Reforming Intellectual Property, Trade and Investment Law in the COVID-19 era By Mr. David Enrique Betancourt Cruz, LL.M., LL.M.

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“Towards a New International Economic and Legal Order for
Sustainable Development”

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Reforming Intellectual Property, Trade and Investment Law in the
COVID-19 era
By Mr. David Enrique Betancourt Cruz1
2021
1
*Master of Laws, LL.M. European Law from Stockholm University and LL.M. Legal Sciences, specialization –
Intellectual Property Law, Stockholm, Sweden. David Betancourt is Director of ElitSD.Org. His work focuses on
Intellectual Property law reforms, innovation policies and sustainable development projects. He is the advisor of
different firms (Spain and Colombia) working on Intellectual Property, access to medicines, sustainable development
projects and policy recommendations.

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Main Questions:
The three major questions to be answered in this book are:
- First, is there an appropriate balance of rights and obligations under existent
international intellectual property rules between innovation and economic
incentives and on the other hand, access and human health protection in
developing countries and Least Developed Countries (LDCs) today?
-Second, to what extent the emerging global Intellectual Property Regime (IPRs)
and the tendency to require strengthening domestic enforcement of IPRs,
beyond (TRIPS)2 Trade Related Aspects of Intellectual Property Rights standards
(i.e., introducing so-called TRIPS-Plus pressures in new Free Trade Agreements
(FTAs) and Bilateral Investment Agreements may be expected to enhance or
impede local development and access to medicines, treatments and vaccines
at affordable prices?
-Third, what is the overarching societal function of the contemporary Intellectual
Property law regime and to what extent is that function attainable given the
existing design of International Patent rules and associated domestic rules
regarding pharmaceutical patents in developing countries and LDCs?
2
The TRIPS Agreement, which came into effect on 1 January 1995, is to date the most comprehensive multilateral agreement on intellectual
property.

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Main Argument:
-The central argument developed in this book is to demonstrate how
strengthening existent IPRs and Bilateral Trade and Investment Agreements in
developing countries and LDCs may strongly affect access to medicines,
treatments and needed vaccines in the context of Covid-19 and environmental
protection as the prices of life saving medicines increase for the benefit of
Transnational Interest Blocks located in developed countries that continue to
benefit from existent international intellectual property rules beyond WTO
Agreements.
-Furthermore, the recent proliferation of Bilateral Investment Treaties (BITs) has led
to many developing countries being sued by transnational corporations, resulting
in the overturning of many health, safety, and environmental laws, as well as
awards in the billions of dollars from taxpayers to corporations which in my view
is a big challenge for the realization of Third Generation Human Rights and
Sustainable Development Goals.
-Then, I will elaborate on how developing countries should seek to collaborate
and create a new legal system in order to foster local innovation and spur
competition domestically and regionally. Developing countries must take the
lead in policy design and intellectual property innovation and reform in order to
offset new protectionist tendencies in developed countries and help LDCs to
become truly independent and accomplish their own development objectives
as well.

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-The international trading system, neoclassical economics and the old economic
model based on unlimited growth and the irrational exhaustion of world
resources and environmental limits governing today's transactions are kicking
away the ladder for new Sustainable Development goals. Neoliberalism tends to
put a lot of weight on efficiency and markets while neglecting equity,
democracy and human life and health over profit hoarding.
-International pressures from developed countries and multinational firms were a
consistent and omnipresent part of the context for TRIPS implementation for all
developing countries. Developing country governments face intense
international pressures to go beyond minimum TRIPS requirements, limit their use
of TRIPS flexibilities, and introduce IP protection at a faster pace than TRIPS
requires.
-Other relevant question from a competition and international transfer of
technology perspective to be developed is whether or not the TRIPS Agreement
is contributing to reduce the productivity difference or technology gap between
nations. Why certain firms from certain nations often preserve technological
advantages for many decades in industries, instead of inevitably losing their lead
as technology gap theories would suggest? Is the TRIPS Agreement fulfilling the
objectives of transfer of technologies?
-No one knows better what is needed in an LDC community than an inventor
who lives there. Why and how do international corporations make particular
nations develop skills and know-how in certain industries and others do not? How
could multinationals and the private sector be involved in developing a coherent
and global framework for technology transfer that would be enforceable and
good for sustainable development through the creation of a Global Governance
Authority for Sustainable Development, ITT and Innovation?

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-Ultimately, this book makes the case for a concerted, multi-stakeholder effort in
moving towards a new paradigm: a paradigm in which fair trade, competition
law and global investment are integrated means moving away from the
traditional theories of trade that look only at costs and excluding ontological and
philosophical considerations that are relevant from a legal perspective on
International Law. By moving from the comparative to the competitive
advantage of a nation, the new theory must reflect a broad conception of
competition that includes sustainable production and consumption, segmented
markets, differentiated products, technology differences and economies of
scale.
-The question is whether the IPRs system helps to reach a global balance in this
sense? This implies rewriting a New Global Economic and Legal Order which
incorporates social welfare and sustainable production and consumption and
the development of social business and real means for redistribution of wealth in
order to transfer power to the people, in other words, a more democratic, fair
and a new power sharing system.

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Legal Method and Approach:
"The pen of the writer must be committed to its time. Writing is a moral issue"
- Jean Paul Sartre-
This book is written from a Global South perspective and in the context of a
pandemic of international scope due to Covid-19, as it intends to put into
perspective the past and present of current international intellectual property
legal infrastructure. For that end, I write from a TWAIL approach or Third World
Approach to International Law, taking into account some of the
epistemological contributions of TWAIL scholars as well as the developments of
international practitioners and commentators from both developed and
developing countries, all with an independent and critical standpoint.
This critical international legal text has been written over time, and contains the
reflections and documents developed in the past 10 years of research
conducted in Stockholm, Paris, Brussels and in Bogotá, D.C. The reader will find
in the following pages solid empirical evidence and argument that demonstrate
the imperial past, character and present operation of international intellectual
property rules, international interest blocks, knowledge monopolies and the
existent international legal system, shaped by economic interests that the legal
system protects.
My ultimate objective in offering these pages, the product of over a decade of
critical thought, research, and reflection in this area, is to enrich an international
dialogue and cooperation and hopefully legal change of present rules for the
achieving of better standards of promotion and protection of Global Public
Goods and sustainable development for all the countries involved, and in
particular for developing and LDCs.

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In other words, the reader should be aware of this work is written from a
developing nation’s perspective in an effort to analyse the philosophical,
economic, social, moral, and public interest considerations and implications of
strengthening the current IPRs system and the real possibilities most LDCs have in
order to face the new “IP fundamentalism” i.e. the introduction of TRIPS- plus
terms in bilateral trade agreements and not to mention recent bilateral free trade
agreements between countries such as Colombia/Peru- European Union.
Offering an original, critical and independent approach is the constant of this
book as a guarantee of objectiveness, as you will see, in the first chapters of this
work no personal position is taken and my sources are both academic and
official documents from international organizations taking into account the work
done by the global north to address these questions. There, the aim rather is to
describe the legal-historical realities of the current system, while highlighting the
historical inequalities and partiality of the system. Most of the referred authors in
this book have submitted their reports for international organizations and/or on
behalf of nation states of the so-called industrialized world; these experts are
considered in the general opinion as some of the foremost thinkers in the field of
IP.
There are, however, some reasonable limitations to this book since the
complicated consequences of trade flows and the lack of strong and recent
studies on the role that the new IP approach in the 21st century should take in
order to balance a system that seems to be currently collapsing under its own
weight. While still some LDCs and developing nations continue to struggle in order
to better represent their interests in the international arena, the weak bargaining
power of these countries cannot be neglected as there is a clear need for
developing and delivering more legal assistance to the most needed
democracies. The rule of law should be applied equally to all Member States;
respect for pacta sunt servanda ought to be the ultimate law. There are many
challenges for developing nations looking at the post hegemonic era. The
question of balancing a power based system so as to advocate and establish a

