WORLD TRADE
ORGANIZATIONIP/C/W/363
11 July 2002
(02-3879)
Council for Trade-Related Aspects
of Intellectual Property Rights
PROPOSALS ON PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS
AGREEMENT AND PUBLIC HEALTH:  THEMATIC COMPILATION
Note by the Secretariat
I. MEASURES TO FACILITATE EXPORTS TO MEMBERS WITH INSUFFICIENT
MANUFACTURING CAP ACITIES ..................................................................................................... 4
A. SCOPE AND COVERAGE........................................................................................................... .4
1. Product coverage............................................................................................................. .................. 4
2. Beneficiary importing Members ................................................................................................ ....... 5
(a) General eligib ility ......................................................................................................... ......... 5
(b) Importing countries where the product is not patented .......................................................... 6(c) Assessment of insufficient manufacturing capacity............................................................... 7
3. Eligible supplying Members ................................................................................................... .......... 8
B. CONDITIONS................................................................................................................... .............. 9
1. General considerations ....................................................................................................... ............... 9
2. Safeguards against diversion................................................................................................. .......... 10
3. Transparency................................................................................................................. .................. 11
4. Involvement of right holder.................................................................................................. ........... 12
5. Applicability of Article 30/31 conditions.................................................................................... .... 13
(a) In exporting countries ...................................................................................................... .... 13
(b) In importing countries...................................................................................................... .... 14
(c) Remuneration to right holder............................................................................................... 1 5
C. LEGAL ME CHANISMS............................................................................................................. .1 6
II. MEASURES TO FACILITATE PRODUC TION UNDER COMPULSORY LICENCES
IN COUNTRIES WITH PRESENTLY INSUFFICIENT MANUFACTURINGCAPACITY....................................................................................................................... ..................... 18
1. Transfer of technology ....................................................................................................... ............. 18
2. Meaning of  "domestic market"................................................................................................ ....... 19
III. OTHER PR OPOSALS............................................................................................................ .............. 20
1. Transition periods ........................................................................................................... ................ 20
2. Exclusive marketing rights................................................................................................... ........... 20
3. Integral to Declaration...................................................................................................... ............... 20
4. Moratorium ................................................................................................................... .................. 20
5. Non-violation ................................................................................................................ .................. 21
6. Public competitive tenders ................................................................................................... ........... 21This document has been prepared under the Secretariat's own
responsibility and without prejudice to the positions of Members
and to their rights and obligations under the WTOIP/C/W/363
Page 2
1. At the TRIPS Council meeting of 25-27 June 2002, the Secretariat was requested to prepare
by mid-July a thematic compilation of the five written proposals that had been received on the
implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.
The paper would identify the various elements or components of the proposals and then set out, in
synoptic form, how each addresses these elements.  The note would also take into account any
additional points made in the oral discussion in the Council.  In addition, the note would providefactual information regarding each of the different legal techniques that had been proposed, including
the procedural requirements relating to each one and information on GATT/WTO experience with the
use of these techniques.
2. This note aims to respond to this request.  It contains a listing of the elements that have been
put forward for inclusion in a TRIPS Council recommendation to the General Council, covering both
points of substance and of legal mechanism.  The second part of the paper that was requested, namely
that relating to information on the procedural re quirements of each proposed legal mechanism and
experience with the use of that mechanism will be issued shortly as an addendum to this note.
3. The five written proposals submitted to the June 2002 meeting of the Council for TRIPS are
as follows:
Document Reference Submitted by How referred to
IP/C/W/351 Kenya on behalf of the African group African group
IP/C/W/352 European Communities and their member States European
Communities and
their member States
IP/C/W/354 United Arab Emirates United Arab Emirates
IP/C/W/355 Brazil on behalf of the delegations of Bolivia,
Brazil, Cuba, China, Dominican Republic,
Ecuador, India, Indonesia, Pakistan, Peru, Sri
Lanka, Thailand and Venezuela (at the TRIPS
Council meeting, the Philippines also associateditself with the proposal).Group of developing
countries
IP/C/W/358 United States United States
4. It is important to note that this document is a checklist of elements proposed for a TRIPS
Council recommendation and does not purport to refl ect fully the views contained in the proposals
and statements of Members.  Explanations given of the reasons for a suggested element have not been
included, except where they help to clarify the substance of the proposed element.  Moreover, thepaper does not record expressions of support by other Members for the elements that are listed in it.
