Opinion: A global pandemic agreement must include IP flexibilities

Today, member states of the World Health Organization will reunite as the Intergovernmental Negotiating Body to negotiate the text of an international instrument on pandemic prevention preparedness and response. Flexibilities around intellectual property protection must feature prominently in any agreed-upon approach for how to handle the next pandemic. To date, the United States, Germany, and several other member states have rejected proposals for a pandemic agreement that involve loosening patent standards, insisting that intellectual property protection is essential to health innovation. What they do insist on, however, are binding commitments by all countries to share all information about pathogens and new variants, which would then be provided to pharmaceutical companies to develop new therapeutics and vaccines. In response, a group of 29 “developing” countries are insisting that a commitment to share information be paired with a commitment to share benefits through IP flexibilities and funding support. It appears the two sides have reached an impasse, though recent White House communications suggest that the Biden administration’s position “could yet evolve.” “However, inducing, even forcing, private firms to change their behavior in favor of the public interest, especially in times of crisis, is not an aberration — that is how the system is supposed to work.” --— A faulty IP system for global health The current global system of IP protection is neither necessary nor sufficient for the development of all future vaccines and therapeutics, and it would behoove the U.S. and other member states to see beyond the catastrophizing concerns of innovator firms and strive to reach a pandemic agreement that is more effective and equitable in its scope and thus in its outcome. Arguments against introducing flexibilities to IP rules consistently strike the same three cords: it is a matter of life, death, and all innovation. First, pharmaceutical industry representatives argue that “coercing” them to share their patented knowledge won’t work. Even with the permission to use patent data, originators would not be willing to share the other necessary information those firms need to effectively produce vaccines and therapeutics. Second, advocates of strong IP protection argue that the status quo of strong IP protection is the solution, not the problem, to saving lives. As chief U.S. negotiator for the pandemic agreement, Pamela Hamamoto, argued that IP protection enabled the rapid development of vaccines and therapeutics, thus saving the lives of millions during the pandemic. Third, and in advance of the second argument, the same advocates assert that providing additional policy flexibilities to countries in the area of IP, even in the narrow context of a pandemic, will sharply curtail pharmaceutical innovation. As a result, they argue, fewer new medicines or vaccines will be developed. However, inducing, even forcing, private firms to change their behavior in favor of the public interest, especially in times of crisis, is not an aberration — that is how the system is supposed to work. These arguments also miss that IP is itself a government intervention to induce innovation. In a pandemic, access to treatments and vaccines is in the public interest. Historic times call for historic measures. As in wartime, pandemics are a time to call private groups to support the public good. Why IP flexibilities are a must The rapid innovation that occurred during the pandemic within the legal protection of patents and other forms of IP was of critical importance. Nevertheless, that does not prove the necessity of the current system, nor that it cannot be improved upon. In fact, research demonstrates conclusively that, while strong IP protection is correlated with innovation in high-income countries, the same cannot be said for low- and middle-income countries. The United States International Trade Commission has noted that patent protection is generally more beneficial to innovation in the health sector for more developed countries and less so for developing countries. Strong IP protection is also correlated with indicators of decreased access to medicines, such as higher prices and lower quantities, especially in LMICs, even in early studies of the COVID-19 pandemic itself. The group of 29 countries arguing for more IP flexibility is poised to share any data they gather on new pathogens and variants. Indeed, many developing countries did so during COVID-19. However, this was not met with benefit sharing from the countries that had early access to COVID-19 products. Pharmaceutical innovation advocates have argued that countries sharing their pathogen data “are not doing [pharmaceutical firms] a favor,” but rather acting in their own self-interest. Yet, sharing their data cannot be in their interest if they do not receive compensation or some other benefit from products derived from that data. In short, any agreed-upon approach for how to handle the next pandemic should unequivocally make space for IP flexibilities. This month, as country representatives gather to negotiate the terms of the pandemic agreement, they should consider the broader ecosystem of access needs — not only of pathogens but also of the countermeasures to protect against them. As WHO Director-General Tedros Adhanom Ghebreyesus has warned, countries should not miss their “chance to make history.”