Você está na página 1de 19

Abstract

It is a given that inventors should be accorded rights for their contribution


to the society, They are, after all, providing us a new way to face struggles head on
and it is just right that they be rewarded for their efforts. Innovations in the field of
medicine affects our lives directly by improving our health to extending it and
saving us from instances that could deprive us of our life but at the same time the
rights accorded to these inventors or innovators could likewise be prejudicial to
the masses their invention sought to protect and help, or render such innovation
inaccessible or just out of their reach. This paper seeks to determine whether or not
patents in the medicine field violate human rights, specifically, the right to health
and access to medicine. It also seeks to recommend ways on how both rights could
be protected without hindering the other.

1
TABLE OF CONTENTS

I.) Introduction 3

II.) Statement of the Problem 4

III.) Scope and Limitation of the Study 5

IV.) Significance of the Problem 5

V.) Review of the Related Literature


a. Conflict between Intellectual Property Right and International
Human Right 7
b. International Human Rights Law on the Right to Health in relation to
Intellectual Property Rights on Patented Medicine 10
c. On the Effects of Patented Medicine in the Implementation of
International Human Rights 12

VI.) Conclusion and Recommendation


a. Conclusion 15
b. Recommendation 16
VII.) Bibliography 18

2
I.) Introduction
It cannot be denied that living is truly expensive, not only because of the luxuries that we
enjoy and necessities such as shelter and food but also because of the cost of maintaining a healthy
life. Illnesses, which may range from a simple cold to more complex ones whether acute or chronic
run rampant and is a hindrance to enjoyment of life.
The right of the people to health, which includes access to quality and affordable medicine
is a right protected by international laws and conventions, one of which is the International
Covenant on Economic, Social and Cultural Rights (ICESCR). Article 11, paragraph 1 states that
the parties recognize the right of everyone to an adequate standard of living for himself and for his
family and to the continuous improvement of living conditions. More specifically, the same
Convention provides that, “The States Parties to the present Covenant recognize the right of
everyone to the enjoyment of the highest attainable standard of physical and mental health.”
(International Covenant on Economic, Social and Cultural Rights (1976), Article 12, paragraph 1).
It also provides the steps to be taken by the States Parties to the present Covenant to achieve the
full realization of this right shall include those necessary for:
xxx
(d) The creation of conditions which would assure to
all medical service and medical attention in the event of
sickness. (International Covenant on Economic, Social and
Cultural Rights (1976), Article 12, paragraph 2).
Other international human rights treaties recognizing the right to health include the 1965
International Convention on the Elimination of All Forms of Racial Discrimination: Article
5(e)(iv), The 1979 Convention on the Elimination of All Forms of Discrimination against Women:
arts. 11 (1) (f), 12 and 14 (2)(b), the 1987 Convention on the Rights of the Child: art. 24, The 1990
International Convention on the Protection of the Rights of All Migrant Workers and Members of
their Families: arts. 28, 43(e) and 45(c), and the 2006 Convention on the Rights of Persons with
Disabilities: art. 25. (World Health Organization & Office of the United Nations High
Commissioner for Human Rights, "The Right to Health", 2008, p. 9)
At the local sphere, one need not look further than The 1987 Constitution, the supreme law
of the land in the Philippines which provides that “The State shall adopt an integrated and
comprehensive approach to health development which shall endeavor to make essential goods,
health and other social services available to all the people at affordable cost. x x x” (1987
Philippine Constitution, Article XIII, Section 11)”
Despite these laws, conventions, and treaties in place, various news show that Filipinos
still have trouble getting access to affordable quality medicine (Yee, 2019). In fact, the Philippines
is classified by the WHO as among the countries where less than 30% of the population have
regular access to essential drugs (Batangan, Echavez, Santiago, de la Cruz, & Santos, "The Prices
People Have to Pay for Medicines in the Philippines"). Medicine is not exactly cheap and in a
paper published by the WHO it was said that the price is definitely a factor which is an obstacle to
accessing medicines (Batangan & Juban, "Philippines Pharmaceutical Situation 2009 WHO
Household Survey on medicines ", 2009). It has also been said that the price of medicine in the
Philippines is actually in fact higher than that of other Asian countries as well as countries that are
in the same status as that of the Philippines.
In a paper made by the National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division, it was said that the factors affecting affordability are product
pricing, price regulation, and research and development costs, to name a few.

3
In the Philippines, as to product pricing and price regulation, pharmaceuticals are allowed
to give a “reasonable” price for their product subject to a ceiling set by the Department of Health
(DOH). The President of the Philippines upon the recommendation of the DOH may likewise
provide for a ceiling on the drugs, a power expressly given to the President by the Cheaper
Medicines Act, RA 9502, Section 17. The actual use of this power for the benefit of the people is
yet to be seen, however, as it has been said that the previous presidents have never exercised said
power. (Porcalla - De Leon)
Another factor that affects the pricing of the drugs is by virtue of the monopoly created in
favor of the pharmaceuticals having patent over a drug for a period of time. This right is part of
those conferred by the Intellectual Property Code in favor of patent holders in order to protect and
secure the exclusive rights of scientists, inventors, artists and other gifted citizens to their
intellectual property and creations, particularly when beneficial to the people, for such periods as
provided in the Code. (Republic Act No. 8293 (1997), Section 2). Patent is a set of exclusive rights
granted by a state to an inventor or his assignee for a fixed period of time in exchange for a
disclosure of an invention. It also seeks to restrain and prevent unauthorized persons from unjustly
profiting from a protected invention (EI Dupont De Nemours v. Therapharma, Inc. G.R. No.
174379, August 31, 2016). In this study, we would look at the patents applying specifically in the
medicine world.
In this paper, the researchers took a look at the implication of patents to human rights,
specifically the right to health and access to medicine. The main question this paper seeks to
answer is whether the existence of medicine patents violate human rights and if it does what can
be done to lessen this. In looking for a resolution to this question, we must also not forget that
Intellectual Property Rights as its name implies is a right protected by law not only locally but also
by international laws, conventions and treaties. The purpose of the patent law is first, to foster and
reward invention; second, it promotes disclosure of inventions to stimulate further invention and
to permit the public to practice the invention once the patent expires; third, the stringent
requirements for patent protection seek to ensure that ideas in the public domain remain there for
the free use of the public. (Salao, Essentials of Intellectual Property Law, 2019)
Article 27 of the Universal Declaration of Human Rights states that “…everyone has the
right to the protection of the moral and material interests resulting from any scientific, literary or
artistic production of which he is the author.” (Christmann, "How Intellectual Property Rights are
Human Rights", 2018) Being a right protected by the UNDHR it follows that the patent holder
may also not be deprived of his right arbitrarily. The question is, can Human Rights and the so
called Intellectual Property Rights co-exist without hindering each other? This paper upon making
a determination of the impact of patents to human rights will also make some recommendations as
to what can be done in order for the two to be able to foster without hindering the other.

