BEYOND DOHA: SEEKING ACCESS TO ESSENTIAL MEDICINES FOR SHARIFAH RAHMA SEKALALA
BEYOND DOHA: SEEKING ACCESS TO ESSENTIAL MEDICINES FOR
HIV/AIDS THROUGH THE WORLD TRADE ORGANISATION
SHARIFAH RAHMA SEKALALA
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.
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.
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.
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
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.
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
that research develop and produce patented medicines.
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.
With the absence of competition, the patentee is able to set higher prices during the period of protection.
Although these tensions existed at the signing of the TRIPS
Agreement, they were brought to the forefront by the HIV/AIDS epidemic.
1
PhD Candidate University of Warwick School of Law.
2
WTO, ‘What is the World Trade Organisation,’ Available at http://www.wto.org/english/thewto-
3 e/whatis_e/tif_e/fact1_e.html last accessed 3 March 2008.
4
Id.
WTO, ‘Overview of the TRIPS Agreement,’ A more detailed overview of the TRIPS Agreement available
5 at http://wto.org/english/tratop_e/trips/e/intel_ehtml 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
6 way of doing things.
Philip McCalman, ‘ The Doha Agenda and Intellectual Property Rights,’ A study on Regional Integration
7 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
8
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: I nfectious Diseases and Access to Essential Medicines , Sub Group Access to Essential
9
Medicines. (2003)
10
Chien, ‘ Cheap Drugs at what price to innovation: Does compulsory licensing hurt innovation?’ at p 1.
Id
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.
The number of people with HIV has continued to rise with Africa remaining the global epidemic centre.
(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.
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.
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.
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.
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.
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.
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.
11
UNAIDS Report on the Global AIDS pandemic ; A UNAIDS 10 th
Summary Edition Executive Summary at p6.
12
Id.
13
Global Fund; The Status and Impact of the three diseases, accessible at http://wwwtheglobalfund.org/EN last accessed 20 August 2006.
14
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.
15
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.
16
17
See Article 12 of the International Covenant on Economic Social and Cultural Rights (1966)
See the 54 th
World Health Assembly Agenda Item 13.6 Scaling Up the Response to HIV/AIDS
WHA54.10, 21 May 2001.
18
Political Declaration on HIV/AIDS 60/262 Resolution adopted by the UN General Assembly 15 June
2006 accessible from http:/data.unaids.org/pub/Report/2006 last accessed on the 20 August 2006.
2
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
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.
Antiretroviral treatment is the difference between life and death for the millions of people who are HIV positive.
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.
The AIDS pandemic drew attention to the fact that many developing countries cannot afford expensive medicines and yet neither can they produce cheaper generic
versions.
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,
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
and that in Africa 37 out of 53 countries have patents on the most popular anti retroviral
combination.
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.
19
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 http://www.who.int/medicines/organisationood/techcoo.shtml last accessed 12 June 2006.
20
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.
21
Since April 2002, the WHO has recognised ARV drugs as essential medicines. WHO, ’12 Model list of
Essential Medicines’ April 2002
22
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<http://www.who.int/hiv/pub/arv/who_hiv_2002_24.pdf> (Dec 20002) See Jane Glavao, ‘Access to antiretrovirals in Brazil’ <http://image.thelancet.com/extras/01art9038web.pdf> (Nov 5, 2002)
23
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.
24
25
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
26
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)
27
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.
3
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.
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.
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.
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.
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)
which allowed compulsory licensing and parallel importing as being incompatible with the TRIPS Agreement.
The USA also put pressure on the South African government.
The matter was never determined by
28
Henry and Lexchin, ‘ The Pharmaceutical Industry as a Medicines Provider,’ at 1590.
29
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.
30
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.
31
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.
32
Sec. 15 c) gave the health Minister broad powers to issue compulsory licenses and allow parallel importing.
33
34
Case No 4138/98 in the High Court of South Africa.
The US Public Law 105-277 (105 th
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
4
court due to an avalanche of negative publicity and the pharmaceutical companies dropped their lawsuit in April 2001.
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.
