Speaker: Yuanqiong Hu, Intellectual Property Advisor
Médecins Sans Frontières welcomes the continuing discussions by the Standing Committee on the issues of health and patents, and the limitations and exceptions to patents. We urge the Committee to deepen these discussions to allow member states to explore policies to facilitate access to affordable medicines and implement public health safeguards in their patent laws. This Committee is being held at a critical time, and comes in the wake of the United Nations’ Secretary General having welcomed the final report that was delivered by his High Level Panel on Access to Medicines in September. MSF notes that WIPO contributed to the formulation of this report through the Expert Advisory Group of the High Level Panel, and would like to urge WIPO and the member states to take full consideration of the analysis and recommendations provided by the report in the future work of the Committee.
In our day-to-day work, MSF continues to face challenges in securing access to more affordable sources of medicines and diagnostic tools; and we note that this issue of access is particularly difficult in middle-income countries. Today, a third-line treatment regimen for HIV is priced over 17 times more than the lowest price of first-line treatment, because patent and regulatory barriers block generic competition and the wide availability of more affordable generic sources. Countries that legitimately use compulsory licences remain under tremendous political pressure, as we saw with Colombia earlier this year, which had the threat of withdrawing international support for the peace process used as a political bargaining chip against the Colombian government’s attempt to curb the high price of medicines. Facing this reality, MSF would urge three improvements in the Committee’s work in light of the recommendations provided by the UN High Level Panel report.
First, WIPO and member states should take concrete steps in assessing the health impact of trade agreements and rejecting the proposals of TRIPS-plus provisions on intellectual property. Despite numerous studies showing the detrimental impact on access to medicines, TRIPS-plus provisions such as data exclusivity and patent term extensions on medicines continue to be pushed by the pharmaceutical industry and backed by the governments of some member states. These proposals are pushed through trade agreement negotiations such as the ongoing Regional Comprehensive Economic Partnership agreement, which involves 16 countries in the Asia-Pacific region. The High Level Panel report recommends countries to consider rejecting TRIPS-plus intellectual property provisions and to conduct thorough health impact assessments in trade agreement negotiations. We hope WIPO and member states will integrate these recommendations in the discussions under the agenda item on patents and health.
Second, WIPO and member states should address the lack of transparency in patent information concerning medicines, vaccines and diagnostics, and establish disclosure requirements for INN names in patent applications. The High Level Panel Report explicitly recommends WIPO to “establish and maintain publicly accessible databases with patent information status and data on medicines and vaccines.” And “This information should be periodically updated and consolidated by WIPO in collaboration with stakeholders to develop an international, easily searchable database which should include:
- Standard international common names for biological products
- International non-proprietary names for product, either as known at the time of application or after the granting of a patent; and
- Dates of granting and expiry.
MSF notes the steps taken by WIPO in providing new chemical search functionality in the PATENTSCOPE database. However, further steps are needed in implementing the full recommendations set out by the High Level Panel report. The disclosure of INN names should also be made as a normative requirement in patent applications.
Lastly, WIPO needs to provide public health-oriented technical assistance, with concrete follow up, on public health safeguards in member states’ patent laws. Many of the challenges facing access to medicines and overcoming patent barriers have been repeatedly shared by member states and observers. Patent ever-greening on medical technologies in particular remains a critical hurdle. The High Level Panel report clearly recommends WIPO to cooperate with other multilateral organisations and UN bodies, to “support governments to apply public health sensitive patentability criteria”, and to “strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive standards of patentability taking into account public health needs.” We urge WIPO to implement these recommendations in its future work, and to review and improve its technical assistance to member states with a better aligned approach of facilitating access to medicines and innovation, as explicitly recommended by the UN High Level Panel report.