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March 29, 2016.
We are accustomed to hearing urgings for calm and evenhandedness from the U.N. Secretary-General. But deep in the massive bureaucracy of the United Nations is an undertaking that appears to have been conceived and designed to be combative - and biopharma may be the target.
The United Nations Secretary-General’s High-Level Panel on Access to Medicines (“UNHLP”) was announced in November with the objective “to review and assess proposals and recommend solutions for remedying the policyincoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies” (emphasis added). One would like to imagine that the term “justifiable” is intended to reinforce that rights of inventors are justified, but use of the highly pejorative term “policy incoherence” suggests it is the opposite; that it is intended to suggest some rights of inventors are NOT justified.
Given the importance of the issues being considered by the UNHLP, the critical reader may wonder why the U.N. doesn’t already have established venues and mechanisms to consider these issues on an ongoing basis. Indeed, it does. The World Intellectual Property Organization (“WIPO”) and the World Health Organization (“WHO”) are U.N.-affiliated bodies with expertise in their respective fields. Additionally, the World Trade Organization (“WTO”), although independent of the U.N., is another locus of expertise and experience. Within each of these entities, nearly every country in the world has voice on global policy. In contrast, the UNHLP is not subject to the direction of national governments. Instead, they are reduced to offering comments along with the public. The European Commission did just that, noting the flawed premises of the UNHLP’s work.
The WIPO, WHO, and WTO are already working on issues of innovation and access in the health field, including through a structured “trilateral cooperation” construct. Related work dates back at least a dozen years of work through entities like the WHO’s Commission on Intellectual Property Rights, Innovation, and Public Health. Just a few years ago the three agencies jointly published a 250-page report on, “Promoting Access to Medical Technologies and Innovation.” Why does the U.N seek to reinvent the wheel? Perhaps because some didn’t like what the previous study concluded. While no one would mistake the conclusions for an industry viewpoint, it was balanced enough to give the activists heartburn. For example, the report found that while cost is “a critical determinant of access to medicines,” it also recognized “unjustified regulatory barriers,” as well as taxes and tariffs raise costs and delay access. Further, the report accepted that “the risk and uncertainty of innovation increases R&D costs,” and there is a need “to ensure sustainable margins for commercial suppliers.” Perhaps most heretical to the activist sector, the report acknowledged, “patents, in principle, promote innovation” and “the absence of an enforceable patent right does not guarantee effective access.”
In the UNHLP process the WIPO, WHO, and WTO are relegated to an advisory role, and grouped with a bevy of other organizations and individuals. And a review of the biographies of those eleven individuals reveals that no fewer than eight have a history associated with anti-patent and/or anti-biopharmaceutical industry views. At least one of these eight even went so far as to co-author an article submitted to the UNHLP during the public comment period, in which he accuses “that pharmaceutical companies have suppressed findings in the clinical testing of new medicines.” This is hardly an arrangement that appears to be designed to produce a balanced outcome.
The conduct of the process to date gives no comfort, either. The call for public comments repeated multiple times the “policy incoherence” smear and exacerbated it with a gratuitous reference to the “misalignment between the rights of inventors, international human rights law, trade rules and public health where it impedes the innovation of and access to health technologies.” UNHLP co-chair Ruth Dreifuss seemed to confirm a structural bias of the UNHLP when she announced at a recent public hearing, “We are not authorized to consider IP rules are fundamental rights at the same level as human rights and right to health.” This statement stands in direct contradiction of the Universal Declaration of Human Rights, which affirms, “Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary, or artistic production of which he is the author.”
The call for contributions indicated that the UNHLP and its experts group, along with the U.N. Development Programme and the Joint U.N. Programme on HIV/AIDS, would evaluate all submissions. No similar role is noted for the WHO, WIPO, or the WTO. Further, the criteria through which contributions will be evaluated is: impact on policy coherence; impact on public health; advancing human rights; implementation (how your contribution advances sustainable health outcomes); and evidence. Glaringly omitted from that list is “impact on innovation,” or indeed any reference to the need to support development of new treatments. How can the UNHLP adequately or accurately assess “the rights of inventors,” as its mandate requires, without consideration of the impact of policies on innovation?
The transparency of the UNHLP process has also been brought into question in a letter from major business groups including the U.S. Chamber of Commerce, and joined by PhRMA and BIO. That letter notes that the selection of panel members and experts was non-transparent and the tight timeline for the panel’s work makes it likely the process “will be ill-informed.” They have a point. The UNHLP received 178 public comments from around the world (including a joint submission of Efpia, IFPMA, PhRMA, and JPMA), public meetings were held in March, and the draft report is slated for early May. The depth and breadth of the issues being considered by the UNHLP, and the importance of getting policies right, demand more than a few weeks of consideration.
What are the consequences of the seemingly predetermined outcomes of the UNHLP? The anti-patent and anti-biopharmaceutical industry bias that appear ingrained at every level of the UNHLP process suggests we should be prepared for recommendations hostile to the granting and enforcement of patents in health technologies, and similarly prejudicial recommendations regarding pricing and nearly every other aspect of the innovative health technology field. While the report is neither binding nor mandatory, it will almost certainly become an oft-cited excuse for governments that are already inclined to weaken patent protection to do so further. Similarly, in countries where innovative industries and others are working to resolve legal issues that stand in the way of proper patent protection, such as India and Canada, a negative set of recommendations from the UNHLP could only stiffen resistance. The report could even spur calls for the weakening of international law, such as the TRIPS Agreement.
Such policies would promote free riding and thereby undermine the fundamental economics of innovation. Consequently, the positive health outcomes and economic development innovative companies create will be reduced. That would have a ripple effect throughout the global economy as companies that supply biopharmaceutical research and development would all see reduced demand.
The intersections between inventors’ rights, international human rights law, trade rules, and public health have long been the subject of discussion and debate. The UNHLP’s stacked-deck framing of the issues and consideration through a partial process is not likely to unify or even advance policy discussions. On the contrary, the shortcomings of the UNHLP process thus far undermine its credibility even before its report is issued.
All of this indicates that the biopharmaceutical industry should be prepared for the worst out of the UNHLP. However, the process is not over yet, and so there is at least a possibility of mitigating the outcome. Just as there were strong currents for anti-patent conclusions in the Paris meeting of the U.N. Framework Convention on Climate Change last December, more moderate views prevailed in the end. PhRMA, BIO, the U.S. Chamber, and other business groups have availed themselves of the opportunity to participate in the UNHLP public process, and are in contact with U.S. and other government officials to warn them of the danger and seek their help to sustain the innovation that generates jobs and makes patients’ lives better. So, as the work to advance a pro-innovation agenda continues, we must also be ready for the very real possibility that the UNHLP report will not be favorable or fair.