Benefiting from pharmaceutical patent protection waiver

Dhaka,  Thu,  21 September 2017
Published : 16 Jul 2017, 20:30:51

Benefiting from pharmaceutical patent protection waiver

Pankaj Chandra Das
The decision of the TRIPS council of the World Trade Organisation (WTO) to extend the waiver in favour of the Least Developed Countries (LDCs) exempting them from implementing the provision of the TRIPS Agreement on the protection of pharmaceutical patents and clinical trial data is pretty much well known by now.

Before the expiry of the previous deadline up to 2016, the TRIPS council granted extension of another 17 years for the LDCs with a view to facilitating these countries to fully comply with the TRIPS provisions dealing with pharmaceutical patents. This waiver extends the deadline to 2033. The agreement also leaves scope for further extension to be made in future if it warranted considering the situation of the LDCs.

Extension of waiver also gives the LDCs the opportunity to develop their own pharmaceutical manufacturing industries while most LDCs currently don't have the capacity to manufacture pharmaceutical products, and most of them are at the starting stage of manufacturing essential drugs for their own consumption. LDCs being able to produce their own pharmaceuticals will significantly help production of affordable essential medicines, and high import cost can be avoided at the same time. 

Granting the extension has been done in line with both Doha Declaration and the sustainable development Goals (SDGs). The 2001 Doha Declaration on the TRIPS Agreement and Public Health affirmed the right of members of the WTO to make use of the flexibilities in the TRIPS Agreement to protect public health. On the other hand, the sustainable Development Goals (SDGs) adopted by the UN General Assembly to ensure healthy lives and promote well-being for all at all stages is the target of achieving universal health and affordable essential medicine and vaccines for all

Many LDCs are now at critical stage of development. 400 million of people i.e. 46 per cent of the LDC population live below the poverty line (USD 1.25 a day). They disproportionately suffer health risk associated with poverty such as malnutrition, unsafe water and poor sanitation. In fact, LDCs are the worst sufferers in all sectors of life, and they need strong support from developed countries to uphold their rights for survival.

It is creditworthy to mention here that on the LDC issue, Bangladesh, on behalf of LDCs, had introduced the LDC request under "other business" at a meeting of the TRIPS council in February, 2015, and the Council at that time had held a brief discussion on it. The request had received wide support from health experts and civil society organisations and international organisations. 

The waiver mainly focused to facilitate the LDCs for low cost treatment of HIV and other non-communicable diseases (NCDS) which appeared as an epidemic for the LDC group, especially in the African countries. In 2011, 9.7 million of the 34 million people suffering from HIV worldwide, lived in LDCs. Out of these, 4.6 million were eligible for antiretroviral (ARV) treatment in accordance with the 2010 World Health Organisation. However, only 2.5 million got the privilege of antiretroviral treatment. LDCs also bear increasing health burdens of non-communicable diseases (NCDS) than in higher income countries. 

The WHO opines that exemption from patents allows LDCs to either locally produce or to import generic products even when those are still under patent in other countries. This can also play a crucial role for LDCs to enhance local production of generic versions of essential medicine through strategic joint ventures.

This is likely to strengthen domestic manufacturing which can contribute in achieving public health objectives by ensuring supply as well as creating knowledge-based economy. 

Long term sustainability of the local pharmaceutical industry would require the development of internal capacity to manufacture generic formulations reducing dependency and the high import costs for obtaining patents. In particular, there is a need to develop a second line HIV treatment which at present more than double the price of the first line regime. Moreover, the cost for a third line HIV treatment could be as much as 15 times the price of the first line treatment. Clearly in this context, growth of pharmaceutical industry in LDCs is particularly important. 

At present, Bangladesh pharmaceutical companies are producing only generic medicines patent rights of which have already expired. We are now exporting our medicine to nearly 107 countries including Germany, USA, France, Italy, UK, Canada, Netherland and Denmark. It is expected that within a very short time Bangladesh pharmaceutical industry will be a major exporting sector. According to the last Annual Report of the Directorate General of Drug Administration, 39 Bangladesh companies exported drugs worth over Tk. 5.39 billion to various countries of the world. But it is very poor in comparison to the potentials of global marketing.

One major problem is that 90 per cent of the raw materials are imported from abroad because the local companies are hardly interested in producing raw materials as the cost of producing locally is much higher than the cost of importing them. At present, only a few companies are manufacturing raw materials for drugs like paracetamol, amoxicillin, flucloxacilin, ampicillin but the volume is very negligible. Experts opine that Bangladesh must develop a strong raw material manufacturing base, otherwise the rising price of ingredients in world market would affect the growth of the pharmaceutical sector in Bangladesh. 

The challenge that is impeding the desired growth of the sector is that most of the pharmaceutical companies are yet to develop their R&D for producing their own products. To be able to reap the benefit of waiver, it is extremely important that the pharma companies invest in R&D which alone can facilitate them increased access in the ever expanding global market..

In fine, we may expect that the pharmaceutical sector of Bangladesh must not lag behind to avail the waiver facility up to 2033 or more. We should give top most priority to developing our own capacity. We believe it is possible if the sector concentrates more on innovation capacity, i.e. by investing increasingly on Research and Development (R&D) to make the sector self-dependent.

The writer is Secretary of Bangladesh Indenting Agents' Association (BIAA).

Editor : A.H.M Moazzem Hossain
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