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THE LEGAL IMPLICATION OF COMPULSORY LICENCE PHARMACEUTICAL PRODUCTS IN THE TRIPs AGREEMENT TO THE PROTECTION OF THE RIGHT TO HEALTH IN DEVELOPING COUNTRIES

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Abstract

Compulsory license of pharmaceutical products in the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement attempts to balance the interest of patent holders and The right to health. The access of medicines in developing countries for the epidemic diseases, such as, HIV/AIDS medicine is crucial to protect The right to health. The objective of the research is to analyze comprehensively the legal implication of compulsory license for the pharmaceutical product to the protection of The right to health in developing countries. It is a normative juridical research by applying conceptual and comparative approaches. The results of the research shows that: first, the implementation of compulsory licence is in accordance with the international human right law: second, the legal implication of the compulsory license causes the adoption of policy and regulations regarding the protection of the right to health in developing countries, such as Indonesia, Malaysia, Brazil, India and South Africa. Keywords : Compulsory license, pharmaceutical products, legal implication and The right to health
1
THE LEGAL IMPLICATION OF COMPULSORY LICENCE PHARMACEUTICAL
PRODUCTS IN THE TRIPs AGREEMENT TO THE PROTECTION OF THE
RIGHT TO HEALTH IN DEVELOPING COUNTRIES
Sri Wartini
Faculty of Law, Universitas Islam Indonesia - Indonesia
E-mail: sri.wartini@uii.ac.id
Abstract
Compulsory license of pharmaceutical products in the Trade Related Aspects of Intellectual Property
Rights (TRIPs) Agreement attempts to balance the interest of patent holders and The right to
health. The access of medicines in developing countries for the epidemic diseases, such as, HIV/AIDS
medicine is crucial to protect The right to health. The objective of the research is to analyze com-
prehensively the legal implication of compulsory license for the pharmaceutical product to the
protection of The right to health in developing countries. It is a normative juridical research by ap-
plying conceptual and comparative approaches. The results of the research shows that: first, the
implementation of compulsory licence is in accordance with the international human right law:
second, the legal implication of the compulsory license causes the adoption of policy and regulati-
ons regarding the protection of the right to health in developing countries, such as Indonesia, Ma-
laysia, Brazil, India and South Africa.
Key words : Compulsory license, pharmaceutical products, legal implication and The right to health
Abstrak
Lisensi wajib produk farmasi dalam perjanjian perdagangan yang terkait dengan HKI berusaha
menyeimbangkan kepentingan pemegang hak paten dan perlindungan hak kesehatan di negara ber-
kembang. Akses terhadap obat di negara berkembang yang mengalami wabah penyakit seperti HIV/
AIDs sangat penting untuk melindungi hak kesehatan di negara berkembang. Tujuan penelitian ini
untuk menganalisa secara komprehensif implikasi hukum lisensi wajib terhadap perlindungan hak
kesehatan di negara berkembang. Penelitian ini merupakan penelitian yuridis normatif dengan pende-
katan konseptual dan komparatif, serta dianalisa secara deskriptif kualitatif dan disajikan secara des-
kriftif. Adapun hasil penelitian ini ialah: pertama, implementasi lisensi wajib dalam Perjanjian TRIPs
di negara berkembang terhadap produk parmasi sesuai dengan ketentuan hukum hak asasi manusia
internasional; kedua implikasi hukum lisensi wajib terhadap produk parmasi di negara berkembang
menyebabkan obat-obat yang penting untuk penyembuhan HIV/AIDs mudah diakses dan harganya
terjangkau, seperti misalnya di Indonesia, Malaysia, Brasil, India and Africa Selatan untuk melindu-
ngi hak atas kesehatan.
Kata kunci: hak kesehatan. implikasi hukum, lisensi wajib, dan produk pharmacy,
Introduction
Developing countries are suffering from
expensive essential medicines to secure deadly
diseases such as HIV/AIDs. For example, World
Health Organization (WHO) reports
1
show that
The article is part of individual research, funded by Fa-
culty of Law Universitas Islam Indonesia by Decree
Number 1/Kaprodi/70/Div.URT/TU/H/6/20l7.
1
Chuan-Feng Wu, “Transnational Pharmaceutical Corpo-
rations' Legal and Moral Human Rights Responsibilities
in Relation to Access to Medicines”, Asian Journal of
infectious diseases kill over 14 million people
per year, 90% of whom live in a developing or
newly industrialized society.
2
Among them, ap-
proximately three million people die annually
from HIV/AIDS, two million from tuberculosis,
and one million from malaria.
3
WTO & International Health Law & Policy, Vol. 7, 2012,
p. 78.
2
Ibid.
