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TWN REPORT ON THE WTO DISCUSSION ON TRIPS AND PUBLIC HEALTH, 20 JUNE 2001.

Introduction

On 20 June 2001 the WTO's TRIPS Council held a special one-day discussion on TRIPS and public health. The meeting was in response to public concerns worldwide on how patents were causing monopoly situations enabling exorbitant prices of medicines for treating AIDS and other diseases, making them unaffordable especially in developing countries.

Developing countries led by the Africa Group requested the TRIPS Council to hold a special discussion. At the meeting, 47 developing countries submitted a Joint Paper, asking for action in the WTO to affirm that nothing in TRIPS prevents countries from taking measures to protect public health.

They called for confirming a flexible interpretation of TRIPS, especially in relation to the use of compulsory licenses and parallel imports. Some developed countries showed varying degrees of sympathy for this position.

In contrast, the US position stressed the importance of upholding patent rights and held to a restrictive rather than flexible interpretation of TRIPS.

This Report is written by Cecilia Oh, Legal Advisor of the Third World Network. The report is written from Geneva, 25 June 2001.

The Report covers the Special Discussion of the TRIPS Council on TRIPS and Public Health on 20 June, 2001, the follow-up decision, some media conferences held by governments, and the NGO media conference on 19 June (preceding the WTO meeting).  There are also two annexes:  a summary of the submission of 47 developing countries to the TRIPS Council on TRIPS and Public Health;  and a joint NGO statement.

 

I:   SUMMARY AND BACKGROUND

The TRIPS Council’s Special Discussion on TRIPS and Public Health was held on 20 June 2001 at the WTO headquarters in Geneva.   The meeting saw an overwhelming number of WTO Members expressing  the need for action before and at the Doha WTO Ministerial Conference on the issue of intellectual property rights and access to medicines.

47 developing countries (including the African Group of countries, and countries from Asia, Latin America and the Caribbean) put forward a joint statement to the TRIPS Council, asking the Doha Ministerial Conference to take steps to ensure that “the TRIPS Agreement does not in any way undermine the legitimate right of WTO Members to formulate their own public health policies and implement them by adopting measures to protect public health”.

The developing countries wanted affirmation of this common understanding as soon as possible, in order to clarify the differing (and restrictive) interpretations of the TRIPS provisions being advanced by some developed countries. They expressed concern that such restrictive interpretations would unduly limit their rights to undertake the full range of public health policy measures, for fear of legal challenge, either in domestic courts or before the WTO dispute settlement mechanism.

Most countries which took the floor during the Special Discussion, including a number of developed countries, expressed support for the proposal for a clear statement by the WTO Ministerial Conference in November. The EC had welcomed the Special Discussion as a means for laying the ground for a “fruitful process” towards Doha. Norway’s statement (which many regarded to be the most forthcoming and developing country-friendly among the statements of the developed countries) suggested that developed countries should exercise due restraint with respect of the dispute settlement actions, until legal certainty on the TRIPS provisions was achieved.

Towards the end of the morning session, many developing country delegates were hopeful that there would be consensus on the way forward. The US statement, due after the lunch break, was keenly awaited. However, it turned out to be a disappointment.

The US statement seemed furthest away from the general line taken by the majority of the countries. In taking the position that strong patent regimes can produce benefits for countries, whether they be developed or developing, the US had refused to acknowledge the concerns of developing countries that TRIPS implementation would have negative implications for access to affordable medicines.

The TRIPS Council had agreed to hold the Special Discussion amidst growing public pressures—from developing countries and their governments, public health and civil society groups in the South and the North—to address concerns that implementation of the TRIPS Agreement are having and will continue to have negative consequences on the access to, and availability of, affordable medicines.

II:   THE FOLLOW UP PROCESS

The TRIPS Council heard over 40 statements from Members, during the Special Discussion, which finally concluded around 8.00pm at night of 20 June.   By the end of the session, it was clear that the majority of the countries regarded the Special Discussion as only the start of a continuing process, with a tangible result expected at the end.

The next day (21 June), the Chairman of the TRIPS Council, Ambassador Boniface Chidyausiku of Zimbabwe, held informal consultations with Members for their views on the way forward. On the last day of the TRIPS Council meeting (22 June), Members agreed to an informal meeting scheduled for July 25, for further discussions. It is expected that a checklist of issues would be presented to Members to guide their discussions. It was also agreed that the TRIPS Council would hold another one-day Special Discussion on 19 September as part of its next formal meeting.

