Pharmacy Law and Regulatory Affairs

Lecture 5

Shaouki Munir
MBBS (DU), Master of GMP (UTS), MPH (UNSW)
 Module Contents

This module covers the following topics:

• GATTs & TRIPs : Basics & Chronology

• WIPO Highlights

• The effects on GATTs-TRIPs-WTO-WIPO on local drug markets, industries & national

economy

• The probable solutions to avoid minimise the effects

 GATTs & TRIPs

GATTs:
General Agreement on Trade & Tariffs

TRIPs:
Trade-Related Aspects of Intellectual Property Rights
 WTO & WIPO

WTO:
World Trade Organization

WIPO:
World Intellectual Property Organization
GATTs / TRIPs Chronology

1945: Uruguay Round Talks of Developed Countries Began

1947: GATTs Signed by 23 Developed Countries
1986: Trade Liberalization Talks under GATTs again initiated
1994: World Trade Organization (WTO) Formed to implement GATT
1994: Also Included in GATTs –
- Agriculture
- Service
- Investment Measures
- Protection of Intellectual Property
1994: WTO framed another agreement on the protection of
intellectual property, which is called Trade-Related Aspects of
Intellectual Property Rights (TRIPs)

All the Components of GATTs and TRIPs declared to be effective from

2005

World Intellectual Property Organization (WIPO) was formed under

WTO to deal with patents.
 WIPO Highlights

➢Patents to be effective worldwide

➢No need to cope with country to country variations in legislation

➢Patents to be effective for 20 years

➢Patent-holder country or company can sue against violating countries

➢Economic sanctions or trade embargo by WTO against violator

countries
 GATTs-TRIPs-WTO-WIPO will destroy our local drug market,
local drug industries and our national economy because -

• Government has to OPEN the drug market for the foreign drug
companies

• Protection to local drug industries will be hampered

• Local drug companies will face an uneven competition

• Big local drug companies will lose own local market, resulting
financial crisis
 GATTs-TRIPs-WTO-WIPO will destroy our local drug market,
local drug industries and our national economy because -

• Small and medium local drug companies will face closure

• Many pharmacists and other professionals working in these local

drug industries will lose their jobs

• Price of the Essential Drugs will go up

• Government Primary Health Care network through out the country

will be difficult to run
 GATTs-TRIPs-WTO-WIPO will destroy our local drug market,
local drug industries and our national economy because -

• Many people will be deprived of their fundamental right of getting

treatment
• Mortality rates will go up in poor families
• People will have to buy patented brand drugs of foreign companies at
exorbitant prices
• As there will be no import prohibition, foreign companies will not be
interested to invest
• Thus no technology transfer will occur to our country
 GATTs-TRIPs-WTO-WIPO will destroy our local drug market,
local drug industries and our national economy because -

• As no new local or foreign drug manufacturing plants will be

established, job opportunities for the pharmacists and other
professionals will become very limited

• Likewise, the Ayurveda, Unani and Homeopathic drug

manufacturers will also face crisis due to patents of traditional drug
items

• Bangladesh economy in totality will face a grave crisis

What can be done ?
✓To find out the gaps in TRIPs patent provisions

✓ Not to accept any internationally uniform patent law

✓ Product patent and process patent to be considered separately

✓ Compulsory Licensing provisions not yet finalised

✓To allow local drug companies to register as many new
molecules as possible

✓Manufacturing and marketing regulations to be liberalised.

Some new molecules can be provided with ‘Third Party
Licensing’

✓To utilise the transitional period fully

✓Try to extend the transitional period (Extension: 2005 ---- 2013

----2021 ---- 2032
Can take some advantage too:

• Bargaining with WTO

- Public Health Coverage
- Transitional Period

• World Generic Market

- Export to LDC Countries
- Export to Others

• Patent Provisions Review

Recent Success
▪ In 2015, Bangladesh Government was successful in extending
patent right waiver up to 2032 for the least developed countries
(LDCs).

▪ In 2010, Prime Minister Sheikh Hasina addressed the UN General

Assembly where she, among other issues, urged the UN and
WTO to waive the patent provision or to extend the transitional
period up to 2030 for the sake of preserving public health.

▪ Since then, the Ministry of Commerce (GoB) had been trying to

achieve this not only for Bangladesh, but also for all the LDCs.
Finally in September 2015, WTO announced the extension of
transitional period from 2015 to 2032.
References

• Ludwig, S., 1998. [online] Available at:

<https://www.sciencedirect.com/science/article/abs/pii/S0167450198800289> [Accessed 18
February 2022].

• Wto.org. 2020. WTO | intellecutal property (TRIPS) - WTO-WIPO agreement. [online] Available at:
<https://www.wto.org/english/tratop_e/trips_e/wtowip_e.htm> [Accessed 18 February 2022].

• Uddin, K., n.d. [online] Dpdt.portal.gov.bd. Available at:

<https://dpdt.portal.gov.bd/sites/default/files/files/dpdt.portal.gov.bd/notices/ae07f046_c5ad_4
97b_9ef8_d60ce413f76c/IP%20Policy.MKU.pdf> [Accessed 18 February 2022].