3
Ibid
2 Jurnal Dinamika Hukum
Vol. 18 No. 1, January 2018
There are many states become the par-
ties of international human rights instruments
which recognized the rights to health, as well
as the parties of Trade Related Aspect of Intel-
lectual Property Rights Agreement (hereinafter
TRIPs Agreement). One of the patented medici-
nes is Antiretroviral which is able to secure the
lethal disease, such as HIV/AIDS.
4
From the
perspective of intellectual property right Law,
an expensive price of patented medicine, such
as “antiretroviral’ is reasonable since the phar-
maceutical industries have already invested a
huge capital and technology to create the me-
dicine. In order to protect their products, they
patented their products so they have the ex-
clusive right
5
to determine the price and prohi-
bit the other parties to produce without their
consent.
On the other hand, patients in develop-
ing countries really deserve the medicine, but
they do not have capability to purchase the
medicine. Consequently, the government of the
developing countries failed to perform the obli-
gation to protect, to fulfil and to promote the
right to health which is stipulated in the Inter-
national Coveant on Social, Economic and Cul-
tural rights (hereinafter ICESCR).
6
However,
the World Trade organization (hereinafter
WTO) as an international trade organisation
states that it is necessary to regulate the ac-
cess of the essential medicine, so that it can be
purchased by the patients in developing coun-
tries including Indonesia by exercising compul-
sory license. The paper urgently attempts to
examine the relationship between compulsory
4
Senai W. Andemariam, “The Cleft-Stick between Anti-
Retroviral Drug Patents and HIV/AIDS Victims: An In-
Depth Analysis of the WTO's Trips Article 31 Bis Amend-
ment Proposal of 6 December 2005”, Intellectual Pro-
perty Quarterly, Vol. 4, 2007, p. 415.
5
Lilian Martins, “The Right to Health Versus the Right to
Property: Conflicts Between Public Welfare and Private
Interests, the Brazilian Approach”, Law & Business Re-
view of the Americas, Vol. 20, Summer 2014, p. 484.
6
Emily M. Cowleya, “The Right to Health: Guatemala's
Conflicting Obligations Under The Central American
Free Trade Agreement and The International Covenant
On Economic, Social, and Cultural Rights”, Michigan
State University Journal of Medicine & Law, Vol. 11,
2007, p. 231.
license and the protection of the right to
health.
In addition, the implementation of com-
pulsory license in developing countries some-
times causes protest from developed countries
since the compulsory license may jeopardize
the interest of the patent holder of the essen-
tial medicines in developed countries. Howe-
ver, the developing countries have to find prac-
tical reasons to implement compulsory license
in order not to contradict the requirements of
the TRIPs Agreement. One of the efforts to be
performed by the developing countries is to
adopt national policy regulations to implement
compulsory license, such us to define what na-
tional emergency situation, non-commercial
used and the mechanism of the compulsory li-
cense in the national law.
The problems of this article are: first.
is the compulsory license of pharmaceutical
product in the TRIPs Agreement in accordance
with the right to health in international human
right law?; second, what is the legal implicati-
on of compulsory license regarding pharmaceu-
tical product in the TRIPs Agreement to the
protection of the right to health in developing
countries?. Thus, the aim of the research is to
analyse comprehensively the legal implication
of compulsory license pharmaceutical product
in the TRIPs Agreement to the protection of the
right to health in developing countries.
Research Methods
This library research belongs to normati-
ve research which uses secondary data consist-
ing of primary legal material, secondary legal
material and tertiary legal material. Then, the
approaches employed in the research are con-
ceptual approach and comparative approach.
The conceptual approach is used to understand
the concept of compulsory license and the re-
lationship with the concept of the right to
health, while comparative approach is employ-
ed to examine the implementation of compul-
sory license in some developing countries, such
as, Indonesia, Malaysia, Brazil, India and South
Africa. All the collected materials are grouped
The Legal Implication of Compulsory Licence Pharmaceutical Products in The TRIPs… 3
based on each variable and qualitatively analy-
zed and descriptively presented.
Discussion
Compulsory License of Pharmaucitical Pro-
duct in the TRIPs Agreement based on Inter-
national Human Rights Law Perspective
The TRIPs Agreement does not explicitly
mention the term compulsory license in the
text but Article 31 is understood to allow com-
pulsory license and government use without au-
thorization of the right holder.