III:  DEVELOPING COUNTRIES CALL FOR  ACTION IN WTO AND SHOW COMMON UNDERSTANDING AND INTERPRETATION OF TRIPS AND PUBLIC HEALTH

The most significant aspect of the TRIPS Special Discussion was that developing countries came well prepared and put up a strong case for:  (a) urgent action in the WTO to address the TRIPS-drugs issue;   (b) a flexible interpretation of the TRIPS agreement to enable national public-health measures. The common understanding by so many developing countries is important because their joint and individual affirmations of their interpretation of the TRIPS Agreement in relation to public health provides an important basis that these interpretations are those of the WTO Members.  In the event of a dispute, the common interpretation of so many members could have a bearing.

Joint Call for Action

The joint developing country paper reflected a common view among developing countries for the WTO to take urgent action to address mounting concerns over the relationship between patents and access to medicines.  Many developing countries took the floor to express their support for the joint statement. A number of the co-sponsors of statement - including Brazil, Egypt, India, Indonesia, Kenya, South Africa, Tanzania and Thailand, also presented their individual statements. The common theme within these various statements was the need for action by the Doha Ministerial Conference.

Zimbabwe, which spoke on behalf of the Africa Group representing 33 African Members of the WTO, proposed that the Doha Ministerial Conference issue a special declaration to affirm the Group’s common understanding that the TRIPS Agreement does not prevent Members from taking measures to protect public health.

Malaysia, speaking for the ASEAN countries, welcomed the developing country paper and expressed its support for the call for action to be taken by the Ministerial Conference. The ASEAN countries said it was important for Members to recognise the rights accorded to them within the TRIPS Agreement to take measures to protect public health and proposed that language for a common understanding of these rights be worked out for the Ministers’ endorsement in Doha.

Common Interpretation of TRIPS Flexibility

The joint developing country paper referred to provisions in the TRIPS Agreement having been drafted with “room to manoeuver” to serve the purpose of accommodating different positions of Members, and that this may elicit different interpretations of the Agreement. The paper urged the TRIPS Council to confirm, as soon as possible, their understanding that the TRIPS Agreement did not limit or reduce the range of options available to governments in promoting public health, and “other overarching public policy objectives “. This was required to prevent the situation of legal uncertainty.

The need for legal certainty was supported by South Africa, which recounted its experience defending its health legislation against legal challenges by the drug companies and a “major trading partner” (i.e., the US). Both challenges have been withdrawn. South Africa said both challenges were demanding TRIPS-plus legislation.

The Africa Group, in its statement, also supported the need for certainty, stating that “this assurance and guarantee was needed to enable governments to adopt such measures, without fear of litigation, at national level or at the WTO, or bilateral pressures being applied on them”.

In asserting their common understanding of the TRIPS Agreement, the developing countries also set out their reading of specific provisions in the Agreement. The various submissions of the developing countries shared many common elements, and these are summarised below.

**  Provisions of the TRIPS Agreement must be read in light of the objectives and principles as set forth in Articles 7 and 8, to ensure the proper balance between patent protection, and overarching public policy objectives, including the need to protect public health and to ensure access to medicines.

**  The TRIPS Agreement does not limit the grounds on which Governments may issue compulsory licenses. Compulsory licenses are essential tools for carrying out public health policies by facilitating access to medicines through the prevention of abuses of rights, promotion of domestic capacities for manufacturing pharmaceuticals and in cases of national emergency or other circumstances of extreme urgency, or of public non-commercial use.

**  Members have the unconditional right to determine the way in which exhaustion of rights regimes are applied in their jurisdictions, by virtue of Article 6, and thus the right to enable parallel import measures within national legislation.

The developing countries were also agreed that whilst differential pricing proposals could be part of a broader set of initiatives to improve access to medicines, such proposals should not be included within the deliberations of the TRIPS Council. More importantly, differential pricing schemes or methods should in no way be used to limit the flexibility of the TRIPS Agreement in any of its provisions.

