The Adequacy of The Doha Declaration and Public Health by mek10591

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                                    SHARIFAH RAHMA SEKALALA 1

1.0 A brief Introduction to the World Trade Organisation (WTO)

The World Trade Organisation is a 151 member organisation which acts as a forum where
countries can reach agreement on lowering tariffs on foreign trade. The major role of the WTO
is to create an enabling environment for businesses which provide goods and services to
conduct commerce freely. 2 At the conception of the WTO in 1995, it was quickly realised that
there was a need for effective and adequate intellectual property rights. Furthermore, there was
a need to ensure that these rights themselves did not become a barrier to trade. 3

1.1 The Agreement on Trade Related Aspects of Intellectual Property (TRIPS)
The TRIPS Agreement covers basic principles, standards on the use of patent enforcement and
dispute settlement mechanisms. 4 It has been fraught with implementation problems due to the
inherent tensions between the holders of Intellectual Property rights (IPRs) and the members
who seek to use patented medicines 5 to combat ongoing epidemics such as HIV/AIDS. This
has always created an enormous north-south divide because the major holders of IP rights
come from the industrialised north while on the other hand the greatest numbers of victims
come from the less developed south. 6 These two sides have differing interests. While the south
needs access to affordable life saving medicines, the North’s interests are more focused on the
profitable proprietary pharmaceutical companies 7 that research develop and produce patented
medicines. 8 The patent system is built on the premise that patents provide an incentive for
innovation by offering the patent holder a limited right to exclude others from using the
patented product. 9 With the absence of competition, the patentee is able to set higher prices
during the period of protection. 10 Although these tensions existed at the signing of the TRIPS
Agreement, they were brought to the forefront by the HIV/AIDS epidemic.

  PhD Candidate University of Warwick School of Law.
  WTO, ‘What is the World Trade Organisation,’ Available at
e/whatis_e/tif_e/fact1_e.html last accessed 3 March 2008.
  WTO, ‘Overview of the TRIPS Agreement,’ A more detailed overview of the TRIPS Agreement available
at last accessed 20 August 2006.
  A patent is an exclusive right granted for an invention which is a product or process that provides a new
way of doing things.
  Philip McCalman, ‘The Doha Agenda and Intellectual Property Rights,’ A study on Regional Integration
and Trade: Emerging Policy Issues for Selected Developing Member Countries. October 2002 pp 2-4.
  Pharmaceuticals have been consistently ranked as the most profitable sector in the Fortune 500 rankings
for the past 3 decades. The top ten US drug makers increased their profits by 32% from 38 billion dollars in
2000 to 37 billion dollars in 2001. Scott Gottlieb, Drug Companies Maintain Astounding Profits, 324
B.M.J. 1054 (May 4 2002)
  Professor Brook Baker, ‘Analysis and Response to WTO Action Regarding Paragraph 6 of the Doha
Declaration on the TRIPS Agreement and Public Health.’ United Nations Millennium Goals Project Task
Force No 5: Infectious Diseases and Access to Essential Medicines, Sub Group Access to Essential
Medicines. (2003)
  Chien, ‘Cheap Drugs at what price to innovation: Does compulsory licensing hurt innovation?’ at p 1.

1.2 A global Epidemic
A considerable number of people are living with HIV/AIDS. At the end of 2006, they were an
estimated 39.5 million people worldwide were living with HIV/AIDS. 11 The number of people
with HIV has continued to rise with Africa remaining the global epidemic centre. 12 (See
Appendix A). Vulnerable groups have been hit the hardest by the epidemic. 75% of young
women aged between 15-24 years are living with HIV/AIDS in sub-Saharan African and this
trend is on the increase in other regions where females represent an increasing proportion of
people with HIV/AIDS. 13 HIV/AIDS related diseases account for 500 million or more illnesses
and 6 million deaths every year. (See Appendix B) Furthermore, the incidences of HIV/AIDS
are disproportionately high among groups who already suffer from a lack of human rights
protection and experience discrimination which in some cases is even criminalised. 14

1.3 International Legal Framework on HIV/AIDS
Although it is evident that HIV/AIDS has reached endemic proportions, there is no binding
international legal framework on HIV/AIDS specifically. The right to health has however been
dealt with extensively in International jurisprudence.15 In order to achieve the highest
attainable standard of health countries must ensure the prevention` treatment and control of
epidemic, endemic occupational and other diseases. 16 The World Health Organisation in 2001
adopted Resolution WHA 10, urging member states to make every effort to provide the highest
standard of treatment for HIV/AIDS in a progressive and sustainable manner. 17

 The General Assembly has issued two declarations on HIV/AIDS. The first in 2001 gave rise
to the Global Fund to Fight AIDS, Tuberculosis and Malaria in 2002. The second one in 2006
reaffirmed the commitments made in the 1st Declaration and encouraged the approach of
prevention, treatment, care and support which included the access to the removal of barriers on
access to essential medicines. 18 Although declarations of the United Nations are not legally
binding documents they represent clear statement by governments on what they have agreed
should be done to fight against the HIV/AIDS and measures that should be taken which are
often backed by specific guidelines.

   UNAIDS Report on the Global AIDS pandemic; A UNAIDS 10th Summary Edition Executive Summary
at p6.
   Global Fund; The Status and Impact of the three diseases, accessible at
last accessed 20 August 2006.
   They are high incidents of criminalisation of drug users, sex workers and homosexual men. All of which
have contrived to drive these practices underground and to increase the infection rate in these marginalised
groups. See Mindy Jane Roseman, Sofia Gruskin, ‘HIV/AIDS and Human Rights in a nutshell,’ Program in
International Health and Human Rights, Francois Xavier Bagnoud Centre for Health and Human Rights:
Harvard School of Public Health and International Council for AIDS Service Organisations.
   See Article 25 of the Universal Declaration of Human Rights (1948) Article 12 of the International
Covenant on Economic, Social and Cultural Rights (1966) Also see General Comment No 14 Of the
Committee on Economic Social and Cultural Rights.
   See Article 12 of the International Covenant on Economic Social and Cultural Rights (1966)
   See the 54th World Health Assembly Agenda Item 13.6 Scaling Up the Response to HIV/AIDS
WHA54.10, 21 May 2001.
   Political Declaration on HIV/AIDS 60/262 Resolution adopted by the UN General Assembly 15 June
2006 accessible from http:/ last accessed on the 20 August 2006.

1.4 Access to Essential Medicines
The major specific guidelines on the UN Resolutions have dealt extensively with access to
medication for people afflicted by the AIDS scourge. This is because people living with
HIV/AIDS need access to essential medicines 19 in order to survive. These are called Anti
Retroviral medicines (ARV’s). These drugs prevent the HIV virus from reproducing and
developing into fully blown AIDS and also make it difficult for the virus to multiply outside
the body. 20 Antiretroviral treatment is the difference between life and death for the millions of
people who are HIV positive. 21 Although millions of people are living with HIV/AIDS in
developing countries need immediate access to affordable antiretroviral medicines, 95% of
them, including 99% in Africa are living and dying without medicines that have dramatically
extended lives in the USA and Europe. 22 The AIDS pandemic drew attention to the fact that
many developing countries cannot afford expensive medicines and yet neither can they produce
cheaper generic 23 versions. 24

Although there have been claims that the ARV’s are not widely patented in Africa and thus
patents on the whole do not impede access to medicines for AIDS, 25 these have been
strenuously rejected by scientists and NGO’s involved in AIDS treatment who have pointed
out that the actual data presented in the article did not support the claim that was made 26 and
that in Africa 37 out of 53 countries have patents on the most popular anti retroviral
combination. 27 The existence of these patents, as illustrated above leads to the prevalence of
exorbitant prices which is an impediment to the accessibility of essential drugs.

   Essential Medicines are those that satisfy the priority needs of the population. From a public health
perspective access to essential drugs depends on a rational selection and use of medicines, sustainable
financing, affordable supply systems and reliable health systems. For more on essential medicines
especially in relation with HIV/AIDS see Technical Cooperation Activities Information from
Intergovernmental organisations. WHO Doc IP/C/W/305/Add3 at last accessed 12 June 2006.
   Collin Tracy, ‘The Pharmaceutical Companies versus AIDS Victims: A Classical Case of Bad versus
Good? A look at the struggle between International Intellectual Property Rights and access to treatment’ at
p 61.
   Since April 2002, the WHO has recognised ARV drugs as essential medicines. WHO, ’12 Model list of
Essential Medicines’ April 2002
   Six Million people living with HIV/AIDS in developing countries need immediate access to affordable
medicines or they will die within 2 years. Despite this compelling need, only 300,000 developing world
patient are receiving ant retroviral medicines including 50,000-57,000 in all of Afrcia. On third of the
developing world is total is being treated in Brazil which provides free access to ARV’s. WHO, A
Commitment to Expanded Access to HIV/AIDS Treatment,’
1<> (Dec 20002) See Jane Glavao, ‘Access to
antiretrovirals in Brazil’ <> (Nov 5, 2002)
   A generic drug is a pharmaceutical product intended to be interchangeable with the original product
which is generally manufactured without a license from the originator company but has exactly the same
make up. Source: Websters Medical Dictionary 2005 ed.
   Oxfam International (2002) TRIPS and Public Health The next battle
   A Attaran, L Gillespie White, ‘Do Patents for anti retroviral drugs constrain access to AIDS treatment in
Africa?’ JAMA 2001 Vol 286, No 15 pp 1186-1892
   Some of the most important low dose, low cost anti viral medicines is patented in countries where the
disease is concentrated. Low cost front line antiretroviral therapies involving 3TC, d4T, AZT, Abacavir and
or Nevirapine are significantly blocked by patents in countries containing 68% of HIV positive persons in
sub Saharan Africa. Consumer Project et als, Comment on Attaran/Gillsepe- Whote and PhrMA Surverys of
Patents and Retrovirals in Africa. (0ctober 16, 2001)
   Pascale Boulet, Christopher Garrison, Ellen t’Hoen, ‘Drug Patents Under the spotlight : Sharing
practical knowledge about pharmaceutical patents,’ Medicins San Frontieres, May 2003. See also a survey
conducted by an MSF Legal team on patents in Kenya Malawi, South Africa, Uganda, Zimbabwe, Zambia
and the 16 member states of the Organisation Africaine de la Propriete Intellectuelle (an organisation of
Francophone African Countries patents on antiretroviral on all of them.

