The implementation of the TRIPS Agreement by Least Developed Countries:

preserving policy space for innovation and access to medicines

The TRIPS Agreement
● The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS
Agreement) was negotiated in the Uruguay Round between 1986-1994 as part of
the Marrakesh Agreement establishing the World Trade Organization (WTO),
with the objectives of ensuring global protection of the Intellectual Property (IP)
rights of the Multinational Companies mostly based in the developed countries
with mandatory enforcement mechanism.
● The motivation was to set global minimum standards for IP protection therefore
all WTO Member states are required to comply with the Agreement by
introducing necessary changes including institutional and infrastructural set-ups
in respective national regulatory frameworks.
● The TRIPS obligations are applicable for all inventions in all fields of
technology (as per Article 27.1 of the TRIPS Agreement), which required huge
financial, institutional and technical burdens for the Least Developed Countries
(LDCs) considering their socio-economic conditions, low levels of
infrastructure, weak industry and institutions, fragile economy and extreme
poverty.
● Pharmaceutical inventions were particularly received huge attention because of
its direct impact on public interests particularly accessibility and affordability of
medicines.
Background:Contention over Intellectual Property and Public Health

●80% of the global population in the developing countries only represent

about 20% of global pharmaceutical sales (Medecins Sans Frontieres
[MSF], 2001; The Cambridge Textbook of Bioethics, Eds: Peter A. Singer
and A. M. Viens, 2008).
●MSF estimates that 90% of the world’s health R&D expenditure is
devoted to only diseases that affect just 10% of the world’s population in
the developed world.
●Of 1393 new drugs approved between 1975 and 1999, only 16 were
specifically indicated for tropical diseases and tuberculosis (Trouiller et al.,
2002).
●Given its broader public health and developmental implications, access
to essential medicines has become a fundamental human rights concern
(Commission on Intellectual Property Rights, Innovation and Public Health
[CIPIH], 2006).
 COVID 19 Vaccine
● Countries representing just 13 percent of the world’s population have already
cornered more than half (51 percent) of the promised doses of leading COVID-19
vaccine (See, Oxfam, 2020).
● “Even in the extremely unlikely event that all five vaccines succeed, nearly two thirds
(61 percent) of the world’s population will not have a vaccine until at least 2022.”-see,
https://www.oxfam.org/en/press-releases/small-group-rich-nations-have-bought-more-half-
future-supply-leading-covid-19.
● As of 10 February 2021 – “Of the 128 million vaccine doses administered.., more than
three quarters of those vaccinations are in just 10 countries that account for 60 per
cent of global GDP. …130 countries, with 2.5 billion people, are yet to administer a single
dose” (see, https://www.unicef.org/press-releases/covid-19-vaccine-race-we-either-win-
together-or-lose-together).
● COVAX –to deliver 2 billion doses to people in 190 countries-to ensure 92 poorer countries
will receive access to vaccines along with 98 wealthier countries. The scheme is steered by
the World Health Organization and involves the Global Vaccine Alliance (Gavi) and the
Coalition for Epidemic Preparedness Innovations (Cepi).As per present situation, the
scheme could cover the doses needed only for 20% of a country's population.
● So here is a question of utilizing available policy spaces and potential to allow the
developing countries and the LDCs having technical capacity to local manufacture of
pharmaceuticals to have access to required technologies for the mass production of the
Vaccine.
● See, https://www.bbc.com/news/world-55795297.
Facts and Evidence

106 investigational new drugs

from 10 organizations around
the world were tested in
humans between 1995 and
2007. The grand total life-cycle
cost of developing a new drug
to nearly $3 billion.
 Facts and Evidence

●It is often argued by the developing countries patent protection

drive up drug prices, restrict access to technologies and hence turn
into a barrier for access to medicines.
●Prior to the TRIPS Agreement, over 50 countries provided no patent
protection for pharmaceuticals, many provided only process and not
product patents, and in many others the duration of patents was
much less than 20 years (WHO, 2001).
●But many essential drugs are off patent. Of the drugs on the World
Health Organization Essential Drugs list, 75% are not currently the
subject to patent protection.
See for details, Amir Attaran, How Do Patents and Economic Policies Affect Access to Essential Medicines in
Developing Countries?, Health Affairs , Vol. 23, No.3, p.155
 Extending the TRIPS Transition Period: Is it a
Measure for Making a Viable Technological Base
or Simply a Further Waste of Time?