Brazil had at the time initiated a highly successful
HIV/AIDS treatment program using generic ARV’s which it provided free of charge.
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.
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.
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.
In the USA, the Bush administration threatened to do the same but this ended with a compromise arrangement with
Bayer.
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.
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.”
35
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.
36
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 www.wto.org.
37
Avin Sarna, (2003) ‘A profile of the new AIDS epidemic in Brazil and its impact on the new AIDS policy,’ accessed from http://www.gwu.edu/srcich/sarna.pdf
38
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.
39
Ed Lake, ‘ Analysing the Anthrax Attacks,’ The 1 st
3 attacks, Commentary and Analysis Barnes and
Noble.com 2005 p 1.
40
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.
41
Bradsher and Andrews, ‘ US says Bayer will cut the cost of its anthrax drug .’ New York Times 24
October 2001.
42
Haoechen Sun, ‘ The Road to Doha and Beyond; Some reflections on the TRIPS Agreement and Public
Health,’ EJIL (2004) Vol 15 No 123-150
5
claiming a national emergency when they were no actual cases of anthrax in Canada at the time.
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.
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.
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.
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.
The resulting meeting provoked strong contrary reactions by the USA
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
which put health before commercial interests and offered a much needed clarification in the field of TRIPS and
Public Health.
The negotiations focused on the access to medicines in relationship with patent rights and focused extensively on the devastating AIDS situation especially in Africa.
43
Dyer and Michaels,’ Anthrax scare raises awkward Patent questions ,’ Financial Times October 2001
44
Haochen Sun id 134
45
WTO News, ‘ Governments share Interpretations on TRIPS and Public Health,’ TRIPS Council
Wednesday 20 June 2001 accessed from http://www.wto.org/English/news/etrips_drugs_010620_htm last accessed 20 August 2006.
46
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
47
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
Venezuela.
48
US Statement at TRIPS Council Meeting, June 20 2001, <http://listsessential.org/pharmpolicy/2001-
June/001175.html>
49
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.
50
Ellen F. M Hoen, ‘ TRIPS, Pharmaceutical Patents and Access to Essential Medicines, Seattle, Doha and
Beyond.’ Pp 13-24.
51
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.
6
2.1 Scope of the Declaration
The opening paragraphs of the Declaration describe the chief concerns of the developing and developed countries
, 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)
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.”
This was essentially a balance between the fundamental objectives of the Agreement; intellectual property and other broader policy objectives like public health.
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.
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.
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
52
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.
53
54
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.
55
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.
56
57
Id at 62
Paragraph 4 of the Doha Declaration.
7
“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.
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.
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.
Thus members should restrain from any action that hinders the exercise of such rights by Members especially LDCs.
In paragraph 5, the Declaration lays out the key measures and flexibilities
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.
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.
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.
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.
Before the declaration came into force, there were a number of tests that had to be satisfied before a compulsory license could be granted.
These were also accompanied by certain procedural safeguards which had to be satisfied before such licenses were issued.
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
58
Carlos M Correa, ‘Implications of the Doha Declaration on the TRIPS Agreement and Public Health,’
World Health Organisation Publications June 2002.
59
Id at 12.
60
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
61
62
See Correa Id at 12.
63
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.
64
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.
65
66
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
67
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
I)
68
Section II.2 B.2 TRIPS Agreement.
8
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.
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.
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.
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.
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.
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.
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
69
Sandra Bartlet, ‘T he TRIPS Agreement and Public Health ,’ JWIP Vol 3 (2003)
70
TRIPS, Article 31 (b)
71
Alberto do Amaral Junior, ‘ Compulsory Licensing and Access to Medicines in Developing Countries, ’ at
10 SELA 2005 Panel 5: Poverty and the International Order
72
Henry and Lexchin ‘The Pharmaceutical Industry as Medicines Provider,’ Medicines Society and
Industry III at p 1592.
73
74
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.
9
provisions
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.
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.
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.
This was accompanied by the
Chairman’s statement
which was essential in order to gain the USA’s compliance.
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)
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.