II.) Statement of the Problem


This is a qualitative research about intellectual property and human rights which aims to
answer the following questions:
1. Do intellectual property rights violate human rights?
2. Is it possible to harmonize the right of patent holders to protection with the human
right to health?
3. Can intellectual property rights be considered as a human right?
4. What recommendations can be given to foster both intellectual property rights and
human rights without hindering the other?

4
III.) Scope and Limitation of the Study
This study focused on the assumed conflict between intellectual property rights and human
rights such as that of the right to health. It sought answers on whether there really was conflict
between the two and whether or not intellectual property rights violated human rights.
The study was purely limited to research and did not include any survey forms or use of
statistical data. As to intellectual property rights, the study focused only on patents and patents
relating to the field of medicine and other health related treatments. As to human rights, the study
mainly focused on the right to health and other related rights. It did not delve into the other
intellectual property rights of trademark and copyright.

IV.) Significance of the Problem


Medicines constitute a huge chunk of the health budgets in resource-constrained countries,
says the World Health Organization. An increasing need for accessible, safe, and effective
medicine was attributed to the country’s changing lifestyle and demographics. The life expectancy
of Filipinos has lowered to 69, while the world average is pinned at 71 years. Despite its increasing
wealth, Filipinos of all ages and incomes are exposed to the same health risks found in the country.
Generally, the more affluent a country, the higher it spends on pharmaceuticals to bring down
the cost for its citizens. The Philippine government spends 15 percent on Total Pharmaceutical
Expenditure. However, these efforts taken by the government are clearly not enough to address
the issue. Philippine medicine is too expensive that an illness can put a low-income family into
poverty. In a study conducted by Ramon L. Clarete and Gilberto M. Llanto of the Philippine
Institute for Development Studies, a chronic and debilitating illness hitting a middle or lower
income family can be its ticket to join the ranks of the poor or remain poor.
Given the skewed pharmaceutical market share, a WHO drug study found that 15 key
medicines were 100 percent available at private pharmacies but only 53 percent available at public
pharmacies. But access plummets for a wider range of 44 medicines that reached only 28 percent
of public facilities and 20 percent of private facilities. Due to limited access, only 66 percent of
Filipinos were able to dispense 75 percent of prescribed medicine. The obvious reason for this lack
or poor access to medicine is attributed primarily to the costly prices of such live-saving treatments.
(Lopez, 2018)
This study seeks to identify the challenges posed by the modern patent system on the right to
access the benefits of science. This basic human right and its implications to pharmaceutical
innovation, is timely because there have been a number of recent intellectual property cases in
various parts of the world that have direct impact on millions of individuals in terms of access to
life-saving treatments.
As Professor Aurora Plomer wrote on her book, entitled Patents, Human Rights and Access to
Science, “Scientific progress has been marred with disputes over ownership of the science by
academic institutions and private companies and the obstructing impact of patents on scientists’
access to essential data and research tools.”
A plethora of pharmaceutical patent infringement cases, including the landmark case of
Novartis v. Union of India, has emerged over the recent years and focused on controversial patents
granted to individual scientists, universities, organizations and powerful pharmaceutical
companies, over scientific discoveries that could lead to ground-breaking diagnoses and treatments
of diseases.
In the case of Novartis v. Union of India, the Indian Supreme Court has refused to allow one
of the world's leading pharmaceutical companies to patent a new version of a cancer drug, a