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more balanced pro-sustainable development international economic and legal
order in which the rule of law and “de jure” equality is pragmatic, and not just a
cynical statement.
The objective of shifting towards more research and discussions aimed at
rewriting the basic principles of a system that can no longer neglect the public
interest and the partialities that continue to affect the materialization of a global
governance authority on IP, international technology exchange and sustainable
development, i.e. the constitution of a new global governance authority for
achieving a “de facto” equality on these matters.
Lack of political will, enlightened judicial self-restraint and the power politics of
the current world economic order are some of the major restrictions for the
advancement of global net-win gains and social value solutions. In the words of
the EPO, there are clear practical limitations that go beyond theoretical ones
and diminish the effectiveness of solutions and new ideas to meet the specific
developmental requirements of disparate nations at a global level “because a
system that blocks the access of poor people to essential drugs and food will
eventually lose its credibility”3.
3 Source: EPO, scenarios for the future: “How might IP Regimes evolve by 2025? What global legitimacy might such regimes have?” (Munich:
European Patent Office, 2007) http://www.oneillinstitutetradeblog.org/wp-content/uploads/2013/11/TRIPS-Flexibilities-and-TRIPS-Plus-under-
the-TPP.pdf
http://www.un.org/ga/search/view_doc.asp?symbol=A/67/348 HYPERLINK
"http://www.un.org/ga/search/view_doc.asp?symbol=A/67/348&Lang=E"Lang=E
http://www.washingtonpost.com/blogs/the-switch/wp/2013/11/13/leaked-treaty-is-a-hollywood-wish-list-could-it-derail-obamas-trade-
agenda/
Patent safeguards give pharmaceutical makers the right to block competition from generic drugs for a set period to protect their research
investments. U.S. negotiators are trying to balance preserving those barriers against the desire to make drugs more affordable and accessible in
developing countries: http://www.bloomberg.com/news/2013-11-14/generic-drugs-seen-limited-in-wikileaks-trade-document.html
Pharmaceutical companies would get marketing exclusivity for their new medicines and could delay the entry of generics during patent disputes.
Generic-drug makers could piggy-back on safety tests conducted by the producers of the branded treatments without fear ofinfringement claims
and would be rewarded for successful patent challenges. http://www.bloomberg.com/news/2013-11-14/generic-drugs-seen-limited-in-
wikileaks-trade-document.html
Human Rights Require ‘Cosmopolitan Constitutionalism’ and Cosmopolitan Law for Democratic Governance of Public Goods: Prof. Dr. Ernst-Ulrich
Petersmann: "The fact that more than 2 billion people live without effective access to protection of human rights, rule of law, food, water, health
care, education, personal and democratic freedom illustrates that worldwide UN and WTO law and governments fail to protect many
international public goods demanded by citizens. The worldwide financial and environmental crises, and the failure of the 158 WTO members
to conclude their Doha Round negotiations since 2001, also illustrate the failures of international economic law (IEL) to effectively regulate
‘market failures’ as well as ‘governance failures. Also international organizations and private corporations have legal obligations to respect

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The important issue of enforcement is not analysed in depth in this book, as the
balance is presently skewed in favour of rights-holders. As enforcement and
critical analysis of TRIPS involves political and diplomatic processes within both
active and passive instruments, they are not the central focus of this work. In
reality the realpolitik of developing countries being vulnerable to aid withdrawal
and trade sanctions, i.e., economic sanctions as state-craft objects and other
questions to the legitimacy of the international trading system will increasingly be
undermined unless and insofar as it concerns intellectual property, there is
improved access to effective and affordable medicines and the technologies
necessary for reversing the rising trend of high mortality and morbidity from
infectious and non-communicable diseases.
A closer look at the patent monopolies and health considerations from a legal
perspective is included in this text as well as a proposal for harmonization of the
relationship between the TRIPS and the Convention on Biotechnological Diversity
(CBD) and a new global environmental authority to be created. The TRIPS
agreement was a defining moment in international IP law making, but such
unifying law leads to new divergences that are never resolved conclusively. The
objective of this book is to bring some of these arguments to the negotiating table
in order to start talking seriously about the new model needed in order to respond
to 21st century realities in the context of Covid-19. The socio-economic and
historical juridical approach of this work aims to view the ways in which institutions
have evolved through historical realities and the need to find new ideas moving
forward from trade regulation to competition regulation and social value for
sustainable development.
I consciously avoid the complexity and fluidity of political power and law making
and describe the status quo of the law as well as some of the major arguments
to propose the reform of the Agreement. TRIPS has its serious gaps, generalities,
human rights as ‘constitutional status rights’ protecting individuals against abuses of public and private powers. The scope of these human rights
obligations remains contested, for instance regarding ‘corporate social responsibilities’ of multinational enterprises and ‘vulture funds’ that
purchase defaulted foreign debt at significant discounts and subsequently litigate for full repayments. Read more:
http://cadmus.eui.eu/bitstream/handle/1814/27155/LAW_2013_04.pdf?sequence=1

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ambiguities, allowances, postponements, etc. There is a need for a more
equitable interpretation of its provisions, however, in a time of increasing
uncertainty and volatility of the political system amid the onslaught of Covid-19,
it also provides a historical opportunity to rebalance and to introduce
appropriate check –and- balances aimed at guaranteeing the preservation of
rights and obligations of all members sates. The appropriate balance between
rights-holders and rights-users is the central question of this book, which is even
more interesting considering discussions over access to global public goods or
common goods.
A one-size-fit all approach is unsustainable. There are national levels of
development to be calibrated while balancing international and national policy
objectives. I will conclude with an optimistic view on the need for reinforcing
multilateralism by coherent and harmonious co-operation. BRICS (Brazil, Russia,
India, China, South Africa), Latin America and the Caribbean, African and Asian
countries should lead by example. Regardless of the international IP law
approach of this work, this book is intended and designed to be consulted by
civil society, trade policy analysts, students, intellectual property lawyers,
practitioners, nongovernmental organizations (NGOs), and last but not least,
individuals interested in understanding and deciphering a system that has gone
astray in ignoring common universal values.
This is a story that we all build together as long as there is faith in democratic
institutions, since they offer better opportunities for promoting the common
values and goals that both developing and developed countries share. Thus,
collective action shall be taken, facing the growing inequities before us and
making sure that reforming the present economic and legal system is our priority
as we open up this new chapter in the 21st century. The historical moment for
change has arrived in 2021.

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Table of Content
Part One:
- Introduction.
- Preliminary Remarks on TRIPS Reform in Times of COVID19.
- Towards a New International Economic and Legal Order for
Sustainable Development.
- An Exceptional International Intellectual Property Law Solution for
COVID-19: Spurring Innovation to Facilitate Access to Affordable
Medicines.
Part Two:
-The current and potential challenges for emerging countries for the protection
of Global Public Goods facing the so-called TRIPS- PLUS pressures and
Transnational Interest Blocks- TIBs.
-Intellectual Property Law proposal for an international erga omnes legally
binding instrument on the protection of Biodiversity, Traditional Knowledge (TK)
Genetic Resources (GRs) and Folklore at the WTO.4
-A combined TRIPS- CBD5 approach which strives to find a compromise to
alleged conflicts between TRIPS and CBD.
4 I believe the discussion should avoid duplication of work carried out in the WTO and the CBD i.e. on the
issue of genetic resources, developing nations have made the proposals in the context of the WTO where
any resultant commitments would have more “teeth” (e.g. enforcement through the Dispute Settlement
System is one example). These results should be beneficial for all the Members involved. For some, this in a
way reflects the position adopted by developed countries in the context of the Uruguay Round, who
sought to move discussions in IP out of WIPO for considerations in the new the WTO system. Also, giving the
limited mandate of WIPO as an organization aiming to promote intellectual property protection, one have
doubts about the possibility to undertake serious analysis of the standards of patentability applied by WIPO
members. That is why I encourage the use of the so- called defensive protection on Traditional Knowledge,
Biological resources and Folklore and not just a positive one. See more at:

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<http://www.wipo.int/export/sites/www/tk/en/igc/pdf/igc_mandate_2018- 2019.pdf> as consulted on
13/01/2020 at 13:34 p.m.
5 The TRIPS Agreement requires a review of Article 27.3(b) which deals with patentability or non-
patentability of plant and animal inventions, and the protection of plant varieties. Paragraph 19 of the 2001
Doha Declaration has broadened the discussion. It says the TRIPS Council should also look at the relationship
between the TRIPS Agreement and the UN Convention on Biological Diversity, the protection of Traditional
Knowledge and Folklore. It adds that the TRIPS Council’s work on these topics is to be guided by the TRIPS
Agreement’s objectives (Article 7) and principles (Article 8), and must take development issues
fully into account: see more at:
<https://www.wto.org/english/tratop_e/trips_e/art27_3b_e.htm as consulted on 13/01/2020 at 17:00>
p.m.
Also, <https://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm> accessed on January
2020.