7
Article 31 of
the TRIPs Agreement states: Where the law of
a Member allows for other use of the subject
matter of a patent without the authorization of
the right holder, including use by the govern-
ment or third parties authorized by the govern-
ment, there are some following provisions shall
be respected”, such as, Article 31 (a), (b), (f)
and (j):
(a) authorization of such use shall be
considered on its individual merits;
(b) such use may only be permitted if,
prior to such use, the proposed user
has made efforts to obtain authoriza-
tion from the right holder on reason-
able commercial terms and conditi-
ons and that such efforts have not
been successful within a reasonable
period of time. This requirement may
be waived by a Member in the case of
a national emergency or other cir-
cumstances of extreme urgency or in
cases of public noncommercial use. In
situations of national emergency or
other circumstances of extreme ur-
gency, the right holder shall, never-
theless, be notified as soon as rea-
sonably practicable.In the case of
public non-commercial use, where
the government or contractor, with-
out making a patent search, knows or
has demonstrable grounds to know
that a valid patent is or will be used
by or for the government, the right
holder shall be informed promptly;
7
Timothy Bazzle, “Pharmacy of the Developing World:
Reconciling Intellectual Property Rights in India with
The Right To Health: Trips, India's Patent System and
Essential Medicines”, Georgetown Journal of Interna-
tional Law, Vol. 42, 2011, p. 788
(f) any such use shall be authorized pre-
dominantly for the supply of the do-
mestic market;
(j) any decision relating to the remune-
ration provided in respect of such use
shall be subject to judicial review or
other independent review by a dis-
tinct higher authority in that Mem-
ber;
Article 31 does not hamper the grounds on
which compulsory licensing is allowable, and it
become the authority of states to determine
the balance of the protection of patent holders
and the interest of the patients. Article 31(b)
provides that this limitation may be waived by
a Member in the event of a national emergen-
cy. Unfortunately, there is no explanation what
constitute national emergency in the TRIPs
Agreement. The Contracting Parties of the
TRIPs Agreement have a freedom to define
what national emergency is. For example, the
endemic of HIV/AIDs which occur in a develop-
ing country can be considered as national
emergency. Article 6 of the International
Health Regulations (2005) (IHR) imposes an ob-
ligation on countries to notify WHO, via the
National IHR Focal Point, of “all events which
may constitute a public health emergency of
international concern within its territory”.1The
IHR define a “public health emergency of inter-
national concern” as an extraordinary event
that is determined to “constitute a public
health risk to other States through the inter-na-
tional spread of disease and to potentially re-
quire a coordinated international response”.
World Health Organization (WHO) Chapter 11:
Public health Emergencies Summary Points.
8
Thus, there is no uniform definition of the na-
tional emergency. The definition of national
emergency is based on the national policy and
interest of each state.
One of the most important restrictions is
adopted in Article 31(f) - the use of commercial
license should be “predominantly for the supply
of the domestic market.” The term “predomi-
nantly” in Article 31(f) implies that some ex-
8
WHO, without years, Health Law, retrieved on: http://
www.who.int/healthsystems/topics/health-
law/chapter11.pdf Accessed on January10th, 2018.
4 Jurnal Dinamika Hukum
Vol. 18 No. 1, January 2018
portation under compulsory license from the
exporting nation could not be allowed to be ex-
ported to other countries which do not have
the capacity to produce the medicine. Based on
Article 31 (f) It is clear that initiates a problem
in the implementation of compulsory license in
developing countries which do not have the
capability to produce medicine.
There are many developing countries
which do not have the capacity to produce the
essential medicine, thus, it is necessary to find
a solution to solve the problem. Consequently,
the fourth WTO Ministerial Conference, held in
November 2001 in Doha, Qatar, adopted a Dec-
laration on TRIPS and Public Health (herein-
after Doha Declaration) which affirmed the so-
vereign right of governments to take measures
to protect public health.
9
Based on the Doha
Declaration, the Member of the TRIPs Agree-
ment has a freedom to implement and to in-
terpret the Provision of the TRIPs Agreement to
support the public health.
Article 5 (c) Doha Declaration recognizes
the flexibility of the TRIPs Agreement provides
a freedom to state to determine what kind of
legal basis to grant compulsory license and to
determine the national emergency which are
various from one state to another state to
protect public health.
10
Thus, Article 5 of the
Doha Declaration has to be read in the light of
article 6 of the Doha Declaration which gives
opportunity to states to carry out parallel im-
port.
11
This term refers to “a practice in which
a third party imports a product marketed in a
foreign country by the patent holder, in com-
petition with the product that same patent hol-
der imports or manufactures locally”.
12
9
Holger Hestermeyer, “Human Rights and the WTO: The
Case of Patents and Access to Medicines”, International
Trade Law & Regulation, Vol. 14 No. 6, 2008, p. 126.
10
Mohammad Towhidul Islam, “TRIPs Agreement and Pub-
lic Health: Implications and Challenges for Bangla-
desh”, International Trade Law & Regulation, Vol. 17
No. 1, 2011, p. 22.
11
Samira Guennif and Julien Chaisse, “Present Stakes
Around Patent Political Economy: Legal and Economic
Lessons from the Pharmaceutical Patent Rights in
India”, Asian Journal of WTO & International Health
Law & Policy, Vol. 2 No. 1, March, 2007, p. 75.