5
decision campaigners hailed as a major step towards enabling poor people to access medicines in
the developing world.
Novartis lost a six-year legal battle after the court ruled that small changes and improvements
to the drug Glivec did not amount to innovation deserving of a patent. The judgment aims to
prevent the ever-greening of patented products and to facilitate early entry of generic medicines
into the market for other medicines and diseases too. The impact will be felt not only in India, but
also across the developing world.
From the perspective of researchers, patients and the general public, concerns are drawn
primarily on the adverse impact of the patents on access to the benefits of science, which is a
universal and fundamental human right enshrined in Article 17 of the 1948 Universal Declaration
of Human Rights (UDHR) and Article 15 of the 1966 International Covenant on Economic, Social
and Cultural Rights (ICESCR).
The interplay between fundamental human rights and the intellectual property regime has
created the tension between the rights of inventors and the public interest in access to the benefits
of science. The timeliness of this issue is underscored by the growing scope of ‘patentability’ over
genetic material and other life forms permitted by patent offices and superior courts across the
world, as well as the entrenchment of corporate power at the expense of basic health needs through
the extension and enforcement of intellectual property rights over essential medicines.
On a heavier note, more than 85% of the world’s population live in developing countries, and
the vast majority of them have no or limited access to drugs that have saved and extended the lives
of people in richer, developed countries. In the developing world, where 95% of the 40 million
people with HIV/AIDS live, 20 million people have already died from AIDS. Every day, over
8,000 more people die and another 15,000 are infected with HIV. The global epidemic is
devastating entire countries and regions. Similarly, tuberculosis (TB) and malaria kill massively
and mainly among the poorest and most vulnerable of the global population, given their extremely
limited access to effective forms of treatment. (Elliott & Bonin, 2002)
The rules imposed on pharmaceutical patents, contained in domestic laws and international
trade agreements, affect the availability and affordability of medicines to treat common diseases
such as HIV/AIDS, TB and malaria.
A particular scheme of rules, crafted to incentivize pharmaceutical innovation, has be put in
place by the legislature or any other law-making body to favor the affluent. Under this scheme,
large financial rewards for pharmaceutical innovators are made to depend on their researching and
developing new medicines for the affluent, on their blocking cheaper access by the poor to such
medicines, and on the continued proliferation among the poor of the target diseases. Millions die
prematurely and billions suffer severely because patents make it impossible to supply them with
competitively priced essential drugs that generic manufacturers are ready and eager to deliver.
The scheme is often defended by arguing that without the incentives afforded to innovators,
future innovation would fail. It would not only lead to the misery of the poor but would also dictate
the fate of all of mankind. This defense, grounded on a false dichotomy, does not hold water. There
is another alternative scheme for incentivizing pharmaceutical innovations and has been proven
effective in eradicating and suppressing diseases
This study seeks to explain the connection between patent issues and the basic human rights
of the people, especially those living in developing countries, in terms of access to affordable
drugs.
Patent was seen to favor more or less competition between manufacturers and producers of
patented and generic drugs. Increased competition is proven to result in lower prices, which in turn

6
contribute to improved access to medicines. Although access depends on several factors, among
those key obstacles that people have to face is the high prices of medicines, which cannot be solely
addressed through foreign aid and drug donations.
In sum, significant reform must be instituted in the global patent system to facilitate democratic
oversight of patent policies and their compliance with human rights, and to ensure meaningful
realization of the right of everyone to access the benefits of science.

V.) Review of Related Literature

Conflict between Intellectual Property Right and International Human Right


Upon the enactment of the Trade Related Aspects of Intellectual Property Rights
Agreement (TRIPS) in 1994, debate from different sectors have been evident. One point of view
states that Intellectual Property Right violates human rights particularly the right to health. On the
other point of view, the right to protection of one’s creative and inventive work is equal to the right
to health. The different point of views is expressed on the succeeding discussions.
Prior to the institutionalization of the controversial Trade- Related Aspects of Intellectual
Property Rights (TRIPS) Agreement in 1994, countries mostly European countries adapt their own
patents systems fitted to their economic and technological needs. Prior to 1994 several countries
excluded pharmaceutical products from patent protection in order to facilitate access to affordable
medicines for their citizens and also to foster the growth of their domestic pharmaceutical
industries by permitting them to ride on the coattails of pharmaceutical inventions made in other
countries. In contrast with the past, several developing countries have to adopt patent policies laid
down under the TRIPS agreement having no freedom to carve their own patent policies favorable
to their domestic needs. They are now constrained to enforce stronger protection to patent. In fact,
patent protection of 20 years somehow impedes the accessibility of cheaper medicines by
monopolizing the market for the said period.
In one of the studies conducted there was an examination of the impact of the agreement
on Trade Related Aspects of Intellectual Property (TRIPS) on the right to health concerning its
impact on prices of essential medicines. This study elucidated the conflicting views between two
acknowledged international rights. The study further provides that upon enactment of TRIPS it has
given rise to global criticisms particularly the obligations of the States to uphold the right to health
and the impact of global patent rules on the prices of essential medicines. Furthermore, it has been
concluded by the author of the said study that Reduction of patent rights or the imposition of price
caps would of course reduce profits. (Joseph, 2019)
Furthermore, in another journal published by Joseph Millum in relation to the discussion
on the enactment of TRIPS, it provides that there are several critics who argued that the present
patent system violates human rights. The cause of high prices of pharmaceutical products is the
right afforded to manufacturers granting them exclusivity which hinders medical innovation and
prevents access to life saving drugs. In the said journal the author concluded that while others
claim that intellectual property rights are similarly recognized by international treaties that protect
author’s rights, intellectual property rights have equal footing with the international human right
to health. (Millum,J. 2016)
Indeed, both rights are recognized internationally by states. The succeeding paragraphs
give clearer view on the global perspective between intellectual property right and the right to
health. The right to health including the right to access medicines are embodied in the International
Bill of Rights. In a research paper conducted by Joseph Millum, stated that intellectual property

