[Ip-health] Joint NGO Statement: LDC Pharma Exemption

Sangeeta Shashikant sangeeta at twnetwork.org
Fri Nov 6 05:29:49 PST 2015

TRIPS Council Decision On Extension of the Transition Period Concerning
Pharmaceutical Products

Today (6th November), the WTO-TRIPS Council adopted a decision granting
Least Developed Countries (LDCs) an exemption from patents and test data
protection for pharmaceutical products for a duration of 17 years.

With this exemption, LDCs will not be obliged to implement or apply or to
enforce patents as well as test data protection for pharmaceutical
products until 1 January 2033.

This decision is without prejudice to the right of LDCs to seek additional
extensions of transition periods pursuant to Article 66.1 of the TRIPS
Agreement. This is consistent with LDCs¹ right to not implement the TRIPS
Agreement at this level of their development.

The TRIPS Council also adopted a recommendation to the WTO General Council
for waivers from mailbox and exclusive marketing rights until 1 January
2033. Hence, LDCs will not be obliged to make available a mechanism for
filing patent applications for pharmaceutical products (mailbox) or to
grant exclusive marketing rights to such applications until 1 January

In numerous letters on this matter, civil society organizations have
highlighted the critical importance of this exemption from pharmaceutical
patents and test data protection for the world¹s poorest nations that
suffer massive challenges in facilitating access to affordable treatment
for infectious as well as non-communicable diseases. Considering the dire
socio-economic conditions in these countries, they also need maximum
flexibility in implementation of national laws to improve their
technological base and to boost local production of affordable medicines.

For this reason, the LDCs¹ request for a pharmaceutical transition period
until a country ceases to be an LDC, has received almost universal
unequivocal support from civil society globally, international and UN
agencies (WHO, UNDP, UNAIDS, UNITAID) and the European Union with no
declared opposition from the WTO members except for the United States.

Had the WTO-TRIPS Council granted the LDCs their desired and valid
requests, it would have demonstrated to the world that the WTO will take
the necessary steps to protect the poor and vulnerable. Instead,
unfortunately due to strong opposition mainly from the US, the WTO-TRIPS
Council reached a decision to accord LDCs¹ a transition period of 17

Nevertheless, with this decision we urgently call on all Least Developed
Countries to actively use the created policy space this renewed transition
period provides and accordingly to take immediate steps to amend their
respective national laws to exclude pharmaceutical products from patent
protection and test data protection with explicit provisions that this
would be until 1 January 2033 or the expiry of such later transition
period that may be granted by the WTO Council for TRIPS.

The Asia Pacific Network of People living with HIV/AIDS (APN+)
Both ENDS (Netherlands)
Bern Declaration (Switzerland)
EquityBD (Bangladesh)
Coastal Association for Societal Transformation Trust (Bangladesh)
Center for Health Human Rights and Development (CEHURD)(Uganda)
Health Action International (HAI)
Health GAP (Global Access Project)
Knowledge Ecology International
LDC Watch
MSF Access Campaign
Public Citizen
Third World Network
Yolse (Burkina Faso)

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