WTO TRIPS Council: World Health Organization issues unequivocal support of LDC transition period for pharmaceutical products

Today, on Wednesday, 10 June 2015, the World Trade Organization's TRIPS Council discussed the LDC Group's Request for an Extension of the Transitional Period Under Article 66.1 of the TRIPS Agreement for Least Developed Country Members with Respect to Pharmaceutical Products and for Waivers from the Obligation of Articles 70.8 and 70.9 of the TRIPS Agreement (Source: IP/C/W/605). According to informed sources, around 30 WTO members including many developing countries, the Holy See and two high income economies - Chile and Norway, issued strong statements of support for the LDC Group's duly motivated "request for an extension of the transitional period (that ends on 1 January 2016) for as long as the WTO Member remains a least developed country."

The World Health Organization (WHO) issued this strong, nuanced statement in support of the LDC Group's request.



Universal health coverage is the central policy objective in global public health and part of the future UN Sustainable Development Goals. Universal health coverage means that all people obtain the full spectrum of essential, quality health services they need without suffering financial hardship. This requires a strong, efficient, well-run health system that meets priority health needs through people-centred integrated care. Health systems must provide for a system for financing health services, a sufficient capacity of well-trained health workers and be able to ensure access to safe, effective and affordable essential medicines and technologies.

Access to essential medicines is also recognized as part of the human right to health as an integral component of primary health care. Unfortunately, we as a community have not yet achieved this aim in all countries. There are many reasons for this gap, which include inadequate health systems, lack of political commitment, lack of good governance and insufficient investment in health in general. Where people have to buy medicines out of their pocket, it is essential that patients are provided with financial protection and essential medicines are affordable. This is particularly true for those countries that the UN classifies as the least developed countries.

Currently, LDCs that are members of the WTO are not required to apply most of the substantial rules of the TRIPS Agreement until 1 July 2021. In particular, they have no obligation to provide any protection for clinical test data or to grant patents, including on pharmaceutical products or processes. In parallel, LDCs benefit from a specific transitional period with respect to the pharmaceutical field under the 2001 Declaration on TRIPS and Public Health which if not extended, ends on 1 January 2016.

Being exempted from granting patents allows least developed countries to either locally produce or to import generic products even when those are still under patent in other countries. This can help countries in expanding health coverage by allowing the health sector to rely on more affordable generic suppliers. Being able to do competitive procurement, including from local or foreign manufacturers is in particular important in the area of HIV as well as for the new treatments for highly prevalent conditions like hepatitis.

The possibility not to grant patents on pharmaceuticals can also play a crucial role for LDCs to enhance local production of generic versions of essential medicines through strategic joint ventures. This can strengthen domestic manufacturing which can contribute to achieving public health objectives by ensuring security of supply as well as creating a knowledge economy.

Consequently, the LDC group stated that the request aims at facilitating access to affordable medicines in LDCs and is motivated by the massive health challenges resulting from communicable and non-communicable diseases in LDCs, their socio-economic and financial constraints, as well as the lack of adequate technological base and local manufacturing capacities in the pharmaceutical sector.

WHO welcomes and supports the LDC request for extension as part of an overall effort to facilitate access to essential medicines in these countries and urges the Council for TRIPS to favourably consider this request.