12
Charles T. Collins-Chase, “The Case Against Trips-Plus
Protection in Developing Countries Facing Aids Epide-
On August 30, 2003, the WTO General
Council for TRIPs resolved the dispute on im-
plementing the Doha Declaration by adopting a
decision which essentially permitted a patent
exception rule to allow countries to produce
medicine for export to fulfill public health
needs in countries that do not have production
capacities.
13
Finally, in order, the decision has
a legal obligation to the Member States of
WTO, on 6 December 2005, the WTO issued a
Protocol to amend Article 31(f) become Article
31 (f) bis of the TRIPs Agreement which allows
parallel import.
14
The Righ to Health in the International Hu-
man Right Law
Article 25(1) of the UDHR affirms that
“everyone has the right to a standard of living
adequate for the health of himself and of his
family, including food, clothing, housing and
medical care and necessary social services.”
15
Hence, based on Article 25 (1) UDHR, a state
has obligation to achieve the standard stipula-
ted on the Article. Besides, there are some In-
ternational instruments, which regulate the
rich to health, such as Article 12 (1) of the In-
ternational Covenant on Economic, Social, and
Cultural Rights (hereinafter ICESCR).
16
Article
5(e) (iv) of the International Convention on the
Elimination of All Forms of Racial Discrimina-
tion of 1965, and Articles 11 (1) (f) and 12 of
the Convention on the Elimination of All Forms
mics”, University of Pennsylvania Journal of Internatio-
nal Law, Vol. 29, Spring 2008, p. 768.
13
Sartika Nanda Lestari, Implementasi Compulsory Li-
censing Terhadap Obat-Obatan Dalam Bidang Farmasi di
Indonesia (Studi Berdasarkan Doha Declaration on The
TRIPs Agreement and Public Health)”, Thesis Program
Magister Ilmu Hukum Fakultas Hukum Universitas Dipo-
negoro, Semarang 2012. p. 77, retrieved from the web-
site: http://eprints.undip.ac.id/42149/1/Bab_I-II.pdf,
aaccessed on November 4, 2017.
14
World Trade Organization, without Years, Amendment
of the TRIPS Agreement’, WT/L/641, 8 December 2005
Amendment, retrieved on website: https://www.wto.
org/english/tratop_e/trips_e/wtl641_e.htm, accessed
on November 4, 2017.
15
Tina S. Bhatt, Amending Trips: A New Hope For Increa-
sed Access to Essential Medicines”, Brooklyn Journal of
International Law, Vol. 33, 2008, p. 600.
16
Kojo Yelpaalaa, “Quo Vadis WTO? The Threat of Trips
and the Biodiversity Convention to Human Health and
Food Security”, Boston University International Law
Journal, Vol. 30, 2012, p. 65-66.
The Legal Implication of Compulsory Licence Pharmaceutical Products in The TRIPs… 5
of Discrimination against Women (hereinafter
CEDAW) of 1979.
17
Access to medicine affects the right to
health. The fundamental legal basis the right to
health is stipulated in the article 12 (1) of
ICESCR, which recognizes “the right of every-
one to the enjoyment of the highest attainable
standard of physical and mental health.” Con-
sequently it needs the active effort of a state
to materialize it, which includes the preven-
tion, treatment and control of epidemic, ende-
mic, occupational and other diseases and the
creation of conditions which would assure to all
medical service and medical attention in the
event of sickness.
18
Related to the health policy in Indonesia,
as one of the examples of developing countries,
health is one of the eleven priorities in the
national development program. It is stipulated
in the Regulation of the President of the Re-
public of Indonesia Number 5 of 2010 on the
National Medium Term Development Plant
(RPJMN) 2010-2015. Furthermore, the right to
health is also recognized as human right based
on Act Number 36 Year 2009 regarding Health.
Article 5 (1) Act number 36 Year 2009 states:
“Every people shall have equal right in obtain-
ing access to health resources”. Thus, it beco-
mes the obligation of the government of Indo-
nesia how to fulfill the right of the people. It
has been stipulated in Article 16 Act Number 36
Year 2009: “The Government shall be responsi-
ble for the availability of fair and proportional
distributed resources of health
19
for all people
in order to achieve maximum health degree.
Thus, it can be submitted that the health policy
of Indonesia is in accordance to the General
17
Timothy Bazzle, loc.cit.
18
Adam Houstona, “A Scientific Approach to Intellectual
Property and Health: Innovation, Access, and a Forgot-
ten Corner of the Universal Declaration of Human
Rights”, John Marshall Review of Intellectual Property
Law, Vol. 13, 2014, p. 800-801.
19
Article 1 (2) Act, Number 36 Year 2009, it states: Re-
sources of health refers to any kind of fund, power,
health supply, pharmacy supply and health equipments
as well as health service facilities and technology used
to maintain health efforts made by the Government, lo-
cal government, and/or the people”.
Comment No 14 of the Highest Commissioner of
Human Rights.