For a full description of the positions of individual delegations, the proposals submitted and the
minutes of the Council meeting recording the statements made should be consulted.
5. The order of the listing of the proposals follows the numbering of the documents in which
they are contained (i.e.  the order in which they were received).  Additional points or clarificationsmade by Members associated with a group submission have been placed below the heading relating to
that submission, but this should not be taken to mean that the others in the group necessarily endorse
the point.IP/C/W/363
Page 3
6. Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health calls for an
expeditious solution to the problem of WTO Members with insufficient or no manufacturing
capacities in the pharmaceutical sector in making effective use of compulsory licensing under the
TRIPS Agreement.  Some elements of the proposals appear to do this primarily by seeking to
facilitate exports to Members with insufficient manufacturing capacities.  These elements are listed in
Section I of the paper, which deals in turn with issues of scope and coverage, conditions and legalmechanisms.  Some other proposed elements appear to be directed primarily at overcoming problems
of manufacturing capacity and market size so as to facilitate production under compulsory licences in
countries with presently insufficient manufacturing capacity;  these are listed in Section II.  Of course,
some of the proposals listed in Section I can also be of relevance to enhancing local capacity/market
size and vice versa.  In addition, a number of other proposals have been made which may be equally
relevant to both of these concerns or are otherwise not easy to place;  they are listed in Section III,
entitled "Other Proposals"IP/C/W/363
Page 4
I. MEASURES TO FACILITATE EXPORTS TO MEMBERS WITH INSUFFICIENT
MANUFACTURING CAPACITIES
A. SCOPE AND COVERAGE
1. Product coverage
African group
"Pharmaceutical products", which should be understood to include, medicines, related technical
processes, and related technical equipment (IP/C/W/351).
European Communities and their member States
The product scope should be defined as pharmaceutical products needed to deal with public health
problems afflicting many developing and least-developed countries, especially those resulting from
HIV/AIDS, tuberculosis, malaria and other epidemics.  It would cover patented pharmaceutical
products and pharmaceutical products manufacture d through a patented process (IP/C/W/352).
United Arab Emirates
Medicines and other public health-related products (statement).Group of developing countries
The proposed solution envisages the export of patented public health-related products (IP/C/W/355).- In no way should the solution be limited to products meant to address diseases specifically
mentioned in the Declaration (Argentina, Brazil).
- Not just medicines but also active pharmaceutical substances and diagnostic kits; at the very
least there should be constructive ambiguity on this issue. (Brazil).
- Products required in those cases which national governments consider to be national
emergencies should be included (Colombia).
United States
The solution should be confined to patented pharmaceuticals needed to address a public health
problem, especially those resulting from HIV/AIDS, malaria and tuberculosis and other epidemics,
afflicting a developing or least-de veloped country Member (IP/C/W/358).
Others
- Any type of patented medicine should qualify for measures taken under paragraph 6
(Norway).
- The scope of the diseases should be limited to the ones in the Declaration (Japan).IP/C/W/363
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2. Beneficiary importing Members
(a) General eligibility
African group
Exports of necessary pharmaceutical products should be to any country, particularly developing and
least developed Members, that needs support to  address public health concerns (IP/C/W/351).
Do not believe that the Doha Declaration excludes any Member but would respect choice of
developed countries not to be included (Kenya).
European Communities and their member States
Members that would qualify for importing these products would be developing country Members,
focusing especially on least developed country Members and low income Members, with no or
insufficient domestic manufacturing capacity, or, in case that product is patented in that Member, no
or insufficient manufacturing capacity other than that of the patent holder of the product in that
Member (IP/C/W/352).
United Arab Emirates
Should take care of all developing countries with insufficient capacities to make effective use of
compulsory licensing.  Should be made available to all Members without further distinction orcategorization of developing countries (IP/C/W/354).
Group of developing countries
Need not and should not be limited to a specific category of countries.  In any event, developing
countries, in particular least-developed countries, should certainly be among the main beneficiaries
(IP/C/W/355).
United States
Those developing and least developed countries that are afflicted by public health problems,
especially those resulting from HIV/AIDS, malaria and tuberculosis and other epidemics, and thathave insufficient or no manufacturing capacities in the pharmaceutical sector (IP/C/W/358).
