Supplier of Essential Medicines Supports TRIPS Waiver For Least-Developed Countries

The IDA Foundation, a worldwide supplier of essential medicines to low-and medium income countries, has backed the request by least-developed countries to extend a waiver that allows them to forfeit the obligations to protect intellectual property on pharmaceutical products. UNITAID, the UN-related drug purchasing mechanism, also issued a statement in support of the extension. The request is expected to be discussed at the World Trade Organization in June.

The IDA Foundation sent a 26 March letter of support to Amb. Shameem Ahsa of Bangladesh, which is speaking on behalf of the least-developed country (LDCs) group at the World Trade Organization Council for the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS). The letter was signed by IDA Foundation Managing Director Edwin de Voogd.

Health outcomes globally have seen significant progress, the IDA Foundation said in the letter [pdf], but “the health systems of least-developed countries continue to face challenges in securing affordable, high quality medications.”

The IDA Foundation “is the world’s leading not-for-profit supplier of essential, quality-assured medicines and medical supplies to low- and medium income countries,” according to the foundation. Founded in 1972, IDA Foundation is headquartered in Amsterdam. It has offices in India, China, Nigeria, and the United States, and distributes over 3,000 different medicines and medical supplies to over 130 countries.

LDCs were granted an exception to their obligation to protect intellectual property rights on pharmaceutical products until 1 January 2016. Parallel to that exception, a general waiver exempting LDCs from the obligation to enforce IP rights on all products, including pharmaceutical products, was adopted in June 2013 ((IPW, WTO/TRIPS, 2 August 2013), to run until 2021.

At the 24-25 February TRIPS Council, the LDC group submitted a request [pdf] to extend the 2016 deadline on pharmaceutical products, and specifically that the transition period be extended for as long as the WTO member remains an LDC. This request was also put forward in 2013 but was resisted by developed countries (IPW, WTO/TRIPS, 25 February 2015).

Important for ARVs, Non-Communicable Diseases

In its letter, the IDA Foundation said its customers “have benefitted from the pharmaceutical waiver for many years, so it allows LDCs to authorize the importation of generic medication regardless of patent status.”

“This proved to be critical where licenses for anti-retroviral drugs to treat HIV were not available,” it said. “The existence of the pharmaceutical waiver, and specifically the provisions of Paragraph 7, gave IDA the necessary legal protection to be able to supply ARVs [antiretrovirals] on a large scale without fear of patent infringement suits.”

The waiver has not just been used on ARVs, but is “exercised for essential medications and will be relevant for both the production and procurement of products increasingly needed in LDCs, such as those for the treatment of non-communicable diseases,” it said.

“In order to ensure that a comprehensive range of affordable drugs remains available to those most in need, IDA Foundation supports the extension of the pharmaceutical waiver, and joins those asking that the WTO honor the request made by the LDC members,” de Voogd wrote.

The LDC request underlined the disease burden from infectious and non-infectious diseases carried by LDCs, but also “the increasing health burdens from non-communicable disease.”

“For example,” the request stated, “cancer incidence is expected to rise 82 % from 2008 to 2030 in low-income countries (compared to 58 % in upper middle and 40 % high-income countries).”

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

At the February TRIPS Council meeting, 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.

According to a civil society source, the significance of the IDA Foundation getting involved in the issue is the fact that a procurement agent would acknowledge the importance of the pharmaceutical exception for LDCs. Procurement agencies are often confronted with the threat of patent infringement suits, the source said.

UNITAID Supports Extension

On 25 March, UNITAID released a statement supporting the LDC extension. UNITAID said it is “concerned about the expiry of the ‘pharmaceuticals exemption’ for least-developed countries (LDCs) which originates from the Doha Declaration on the TRIPS Agreement and Public Health.”

“As an organization that funds projects to improve access to medicines for HIV, TB and malaria in 94 countries, including many LDCs, UNITAID strongly supports the request by the least-developed counties for an extension of the transition period for pharmaceuticals,” said UNITAID Executive Director Lelio Marmora, according to the release. “This exemption has facilitated access to affordable medicines in LDCs, and UNITAID urges WTO Members to unconditionally approve the request by the LDCs.”

Commenting on the flexibilities enshrined in the TRIPS Agreement for developing and least-developed countries, the release said: “One of the most important flexibilities for least developed countries (LDCs) is that they are not obliged to implement key sections of the TRIPS Agreement – notably the granting of patents and the provision of data protection – with regards to pharmaceuticals.”

“UNITAID believes that it is crucial that countries can make use of ‘TRIPS flexibilities’ in order to safeguard access to medicines,” said Marmora. “This certainly should apply to the most vulnerable members of the international community: the LDCs.”