20
In its General Comment No. 14 on the
“Right to the Highest Attainable Standard of
Health,” the Economic, Social and Cultural
Rights Committee (hereinafter ESCR Commit-
tee”) explained that all health care facilities,
goods, and services including medications and
the provision thereof should be: (1) available in
sufficient quantity; (2) accessible to everyone
without discrimination; (3) acceptable in the
sense of respectful of medical ethics and cus-
toms; and (4) of good quality and scientifically
appropriate.
21
Thus, it is essential to materia-
lize those accessibility of the right to health by
providing easy access and affordable essential
medicine which is demanded by the patients.
Conflict or Congruence between Compulsory
License of pharmaceutical Product in the
TRIPs Agreement and the Protection of the
Right to Heath in Developing Countries
TRIPs Agreements are auspicious steps
toward making access to HIV/AIDS medicine be-
comes a reality for developing nations.
22
The
WTO negotiations and agreements outstanding-
ly avoid any obvious recognition of human
rights, particularly the right to health. The
TRIPs Agreement more focus on public health
rather than the discussion to the protection of
individual human rights, such as the right to
health.
23
Consequently, it results in less effec-
20
Office of the Highest Commissioner of Human Rights,
CESCR General Comment No. 14: The Right to the Hig-
hest Attainable Standard of Health (Art. 12). Adopted
at the Twenty-second Session of the Committee on
Economic, Social and Cultural Rights, on 11 August 2000
(Contained in Document E/C.12/2000/4), retrieved on:
http://www.refworld.org/pdfid/4538838d0.pdf, Acces-
sed on November 4, 2017.
21
- Rudolf V. Van Puymbroeck, “Basic Survival Needs And
Access To Medicines-Coming To Grips With TRIPs: Con-
version + Calculation”, Journal of Law, Medicine &
Ethics, Vol. 38, Fall 2000, p. 521-522.
22
Erika Georgea,” The Human Right to Health and HIV/
AIDs: South Africa and South-South Cooperation to Re-
frame Global Intellectual Property Principles and Pro-
mote Access to Essential Medicines”, Indiana Journal of
Global Legal Studies, Vol. 18, winter 2012, p. 179-180.
23
Chuan-Feng Wu “Raising the Right to Health Concerns
Within the Framework of International Intellectual Pro-
perty Law”, Asian Journal of WTO & International
Health Law & Policy, Vol. 5, 2010, p. 144-145.
6 Jurnal Dinamika Hukum
Vol. 18 No. 1, January 2018
tive laws to achieve access to HIV/AIDS medici-
nes.
The majority of TRIPs Agreement Mem-
bers are also the Members of ICESCR, thus, the-
re is possibility of conflict between the obliga-
tions in the TRIPs Agreement and the obligation
in the ICESCR. At glance, the two agreements
regulate two different things; the TRIPs Agree-
ment regulates intellectual property right while
ICESCR regulates the protection of human right.
Actually, the two Agreements interrelate since
the access of medicine affects the protection
to the right to health. The TRIPs Agreement
should be flexibly interpreted to promote ac-
cess to medicine.
24
The Doha Declaration opens
the way for developing countries to access es-
sential medicine.
The Legal Implication of Compulsory License
of pharmaceutical Products in the TRIPs
Agreement to the Protection of the Right to
Heath in Developing Countries
Compulsory license which has been regu-
lated based on the TRIPs Agreement and also
Doha Declaration causes some legal implicati-
ons in developing countries to access to medici-
ne in order to protect the right to health. First,
one of the legal implication is the accessibility
and affordability of the essential medicine
which are deserved by patients in developing
countries, such as Antiviral and Antiretrovi-
ral,
25
since the developing countries can use
the justification based on the reason of pro-
tecting public health and also the developing
countries have a freedom to issue the law to
determine what emergency situation to justify
to implement compulsory license. Thus, the
compulsory license enables state to protect the
right to health
Second, the developing countries can
exercise the compulsory license to support the
right to health. However, it is necessary to
adopt policy and regulations to take the benefit
of the compulsory license to protect the right
to health. Indeed, the right to health does not
only oblige states to take positive measures to
24
Chuan-Feng Wu, op.cit, p. 81-82.
25
Adam Houstona, op.cit, p. 802.
ensure the access to affordable medicine for
all, but also requires them to refrain from ta-
king measures that could impede this access.
Consequently, when implementing compulsory
license rules, countries have to take the right
to health into account, ensuring the access to
quality medicines is affordable prices,
26
so that
the patients in developing countries will not
find difficulty in accessing the medicine.
Third, access to essential medicine which
is protected by patent has already become the
important issue in international human rights
law. The accessibility and affordability of es-
sential medicine needs to be materialized in
order to protect the right to health.