Others
- The high-income countries under the World Bank classification should not make use of a
paragraph 6 solution (Switzerland).IP/C/W/363
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(b) Importing countries where the product is not patented
African group
Members may take measures such as compulsory licences, parallel imports, other importation, and
exportation where there are patents in force on the pharmaceutical products concerned as well as
where there are no such patents, or where the TRIPS Agreement or the provisions on pharmaceutical
patents are not yet in force (IP/C/W/351).
European Communities and their member States
Recognize that there could be cases where the product in question is not patented in the country of
consumption and no special conditions are required  to be applied in such a case (IP/C/W/352).
The intention to request another Member to issue a licence should be notified to the WTO (statement).Group of developing countries
The expeditious solutions envisaged by the TRIPS Council should also apply to countries where no
patents exist (IP/C/W/355).
United States
If the needed pharmaceutical is not patented in the territory of the importing country, the proposed
mechanism would apply where a request has been made by the importing Member to a developing or
least-developed Member to manufacture and export the needed pharmaceutical to its territory
(IP/C/W/358).IP/C/W/363
Page 7
(c) Assessment of insufficient manufacturing capacity
African group
Limitations of small domestic markets should also be addressed (Kenya).
European Communities and their member States
It is up to each Member to determine whether it has sufficient manufacturing capacity but the TRIPS
Council should ensure that this is done on the basis of objective criteria, perhaps looking at an
indicative list of such criteria (statement).  In assessing whether a country has insufficientmanufacturing capacity, capacity held by the patent holder of the product in that Member should be
excluded (IP/C/W/352).
Group of developing countries
Each Member shall have the right to determine whether it is in a situation of insufficient or no
manufacturing capacity in the pharmaceutical sector (IP/C/W/355).
- Assessment should be made product-by-product (Brazil).
- Production capabilities in active substances and not just final pharmaceutical products should
be taken into account (Brazil, Sri Lanka).
- Assessment should not be limited to any one po int in time as ability to manufacture is a
dynamic concept (India).
- Manufacturing capacity should not be viewed solely in terms of technological capability but
should take into account economic feasibility and economies of scale (Malaysia).
United States
Members should establish a procedure to clarify which developing country members can be
considered to have insufficient or no manufacturing capacity in the pharmaceutical sector or at least
the factors to be taken into consideration.  All least developed Members would be considered to have
insufficient capacity in the pharmaceutical sector (IP/C/W/358).
Others
- The meaning of manufacturing capacities in the pharmaceutical sector should be limited to
the scope of the diseases mentioned in the Declaration.  A fact-finding survey should be
conducted with regard to which countries faced difficulties on which diseases and with whatlevel of seriousness, taking into account the patent status for the products in that country
(Japan).
- One has to make a concrete assessment of a given member's capacity to produce a specific
drug as even if a Member has general production capacity it is not clear it would be able toadjust its production lines to produce the specific drug in sufficient time or expense
(Norway).
- Least-developed countries according to ECOSOC's  annual list should qualify automatically as
recipient countries without any further examination as to eligibility.  For the rest, a case-by-case examination to decide whether a Member has sufficient manufacturing capacity is
appropriate (Switzerland).IP/C/W/363
Page 8
3. Eligible supplying Members
African group
No basis whatsoever in the Doha Declaration to limit the sources of supplies of pharmaceutical
products to developing and least-developed countries (Kenya).
Restricting supplying members to developing count ries would narrow the options available to the
people most in need of the medicines as not many developing countries have the capacity to export
(Zimbabwe).
European Communities and their member States
No fixed views (statement).Group of developing countries
No basis in the Doha Declaration to exclude developed countries from being sources of supply under
a paragraph 6 solution and indeed, this may place significant restrictions on offers (Brazil).
United States
The mechanism shall operate to permit a developing county Member having sufficient manufacturing
capacity in the pharmaceutical sector to export needed pharmaceuticals (IP/C/W/358).
A solution could only provide or facilitate technology transfer to developing country Members if
developed country Members were not included as exporters (statement).
Others
- Developing countries should be the suppliers, at least in cases where the money from the
Global Fund is used to fight epidemics (Czech Republic).