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-Non-patentability and Traditional Knowledge. Balancing the main arguments
against the patentability of plants vs. the arguments of developed nations for the
patentability of plants and animals.
-Why Free Trade Agreement (FTAs) and contractual provisions are not the best
way to protect Biodiversity, TK and GRs in this context.
-Agreements for the Promotion and Reciprocal Protection of Investments–
APPRIs- Colombia – Switzerland.
(A) The International Architecture of Intellectual Property
Rules and Transnational Interest Blocks- TIBs-
(B) Rethinking the Patent basis- are Patents and IPRs really promoting
innovation and progress?
(C) The New United States-Mexico-Canada Agreement (USMCA).
(D) The Imatinib –marketed as Gleevec™ case.
(E) The Brazilian and Indian Compulsory License of Drugs Products.
(F) Final conclusions.

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Part Three:
“Actual and Potential Impacts of the TRIPS Agreement on the Protection of
Global Public Goods, International Technology Transfer-Exchange and
Sustainable Development”
Substantive justice responding to international coercion
- Implications for Developing Countries –
I. Methodology, approach and research limitations.
Introduction.
II. Possible protectionism within the TRIPS Agreement and possible effects of
Stronger IPRs protection for Developing Countries:
A. Exceptions to Patent Rights: Rethinking the current Patent system.
B. Patent monopoly and knowledge cartels vs. a coherent IT.
III. The effect of IPRs on International Technology Transfer under the TRIPS
Agreement an empirical question.
A. TRIPS Implementation.
B. TRIPS flexibilities on ITT.
IV. From international technology transfer to technology generation
A holistic long-term strategy. Review of the TRIPS agreement: Fostering the
Transfer of technology to developing countries through technology exchange
“Ecology of innovation”:

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A. Competition law provisions on Technology Transfer under the TRIPS
Agreement, careful consideration, a question of balance.
B. Foreign direct investment, impact on competitiveness and growth.
C. Research and Development.
V. A proposal of four elements for a cosmopolitan framework on innovation
and Sustainable Development. Towards a new paradigm on global
cosmopolitan governance:
A. TRIPS Implementation and moratorium.
B. Flexibilities and IPRs related competition tools.
C. International co-operation.
D. A new global governance authority on ITT and Sustainable Development
Evaluation and enforcement.

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PART ONE

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Introduction
Can international law and current international intellectual property law
regime achieve fairer outcomes for developing countries in terms of access to
medicines, treatments, diagnostics, technology, knowledge and protection of
health, the environment and the new Sustainable Development Goals?
This is not a simple question. This book intends to highlight some new
instruments of domination and control exercised today over the periphery that
could be regarded as sophisticated and “enlightened” tools of extraction and
exploitation in the 21st century. From a critical perspective -rather than a
positivist one - on International Law4, and following Dr. Antony Anghie’s work
in Imperialism, sovereignty, and the making of international law, and by
analyzing similarities between European influence over colonies in the
Americas from the 16th to 19th centuries, I will discuss how modern imperialism
uses several practices in order to extract and control systematically the
territory, the resources and the way of life of the local communities by
implementing a neo- colonial administration for the benefit of the
international global powers and Transnational Interest Blocks in the present
day. Given this modern neo-colonial context, and taking into account the
critics to Antony’s work highlighted by Ann Orford:
“the past could be a source of obligations today, as concepts and legal practices
that were developed in the time of formal rule could be shaping international law
today in a post-colonial era”.5
Today a new form of international administration continues to operate under
4 “Critical international legal studies constitute a so-called post-modern approach to international law. This is to assert that the discipline is
governed by a particular, historically conditioned discourse which is, in fact, quite simply, the translation onto the international domain of
some basic tenets of liberal political theory. It opposes itself to positivist international law, as representative of an actual consensus among
states. The crucial question is simply whether a positive system of universal international law actually exists, or whether particular states and
their representative legal scholars merely appeal to such positivist discourse so as to impose a particular language upon others as of if were
a universally accepted legal discourse. So post-modernism is concerned to unearth difference, heterogeneity and conflict as reality in place
of fictional representations of universality and consensus”, available at:
<http://www.ejil.org/article.php?article=2026&issue=101> as consulted on 14/01/2019.
5 Anghie, Antony. “Imperialism, sovereignty, and the making of international law”. Cambridge University Press, 2005.

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the umbrella of the Washington consensus 6 and the use of legal instruments
that have evolved with time in order to secure the distribution of the peripheral
world (i.e. the global south) into de facto colonies of established economic
powers.
The past is important as it has defined the present in some way, and it does
not constitute an anachronism. As Dr. Anghie stated, “imperialism has
structured international law today, and it’s not a matter of history but a present
obligation”.7
I ask if developing countries in the periphery really have an obligation to be
loyal to the current international economic order, i.e. the new Bilateral
Investment Agreements that are far from reciprocal or Intellectual Property
rules that impede access to life-saving medicines for millions of people in times
of a pandemic of international scope due to COVID-19 or real and effective
technology transfer to Least Developed Countries (LDC) as the TRIPS
Agreement indicates? The current system continues to neglect the challenges
facing the environment today as climate change continues to expand in a
capitalist oriented society that tends to believe that economic growth is
unlimited and climate change is not a fact.
Such a system,thus, condemns millions of people to live in poverty as the ladder
toward sustainable development is eliminated, taking with it the possibility of
creating clean energy sources or industrializing the so-called developing or
least developed countries. In doing so, the chances that these peripheral
zones may have to compete more equally in the international markets by
promoting and expanding their own market is eliminated to the detriment of
LDCs. Without being able to create, promote and expand their own markets
abroad for the benefit of all the parties involved.
The Washington Consensus 8, did not provide answers for promoting the
6 The Washington Consensus is a set of 10 economic policy prescriptions considered to constitute the "standard" reform package promoted
for crisis-wracked developing countries by Washington, D.C.– based institutions such as the International Monetary Fund (IMF), World Bank,
and the US Treasury Department.
7 Anghie, Antony. “Imperialism, sovereignty, and the making of international law”. Cambridge University Press, 2005. P. 212.
8 The term was first used in1989 by English economist John Williamson: 1. Fiscal policy discipline, with avoidance of largefiscal deficits relative
to GDP; 2. Redirection of public spending from subsidies ("especially indiscriminate subsidies") toward broad-based provision of key pro-

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development of the poorest countries in the world. The post-Washington
consensus for leading economist, Joseph Stiglitz, was also a failure in
understanding economic structures in the developing world 9. This outline of
the International Monetary Fund (IMF) policies in Latin America10 confirms11 the
relationship between imperialism and international law.
Just as under the rule of colonialism and its administrative apparatus, today
we live under the rule of new institutions that lack legitimacy and democratic
participation and that continue to advance the interests of the few using the
international framework of the GATT, the WTO and WIPO in which developing
or least-developing nations struggle to betaken seriously as the legal costs are
high and the number of cases brought against developed countries are in the
minority.
The WTO pledged to improve access to its expensive and complex legal
system but has failed. In 15 years of dispute settlement under the WTO, 400
cases have been initiated. No African country has acted as a complainant
and only one least-developed country has ever filed a claim 12.
growth, pro- poor services like primary education, primary health care and infrastructure investment; 3. Tax reform, broadening the tax base
and adopting moderate marginal tax rates; 4. Interest rates that are market determined and positive (but moderate) in real terms; 5.
Competitive exchange rates; 6.Trade liberalization: liberalization of imports, with particular emphasis on elimination of quantitative
restrictions (licensing, etc.); any trade protection to be provided by low and relatively uniform tariffs; 7. Liberalization of inward foreign direct
investment; 8. Privatization of state enterprises; 9. Deregulation: abolition of regulations that impede market entry or restrict competition,
except for those justified on safety, environmental and consumer protection grounds, and prudential oversight of financial institutions;10.
Legal security for property rights. Available at:
<https://www8.gsb.columbia.edu/faculty/jstiglitz/sites/jstiglitz/files/2008_Is_There_a_Post- Washington_Consensus_Consensus.pdf>
accessed on January 2019.
9 See also, “Globalization and Its Discontents” is a book published in 2002 by the 2001 Nobel laureate Joseph E. Stiglitz.
10 i.e. Colombian law 1116/2006 regulating insolvency has been designed to protect and provide tax benefits for big companies rather than
small and medium ones following the recommendations and guidelines of international institutions such as the IMF and World Ba nk. Also,
big international companies have benefitted of tax cuts (like the oil sector) that local, small and medium firms or even natural persons do not
enjoy. This contradicts the principle of solidarity of article 95.9 of Colombian Constitution.
11 The US-based Global Financial Integrity (GFI) and the Centre for Applied Research at the Norwegian School of Economics recently published
some fascinating data. They tallied up all of the financial resources that get transferred between rich countries and poor countries each year:
not just aid, foreign investment and trade flows (as previous studies have done) but also non-financial transfers such as debt cancellation,
unrequited transfers like workers’ remittances, and unrecorded capital flight. As far as I am aware, it is the most comprehensive assessment
of resource transfers ever undertaken. The flow of money from rich countries to poor countries pales in comparison to the flow that runs in
the other direction, see more at: <https://www.theguardian.com/global- development-professionals-network/2017/jan/14/aid-in-reverse-
how-poor-countries-develop-rich- countries as consulted on > accessed on Sat 14 Jan 2017.
12 “In the 10 years since the WTO pledged to deliver pro-development changes, developing countries have been completely side-lined by the
global powers. There are several examples of how the WTO has failed the poor:
1. Cotton: The Fairtrade Foundation revealed last year how the $47bn in subsidies paid to rich-country producers in the past 10 years
has created barriers for the 15 million cotton farmers across west Africa trying to trade their way out of poverty, and how 5 million of the
world's poorest farming families have been forced out of business and into deeper poverty because of those subsidies.
2. Agricultural subsidies: beyond cotton, WTO members have failed even to agree how to reduce the huge subsidies paid to rich
world farmers, whose overproduction continues to threaten the livelihoods of developing world farmers.
3. Trade agreements: the WTO has also failed to clarify the deliberately ambiguous rules on concluding trade agreements that allow
the poorest countries to be manipulated by the rich states. In Africa, in negotiations with the EU, countries have been forced to eliminate
tariffs on up to 90% of their trade because no clear rules exist to protect them.
4. Special treatment: the rules for developing countries, called "special and differential treatment" rules, were meant to be reviewed

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In other words, the mechanisms for excluding non-G20 countries from
sovereignty continue today after the official finalization of colonial order. As
such, it has become imperative to expose the different and new instruments
of neo-colonialism today in order to face, challenge and oppose these
structures of domination.
Professor, Martti Koskenniemi 13, concludes that European Imperialism was all
about free trade executed among private companies and private
transactions and private wars. It is not so hard to tell where the power of a part
of humanity over other human beings is exercised more effectively: not by
public treaties but by private contracts. This is exactly my starting point: is the
international intellectual property law regime, the international trading system
and the current global economic order seeking the interest of the majority
and the protection of global public good, or are these institutions and
structures reflective of the self-centered and greedy side of mankind, of a
business as usual mentality in the interest of a few, powerful transnational
corporations?
to make them more precise, effective and operational. But the WTO has failed to work through the 88 proposals that would fill the legal
vacuum.
5. Medicine: the poorest in developing countries are unable to access affordable medicine because members have failed to clarify
ambiguities between the need for governments to protect public health on one hand and on the other to protect the intellectual property
rights of pharmaceutical companies.
6. Legal costs: the WTO pledged to improve access to its expensive and complex legal system, but has failed. In 15 years of dispute
settlement under the WTO, 400 cases have been initiated. No African country has acted as a complainant and only one least developed
country has ever filed a claim”. see more at: <https://www.theguardian.com/global-development/poverty-matters/2011/nov/14/wto-fails-
developing-countries> and <https://www.wto.org/english/tratop_e/dispu_e/dispu_by_country_e.htm as consulted on Mon 14 Nov 2020.
Also, developing countries face three major challenges while participating in the WTO dispute settlement system. 1. Lack of legal expertise
on WTO law. 2. Financial constraints. 3. Fear to political and economic pressure from the European Union or the United States for instance:
https://www.theguardian.com/global-development-professionals-network/2017/jan/14/aid-in-reverse-how-poor-countries-develop-rich-
countries last accessed on 1/12/2020.
13 Koskenniemi, Martti. “Imperio y derecho internacional: la verdadera contribución española”. P. 189.

23. 23
In this book, from a TWAIL approach14, I proposes a critical and independent
reading to international law from a Global South perspective in order to
analyze the real motivations behind i.e. the present lack of democratic
legitimacy of international investment law regarding recentlawsuits for alleged
violation of the Agreements for the Promotion and Reciprocal Protection of
Investments – APPRIs- against the Colombian State and the risk of establishing
a precedent that is legally binding and undermines the sovereignty and
regularity powers of States, as private corporations can take them to the ICSID
in the World Bank 15 or UNCITRAL.16
In this section, some words will be dedicated to the criteria of patentability
used by the national authorities in the case of the medicine, IMATINIB - GLIVEC
as the first case of study of what we have called selective multilateralism that
which is opposite to a coherent and consistent liberalization of markets as this
may constitute policy incoherence in international intellectual property law.
Then, I will analyze two examples of the current challenges for the protection
of the global common goods and third-generation human rights 17 in
developing countries and an Intellectual Property Law proposal for an
international erga omnes legally binding instrument on the Protection of
Biodiversity, Traditional Knowledge (TK) Genetic Resources (GRs) and folklore
and the current and potential challenges for emerging countries for the
protection of global public goods facing the so called TRIPS- PLUS pressures
(health, environment and non-welfare considerations) in the global system of
14 Makua Muta and Antony Anghie, “what is TWAIL?” (2000) P. 94. Third World Approaches to International Law (TWAIL) is a critical school of
international legal scholarship and an intellectual and political movement. It is a “broad dialectic opposition to international law”, which
perceives international law as facilitating the continuing exploitation of the Third World through subordination to the West. TWAIL scholars
(known as TWAIL-ers) seek to change what they identify as international law's oppressive aspects, through the re-examination of the colonial
foundations of international law. TWAIL’s main objectives include: Developing an understanding as to how international law perpetuates the
subordination of non-Europeans to Europeans and developed countries through international legal norms. Creating opportunities for Third
World participation in international law. Proposing an alternative mechanism of international law that coexists with other critiques of the
neoliberal approach to international law and eradicating underdevelopment of the Third World through scholarship, policy and politics.
Understanding and engaging Third World scholarship in the analysis of international law. See also:
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1876682 as consulted on November 2020. See also: https://twailr.com/wp-
content/uploads/2020/11/Anghie-Welcoming-the-TWAIL-Review.pdf
15 CIADI known as the International Centre for Settlement of Investments Disputes.
16 United Nations Commission on International Trade Law.
17The African Charter on Human and Peoples' Rights ensures many of those: right to self- determination, right to development, right to natural
resources and right to satisfactory environment: African Charter on Human and Peoples' Rights, Article 20, 21, 22 and 24. For some including,
right to participation in cultural heritage and rights to intergenerational equity and sustainability.