7
right is also a human right by stating that there is also a human right that protects creative works,
including scientific productions thus, creating a dilemma as to what should be given greater
weight: the intellectual property rights of innovators to incentivize them to keep on creating or the
right of the people to access the benefits of science, particularly, live-saving treatments or essential
medicines. The question that comes to mind then would the right to support intellectual property
protections be considered even when they might affect health negatively?
According to one study conducted, the improvement of access to medicine in developing
countries can be interrelated with the adjudication and resolution of patent law disputes. The court
of developing countries can incorporate a right to health in adjudication of patent cases involving
pharmaceutical products. It is argued that since patent are not human rights, they should not be
allowed to trump the right to health. Courts in the developing countries cannot afford to ignore the
right to health when an issue involving patent rights in relation to pharmaceutical products that is
submitted before the court for resolution. (Oke, 2013)
Indeed, as stated by the author there must be harmonization between the adjudication of
cases involving protection of human right on one hand and protection of intellectual property right.
However, the statement that since patent are not human rights, they should not be allowed to trump
the right to health is controverted by the succeeding paragraphs arguing that inventors shall be
rewarded for their inventive works.
Patent rights have a direct impact on the right to health, especially in developing countries
where pharmaceutical products are priced beyond the reach of poor patients. According to Sarah
Joseph, “as intellectual property laws confer monopoly rights, they generally inflate prices. This
circumstance is problematic as goods that are essential for the enjoyment of human rights, such as
new medicines, can be priced out of the reach of poor people.
Intellectual Property Rights reward the inventors of new products for their hard work and
fruits of their labor. Said right, protects the inventor from being robbed of the fruits of his labor by
providing absolute monopoly of three years from filing date. After the first 18 months of the
publication requirement which comes with the disclosure of the patent application must have been
complied with. The grant of patent is to provide protection to any inventor from any patent
infringement. Furthermore, once the invention is disclosed to the public, only the patent holder has
the exclusive right to manufacture, utilize, and sell the invention to the market. The Intellectual
Property Code of the Philippines confers exclusive rights to inventors where the subject matter of
patent is a product, to restrain prohibit and prevent any unauthorized person or entity from making,
using, offering, sale, selling, importing that product; where the subject matter of a patent is a
process, to restrain, prevent or prohibit any unauthorized person or entity from using the process,
and from manufacturing, dealing in, using selling or offering for sale importing any product
obtained directly or indirectly from such process. (Intellectual Property Code.sec 71,par. a and b)
in summary, said right provides monopoly by the inventor over the patented product.
TRIPS requires States to confer patent rights, that is exclusive rights of exploitation, for
20 years in respect of ‘new’ inventions involving an ‘inventive step’ and which ‘are capable of
industrial application’. Contrary to such, critics of the TRIPS Agreement voiced out that monopoly
of patented product substantially increases price of medicines instead of providing cheaper
medicines accessible to the public and not just catering for the few.
In fact, one of research regarding the impact of Intellectual Property Right on the increase
of price of medicines provides that oppositors of patenting processes argue that patents encourage
monopolies. The holders of pharmaceutical patents, or their licensees, can therefore charge much
more than the cost of production for drugs without being undercut by competition. (Millum,

8
J.2016) An example of which is that pharmaceutical companies who patent their invented drugs
can dictate the price selling them at a higher cost. Since these companies are given exclusivity
right to preclude third persons or other companies to sell, use and manufacture product having the
same ingredient or substance there will be no competition in the market. Having no competition
in the market the patent holder may dictate the price without considering prices that may be given
by other competitors involving the same pharmaceutical product. The operation of patent precludes
most forms of competition. Patents have also been critiqued given that they preclude competition
even where another inventor has created the same or a similar product using independent methods.
In relation to the preceding paragraph in another research paper it stated that strong
intellectual property rights were developed for pharmaceutical companies who invested in the
creation of new medicines to receive the maximum profit from their innovation. However, the
monopolization of these medicines’ production gives the corporation the ability to sell their
product at a high cost, often unreachable for poor countries to afford. (Morisson, 2016)
Furthermore, the said paper even provides an implication of the research that there is a need to re-
evaluate the effects of intellectual Property Rights impose.
The question now is, can we consider the right to health superior than Intellectual property
right or vice versa. The increase of prices of medicines due to monopoly curtails the right of every
citizen to access cheaper medicines. In a third world country such as the Philippines, the
equilibrium between the rich and the poor is imbalanced. There are more who cannot afford
branded medicines protected by patent than those who who are willing to pay regardless of the
cost of medicines. Hence, it can be surmised that intellectual property right hinders the ability of
the public to access lifesaving drugs and inventions which may cure unknown causes of illness.
According to Sarah Joseph in her research, Intellectual Property regimes are said to be
justified because they encourage research, creative endeavor and innovation. For example, patent-
holders enjoy commercial benefits from their inventions before being exposed to competition. A
natural outcome from such monopoly rights is that prices for IP-protected products are inflated.
This circumstance creates problems in terms of human rights if the product is essential for the
enjoyment of human rights yet it becomes inaccessible to poor people.
Before investigating the specific issue of the impact of TRIPS on access to drugs, one must
examine whether Intellectual Property Rights are themselves human rights. Article 15(1)(c) of the
ICESCR recognizes the right of everyone to benefit from the protection of the moral and material
interests resulting from any scientific, literary or artistic production of which he is the author.
In 1994 the World Trade Organization (WTO) established the Agreement on Trade and
Related Aspects of Intellectual Property Rights (TRIPS) to standardize worldwide intellectual
property laws, including patent laws. When TRIPS is fully implemented, in 2016, the international
patent regime will require patents, including those on pharmaceutical products, to extend a
minimum of 20 years from filing in all countries, including least developed countries. This will
constitute a substantial strengthening of international intellectual property protection. Patents give
their holders a temporary monopoly on the manufacture, sale and use of the product or process
patented.
Traditionally, intellectual property regimes sought to balance the rights of creators with the
interests of the public to have access to artistic works and technology products. The very
existence of intellectual property rights was originally justified on the grounds that incentives
and rewards to artists and inventors result in benefits to society. However, current
developments tend to weaken these balances and to skew the system in favor of a much
narrower range of interests. Commercialization has changed intellectual property from a means

9
to provide incentives to researchers and inventors to a mechanism intended to encourage
investment and protect the resources of investors. (Guerassimov, 2001)
The entitlement of the inventor of protection with respect to his work is evidently justified
as discussed in the previous paragraphs. However, its protection also gives rise to detrimental
impacts on realizing the right to health.
The right to health includes access to appropriate health care. The present intellectual
property system reduces the availability of pharmaceuticals in a variety of ways. By increasing
development costs, intellectual property protection may hinder research and development of
new drugs and technologies appropriate to smaller markets, such as the needs of developing
countries. Patented drugs are almost always far more expensive than their generic
counterparts. Patent holders, which are almost always corporations, have the freedom to price
their products at arbitrary, often high, levels that make many essential drugs beyond the
means of poor persons lacking health insurance, which includes the majority of residents
under developed countries.
Intellectual Property (IP) protection restricts trade and competition, so IP clauses are
somewhat anomalous in trade agreements, which are normally designed to decrease trade barriers.
What is the justification for IP protection? Patents reward people for their inventions, thus
encouraging creativity and innovation. Patents operate on the assumption that people are not
inherently altruistic, and expect rewards for their endeavors, especially when those endeavors are
risky as they may, and often do, result in costly failure. Furthermore, the money raised from patent
protection is said to be necessary to fund the considerable costs of research and development.
Therefore, without patents, innovation in the pharmaceutical field or any industrial field might
grind to a standstill. While it is true that the high prices generated by patent protection may render
access to drugs selective, it is nevertheless better that a drug is available to some rather than non-
existent and available to no one. (Joseph,S. 2019) The argument seems to make sense, with no
motivation there will be less medicines invented and manufactured available in the market.
However, it can also be argued that patent also provides exclusive monopoly over the product for
a period of time. The only way to access such product and innovate new products is to grant
License to interested parties and by way of Compulsory Licensing. Under the Intellectual Property
Code, Compulsory Licensing allows the grant of a license to exploit a patented invention even
without the agreement of the patent owner under certain circumstances such as national
emergencies or other circumstances of extreme urgency.

