Challenges & Impact in Pharma Sectors
After Graduation (2026) from LDC
Mohammad Mozammel Hossain
Deputy Director
Directorate General of Drug Administration

Background
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Sub Committee on Intellectual Property Rights (IPR)–
Lead by Secretary, Ministry of Industries
Co-Lead: Secretary, Ministry of Commerce.
Members: Total Member-09.

As a member of the WTO, Bangladesh has been getting some benefits from the TRIPS
Agreement for its LDC status since its inception. These benefits will be no more after
graduation from LDC. Hence questions arise what will be the impacts and how
Bangladesh will cope.
For the accomplishment of said assignments, the TRIPS Agreement should be
discussed. As an LDC member, Bangladesh enjoys some benefits from the TRIPS
Agreement and simultaneously loses few potential.
Introduction

1. articles 3, 4, and 5. This exemption has been extended till 01 July 2034 recently*. The
authority of such extension is the council for TRIPS (article 66.1 of the TRIPS
Agreement).
2. LDC countries are also exempted from patent protection for pharmaceutical and
agricultural chemical products. (Article 70.8 of TRIPS Agreement )
3. Because of the LDC countries are exempted from applying the TRIPS Agreement’s
provisions other than above exemptions, LDC countries can copy and produce any
patented pharmaceutical and agricultural chemical products without getting permission
from the inventors. These provisions are helping billions of people from LDC
countries to get medicine, fertilizer, and pesticides at cheap affordable prices.
Benefits of TRIPS Agreement for LDC countries-

 According to Article 3.1 of the TRIPS Agreement, the treatment of the nationals of other
members shall not be less favorable than its nationals of a member.
 On the other hand, Article 4 states that if a member grants any advantage, favor, privilege,
or immunity to the nationals of any other country regarding intellectual property, it shall
accord immediately and unconditionally to the nationals of all other members.
 On account of the above provisions, LDC countries cannot grant any patent for
pharmaceutical and agricultural chemical invention.
 Once any LDC country grants any patent for pharmaceutical and agricultural chemical
invention, simultaneously, it has to grant patents to the companies of developed countries
and has to take regulatory measures for unauthorized producers of patented products.
 For keeping the pharmaceutical and agricultural chemical prices at an affordable level LDC
countries have been avoiding granting any patent for those products.
Waivers of LDC countries for enjoying benefits of TRIPS-

 Suggest strategy in developing local capacity and prepare to ensure availability of
medicine, vaccine, and medical products after graduation.
Development of local capacity can be gained by enhancement of investment in
Research & Development (R & D). New policy formulation may be required to
compel pharmaceutical companies to invest their certain portion of profit to R & D.
Remarkable percentage of such investment should be allotted to universities.
Universities should introduce institutional IP Policies to increase collaboration with
industrial entities for research.
Logics/proposals for assigned matters-
Cont..

In order to acquire the ability to prepare new medicine i.e. new
molecule, placement-based goals and plans have to be adopted in
the pharmaceutical industry. A policy may be adopted for
government incentives to encourage the development of new drugs,
such as the new molecules.
Global accredited Drug Testing Laboratories should be establish
under the DGDA to ensuring the quality of drugs.

 If the waiver period is over in 2026 the impact on domestic industries and general public
health might not be severe. All the common medicines (including antibiotics) are now
public domain.
 This means the patented period of these medicines has been expired. All patents period
expire after twenty years from the filing date (article 33 of the TRIPS Agreement). So no
private or sole ownership can not be claimed for the medicine which was patented 20
years back.
 Probably only a few medicines for severe diseases like cancer and new diseases like
Covid-19 will remain patented after 2026.
 However, a study/ survey in this regard is required to find out the complete picture.
Whatever findings come in that study will not change the fate of Bangladeshi nationals
comparing other nationals of developing countries as they are also buying patented
medicines at a higher price.
Analyze the impact on domestic industries and general public
health, if the waiver period is over in 2026.