The Africa Group added that developing countries should be allowed a reasonable period of time to put into place legal frameworks, which properly reflect their understanding of the TRIPS provisions. For many of the developing countries, the implementation process still required development of capacity and expertise, so as to enable formulation of laws and policies which were consistent with their national priorities and needs. The Group therefore, proposed an extension of 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.  (The joint paper of 47 developing countries also called for extension of transitional periods, as foreseen in TRIPS Article 65.4 and 66.1. )

In addition, the Africa Group also called for the Doha Ministerial Conference to adopt a moratorium in the dispute settlement mechanism, to allow Members to take measures to protect public health, and to not hinder their ability to promote access to medicines and protect public health (including compulsory license and parallel import) measures.

In putting forth their common reading and understanding of the TRIPS provisions, the developing countries have shown a great deal of commonality on their interpretation of the TRIPS Agreement.

There were also references to revision of the TRIPS Agreement. The joint developing country paper made it clear that “Where the provisions of the Agreement may be considered insufficient to protect public health, Members may wish to bring further proposals for modifications in the Agreement, with a view to increase its flexibility”.

IV:  DEVELOPED COUNTRIES’  RESPONSES

European Union

In its submission, the European Commission welcomed the process to address the link between intellectual property and health policy, and expressed its full commitment to finding solutions to the problem of access to affordable medicines in developing countries, including a reference to the Doha Ministerial.

Remarking on the tone of the statement, commentators said that it was a significant change from the EC stance a year ago. However, it was clear from its statement that the EC was not prepared to discuss any downgrading in the current level of IP protection, required by the TRIPS Agreement. On other substantive issues, the EC statement appeared to agree with the developing countries on a number of points.

Articles 7 and 8, the EC said, were important for interpreting other provisions of the TRIPS Agreement, including “where measures such as compulsory licences were taken by Members to meet public health objectives”. The EC also agreed that Article 6 of TRIPS enables Members to allow for parallel imports of patent protected goods, but added that a global tiered pricing scheme for medicines would require measures to prevent tiered priced drugs from “popping up in rich country markets” - implying limitations on parallel importation measures.

On the question of compulsory licences, the EC said that Members should be able to make use of the provisions of the Agreement about compulsory licensing (Art. 31) without fear of challenge, adding that compulsory licences can be issued for any reason, so long as the procedural requirements in Article 31 were respected. On whether compulsory licensees could produce for export, the EC said the Agreement did not offer any legal certainty on the issue, but expressed its willingness to find solutions that could meet consensus among Members.

Norway

Among the developed countries, Norway was perhaps the most supportive of the position of  developing countries. On the link between patents, price and access to medicines, Norway said, price was not the only issue for access to medicines, but “price does make a difference”. This was especially true in the case of poor people in developing countries who have to pay out of pocket for healthcare, including for medicines.

On the issue of differential pricing, Norway agreed with the developing country view that it should not be used as an argument for not interpreting the TRIPS Agreement as flexibly as possible in the area of public health. 

According to Norway, the aim of the Special Discussion was to seek more legal clarity on the provisions of the TRIPS Agreement. In this regard, Members must examine carefully the relevant provisions of the Agreement, and take into account its objectives and principles as set out in Articles 7 and 8. Until the required degree of legal certainty was achieved, Norway called on developed countries to exercise restraint until the required degree of legal certainty was achieved.

The US is out of step 

The basic premise of the US position was that in establishing standards for patent regimes, the TRIPS Agreement strikes a proper balance between offering incentives for innovation and ensuring access to medicines. Unlike almost all other statements at the Special Discussion, the US paper did not refer to the use of Articles 7 and 8 in the interpretation the TRIPS Agreement, leading some commentators to conclude that the US did not agree with the majority opinion expressed by the other Members.

The US asserted that flexibilities were inherent within the TRIPS Agreement, citing the transition period for developing country Members, as one of the most significant flexibilities contained in the TRIPS Agreement. In this context, the US also issued a challenge to countries to justify proposals for extension of transition periods, since Members, which have not had the experience of implementing the TRIPS Agreement could not have seen the impact the Agreement will have on their health care regimes.

It also took the position that Article 6 of the Agreement, which stipulated that the provisions of TRIPS could not be used to settle the issue of exhaustion of rights for dispute settlement purposes, did not authorise parallel imports. This was, again, out of line with the other Members’ reading of the same provision.