International Human Rights Law on the Right to Health in Relation to Intellectual Property
Rights on Patented Medicine
Health is a fundamental human right indispensable for the exercise of other human rights.
The Article 25 of the Universal Declaration of Human Rights, 1948 mentioned health as part of
the right to an adequate standard of living. The International Covenants, Treaties relating to human
rights and the Constitutions of various nations recognize that a number of elements would be
encompassed by the right to health from prevention to cure to access to drugs. (Anuradha Chadha)
The association between intellectual property laws and the provision of new drugs to those
who need them is argumentative. Critics of the present patent system dispute that the high prices
supposed necessary to promote medical innovation prevent access to lifesaving drugs. However,
others contend that this is a violation of the right to health recognized in international treaties.
Others claim that intellectual property rights are similarly recognized by international treaties that
protect the rights of authors. The debacle on both topics incite a question on whether the IP rights

10
should always be subordinate to other human rights as well as up to what extent to which access
to medicines is protected by human rights.
The right to health is explicitly stated in the UDHR and the ICESCR (UDHR Article
25.1and ICESCR Article 12). According to the ICESCR everyone has a right to “the enjoyment of
the highest attainable standard of physical and mental health.” The content of the right is specified
more exactly in the ICESCR and, the interpretation of the right issued by the Committee on
Economic, Social and Cultural Rights. The law and jurisprudence asserts that states have a core
obligation to “provide essential drugs, as from time to time defined under the WHO Action
Program on Essential Drugs.”
A report from World Health Organization (WHO) and Health Action International on the
results of surveys undertaken in 36 nations reported that only one third of essential medicines
needed were available in the public sector and the remaining two thirds of such medicines were
available in the private sector. (Cameron, 2009) One of the significant reasons for the lack of
access of essential medicines required for needed treatment is the high prices fixed for those drugs
(Ellen F., 2009). Exorbitant drug prices are frequently the result of strong intellectual property
protection (Ellen F., 2002).
The creation, use and the exploitation of mental or creative labour are regulated by the
intellectual property law and it also consists of copyright, trademark, geographical indications,
industrial designs, layout designs of integrated circuits, patents and their designs, undisclosed
information and trade secrets. On inventors, legal rights and more significantly over the product
inventions or process, negative rights are conferred by patents. Therefore, the persons not
authorized by patentee can be prevented by him from making, using, offering for sale, selling or
importing the patented invention (Grover, 2009). While absolute monopolies are created by
product patents, so patents lead to relative monopolies. These monopolies when created by patents
restrict competition and pave way for patentee to set up high prices. Thus, patent protection keeps
prices inflated up to one hundred times the cost of manufacture of drugs also as a patent product.
So, it is evidently clear that there is very close relationship between intellectual property rights
(IPR) as human rights on the one hand and right to health as another human right on the other
hand. Intellectual property law has a very strong influence upon the right to health as the
pharmaceutical products are protected by it (Helfer, 2003). However, the linkage between
intellectual property rights and health has been the focus of much debate. No other legal subjects
have been attracting so extensive social and academic concerns as the conflict between intellectual
property rights and the right to health for the last few decades.
The IP Code provides for an international exhaustion of patents regime for drugs and
medicines. Under Section 72.1 of the IP Code, as amended, the patent rights holder “has no right
to prevent third parties, without his authorization from using a patented product which has been
put on the market in the Philippines by the owner of the product, or with his express consent,
insofar as such use is performed after that product has been put on the said market: Provided, that,
with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or
medicine has been introduced in the Philippines or anywhere else in the world by the patent owner,
or by any party authorized to use the invention; Provided, further, that the right to import the drugs
and medicines contemplated in this section shall be available to any government agency or any
private third party.” (Chua, 2017)
A human rights-based approach focuses particularly on the needs of the most
disadvantaged and marginalized individuals and communities. Because a right to health as a
human right is a universal entitlement, its implementation is evaluated particularly by the degree

11
to which it benefits those who hitherto have been the most disadvantaged and marginalized and
brings them up to the mainstream level of protection. Thus, in adopting intellectual property
regimes, States and other actors must give particular attention at the national and international
levels to the adequate protection of the human right to health of the disadvantaged and
marginalized individuals and groups, such as indigenous peoples by providing them access to the
drugs and medicines at affordable prices. In order to achieve this objective, the following solutions
can be recommended:
1) the need of the hour is to make coherent, consistent and balanced legal norms at
international level clarifying different concepts and issuing in clear terms stringent and mandatory
guidelines/regulations in TRIPS to be followed by both developing and developed nations
regarding allowing greater opportunity for airing a human rights perspective on intellectual
property issues in order to facilitate the integration of an increasingly impenetrable thicket of legal
rules governing the same broad subject matter that boost up both individual rights and global
economic welfare. It is essential to distinguish the inability from the unwillingness of a State Party
to act in accordance with its right to health obligations.
2.) High patentability standards should be established at international level and national
level (particularly by developing countries and LDCs) for exclusions from patentability, such as
new forms and new or second uses, and combinations, with the aim of addressing ever-greening,
ensuring the grant of patents only to genuine inventions in the pharmaceutical field so as to
facilitate the generic entry of medicines into the market.
3.) Innovative approaches to medical research and development (R&D) and its funding
need to be developed particularly for the neglected diseases with the emphasis upon public/private
initiatives for developing required medical technologies. Publicly funded research or
pharmaceutical subsidies might not only help ensure that pharmaceutical corporations prioritize
affordable diseases-related innovations but also provide a better balance between humanitarian
urgency and patent protection.
4.) A coordinated effort of global system consisting of international lawyers, world leaders
and public health experts for creating policies to relax patents and increase the affordability of
generic antiretroviral would be one step in this direction providing patients with the right to live
longer, more dignified and productive lives. (Chadha, A.)