If the nationals of other developing countries enduring the higher price of
patented medicines, it will not be unbearable for Bangladeshi nationals when
they become a citizen of a developing country.
## https://en.wikipedia.org/wiki/Public_domain
Intellectual property laws particularly Patent & Design Act 1911 should be
complied with the TRIPS Agreement. Traditional knowledge in Bangladesh
may be protected. In this regard a new Traditional Knowledge Act may be
formulated. Additionally Trade Secret and Integrated Circuit Layout Design
Act may be considered to be formulated.
Impacts

 The transition periods enjoyed by Bangladesh as LDC to delay the implementation
of the TRIPS Agreement have been a defining feature of LDC flexibility in the
WTO
 The access to manufacture and supply generic medicine
 Access to Manufacture API
 Manufacturing facilities must have to be compliant by defined regulatory
authorities
 Earning of foreign revenue by exporting generic drugs
 Partnership with international companies
 Access to essential life-saving medicines
Graduation shall limit

1. If Waiver of TRIPS Agreement will not be effective up to 1st January 2033 then it
will be a challenges for our small and medium size pharmaceuticals and they will
be affected.
2. Cost of API will increase many fold due to proprietary rights and at the same time
cost of generic drugs will be increased after graduation from LDC category.
3. Cost of the product and API will increase many fold and Affordability of medicine
by common people will face difficulties.
4. Export of medicine to many countries will reduce due to proprietary rights or short
of competitive biotech drugs like vaccines, biologics, and monoclonal antibodies
instead of generic drug.
Challenges

5. In case of antimicrobial resistance to antibiotic is a big challenges in the future if
new molecule does not introduced or launched by the world or any country.
6. If our enlisted CRO’s will not fully active in clinical trials for bio-similar or
biotech products introduced by the manufacturer then it will create a barrier for
introduce new generation molecules.
7. Our respective academic institutions or universities need to develop or establish
R&D lab for introduced new molecule or patented drug in the country.
8. We need to develop a facility three-tier direction among Government, academia
and industries.
9. Facility to conduct Bio-Equivalance study is must need for Bangladesh
Challenges

What other’s
are doing after
graduation

Constitutional protections for access to medicines
It is the policy of the State to protect public health and, when the public interest
or circumstances of extreme urgency so require, it shall adopt appropriate
measures to promote and ensure access to affordable quality drugs and
medicines for all.
Example: Philippines & Panama

Using international treaties to promote access to medicines
In some countries, the treaty obligations assumed by countries are enforceable through
the domestic courts, providing members of the population with a legal pathway for
seeking greater access to essential medicines at affordable prices. For example,
Argentina’s Constitution refers to a number of human rights treaties which supersede
domestic law.
Example: Argentina

On public interest grounds, the practice of WTO Members
illustrate that national laws may authorize compulsory
licenses on a number of additional grounds.
For example, Zimbabwe’s Patent Act

Article 31 of the TRIPS Agreement states that in circumstances where the national law
of a WTO Member permits a compulsory license to be issued, the Member must first
seek permission to use the patent from the patent holder on reasonable commercial
terms. However, prior attempts to obtain access to the patented drug on commercial
terms are not required in the case of a national emergency (which each Member is free
to define), in other circumstances of extreme urgency, or in cases of public, non-
commercial use – such as when a government is seeking to ensure universal access to
essential drugs or is using the patent for other government purposes
Example: “The operation of Article 31 is
illustrated by the case of Thailand”

Legislation authorizing the issuing of a compulsory license
In order to establish a clear legal basis for exercising the flexibilities that are
permitted under the TRIPS Agreement, WTO Member States should enact
legislation that sets out the circumstances in which the government reserves the right
to issue a compulsory license. Apart from the exceptions mentioned in Article 31(b),
such legislation should provide for a reasonable, yet time-limited period for
negotiating with the patent holder before the designated national authority issues the
license
Example: “Industrial Property Law of Brazil”

Strategies
we should
adopt

Strategies
01
Considering this paradigm shift Bangladesh should update the National lP Policy which was
framed during the year 2008 and a National Health Strategy integrating long-term innovation
and access objectives through the collaboration between universities, industries and
government and public-private partnerships.
02
Registration of New Molecules must have to be facilitated/simplified so that our
Pharmaceutical industries can register as many molecules as possible before the graduation.
With respect to Article 31, if we register any drug before the originator, the need no
compulsory license from originator for that molecule.
03
The Government of Bangladesh may also approach the WIPO, WHO and lP offices of
leading developing countries for technical assistance in dealing with TRIPS-compliant patent
regime, particularly pharmaceutical patents.
04
Bangladesh can still negotiate for increasing the threshold of LDC graduation or for
extending the waiver by creating a new category like 'Newly Graduated Countries in
Transition' to achieve SDG on global health and well-being.