● Art. 66.2 and 67-disputed adequate technical and financial cooperation from the
developed countries to the LDCs.
● Technology need assessment and initiation of legislative, institutional and
infrastructural adjustments to utilize the policy spaces in the LDCs.
 TRIPS Waiver and Transitional Periods

● While the initial deadline for transition to full compliance for LDCs was 1 January 2006,
the TRIPS Agreement provides that the TRIPS Council “shall, upon duly motivated
request by a LDC Member, accord extensions of this period”.
● Accordingly, there have been three subsequent extensions in favour of the LDCs. The first
was particularly related to pharmaceutical patents and lasted until 1 January 2016.
● The second was approved by the TRIPS Council on 29 November 2005 and meant that
LDCs would not have to apply TRIPS provisions (in general, not just as they apply to
pharmaceuticals) other than Articles 3, 4 and 5 until 1 July 2013; this was again extended
to 1 July 2021 by a TRIPS Council decision on 11 June 2013.
● The Doha waiver that specifically addressed pharmaceutical patents was further
extended until January 2033 based on a request from the LDC group.
● On 1 October 2020, Chad, on behalf of the LDC members of the WTO, has
presented a proposal to the Council for TRIPS for the extension of the
transition period for LDCs under Article 66.1 of the TRIPS Agreement.
● The 2005 TRIPS Council decision to extend the transitional period for the LDCs acknowledged the
continuing needs of LDCs for technical and financial cooperation, “to enable them to realize the
cultural, social, technological and other developmental objectives of intellectual property protection”
as laid down in Articles 7 and 8 of the TRIPS Agreement.

● Council for TRIPS, ‘Extension of the Transition Period under Article 66.1 for Least-Developed
Country Members’, 30 November 2005, WTO document IP/C/40.
 Case Study on Bangladesh
● Among the 47 countries classified as LDCs (of which 36 are WTO members),
Bangladesh is one of the few with an adequate pharmaceutical manufacturing
capability, and it is nearly self-sufficient in pharmaceuticals.

● Bangladesh’s pharmaceutical industry now accounts for 97% of the country’s

pharmaceutical needs (the remaining 3% includes insulin, vaccines and high-end,
anti-cancer drugs, the production of which are very capital intensive and hence
not economically feasible for Bangladesh.

● Bangladesh devoted too much of its developmental efforts and economic diplomacy to
exploiting the benefits of its LDC status and TRIPS waiver, including for pharmaceutical
patents.

● Bangladesh has reached eligibility for LDC graduation in 2018 and following two
triennial reviews by the Committee for Development Policy (CDP), the country will
graduate out of the LDC group in 2024.

● Once Bangladesh graduates out of the LDC status, it will no longer be able to enjoy
the TRIPS transitional periods and extended waiver periods for the pharmaceutical
patents.
 Balancing Innovation and
Societal Goals

1.Utilise TRIPS Flexibilities

2. Support Measures
3.Institutional and Infrastructural
Development
TRIPS Flexibilities

•While TRIPS ensures strong and universal patent

protections, the Agreement also provides flexibilities
for greater public good and societal goals.

•However, there is always the risk of retaliatory

political and economic measures for using these
flexibilities.

•Again, to take the benefits of these flexibilities,

countries need to have adequate regulatory,
institutional and technical expertise.
 TRIPS Flexibilities
high threshold for patentability and exclusion clause from
patentability provisions,
 a best mode of patent disclosure and disclosure of origin,
narrowing the scope of patent claims to prevent ever-greening
providing exceptions to product patent rights such as early
working,
parallel imports, and research and experimental-use exceptions,
a strong compulsory licensing mechanism,
prior-use exceptions,
 pre-grant and post-grant oppositions
 making the duration of patent protection subject to exceptions,
and
 not adopting overprotective enforcement provisions.
● See, M. Monirul Azam, Globalizing Standard of Patent Protection in WTO Law and Policy Options
for the LDCs, Vol. 13.2, Chicago-Kent Journal of Intellectual Property, 2013, USA, pp.402-488.
 Support Measures

1. Drug Price Control-Essential Medicines List

2. National Competition law
3. Innovation in bargaining and drafting of contracts
4. Governmental bulk procurement and/or advance
buyouts
5. Patent Pool on country specific diseases
6. Introduction of Patent Prize system
7. Traditional Knowledge
See, M. Monirul Azam, The Experiences of Patent Law Reforms in Brazil, India and
South Africa and Lessons for Bangladesh, Vol. 7.2, Akron Intellectual Property Journal,
2014, USA, pp.61-100.
 Changes need to be in place for TRIPS compliant Pharmaceutical Regulation
Issues Existing Pharmaceutical Regulation in Changes need to be in place for TRIPS compliant
Bangladesh
 Product patent for  As of February 2021, pharmaceutical patents  Both process and product patents for
pharmaceuticals. are prohibited in Bangladesh. pharmaceuticals need to be introduced.
 Duration of Patent protection  Exiting patent law of Bangladesh provides  This needs to be extended until 20 years.
protection for only sixteen years. (Patents and
Design Act, 1911).
 Local production facilities and  Certain pharmaceutical products are excluded  It is not mandatory to have local production
local working. from licensing unless having local production facility. However, there is a debate regarding
facilities by the MNCs. local working provision as a ground for issuing
compulsory license.