The crux of the problem is that developing countries claim that patents restrict access to
essential medicines by keeping prices artificially high while those of the developed world
argue that the research and development (R&D) of new products require strong patent
protection. 28 The lack of patent protection makes generic drugs much cheaper than their brand
name, patent protected counterparts. This can be illustrated by the fact that four generic
producers supply the World Health Organisation (WHO) preferred fixed dose combination
medicine for less than US $ 140 which is over ten times less than the patented equivalent. 29
Generic drugs have thus found favour with developing countries who believe that they are
essential in addressing the HIV/AIDS pandemic.

Developing countries have always maintained that the TRIPS Agreement does not limit their
sovereignty to address crises such as HIV/AIDS. Developed countries particularly the United
States and Switzerland in turn argued that the only leeway developing countries enjoyed under
the Agreement is the longer implementation schedule they had before they had to implement
the TRIPS Agreement. 30 It was therefore clear that an international framework would be
integral in addressing the concerns that were afflicting both the developed and the developing
world. Moreover the AIDS pandemic, presented an immediate problem to the supply of
essential drugs. Thus, there was a need to clear any ambiguities on access to generic medicines
through compulsory licensing and the importation of generic drugs without the consent of the
patent holders.

2.0 Background to the Doha Declaration
In the run up to the Doha Declaration they were three widely publicised scenarios that clearly
illustrated that there was not only a lack of clarity in the TRIPS Agreement but that many
developing countries and even their developed counterparts had difficulties in exploiting the
flexibilities contained in it which could lead to better access of HIV/AIDS medicines.
The South African Medicines Act Litigation; At the height of the South African epidemic in
1997, the government introduced the Medicines and Related Substances Control Amendment
Act in order to promote the availability of affordable HIV/AIDS related medicines using
compulsory licensing and parallel importing under the TRIPS Agreement. 31 However in
February 1998, 39 pharmaceutical companies instituted a suit in the High Court challenging the
constitutionality of the Act and in particular whether section 15c) 32 which allowed compulsory
licensing and parallel importing as being incompatible with the TRIPS Agreement. 33 The USA
also put pressure on the South African government. 34 The matter was never determined by

   Henry and Lexchin, ‘The Pharmaceutical Industry as a Medicines Provider,’ at 1590.
   Brook K Baker, ‘Analysis and Response to WTO Action Regarding Paragraph 6 of the Doha Declaration
on the Trips Agreement and Public health,’ United Nations Millennium Development Goals Project, Task
Force; Sub Group Access to Essential Medicines 2003 at 6.
   Gathii J, (2002) ‘The Legal status of the Doha Declaration on TRIPS and Public Health under the Vienna
Convention on the Law of Treaties,’ Harvard Journal of Law and Technology Vol 15 at 292.
   The act provided for the (1) generic substitution of off patent medicines and medicines imported and
produced under compulsory licenses (2) parallel importation of patented medicines and (3) a transparent
medicine pricing system through the establishment of a pricing committee.
   Sec. 15 c) gave the health Minister broad powers to issue compulsory licenses and allow parallel
   Case No 4138/98 in the High Court of South Africa.
   The US Public Law 105-277 (105th Congress 1999) established that “…None of the funds appropriated
under this heading may be available for assistance for the central government of the Republic of South
Africa, until the Secretary of State reports in writing to the appropriate committees of the Congress on the
steps being taken by the United States Government to work with the Government of the Republic of South

court due to an avalanche of negative publicity and the pharmaceutical companies dropped
their lawsuit in April 2001. 35
USA V Brazil; At around the same time (February 2001), the United States instituted a suit
against Brazil in the WTO challenging the compatibility of Article 68 of Brazils’ Industrial
Property Law with the TRIPS Agreement. 36 Brazil had at the time initiated a highly successful
HIV/AIDS treatment program using generic ARV’s which it provided free of charge. 37 The
United States’ major argument was that the provision for the granting of compulsory licensing
in the event that a patent was not worked within 3 years of its’ issuance was tantamount to a
protective industrial measure and was inconsistent with the TRIPS Agreement. 38 Brazil’s
threat of compulsory licensing won it major price concessions from the manufacturers and with
the threat of compulsory licensing removed, the USA withdrew its case.
Both these cases however, highlighted the discord between drug manufacturers and the
industrialised north on one hand and the developing countries who were trying to use
flexibilities on Compulsory licensing in the TRIPS Agreement to give better access to their
populace that had been ravaged by HIV/AIDS.

Following the September 11 attacks, the USA faced an anthrax scare.39 To prepare for the
possibility of a recurrence, both the USA and the Canadian government decided to stockpile an
adequate supply of Cipro an antibiotic used in the treatment of anthrax. Canada immediately
overrode the German pharmaceutical company Bayer’s patent and ordered a million tablets for
a generic version from a Canadian pharmaceutical company. 40 In the USA, the Bush
administration threatened to do the same but this ended with a compromise arrangement with
Bayer. 41

The Anthrax scare had suddenly changed the focus of the relationship between patent holders
and states; not only in developing nations but to those in the developed world. The US was
criticised heavily for its hypocritical behaviour in its eagerness to use the threat of a
compulsory license for what it perceived as a health emergency while on the other hand forcing
developing countries to stick to restrictive patent laws in the face of increasingly dire health
crises. 42 It was not even clear whether Canada satisfied the test of the TRIPS Agreement by

Africa to negotiate the repeal, suspension or termination of section 15 c) of the South African Medicines
and Related Substances Control Act No 90 of 1997.”
   For the details of the lawsuit see Kongolo, ‘Public Interest versus Pharmaceutical Industry’s Monopoly in
South Africa,’ 4 Journal of World Intellectual Property (2001) 609-627.
   Measures Affecting Patent Production- Request for Consultation by the United States WT/DS199/1 Also
see Brazil- Measures Affecting Patent Protection- Request for the Establishment of a Panel by the United
States, WT/DS199/3, available at
   Avin Sarna, (2003) ‘A profile of the new AIDS epidemic in Brazil and its impact on the new AIDS
policy,’ accessed from
   The US argued that such a requirement is inconsistent with Brazil’s obligations under Article 27 and 28
of the TRIPS Agreement and Article III of the GATT 1994 which stated that patents shall available and
patent rights enjoyable without discrimination as to the place of invention, the field of technology and
whether products imported or locally produced.
   Ed Lake, ‘Analysing the Anthrax Attacks,’ The 1st 3 attacks, Commentary and Analysis Barnes and 2005 p 1.
   See Harmon and Pear, ‘Canada overrides patent for Cipro to treat Anthrax,’ New York Times 19
October 2001. The Canadian government subsequently withdrew its decision after agreeing on Monday to
buy the tablets from Bayer.
   Bradsher and Andrews, ‘US says Bayer will cut the cost of its anthrax drug.’ New York Times 24
October 2001.
   Haoechen Sun, ‘The Road to Doha and Beyond; Some reflections on the TRIPS Agreement and Public
Health,’ EJIL (2004) Vol 15 No 123-150

claiming a national emergency when they were no actual cases of anthrax in Canada at the
time. 43

Following the anthrax scare, it became imperative to seek clarity on what constituted a national
public health emergency; and whether it was permissible for a government to grant compulsory
licenses on the grounds of protecting national health pursuant to the TRIPS Agreement. 44

It was against this background that the TRIPS council held a special discussion on intellectual
property and access to medicines at the request of the African group. 45 They had a strong
conviction that the TRIPS Agreement should not prevent Members from adopting measures
necessary to ensure access to medicines and to satisfy other public health needs. 46 The
developing countries thus not only sought clarity through a declaration but also protection from
more developed countries in trying to use the flexibilities in the TRIPS Agreement at a national
level. The goal was to initiate discussions on the interpretation and application of the relevant
provisions of the TRIPS Agreement with a view to clarifying the flexibilities that Members are
entitled to and in particular to establish the relationship between IP rights and access to
medicines. 47 The resulting meeting provoked strong contrary reactions by the USA 48 backed
by Japan, Switzerland, Australian and Canada who jointly advanced pro PhRMA positions.

On the 14 November 2001 at the Fourth Ministerial Conference of the WTO in 2001, there was
a breakthrough in international discussions on TRIPS and access to medicines. The WTO
Ministerial Conference adopted a declaration on TRIPS and Public Health 49 which put health
before commercial interests and offered a much needed clarification in the field of TRIPS and
Public Health. 50 The negotiations focused on the access to medicines in relationship with
patent rights and focused extensively on the devastating AIDS situation especially in Africa. 51

   Dyer and Michaels,’ Anthrax scare raises awkward Patent questions,’ Financial Times October 2001
   Haochen Sun id 134
   WTO News, ‘Governments share Interpretations on TRIPS and Public Health,’ TRIPS Council
Wednesday 20 June 2001 accessed from last
accessed 20 August 2006.
   This position was strengthened by documents presented by WHO, UNCTAD as well as extensive
academic work and NGO statements all of which highlighted the flexibilities allowed by the TRIPS
Agreement especially in relation to exceptions to patent rights and parallel importing and compulsory
licensing. See annotated bibliography in WHO (2001) UNCTAD (1996) Also see Abbot (2002)a
   Two papers were submitted to the TRIPS Council from the African Group and the EU. See
Communication from the European Communities and Their Member States, ‘The Relationship between the
provisions of the TRIPS Agreement and Access to Medicines’, 12 June 2001, IP/C/W/280; ‘TRIPS Public
Health Submission by the African Group, Barbados, Bolivia, Brazil, Dominican Republic, Ecuador,
Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and
   US Statement at TRIPS Council Meeting, June 20 2001, <
   Doha Ministerial Declaration on the TRIPS Agreement and Public Health hereafter referred to as the
Doha Declaration WT MIN/01DEC/W2 14 November 2001. See full text in Appendixes.
   Ellen F. M Hoen, ‘ TRIPS, Pharmaceutical Patents and Access to Essential Medicines, Seattle, Doha and
Beyond.’ Pp 13-24.
   Paragraph 17 of the Ministerial Declaration is reflective of this; “We stress the importance attached to the
implementation and interpretation of the Agreement on Trade Related Aspects of Intellectual Property
TRIPS Agreement in a manner supportive to public health by promoting access to existing medicines and
research and development into new medicines and in this connection are adopting this resolution. Also see
paragraph 1 of the declaration which in broad terms recognises the “gravity” of public health situations in
LDC’s especially those resulting from HIV/AIDS, tuberculosis and malaria.

2.1 Scope of the Declaration
The opening paragraphs of the Declaration describe the chief concerns of the developing and
developed countries 52 , and form the framework for understanding the rest of the declaration.
These are preambular provisions (paragraph 1-4), which are aimed at confirming the
interpretation of certain rules of the TRIPS Agreement, (paragraph 5) operative provisions
requiring action by the Council for TRIPS in relation to countries with little or no sufficient
manufacturing capacity in pharmaceuticals; (paragraph 6) for the extension of the transitional
period for LDC’s in relation to the protection of pharmaceutical products and technical support.
(paragraph 7) 53

The Doha Declaration was in theory a breakthrough for developing countries because it
appears to solve the quintessential dilemma between which is supreme public health or
Intellectual Property rights. From the onset of the pre Doha negotiations, the main point of
contention was the text proposed by developing countries: “Nothing in the TRIPS agreement
shall prevent Members from taking measures to protect public health.” 54 This was essentially a
balance between the fundamental objectives of the Agreement; intellectual property and other
broader policy objectives like public health. 55 This balance is a fundamental principle of
intellectual property and is laid out in Articles 7 and 8 of the TRIPS Agreement (objectives and
principles) which refer inter alia, to the need to put in place measures to protect public health
and nutrition, the prevention of the abuse of intellectual property rights, the pursuit of social
and economic welfare and the need to strike a proper balance of rights and obligations. 56 The
essence of the declaration was reflected in Paragraph 4 which reiterated the fact that TRIPS
Agreement should be interpreted and implemented in light of the members’ right to public
health and to promote access to medicines for all
        We agree that the TRIPS Agreement does and should not prevent Members from taking
        measures to promote public health. Accordingly while reiterating our commitment to
        the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and
        implemented in a manner supportive of the WTO’s members right to protect public
        health and in particular to promote access to medicine for all.57

This text thus unequivocally acknowledges the right of countries to take measures to protect
public health. It clarifies the relationship between the TRIPS Agreement and public health
interests while reaffirming the Members’ commitment to the Agreement. Thus in a potential
conflict of interest between the two i.e. intellectual property being an obstacle to accessing
better public health or exorbitant patented prices of medicines in the face of people who
desperately need medicines, the patent can and should be overridden in the interests of public
health. It should also be noted that paragraph 4 makes a specific reference to the issue of

   As stated in paragraph 1 and the second sentence in paragraph 3, developing countries are primarily
concerned about the overwhelming public health epidemics in their countries and the high cost of
medications that are needed to treat their affected populace. On the other hand developed countries want to
emphasise the demonstrated value of patent protection.
   See generally DOHA Declaration on Health 2001.
   WTO Council for Trade Related Aspects of Intellectual Property Rights. Special Discussion on
Intellectual Property Rights and Access to Medicines 4, WTO Doc No IP/C/M31 (Restricted) July 10 2001.
   Paul Vanderon, ‘The WTO Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement
and Public Health Making it work’. Journal of World Intellectual Property 2000 at 1.
   Id at 62
   Paragraph 4 of the Doha Declaration.

“access to medicines for all” indicating that in interpretation of the Agreement’s obligations,
special consideration should be given to the achievement of this goal.58

Furthermore this paragraph refers to the implementation as well as the interpretation of the
Agreement. Though implementation takes place at a national level, it must be influenced by
other governments either in a bilateral or multilateral trading framework. 59 In this respect the
import of the decision lies in the fact that the Agreement must be implemented in manner
supportive of WTO’s members’ right to protect public health. 60 Thus members should restrain
from any action that hinders the exercise of such rights by Members especially LDCs. 61

In paragraph 5, the Declaration lays out the key measures and flexibilities 62 within TRIPS i.e.
compulsory licenses which can be used to overcome intellectual property barriers to access
medicines. Under TRIPS the fastest way in which a country could get a compulsory license
was to claim a national emergency. 63 The declaration categorically makes it clear that that the
use of compulsory licensing is in no way limited to cases of ‘emergency’ or ‘urgency’. It
reasserts the sovereignty of member states by giving them the discretion in not only declaring a
compulsory license but also in ascertaining for themselves what amounts to a national
emergency. Despite pressure from developing countries the disease list is not exhaustive. 64
Finally this paragraph resolves the issue of whether measures like parallel trade are acceptable
in the TRIPS Agreement by allowing members to establish exhaustion regimes without
challenge. 65

A compulsory license is a license granted by the competent national authority to allow a third
party to manufacture a patented drug without the authorisation of the right holder. 66 Before the
declaration came into force, there were a number of tests that had to be satisfied before a
compulsory license could be granted. 67 These were also accompanied by certain procedural
safeguards which had to be satisfied before such licenses were issued. 68 This situation changed
under paragraph 5b) which gave the Member countries the freedom to determine the grounds
under which a compulsory license could be granted. Thus it was clarified under the Doha

 Carlos M Correa, ‘Implications of the Doha Declaration on the TRIPS Agreement and Public Health,’
World Health Organisation Publications June 2002.

   Id at 12.
   Since implementation is in the last sentence an obligation imposed on Member States, the logical reading
of the second sentence of paragraph 4 is that the Agreement should be interpreted in a manner supportive
of WTO Members’ right to protect public health. See Correa supra 65
   See Correa Id at 12.
   Flexible means “adaptable, manageable, versatile,” Concise English Dictionary 2001 ed at 373.
   See TRIPS Art. 31b) which outline the steps that a Member must take prior to authorising the use of a
Compulsory License under Article 31. Both developing countries and developed countries attempted to
define this because it had not been defined in the TRIPS and this led to ambiguity.
   The language of the declaration does not limit the diseases that can amount to a national emergency to
those listed by using the language ‘including’ AIDS, malaria and tuberculosis.
   Id at Para 5 d
   Surya Subedi, ‘The Road from Doha: The issues for the Development Round of the WTO and the future of
International Trade.’ Int And Comparative Law Quarterly Vol 52 No 2 pp 425-446
   These were national emergency or other conditions of extreme urgency Article Public non commercial
use, (Article 31 b), remedy for ant competitive practices (Article 31f) and dependent patents under Article 3
   Section II.2 B.2 TRIPS Agreement.

Declaration that the reading of Article 31 should be done in tandem with that of Article 8
which allows Members to adopt measures to protect and promote public health. 69

Paragraph 5c) attempted to define what could amount to a ‘National Emergency’. Although the
notion of a national emergency was first introduced in Article 31b) of the TRIPS, there was no
clear definition of what amounted to one and this made it extremely difficult for member
countries to use this mechanism as each member country seemed to have a different view on
what amounted to such a situation. Para 5c) specified that public health crises including those
related to HIV/AIDS, tuberculosis, malaria and other epidemics can represent a national
emergency or other circumstances of extreme urgency. It is important to note that the overt
mentioning of HIV/AIDS was a real indication of the distinctive nature that the epidemic
presented to the world. Invoking the right to public health under the Doha Declaration is
particularly advantageous because it does not require prior request for a voluntary license from
the right holder. 70 This makes the process faster which is crucial in the event of a public health
emergency where lives are at stake.