24. 24
protection of Intellectual property and Patents derived from the TRIPS
Agreement in the WTO. Everything in the frame of a rationalist conception of
the rights as a preferential position to power politics and market forces in times
of globalization and International Interest Blocks.
“The life of a third world international lawyer is devoted to resistance of norms
of international law designed by agents with power to promote the interest of
the powerful sections of the international community”18
M. Sornarajah
18 https://www.tandfonline.com/doi/abs/10.1080/01436597.2016.1180955

25. 25
Preliminary Remarks on TRIPS Reform in Times of COVID-19:
Towards a New International Economic and Legal Order19 for Sustainable
Development.
It is crystal clear that we need a bold new international order to make vaccines,
treatments and medicines true global public goods, placing human life and
health as priorities over profits. Also, the human being should be the central
subject of every effort for sustainable development20 as a means for fulfilment
of other human rights. In other words, there is a need to build a brand new
international economic and legal order to materialize sustainable
development worldwide21.
Bangladesh and Chad among other Least Developed Countries are working
towards a new bold international legal transition that will allow them to develop
their own infrastructure, realize their development objectives and a viable
technological base; and with the great leadership of India and South Africa
the TRIPS Council has 90 days to decide on a waiver of TRIPS obligations in the
context of COVID-19.
A. Towards International Legal Reform: The TRIPS Waiver Proposal and Request
for Extension of Transition Period by LDCs:
I very much welcome the waiver proposal submitted by India and South Africa
to the TRIPS Council asking that it allow countries to suspend the protection of
certain kinds of intellectual property (IP) related to the prevention, containment
and treatment of COVID-1922. The proposal23 requests that the Council for TRIPS
urgently recommends to the General Council adoption of a decision of a
waiver from the implementation, application and enforcement of sections
19Or new international legal system as explained by Anghie: http://humanityjournal.org/wp-content/uploads/2014/06/HUM-6.1-final-text-
ANGHIE.pdf accessed on 23/11/2020. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2914650
See also: https://www.ucl.ac.uk/bartlett/public-purpose/sites/public-purpose/files/iipp-pb12_delivering-the-peoples-vaccine_final.pdf
20 See more at: https://legal.un.org/avl/ha/drd/drd.html last accessed on 9/12/2020. Also:
https://www.nytimes.com/2020/12/07/opinion/covid-vaccines-patents.html?action=click&module=Opinion&pgtype=Homepage
21 Available at: https://www.ohchr.org/EN/Issues/Development/Pages/DevelopmentIndex.aspx accessed on 9/12/2020.
22 See more at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext#.X83rKA0rUdQ.twitter
23Council for Trade-Related Aspects of Intellectual Property Rights:
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True

26. 26
1,4,5 and 7 of part 2 of the TRIPS Agreement and until widespread vaccination
is in place globally.
For India and South Africa24: “it is important for WTO Members to work together
to ensure that intellectual property rights such as patents, industrial designs,
copyright and protection of undisclosed information do not create barriers to
the timely access to affordable medical products including vaccines and
medicines or to scaling-up of research, development, manufacturing and
supply of medical products essential to combat COVID-19”. “There are several
reports about intellectual property rights hindering or potentially hindering
timely provisioning of affordable medical products to the patients.” (The
highlight is ours).
In their communication, India25 and South Africa also made the point that:
“many countries especially developing countries may face institutional and
legal difficulties when using flexibilities available in the Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS Agreement). A particular
concern for countries with insufficient or no manufacturing capacity are the
requirements of Article 31bis and consequently the cumbersome and lengthy
process for the import and export of pharmaceutical products26”.
Despite opposition from developed countries27, the proposal was also co-
sponsored by Eswatini and Kenya, the African Group (Tanzania), the LDC
Group (Chad), Argentina, Bangladesh, Egypt, Honduras, Indonesia, Mali,
Mauritius, Mozambique, Nepal, Nicaragua, Pakistan, Sri Lanka and Venezuela
supported the proposal, also the Director-General of the WHO expressed
support for the proposal. The proposal was also welcomed28 in principle by
Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Jamaica, Nigeria,
the Philippines, Thailand and Turkey.
This is important specially since no IP holder has endorsed so far the COVID-19
Technology Access Pool29 (C-TAP) which promotes the idea that voluntary
licences are the most viable solution to tackle COVID-19. So, the TRIPS Council
decision becomes crucial in order to respond quickly with effective means to
find a solution to this pandemic of international scope. There is no reasonable
24 https://www.courier-journal.com/story/news/2020/04/03/beshear-calls-3-m-release-patent-n-95-respirator-amid-
pandemic/5112729002/
25 https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True accessed on 9/12/2020.
26 See full text at: https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True
27 Available at: https://www.project-syndicate.org/commentary/covid-vaccines-for-profit-not-for-people-by-mariana-mazzucato-et-al-2020-
12?fbclid=IwAR2KXCSIAF3yQJF6zuKIX6corM667uuql95YHf7uAADTaI09tETka-ss6LU
And https://www.theeastafrican.co.ke/tea/science-health/covid-vaccine-patent-rights-
3214866?fbclid=IwAR2Zy7NNb9hhLpXhjnoIwXh5mYdhQVehWjMy2BUNuhOr6sgUSnhKeNyG_n4 last accessed on 1/12/2020.
28 https://us5.campaign-archive.com/?u=fa9cf38799136b5660f367ba6&id=a9b27dc5a8
29 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-
technology-access-pool/endorsements-of-the-solidarity-call-to-action

27. 27
or moral justification for developed countries and relevant IP holders not to
endorse the proposal, especially when we take a closer look to the number of
deaths worldwide is currently: 1,214,809 and rising as I write this chapter.
All countries should implement C-TAP now. How many more people must die
because they lack an effective vaccine, treatment or medicine for COVID-19?
TRIPS should be waived now, what are they waiting for?
B. Request by LDCs Members for Extension of Transition Period:
Chad on behalf of the LDC members of the WTO submitted a request30
(IP/C/W/668) to the TRIPS Council proposing an extension of the transition
period available to LDCs under Article 66.1 of the TRIPS Agreement, during
which the LDC members of the WTO do not have to implement the substantive
obligations for protection and enforcement of IP as required under TRIPS:
“Developing a viable technological base is a long-term process. LDCs need a
continuing exemption from the Agreement on Trade-Related Aspects of
Intellectual Property Rights ("TRIPS Agreement") in order to be able to grow
economically viable industrial and technological sectors, to consolidate
capacity, and to work their way up the technological value chain. To
overcome the difficulties confronting LDCs, magnified manifold by the COVID-
19 crisis, LDCs need maximum policy space inter alia to access various
technologies, educational resources, and other tools necessary for
development and to curb the spread of COVID-19 pandemic. Most intellectual
property (IP)-protected commodities are simply priced beyond the purchasing
power of least developed countries31”.
Countries with developed economies should be aware that developing a
viable technological base is a long term process. The USA and European
counties for instance had to wait for centuries to develop their own
infrastructure and local industry before they were able to apply strong
protection to foreign intellectual property. In other words, there is no
coherence in the argument of liberalization and opening up of markets to
foreign competition and protection of foreign Intellectual Property of
metropole countries in the context of a pandemic of international scope
because even those countries (most industrialized countries today) at their own
stage of development did not apply a policy of strong protection to foreign IP
under “normal circumstances”.
Rather than sympathy and more delay, what LDCs desperately need is real
international cooperation and solidarity to develop their own technological
base and to be able to compete evenly in the international markets; otherwise,
they can hardly “graduate” and develop their own economies. But, you might
be wondering, how can they create viable technological bases or industrialize
30 https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W668.pdf&Open=True
31 https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W668.pdf&Open=True