On the Effects of Patented Medicine in the Implementation of International Human Rights


Patent protection is considered as a double edge sword because it promises exclusivity which
provides temporary monopoly and guarantees monetary incentives that lead to creation, invention
and discoveries. However, there is also a consequence of exclusivity where it tends to impede the
flow of information that might permit, indeed spur, invention.
One effect of patenting pharmaceuticals on health and consumer welfare is the launch of new
drugs. There can be long delays before newly approved drugs become available outside the
country in which they are first approved and sometimes, they are never launched. Factors behind
these delays are the influence of Intellectual Property Rights (IPRs) and price regulation wherein
countries of weak IPRs and aggressive price regulation, new drugs become available for sale (if at
all) only with substantial delays. (Cockburn, Iain M.)
Because of the consequence of exclusivity, there is a need of risking the benefits of patent
protection to avoid delay. It will certainly affect the right of patent holders but may also result to
rapid distribution and launching of the new drugs. Sometimes, there is a need to sacrifice

12
something because if delay happens, it might also be too late to be used by public. It may affect
the right to appropriate medical care which includes access to available and cheaper medicines.
In a local study conducted by Cruz, (2008), it was found out that many Filipinos have no access
to affordable drugs and the patent system is partly to blame. Patent protection provides monopoly
to patent holders where they can fix the price of their patented drugs. Usually, the high research
and development costs of developing medicines justify the high prices. Patent holders also have
right to recover their investment in developing the product. However, public cry for affordable
medicines given the economic situation in the country. Indeed, not everyone can afford medicine
especially when some are just trying to make ends meet. Medicines are one of the essential needs
of the public that they cannot forego as it is related to health. The study provided that debate on
the issue of price regulation has always been in favor of patent holder. In poor countries like the
Philippines, patents on Pharmaceuticals can become obstacles to public health, because patent
holders can set prices that the majority of the people cannot afford.
Similarly, Millum, (2008) said that the present Intellectual Property (IP) regime leads to higher
prices for essential medicines. Higher prices for essential medicines reduce the ability of people
and governments to access them. Consequently, the international IP regime appears to be in direct
conflict with state obligations under the right to health.
Cruz, (2008) and Millum, (2008) said that patents on pharmaceuticals may provide incentives
to patent holder but may also become a hindrance in the implementation of human rights especially
the right to health because of its accessibility and high price that burdens the public.
The access to essential medicines campaign advocates for the right of poorer countries to
use completely legal trade measures in a public health emergency which include compulsory
licensing. It is the legal right to produce patented medicines in exchange for a royalty payment to
the patent holder. Also, parallel import is the legal right to import patented drugs from another
country where they can be obtained more cheaply. These measures lead to introduction of generic
drugs which lower costs. A study by Médecins Sans Frontières found that the introduction of
generic AIDS drugs in Brazil means that it now costs the same to treat 1000 patients there as it
does to treat 552 in Thailand, where generic drugs are less available. (Schull, (2000).
The pharmaceutical patent protection works well only in high income countries with citizens
having purchasing power to buy expensive patented pharmaceuticals but it does not work well in
developing and least developed countries because of different factors, affordable access to
medicines being the most important of them. In a study conducted by Abbas, (2013), it focuses on
the compulsory licensing of pharmaceuticals. The study enumerated several benefits of the
compulsory licensing of pharmaceuticals. Some of it are: 1) lower risks to consumers of counterfeit
products in buying the inferior quality unapproved generics which may contain many dangerous
impurities; 2) research and development by pharmaceutical companies may be carried out which
would lead to an opportunity to invest and examine diseases which are incurable; 3) humanitarian
consideration is observed by pharmaceutical companies where they lower prices to cover only the
cost of production. It becomes inevitable to save lives of the populace by ensuring the accessibility
of drugs at affordable prices.
Compulsory licensing under the Intellectual Property Code (IPC), Section 93, is the grant of a
license to exploit a patented invention, even without the agreement of the patent owner, in favor
of any person who has shown his capability to exploit the invention. This measure as discussed by
Abbas, (2013) and Schull, (2000) is a violation of the rights of the patent holder because it may
have scrap their right to fix their own prices considering the cost of production. However, this
violation is somewhat needed in order to avoid abuses in the patent system like the misuse of

13
monopoly right and also to protect the human right to health. Without this measure, people may
die without even having the chance to access essential medicines. This measure may be the solution
to grant the public access to essential medicines thereby protecting their human right to health.
Under the same section, public interest, in particular, national security, nutrition, health, or the
development of other vital sectors of the national economy is sufficient ground to grant a
compulsory license. Under the TRIPS Agreement, however, not every patented medicine may be
a subject of a compulsory license. While it seems that the IP Code may subject any patented
medicine to compulsory licensing as long as there is a public interest to be protected, international
agreements such as the TRIPS Agreement limit such scope. Section 15, Article II of the Philippine
Constitution provides that the State shall protect and promote the right to health of the people and
instill health consciousness among them. Countries such as India, Brazil, and Thailand went as far
as violating the TRIPS Agreement in order to protect the health of its citizens. Intellectual property
protection is indeed vital to the growth and development of civilized society. However, at a certain
point, an individual’s right to life of the people should be considered paramount. (Fernan, (2015)