It has been proved that the use of compulsory licenses contributes to raising the degree of
competition, which causes a reduction in price. 71 Due to increased competition from generic
manufacturers, the prices of AIDS medicines have undergone a remarkable transformation.
From doses of over 10,000 dollars for an annual course of ARV’S 10 years ago the lowest
discounted price of Boehringher Ingelheim’s Nevarapine a drug used in many first line anti
retroviral therapies now costs US $ 438 patient per year. The generic version however, is still
cheaper and costs only US $ 166 per patient per year. 72

There have been suggestions that compulsory licenses are not as effective as they first appear
to be. In many cases, the threat of the use of compulsory licenses is actually more effective
than the actual use of this mechanism. 73 As noted by Ladas, the practical value of the
existence of a compulsory license provision is that the threat of it usually induces the grant of
contractual licenses on reasonable terms and thus the objective of actually working the
invention is accomplished. 74 The Brazilian government for example was able to successfully
use the threat of compulsory prices to gain substantial reductions on ARV’s. However, it is
important to note that the use of this threat is only sustainable when it is backed by access to a
domestic market which has the ability to reverse engineer the drugs and the capacity to produce
them on a viable scale. This would in effect rule out most developing countries Refer to
appendix D.

Moreover most developing countries have been unable to use compulsory licenses or even the
threat of them because of the fear that developed countries would impose sanctions on them.
The US threat to impose sanctions on Thailand if it went ahead with compulsory licensing

   Sandra Bartlet, ‘The TRIPS Agreement and Public Health,’ JWIP Vol 3 (2003)
   TRIPS, Article 31 (b)
   Alberto do Amaral Junior, ‘Compulsory Licensing and Access to Medicines in Developing Countries,’ at
10 SELA 2005 Panel 5: Poverty and the International Order
   Henry and Lexchin ‘The Pharmaceutical Industry as Medicines Provider,’ Medicines Society and
Industry III at p 1592.
   Phillip McCalaman supra 2 at 10.
   More recently Beier (1999) has presented a similar view in a comprehensive study on the matter. He
argues that compulsory licenses “through their mere existence as well as through the apprehension of
compulsory license proceedings are liable to increase the willingness of a patent owner to grant a voluntary
license.” p 260.

provisions 75 and that of South Africa and Brazil which were discussed earlier in this paper are
ideal examples of the very real threat of the punitive repercussions that developing countries
face in trying to use compulsory licensing as a mechanism in accessing essential medicines.

Paragraph 6 of the declaration revisits the problem inherent in Article 31(f) of the TRIPS
Agreement, which stipulated that a compulsory license could only be issued to service the
domestic market. This had caused serious concerns to many developing countries that had
neither the manufacturing capabilities nor the infrastructure to take advantage of the
compulsory licensing provisions. 76 See Appendix D. Moreover; key transitional time periods in
the TRIPS Agreement would soon require worldwide protection for pharmaceutical products
beginning in 2005 even for key importers like India who had previously given patent protection
only to pharmaceutical processes. 77 This change in India’s patent law would dramatically
curtail its formerly lawful practice of reverse engineering of drugs and then producing them for
export. Post 1995, pursuant to the TRIPS Agreement, the production of generic drugs would
have had to be pursuant to a compulsory license with the exception of those from least
developed countries who did not actually have the manufacturing capacity. Thus to many
countries the existence of compulsory licensing did not provide any practical relief in
providing of essential medicines.

 Consequently, it was agreed under Paragraph 6 that the Council for TRIPS would find an
expeditious solution and report to the General Council by 2002. However coming to an
agreement was not easy especially with the dissenting opinion of the USA and Switzerland
backed by the pharmaceutical lobby. Thus, it was not until August 2003 shortly before the
Cancun Ministerial Conference that a consensus was reached. 78 This was accompanied by the
Chairman’s statement 79 which was essential in order to gain the USA’s compliance.80 This was
known as the Paragraph 6 Implementation Agreement (hereinafter referred to as The
Agreement) It granted rights to developing countries to waive the provisions under Article
31(f) 81 and also allowed member countries to export generic pharmaceutical products made
under compulsory licenses to meet the needs of importing countries also subject to certain
conditions. 82

This Agreement created a waiver to Article 31 of TRIPS which was supposed to be temporary
pending an amendment which was achieved on the 6th of December 2005. The new amendment
approved changes to the TRIPS Agreement making the August 30th decision permanent.

   The USA later withdrew these threats, for more on the Thai case see Human Rights Watch, ‘WTO
Summit; Don’t undercut AIDS drug access,’ (2001) accessed from last accessed 20 August 2006.
   Thus while members with large markets like the UK or India could easily grant compulsory licenses for
the supply of patented medicines to meet public health needs, those from smaller markets were the AIDS
pandemic was most severe would have found it extremely difficult to establish economically viable
production if the manufactured product was to be “predominantly” in the domestic market.
   Article 65.4 The transitional period for least developed countries has now been increased from 2006-
2016 but the practical chances of any of these countries becoming a large scale manufacturer is highly
   This consensus was referred to as the Paragraph 6 Implementation Agreement Ref to Appendix E.
   World Trade Organisation, ‘The General Council Chairperson’s Statement,’ August 30, 2003 see
appendixes.. The statement was supposed to clarify certain parts of the Implementation Agreement.
   The Agreement was accompanied by a Chairman’s statement that added further clarifications on the
Paragraph 6 Implementation Agreement. See Appendix F.
   This in effect waives the decision under that article that states that production under compulsory licensing
must be predominantly for the domestic market.
   See Paragraph 6 Implementation Agreement 2003.

Although this amendment was supposed to come into force on December 1 2007 it still lacks
the assent of two thirds of member states. However, it is important to note that this is the first
time a core WTO Agreement has been amended. This is a triumph for the prospects of
developing countries rights to public health.

The Amendment comprises of three parts; the first allows developing countries without a
significant pharmaceutical capacity or sector in the event of a public health crisis to access
alternative supplies of medicines. 83 The annex of this amendment then goes out to spell the
specific circumstances on which a compulsory license can be used and provides safeguards
against parallel importing. Lastly the appendix deals with the criteria for accessing lack of
manufacturing capacity in the importing country. 84 It is beyond the scope of this paper to deal
with this amendment because it is not yet in force, the discussion below will instead focus on
dealing with the Paragraph 6 Implementation Agreement and the chairman’s statement that
accompanied it which are still in force and their efficacy.

The Implementation Agreement makes Compulsory Licenses easy to least developed countries
by defining an eligible importing Member 85 as “any least developed Member without any
supplementary proof required from that Member. It also clears some prior concerns of double
compensation to the patent holder that a Member would encounter under the requirement of
adequate remuneration in Article 31 h) 86

Although the Agreement was a welcome step in trying to legitimise the changes wrought by
the Doha Declaration, it also contained further ambiguities that seemed to go back on the
progress made in Doha. Among these problems are the possibilities for delay, the fact that two
Member countries will have to obtain compulsory licensees which would lead to an increase in
transactional costs. 87

The paragraph 6 Implementation Agreement also introduces remuneration requirements which
are not only difficult to calculate88 but are also paradoxically required even when the product is
not produced for a country where medicine is not patented. This ideally means that a poor
country is in worse situation under Paragraph 6 than it would have been if it had the local
capacity to produce medicines. 89

Basing on the Chairman’s statement would also virtually halt the option of middle income
developing countries. This is because the US has set up an ad hoc procedure where countries

   Article 31 b)
   World Trade Organisation, “Proposal for a Decision on an Amendment to the TRIPS Agreement
(Geneva: World Trade Organisation, December 6, 2005) available at accessed 10 June 2006
   See World Trade Organisation, Least Developed Countries at 2003) last accessed 20 August 2006.
   See Implementation Agreement;
   See Rudolf V Van Puymnroek, Exportation of Drugs under Compulsory Licenses: The WTO Decision on
Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health
(October 3 2003) available at last visited 20 August 2006.
   The object of TRIPS to promote protection of intellectual property rights and public health can be
conflicting when trying to interpret “adequate remuneration” See Arvind Subramanuan, The AIDS crisis,
Differential pricing of drugs and the TRIPS Agreement 4 J World Intell Prop 323 (2001) On the one hand,
the developed countries want to protect their intellectual property rights and investments which means full
compensation and prices too high for impoverished individuals to afford. On the other hand, developing
countries want to increase access to essential drugs at minimal costs.

needing to import generics because of incapacity of their pharmaceutical sector must actually
prove and defend such assertions. 90 Unfortunately for many developing countries the standard
for proving “insufficient capacity” is uncertain. This is another issue on which there has been
widely differing opinion from developing and developed countries, while the USA addresses
this as a technical terms focusing on physical plant capacity notwithstanding their efficacy in
local production, or inability to produce much needed medicines in the short term, the
developing countries on the other hand have consistently argues that “insufficient capacity”
must be analysed in pragmatic economic terms to cover situations where local production may
be economically inefficient. 91

The chairman’s statement that differential packaging of medicines should not have a significant
impact on the price of pharmaceuticals is erroneous, See Appendix D while it is sensible to
have protections against using a proprietary name and identical packaging or any possible trade
mark infringements any requirement that allows exporters to vary pill size, shape or colour
cannot be cost free. Developing countries should therefore detest from following the best
practice guidelines which attempt to differentiate drugs because they invariably make prices
more expensive.