Although the US paper agreed with others that Article 31 of the Agreement does not itemize the purposes for which compulsory licences may be granted, it made clear its view that compulsory licences for non-working were not allowed. Referring to the need to read Article 31 with Article 27.1 (which prohibits discrimination between products locally produced and imported for the grant of patent rights), the paper concluded therefore, that “importation of a product, rather than domestic production, cannot justify the grant of a compulsory licence”.

In a comment clearly directed at civil society groups and NGOs (and perhaps some international organisations), the US paper also encouraged Members to refer to the WTO website for documents highlighting how the TRIPS Agreement has struck a proper balance between innovation and access to healthcare. The paper asked Members to “avoid documents circulated by other individuals and organisations that lack the WTO’s expertise”.

This comment has led some observers to say that the on-going civil society campaigns on TRIPS and access to medicines may finally have begun to affect the US. 

V:  MEDIA CONFERENCE:  DEVELOPING COUNTRIES’ REACTIONS

Speaking at a media briefing towards the close of the Special Discussion, Mr Tadeous Chifamba from the Zimbabwe Mission in Geneva, said that the African countries had put forward their interpretation of the TRIPS Agreement in the Africa Group statement. He added that other developing countries had also affirmed this interpretation of the TRIPS Agreement in their statements during the day’s proceedings.

The next step, Mr Chifamba said, was for the Africa Group to work towards having this interpretation of the TRIPS Agreement affirmed by the Ministerial Conference in Qatar.

Asked for his response to the US statement, Mr Chifamba said he had been disappointed. He cited the US position that the compulsory licensing provision in Article 31 should be read with Article 27.1. ‘This limits the flexibility for Members to issue compulsory licences. There is reference to Article 27.1 but not Articles 7 and 8’, he said. He added that he would need to carefully study the reference to parallel importation, ‘as what it is saying would nullify or prohibit the use of parallel import measures’.

The Director of the Brazilian Aids Programme, Dr Paulo Roberto Teixeira, agreed. He said that the US statement reflected a very ‘strict’ interpretation of the TRIPS Agreement. ‘This statement has sent countries like Brazil a very clear message: that compulsory licences under Article 31 cannot include the objective to develop national production of medicines’, he added.

Mr Mohan Kumar, of the India Mission in Geneva, said that the Special Session was the beginning of a process. It was an accomplishment of the meeting that all the relevant issues had been placed on the table. ‘A large number of delegations have expressed their views and this gives us a good sense of the positions. We look forward to further consultations with a view to achieving something tangible in Doha’, he said.

The delegate from Egypt, Professor Bahaa Fayez, said he had been encouraged by the proceedings. ‘Changes will be forthcoming because frank and candid exposures of the problem have been tabled,” he said.   He added that it was positive that the issues raised and discussed during the Special Discussion were not only those relating to the inherent flexibilities embedded in the TRIPS Agreement itself, but also included issues such as the call for a moratorium on dispute settlement actions against developing countries.

Mr Chifamba said that the process started at the TRIPS Council is not operating within a vacuum. ‘There are other organisations, which are also actively working on the issues related to access to medicines. What will be important are long-term solutions’, he said.

He further added that, within the WTO, there were also other processes within which the issue could be addressed. He referred to the review of the TRIPS Agreement under Article 71.1, as one example.

Mr Chifamba concluded:   ‘Qatar cannot afford to fail. The Ministerial Conference should send a clear, unambiguous message that international patent protection does not prevent Members from taking steps to protect public health and to ensure their citizens’ access to medicines’.

VI:   EC PRESS BRIEFING AND THE SCENARIO FOR DOHA

During a separate press briefing earlier, the EC Ambassador, Mr Carl Trojan, repeated the EC’s willingness to consult and dialogue with other Members, particularly, on the problems of small economies and their difficulties in issuing compulsory licences for production, when their own markets were too small to produce or absorb such production. The developing countries had made it clear in their statements that it was within their rights to issue compulsory licenses for the “working” of a patent within their territory, for foreign suppliers to provide medicines in the domestic market, and for the supply of foreign markets.

When asked about the developing countries proposal for a declaration at the Doha Ministerial Conference, the EC said that it favoured “preambular language” in the Doha Ministerial declaration that would clarify the grounds of public health exceptions. It should be clarified whether such preambular language would have less status than the operative text of a declaration.