27
It has
been noted by the UN Sub-Commission on
Human Rights
28
that there are apparent con-
flicts between the fundamental principles of
international human rights and the principles of
international intellectual property regime as
embodied in the TRIPS Agreement. Thus, the
compulsory license can be used as a legal ins-
trument to justify of producing generic version
of essential medicines in developing countries.
Hence, the TRIPs Council made an Amendment
of the TRIPs Agreement in November 2005
which permits the parallel import.
Finally, international human rights docu-
ments cannot serve as a substitute for an expli-
cit recognition of the right to medicine in the
TRIPS Agreement. By embodying the right in
the TRIPS Agreement, the WTO would help se-
cure the right to medicine by supplying Member
26
Center for Health, “Transnational Pharmaceutical Cor-
porations' Legal and Moral Human Rights Responsibili-
ties in Relation to Access to Medicines”, “Health and
Human Rights Resource Guide”. retrieved from:
https://www.hhrguide.org/2017/06/09/access-to-
medicines-and-human-rights/. Accessed on November
4, 2017.
27
Peter K. Yua, “Intellectual Property in International
Perspective: Institute for Intellectual Property & Infor-
mation Law Symposium”, Houston Law Review, Vol.46,
2009, p. 990.
28
WTO Doha Ministerial Declaration on the TRIPS Agree-
ment and Public Health, WT/MIN(01)/DEC/2 (14 Nov.
2001) [hereinafter Declaration on TRIPS and Public
Health]; WTO Council for TRIPS, Implementation of Pa-
ragraph 6 of the Doha Declaration on the TRIPS Agree-
ment and Public Health, IP/C/W/405 (30 Aug. 2003)
[hereinafter WTO, Implementation of Paragraph 6]”.
Available on the website: https://www.wto.org/eng-
lish/res_e/booksp_e/ddec_e.pdf, retrieved on June 7,
2017.
The Legal Implication of Compulsory Licence Pharmaceutical Products in The TRIPs… 7
States with a legal justification for implement-
ing patent laws that do not impede access to
essential medicines. Hence, the compulsory li-
cense is the gate way to embody protection of
the right to health in developing countries, if
the developing countries can performed the
legal instrument which is in accordance with
the TRIPs Agreement.
Legal Implication of Compulsory License by
State Practicses to Protect the Right to
Health in Some Developing Countries
The right to health has been recognized
as part of human right and as constitutional
right in most developing countries. On the ot-
her hand, as the Members of the TRIPs Agree-
ment in the WTO, states have obligation to har-
monize the national intellectual property right
law in accordance with the TRIPs Agreement. In
order to analyse further the legal implication of
compulsory license to the protection of the
right to health in developing countries, the re-
search analyses briefly the legal implication of
compulsory license in five developing coun-
tries, namely Indonesia, Malaysia, Brazil, South
Africa and India.
First, the legal implication of compulsory
license of pharmaceutical products in indonesia
in order to protect the right to health. The
right to health in Indonesia is not explicitly sti-
pulated in the Indonesian Constitution and Act
Number 36 Year 2009 on Health. The right to
health can be found in Article 28 H (1) Indo-
nesian Constitution, and Article 62 Human Right
Act which regulates the right to have health
service. However, when the Indonesian govern-
ment would like to protect the right to health
in Indonesia, they have to comply with the
TRIPs Agreement. Hence, the Indonesian go-
vernment have already amended the Patent Act
in accordance with the TRIPs Agreement. The
reason of exercising compulsory license in Indo-
nesia is based on Article 109 Indonesian Patent
Act. However, unlike Malaysia which imported
generic versions of the drugs from India, Indo-
nesia used the compulsory license to appoint
local manufacturers to produce 7 medicines for
treating Hepatitis B and HIV/AIDs based on
Decree of the President Republic of Indonesia
No 76 of 2012.
29
Second, the legal implication of Compul-
sory License of Pharmaceutical Products in Ma-
laysia in order to protect the Right to Health.
The right to health in Malaysia is recognized as
a human right and also as Constitutional right
in the Federal Constitution.
30
The Malaysian go-
vernment seriously concerns and protects the
right to health. Thus, when there is an epide-
mic case of HIV/AIDS in Malaysia which can be
considered as national emergency, the govern-
ment of Malaysia issued compulsory license for
the medicine to secure the patients because
the price of the medicine is very expensive.
Malaysia was the first Asian country that har-
monized its legislation
31
with the Doha Declara-
tion and the 2003 Decision.
Based on the compulsory license regulat-
ed in the TRIPs Agreement, Malaysia can take
advantages of the mechanism. Under Section
84 of the Malaysian Patents Act, it allows the
grant of compulsory licence in case of national
emergency or in public interest. Based on this
provision, Malaysia issued the license to import
generic Antiretroviral (ARV) medicines from In-
dia, and this measure has certainly helped the
country bring down the cost of treatment.
