In an email, Leena Menghaney, South Asia Head of Médecins Sans Frontières’s Access Campaign, says that the voluntary license will exclude India from even supplying raw materials (active pharmaceutical ingredients) to generic manufacturers in upper middle-income countries, thus compromising their options for securing affordable access.
As per Medicines Patent Pool listing, India is categorised as a lower middle-income country, and so will be able to produce and make available both Merck’s and Pfizer’s antivirals for use in India. How do you compare India with Brazil, which can manufacture the drugs but will have to pay a higher price to access them as it is an upper middle-income country?
World over, leaders called for COVID-19 drugs and vaccines to be treated as public goods accessible to all countries. There are no granted patents yet on Pfizer’s antiviral candidate PF-07321332, and ritonavir has been off-patent since last year. India is going to play a vital role in the supply of raw materials and finished formulations of the drug. The MPP-Pfizer license on this new antiviral is business as usual, with supply restricted to just 95 countries, excluding many upper-middle-income countries in Latin America, Central Asia, South East Asia from benefiting from affordable generic supply or using their established generic capacity based on supply of raw materials (API) from countries like India.
Using the chilling effect of patent filings, and restrictive license terms and conditions, pharmaceutical corporations like Pfizer set limitations on where and to whom a low-cost generic product can be sold, control the supply of active pharmaceutical ingredients (API) and impose other restrictions on licensees. Pfizer’s business strategy has set a negative precedent by offering a voluntary license that excludes nearly half of the world’s population during a global pandemic.
According to the agreement signed by the two companies and MPP, access to these drugs will be available to low- and middle-income countries. But the MPP website distinguishes middle-income countries into lower-middle-income and upper-middle-income countries. Except for a few upper-middle-income countries, most do not qualify for access of these two drugs at a cheap price. Your comments.
In the current practice of voluntary licenses, most high- and upper-middle-income countries are excluded, including many with a high burden of COVID-19. Almost 50% of the upper-middle-income countries are excluded from the Merck license and more than 70% of the upper middle-income countries are excluded from the Pfizer license. When countries are excluded from voluntary licenses on lifesaving medicines or vaccines, their options for securing affordable access are compromised.
Technically, manufacturers in excluded countries can take a sub-license from the MPP to produce the medicine or its raw material, but they cannot supply it domestically. China is one such country. This licensing practice raises ethical questions about harnessing the capacity of developing countries to develop, produce and supply quality medicines while at the same time prohibiting generic companies from responding to considerable unmet medical needs domestically.
Considering that Pfizer has not signed any non-exclusive agreement with manufacturers to produce its vaccine, is it not welcome that people in 95 countries (53% of the world population) will benefit from easy access to drugs at a cheap price?
The regulatory pathway for drugs like antivirals is straightforward. Companies with GMP certificates and showing bioequivalence can develop and register low-cost generic versions within months. This has happened in the case of baricitinib, molnupiravir in India and Bangladesh. It is in the business interest to restrict such generic competition. Through the license terms and conditions, pharmaceutical corporations like Pfizer set limitations on where and to whom a low-cost generic product can be sold, control the supply of API and impose other restrictions on licensees.
In the case of vaccines, in the absence of access to the regulatory dossier and different kinds of IP, including trade secrets, pharma corporations can delay competition for much longer. Pharma corporations take advantage of these complexities to avoid negotiations on sharing of data, know-how, and IP.
Will the poor living in upper middle-income countries have the same easy access as people in lower middle-income countries? Is this ethical and correct in the midst of a pandemic when these drugs can prevent deaths?
A key issue present in many voluntary licenses, including this one between the MPP and Pfizer, is that the benefits of these agreements are not available to all populations equally due to geographic restrictions imposed on licensees. The determination of the list of countries/territories in a voluntary license is often justified based on country income, driven by business interests of the patent-holding company, which may leave out many countries with a high burden of disease where more affordable generic medicines are desperately needed. For instance, despite facing a global pandemic, people in Brazil and most South American countries, Central Asia, and South-East Asian countries like Thailand and Malaysia have been excluded from voluntary licenses on COVID-19.
Can India at least supply API to countries like Brazil which are categorised as upper middle-income countries?
Voluntary licenses include restrictive terms on active pharmaceutical ingredients (APIs), which are an indispensable part of formulating the final products of medicines and constitute a significant percentage of the total cost of production. The ability to procure API from India plays an important role in ensuring affordable prices for finished products.
This license prohibits Indian companies who may sign the license from supplying API to independent manufacturers in countries like Thailand, Brazil and all other countries which are excluded from the list of territories. Effectively restricting the sources of API blocks potential producers in countries excluded from the license from producing and supplying their health ministries and in their region.
Can’t countries manufacture the two antivirals through the compulsory licensing route?
Yes, they can but compulsory licensing takes time, and we need a speedy response in the pandemic. It is crucial that governments continue to use all means, including refusing to grant any patents on this treatment — and the adoption of the IP waiver at the upcoming WTO Ministerial Conference at the end of November — to ensure that there are no restrictions on generic production of this and other COVID-19 treatments anywhere, in order to ensure true global access and save as many lives as possible.