This Agreement created a waiver to Article 31 of TRIPS which was supposed to be temporary pending an amendment which was achieved on the 6 th
of December 2005. The new amendment approved changes to the TRIPS Agreement making the August 30 th
decision permanent.
75
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 http://hrw.org/english/docs/2001/11/07/global3340.html last accessed 20 August 2006.
76
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.
77
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 debatable.
78
79
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.
80
The Agreement was accompanied by a Chairman’s statement that added further clarifications on the
Paragraph 6 Implementation Agreement. See Appendix F.
81
This in effect waives the decision under that article that states that production under compulsory licensing must be predominantly for the domestic market.
82
See Paragraph 6 Implementation Agreement 2003.
10
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.
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.
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
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)
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.
The paragraph 6 Implementation Agreement also introduces remuneration requirements which are not only difficult to calculate
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.
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
83
Article 31 b)
84
World Trade Organisation, “Proposal for a Decision on an Amendment to the TRIPS Agreement
(Geneva: World Trade Organisation, December 6, 2005) available at http://www.wto.org/English/news_e/news05_e/trips_decision_e.doc accessed 10 June 2006
85
See World Trade Organisation, Least Developed Countries at http://www.wto.org/english/thewto_e/whatis_e/tif_e/org7_e.(Nov 2003) last accessed 20 August 2006.
86
See Implementation Agreement;
87
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 http://www.worldbak.org/hiv_aids/docs last visited 20 August 2006.
88
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.
89
Id
11
needing to import generics because of incapacity of their pharmaceutical sector must actually prove and defend such assertions.
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.
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.
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.
90
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.
91
92
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 requirements.
93
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.
12
Ten Latin American countries
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.
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.
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.
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.
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.
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.
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.
94
The Andean Community which comprises of Peru, Bolivia, Columbia, Ecuador, Venezuela,) and
Argentina, Chile, Paraguay and Uruguay.
95
European Parliament Resolution on Access to Drugs for HIV/AIDS Victims in the Third World, 2001 OJ
(C 343) 300
96
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)
97
98
See Hoechun Sun supra 39 at p 145
PhRMA, WTO Doha Declaration Reaffirms Value of Intellectual Property Protection , 14 November
2001 available at www.phrma.org/mediaroom/pressreleases/14.11.2001.310.cfm.
99
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.
100
See Oxfam Briefing Paper, TRIPS and Public Health: The next battle (2002) 27 at 2.
13
Professor Abbott,
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.
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.
Other bilateral agreements
require the protection of data under a suis generis regime of data exclusivity for at least 5 years from the date of 1 st
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.
The implication of these agreements is quite significant and may delay introduction of generic products even where compulsory licenses are issued.
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
are also legitimate. The importing country is required to first obtain a voluntary license from the
101
Professor Abbott is a leading TRIPS expert who has been highly involved in advising developing countries on their rights and obligations under the Agreement.
102
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. http://www.grain.org/brenfargs_files/trips-plus_pdf last accessed 10 August 2006.
103
---“ One step Forward two steps back ? Issues for the 5 th
WTO Ministerial Conference (Cancun 2003)
Campaign for Access to Essential Medicines, Medicins San Frotieres Briefing Note August 2003.
104
The USA has signed bilateral agreements with Australia, the Central American Colonies , Chile Jordan and Mexico.
105
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.
106
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.
107
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 http://www2warwick.ac.uk/fac/soc/law/elj/2004_1_matthews/
14
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.
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 rewrite 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.
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.
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.
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 medicines.
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
108
See Implementation Agreement of Paragraph 6 para 2-4 (2003)
109
Michael Schroeder, ‘ Drugs patents draw scrutiny as Bush makes African visit,’ The Wall Street Journal
9 July 2003.
110
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. <www.accessmed-msf.org>
111
MSF press release supra note 135 at 2.
15
companies into programmes targeting the countries of the south.
Some pharmaceutical companies have also initiated programs where they supply free HIV drugs.
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.
In South Africa for instance, the government had to be taken to court in order for it to accept free stockpiles of this drug.
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.
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.
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 countries.
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.
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.
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
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.