28. 28
their economy and exit the so- called, “peripheral economy trap” with current
IP agreements, economic policy, trade and Investment laws? We shall create
and develop a fairer international economic order that will allow them to grow,
prosper and become truly independent. This is a win-win situation for all the
counties in the world.
It is questionable that the TRIPS Council will take more time to evaluate this
proposal while the US consult their capital; every day that passes without a
solution, many people die waiting for a vaccine, medicine or treatment. On
the other hand, there is a need to eradicate poverty, growing inequality and
unemployment; in other words, a brand new international economic and legal
order to materialize sustainable development worldwide is needed, placing
people and the environment at the centre of every decision.
Finally, LDCs would be better off adopting less protection to foreign IPRs and
developing and fostering their own industry as developed countries did in their
own stage of development. Let us hope the waiver proposal will pass before
the end of 202032 and that LDCs receive a positive answer to their valid request
before too many people test positive for COVID- 1933.
32 See more at: https://www.reuters.com/article/us-health-coronavirus-wto/wealthy-countries-block-covid-19-drugs-rights-waiver-at-wto-
sources-idUSKBN280211?il=0 accessed on 12/11/2020
33 See also: https://www.washingtonpost.com/health/2020/12/06/covid-vaccine-messenger-rna/ and
https://www.nytimes.com/2020/12/07/opinion/covid-vaccines-patents.html?action=click&module=Opinion&pgtype=Homepage on TRIPS
waiver: https://genevahealthfiles.substack.com/p/regulatory-discoherence-the-case and
https://www.thehindubusinessline.com/economy/wto-members-may-seek-more-time-to-decide-on-trips-waiver-to-fight-covid-
19/article33250222.ece# accessed on 9/12/2020
On Thursday, 10 December 2020, the World Trade Organization (WTO) convened a formal meeting of the WTO TRIPS Council to discuss a
waiver from certain provisions of the TRIPS Agreement: https://www.keionline.org/34811 accessed on 11/12/2020

29. 29
“I see sustainable development as a process of deep and profound changes
in the economic and political structures of power and as an institutional
paradigm. To reach a fair balance between developing and more developed
countries; a framework of intergovernmental cooperation has to be
established and based on the rule of law, environmental protection and
human rights, and must not impair the prospects of future generations while
improving the living standards of the present and the poorest”.
David Enrique Betancourt Cruz

30. 30
On July 13, 2020 I had the opportunity to participate in the webinar series III:
“Intellectual Property Rights: Global Rules, Regional and Local Realities.” In that
excellent webinar, I shared four Ideas that I would like to expand further in this
section, by building on my previous contribution titled “An Exceptional
International Intellectual Property Law Solution for COVID-19: Spurring
Innovation to Facilitate Access to Affordable Medicines.”
Six months have passed since the publication of the above mentioned essay
acknowledging the need for equal access to medicines and a Global Public
Goods approach, and not a business as usual approach of market exclusivities
and market-driven R&D. The latter approach cannot solve the current crisis,
and only exacerbates inequalities in access to medicines in the pursuit of an
efficacious vaccine, treatment or technology to stop COVID-1934. There is no
doubt that solving this pandemic is the most pressing challenge of our time. This
is not a zero sum game. Below, I elaborate on the four points for effective global
solidarity to tackle the pandemic.
First, global solidarity in practice entails deploying knowledge-sharing schemes
to deal with COVID-19. In order to improve efficiency, accelerate scientific
progress and ensure global timeliness and equal global access, all countries
should commit to sharing knowledge, intellectual property (IP) and data to
ensure that any resulting medical tool is globally available and affordable. This
is of particular importance in developing and least developed countries, so
that IP rights do not become a barrier to access and quick innovation.
The international community must guarantee equal global access35 to a covid-
19 vaccine. Whether a person can access tests, treatment and a vaccine for
COVID-19 should not be determined by where they live. To end the pandemic,
health systems need to vaccinate 50 to 75% of the global population. Latin
America and the Caribbean, Africa and other countries in the Global South
should develop domestic manufacturing capacities, since local infrastructure
is key to solving this pandemic, and preparing for future ones. This requires
building manufacturing36 and effective distribution capacity, with the aim of
making a new vaccine affordable, transiting towards greater autonomy and
cognitive independence while fostering local and regional innovation
strategies in a co-ordinated way between Global South countries.
34 https://www.worldometers.info/coronavirus/?utm_campaign=homeAdUOA?Si accessed on 11/12/2020.
35 https://www.washingtonpost.com/opinions/2020/07/15/international-community-must-guarantee-equal-global-access-covid-19-
vaccine/
36 https://www.southcentre.int/wp-content/uploads/2020/07/SouthViews-Correa.pdf

31. 31
Second, all SARS-Cov-2 related medicines, diagnostics, vaccines and health
products, existing or future, should be considered Global Public Goods37; this
will be the best way to make these products available to everyone,
everywhere. Some World Health Organization (WHO) Member States have
informed WHO and/or the Government of Costa Rica that they are joining the
Solidarity Call to Action proposed in May,29, 2020: 37 countries have
endorsed the proposal of Costa Rica38 that WHO establish a COVID-19
technology pool. Only five European countries have joined so far, namely,
Belgium, Luxembourg, Norway, Portugal and The Netherlands. The others are
low and middle income countries. Such a pool could facilitate the sharing and
transfer of knowledge and data crucial for the development of the tools
needed to stop the current pandemic. The Secretary-General of the United
Nations, António Guterres, issued a statement39, declaring that “African
countries should also have quick, equal and affordable access to any eventual
vaccine and treatment, which must be considered as global public goods.”
There is a risk of growing drug nationalism40 and other41 commercial and
corporate initiatives42, which is why the proposal by Costa Rica and the WHO
of creating a global pool for rights in inventions, data, biological resources and
know-how is useful in the prevention, detection and treatment of COVID-19,
relevant and needs to be implemented with urgency.
Third, these trying times call for a commitment to reinforce a new type of
multilateralism that responds to the most vulnerable populations worldwide. For
some, the main objective of the IP system is to protect innovators and the
recuperation of profit for as long as possible, without welfare considerations
such as universal access to medicines, treatments and technologies to tackle
COVID-19. The international (IP) law system and the neoliberal policies that the
regime reinforces tend to privilege developed countries, rent seekers,
transnational interests at the expense of innovators, citizens and developing
countries. LDCs would be better off implementing an IP system that reflects their
socio-economic needs and current realities whilst focusing on fostering
37 https://www.indiachinainstitute.org/2020/07/09/the-use-and-abuse-of-global-public-good/
38 https://www.aa.com.tr/en/europe/who-costa-rica-launch-covid-19-technology-access-pool/1858370
39 https://www.un.org/press/en/2020/sgsm20089.doc.htm
40 https://www.project-syndicate.org/commentary/politics-of-covid19-vaccine-by-richard-n-haass-2020-
07?utm_source=twitter&utm_medium=organic-social&utm_campaign=page-posts-july20&utm_post-
type=link&utm_format=16%3A9&utm_creative=link-image&utm_post-date=2020-07-14&barrier=accesspaylog
41 https://medicinespatentpool.org/what-we-do/disease-areas#pills-COVID-19
42 https://www.project-syndicate.org/commentary/covid-19-vaccine-cooperation-covax-by-seth-berkley-et-al-2020-
07?utm_source=twitter&utm_medium=organic-social&utm_campaign=page-posts-july20&utm_post-
type=link&utm_format=16%3A9&utm_creative=link-image&utm_post-date=2020-07-20&barrier=accesspaylog

32. 32
domestic industry as developed countries did in their early stage of
development.
There is a need to build new, effective institutions and tools to achieve the
sustainable development goals by 2030. For this, critical thinking and
cooperation with experts, activists and academics from developed countries
and the Global South are key components to inciting the discussion and finding
alternative responses.
Fourth, countries in the Global South should seek to reform the international IP
law regime. There should be no monopolies on patents, data or know-how in
this pandemic, instead, key stakeholders and the global community should
voluntarily pool knowledge, intellectual property and data necessary for
COVID-19. All relevant technology for COVID-19 products should be available
either for free, or openly licensed. This will scale up global production of
relevant products, and guarantee availability in Africa, Latin America and the
Caribbean, Asia and wherever needed, and ensure globally fair allocation and
access for low and middle income countries (LMIC) – nobody is safe from
COVID-19 until everybody is safe.
This is why we need to come up with new legal tools and South- South political
and economic cooperation. This could include examining how to better use
the current flexibilities of the patent system such as compulsory licences,
parallel importation or make use of Article 73(b)(iii) of the Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS Agreement) to suspend
the enforcement of any IP right including patents, designs and trade secrets on
the grounds of the security exception. Article 73 of the TRIPS Agreement, states
that any World Trade Organization (WTO) member can take the ‘actions it
considers necessary for the protection of its essential security interests.’ The use
of this exception will be fully justified to address the current health emergency.
Reforming the international patent system and the TRIPS Agreement ( and
article 31bis) is the type of real and pragmatic solidarity that we need to
protect the most vulnerable individuals around the world, in accordance with
the provisions of diverse international treaties, including the TRIPS Agreement
and the Doha Declaration43 on the TRIPS Agreement and Public Health. Let’s
take the example of the South African government’s attempt to amend its laws
in 1997 to resort to the use of affordable generic drugs for the treatment of HIV
/ AIDS44, amidst international and corporate pressures and litigation. South
43 https://www.traderxreport.com/patents/ip-barriers-in-tackling-covid-19-anything-in-trips-to-help-
out/?__FB_PRIVATE_TRACKING__=%7b%22loggedout_browser_id%22%3A%22247411d07242fc95c5de8c0e9215f87861d4ac79%22%7d
44 https://www.project-syndicate.org/commentary/africa-covid-19-undermine-progress-hiv-tb-malaria-by-abdourahmane-diallo-et-al-2020-
07?utm_source=twitter&utm_medium=organic-social&utm_campaign=page-posts-july20&utm_post-
type=link&utm_format=16%3A9&utm_creative=link-image&utm_post-date=2020-07-19&barrier=accesspaylog

