WTO Least-Developed Countries Request Waiver Of IP Rights On Pharma Products

Source: IP Watch

3 Sep 2015

This week at the World Trade Organization intellectual property committee meeting, least-developed countries submitted a request to extend a waiver allowing them not to enforce intellectual property rights on pharmaceutical products. The countries have extended the waiver before, but this time they are seeking to make it indefinite, until they are no longer considered LDCs.

Least-developed countries are disproportionately exposed to the health risks associated with poverty, and “patent protection contributes to high costs, placing many critical treatments outside the reach of LDCs,” said a communication [pdf] by the group, proposing to extend the current waiver to intellectual property rights enforcement past the deadline of 2016.

In June 2013, a general waiver exempting LDCs from the obligation to enforce IP rights was extended to 2021 (IPW, WTO/TRIPS, 2 August 2013). This extension covers all products, including pharmaceutical products, and has been running in parallel with the special waiver on pharmaceutical products granted to LDCs until 2016.

At the 24-25 February Council for the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS), the LDC group submitted a request to extend the 2016 deadline and in particular to prolong the transitional period for as long as the WTO member remains an LDC. This element was part of the request for the general extension in 2013 but was resisted by a number of countries (IPW, WTO/TRIPS, 12 June 2013).

LDCs, building upon TRIPS Article 66.1 (Least-Developed Country Members) providing that the Council for TRIPS “shall, upon duly motivated request by a least developed country Member, accord extensions of this period,” further request that:

LDCs be exempted from obligations under TRIPS Article 70.8 (Protection of Existing Subject Matter), relating to patent protection for pharmaceutical and agricultural chemical products, and Article 70.9, relating to exclusive marketing rights, as long as the WTO member remains an LDC. The proposed extension is not intended to apply to agricultural chemical products, a source said.

According to a WTO official at a press briefing today, Article 70.8, otherwise dubbed the “mailbox provision” allows an inventor to file a patent application even if there is no patent protection in a given country. It means that even if countries do not have to protect patents, they still have to provide means for patent applications to be submitted [corrected], which would be activated when that country starts protecting IP rights.

Taking the floor in the TRIPS Council on behalf of LDCs, Bangladesh said in its statement [pdf] that, “In 2011, some 9.7 million of the 34 million people living with HIV worldwide, lived in LDCs. Of the people living with HIV in LDCs, 4.6 million were eligible for antiretroviral (ARV) treatment in accordance with the 2010 World Health Organization HIV treatment guidelines, however only 2.5 million were receiving it.”

“LDCs also bear increasing health burdens from non-communicable disease. For example, cancer incidence is expected to rise to 82 percent in 2030 in low-income countries compared to 58 percent in upper-middle and 40 percent in high-income countries,” the delegate said.

The delegate quoted UNAIDS saying, “There is concern that without extension of the transition period, access to antiretroviral therapy and other key medicines in LDCs will face real challenges.” He also quoted UNAIDS saying, “There is a real danger that if the LDCs do not get a further extension, the progress that has been made to improve access to HIV-related medicines in these countries will be reversed.”

Nepal, China, Brazil and India supported the LDC proposal, as well as the European Union, which said it could not comment yet, but gave general support to the idea, according to the WTO. No country voiced reservation, it said.

The WTO official said no substantive discussions were carried out during this session, but the subject should be developed at the next TRIPS Council meeting, scheduled for 9-10 June.

Civil Society Reacts to LDC Request

A set of responses by nongovernmental organisations was provided to Intellectual Property Watch.

Sangeeta Shashikant of the Third World Network said, “a specific extension of transition period with regard to pharmaceutical products for as long as a country remains a LDC is critical to facilitate access to affordable medicines in LDCs that already face numerous development and health challenges.”

“WTO Members have no right to deny or condition the requested extension as Article 66.1 of the TRIPS Agreement expressly states that the TRIPS Council ‘shall’ accord extensions upon a duly motivated request by LDCs. Such a request has been submitted to the TRIPS Council by Bangladesh on behalf of the LDCs,” she said.

Brook Baker of Health GAP (Global Access Project) said, “Least developed countries need absolute clarity about their right to deny patents on pharmaceuticals, to deny protections for pharmaceutical related data, and to be relieved of any obligations to collect pharmaceutical patent applications and to grant exclusive marketing rights.”

“To maximize health outcomes, LDCs should be free from TRIPS obligations for pharmaceuticals as long as they maintain LDC status, which is, in itself, a signal of their many capacity constraints,” he said.

“In the past the US, the EU and even the WTO have tried to deter LDCs from seeking their maximum transition periods as guaranteed by Article 66.1 of the TRIPS Agreement. They have also attempted to impose unwarranted conditions. Any such efforts in response to the LDCs’ new request would be a grave infringement of the right to health and ironclad flexibilities within the TRIPS Agreement,” he added.

Médecins Sans Frontières (MSF, Doctors without Borders) Policy and Analysis Director Rohit Malpani said MSF “welcomes the request by Bangladesh, on behalf of least-developed countries, to extend the pharmaceutical transition period until LDCs are no longer classified as such.”

“MSF works in many LDC countries and relies on low-cost affordable generic medicines to provide affordable access to treatment,” he said. “Any flexibility which can safeguard access to low cost generic medicines and vaccines is welcomed by MSF.”

Primah Kwagala of the Center for Health, Human rights and Development in Uganda said “Uganda is in the process of building a strong technological base, and yet to put in place institutional, a legal and policy environment to enable it to move towards TRIPS implementation, freedom from patents on pharmaceutical products will enable Uganda and several LDCs to improve the health prospects of their citizens.”

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