Facing a shortage of health care workers and basic infrastructure these countries makes these countries hard pressed to make effective use of increased supplies
112
Coriat, Dumoulin, Antione Flori, Barnett, Souteyrand, Maotti, (2003) ‘Patents, Generic Dru
113
Hans P Biswinger, ‘ Public Health for HIV/AIDS, treatment for Millions’ Health Gap Centre Vol 292, No
512 13 April 2001 pp 221- 233.
114
115
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 http://www.actupparis.org/pdf/nord_sud/02_05_15Accele_Acc_ENG.pdf.
116
117
Coriat, Dumoulin supra note 8 at 35.
The Global Fund to Fight AIDS, Tuberculosis and Malaria http:www.globalfund.org/EN.
118
119
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
15 th
International Conference June 2006
120
__________ ‘Global Fund to fight AIDS, TB and Malaria has advanced key areas but difficulties remain,’ Global Health GAO-03-601 accessed from http://www.gao.gov/new.items/doc601.pdf last accessed 20 August 2006.
16
of medicines and other inputs for the prevention and treatment of these diseases.
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.
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.
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.
Assistance in improving capacity to address public health is within the World
Banks mandate although at the moment it has not been given priority.
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.
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)
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.
121
CRS Global Report for Congress; The Global Fund to Fight AIDS, Tuberculosis and Malaria: Back ground and current issues. Received through CRS WEB
122
__________ 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.
123
See earlier discussion on the legality of the declaration, see also Vienna Convention on the Law of
Treaties (Article 26)
124
125
Fredrick Abott supra note 65 at 477
See World Bank Development Report 2002.
126
See Description of IMF activities at http://wwwimf.org.
127
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.
17
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.
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.
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.
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.
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.
Additionally developing countries can emulate South Africa’s example and make competition policy an integral part of
128
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.
129
See commentary interalia on the profitability of the pharmaceutical industry.
130
Hoechan Sun supra 39 at p 150
131
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)
132
Abbott supra 55 at 499
18
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.
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.
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.
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.
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
133
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.
134
Id
135
In this regard the Quaker United Nations Office (QUNO) has actively provided logistical support for the developing country delegations.
136
See interalia discussion on South Africa’s Medicines Act 1997.
19
raw materials for drug production.
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.
Considering that the Global Fund estimates that as many as 8.5 million Indians could have AIDS this risks being a dire situation.
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.
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
Declaration.
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.
This right should be given by the members and the Dispute Resolution Body.
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.
Although the
WTO Appellate body has little precedent of applying the Most Favoured Nation to intellectual
137
Roger Bate Richard Tren and Jason Urbech, “Taxed to Death,” Working Paper, AEI Brookings Joint
Centre, Washington DC, 2005 available at http://aeil-brookings.org/publications/abstract.php?pid=930
138
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.
139
UNAIDS, 2004 Report on the Global AIDS Epidemic, (Geneva UNAIDS, 2004) available at http://www.unauds.org/bangkokreport.html accessed 13 June 2006.
140
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 http://www.quno.org
141
142
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.
143
I d at 357.
20
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.
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.
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.
In this time the HIV prevalence rate increased fifteen fold making South Africa the most infected nation worldwide with 4.5 million people.
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.
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.
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 system.
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.
144
Id
145
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.
146
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,
147
Figures are from Human Sciences Research Council’s Study on HIV/AIDS , December 2002, www.hsrc.ac.za which puts HIV prevalence rates at 16 percent and total prevalence rates at 11 percent.
148
See Uganda AIDS Commission, ;Uganda’s HIV/AIDS success story or myth?’ available at http://www.aids.uganfa.org/response/success/index.htm last accessed 12 August 2006.
149
See Drahos supra note ------
21
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,
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.