- If production capacity is simply not available in a developing country, a requesting country
would have to have its medicines supplied by an industrialised country.  A recipient countryshould be able to seek authorisation for more than one patented product with the same
therapeutic effect and in more than one producing country at the same time if several
countries are producing the medicines in question (Norway).IP/C/W/363
Page 9
B. CONDITIONS
1. General considerations
African group
Any safeguards agreed to must not be costly, complicated, burdensome, inconsistent with available
resources and development needs, and negate or undermine the envisaged solution and must be in
accordance with the TRIPS Agreement (Kenya).
European Communities and their member States
There is the need to ensure that the necessary measures are taken to avoid abuses and trade diversion.
Such measures should be reasonable in view of the complexity of the problems and the situations thatmay arise from the practical application of the proposed exception (IP/C/W/352).
Group of developing countries
It would be unacceptable to consider safeguards or conditions that would in any way limit either the
flexibilities of Members under the TRIPS Agreement or the clarifications established in the Doha
Ministerial Declaration on the TRIPS Agreement and Public Health.  However, in line with the spirit
of the "limited" exceptions in Article 30, Members may consider the possibility of establishing
appropriate safeguards that would ensure legal predictability in this particular use of the provision, if
such safeguards do not have the effect of undermining its practical use, or to prejudice the existingright of countries to use Article 30 of TRIPS in other circumstances (IP/C/W/355).
United States
The balance in the TRIPS Agreement and the Doha Declaration which recognize the importance of
patents in providing incentives for new vaccines and medicines should be respected (Statement).
Others
- When drawing up conditions and safeguards the Council should not set stricter conditions for
Members not possessing sufficient manufacturing capacity in the pharmaceutical sector than
those set in Article 31 for those that have such an industrial base (Hungary).IP/C/W/363
Page 10
2. Safeguards against diversion
African group
Members shall provide or permit in their domestic laws and measures, the right for the right holders to
seek remedies against infringing re-exports out of the "domestic market".  Producers of productsunder compulsory licences to address public health needs in specific Members may label them for
consumption within designated domestic markets (IP/C/W/351).
Safeguards that are reasonable and proportional could be considered, for instance patent holders
should be allowed to seek legal remedies in accordance with the TRIPS Agreement against re-exports
(Kenya).
European Communities and their member States
The Member granting the licence for export should take all necessary regulatory and administrative
measures to ensure that the products manufactured  on the basis of the authorization are, in their
entirety, exported to the Member(s) designated by the authorization; and the importing Membershould take all reasonable and necessary regulatory and/or administrative measures to ensure that the
product is offered for sale, sold or distributed solely in the Member designated by the authorization
and not re-exported from that Member, in particular, but not exclusively, proper border controls,
supervision over the distribution of pharmaceuticals concerned and the imposition of the necessary
constraints on the distributor (IP/C/W/352).All WTO Members should be responsible for preventing the importation of the products concerned
into other markets. The measures to be taken should remain reasonable and proportional, both with
regard to the risk of trade diversion as with regard  to the institutional and administrative capacities of
the Member concerned (IP/C/W/352).
Group of developing countries
It would be reasonable to place the burden of sa feguards against trade diversion on the patent owners
under existing provisions of the TRIPS Agreement. (Brazil).
United States
The exporting country should ensure that the entirety of the production is exported to the Member
making the request under the proposed mechanism (IP/C/W/358).
All WTO Members, consistent with their existing TRIPS obligations, should ensure that means are
provided, to prevent diversion of the relevant pharmaceuticals into their markets or from the markets
for which they were intended  (IP/C/W/358).The TRIPS Agreement already provides obligations in this regard, under Articles 28 and 44.1, which
are sufficient.  The US paper does not in any way suggest that Members should undertake new
obligations to enforce proposed measures (statement).
Others
- It would be highly desirable if, before deliver ing the compulsory licences both for import and
production, the producer could make a binding confirmation with respect to the price,
quantity, quality and delivery conditions of the pharmaceutical in question as this could help
in checking diversion (Czech Republic).IP/C/W/363
Page 11
3. Transparency
African group
Members that, adopt laws or measures to produce for export to address public health needs abroad, or
issue compulsory licences, or that have public health concerns, may notify them to other Membersdirectly or through the Secretariat of the World Trade Organisation and to any relevant international
organisations.  It is understood that this paragraph does not create a notification obligation on
Members (IP/C/W/351).