32
Third, the Iegal implication of Compul-
sory License of Pharmaceutical Products in Bra-
zil in order to protect the Right to Health. The
Brazilian Constitution of 1988 granted the right
to health to all citizens and mandated the cre-
ation of a national health-care system. Thus,
when there is an epidemic case of HIV/AIDS in
Brazil which can be considered as national
emergency, the government of Brazil issued
compulsory license for the medicine to secure
29
Helmi Khair, “Is The Right to Health Undermined by
The Agreement of Trade-Related Aspects of Intellectual
Property Rights? Journal of Academia UiTM Negeri
Sembilan, Vol. 4, 2016, p. 30.
30
Ibid.
31
Raadhika Gupta, “Compulsory Lisencing under TRIPs:
How Far it Addresses Public Health Concern in Deve-
loping Nations, Journal of Intellectual Property Rights,
Vol. 15, September 2010, p. 362.
32
Samira Guennif and Julien Chaisse, op.cit, p. 79-80.
8 Jurnal Dinamika Hukum
Vol. 18 No. 1, January 2018
the patients,
33
because the price of the medi-
cine is costly. However, it should bear in mind
that Brazil is the member of the TRIPs Agree-
ment; consequently, Brazil has to comply with
the TRIPs Agreement in exercising the compul-
sory license. Based on Article 31 (b) TRIPs Ag-
reement, Brazil has consistently taken a positi-
on in favor of public health in trying to nego-
tiate a balance between pharmaceutical IPR
and access to medicine.
34
Fourth, the Iegal implication of compul-
sory license of pharmaceutical products in
South Africa in order to protect the Right to
Health. South Africa is estimated to have the
highest absolute number of people living with
HIV of any country in the world, it is also home
to the world’s largest public sector antiretro-
viral (ARV) treatment programme.
35
Access to
medicines is an essential component of the
right to health. Undoubtedly, the challenge
ahead is to ensure that the South African go-
vernment is equipped with a public health-sen-
sitive legal framework that can achieve the pri-
ce reductions needed to sustain a public HIV
treatment programme and ensure all people’s
access to medicines.
36
Indeed, South Africa as
the member of the TRIPs Agreement, its Patent
Act has to comply with the TRIPs Agreement.
Unfortunately, Africa does not take ad-
vantage of the compulsory license which is
adopted in Article 31 TRIPs Agreement since
South Africa feared retaliation from other
countries
37
especially United States. Thus, what
has been done by the South African government
only make bilateral agreement with United
State to get reducing price of the essential me-
dicine, especially in a national emergency si-
tuation dealing with epidemic HIV/AIDS and its
33
Anna Dontje,” Rethinking Trips: The Future of Pharma-
ceutical Patents”, Wisconsin International Law Journal,
Vol. 33, Fall, 2015, p. 388.
34
Ibid.
35
Erika George, “The Human Right to Health And HIV/
AIDs: South Africa and South-South Cooperation to Re-
frame Global Intellectual Property Principles and Pro-
mote Access to Essential Medicines”, Indiana Journal of
Global Legal Studies, Vol. 38, Winter, 2011, p. 168.
36
Ibid.
37
Siobhán Elizabeth Stade Murillo, Fair Or Fraud: Has The
Protocol Amending Trips Flourished Or Failed?”, Indiana
International & Comparative Law Review, Vol. 27,
2017. P. 198.
citizens does not have capability to afford the
medicine.
Fifth, the Iegal implication of compulso-
ry license of pharmaceutical products in India
in order to protect the Right to Health. The
Constitution of India has provisions regarding
the right to health. The Constitution incorpora-
tes provisions guaranteeing everyone’s right to
the highest attainable standard of physical and
mental health.
38
In Indian Constitution does not
explicitly recognize the fundamental right to
health. However, Article 21 of the Constitution
of India guarantees a fundamental right to life
and personal liberty.
The Indian Patent Act of 1970 prohibited
the patent ability of pharmaceutical products
in order to boast the availability of low-cost
medicines. However, the Act allowed patents
on the manufacturing process of said products.
As a result of the Act India turn out to be the
largest manufacturer and provider of generic
pharmaceutical products in the world. Howe-
ver, when India becomes the member of the
TRIPs Agreement, India has to comply with the
TRIPs Agreement. The TRIPS Agreement, al-
though attempting to establish uniformity of in-
ternational patent law, allowed each individual
country to establish its standards of patent
ability as long as the standards did not violate
the agreement.
Accordingly, Article 31 of the TRIPS Ag-
reement, without stating the words “compul-
sory license,” establishes a procedure by which
a compulsory license could be granted if cer-
tain conditions were met. The Patent Act of
1970 was amended in 2005. The legal implica-
tion of the Compulsory license causes the Indi-
an Patent Act has to be harmonized with the
TRIPs Agreement.