While many delegates were encouraged by the “positive” approach taken by the EC, there were also concerns that the EC had not taken a hardline approach because it did not want to risk the debate on the TRIPS and public health issues taking centre-stage and jeopardising its attempts to launch a new Round at Doha. Indeed, the issue of the new Round was brought up at the press briefing, when the EC Ambassador took the opportunity to point out that the US and EU have now agreed on the launch of a new Round.

It has also been suggested that the TRIPS and public health issue could later be used as part of a negotiating strategy, to be traded against other issues in the context of a new Round with new issues. The EC has said previously that developing country demands in the Agriculture negotiations could not be addressed, save in the context of a new Round. The same approach may be taken here.

It must also be taken into account that the EC, and even more strongly the US and Switzerland (and other industrial countries) have made clear that they will not agree to any diminution in the current standard of intellectual property protection. It remains to be seen how much scope these countries would be prepared to accept with respect to the use of measures, such as compulsory licences. The US, in particular, has said that the use of compulsory licences will have negative implications for patent systems.

In this regard, it is a possibility that other proposals, such as the Global Health Fund and differential pricing schemes, may be offered as substitutes to developing countries, in place of decisions on the TRIPS Agreement.

VIII:  NGO PRESS BRIEFING, 19 JUNE

NGOs around the world have been actively involved in the TRIPS-drugs issue.  Indeed, many delegations in WTO acknowledge that it is the public concerns and campaigns on this issue that has led to the special discussions in the TRIPS Council.

The NGOs’ concerns orignated with the rising prices of medicines as a result of patents, especially following the TRIPS agreement’s coming into force.  The concerns turned to outrage when evidence accumulated that developing countries were coming under pressure and attack by drug companies and the US government, when they tried to take measures such as introducing compulsory licensing in their laws.

On 19 July, on the eve of the TRIPS Council special discussion, a press conference was held by Third World Network, Oxfam and Medicins Sans Frontiers, at the United Nations building (Palais des Nations) in Geneva.  At the press conference, an NGO Joint Statement,  “Patents and Medicines: The WTO Must Act Now”  was launched.  The statement was signed by over a hundred NGOs and more endorsements are being received.

In the statement, the NGOs issued a seven-point challenge to the WTO to deal effectively with the drug-patent problem.  These included a call to the WTO Members to:

**  Adopt a pro-public health interpretation of TRIPS through the flexible use of existing safeguards and exceptions, including upholding the right of countries to grant compulsory licenses for local manufacturing, import and export and their right to implement parallel importation measures.

** Strengthen existing public health safeguards in TRIPS so that governments have unambiguous right to override patents in the interests of public health.

** Remove the burdensome conditions and requirements that governments have to fulfil in issuing compulsory licenses, so that licenses can be granted on a “fast track” basis for health purposes.

** Extend the TRIPS implementation deadline for developing countries in relation to patent protection (both product and process) regarding medicines.

** Stop putting bilateral or regional pressure on developing countries aimed at preventing them from exercising their rights to take measures to obtain cheaper medicines, or to compel them to implement unnecessarily strict (or TRIPS-plus) standards.

** Observe with immediate effect a moratorium on dispute settlement action against developing countries that hinder ther ability to promote public health measures.

** Allow developing countries the option to exclude medicines from being granted patents, to ensure that medicines are more affordable to the poor.

Third World Network

228 Macalister Road

Penang, Malaysia

25 June 2001

FOR FURTHER INFORMATION, write to Third World Network at twnet@po.jaring.my.

ANNEX 1

SUMMARY OF THE SUBMISSION BY 47 DEVELOPING COUNTRIES TO THE WTO’S TRIPS COUNCIL ON “TRIPS AND PUBLIC HEALTH”.

Dated:   19 June 2001

TRIPS and Public Health

Submission by the Africa Group, Barbados, Bolivia, Brazil, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela

Summary

·        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 the TRIPs Agreement does not in any way undermine the legitimate right of WTO Members to formulate their own public health policies and implement them by adopting measures to protect public health.

·        The TRIPs Agreement allows for implementation of public health policy measures. Nevertheless, where the provisions of the Agreement may be considered insufficient to protect public health, Members may wish to bring further proposals for modifications in the Agreement, with a view to increase its flexibility.