150
Fredrick M Abott (2002) Doha and the TRIPS Agreement and Public Health,’ JIEL 505
22
Appendixes
Appendix A Regional Statistics for HIV/AIDS at the end of 2006
Region Adults New infections
Children living with AIDS
Adults and
Children
Adult (15-49)
Prevalence*
Deaths adults and children
Sub-Saharan
Africa
24.7 million 2.8 million 5.9%
North Africa and
Middle East
460,000 68,000 0.20%
Asia
7.8 million 860,000 0.60%
Oceania
81,000 7,100 0.40%
Latin America
1.7 million 140,000 0.50%
Caribbean
250,000 27,000 1.20%
Eastern Europe and Central Asia
1.7 million
North America
Western &
Central Europe
2.1 million
Global Total
38.6 million
270,000
67,000
0.90%
1.1%
4.1 million 1.00%
*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
2.1million
36,000
590,000
4,000
65,000
19,000
84,000
30,000
2.8 million
23
Sophisticated
Pharmaceutical
Industry and
Research base
Innovative
Capability
Reproductive
Capabilities-
Active
Ingredients and
Finished products only
Reproductive
Capabilities-
Finished Products from Imported
Ingredients only
No
Pharmaceutical
Industry
Belgium Argentina Bahamas Afghanistan Andorra
France Australia Bolivia Albania
Antigua and
Barbuda
Germany Austria Brazil
Italy Canada Bulgaria
Algeria
Angola
Aruba
Bahrain
Netherlands Denmark Czechoslovakia Barbados Bhutan
Sweden Belize Botswana
Switzerland Hungary Indonesia Benin
British Virgin
Islands
United Kingdom
United States
India
Ireland
Macau China
Norway
Brunei Darussalem Burkina Faso
Cambodia Burundi
Cameroon
Central African
Republic Israel
Korea Rep Of
Mexico
Spain
Poland
Puerto Rico
Romania
Turkey
Cape Verde
Chile
Colombia
Chad
Comoros
Congo
USSR
Yugoslavia
Costa Rica
Cote d’Ivoire
Cyprus
Cook Islands
Djibouti
Dominica
Democratic Rep Of
Korea
Dominican Rep
Ecuador
El Salvador
Ethiopia
Fiji Islands
Gambia
Ghana
Greece
Guatemala
Guyana
Haiti
Equatorial
Guinea
Faeroe Islands
French Guyana
French
Polynesia
Gabon
Greenland
Grenada
Guadeloupe
Guam
Guinea
Guinea Bissau
Iceland
Honduras
Hong Kong China
Iran
Lao People’s
Dem Rep
Libyan Arab
Jamah
Liechtenstein
24
Sophisticated
Pharmaceutical
Industry and
Research base
Innovative
Capability
Reproductive
Capabilities-
Active
Ingredients and
Finished products only
Reproductive
Capabilities-
Finished Products from Imported
Ingredients only
No
Pharmaceutical
Industry
Iraq
Jamaica
Jordan
Kenya
Kiribati
Kuwait
Lebanon
Malaysia
Mali
Malta
Mauritius
Mongolia
Morocco
Mozambique
Myanmar
Namibia
Nepal
New Zealand
Nicaragua
Niger
Nigeria
Luxemburg
Maldives
Martinique
New Columbia
Niue
Oman
Qatar
Reunion
Rwanda
St Kitts and
Nevis
St Lucia
St Vincent-
Grenadines
Samoa
San Marino
Sao Tome and
Principe
Senegal
Suriname
Swaziland
Togo
Tuvalu
United States
Virgin Island
Pakistan
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Saudi Arabia
Seychelles
Sierra Leone
Singapore
Solomon Islands
Somalia
South Africa
Vanuatu
Western Samoa
25
Sophisticated
Pharmaceutical
Industry and
Research base
Innovative
Capability
Source: Balance et al (1992)
Appendix C
Reproductive
Capabilities-
Active
Ingredients and
Finished products only
Reproductive
Capabilities-
Finished Products from Imported
Ingredients only
No
Pharmaceutical
Industry
Sri Lanka
Sudan
Syrian Arab Rep
Taipei China
Thailand
Tonga
Trinidad and
Tobago
Tunisia
Uganda
United Arab
Emirates
United Rep of
Tanzania
Uruguay
Venezuela
Vietnam
Yemen
Zaire
Zambia
Zanzibar
Zimbabwe
26
27