European Communities and their member States
It will be of paramount importance to ensure full transparency of the process and to ensure that the
patent holder(s) and other WTO Members remain fully informed of the steps undertaken in view of
granting the authorization. Transparency would also contribute to preventing trade diversion: by being
informed of the use of the exception, other Members will be able to increase their vigilance with
regard to possible (re) importation of  the products concerned (IP/C/W/352).
The intention of an importing country, where no patent exists on the relevant pharmaceutical product,to request another Member to issue a licence should be notified to the WTO (statement).
Group of developing countries
Willing to consider measures for transparency pos itively as it may be helpful to ensuring better
competition and to not resort to compulsory licences (Brazil).
United States
Members seeking to import the needed pharmaceutica l under the proposed solution will inform the
TRIPS Council and provide the Council with in formation enabling interested Members to be
responsive in the shortest time possible. The TRIPS Council shall keep under review the operation
and effectiveness of this measure (IP/C/W/358).
Others
- Article 63.1 of the TRIPS Agreement provides a sufficient basis for notifications on this
subject to the TRIPS Council (Czech Republic).
- It is important to establish a system to monitor and review issues of diversion and
transparency (Japan).
- Both export and recipient country should provide the WTO with relevant information when
actually using a paragraph 6 mechanism (Switzerland).IP/C/W/363
Page 12
4. Involvement of right holder
European Communities and their member States
Both Members involved should promptly notify the right holder of their intention to issue a
compulsory licence. In case the product in question is not patented  in the country withoutmanufacturing capacity, the intention to request another Member to issue a licence in view of its
supply should be notified to the WTO (IP/C/W/352).
The right holder should be given the opportunity, w ithin a short timeframe after notification, to make
an offer to supply the relevant products at strongly reduced prices (IP/C/W/352).
If such commitment by the original manufacturer of the product meets the needs of the Member
without manufacturing capacity, notably in terms of price, safety and sustainability, this should be a
sufficient reason not to resort to a compulsory licence under the proposed exception.  It would be upto the Member without manufacturing capacity to judge whether the offer by the original
manufacturer is sufficient  to meet its needs (IP/C/W/352).
If the use of the product is intended to address a case of a national emergency or other circumstances
of extreme urgency in the importing Member, the Member authorizing the production will not be
obliged to first apply the condition set out in the first sentence of subparagraph (b). This should not bea reason for both Members involved not to promptly notify the right holder of the intention to grant a
licence (IP/C/W/352).  In such a case the right holder should be given a short period of time to make
an offer (statement).
United States
The transparency provisions should ensure that  patent owners are provided with information
necessary for them to respond first with offers of severely discounted prices, as already provided for
under the TRIPS Agreement, so that there would no t be the need for the mechanism to be employed
(statement).
Others
- Voluntary licences, negotiated by means of regular commercial arrangements, should be the
normal way by which patented medicines should become accessible to all Members
(Norway).IP/C/W/363
Page 13
5. Applicability of Article 30/31 conditions
(a) In exporting countries
African group
Article 31:
- Option 1: Article 31(f) would be completely revised; only a few of the existing conditions of
Article 31 would apply.
- Option 2: All conditions of Article 31 woul d apply except Article 31(f), which would be
deleted.
- Option 3: All conditions of Article 31 except Article 31(f) would apply as Article 31(f) would
not apply to any laws, measures and administrative regulations including compulsorylicences, adopted to protect public health and in particular to ensure affordable access to
pharmaceutical products.
The conditions under Article 30, as interpreted by the proposed decision, would apply  (IP/C/W/351).
European Communities and their member States
All relevant requirements of Article 31, other than Article 31(f), would remain fully applicable to the
Member granting the licence under the proposed exception (IP/C/W/352).
Group of developing countries
The conditions provided for in Article 30, as interpreted by the proposed authoritative interpretation,
would apply (IP/C/W/355).
Under a Article 31-based proposal, there would be a need to issue a compulsory licence both in the
importing and exporting countries, which would be  administratively burdensome  (IP/C/W/355).
United States
Members seeking to export needed pharmaceuticals under the proposed mechanism shall authorize
the use of the patent in compliance with each provision of the TRIPS Article 31, except for Article31(f), including notice to the right holder in conformity with Article 31(b) (IP/C/W/358).IP/C/W/363
Page 14
(b) In importing countries
African group
Article 31:
- Option 1: Article 31 would be completely revise d and only a few of the existing conditions of
Article 31 would ap ply (IP/C/W/351).