14
VI.) Conclusion and Recommendations

Conclusion
The debate tackling the connection between Intellectual Property Rights and Human
Rights, specifically the right to health, had come a long way. As discussed in this paper, the two
rights are hardly reconcilable. The problem arises when questions are raised regarding which right
should be given more priority or whether it would be possible to harmonize the two.
As mentioned in the review of related literature, the realization of one right might operate
to trample the other. On one side of the coin, the enforcement of one’s right to access to medicines,
by removing the patent barriers, undeniably, makes a huge impact to the rights of innovators to be
protected with their inventions as they would have less chances of recovering full expenses in
research and development. On the other side of the coin, the stringent policies protecting the rights
of patent holders would undoubtedly create monopoly, which ultimately result in costly prices of
medicines.
With the advent of the TRIPS Agreement, pharmaceutical companies were afforded strong
intellectual property protection to the detriment of the people, particularly those living in
developing countries. While bringing immense progress in the intellectual property protection for
developed countries and the pharmaceutical industry, the TRIPS has in fact, considerably
downgraded the process of development for developing countries. By imposing upon all members
states the obligation to provide protection for all forms of invention, it has effectively deprived
developing states of their right to decide for the benefit of its citizenry, that is, by excluding
pharmaceutical patents from patentability, at least until the situation concerning the right to health
of their citizens has improved.
As to the question of whether both rights may be harmonized, the stakeholders of the
pharmaceutical industry and advocates of human rights must meet half way and make
compromises that will not be too ideal for either side. For so long as differences exist with respect
to approaches exercised by either party, reconciliation for both would be to no avail. Hence, a
consensual approach to the conflict between pharmaceutical patents and access to medicines will
help pave the way for the realization and enjoyment of human rights, on one side, while on the
other side, inventors enjoying the fruits of their hard work. Undeniably, removing the patent barrier
would not automatically mean that the access to medicine shall be sufficiently addressed with. The
patentability requirement is only among the key factors influencing one's access to medicine. There
will still remain the need for better funding for the medicines in both public and private health care
facilities, for effective health care systems that are free from corruption, wise selections of drugs
and better social security schemes, but as soon as the prices are lowered and as soon as more people
can afford and access the necessary medicines, these other tasks will be much easier.
On the issue of whether intellectual property rights may be considered as a human right,
the researchers are of the opinion that the same may be treated as a human right, anchoring the
justification from the provision under Article 17 of the Universal Declaration of Human Rights,
which states that ‘everyone has the right to own property alone, as well as, in association with
others and no one shall be arbitrarily deprived of his property. However, caution must be exercised
in treating the same as a human right to the effect that the basic human right to health, particularly,
on the right to access to pharmaceutical drugs, must always be afforded greater weight. The reason
for this is borne by the fact that the extent of the impact of one’s right to health, once prejudiced,
is greater in scope rather than that of the proprietary rights of huge pharmaceutical companies. It
will not only result in millions of deaths in developing countries, but it may also extend to

15
developed countries, which, clearly, would not serve the purpose of the patent, that is, to provide
technical solutions to problems in the field of human activity.
Basically, the right to access to medicine forms part of the human right to health.
Noteworthy is the fact that the right to the highest attainable standard of health is indispensable for
the enjoyment of all other rights, such as, civil, political and socio-economic rights. Without health,
no other spheres of life can be realized in their full extent. Every person has the right to access
affordable essential medicines, which are of good quality. This is guaranteed to everyone without
distinction of any kind, such as race, color, sex, language, religion, political or other opinion,
national or social origin, property, birth, or other status.

Recommendation
Notwithstanding the extensive literature on this issue, there appears to be no concrete
solution that would be acceptable to all stakeholders. Several campaigners, advocates and
organizations have taken serious efforts into finding the solution which would yield a win-win
situation for both the general public and the pharmaceutical industry. However, it would be
impossible to turn such endeavors to reality, without the efforts of the States, especially Members
of the WTO, international organizations, and the pharmaceutical industry in deciding which
solution would be feasible to implement.
Primarily, States have the ethical duty to ensure full realization of the right to health.
According to the UN Committee on Economic, Social and Cultural Rights, in respecting the right
to health, States should ensure that this right is given consideration in international agreements and
should ensure that these agreements do not negatively affect the right to health. A separate body,
the UN Commission on Human Rights, has also recognized that access to medication in the context
of pandemics such as HIV/AIDS is one fundamental element for realizing everyone’s right to
health.
Moreover, pharmaceutical companies need to consider whether the medicines developed
today are being utilized to serve their initial purpose, which is saving people’s lives or are they
simply a source of income for the stakeholders.
Another recommendation is the stricter application and the use of powers that are already
within our disposal. One such solution already within our grasp is the enactment of Republic Act
9502, An Act Providing For Cheaper and Quality Medicines. RA 9502 or the Cheaper Medicines
Act seeks to adopt appropriate measures to promote and ensure access to affordable quality drugs
and medicine for all. This law is more commonly associated with the Botika ng Barangay (BnB)
program where people can go to for free medicines. However, not everyone is aware that they
could go to their local government unit to seek assistance for their medicine needs, nor can it be
said that BnBs available drugs are sufficient since there are still cases wherein people are asked to
buy medicines not available in BnBs. There is also a call for the President to exercise the power
expressly conferred to the office by Section 17 of the same Act, to impose maximum retail prices
on drugs listed under Section 23 of the same Act. This prerogative has never been exercised and it
might be high time for the government to take a hard look at the cost of medicines and make a
determination whether it is time to lower the price ceilings currently imposed. The fact that the
masses still feel that proper medicine is out of their reach just shows how much adjustment should
still be made with our current laws and implementation as well as our approach. Another reason
why people do not patronize generics or those available in the BnBs is due to the belief that branded
drugs are so much more effective than generic ones. As such, proper information dissemination
should be given to the public to debunk this and encourage its use.