Strategies
Bangladesh can
also bargain for
additional
transition period
during the
process and even
after being
declared formally
for some well-
founded and duly
motivated
reasons.
Bangladesh may
refuse to accept
the patent with
respect to the 3
(three) reasons
that may relate
to the Public
Health (Article
27.2, Article
27.3A, Article
27.3B of TRIPS
agreement)
Bangladesh can
adopt measures
necessary to
protect Public
Health as per
Article 8 &
Article 31 of
TRIPS
agreement
Bangladesh
should
formulate the
patent law
with respect
to future
business
perspective.
05 06 07 08

1. We need to add some line in the Patent Act like, “Bangladesh would not grant patent to any
product already marketed before graduation to middle-income country.”
2. Bangladesh should provide “process patent” initially, not “product patent”. Bangladesh could
use India as an example. India got a transition period until 2005 to fully comply with TRIPS.
3. No secondary patent, no patent term extension. Bangladesh could refer the Section 3d of Indian
patent amendment act 2005 where it is stated that “The mere discovery of a new form of a
known substance which does not result in the enhancement of the known efficacy of that
substance or the mere discovery of any new property or new use for a known substance or of
the mere use of a known process, machine or apparatus unless such known process results in a
new product or employs at least one new reactant, is not patentable. For the purposes of this
clause salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixture
of isomers, complexes, combinations and other derivatives of known substances shall be
considered to be the same substance, unless they differ significantly in properties with regard to
efficacy.”
Points to be consider during drafting Patent Act

4. TRIPS safe guards like compulsory licensing, parallel imports, anti-competitive behavior,
research exception etc. should be included in the revision of patent law. Also, in case
of any emergency or pandemic, Govt. should have the power to decide on whether or not
to grant a patent for any particular lifesaving medicine.
5. We need to avoid mailbox provision as it may allow MNC companies to get patent which
was filed before the Patent implementation in Bangladesh.
Points to be consider during drafting Patent Act:

1. Bangladesh should increase the number of patent examiners with knowledge of
chemistry and pharmacokinetics to ensure that frivolous and ever greening patent
claims over existing drugs are rejected in the light of robust patentability criteria to be
applied by the patent examiners.
2. Our academic institutions like universities need to gear up their innovation and we
need productive academia-industry collaboration for developing new technology and
products. Government should implement Research Lab facility in all public university
at respective department.
3. For research, clinical trial is a very important area. We need many more CRO who can
take care of clinical trials for the Pharma companies who manufacture biological
products, monoclonal antibodies, oncological products etc.
4. We have to start giving more focus on API manufacturing. This is very crucial for
sustainability of the industry post Patent era.
Points to be consider for capacity building on IPR:

5) After patent implementation, many of the local companies can tie up with patent holder
companies to manufacture patented products by acting as Contract Manufacturing
Organization (CMO). For this our local industry need to develop expertise in technology
transfer process as well as expertise in in-licensing & out licensing legal procedures.
6) Biosimilar Drug, Blood Product, Plasma substitute & Hormone Drug may registered in the
country who have the facility to manufacture this drugs before graduation.
7) Simultaneously Clinical Trial should continue with CRO for including High Tech introduced
drugs like Biological Products, Monoclonal Antibodies (MABS) & Oncological Products
before graduation.
8) Available molecule under patent which may be manufactured by capable industries in the
country should be registered immediately.
9) Facility to conduct Bio-Equivalance study is must need for Bangladesh.
Points to be consider for capacity building on IPR: