“Balancing Public Health and Patent Rights: The Challenges of TRIPS Agreement for Developing Countries”

Patent Rights and Public Health: A Balancing Act

Ensuring the right to health and access to affordable medicine is a primary requirement of life. Both developed and developing countries strive to promote the welfare of their people by ensuring public health and optimizing the availability of medicines. However, the protection of pharmaceutical products through patent rights has sparked debates from a human rights perspective.

The TRIPS Agreement and its Impact on LDCs

The Trade–Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) entered into force on January 1, 1995, to protect public health. This agreement has been a subject of ideological discourse, with divided opinions on its framing and its ability to protect the interests of poor countries, especially Least Developed Countries (LDCs).

After its enactment, TRIPS allowed a one-year grace period for all members under its article 66.1 and an additional ten years for LDCs to avoid treaty obligations. However, it also spelled out that LDCs with no existing patent regime could establish a mailbox with exclusive marketing rights (EMR) for accepting patent applications in the pharmaceuticals and agricultural chemical fields’ products starting from January 1, 1996.

The Case of Bangladesh

As a founder member of WTO, Bangladesh must abide by the principles of the TRIPS agreement. However, so far, Bangladesh has been enjoying the TRIPS flexibilities as one of the LDC countries. After graduation, Bangladesh will have to abide by the treaty obligations. Bangladesh is among the LDCs with capacities to produce pharmaceutical products, especially for domestic needs, while exporting to several countries.

Since 2006, Bangladesh has received applications for pharmaceuticals and agrochemical products and preserved them in the mailbox, which is 1340 till 2021, meaning about 84 applications per year. However, since Bangladesh has a patent regime, it is not supposed to provide a mailbox facility for storing patent applications and offering Exclusive Marketing Rights(EMR). Thus the executive order is a contrast with TRIPS.

Challenges and Opportunities

Under TRIPS, patent rights will be given from the date of application if such mailbox applications are successful. This could pose a challenge for the country as generics are already produced out of some applications that succeeded after the country’s transition period ending in 2026 because of LDC graduation, patents right will be due from the filing date.

However, Bangladesh, one of the leading LDC member countries of WTO, carefully played the card. Some changes emerged in the Doha Round on TRIPS and Public Health in 2002; TRIPS Council on June 27, 2002, permitted a delay in implementing patents until January 2, 2016. Or until graduation to a developing country, whichever date is earlier. This decision has given LDCs with no patent regime, a relief as they are waived from patenting pharmaceuticals but were asked to mail the patent and grant them EMR under the clauses of 70.8 and 70.9 for pharmaceutical and agricultural chemicals with its obligation under article 27(patentable subject matter).

Looking Ahead

Several health and development NGOs and workers suggested LDCs actively use the created policy space this renewed transition and accordingly take immediate steps to amend their respective national laws to exclude pharmaceutical products from patent protection with explicit provisions that this would be until January 1, 2033 that the WTO Council may grant for TRIPS.

However, Bangladesh’s case is different from other LDCs, as it will graduate from November 2026, and TRIPS flexibilities after January 2033 may not apply to the country. Ministry of Industries has tried to amend its existing patent law and remove the mailbox with retrospective effect. This should be done in a proper way to avoid any further confusion, on the other hand, amended IP law would also need adequate provisions to get rid of the mail box predicament.

The writer is CEO of BUILD a Public Private Dialogue Platform. She can be contacted at [email protected]