WORLD TRADE
ORGANIZATIONIP/C/W/402
24 June 2003
(03-3360)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
THE IMPLEMENTATION OF THE DOHA DECLARATION
ON THE TRIPS AGREEMENT AND PUBLIC HEALTH
The following is the text of a communication received from the Permanent Mission of the
European Communities and their member States, which was circulated as an advance copy for the
Council's meeting of 4-5 June 2003.
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Communication by the European Communities
and their Member States
I. INTRODUCTION
1. On 14 November 2001 the Ministers adopted the Doha Declaration on the TRIPS Agreement
and Public Health.  Since then, Members have focused most of their attention on the issue identified
under paragraph 6 of this Declaration.  While the European Communities (hereinafter "the EC")
maintain their position that this issue should be resolved as soon as possible, the EC believe that itwould be equally useful to focus on the im plementation of the Doha Declaration itself.
2. The Doha Declaration stresses the need for the TRIPS Agreement to be part of the wider
national and international action to address public he alth problems.  It recognises that intellectual
property protection is of key importance for innovation and in particular the development of new
medicines, but it also recognises the concerns about its effects on prices.
3. The Declaration clarifies the relationship between the TRIPS Agreement and public health
policies of WTO Members, outlines the flexibility of several relevant provisions of the TRIPS
Agreement in particular with regard to patent s, and shows that they can be interpreted and
implemented in ways that are supportive of public health.  While the Declaration does not amend the
rights and obligations laid down in the TRIPS Agr eement, it provides guidance for the interpretation
of the relevant parts of the TRIPS Agreement.  This creates a safer environment for developing
country Members as well as for suppliers and purchasers of patented and generic drugs.  Finally, the
Declaration also specifies that the least-developed country Members will not be obliged, with respect
to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS
Agreement or to enforce rights provided for under these Sections until 1 January 2016.IP/C/W/402
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II. ENSURING THE EFFECTIVE IMPLEMENTATION OF THE DOHA
DECLARATION
4. In establishing intellectual property laws and related policies, and in particular in
implementing the TRIPS Agreement, developing countries must be enabled to (a) ensure that an
appropriate balance is found between the need to protect research and development, throughintellectual property, and public health policy issues, in accordance with Articles 7 and 8 of the
TRIPS Agreement, and (b) adequately take into account the safeguards and flexibilities available
under the Agreement as identified in the Doha Declaration.
5. Except for its paragraph 6, for which an adequate solution is still outstanding, the Doha
Declaration does not call for further work at WTO level
1.  However, the implementation of the Doha
Declaration by a developing country or by a least developed country, in so far as the latter has already
implemented the TRIPS Agreement or put an intellectual property system into place, may requirelegislative, administrative or policy adjustments.  In some instances, Members may deem it necessary
to adjust already existing intellectual property laws.  For developing countries and several least
developed country Members, which have only just made significant efforts to bring their legislation in
line with the TRIPS Agreement, this may not be an easy task.  It may also require the introduction of
administrative and/or judicial structures, procedures and disciplines (for instance for compulsorylicensing) which do not yet exist in many of the countries concerned.
6. The implementation of the Doha Declaration by developing and least developed countries
faces severe structural challenges.  In many instances technical assistance and capacity building will
be paramount to enable these countries to recognise and act on the implications of the TRIPS
Agreement on public health policies and establish workable laws, procedures and practices to giveeffect to the Doha Declaration.  This will require sound technical advice on how to best integrate the
Doha Declaration into intellectual property policie s and practices.  This advice must be balanced,
transparent and unbiased.
7. In this regard, it is critical that the main technical assistance providers on intellectual property,
and in particular the World Intellectual Property Organization (WIPO) and the WTO, fully integratethe Doha Declaration in their technical assistance policy.  The WIPO and the WTO are the main
providers of technical assistance on intellectual property to developing and least developed countries,
in particular through their "Joint Initiative" on technical assistance in the area of intellectual property
rights for the least-developed countries.  The WIPO-WTO legal and technical assistance programmes
must therefore integrate fully and completely the effects of the Doha Declaration and be geared
towards standards appropriate to the specific needs and level of development of the recipient country.
8. In this respect, it will be appropriate to take full advantage of the available expertise on health
matters, in particular in the World Health Organization.  Its observer status, on an ad hoc basis, in the
TRIPS Council, supported by the EC, allows the WHO to monitor developments on TRIPS and Public
Health.  The EC note that the WHO has also engaged in providing technical assistance to countries to
help them develop informed approaches to addressing the health implications of multilateral trade
rules
2.  The EC also warmly welcome recent steps taken by the WTO as well as by the WIPO to
involve the WHO more closely in their technical cooperation programmes, and strongly encourage the
WIPO and the WTO to further strengthen this coope ration and fully associate the WHO in their Joint
Initiative.
                                                     
1 The extension of the transition period for least developed countries with regard to patents and data
protection of pharmaceutical products was put into effect through a decision of the TRIPS Council of27 June 2002 (IP/C/25).
2 Information on Technical and Financial Cooperation Programmes carried out by the World Health
Organization and that are Relevant to TRIPS Impl ementation and Access to Drugs, IP/C/W/376/Add. 3.IP/C/W/402
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III. SPECIFIC TECHNICAL AND POLITICAL ISSUES RAISED BY THE DOHA
DECLARATION3
A. COMPULSORY LICENSING
9. In Doha, Ministers confirmed that each WTO Member has the right to grant compulsory
licenses and the freedom to determine the grounds upon which such licenses are granted, whilerespecting the terms and conditions of Article 31 of the TRIPS Agreement.