The Doha Declaration was supposed to offer a simple and efficient solution to the problem
posed by paragraph 6, however the solution given by the Paragraph 6 Implementation
Agreement is far from that, it presents an increasingly complex and burdensome solution. This
includes increased risks in producing generic drugs coupled with reduced benefits to shrinking
markets by virtue of the exclusion of some markets. There is also an ever increasing threat of
law suits or at the very least immense pressure on already impoverished countries because of a
lack of clear determination of salient issues that are crucial before importation which includes
what amounts to insufficient pharmaceutical capacity and a public health need.

3.0 The Aftermath of Doha
The aftermath of the Doha Declaration brought some positive changes in enabling developing
countries to gain access to essential drugs. Some of these countries have actively used the
flexibilities of the Doha Declaration in order to achieve better and cheaper medicines for
HIV/AIDS. Cambodia for example has implemented new patent legislation which excludes
patent protection until 2016, explicitly citing the Doha Declaration as its justification.92 Several
countries have also gotten cheap access to drugs through the declarations mechanisms;
Cameroon has been able to access ARVS at the incredibly low figure of around 277 US dollars
for its first online treatment combination because its Ministry of Health authorised the
importation of generic versions of patented drugs when they were available at lower prices
from the originator. Malawi has a similar arrangement which has also led to substantial
reduction in the price of its HIV/AIDS medicines. 93

   See General Council Chairpersons statement, WTO News 2003 available at
http://www.wtonnews_e/news.o3_etrips_stat_28aug03_e.htm last accessed 20 August 2006.
   See Baker Brook supra note 26 for more information on the two divergent views on sufficient capacity.
   Article 136, Law on the Patents, Utility Model Certificates and Industrial Designs, Cambodia. In its
preparation for its accession to the WTO at Cancun, Cambodia started adapting its legislation to WTO
   In Malawi it is possible to get a first line treatment combination for 288 us dollars. It is also listed as a
Least Developed Country and does not have to have patents until 2016.

Ten Latin American countries 94 have also managed to substantially reduce the prices of ARV
combinations from US $ 1000- $5000 down to US $350- $690 by setting a maximum
reference price that only generic producers with the exception of Abott Laboratories were
willing to meet. This was done despite the fact that some of the drugs were patented. However
in the true spirit of the Doha Declaration, public health was conceded as a superior to patent
rights thus generating estimated savings of US $120 million a year.

The EU has been instrumental in following the spirit of the declaration. Of late the European
Union has passed several resolutions that reflect a shift in support of a pro-public health
approach to TRIPS. 95 As part of this approach, the EU changed its policy to acknowledge the
concerns of developing countries. Reflecting this change, EU dropped its objections to the use
of compulsory licensing to overcome patent barriers to medicines access and became an
advocate for global tiered pricing system for pharmaceuticals. 96 This shift represented a far cry
from the former antagonistic mode of the EU presented and part of this can be attributed to its’
conforming to the declaration.

The above examples not withstanding, since the signing of the Doha Declaration; severe
problems still remain in the access and availability of HIV/AIDS drugs in developing
countries. It was evident after the adoption of the Doha Declaration that they were still
substantially different view points on the relationship between the TRIPS Agreement and
public health which negated the earlier compromises that had been struck in the declaration. 97

The pharmaceutical industry in particular which had always lobbied for high levels of
intellectual protection in developing countries took the position that the main theme of the
declaration was to reaffirm the value of intellectual property protection and to recognise the
TRIPS Agreement as part of the solution to better public health and better access. 98 This was
at odds with the widely held view that the Declaration gives broad discretion to Member States
in deciding how to counter the prices of drugs and that the declaration amounted to an explicit
statement that public health concerns outweigh full protection of intellectual property. 99 For
instance, as early as February 2002, the US Pharmaceutical industry lobbied to urge the Office
of the United States Trade Representative (USTR) to add four new countries listed as ‘Priority
Foreign Countries’ for monitoring and potential trade sanctions under the ‘Special 301’
provisions of the US trade law, for their failure to protect patented products. 100 Such actions
put the very existence of the Doha Declaration in jeopardy because to many of the worlds
developing countries the United States is too crucial a trading partner to antagonise even if the
alternative would be to save their countries from the public health disaster of HIV/AIDS.

   The Andean Community which comprises of Peru, Bolivia, Columbia, Ecuador, Venezuela,) and
Argentina, Chile, Paraguay and Uruguay.
   European Parliament Resolution on Access to Drugs for HIV/AIDS Victims in the Third World, 2001 OJ
(C 343) 300
   Press Release of Pascal Lamy’s Speech marking World AIDS,: Lamy calls for More Action on Access to
Medicines After Progress in Doha. European Union Trade Commissioner (Nov 30, 2001) Available at
http://lists.essential/org/pipermail/ip-health/2001-December/002515.hmtl (last accessed 20 June 2006)
   See Hoechun Sun supra 39 at p 145
   PhRMA, WTO Doha Declaration Reaffirms Value of Intellectual Property Protection, 14 November
2001 available at
   Hoen, “TRIPS Pharmaceutical Patents and Access to Essential Medicines: A long way from Seattle to
Doha,’ Chicago Journal of International Law (2002) 27 at 47-48.
    See Oxfam Briefing Paper, TRIPS and Public Health: The next battle (2002) 27 at 2.

 Professor Abbott, 101 makes a strong case for the fact that it is not the rules under paragraph 6
of the declaration that are the problem but the risk of poor countries are being pressured into
not making use of the mechanism. The USA has been pursuing a number of regional or
bilateral trade agreements that have in effect weakened the spirit of the Doha Declaration.
These are commonly referred to as TRIPS-plus agreements. 102 These have involved
negotiations to tighten the patent protection in areas already shown to be vastly affected by the
HIV/AIDS pandemic like the South African Customs Union and Central America. The most
severe of these was the now defunct Free Trade Agreement of the Americas (FTAA)
Agreement which includes 34 countries. Among the proposed measures were; limits on the
circumstances under compulsory licenses on pharmaceuticals may be issued; extension of the
patent terms beyond 20 years required by TRIPS which impacts on the generic industry; a
prohibition on the export of drugs produced under compulsory license, and exclusive rights on
pharmaceutical test data, which would delay the introduction of generics even when they are
no patents. 103
Other bilateral agreements 104 require the protection of data under a suis generis regime of data
exclusivity for at least 5 years from the date of 1st approval of first approval of a
pharmaceutical product in that country. Many of these agreements also put into place linkage
requirements so that without the consent and acquiescence of the patent owner, national health
authorities are prevented from granting marketing approval for a generic product as long as a
patent over the product is in force. 105 The implication of these agreements is quite significant
and may delay introduction of generic products even where compulsory licenses are issued. 106
Such bilateral agreements have been instrumental in erasing the flexibilities attained in the
Doha Declaration that were designed to protect public health and give developing countries
better access to essential medicines for their population. They are also contrary to paragraph 4
and 5 of the declaration, which as discussed interalia prohibits members from any action that
hinders other member’s rights to protect public health.

However, the concern that the Decision sets out burdensome procedural requirements 107 are
also legitimate. The importing country is required to first obtain a voluntary license from the

    Professor Abbott is a leading TRIPS expert who has been highly involved in advising developing
countries on their rights and obligations under the Agreement.
    TRIPS plus agreements are bilateral or multi-lateral agreement that go beyond the commitments that
were agreed under the multi lateral trade system governed by the WTO. Accessed from “TRIPS –plus
through the back door, How bilateral treaties impose much stronger rules for IPRS than the WTO. last accessed 10 August 2006.
    ---“One step Forward two steps back? Issues for the 5th WTO Ministerial Conference (Cancun 2003)
Campaign for Access to Essential Medicines, Medicins San Frotieres Briefing Note August 2003.
    The USA has signed bilateral agreements with Australia, the Central American Colonies , Chile Jordan
and Mexico.
    Carlos M Correa, ‘Implementation of the WTO General Council Decision on the TRIPS Agreement and
Public Health,’ Essential Drugs and Medicines Policy 2004 at 7.
    This because under the Data exclusivity terms, if a compulsory license were to be granted in a country to
import a pharmaceutical product a generic company would have to develop all on its own all the test data as
required for approval. This is a very lengthy, costly duplicative and wasteful process given that the data
have already been generated by a brand name company and will create an enormous obstacle to the use of
the decision. Moreover this linkage between patent protection and marketing approval seem to create an
almost insurmountable barrier to the execution of a compulsory license or government non-commercial use
since the compulsory license or government would be authorised to use the patented invention but not to
obtain the regulatory approval to make it available.
    Medicins San Frontiers, Oxfam, Oxfam Briefing Paper supra also see Duncan Mathews, ‘Is History
repeating itself, the outcome of the negotiations on Access to Medicines, the HIV/AIDS Pandemic and
Intellectual Property Rights in the World Trade Organisation, ’Law Social Justice and Global Development
Journal 2004 (1) accessed from

patent holder on reasonable commercial terms for a reasonable period. If this is not possible the
importing country must then assess its generic industry’s capacity to produce the medicine
locally, and if capacity is deemed insufficient, then notify the WTO with a detailed justification
of its decision. The importing country must then notify a potential importer, who in turn seeks
a voluntary license and failing that, must seek a compulsory license from its own government
on a single country basis with compensation payable in the importing country. 108

I think that none of the problems on its own is conclusive. While Professor Abott also has a
point that the pressure being imposed on developing countries is a major deterrent to the use of
Doha Declaration, it is also true that the decision in its current format is extremely
burdensome. In my opinion, however both these factors are of equal importance in leading to
the abysmal implementation of the Doha Declaration.