 Import Restrictions.  Import restrictions on the pharmaceuticals  No import restrictions whether locally
and pharmaceutical raw materials that are produced or not as it will be discrimination and
locally produced. Again, if it is not within the hence violation of WTO and TRIPS principles.
essential drug lists of DGDA but produced by
at least three local companies may not be
imported.
 Marketing Approval restrictions.  Marketing approval is not granted to MNCs if  No restrictions on the marketing based on
a particular pharmaceutical product is locally produced locally or imported.
produced.
 Production restrictions.  MNCs are not allowed to produce some drugs  There must not be any restriction as it will be
such as vitamins, antacids. discrimination.

 Single ingredient.  Only single ingredient products are allowed for  Combination drugs need to be allowed.
production and distribution in the local
market.
 Advertising restrictions.  No advertising is allowed on the  Although unethical advertising may be
pharmaceutical products. restricted, advertising need to be allowed.
 Test data protection.  There is no test data protection for  There may be pressure from the MNCs and
pharmaceuticals in Bangladesh. developed countries like USA and the EU for
the introduction of test data protection.

See, M. Monirul Azam, The Impacts of TRIPS on the Pharmaceutical Regulation and Pricing of Drugs in Bangladesh: In Search of
Policy Direction, International Journal of Law and Management, Vol.59.3, 2017, Emerald Publishing, UK, pp. 376-393.
Institutional and Infrasturctural Issues

1.Institutional Innovation: National

IP Office and Drug Regulatory
Authority.
2.National Innovation System,
National Health Policy and IP
Policy
3.Triple Helix-Government-Industry-
University Collaboration from
public interest perspectives
4.National health insurance system
Capacity Building in the Department of Patents, Designs and Trademarks (DPDT)

● Patent Information System. A database is required of patents, non-working patents

and expired patents. In Bangladesh there is currently no patent information system
at the DPDT, and public access to the patent database is mostly restricted and
subject to slow bureaucratic processes.
● Traditional Knowledge Database
● Considering the low level of IP awareness in Bangladesh, it is necessary to establish
information centres around the country with support policies for SMEs.
● The DPDT could take initiatives to promote innovation and patenting practices among
local SMEs and research institutions: more than 70% patent applications by the foreign
companies and non-resident.
● Using the experience of Brazil, Bangladesh could examine potential policy spaces to
examine pharmaceutical patent applications from public health dimension in a post-
TRIPS situation.
● Training of patent examiners and other relevant stakeholders to consider the TRIPS
flexibilities from a balancing perspectives of promoting innovation and accessibility of
technologies particularly pharmaceuticals.
 Capacity Building in the Directorate General of Drug Administration (DGDA)

● To promote Investment in R&D and requirements for domestic supply

● Developing Standards for Pharmaceutical Companies-Good Manufacturing Practices
(GMP).
● Setting up Excipient based pharmaceutical companies
● International Certificates for Export, and Modern Test Facilities
● the establishment of the Active Pharmaceutical Ingredients (API) Park and adequate
facilities for bio-equivalency lab
● the DGDA needs to have continuous supervision to maintain the quality of medicines
both produced locally and imported for local market.
● the DGDA should enhance expertise to determine counterfeiting medicines.
● Infrastructural facilities like cost effective and adequate supply of energy, efficient
local transport, one stop services for permits and other administrative requirements
to avoid bureaucratic delay, port facilities for export and import and international
transportation.
● As infrastructural facilities could reduce cost of production and facilitate the import
of raw materials and export of medicines efficiently, these need to be taken into
consideration for determining competitiveness of the local industry.
Necessity of National Development-centred Intellectual Property
Policy and a National Health Strategy

● Integrating Long-term Innovation and Access Objectives

● Having a public-interest based national health strategy and national IP policy could
help national institutions such as DPDT, DGDA and Courts to utilise the policies
while making interpretations of the IP laws in the context of public health and other
societal objectives.

● National health insurance system-to avoid burden of excessive out of pocket expenditure
for the patients.
 University–Industry–Government Collaboration and Public–
Private Partnerships
● Not simply for promoting patenting in the Universities!!!!

● Government should set objectives making short term and long-term action plan for promoting R&D
in the local institutions on the country specific and urgently needed areas.

● Universities should have access to adequate funding and establish collaboration with the Industry to
innovate and commercialise inventions.

● Local pharmaceutical industry and MNCs active in Bangladesh mostly concentrate on generic
medicines and generating more profits out of exporting to other countries and hence lack of interest to
invest or re-invest in basic R&D and collaborate with the local universities.

● Cooperation between industry-government and universities can help to develop an

environment of self dependence and confidence, entrepreneurship, and experimentation that
brings together researchers, practitioners, and policy makers, across disciplines to solve some
of the pressing health problems facing by Bangladesh.

● There is no problem that Bangladesh and its pharmaceutical companies should take advantage of its
LDC status and TRIPS waiver as much as possible, but it should also learn to think and act for when
and how it could make graduation from LDC status, how it could utilize available policy spaces and
progression towards innovation and TRIPS compliance.
Thank you all for
attention.