The WHO appeal. Following an appeal by the President of Costa Rica, Carlos Alvarado, to create a voluntary pool of intellectual property rights for Covid-19 treatments, WHO on Friday launched the COVID-19 Technology Access Pool (C-TAP) with a “Solidarity Call to Action.”
This initiative complements the European Commission-led Covid-19 Tool Access Accelerator (ACT), which has already raised over 7 billion Euros for R&D and expanded distribution of future drugs. ACT has been supported by industry, non-profits such as the Bill and Melinda Gates Foundation and the Global Alliance for Vaccines (GAVI), and the UN-hosted drug purchasing facility, UNITAID.
Through C-TAP, WHO is now asking public and private funders of R&D to commit to IP knowledge-sharing, in particular through open licensing. Access advocates have underlined that products receiving public funding for their R&D, in particular, should be exempt from exclusive patent protections. WHO has recommended that this voluntary patent pool be managed by MPP. Kieny, a virologist by training with extensive experience in research and in industry, explains how this might really work.
GS: How does the Medicines Patent Pool operate?
Marie-Paule Kieny: It is an instrument created in 2010 and financed by UNITAID ever since, with a contribution from Switzerland. It is a foundation under Swiss law that negotiates licences for patents on medicines from the WHO “Essential Medicines List” to facilitate their production by generic manufacturers. The aim is to make them available faster and cheaper to the greatest possible number of people, in order to have the greatest impact in terms of public health. In concrete terms, this means negotiating with the pharmaceutical companies on the one hand to give us these licences and on the other hand to select and monitor the generic producers of these treatments.
With what results?
It has been more efficient for [generic] companies to negotiate with the MPP for access rights to a licence than to do so directly themselves. What we are looking for is the most favourable in terms of public health. This means getting the best prices, the widest geographical coverage and the best quality downstream. We have achieved global coverage for two HIV drugs and one TB drug, but most often this covers between 90 and 131 countries. Usually we try to expand the initial license after a while.
There is no payment at the outset; in some cases the generics companies may have to pay reduced royalties, although at others, they pay no royalties at all. The most important thing is that patients have accelerated access to treatment. For example, three to four years for HIV [generics] as compared to seven to ten years previously. This mechanism has resulted in delivery of more than 12 billion drug doses.
Why does a pharmaceutical company give up its intellectual property for a treatment in some countries?
Pharmaceutical companies have realized that they are not losing anything for the simple reason that there is no market in low-income countries. On the other hand, there is a gain in terms of image and social responsibility. This is more effective than trying to earn a few extra francs or cents. In the case of the coronavirus, it will also be crucial to have a very large production capacity for a product proven to be effective. This is something we can facilitate.
How do you select generics?
Once we obtain the best possible licence on a patent, we put out a call for expressions of interest among companies. A committee evaluates the applicants and selects those that have both the means to produce at scale, and the best quality control. The companies obtain the licenses, and are then closely monitored through reports of sales and quarterly meetings. We publish everyone's progress in order to maintain competition and bring prices down. We make sure that there is a watertight seal between markets. We have a right of audit at any time, which we have put into practice only once. We are about to use it again.
You have only worked on infectious diseases?
We initially focused on diseases that were of primary interest to Unitaid: HIV, then tuberculosis and hepatitis C. Two years ago our board decided to extend our model to non-communicable diseases, such as [drugs for] cancer or diabetes. We don't have a licence in this area yet, but we're at an advanced stage of discussions.
What about Covid-19?
On February 5 we indicated that we are ready to assist and apply our model in the face of this disease. On March 30, this extension of our mandate was formalized by our foundation board, whether it be for diagnosis, treatments or vaccines that are developed against Covid-19.
Why would you be in a better position than other institutions to manage this patent pool?
Because we have the experience and because we have created a network of trust with both pharmaceutical companies and generics companies and governments. And also because there would be a cost to creating additional infrastructure. In addition, we are already working in this area with a universal license obtained from Abbvie for its lopinavir/ritonavir HIV antiviral combination that is currently being tested against Covid-19. And we are negotiating with Gilead Sciences for a license allowing generic manufacturers to produce, at lower cost, its anti-viral remdesivir. This was originally developed against Ebola, and is now being tested against the SARS COV-2 virus.
What are your chances of success?
It's very political. We were pleased that the director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Thomas Cueni, has come out in favour of the MPP. But the question of whether and how we will be integrated is still open, especially in terms of governance. This could involve an expansion of our board or setting up a dedicated committee for Covid-19. It is necessary for all WHO member countries to adopt a resolution that serves as a legal basis. We have already been talking about this for two months and we must speed it up. I was telling you that in the case of HIV treatments, our model has made it possible to accelerate access by several years. But in the case of Covid-19, we need to go much faster.
What about the nationalist tendencies of some to prioritize their own countries for treatment or vaccines?
We are talking about access to a licence. We are not talking about access to doses of drugs or vaccines. So it's not about taking someone's production, but about creating new production capacity so that as many people as possible have access to treatment. This is potentially huge in the case of vaccines. Basically, we are in favour of universal licensing. And in any case we will not compromise below a minimum number of countries, all low-income countries.
To date the Covid-19 pandemic has hit some rich countries even harder than poor countries. Do you think that the pharma will agree to give you licences for rich countries?
I think the pharma will play the game for poor countries. Afterwards in rich countries, the question is more open and could, for example, be limited to the duration of the pandemic. All this needs to be discussed with each company or patent holder in order to find solutions that allow universal access.