10. It is up to each Member to provide for efficient and equitable granting procedures.
Compulsory licensing is the most important technical issue of the Declaration: Article 31 of the
TRIPS Agreement is flexible, but imposes a number of procedural requirements, in order to ensure
that the rights of the right holders are protected, while leaving sufficient scope to provide for
transparent and expeditious procedures.  This requires administrative and legal infrastructure that is
absent in many developing and least developed countries.  These Members may therefore needtechnical assistance in setting it up.
11. In this respect it will be important to ensure that, for example, where compulsory licences are
provided for, patent legislation clearly defines the grounds for the granting of these licences, which
should correspond to clear policy objectives (in casu public health objectives).  Also, administrative
and/or judicial procedures must be transparent and equitable and respect the rights of the patentholders, while ensuring that the grant of a compulsory licence is not hindered by unnecessary delays.
In the same vein, equitable, guidelines must be determined for setting royalty rates for the
remuneration to the right holder.
12. As regards voluntary licensing and differential pricing, least developed country Members and
developing country Members may need technical support in terms of setting up an efficientnegotiating machinery in obtaining price reductions or voluntary licences.
B. E
XHAUSTION AND PARALLEL IMPORTS
13. The Doha Declaration confirms that each WTO Member is free to establish its own regime of
exhaustion of intellectual property rights without there being a challenge in the WTO dispute
settlement system, subject to the MFN and national treatment provisions laid down in Articles 3 and 4of TRIPS.  This means that Members have the freedom to opt for a national, a regional or an
international exhaustion regime.
14. However, account must be taken of the possible impact of international exhaustion regimes
on the diversion of reduced-price supplies of pharmaceuticals.  One of the most important means to
supply low-priced medicines to the poorest popul ations is through price reductions offered by
manufacturers, be it the R&D based industry or th e generic industry.  The EU's Programme for Action
of February 2001
4, which provides for a number of measures and solutions for combating the most
widespread communicable diseases, encourages companies to engage into an effective and sustainable
tiered pricing scheme - preferably, at the lowest price possible.  Many of the major pharmaceutical
companies have already launched specific initiatives along these lines, which the EC welcome.
15. An essential condition for the implementation of effective tiered pricing policies by
companies is that markets need to be segmented to prevent low priced products from flowing back to
                                                     
3 In this respect, it should be borne in mind that the principles of the Doha Declaration can also be
carried through to issues other than compulsory licensing or parallel imports, such as exceptions to exclusiverights or other policy options.
4 COM (2001) 96 of 21 February, 2001, as updated 26 February 2003.IP/C/W/402
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high price markets. Otherwise, this may lead to trade diversion, which will disincentivise companies
to engage in differential pricing.  Therefore, Members may have to adopt measures to avoid diversion
of such products and their (re-)importation into high-price markets.  For those countries which apply
an international exhaustion regime, this would imply certain exceptions to this regime insofar as low
priced medicines are concerned.  Such policy option would have the beneficial effect of encouragingsupply of medicines at strongly reduced prices
5.
IV. THE IMPORTANCE OF REGIONAL COOPERATION
16. Regional cooperation is not mentioned in the Doha Declaration itself.  However, the EC
believe that regional and/or sub-regional cooperation on intellectual property matters is highly
instrumental in implementing the TRIPS Agreement,  including the Doha Declaration, by pooling the
resources of the countries participating in such cooperation.
17. In particular, regional institutions dealing with intellectual property in Africa, such as the
Organization Africaine de la Propriété Intellectu elle (OAPI) or the African Regional Industrial
Property Organization (ARIPO), ha ve already shown that they can play a vital role in the
implementation of the TRIPS Agreement, and could play a similar role as regards the Doha
Declaration.  For instance, the implementation of  an effective compulsory licensing system for
production and import of products to address public health problems may likely take the form of aregional arrangement, based on a common patent system, taking advantage of the greater political
weight of a regional institution.  In particular, re gional patent systems are instrumental in overcoming
possible constraints stemming from the principle of territoriality and independence of patents.
Regional cooperation would also be extremely relevant  with regard to non-intellectual property issues
related to access to medicines, in particular practical matters such as bulk purchasing.
18. The EC therefore encourage Members to engage into regional cooperation arrangements in
view of implementing the TRIPS Agreement in general, and the Doha Declaration in particular.
V. CONCLUSION
19. The Doha Declaration provides for a roadmap fo r the right balance to be struck between the
flexibilities and safeguards of the TRIPS Agreement, to be applied where needed in accordance withthe provisions, principles and objectives of the TR IPS Agreement in order to ensure affordable supply
of medicines, while not discouraging th e development of needed new medicines.
20. The EC are committed to fully take the Doha Declaration into account in their trade policy,
and in particular as regards technical assistance for the implementation of the TRIPS Agreement.  The
EC therefore call upon all technical assistance providers, and in particular multilateral organizations,
to join them in taking up this commitment, and to fully integrate the Doha Declaration in their policies
and practices.
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5 In this respect, although the EU does not have an international exhaustion regime, the European
Union has taken its responsibilities, and has a dopted a Regulation on 26 May 2003 which prevents
pharmaceutical products sold to developing countries at reduced prices to be brought back into the Europeanmarket.  It provides for an extra mechanism for protection, which applies irrespective of whether thesemedicines are IP-protected, in order to encourage companies to supply medicines at reduced prices.