Imports could be permitted either on the basis of the doctrine of regional or international exhaustion
of intellectual property rights adopted in the country or on the basis of compulsory licences issued by
other Members that export some of the products produced under the licence, or importation under
compulsory licences that issue from legitimate sources abroad (IP/C/W/351).
European Communities and their member States
In case the pharmaceutical product concerned is patented in the country of importation, the latter will
have to issue a compulsory licence for its import, th ereby also respecting the relevant requirements of
Article 31 of the TRIPS Agreement.  If no such patents are in place, importation would not be
circumscribed by patent rules (IP/C/W/352).
United States
A developing country Member seeking to import a needed pharmaceutical that is patented in its
territory has authorized the use of the patent, in compliance with the provisions of TRIPS Article 31
(a) to (l) (IP/C/W/358).IP/C/W/363
Page 15
(c) Remuneration to right holder
African group
Members have the right to restrict any remedies relating to compulsory licensing to the  right to
adequate remuneration, notwithstanding the other provisions of the TRIPS Agreement.
Article 31:- Option 1:  Members shall provide for just compensation to the right holder (IP/C/W/351).
It will also be important for international mechanisms  to be put in place for assisting in funding the
compensation required on compulsory licences (IP/C/W/351).
European Communities and their member States
Proposed solution is within the existing legal framework of Article 31 of the TRIPS Agreement (and
hence 31(h) would apply) (IP/C/W/352).
Group of developing countries
An Article 30 based solution would obviate th e problem of double remuneration (IP/C/W/355).
Under an Article 31-based proposal, the patent holder should not in any case be entitled to double
remuneration as both compulsory licences would be issued to address essentially the same problem.
In this respect, it may be more reasonable to determine compensation in the country where the product
is consumed, since the amount of compensation should maintain some relationship with the ability of
patients to afford the product (IP/C/W/355).
United States
In the event that the importing Member owes, in accordance with Article 31, an amount of
compensation to the right holder, such amount could take into account any compensation paid to the
right holder under licence issued in the Member exporting the product (IP/C/W/358).
The burden should fall on the exporting country which clearly has more resources than the importing
country and should be worked out taking into account the value of the licence (statement).
Others
- TRIPS Council should establish guidelines for remuneration taking into account whether or
not the active ingredient was acquired from the patent owner (Colombia).
- The adequacy of the compensation to the right holder might be easiest determined in the
recipient's country since the judicial authorities there would be in the best situation to assess
the facts.  Any compensation in the exporting country should then take into account the
compensation already allotted in the recipient country (Switzerland).
- Suppliers should be encouraged to make medicines available on as-close-to-cost-recovery-
basis as possible (Canada).IP/C/W/363
Page 16
C. LEGAL MECHANISMS
African group
3 options for amendment of Article 31 of the TRIPS Agreement:
- Option 1: Article 31(f) would be completely revised.
- Option 2: Article 31(f) would be deleted.
- Option 3: Article 31(f) would not apply to any laws, measures and administrative regulations
including compulsory licences, adopted to protect public health and in particular to ensure
affordable access to pharmaceutical products (IP/C/W/351).
There should be an assurance and understanding that all procedures for an amendment would be
completed by June 2003 and that the amendment would be binding on all Members (Kenya).
Exports could be permitted as a limited and reasonable exception to patent rights under Article 30, or
as a ground for a compulsory licence determined by a Member in its own discretion (the ground being
to protect public health in another country), or as a measure taken in compliance with UN
responsibilities regarding the international health cr isis as recognised by the United Nations and the
World Health Organisation (IP/C/W/351).
European Communities and their member States
Adding a new paragraph to Article 31 which would ca rve out a clearly circumscribed exception to the
restriction imposed by Article 31(f) with the view to facilitating the use of a patent, under a
compulsory licence, on a pharmaceutical product needed to address public health problems in another
Member (IP/C/W/352).
Members could, once an agreement has been reached on the substance of the amendment, agree on a
temporary arrangement pending the entry into force of the additional paragraph to Article 31, such as
for example a dispute settlement moratorium, or pos sibly a waiver, although the latter may take more
time from a procedural point of view (IP/C/W/352).