In pursuing technical assistance to less developed countries, some wealthy member states have
done their best to frustrate the spirit of the Doha Declaration by providing technical support
that ignores the flexibilities of the Doha Declaration and instead focusing on enhanced IP
protection. For example the US Agency for International Development (USAID) has been
funding the Commerce department of Nigeria in providing it with technical assistance to re-
write its patent laws. The draft legislation demands far more stringent measures than are
required by TRIPS Agreement. These even go as far as criminalisation of patent infringements
all of which send a strong message discouraging Nigerians from trying to access affordable
generic drugs. 109 MSF has also produced a comprehensive document detailing the lukewarm
response the World Intellectual Property Organisation (WIPO) in incorporating the Doha
Declaration in its technical assistance despite being charged with providing technical assistance
on IP matters worldwide. 110

Paradoxically there has been increasing pressure put on the countries that want to join the
WTO to adopt measures that contravene the spirit of the Doha Declaration. The case of
Cambodia is a classic example. 111 Hailed for its proactive legislation that excluded
pharmaceutical patents till 2016, it totally changed tack as a result of closed door negotiations
for its ascension to the WTO. Under pressure from the USA, Cambodia has evidently agreed to
implement TRIPS earlier in 2007, while immediately linking drug registration approval with
patent status and granting 5 years of data exclusivity which measures will invariable hinder or
delay generic availability and thus increase and cause a massive reduction in access to essential

There is another category of initiatives that although were not categorically stated in the Doha
Declaration have arisen as a result of an improved focus on public health over IP rights. These
initiatives will be examined below in order to evaluate their success.
3.1 Pharmaceutical Companies initiatives; A large number of pharmaceutical firms have
together with international organisations worked under the auspices of specific programmes to
deliver patented ARV’s at negotiated prices through the Accelerated Access Initiative (AAI)
which brings together 6 organisations from the United Nations and 6 large pharmaceutical

    See Implementation Agreement of Paragraph 6 para 2-4 (2003)
    Michael Schroeder, ‘Drugs patents draw scrutiny as Bush makes African visit,’ The Wall Street Journal
9 July 2003.
    For more information on the shortcomings of WIPO technical assistance, see MSF Consumer Report on
the Implementation of the Doha Declaration on the TRIPS Agreement and Public Health. Technical
Assistance – How to get it Right.” March 2002. <>
    MSF press release supra note 135 at 2.

companies into programmes targeting the countries of the south. 112 Some pharmaceutical
companies have also initiated programs where they supply free HIV drugs. 113 However these
programs have not proved very successful, for instance since 2000 only 2 African countries
(Uganda and Botswana) have accepted an offer by a German pharmaceutical company
Boehringer Ingelheim to provide free donations of nevaripine and anti retroviral drug which is
designed to stop the transfer of HIV from mothers to unborn babies. 114 In South Africa for
instance, the government had to be taken to court in order for it to accept free stockpiles of this
The very legitimacy of this initiative is in doubt due to its low appeal and also due to the fact
that by the 2002, 2 years after its conception, it had only resulted in getting an additional 0.1%
of people with AIDS on treatment. The initiative seems to have left a legacy of discrimination
between recipient countries, market fixing and in many instances stopping the rise of generic
industries by offering conditionalities to the discounted drugs which invariably ends up
frustrating the very objective of making drugs easier to access and more affordable. 115 Such
programs also have the added disadvantage of only having the capacity to treat a small number
of patients in comparison with the existing needs. 116
This initiative however still remains welcome because the pharmaceutical industry is such an
integral part of the IP debate and any attempts made at getting it to recognise the plight of the
victims of IP rights is a welcome step. However it goes without saying that, such initiatives
need to be expanded and have better participation from all the stakeholders. The challenge in
making these initiatives work is for WHO to take a firm stand in not allowing any agreements
unless they can guarantee transparent negotiations that are beneficial to the developing

3.2 The Global Fund; The Global fund to Fight AIDS, tuberculosis and Malaria was set up in
2001 to provide resources in order to eradicate these 3 diseases in the developing world. 117
This fund has been highly instrumental in the fight against HIV/AIDS by providing ARV’s to
around 1.8 million people and counselling services. 118 However in order to be truly effective
the Fund needs more resources from its donors. It is currently suffering a shortfall of 18 billion
US dollars 119 which will invariably affect its programs in the future. However, far more serious
are the concerns on whether the poor countries will have the capacity to absorb the new found
resources from the fund. 120 Facing a shortage of health care workers and basic infrastructure
these countries makes these countries hard pressed to make effective use of increased supplies

    Coriat, Dumoulin, Antione Flori, Barnett, Souteyrand, Maotti, (2003) ‘Patents, Generic Dru
    Hans P Biswinger, ‘Public Health for HIV/AIDS, treatment for Millions’ Health Gap Centre Vol 292, No
512 13 April 2001 pp 221- 233.
    Duncan supra note 135 at 98.
    For a critique of the Initiative see Act up Paris, “Accelerating Access” Serves Pharmaceutical
Companies while Corrupting Health Organisations.’ Available at
    Coriat, Dumoulin supra note 8 at 35.
    The Global Fund to Fight AIDS, Tuberculosis and Malaria
    Supra note 147 Global Fund fact page
    The funding gap would jeopardise the aim of providing of ARVS TO 75% of individuals qualified to
receive these medicines in 2008. This is approximately 6.6 million people. UNAIDS Report released at the
15th International Conference June 2006
    __________ ‘Global Fund to fight AIDS, TB and Malaria has advanced key areas but difficulties
remain,’ Global Health GAO-03-601 accessed from last
accessed 20 August 2006.

of medicines and other inputs for the prevention and treatment of these diseases. 121 It is my
view that in order for the Global Fund to become truly effective it must go above merely
looking at the national health capacity and whether funds can be handled effectively and
instead provide support for the expansion and modernisation of the health sector through
training and investment. Furthermore the Fund needs to have stricter controls of ensuring that
the funds reach their recipients. The recent judicial inquiry into the Global Fund activities in
Uganda for instance declared that there was gross misuse of the funds by many public health
officials and government officials. 122

4.0 Recommendations
Having seen the magnitude of inadequacies that the current framework has in providing
essential drugs to people in developing countries, there is a need to examine what can be done
both policy wise and legally in order to have better and improved access to HIV/AIDS drugs.
There is a need to adapt national patent legislation to take advantage of the flexibilities in
TRIPS and the Doha Declaration. This will entail Least Developed Countries resisting the
pressure of enforcing or providing patents on pharmaceutical products until 2016 in the
interests of protecting public health. The implementation of the decision through appropriate
amendments to national laws is a necessity and should not be regarded as a matter of mere
convenience or political choice. The decision creates international obligations that must be
complied with in good faith. 123

In order for developing countries to improve public health and increase on the supply and
availability of generic drugs, it will be crucial that they get increased public funding.
International Institutions like the IMF and the World Bank can play a pivotal role not only in
granting this funding but in providing the expertise to make sure that it is utilised
effectively. 124 Assistance in improving capacity to address public health is within the World
Banks mandate although at the moment it has not been given priority. 125 The IMF at the
moment already plays an instrumental role in the determination of developing countries health
policies as it aids in the development and implementation of national budgets. 126 Thus it is
imperative that these institutions, not only alter their policies that have hindered the growth of
the public health sector (i.e. privatisation) 127 but also actively expand their roles in order to
effectively give developing countries the support that they so critically need.

As discussed earlier, pharmaceutical companies must be an integral part to any attempt to solve
issues of access to medicines as they are key players. These companies ought to ensure that
their patent policies, practice and lobbying are compatible with the Doha Declaration and the
major governments of the North especially the US government must adapt all its intellectual
property enforcement policies accordingly. This means respecting the rights of governments to
use the TRIPS health safeguards especially those mandated by the Doha Declaration.

    CRS Global Report for Congress; The Global Fund to Fight AIDS, Tuberculosis and Malaria: Back
ground and current issues. Received through CRS WEB
    __________ Uganda: Misuse of funds as global fund inquiry quizzes ministers,’ IRIN (24 March 2006)
available at http://www.aegis/com/news/irin.2006/IR060372.html last accessed 20 August 2006.
    See earlier discussion on the legality of the declaration, see also Vienna Convention on the Law of
Treaties (Article 26)
    Fredrick Abott supra note 65 at 477
    See World Bank Development Report 2002.
    See Description of IMF activities at
    Privatisation is part of the Structural Adjustment Programs being forwarded by the World Bank and the
IMF. For more information see home pages for both organisations.

