The Director-General of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, first described the present coronavirus (COVID-19) outbreak as a pandemic on the 11th March 2020. The threat of such a pandemic has been discussed for decades. It is nevertheless clear that pandemic preparedness planning, at least at national level, has fallen far short of adequate. Countries have already been forced into almost unthinkable competition for resources to support their individual health systems, such as personal protective equipment (PPE) for medical professionals and ventilators.
Even if the immediate emergency can be confronted without national health systems being overwhelmed, the threat will likely continue for some time. The very nature of a pandemic suggests the possibility of successive waves of infections. It should therefore be obvious to decision makers everywhere that looking within their national borders will not be enough and that all countries, rich and poor, must overcome the pandemic together. Time is not on our side. It is not clear how long the social distancing and quarantine measures that have been implemented in so many countries will be able to be maintained. There is a very real danger that either the pandemic itself or the dislocation caused by the measures to combat it will produce cascading crises in other areas and that, at some point, social, economic or (geo-) political thresholds will be crossed from which there is no straightforward return.
The scientific community has responded admirably to the pandemic, sharing data and research findings rapidly and openly. The early sharing of genomic data has been particularly important. They have been supported by the decision of many scientific journals and publishers to move to an open-access model for all coronavirus related publications. The response from the holders of intellectual property rights over potential therapies has been more mixed. AbbVie has now waived the patent rights they own to one candidate therapy for coronavirus, a combination of the antivirals lopinavir and ritonavir (marketed under the trade name Kaletra), removing a barrier to this combination therapy being manufactured by qualified producers everywhere. In stark contrast, the response of Gilead has been to try to strengthen their proprietary rights over another candidate therapy for coronavirus, the antiviral remdesivir. Taking an approach which relied on the letter of the law, rather than its very obvious spirit, they managed to persuade the Food and Drug Administration (FDA) that the early coronavirus infections in the USA should be regarded as a rare disease for the purposes of the Orphan Drug Act, so that remdesivir could enjoy the considerable benefits provided under the Act, including seven years of (post-approval) market exclusivity. Following outcry over this improper use of the legislation, Gilead has now withdrawn its remdesivir orphan drug designation.
It is not yet known which particular therapies (or combinations of therapies) are going to be most helpful in the treatment of coronavirus patients. Rigorous clinical trial data needs to be shared quickly and openly as never before. Public funding of clinical trials, for both candidate therapies and vaccines, has been significantly increased. The WHO has just launched its SOLIDARITY trial, comparing the safety and effectiveness of four different candidate coronavirus medicines, including remdesivir and lopinavir/ritonavir (Kaletra), across forty-five countries. Once decisions have been made to deploy whichever therapies are most helpful at scale, unprecedented efforts from both intellectual property right holders and qualified generic manufacturers may be needed to rapidly scale up production and provide timely and affordable access to all those in need. Valuable time cannot be wasted in engaging in protracted negotiations with those intellectual property rights holders or campaigns to persuade them to co-operate. The same is true regarding the diagnostics which will be vital in improving our epidemiological understanding, the equipment which will protect medical professionals or, absent effective therapy, the ventilators that will help keep alive the most compromised of those infected and, in due course, the vaccines which could help bring an end to the pandemic. The urgency of the situation cannot be better underlined than by President Trump invoking the provisions of the Defence Production Act against General Motors in order to compel them to make ventilators in larger numbers, at a lower price and more quickly than they had seemingly been willing to contemplate. Wherever necessary, intellectual property right holders will therefore hopefully move swiftly to offer licences to coronavirus related rights (or waive them) on a voluntary basis. If not, then compulsory licences will have to be used. Countries that have compromised their own ability to make swift and effective use of compulsory licensing, including those high-income countries that decided to opt-out of the system established under the August 30th 2003 Decision of the World Trade Organization (WTO) which in 2017 became an amendment to the TRIPS Agreement, should now be urgently questioning whether that was a good idea.
If efficient access to all the intellectual property rights necessary to overcome the pandemic worldwide is to be co-ordinated and administered, a proactive rather than a reactive solution is vital. This is why the suggestion of the government of Costa Rica, calling for the WHO to create a voluntary pool of coronavirus related intellectual property rights (including patents, regulatory test data, know-how, copyrights and design rights), is of such central importance. The tried-and-trusted example of the Medicines Patent Pool (MPP) is already there to draw on. There will be important challenges to be faced and operational details to agree in due course but that must not let the initial work be delayed. Medical professionals everywhere are making heroic efforts (risking and losing their own lives) to treat as many coronavirus patients as possible. They are rapidly and often ingeniously reconfiguring equipment and hospital spaces to increase capacity as they go. In weeks rather than months, engineering companies have combined their expertise with medical equipment experts to design, test and already produce (3D print) new PPE and assistive breathing devices. Let’s show the same speed and ingenuity in operationalising this pool and so help to bring medical professionals more of the tools they need – including affordable and effective diagnostics, medicines, medical equipment and vaccines – as quickly as possible. There is no time to lose.