·        Nothing in the TRIPs Agreement should prevent Members from taking measures to protect public health.

·        Each provision of the TRIPs Agreement should be read in light of the objectives and principles set forth in Articles 7 and 8. The 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 medications.

·        Compulsory licenses are an essential tool for Governments to carry out public health policies, as they may facilitate access to medicines through prevention of abuses of rights, encouragement of domestic capacities for manufacturing pharmaceuticals and in cases of national emergency or other circumstances of extreme urgency, or of public non-commercial use. Nothing in the TRIPs Agreement limits the grounds for Governments to issue compulsory licenses.

·        Parallel imports can also be an important tool to ensure adequate access to medications. In light of TRIPs Article 6, the TRIPs Council should confirm the unconditional right of Members to determine the way in which exhaustion of rights regimes are applied in their jurisdiction.

·        While we favor discussions on differential pricing arrangements, they are only part of a broader set of initiatives to improve access to medications. Differential pricing should in no way be used to limit the flexibility of the TRIPs Agreement in any of its provisions. Given that the issue is not within the sphere of discussions on intellectual property rights, it should not be covered by the TRIPs Council, but rather by other intergovernmental international organizations, such as the World Health Organization.

·        Other issues related to the provisions of the TRIPs Agreement also deserve further discussion by Members, such as the extension of transitional arrangements.

·        Finally, the Ministerial Conference in Qatar in November 2001 will be the best opportunity to take such action as will ensure that the TRIPs Agreement does not in any way undermine the legitimate right of WTO Members to formulate their own public health policies and implement them by adopting measures to protect public health.

ANNEX 2:  

JOINT NGO STATEMENT ENDORSED BY OVER 100 NGOS AND ISSUED IN GENEVA, 19 JUNE 2001

at a Media Conference organised by Third World Network, Oxfam and Medicins Sans Frontiers

PATENTS AND MEDICINES: THE WTO MUST ACT NOW!

Joint NGO Statement on the Special Discussion in the WTO TRIPS Council on Patents and Access to Affordable Medicines.

The deepening health crisis in many developing countries has raised public concern about the lack of access of poor people to affordable medicines. Public outrage over the exorbitant prices of HIV/AIDS drugs has also put the spotlight on the negative effects of global patent rules on the price and affordability of essential and vitally-needed medicines. Each year about 11 million people die from preventable infectious diseases. The AIDS epidemic is claiming millions of lives, to the extent that in some countries over a quarter of the population is affected.

Around the world, public concern is mounting at how the introduction of strict patent regimes in developing countries required by the WTO’s TRIPS Agreement is causing the price of patented drugs to be set at high, often exorbitant levels. The effective monopolies granted by TRIPS allow pharmaceutical giants to suppress competition from alternative, low-cost producers and to charge prices far above what is reasonable. This is done at the expense of many ordinary consumers who are too poor to afford treatment.

Before the establishment of the TRIPS Agreement in 1994, countries were allowed more options to exclude sectors from patent rules in their national laws. Approximately 50 countries (both developed and developing) excluded pharmaceutical products from patenting. However, with the implementation of the TRIPS Agreement, member countries are no longer allowed to do this.

The Agreement does allow member countries to take compensatory measures to counter the effective monopolies of companies owning patents. Two of the most important measures are the issuing of compulsory licences, whereby a government can give permission to other parties to produce or import products on which patents had been given without the permission of the patent holder, and the practice of parallel imports. Since TRIPS does not limit the grounds on which compulsory licences can be given, a country should not be prevented from issuing compulsory licenses on other grounds that it may consider necessary to meet public health and other public interest objectives.

However, pressures have been put on many developing countries by governments and companies in some developed countries not to exercise their rights to compulsory licensing or parallel importation. Recent examples of harassment faced by developing countries include the case brought by 39 pharmaceutical companies against the South African government over its Medicines and Related Substances Control Amendment Act, and the dispute settlement case lodged by the USA against Brazil in the WTO in relation to its Industrial Property Law. People everywhere, in developing and developed countries, are outraged at these kinds of pressures imposed on poor countries to prevent them from using the flexibility of TRIPS to improve the access of ordinary people, particularly the poorest, to medicines.