33. 33
Africa eventually won the case. This pandemic also provides us with the
opportunity to challenge the conventional global regime governing IP.
On the other side of the SARS-Cov-2 pandemic, we may very well witness
increased inequality worldwide, in particular in LDCs. To avoid such a scenario,
it is important to elaborate and implement policies at the international, regional
and local level to protect the most vulnerable countries since economic
recovery will only commence in a post-COVID-19 world. This is why it is essential
to develop a new legal framework to enable countries to attain the Sustainable
Development Goals, to increase the level of health protection domestically
and to transition to a more sustainable and progressive economic model that
takes into account the need to protect the environment and end the fossil fuel
era.
Finally, a new global regime should protect human life and the health of
people, instead of safeguarding the exorbitant profits of transnational interests
and pharmaceutical monopolies. Taken together, the aforementioned
considerations are why we need open science frameworks such as the
proposal of Costa Rica that WHO establish a COVID-19 technology pool of
data and IP, to collect, develop and share knowledge to guarantee effective
vaccines, treatments and technologies to overcome COVID-19.

34. 34
An Exceptional International Intellectual Property Law Solution for COVID-19:
Spurring Innovation to Facilitate Access to Affordable Medicines45.
There is no doubt about the role international law can play in order to face the
current COVID-19 pandemic. The answer is clear now: reform the current
International Intellectual Property Law regime46 ( Article 30, Article 31, Article
31bis and the flexibilities to the TRIPS Agreement as well as existent incentives to
their enterprises and institutions to promote and encourage technology
transfer to least-developed country members pursuant to Article 66.2. ) in order
to accelerate innovation and facilitate access to affordable medicines
worldwide.
This could include examining how to better use the current flexibilities of the
patent system so as to allow for more innovation, and effective co-
operation/coordination in the scientific world. This unprecedented crisis of
international scope offers us a rare opportunity to galvanize support for stronger
international co-operation among the World Health Organization47 (WHO),
World Intellectual Property Organization (WIPO), World Trade Organization
(WTO),United Nations (UN), G2048, and the European Union49 (EU) – as the top
net exporter of pharmaceuticals50. Reforming the international patent system
and the Trade- Related Aspects of Intellectual Property Rights 51Agreement
45 May 15, 2020. Witten for Afronomicslaw by David Betancourt. The author would like to express his special thanks to James Thuo Gathii,
Wing-Tat Lee Chair in International Law and Professor of Law for his comments on this piece and for accepting the proposal for publication.
46 Available at: https://www.wto.org/english/docs_e/legal_e/31bis_trips_04c_e.htm#5 and the Declaration on the TRIPS Agreement and
Public Health (WT/MIN(01)/DEC/2). “4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures
to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should
be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access
to medicines for all”. “6. We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could
face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an
expeditious solution to this problem and to report to the General Council before the end of 2002”. Last accessed on 14/12/2020.
Annex and Appendix to the TRIPS Agreement: “5. With a view to harnessing economies of scale for the purposes of enhancing purchasing
power for, and facilitating the local production of, pharmaceutical products, it is recognized that the development of systems providing for the
grant of regional patents to be applicable in the Members described in paragraph 3 of Article 31bis should be promoted. To this end, developed
country Members undertake to provide technical cooperation in accordance with Article 67 of this Agreement, including in conjunction with
other relevant intergovernmental organizations.”
“(ii) where the Member has some manufacturing capacity in this sector, it has examined this capacity and found that, excluding any capacity
owned or controlled by the patent owner, it is currently insufficient for the purposes of meeting its needs. When it is established that such
capacity has become sufficient to meet the Member's needs, the system shall no longer apply”:
https://www.wto.org/english/docs_e/legal_e/31bis_trips_annex_e.htm
Last accessed on 14/12/2020.
47 See more at: https://www.who.int/news/item/20-04-2020-joint-statement-by-wto-director-general-roberto-azev%c3%aado-and-who-
director-general-tedros-adhanom-ghebreyesus
48 Available at: https://medicinespatentpool.org/uploads/2020/04/The-Medicines-Patent-Pool-and-Unitaid-respond-to-access-efforts-for-
COVID-19-treatments-and-technologies.png
49 See also: https://www.statnews.com/pharmalot/2020/04/16/european-union-who-voluntary-pool-covid19-
coronavirus/?utm_content=bufferdc6e9&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic
50 http://www.worldstopexports.com/drugs-medicine-exports-country/ accessed on 14/12/2020.
51 https://medicineslawandpolicy.org/2020/03/covid-19-and-the-come-back-of-compulsory-licensing/?fbclid=IwAR3WYvlmGDI7B-
6PLpxvotV9TJrZ2RMJ9KRxd9ZaIP3mQlxkVnTeoJnEkX8

35. 35
(TRIPS) is the type of real and pragmatic solidarity that we need to protect the
most vulnerable individuals around the world.
This new pandemic hearkens back to debates in prior decades about
whether certain essential medicines could be declared as global public
goods52 through efforts such as compulsory licensing53. It is time to reform the
international intellectual property system, especially the patent regime, as we
are in need of shared research and development(R&D). Most of the
pharmaceutical discoveries and advances have been made with state
investments. Regardless, several pharmaceutical multinationals in recent
months have oriented their strategy towards filing new patents, test data and
utility models aimed more at increasing royalties than at saving us from the
onslaught of COVID-19.
In other words, many patented inventions are based on publicly subsidized
research in public institutions. It is, therefore, the global public that pays taxes
that often finance many research activities. Consumers, in turn, have to pay
higher prices for patented products and in this process of increasing profits
there is a parallel loss of intellectual commons. This is why it is imperative to de-
link R&D from the final cost paid by consumers. The prices54 of medicines and
other health products should be set on the basis of accessibility by all those in
need. This improved accessibility is essential in Least Developed Countries; to
this end, a new legally binding international R&D treaty should include
mechanisms to decouple the cost of R&D for all diseases and pandemic out-
breaks from end consumer pricing mechanisms.
A legal system that allows the monopoly of transnational corporations brings
more inequality and less growth. The lack of leadership and cooperation
amongst international stakeholders is evident. However, not all is lost. The
President of Costa Rica55 sent a letter to the WHO Director requesting that
access and use of intellectual property covering technologies that help
detect, prevent, control and treat the COVID-19 be allowed. This “pool” of
technologies would include patents, copyrights, test data, research for
diagnosis, treatment, medicines and vaccines, among others. This proposal has
been endorsed by directors of global pharmaceutical companies as well as,
52 Available at: https://www.southcentre.int/wp-content/uploads/2020/04/PB75_Rethinking-RD-for-Pharmaceutical-Products-After-the-
Novel-Coronavirus-COVID-19-Shock_EN.pdf
53 See more at: https://www.southcentre.int/wp-content/uploads/2018/06/RP85-Acceso-a-medicamentos_-licencias-obligatorias-y-uso-
gubernamental_Hep-C.pdf
54 See more at: https://www.theguardian.com/commentisfree/2020/apr/15/coronavirus-treatment-drug-
companies?utm_term=Autofeed&CMP=twt_gu&utm_medium&utm_source=Twitter#Echobox=1586954074
55 Available at: https://www.keionline.org/32599 accessed on 14/12/202.