The pharmaceutical industry should also perform its corporate responsibility and respond to the
growing public concern about the accountability and the social and economic impact of its
comparatively high- priced drugs and corporate policies. This can be done through safe guards
like signing up to the UN Global Compact. 128 Although the pharmaceutical company has made
a head start in participating in the Access Initiative, this is not commensurate with the profit
that it earns. 129 The pharmaceutical industry can and should play a greater role in addressing
the deeply unequal or asymmetrical access to essential drugs between the rich and the poor. 130

Countries should also consider legally challenging pharmaceutical companies that show
reluctance towards granting TRIPS flexibilities in the interests of public health pursuant to the
Doha Declaration. For instance Article 31 k gives country’s the right to compulsory licenses
due to abusive prices or non working of the patent. The South African example is a good
example of the efficacy that legal challenges have. In 2003, for instance the South African
Competition Commission announced a finding upholding a complaint by the Treatment Action
Campaign and others against two pharmaceutical companies Glaxo Smith Kline South Africa
and Boehringer Ingelheim holding that both companies had charged excessive prices for their
patent-protected anti-retroviral medicines. The ruling further held that they had both unlawfully
failed to issue voluntary licenses to generic competitors and that they had thereby unreasonably
restricted access to an essential facility preventing production of fixed dose combination
medicine. 131 In response to this ruling both companies voluntarily changed their policies and
announced voluntary licensing agreements. These agreements are essential not only to set clear
precedent that the right to public health first and IP rights second, but also in improving access
to essential HIV/AIDS medicines.

In order to find an expedient and lasting solution to the limited use of the compulsory licensing
tool, substantial attention must be paid to putting into place an adequate legal infrastructure.
For many members who have just changed their laws in order to be TRIPS compliant, this will
represent a major challenge. It will also require the introduction or updating of administrative
or judicial structures and procedures. Sound technical assistance will be crucial in achieving
workable health policies and establish workable law procedures and practices which will make
the Doha Declaration truly effective. A cue can be taken from the European Community which
committed itself to providing technical assistance if requested. This was a welcome provision
in that it reiterated the case for appropriate technical assistance. However, in this regard
developing countries will need to seek and gain more assistance from other sources such as
UNCTAD, WHO, and NGO’s sympathetic to their interests.132 Additionally developing
countries can emulate South Africa’s example and make competition policy an integral part of

    The UN Global Compact (December 2004) is an initiative between companies and the United Nations
and lists ten principles that ensure that companies work in a manner conducive to human rights, labour,
environment and anti corruption tendecies.
    See commentary interalia on the profitability of the pharmaceutical industry.
    Hoechan Sun supra 39 at p 150
    Although the fixed dose combination has been recommended by the WHO as a first line therapy in poor
settings, drug companies do not make them the most effective ARV combinations because patents on the
different medicines are held by different countries and they are unwilling to cross license medicines with
competitors. This refusal has negative implications on AIDS sufferers as it increases the patients pill
burden and also complicates the patients compliance with complex pill taking schedules. See generally
WHO Scaling an antiretroviral therapy in resource-limited settings: Treatment guidelines for a public
health approach, 9-13 (Dec 2003) WHO and UNAIDS , Treating 3 Million people by 2005: Making it
Happen- The WHO Strategy (Dec 2003)
    Abbott supra 55 at 499

their patent laws. As the South African Commission case discussed above reveals an
effectively used competition policy can prove instrumental in countries efforts to access to
essential drugs.

In addressing the issue of compulsory licensing paragraph 6 is noticeably silent on whether
only essential medicines can be the subject of compulsory licenses or whether this can also be
applicable to other health care products for instance diagnostic kits. The delivery of complex
ARV regimens requires that drugs be complemented by sophisticated health cares systems
which need proper equipment for testing. It is therefore imperative that the Doha Declaration
be given a broader scope to include diagnostic and testing equipment all of which make the
delivery of essential drugs to those who need them more effective.

The comparative lack of resources among developing countries is a systemic and persistent
problem. The United States and European Union each maintain local operations with the
capacity to develop and track policy operations in multiple fora. 133 Many countries missions in
Geneva have delegations comprising of only a few individuals who not only attend to WTO
matters but invariably to matters at other international institutions. Adequate staff is necessary
in order to man often protracted talks in the World Trade Organisation. 134 Although the
Geneva Capacity Problem is widely recognised, only a few members such as Norway and the
Netherlands have provided much needed funding to assist in the formulation of developing
countries policy papers and for the organisation of fora where developing countries may
exchange views. 135 The assistance which provides systematic coordination was highly
instrumental in the success of Doha but far more support is necessary if developing countries
are to act in a unified manner in order to address the remaining serious concerns that
developing countries continue to have about the Doha Declaration and the TRIPS Agreement.

International collaboration should be strengthened in order to address the HIV/AIDS crisis as a
global issue. The WTO should cooperate with other relevant international organisations and
NGO’s. The cooperation should encourage states to make constructive dialogue on how to
successfully implement the Doha Declaration in line with their human rights obligations.
Additionally it should inspire the engagement and participation of civil society for the sake of
fostering public scrutiny. The role of NGO’s who have an honest commitment to the plight of
developing countries cannot be underestimated. These organisations for instance played a
pivotal role in organising the massive negative publicity in the South African Medicines that
ended in the withdrawal of the case by the pharmaceutical companies. 136

Domestically, developing countries should also play their part by considering the removal of
import tariffs on essential medicines. The American Institute for Public Policy Research has
measured that on average the prices of essential medicines is raised by 30 percent because of
import tariffs for essential medicines and essential medicinal products like bandages and the

    The United States for instance has 70 full time staff in the Geneva Office who represent its’ interests in
the World Trade Organisation. Uganda has 4 in comparison who not only represent it in the World Trade
Organisation but also in the United Nations. Interview with the Ambassador of Uganda to Geneva 16
October 2004 on sanitary and phytosanitary measures in the World Trade Organisation, a developing
countries perspective.
    In this regard the Quaker United Nations Office (QUNO) has actively provided logistical support for the
developing country delegations.
    See interalia discussion on South Africa’s Medicines Act 1997.

raw materials for drug production. 137 Although the onus is on individual countries to exercise
their sovereignty by raising revenue as they see fit, it the high tariffs in many countries
invariably affect the price of essential medicines and therefore its access to the most vulnerable
people who need it the most. For example although India is often hailed as a purveyor of
cheap generic drugs abroad, high tariffs at home limit patient access to critical drugs made by
foreign manufacturers. This has led to a situation where only 35 percent of the Indian
population have access to essential medicines and far less have access to domestically
produced copy cat versions of ARV’S for HIV. 138 Considering that the Global Fund estimates
that as many as 8.5 million Indians could have AIDS this risks being a dire situation. 139

All attempts at any end in the temporary ban on non-violation complaints should be
strenuously rejected as their existence can significantly constrain members’ abilities to
introduce new and perhaps vital social, economic and health and cultural measures that might
be construed as denying ill-defined benefits under the TRIPS Agreement. 140 This would be
extremely detrimental to countries that would like to make changes to their legislation in order
to embrace the mechanisms allowed in the production of essential drugs by the Doha

4.1 Proposed Changes in the law
There is a need to challenge bilateral and regional agreements that threaten to erode the spirit
of public health as overriding that of intellectual property. This can be done in several ways;
The Doha Declaration was a clear expression by Ministerial Council and WTO members of the
right to protect the health of their citizens. 141 This right should be given by the members and
the Dispute Resolution Body. 142 I agree with UN Human Rights Organs in their assessment
that regional and bilateral TRIPS plus agreements have provisions that might impede access to
the right to protect public health and this should be put to the test through bodies like the WTO
Committee on Regional Trade Agreements.

Another approach might be to consider a review for consistency with the most favoured nation
treatment provision of the TRIPS Agreement in order to ascertain whether there might be a
claim of a defacto discrimination against generic pharmaceutical exporters.143 Although the
WTO Appellate body has little precedent of applying the Most Favoured Nation to intellectual

    Roger Bate Richard Tren and Jason Urbech, “Taxed to Death,” Working Paper, AEI Brookings Joint
Centre, Washington DC, 2005 available at
    Roger Bate, Richard Tren, “The WTO and Access to Essential Medicines: Recent Agreements, New
Assignments,’ American Enterprise Institute for Public Policy Research No 4 2006.
    UNAIDS, 2004 Report on the Global AIDS Epidemic, (Geneva UNAIDS, 2004) available at accessed 13 June 2006.
    See Abott, ‘Non Violation Nullification or Impairment Causes of Action under the TRIPS Agreement
and the Fifth Ministerial Conference.’ Occasional Paper No 11 July 2003, Quaker United Nations Office
available at
    Doha Declaration supra note at para 4.
    It has been suggested that the statement in the Doha Declaration does not import a right to health in the
WTO legal system and that in any case the nature of the “right to health” is complex and not well settled.
As to the first point the Doha Declaration speaks for itself and the Appellate body continously stresses that
the words of WTO texts are there for a purpose. As to the second point, neither of the trade terms “national
treatment” and “most favoured treatment” is self defining but that has not prevented the WTO Appellate
body from giving them meaning. Adapted from FM Abott, ‘The WTO Medicines Decision: World
Pharmaceutical Trade and the Protection of Public Health,’ The American Journal of International Law
Vol 99.317 at 356.
    Id at 357.

property rights, it might be worth exploring whether some developing countries generic
producers may be suffering defacto MFN discrimination by granting preference to a few to
originator companies based in a few WTO countries. 144 Thus rules regarding the assessment of
pharmaceutical products might also be reviewed for consistency with the Agreement on
Technical Barriers to Trades which is aimed at ensuring that technical regulations do not create
unnecessary obstacles to International trade.