Growing public reaction to the scandal of patents and high medicine prices provides the background to a one-day Special Discussion on patents and access to medicines, which will be held by the TRIPS Council at the WTO in Geneva on 20 June. This special discussion was proposed by the Africa Group of countries in the WTO and supported by many others.

We, the undersigned NGOs, welcome this decision and regard the Special Discussion as an important opportunity for the urgent consideration and resolution of the negative impacts of the TRIPS Agreement on health and access to medicines.

In agreeing to the Special Discussion, WTO member countries have taken the first step towards clarifying the role of intellectual property rights and interpreting the TRIPS Agreement in such a way that intellectual property protection does not hinder access to vitally needed medicines. This meeting represents an opportunity to shift the balance of global patent rules in favour of the public interest and the protection of public health.

In developing countries, the TRIPS Agreement has exacerbated conflicts between private corporate interests, and the public interest including public health. The controversy over access to medicines has highlighted just one aspect of the imbalances within the TRIPS Agreement, which is too heavily tilted in favour of private right holders and against the public interest. There is growing evidence of social and economic problems caused by the introduction and enforcement of stricter intellectual property rights, which developing countries are obliged to implement as part of their obligations under TRIPS. This has resulted in calls for a re-assessment of the Agreement itself.

The key principle that should guide the discussions in the WTO is that access to essential and vitally-needed medicines is a fundamental human right. Poor people have the right to good health, and therefore to medicines for the treatment of poverty-related diseases. Protecting people’s health and saving their lives must take precedence over the strict protection of intellectual property and the very high profits which drug companies derive from this. Governments need a permanent guarantee that they can put public health and the welfare of their citizens before patent rights, without having to face the kind of legal pressures or threat of trade sanctions experienced by South Africa and Brazil.

We therefore call on WTO member countries, during the Special Discussion, to:

·        Strengthen the existing public-health safeguards within TRIPS to ensure that governments have the unambiguous right to override patents in the interests of public health;

·        Adopt a pro-public health interpretation of the Agreement through the flexible use of existing safeguards and exceptions. These include upholding the right of countries to grant compulsory licences for local manufacturing, import and export, and their right to implement parallel importation measures;

·        Remove the burdensome conditions that governments have to fulfil in the issuing of compulsory licences, so that licences can be granted on a ‘fast track’ basis for public-health purposes;

·        Extend the implementation deadlines within TRIPS for developing countries in relation to patent protection (both product and process) for medicines;

·        Agree not to exert bilateral or regional pressure on developing countries which take measures to exercise their rights under TRIPS to protect public health and promote access to medicines, nor to pressure them to implement unnecessarily strict and potentially harmful intellectual property protection standards or ‘TRIPS-plus’ measures.

·        Observe, with immediate effect, a moratorium on dispute settlement action against developing countries which hinders their ability to promote access to medicines and protect public health (including the use of compulsory licence and parallel importation measures).

·        Allow developing countries the option of excluding medicines from patenting on humanitarian or public-health grounds, in order to meet the objectives of saving lives, countering and controlling epidemics, and ensuring that the poor obtain access to essential medicines for the treatment of poverty-related diseases.

The NGOs signing this statement will use the above recommendations as the yardstick to judge the decisions and actions taken by the WTO TRIPS Council and higher bodies of the WTO, and whether the process initiated by the Special Discussion on TRIPS and medicines has been a success or a failure.

People all over the world will be watching whether WTO member countries meet the challenge of tackling the global health crisis, and demonstrate their commitment and contribution to the prevention of further unnecessary deaths.

We also call on governments in developed countries not to be influenced by any attempts by multinational drug companies to block clarifications of, or changes to, the TRIPS Agreement which are needed to make medicines affordable to the poor. We also call on the governments of developing countries to stand firm in putting forward proposals that affirm and strengthen their rights under TRIPS (especially in relation to compulsory licensing and parallel importation). Discussions on schemes such as ‘differential pricing’, or a global fund for AIDS, should not distract from, or be a substitute for, the need for action on patents and the TRIPS Agreement.

For more information on this Statement or to sign on, please contact:

Cecilia Oh, Third World Network

Tel: +604 2266159

Fax: +604 2264505

twnet@po.jaring.my

Liz Leaver, Oxfam GB

Tel: (0)1865 313446

Fax: (0)1865 313133

lleaver@oxfam.org.uk

 


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