39
Thus, it is reasonable that the implemen-
tation of compulsory license for essential medi-
38
Indrajit Khandekar et al, “Right to Health Care”, Jour-
nal Indian Acad Forensic Med, Vol. 34 No. 2. April-June
2012, p. 160.
39
Javier Esparza, Indian Patent Law: Working Within the
TRIPs Agreement Flexibilities to Provide Pharmaceu-
tical Patent Protection While Protecting Public Health”,
retrieved from: http://heinonline.org/HOL/Landing
Page?handle=hein.journals/jtrnlwp24&div=8&id=&page
=. Accessed on 19 December 2017.
The Legal Implication of Compulsory Licence Pharmaceutical Products in The TRIPs… 9
cine in order to protect, to fulfill and to pro-
mote the right to health. Provisions related to
the grant of compulsory license in India are
prescribed under Sections 82-94 (Chapter XVI)
of the Patents Act, 1970, and Rules 96-102
(Chapter XIII) of the Patents Rules, 2003.
40
Ho-
wever, in issuing Compulsory license India also
refers to the International TRIPs Agreement Ar-
ticle 31 and its Amendment and Doha Decla-
ration. The Compulsory license is issued in the
circumstances of national emergency or in cir-
cumstances of extreme urgency or in case of
public non-commercial use including public
health crises.
Conclusion
The compulsory license of pharmaceuti-
cal product in the TRIPs Agreement is in accor-
dance with the protection of the right to health
in international human right law. It can be pro-
ven from the efforts that have been done by
WTO to harmonize the protection of patent
holders and the protection of the right to
health by providing compulsory license mecha-
nism in the TRIPs Agreement and the Doha Dec-
laration as well as the amendment of of TRIPs
Agreement in November 2005. In the mean ti-
me, the international instruments of human
rights, such as UDHR and ICESCR established
the protection of the right to health for all
people. However, the developing countries as
the member of the TRIPs Agreement, they have
their own policy and national regulations to re-
gulate the implementation of the compulsory
license. The developing countries utilize the
compulsory license scheme to protect the right
to health.
The legal implication of compulsory li-
cense regarding pharmaceutical products in the
TRIPs Agreement to the protection of the right
to health in developing countries has caused
accessibility and affordability of essential me-
dicine to secure deadly disease, such as HIV/
AIDs in developing countries. Indonesia, Malay-
40
Vipin Mathur et.al, “Compulsory Licensing of Pharma-
ceutical Patents In India: A Research Study”, “Euro-
pean Journal of Pharmaceutical and Medical Research,
Vol. 3, 2016, p. 537.
sia, Brazil, South Africa and India recognize the
right to health in their Constitution. Hence, in
order to protect, to fulfill and to promote the
right to health for their citizens, they issued
compulsory licence. The Doha Declaration clari-
fies the right of WTO Members to incorporate
flexibility built into the TRIPS Agreement into
their domestic intellectual property laws to
protect and promote the right to health. The-
refore, the direct legal implication of exerci-
sing compulsory license in developing countries
has already enabled the developing countries
to establish the policy and national regulations
how to regulate compulsory license in the na-
tional level and also to utilize the compulsory
license to protect the right to health.
Suggestion
The legal implication of the Compulsory
license of pharmaceutical products in develop-
ing countries to the protection of the right to
health in developing countries are not so diffe-
rent among the developing countries. However,
since there are different situation and conditi-
on of each developing country, specific policy
of each developing country to deal with the
deadly disease, such as HIV/AIDs from one
country to another country is required. Thus,
the following suggestions are proposed: firstly,
each developing country has to regulate the
compulsory license in its national law especially
when determining the national emergency, pa-
rallel import and non commercial use of the
essential medicine; secondly, in order to pre-
vent disputes among developing countries and
the pharmaceutical industries in developed
countries, the government involvement in de-
veloped countries is needed to encourage the
pharmaceutical industries to participate in the
protection of the right to health.
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... In essence, LWR aims to make a new product inventions economically empower for patent owners [12], and for users to obtain new, better and more sophisticated products. This also applies to pharmaceutical product patents, so that with LWR, patent owners can immediately benefit economically [13] which comes from compensation for research costs that take a long time and are expensive to produce new drug inventions and for the public can get access to new nutritious drugs [14]. ...
... Proscription of any promotion alluding to any article to prompt its utilization as a prescription, application or remedial measure with the intention of the prevention, management, mitigation, remedy or identification of ailments and conditions as the renal disease, asthma, cardiac disease, epilepsy, paralysis, leprosy, malignancies, deafness, drug dependence, diabetes, hernia, optical diseases, hypertension, tuberculosis, psychological, infertility, rigidity, weakening of the sexual function, venereal illness, nervous debility, or other complaint emerging from or involving sexual intercourse [32]. Advertisement ought not to encourage practicing contraception among people, improving the working of the human kidney or heart, or improving the sexual capacity and securing the miscarriage of women. ...
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