The issue of adequate remuneration needs clarification. Compulsory licenses are supposed to
be granted to protect public health. The licensee who usually issues the compulsory license
more often than not can’t afford to buy drugs from western pharmaceutical companies, bearing
these circumstances in mind; the WTO must amend the TRIPS Agreement to clearly define
what amounts to adequate remuneration. If compulsory licenses are going to be effective to the
developing countries who need them the most, remuneration should not be prohibitive.

Realistically, it would be very hard to make these changes in the law because as illustrated in
the course of this thesis, any attempts to lower patent protection has met with strenuous
objections from the more developed countries in the North. In order to make any of the above
changes whether policy wise or legally, their must be a real political will from both developing
countries and their developed counterparts. 145 Bad politics is often as lethal as a lack of access
to essential medicines. Take the case of South Africa where as late as 1999, the president was
disclaiming the link between HIV and AIDS and the Health Minister was advocating that
people with HIV/AIDS eat sweet potatoes and use local remedies. 146 In this time the HIV
prevalence rate increased fifteen fold making South Africa the most infected nation worldwide
with 4.5 million people. 147 Uganda, on the other hand, an even poorer developing country has
had a remarkable decline in prevalence rates for HIV/AIDS because of the government’s
proactive role. 148

Furthermore developing countries should remember the advantages of working together as one.
The eventual adoption of a declaration on Public Health and TRIPS was the outcome of a
carefully orchestrated strategy by developing countries. 149 For the first time countries led by
the African group had come together to speak with one voice on issue that affected all of them.
Developing Countries should take to heart the lesson learnt in the run up to Doha, it is true that
they are not as powerful or as rich as their more developed counterparts, however when they
work together as a single unit, they can gain significant concessions in the Multi lateral trading

5.0 Conclusion
The Doha Declaration was a step in the right direction, it is true that patents are immensely
important, that they spur innovation and promote industry, however where there is a clear
public health crisis like that of HIV/AIDS it would be criminal to stand by and let the minority
rights of pharmaceutical companies subsume the rights of the majority.

    Also see the tension between developed countries who agree with the spirit of Doha but in turn sign
bilateral and multilateral agreements which go back on the developments made in the Doha Declaration.
    See Mary Beth Walker, ‘Assessing the Barriers to Universal Antiretroviral treatment access for
HIV/AIDS in South Africa,’ 15 Duke J Comp and Int’L Law 193,
    Figures are from Human Sciences Research Council’s Study on HIV/AIDS , December 2002, which puts HIV prevalence rates at 16 percent and total prevalence rates at 11 percent.
    See Uganda AIDS Commission, ;Uganda’s HIV/AIDS success story or myth?’ available at last accessed 12 August 2006.
    See Drahos supra note ------

More importantly so it is important that the spirit of Doha be preserved and that the
implementation decisions there-under be applied in good faith. I end with an apt quote from
Fredrick Abbott, 150
        It appears to be the natural order of things that some are better off than others. Indeed
        unwillingness to drive a hard bargain and let the chips fall where they may could be
        taken as a lack of strength. With that said, the North is perilously close to standing by
        while more than 30 million people die prematurely from HIV/AIDS and its
        complications. The danger is clear and present. The disease can be controlled with
        existing medicines. We will not be able to say in hindsight, ‘If only we had known.’
Changes must be made in the multi lateral framework in order to make it easier for developing
countries to utilise the flexibilities necessary to provide essential drugs, developed must also
desist from preventing these countries from doing so. The above recommendations on policy
and legal changes will be vital in order to provide essential ARV’s that are so crucial in the
fight against HIV/AIDS.

      Fredrick M Abott (2002) Doha and the TRIPS Agreement and Public Health,’ JIEL 505

Appendix A Regional Statistics for HIV/AIDS at the end of 2006
     Region          Adults and       New infections Adult (15-49)       Deaths adults and
                   Children living      Adults and      Prevalence*          children
                     with AIDS           Children
Africa               24.7 million       2.8 million        5.9%                2.1million
North Africa and
Middle East            460,000            68,000           0.20%                 36,000
Asia                  7.8 million        860,000           0.60%                590,000
Oceania                81,000             7,100            0.40%                 4,000
Latin America
                      1.7 million        140,000           0.50%                 65,000
                       250,000            27,000           1.20%                 19,000
Eastern Europe
and Central Asia
                      1.7 million        270,000           0.90%                 84,000
North America
Western        &
Central Europe
                      2.1 million         67,000           1.1%                  30,000
Global Total         38.6 million       4.1 million        1.00%               2.8 million
*Proportion of adults aged 15-49 who were living with HIV/AIDS
Figures in millions
Source UNAIDS Global Facts and Figures 2006.

Appendix B: HIV/AIDS Prevalence rates
                                              Estimate         Range
People leaving with HIV/AIDS in
2005                                      38.6 million       4-4.6 million
Adults leaving with HIV/AIDS in 2005      36.3 million      4-4.34 million
Women living with HIV/AIDS in 2005        17.3 million     14.8-20.6 million
Children leaving with HIV/AIDS in
2005                                         2.3 million    1.7-3.5 million
People newly infected with HIV/AIDS
in 2005                                      4.1 million    3.4-6.2 million
AIDS deaths in 2005                  2.8 million     2.4-3.3 million
Figure from UNAIDS/WHO 2006 Report on the global AIDS epidemic

Sophisticated    Innovative     Reproductive        Reproductive        No
Pharmaceutical   Capability     Capabilities-       Capabilities-       Pharmaceutical
Industry and                    Active              Finished Products   Industry
Research base                   Ingredients and     from Imported
                                Finished products   Ingredients only
    Belgium       Argentina         Bahamas            Afghanistan        Andorra
                                                                         Antigua and
    France         Australia         Bolivia             Albania          Barbuda
   Germany         Austria            Brazil              Algeria           Aruba
     Italy         Canada            Bulgaria             Angola           Bahrain
    Japan           China             Cuba             Bangladesh          Bermuda
  Netherlands      Denmark       Czechoslovakia         Barbados            Bhutan
    Sweden         Finland            Egypt               Belize          Botswana
                                                                         British Virgin
  Switzerland      Hungary          Indonesia             Benin             Islands
United Kingdom       India        Macau China       Brunei Darussalem    Burkina Faso
 United States     Ireland           Norway             Cambodia           Burundi
                                                                        Central African
                    Israel           Poland             Cameroon          Republic
                 Korea Rep Of      Puerto Rico         Cape Verde            Chad
                   Mexico           Romania                Chile           Comoros
                    Spain            Turkey             Colombia            Congo
                    USSR                               Costa Rica        Cook Islands
                  Yugoslavia                           Cote d’Ivoire       Djibouti
                                                         Cyprus            Dominica

                                                    Democratic Rep Of     Equatorial
                                                        Korea              Guinea
                                                     Dominican Rep      Faeroe Islands
                                                         Ecuador        French Guyana
                                                       El Salvador         Polynesia
                                                         Ethiopia           Gabon
                                                        Fiji Islands      Greenland
                                                         Gambia            Grenada
                                                          Ghana          Guadeloupe
                                                         Greece             Guam
                                                       Guatemala           Guinea
                                                         Guyana         Guinea Bissau
                                                           Haiti           Iceland

                                                                         Lao People’s
                                                        Honduras          Dem Rep
                                                                         Libyan Arab
                                                    Hong Kong China         Jamah
                                                           Iran          Liechtenstein

Sophisticated    Innovative   Reproductive        Reproductive        No
Pharmaceutical   Capability   Capabilities-       Capabilities-       Pharmaceutical
Industry and                  Active              Finished Products   Industry
Research base                 Ingredients and     from Imported
                              Finished products   Ingredients only
                                                         Iraq           Luxemburg
                                                       Jamaica           Maldives
                                                       Jordan           Martinique
                                                        Kenya         New Columbia
                                                       Kiribati            Niue
                                                       Kuwait             Oman
                                                      Lebanon             Qatar
                                                      Malaysia           Reunion
                                                         Mali            Rwanda
                                                                        St Kitts and
                                                        Malta              Nevis
                                                      Mauritius          St Lucia
                                                                        St Vincent-
                                                      Mongolia          Grenadines
                                                      Morocco             Samoa
                                                     Mozambique        San Marino
                                                                      Sao Tome and
                                                      Myanmar           Principe
                                                       Namibia           Senegal
                                                        Nepal           Suriname
                                                    New Zealand         Swaziland
                                                      Nicaragua            Togo
                                                        Niger             Tuvalu
                                                                       United States
                                                       Nigeria         Virgin Island
                                                      Pakistan           Vanuatu
                                                       Panama         Western Samoa
                                                  Papua New Guinea
                                                     Saudi Arabia
                                                     Sierra Leone
                                                   Solomon Islands
                                                     South Africa

 Sophisticated     Innovative   Reproductive        Reproductive        No
 Pharmaceutical    Capability   Capabilities-       Capabilities-       Pharmaceutical
 Industry and                   Active              Finished Products   Industry
 Research base                  Ingredients and     from Imported
                                Finished products   Ingredients only
                                                        Sri Lanka
                                                     Syrian Arab Rep
                                                       Taipei China
                                                       Trinidad and

                                                       United Arab
                                                      United Rep of

Source: Balance et al (1992)
Appendix C


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