36. 36
different international public health organizations and by the director56 of the
WHO57.
Hopefully, this opportunity for technology transfers, financing, shared R&D and
global cooperation is not wasted and is supported by the governments of the
world. Colombia must lead by following up on this issue, as I will explain later.
The price control strategy or the use of compulsory licenses in the framework of
a national state of emergency are insufficient measures that require other
urgent emergency actions. Before presenting the recommended strategy for
Colombia, let’s briefly review some measures that have been taken by
different countries58 so far regarding patent law regulatory changes.
Chile and Israel59, for instance, have requested the implementation of the
compulsory licensing mechanism that would allow for the local
development of low-cost medicines, better known as generics, upon payment
of royalties to the holders of said rights. Ecuador has done the same; it has also
requested access to test data for non-commercial public use. Canada and
Germany60 seek by law to nullify patents. The ministers of science and
technology of Spain, Australia, Brazil, Canada, France, Germany, India, Italy,
Japan, New Zealand, South Korea, Portugal, Singapore and the United
Kingdom have considered “the possibility of excepting global patent
regulation, with the aim of speeding up technology licensing and transfer
processes, so that we can manufacture certain products around the world
quickly61”.
The true wealth of countries should now be measured in their ability to respond
effectively to the pandemic and to safeguard the life and health of all
inhabitants without exception or exclusion. All lives have the same
intrinsic value. Now, let us highlight some recent proposals on the roadmap of
countries like Colombia facing this challenge of enormous ethical, legal and
existential dimensions. Costa Rica’s proposal should be the foundation both
regionally and globally as it is beneficial to all countries involved. The use of
56 https://www.ft.com/content/b69afd98-a8af-40d9-b520-4231d9cac68f?fbclid=IwAR2Q4aXN2-jnXXgeXeAAfhDOR8M-
FrYJY7RMu6NuqbR7bwW-vO16GEFAMQc
57 Watch full video link here: https://mobile.twitter.com/claudiavaca5/status/1247327199029604352?s=20
58 http://www.derecho.uba.ar/investigacion/pdf/covid-19-medicamentos.pdf
59 https://www.keionline.org/32503
60 http://patentblog.kluweriplaw.com/2020/03/24/german-government-plans-possibilities-to-limit-patents-in-view-of-corona-pandemic/
See also: https://www.lifesciencesipreview.com/news/canada-authorises-compulsory-licences-for-covid-19-shortfalls-3972
https://www.keionline.org/32837 and https://laws-lois.justice.gc.ca/eng/acts/p-4/FullText.html
61 http://www.proyectodime.info/informacion-regional/informacion-seleccionada-sobre-covid-19/informacion-de-mercado-patentes-
precios-y-otros-asuntos/

37. 37
compulsory licenses has been tried in the past in Colombia without success for
various reasons. Recall the case of Lopinavir / Ritonavir to treat HIV/ AIDS ended
in price regulation. Remdesivir is also being studied for the COVID-19, which is
patented alongside other patents currently being reviewed. The same must be
said regarding Hepatitis C drugs and more recently, the debate related to
IMATINIB, which also ended up in price regulation and not in compulsory
licenses.
Compulsory licenses have been given in many countries like Thailand, Brazil,
Mozambique, Zimbabwe, Zambia, Rwanda, Malaysia, Indonesia and recently
India. Also, developed countries in Europe and the USA have used compulsory
licenses in the past. According to estimates from the WHO, nearly 6.5 million
people in low and middle income countries are in urgent need of ARV
treatment. However, due primarily to patent protection and high prices
charged by drug companies, only 1.3 million people actually receive
treatment. Nearly 80% of the 3 million people who die each year from AIDS
have no access to the available medicines62. Brazil had to comply with the
TRIPS Agreement in order to protect foreign technology and recognize
minimum standards for the protection of pharmaceuticals and patents.
Furthermore, the Brazilian government modified its domestic legislation even
though the costs were too high for the Brazilian health budget.
There are many advantages of compulsory licenses for developing countries.
The main benefit for society as a whole is making the drug product available
at a reasonable cost and as a consequence, saving more lives as developing
countries are able to access medicines that have become more affordable.
At the same time, knowledge cartels and transnational interest blocks are
challenged as governments may control dominant positions of firms. Also,
voluntary licensing of patents can help create new solutions and promote
access to medicines. Some have pledged to make intellectual property
available free of charge for use in ending COVID-19 and minimizing the
damage of the disease.
It is precisely in times like these that we must ask ourselves what is the
overarching societal function of the contemporary Intellectual Property regime
in the context of COVID-19? To what extent is that function attainable given
the existing design of International Patent rules and associated domestic rules
regarding pharmaceutical patents in developing countries?
62 https://www.who.int/hiv/fullreport_en_highres.pdf

38. 38
There are different proposals in Colombia aimed at directing the policy of the
national government to suspend the exclusive effects of patents to respond to
this pandemic of international scope. That is, the temporary suspension63 of
intellectual property rights (monopolies) granted by patents, test data and
utility models without this implying any infringement since a subsequent
mechanism for the payment of royalties can be established. Also, proposed is
the suspension of all patent procedures and other forms of intellectual
property, utility models and protection of test data on technologies or
information that could be useful to face the pandemic and request companies
that have relevant industrial secrets for the development of mechanical
ventilators, for example, to disclose such information that is of public interest.
This would guarantee the supply of medicines that must be produced in
Colombia in order to cover the needs for all citizens and residents in the
national territory.
The Global South should use existing TRIPS flexibilities more aggressively
combined with competition policy and better international coordination to
face and solve this pandemic. There is a need to put life and human rights at
the centre of the international institutional and regulatory system. Political
cooperation is required now more than ever and international aid from the
Global North is also essential. Subscribing to the “medicines patent pool of
technologies” proposed by Costa Rica with WHO coordination is the key since
representatives from developer companies have welcomed this solution so far.
Patent pools significantly reduce the cost of research and it makes licenses
available on a non-discriminatory, transparent, proportionate and non-
exclusive basis to facilitate the production of an affordable solution vaccine.
Other international organizations from the Global South recently proposed to
make use of Article 73(b) of the TRIPS Agreement to suspend the enforcement
of any intellectual property right including patents, designs and trade secrets
on the grounds of the security exception64.
Finally, there is a need to rewrite and reform the basic premises of the present
Intellectual Property Law system one that constitutes a major legal tool of
control. COVID-19 is a wake-up call that challenges mainstream views about
the world economy, knowledge monopolies and market oriented incentives to
innovate.
63
http://pensamiento.unal.edu.co/fileadmin/recursos/focos/medicamentos/docs/RECOMENDACIONES_AL_PAIS_SOBRE_PROPIEDAD_INTELE
CTUAL_EN_EPOCAS_DE_PANEMIA.pdf
64 https://www.southcentre.int/wp-content/uploads/2020/04/COVID-19-Open-Letter-REV.pdf last accessed on 14 /12/2020.
The author would like to thank: Cale, Jesse, Derick and Shane for their spelling review of some parts of the English version of this chapter.

39. 39
The current international, regional and national architecture of Intellectual
Property law confers privileges to foreign transitional interest blocks in order to
profit from patents by extending, trademarks, copyrights and so on for longer
periods of time.
This legal enclave diminishes the possibility of developing technologies,
including diagnostics, medicines, vaccines and other medical supplies vital to
treating patients infected by COVID-19 and it hampers efforts to distribute them
in a timely manner to all the countries currently affected by the pandemic.
However, the creative elements of a new global system are emerging now,
one characterized by coordination between WIPO, WTO and WHO. A new
system where R&D is de-linked from costs and prompt access for all the
countries of the world is guaranteed since the Sustainable Development Goals
shared mandate to work for good health and well-being for all.
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