United Arab Emirates
The approaches aimed at amending Article 31 of the TRIPS Agreement or interpreting, through an
interpretative note, Article 30 could form the basis of an eventual solution (IP/C/W/354).
Group of developing countries
Authoritative interpretation of Article 30 so as to recognize the right of WTO Members to authorize
third parties to make, sell and export patented public health-related products without the consent ofthe patent holder to address public health needs in another country is the most effective solution to the
problem identified in Paragraph 6 (IP/C/W/355).
Other non-exhaustive solutions could also be contemplated.  For instance, the TRIPS Council could
also consider the possibility of an amendment of Article 31 of the TRIPS Agreement in order toeliminate paragraph (f) (IP/C/W/355).
Members may explore the use of Article 31 (k) of TRIPS as part of the expeditious solutions to the
problem envisaged in Paragraph 6 (IP/C/W/355).
Merely partial or temporary arrangements, however, such as moratorium or waivers, would not
amount to sustainable or legally predictable solutions  (IP/C/W/355).IP/C/W/363
Page 17
United States
While each option has some merit, an expeditious, workable, transparent, sustainable and legally
certain solution may more likely be achieved through either a moratorium for dispute settlement or a
waiver of the obligation in TR IPS Article 31(f) (IP/C/W/358).
Others
- The approach of using a waiver under  Article IX of the Marrakesh Agreement offers great
promise.  The waiver could be formulated for an extensive period of time (on a long-term
basis - Korea) with an annual requirement being essentially a pro forma assessment of any
associated conditions such as transparency, efforts to prevent diversion and applications of theprovisions of Article 31 (Canada).
- Waivers should be granted on a country-by-c ountry basis at the minimum but broader options
could be considered (New Zealand).IP/C/W/363
Page 18
II. MEASURES TO FACILITATE PRODUCTION UNDER COMPULSORY LICENCES
IN COUNTRIES WITH PRESENTLY INSUFFICIENT MANUFACTURING
CAPACITY
1. Transfer of technology
African group
Developed Members may adopt measures to build sound technological bases in developing and least
developed Members such as to immediately operate to transfer technical skills and technical products
necessary for sustainable technological innovation and sustainable domestic production of
pharmaceutical products to meet public health needs in developing and least developed Members
(IP/C/W/351).
In this regard, the expeditious solution the TRIPS Council is required to find should be part and parcel
of a broader implementation of the TRIPS Agreement, taking into account the objectives andprinciples set out in Articles 7 and 8, as well as Article 66.2 that deals specifically with least
developed Members (IP/C/W/351).
It needs to be clearly acknowledged that the effective solution to insufficiency or lack of domestic
manufacturing capacity is to build such capacity (Kenya)
United Arab Emirates
The "interpretation of Article 30" approach, if adopted, should provide mechanisms that foster the
transfer of technology and dissemination of pharm aceutical technology and exports of medicines and
other ways to address health needs in a third country (IP/C/W/354).Transfer of technology is crucial for developing countries to build a better manufacturing capacity in
the pharmaceutical sector with a aim to ensuring sustainable access to medicines and other public-
health related products (statement).
Group of developing countries
In no way should the envisaged solutions under paragraph 6 be detrimental to the fulfilment of the
objectives of the TRIPS Agreement of transfer of technology.  Developed country Members should
provide incentives, as required under Article 66.2 and the Doha Declaration, to enterprises and
institutions in their territories for the purpose of promoting and encouraging technology transfer to
least-developed country Members in order to enable them to create a sound and viable technological
base in the pharmaceutical sector (IP/C/W/355).
United States
A solution under paragraph 6 of the Declaration could only provide or facilitate technology transfer if
developed country Members are not included as exporters.  If developed country producers are
included in this solution there would be no incentive for production capacity to shift to developing
and least developed countries (statement).
Others
- When assessing transfer of technology issues in the context of paragraph 6 the problems of
those Members not currently applying patent protection should also be considered (New
Zealand).
