[This commentary was published by Barrons on 16 April 2020 and is posted here with permission]
While drug and vaccine developers are working on tools to prevent and treat Covid- 19, here is a question the rest of us should consider: Who will get access to those new products? Experience of previous pandemics shows that unless deliberate steps are taken, universal access will not happen. The most vulnerable people will be left out in the cold.
Recent company behavior feeds into the growing concern that businesses may seek to profit from the pandemic to the detriment of access to Covid-19 technologies. Roche initially refused to share the formula and technical specifications hospital pharmacists needed to make the lysis buffer used in the company’s testing machines in the Netherlands. A huge global demand Roche could not meet had resulted in a shortage of this buffer, which pharmacists could have addressed with the right technical information. It required a media outcry and fierce debates in the Dutch Parliament before Roche gave up its formula. Gilead applied for seven years of orphan drug exclusivity for its Covid-19 candidate drug remdesivir, a regulatory incentive for the development of medicines for rare diseases. (If only Covid-19 were rare.) The U.S. Food and Drug Administration granted the exclusivity 12 days after the World Health Organization declared the Covid-19 outbreak a pandemic. The move was met with strong criticism by civil society, and Gilead has since rescinded the orphan drug status.
Countries can also make universal access difficult. On March 25, India banned the export of hydroxychloroquine, an existing medicine that is being tested for Covid-19. The ban was lifted two weeks later. The demand for the drug, despite concerns from experts that its use for Covid-19 might be premature, is causing shortages for lupus and rheumatoid arthritis patients. The price of the active ingredients for the drug is soaring. The United States has come under criticism for its tactics of hoarding protective materials, diverting shipments of goods destined for other countries, and outbidding other nations on the global market.
What will this mean when a vaccine becomes available? The concern that wealthy nations will seek to monopolize the supply is not imaginary. During the A/H1N1 pandemic in 2009, wealthy nations negotiated advanced orders of vaccine to the detriment of developing countries.
By contrast, the scientific community has responded by collaborating, sharing data and research findings related to Covid-19, rapidly forgoing appropriation for reputational or financial gains. A group of scientists and researchers have formulated the Open COVID Pledge to promote the removal of intellectual-property obstacles to an effective response to the pandemic. Much of the research and development for Covid-19 technologies benefit from government and charitable financing, which will help to ensure that potential products go to market at very low cost. The spirit of collaboration, sharing, and solidarity now needs to find its way further downstream in the product development cycle so when products go to market the same spirit of solidarity rules.
Countries are taking preemptive measures to ensure that they can break through patent barriers to access needed innovations. Several have turned to compulsory licenses, a legal provision in patent law that suspends the monopoly effect of a patent so others than the patent holder can produce and supply the product. Israel’s recently issued compulsory license suspends patents related to an HIV medicine being tested for effectiveness in treating Covid-19, called lopinavir/ritonavir, and allows a generic producer to import the medicine. Canada and Germany have amended their patent laws to make the grant of a compulsory license a swift affair. In Ecuador, a National Assembly commission adopted a resolution asking the minister of health to issue compulsory licenses over patents related to coronavirus technologies. The parliament of Chile unanimously adopted a resolution declaring that the global coronavirus outbreak justifies the use of compulsory licensing to facilitate access to all technologies needed to address the outbreak. Dutch parliamentarians have asked the same from the Netherlands government. Brazil’s parliament is contemplating patent law amendments that would introduce effective automatic compulsory licensing. High-income countries that in 2003 opted out as importers of the World Trade Organization’s mechanism for compulsory licensing are urged to opt back in.
While these are sensible measures for individual countries to take, they do not address the need for a preemptive global mechanism. A proposal by Costa Rica to the WHO to establish a global pooling mechanism for Covid-19 does. (It was described in Barrons by Marie-Paule Kieny and Charles Gore of the Medicines Patent Pool.) Such a pool would offer access to patents and other forms of intellectual property rights for others to use to fire up production and advance product development. The Covid-19 pool would offer the predictability that the knowledge needed in the response to the pandemic is available and would make country-by- country, product-by-product confrontations over such knowledge redundant.
The stars are aligning for the Covid-19 pool proposal. WHO’s director-general has welcomed the proposal and called for countries, companies, and research institutes to support open data, open science, and open collaboration. Unitaid, a multilateral donor in global health, has embraced the plan and is offering funding. The Medicines Patent Pool has expanded its mandate so it can play a central role in getting the Covid-19 pool off the ground. The global pharmaceutical industry has made cautious positive noises, saying that proposals for voluntary pooling of intellectual property assets “add to the arsenal” of ways to make needed products available.
The world needs to learn from the past. During the HIV pandemic, global access to antiretroviral medicines was only realized a decade after they had become available in wealthy nations. Thankfully, because of the Medicines Patent Pool experience, the global community can now hit the ground running. The WHO and its member states should make the Covid- 19 pool a reality in the same spirit of openness that the scientific world displays. This norm of sharing and solidarity now needs to spill over when products move closer to market.