Fight for Specific Pharmaceutical Waiver/Transition Extension to LDCs with a Good Start

In recognition of the massive health challenges in LDCs, Paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health accorded LDCs a specific waiver extension concerning “pharmaceutical products” until 1 January 2016. This extension was given effect through a TRIPS Council decision adopted in 2002 (IP/C/25 ). In addition, a General Council decision (WT/L/478) was adopted in July 2002, waiving LDCs’ obligations under Article 70.9, to provide for exclusive marketing rights during the transition period.

Unlike the general LDC extension decision which was last granted in 2013 until 2021; the 2002 pharmaceutical extension is specific to pharmaceutical products with no conditions attached. The 2002 decision explicitly states that with regard to “pharmaceutical products” LDCs are not required “to implement or apply” patents (Section 5 of the TRIPS Agreement) and undisclosed information (Section 7 of the TRIPS Agreement) or to such “enforce rights” until 1 January 2016. This decision was also without prejudice to the right of LDCs to seek further extensions.

The 2002 specific pharmaceutical decision has proven to be invaluable to policymakers at the national and regional levels. This decision has been relied on as the legal basis to amend national patent laws to exclude pharmaceutical products, from patenting. Numerous LDCs have relied on the Doha Declaration Paragraph 7 and the 2002 pharmaceutical decision to allow the importation/procurement of HIV-related generic medicines by declaring any existing patents unenforceable.

In addition, multiple international, regional, and sub-regional initiatives acknowledge the importance of governments incorporating in patent legislation and fully utilizing TRIPS flexibilities to facilitate access to affordable medicines. The African Union Roadmap on Shared Responsibility and
 Global Solidarity for the AIDS, Tuberculosis, and Malaria Response in Africa; the Pharmaceutical Manufacturing Plan for Africa (PMPA), the EAC East African Community Regional Pharmaceutical Manufacturing Plan of Action for 2012–2016 are some of the initiatives that are specifically supportive of extending the pharmaceutical exemption beyond 2016 as they consider the exemption to be essential to addressing the public health challenges as well to building a sound and viable technological base in the pharmaceutical sector.

In addition to facilitating access to affordable medicines, the extension is also important to the aspiration of LDC Members to develop and sustain local pharmaceutical production for national use and for export. In sum, it is critical for LDCs to act immediately and collectively to exclude pharmaceutical products from patent protection. Additionally, to fully benefit from a pharmaceutical extension, it would be equally important for LDCs to request a waiver from the mailbox obligation (provided for under Article 70.8) as well as obligations concerning exclusive marketing rights (provided for under Article 70.9) of the TRIPS Agreement. Unless waived, these obligations will be burdensome on the LDCs and hinder access to affordable pharmaceutical products during the transition period. These waivers too should be without conditions and last as long as an LDC Member retains that status.

In this context, ahead of the TRIPS Council meeting on 24-25 February 2015; LDC Watch lobbied LDC Ambassadors in Geneva to submit as a group a “duly-motivated request” to the TRIPS Council meeting for an extension of the transition/waiver period for as long as a country remains a LDC. It is important to note that according to Article 66.1 of the TRIPS Agreement “The Council of TRIPS shall, upon duly motivated request … accord extensions of this period”. The good news is that Bangladesh on behalf of the LDC Group has submitted a request (which is attached) for an extension of the transition/waiver period for as long as a member remains an LDC including a waiver from the mailbox and exclusive marketing rights obligations.

The next TRIPS Council meeting is in June and we need to continue to partner with as well as pressure our governments to sustain the fight for the extension. Undoubtedly, there will be strong resistance from the developed countries, nonetheless, we will fight a collective fight as we did in the past with the general waiver extension with considerable success!

(File) Bangladesh request for pharmaceutical waiver – 20 kB (File Size)

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