, functions and competence of
>the TRIPS Council, so that we must be particularly careful to ensure that
>our discussions remain within the strict confines of our competence.  We
>feel that this issue should be addressed not only in the light of the
>growing international concern over the relationship between intellectual
>property and access to medicines - proof of which lies in the great media
>expectations of this meeting - but also because there is a distinct lack of
>information on the issue which is our responsibility to overcome.
>
> The following four basic questions came to mind in relation to our
>statement.  Do WTO disciplines in general and the TRIPS Agreement in
>particular constitute an obstacle to the formulation and implementation of
>national policies on health and access to medicines?  If so, which
>disciplines or rules could prevent Members from adopting decisions on this
>matter?  In what way would it be possible to amend or improve those
>disciplines?  Who should be taking part in these discussions?
>
> First of all, the answers to these questions, and consequently the
>conclusions drawn, will depend upon the kind of policy each Member wishes
>to pursue and the factors taken into consideration in its formulation.
>
> I should like on this occasion to briefly discuss our country's experience
>in and interpretation of this issue on the basis of the current provisions
>of the TRIPS Agreement.
>
> The National Medicinal Drug Policy established by the Chilean Government
>in 1996 not only confirmed the right of the population to access health
>services, including medicines, but also the Chilean State's responsibility
>in the matter.
>
> In our opinion, medicines are essential social goods which afford people
>the opportunity of protecting and recovering their health.  The quality,
>effectiveness, safety and affordability of medicines, inter alia, form the
>basis of a rational medicinal drug policy.
>
> State intervention, through the formulation of a policy and strategic plan
>in the field of medicine, can be justified by certain national realities
>which, in the case of Chile, are basically as follows:
>
> (a) unequal access by the population to medicines;
>
> (b) unsuitable prescriptions and a lack of systems to monitor the use of
>medicines;
>
> (c) widespread uninformed and irresponsible self-medication;
>
> (d) the need for adequate monitoring to guarantee bioequivalence;  and
>
> (e) the upward trend in the price of medicines.
>
> Chile has granted patent protection to pharmaceuticals since 1991.  Prior
>to that date, only the right to grant process patents was recognized.  This
>change entailed major efforts on the part of Chile's Industrial Property
>Office since it had to train specialized staff and earmark greater
>financial resources for building up its capacity with a view to the
>technical analysis of these new patent applications.
>
> Even at that time, the conditions for granting patent rights were
>established on the basis of the three core patentability requirements
>stipulated in Article 27.1 of the Agreement, i.e. that patents be new,
>involve an inventive step and be capable of industrial application.  We are
>of the opinion that these three cor
>
>
>