- In the medium and long term the solution lies in promoting the transfer of technology in order
to improve the domestic manufacturing capacity of members to produce pharmaceuticals
(Peru).IP/C/W/363
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2. Meaning of "domestic market"
African group
For purposes of Article 31(f) of the TRIPS Agreement, the "domestic market" of the Member shall be
understood to mean,
(a) The domestic market of the Member provided that up to 49.9 per cent of the
production under a compulsory licence may be for exports to or consumption in
markets other than the domestic market;
(b) The whole free trade area or customs union, including their interim arrangements,
where the Member is party to a free trade area or customs union or the interim
arrangements within the meaning of the General Agreement on Tariffs and Trade1994;
(c) All the territories collectively of the parties to that arrangement, where the Member is
party to an arrangement among developing countries within the meaning of the
Enabling Clause; and
(d) All least developed countries, where the Member is a least developed country and the
public health needs to be addressed by the authorisation under Article 31 generally
applies to least developed countries as a whole, for instance the need for medical
technology and essential medicines for the treatment or alleviation of the HIV/AIDS,malaria, tuberculosis and other health crises within the meaning of the Ministerial
Declaration on the TRIPS Agreement and Public Health (IP/C/W/351).
Regional integration schemes relating to intellectual property, such as OAPI and ARIPO, should be
taken into account (Senegal).
Group of developing countries
In implementing a paragraph 6 solution, countries may consider establishing economies of scale that
would reduce costs of production and thus provide more affordable prices for the beneficiary
countries in situations, for instance, where domestic production in small quantities from a compulsory
licence for a particularly high-priced product may be impractical or too costly (IP/C/W/355).IP/C/W/363
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III. OTHER PROPOSALS
1. Transition periods
African group
Transition periods relating to pharmaceutical and agricultural chemical products for developing
country should be extended in advance to permit and give predictability for certain measures that maybe necessary to address public health concerns, for instance where that would permit the exportation
by or into those developing Members of pharmaceutical products.  The TRIPS Council is, therefore,
instructed to grant extensions of transition periods relating to Article 65.4 of the Agreement to
developing and least developed country Members with insufficient or no manufacturing capacity in
the pharmaceuticals sector. The length of any additional transition periods to be granted shall be based
on objective criteria such as, adjustment costs, resource needs and constraints, levels of development,
and practical and operationalized technical assistance.  The transition periods shall reflect periods thatit will take developing and least developed Members with insufficient or no manufacturing capacity to
develop to social economic levels where they can meaningfully and sustainably protect public health
on the basis of domestic capacity (IP/C/W/351).
2. Exclusive marketing rights
African group
Clarifications of the provisions on exclusive marketing rights, including that these shall not prejudice
the issue or operation of compulsory licences under any intellectual property laws that are in force for
the time being in developing and least developed country Members and are not equivalent to patentrights. Members have the right and the freedom to define what constitutes exclusive marketing rights.
In particular, exclusive marketing rights when granted shall not prevent the importation or production
in the country of any products relevant to the pending application (IP/C/W/351).
3. Integral to Declaration
African group
In light of the tendency seen in some bilateral and plurilateral arrangements involving some
developed and developing countries, where the latter countries have sometimes given up the
flexibility due to them under the TRIPS Agreement, Members should avoid the fragmentation of the
multilateral regime on intellectual property rights provided by the TRIPS Agreement, and should
respect, and ensure the use to the full of, the flexibility in the TRIPS Agreement (IP/C/W/351).
4. Moratorium
African group
There should be a comprehensive moratorium on disputes against any Member that takes measures to
address the international and national health concerns in countries with insufficient or no
manufacturing capacity.  Such a moratorium would operate for as long as it would take the
international community to effectively combat the diseases, and such a determination could be made
by the World Health Organisation in accordance with its statutes (IP/C/W/351).IP/C/W/363
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5. Non-violation
African group
Members agree that the provisions of Articles XXII and XXIII of GATT 1994 as incorporated in
Article 64 of the TRIPS Agreement shall not be exercised with respect to any non-discriminatory
intellectual property law, regulation or other measure adopted to address public health concerns inmember countries with insufficient or no manufacturing capacity in the pharmaceuticals sector
(IP/C/W/351).
6. Public competitive tenders
Irrespective of use within or outside the paragraph 6 mechanism, a voluntary public tender procedure
would help ensure that the Member in need of pharmaceutical products would obtain the offer quickly
and efficiently while ensuring transparency.  Such members could be assisted by the WTO or theWHO (Switzerland).
Competitive tenders or offers that include the right holder as well as producers operating under
compulsory licences would result in better outcomes for purchasers (New Zealand).
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