UN Declaration On Noncommunicable Diseases Upholds Intellectual Property Flexibilities

After weeks of uncertainty among civil society organisations as to whether or not the United Nations political declaration on noncommunicable diseases (NCDs) would uphold language on intellectual property flexibilities for affordable access to medicines, the document was finalised today with even stronger language affirming the use of these flexibilities.

The final draft of the political declaration on NCDs has entered a “silence period” until 6pm EDT on Wednesday 19 September, during which member state delegates can break consensus on the document and bring it back into negotiation. If the silence holds, then this intended final version of the NCD declaration will become official.

The uncertainty among civil society organisations regarding the inclusion of the language on intellectual property flexibilities was due to the broken silence of the TB declaration, negotiated in parallel, after key language on these flexibilities was removed. The TB declaration [pdf] has since been renegotiated and finalised (IPW, IP & Health, 18 Sept 2018).

The co-facilitators of the NCD declaration recognised that the negotiation of this parallel document could have some bearing on the final draft of the NCD declaration, so they kept the paragraph on intellectual property flexibilities “open” to allow for further consultations.

The language in question references the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement that enshrined into law the rights of countries to make full use of intellectual property flexibilities, including the compulsory licensing of drugs for generic production, as a public health safeguard, as well as the 2001 WTO Doha Declaration on the TRIPS Agreement and Public Health, that reinforced the TRIPS Agreement.

Comparison of the Final Draft with an Earlier Draft

The final draft of the NCD declaration that was released today not only includes language on intellectual property flexibilities, but it strengthens this language considerably as compared to the earlier 26 July draft of the text.

On TRIPS and the Doha Declaration, while the earlier draft simply “includes” TRIPS as one way to promote access to affordable medicines, the final draft “reaffirms” the use of TRIPS flexibilities. Where the earlier draft simply referenced “TRIPS” in parentheses, the final draft has included the entire name of the TRIPS agreement in full, along with that of the Doha Declaration.

Additionally, where the earlier draft language recognised intellectual property rights as an “important incentive” in the development of new NCD drugs, the final draft “recognizes that intellectual property rights should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all,” while also noting “the need for appropriate incentives in the development of new health products.”

This phrasing is significant in that it requires intellectual property rights to be interpreted and implemented in the context of the rights of member states to use intellectual property flexibilities. Additionally, it removes “intellectual property” as a descriptor of “appropriate incentives,” opening the way for other forms of incentives in the development of new drugs, such as those that promote the de-linkage of the price of drugs from the costs of research and development, and the volume of sales.

The language of the intended final version of the NCD declaration that was released on 18 September is included below, along with the 26 July version of the draft for comparison.

18 September Final Draft

“OP 20. Promote increased access to affordable, safe, effective, and quality medicines and diagnostics and other technologies, reaffirming the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) as amended, and also reaffirming the 2001 WTO Doha Declaration on the TRIPS Agreement and Public Health which recognizes that intellectual property rights should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all, and notes the need for appropriate incentives in the development of new health products;”

26 July Draft

“OP 20. Promote increased access to affordable, safe, effective, and quality medicines and diagnostics and other technologies, including through the full use of the provisions of the trade-related aspects of intellectual property rights (TRIPS) flexibilities for the protection of public health, while recognizing that intellectual property rights are an important incentive in the development of new health products for non-communicable diseases;”