UNDP, Unitaid, and WHO caught in Big Pharma’s crosshairs

PhRMA’s Special 301 submissions are part of a yearly ritual to shape the “Special 301” Report, an annual review of the global state of intellectual property rights (IPR) protection and enforcement, conducted by the Office of the United States Trade Representative (USTR) pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).

Not content with the naming and shaming countries deemed deficient in their protection of intellectual property rights, PhRMA’s 2019 Special 301 submission trains its sights on multilateral organizations and UN agencies including the World Health Organization the United Nations Development Program (UNDP), the United Nations Conference on Trade and Development (UNCTAD), and Unitaid.

What appears to gall PhRMA is the work of WHO, UNDP, UNCTAD and Unitaid in providing the technical assistance on the application and use of WTO TRIPS flexibilities to promote access to medicines and safeguard public health.

In the words of PhRMA:

Multilateral organizations that once served as custodians of the international rules-based system increasingly are seeking to undermine and even eliminate intellectual property protections that drive and sustain biopharmaceutical innovation in the United States and around the world. By reinterpreting international agreements and through meetings, reports, guidelines and training programs, the WHO, the United Nations Development Program (UNDP), the United Nations Conference on Trade and Development (UNCTAD), Unitaid and other organizations are promoting acts, policies and practices globally and in specific countries that prevent biopharmaceutical innovators from securing and maintaining patents, protecting regulatory test data and from enjoying fair and equitable market access.

PhRMA specifically targeted UNDP and Unitaid for promoting strict patentability criteria. In a fit of pique, PhRMA described UNDP as not appearing to have “specialized expertise on intellectual property matters” in relation to UNDP’s 2016 publication, Guidelines for the Examination of Patent Applications relating to Pharmaceuticals. PhRMA trained its crosshairs on Unitaid for funding the work of the International Treatment Preparedness Coalition (ITPC), South Centre, and Third World Network to work on the “flexibilities and provisions under global intellectual property agreements and laws to improve access to affordable medicines in order to safeguard public health.” (Source: Unitaid)

In addition, multilateral organizations such as UNDP and Unitaid advocate actively for patentability restrictions and additional patentability requirements that are inconsistent with international practice. For example, although UNDP does not appear to have specialized expertise on intellectual property matters, it issued patent examination guidelines in 2016 that, if followed, would prevent innovators from securing patents on many kinds of biopharmaceutical inventions. Similarly, Unitaid partnered with various non-governmental organizations in 2018 to launch a campaign to erode intellectual property policies and laws globally.

In its 220 page submission, PhRMA calls for the “[f]ostering and strengthening” of coalitions to support innovation at multilateral fora including the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO) noting that even these fora are vulnerable to work “inappropriately focused on limitations and exceptions to intellectual property rights, if not actively seeking to undermine and even eliminate the intellectual property protections that drive America’s innovation economy.”

All this provides a valuable foundation on which to build in the coming year and beyond. Fostering and strengthening coalitions that support innovation will be particularly critical in multilateral organizations, such as the WHO, the World Intellectual Property Organization (WIPO),the WTO, UNDP, UNCTAD and Unitaid, where work can be inappropriately focused on limitations and exceptions to intellectual property rights, if not actively seeking to undermine and even eliminate the intellectual property protections that drive America’s innovation economy. This is even the case at WIPO – an organization that was created to “encourage creative activity” and to “promote the protection of intellectual property throughout the world.”

While PhRMA has trained its sights on the development work of multilateral institutions including UNDP, UNCTAD, Unitaid, WHO, and even WIPO and WTO, it remains to be seen how USTR will respond in its 2019 Special 301 Report.

James Love, Director, Knowledge Ecology International, provided the following comment.

PhRMA is seeking to use its immense power and influence with President Trump to twist the mission of UN agencies and intergovernmental bodies like Unitaid, on matters involving access for billions of persons living in developing countries. President Trump should reject this pressure, from an industry that is “getting away with murder” on a regular basis, and sees itself as a regulator of governments, not an industry to be regulated.

Ellen ‘t Hoen, LLM, PhD. Director, Medicines Law & Policy, provided the following response.

One wonders what the pharmaceutical industry has to gain from going after institutions that do so much to prevent disease, promote health and access to care. We have seen pharma attacks on global health institutions for decades. But this time around it seems more deliberate and coordinated.

Diarmaid McDonald, Lead Organiser, Just Treatment, provided this comment:

The US pharmaceutical industry is going after the World Health Organisation – and other important international bodies – for promoting lifesaving legal routes to affordable medicines. Remember, if @PhRMA are pissed off with you, you’re doing something right. As pressure grows on the US pharmaceutical industry with broad congressional support for legislative efforts to curb the high drug prices crippling American healthcare Phrma and Trump seem to be focused not on solving the problem, but exporting it around the world. Everything these important institutions are doing is good for global health and completely legal. They should stand strong for patients against US and industry aggression.

Brook K. Baker, Senior Policy Analyst Health GAP (Global Access Project), stated:

The U.S. government has not waited for PhRMA’s formal Special 301 submission to start exerting pressure on multilateral institutions to stop all work supporting adoption, use, and protection of public health flexibilities allowed under international law. These flexibilities – negotiated within the World Trade Organization and signed onto by the U.S. – give countries policy options for rejecting weak patents, denying monopolies on test data, and allowing competition from generics to increase access to affordable medicines. NGO activists know about U.S. backroom pressure on the Global Fund to Fight AIDS, Tuberculosis and Malaria, which the U.S. funds, and even on Unitaid, which it does not fund. The “flexibilities” that PhRMA complains about are integral features of the international IP bargain, and thankfully PhRMA did not get everything it wanted in the TRIPS Agreement. PhRMA likes to think that the U.S. should be its strike force to expand its bloated monopoly profits and to silence IP reformers pursuing fully lawful ends. All too often the U.S. follows the orders of its PhRMA puppet masters with no regard for the legality of its efforts or the morality of pricing billions of people out of access to life-saving medicines.

Katy Athersuch, Senior Policy Adviser – Medical Innovation & Access, Médecins Sans Frontières- Access Campaign, provided this response:

The overreach of PhRMA in attacking multilateral organisations mandated to promote health and safe lives is astonishing. To read their submission is to imagine a dystopian reality where the 2001 WTO Doha Declaration on the TRIPS Agreement and Public Health never existed. The work done by UNITAID, WHO and UNDP to support countries in their legal rights to use the flexibilities outlined in the TRIPS Agreement to ensure that the right to health takes precedent over other private rights is essential lifesaving work.

Fifa Rahman LLB (Hons), MHL (Health Law) (Sydney), PhD Candidate in International Trade/Intellectual Property, University of Leeds, Board Member for NGOs, Unitaid, stated:

The Special 301 itself is aggressive unilateralism that is out of line with internationalist values and should be ignored. On the merits of the complaints about Unitaid – TRIPS flexibilities are entirely legal measures – as the U.S. will attest to as they are the country that uses them the most. Unitaid catalyses access to affordable medical technologies and treatments which in turn improves global health security. I can’t imagine why anyone would be against global health security and more stable communities. I would be wary of commentary from an organisation who is against these values, attacks global health agencies who are making tangible changes in the world, hides real R&D costs, and openly price gouges. There is no legal or moral ambiguity on who here is on the right side in terms of intellectual property measures for access to medicines.