16
As to studies that could be further undertaken, a more in depth study should be done to see
whether intellectual property rights can really be considered as one protected in equal terms as
other property and human rights, and if so is the act of limiting the rights associated under the
family of intellectual property laws constitutional.
Other research could also take a look at the application of various programs such as those
constituted under the Cheaper Medicines Act or the Generics Act and other related laws, and see
how its application is actually faring in terms of helping the masses in getting proper access to
health care.
All in all, the researchers feel like while there are already good laws and regulations in
process, the implementation part is lacking or that the assistance taken from these things cannot
cope with the present status of our country in terms of healthcare and therefore, further steps should
be taken in order to fill these lapses.

17
V.) Bibliography
Abbas, M. Z. (2013). PROS AND CONS OF COMPULSORY LICENSING: AN ANALYSIS OF
ARGUMENTS. International Journal of Social Science and Humanity, 3(3), 254–258. Retrieved
from
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2368116&fbclid=IwAR0IoMGUcOEqOE7
MJ8QAZkiNcuWJqNN74vL70RRpBE1dOyIU9hLQ6WDXFD0
Augustine et.al; Making Medicines Affordable Health and Medicine Division. (n.d.). The National
Academic Press. doi: https://doi.org/10.17226/24946
Batangan, D., & Juban, N. (2009). PDF.
Batangan, D. D., Echavez, C. D., Santiago, A. A. D., de la Cruz, A. C., & Santos, E. (n.d.). PDF.
Cockburn, Iain M. INTELLECTUAL PROPERTY RIGHTS AND PHARMACEUTICALS:
CHALLENGES AND OPPORTUNITIES FOR ECONOMIC RESEARCH. The Economics Of
Intellectual Property, 150–173. Retrieved from
https://www.wipo.int/edocs/pubdocs/en/wipo_pub_1012-
chapter5.pdf?fbclid=IwAR2B9TPrY0b8jPf3sU4WSQl0o2yKNZt9-
VqH_CXScztRb9GCwMvPw9pyY_8
Cruz, C. E. (2008). THE PATENT SYSTEM AND THE QUEST FOR AFFORDABLE MEDICINES.
DLSU Business & Economics Review 18:1, 63–72.
Fernan, H. M. (2015, September 16). BRINGING DOWN THE COST OF MEDICINE THROUGH
COMPULSORY LICENSING. Business World Online. Retrieved from
http://www.bworldonline.com/content.php?section=Opinion&title=Bringing-down-the-cost-of-
medicine-through-compulsory-licensing&id=115375
Guerassimov, E. (Ed.). (n.d.). APPROACHING INTELLECTUAL PROPERTY AS HUMAN
RIGHT. Retrieved from Unesdoc.unesco.org.
Joseph, S. (2019). TRIPS AND THE RIGHT TO HEALTH. Oxford University Press, 214. doi:
10.1093/acprof:oso/9780199565894
Millum, J. (2016). ARE PHARMACEUTICAL PATENTS PROTECTED BY HUMAN RIGHTS?
Journal of Medical Ethics. doi: https://dx.doi.org/10.1136/jme.2007.022483
Morisson, C. (2016, July 1). HUMAN RIGHTS PERSPECTIVE BEHIND PATENT LAWS.
Retrieved November 17, 2019, from
http://digitalcommons.calpoly.edu/cgi/viewcontent.cgi?article=1044&context=paideia
Oke, E. K. (2013). INCORPORATING A RIGHT TO HEALTH PERSPECTIVE INTP
RESOLUTION OF PATENT LAW DISPUTES. Health and Human Rights Journal, 15, 97–109.
Retrieved from https://www.hhrjournal.org/2013/12/incorporating-a-right-to-health-perspective-
into-the-resolution-of-patent-law-disputes/
Picazo, O. (n.d.). PDF.
Porcalla - De Leon. (n.d.). Review of Cheaper Medicine Law Sought. Retrieved December 17,
2019, from https://pressreader.com/article/281608125156590.
Schull, M. (2000). EFFECT OF DRUG PATENTS IN DEVELOPING COUNTRIES. BMJ
321(7264): 833. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1118638/
Sison, M. (2018, September 23). ‘Most disabled Filipinos can’t afford healthcare, drugs.’
Retrieved December 17, 2019, from https://www.scidev.net/asia-pacific/health/news/most-
disabled-filipinos-can-t-afford-healthcare-
drugs.html?__cf_chl_jschl_tk__=41bf43821cd4d8e3c2dcffdd8658a5ce90e1b74f-1576567937-0-
ATF-BXUTetF-NFtiYAbjjKqGV_pLvEM_lu-

18
_K7zQkMSWJsPYF_wHoVN72fts5yrK9omAemWndZsGx24wRDQCsEyVBMM_7Rnu3ygX
QNQaigL0pK32nVV8-Txg_GPPJMUJluXzyunzGLtDxKcNnMXZeWCRgNKbKNjGD4-
Ku2UF4YLU9o4MW16IGk5dRXvV4KS6hlf67Szz_uuyGe6UYbvOrZNwb91APdJ62omKhAT
3WeYMEBEBOxdpQVTMykIGltyQIPCjBLJuXVSPJ-
cjhaKegrmV4DVx72Hu1jPMKwf9pj7X4oxnRNedQgTAhMM9D97R1GMdDX2w-
aYcvDvGdSPZPMsyqVT-lZMCmkR-zpmyNK3KQiB3uQWBzfRMAEPglHdaUQ.
Yee, J. (2019, December 6). 99 Percent of Filipinos can't afford prescription drugs, says survey.
Inquirer. Retrieved from https://newsinfo.inquirer.net/1198647/99-percent-of-filipinos-cant-
afford-prescription-drugs-sasys-urvey

19

Você também pode gostar