6 de abril de 2021

The PI is not the problem in the production and distribution of vaccines

Por: Carlos A Conde G
PhD, Professor

On March 5, the director of the World Health Organisation (WHO) , Dr. Tedros Adhanom Ghebreyesus , in an opinion column for the British newspaper The Guardian, back the proposal submitted by  Africa and India to the World Trade Organisation (WTO) to allow  members to waive certain provisions of the TRIPS Agreement (TRIPS) for the prevention, containment and treatment of COVID 19, [1] which would imply, among other things, a temporary suspension of the effects of patents on COVID 19 vaccines in order to facilitate access to the global south.[2]


This would lead any company could produce a vaccine against the COVID 19 without requesting a permit to those who developed the vaccines in the record time of less than a year, providing that royalties have been paid to the patent owner. The support of the WHO Director, was vehemently welcome by organisations and individuals who have always advocated for free access to treatments that serve to combat diseases for the poorest. This is something that seems to vindicate those organisations long struggle against patents on medicines whose beginnings date back in the negotiations and implementation of TRIPS obligation to grant patent protection to all kind of inventions, including pharmaceuticals . This was particularly relevant in the 1990s in South Africa, when a dispute arose between pharmaceutical companies that owned patents on treatments for HIV/AIDS , and the South African government who sought to access to generic versions,  cost that was much lower than those of patented products, in order to counteract the health AIDS emergency caused. This led to the Doha Declarations, a forum created within the WTO, in which countries asserted that it was necessary to protect the autonomy of States in determining whether they could license to third parties nationally or internationally the production and distributions of patented protected medicines without authorisation from their holders in cases that there was a public emergency. This is known as compulsory licenses. [3]



The controversy has again emerged with vaccines and other treatments for COVID 19 , because of the potentiality that patents could result in a barrier to the access to these treatments for the largest and poorest part of the world. However, the problem goes far beyond patents. In the hypothetical case that there was no patent on the vaccine, the production and distribution problems would not end. It can be observed in news outlets that every day governments around the world have encountered problems with the distribution of the vaccine, despite its availability through either companies or mechanisms of international cooperation such as the COVAX . Likewise, only a handful of countries in the world have the capacity to produce the different types of vaccines, many of them with technologies that had never been employed.[4] For instance, the distribution problems in Colombia of the different vaccines, i.e. country’s little or no capacity to produce any of the currently available vaccines, makes a proposal such as the one presented by South Africa and India before the WTO ineffective .


Furthermore, if allowed to import vaccines generic from countries such as India, problems would arise again such as the fulfilment of the requirements of each health authority, which in the case of Colombia is the National Institute for Food and Drug Surveillance (INVIMA) . In addition, questions would be raised as to whether generic vaccines would have the same efficacy and quality as those produced by companies such as Pfizer or Moderna.


For these reasons, more than patents , pressing problems that need to be addressed, includes growing production of highly technical treatments with efficiency and quality required worldwide. The director of the WHO himself points out these drawbacks in his opinion column and uses as an example monumental efforts that countries like Canada are making to increase their production capacity. Likewise, different member countries of the WHO, including Colombia, issued a joint statement on March 8 requesting the Director-General of the WTO to promote the debate beyond intellectual property, and focus on: ( i) identify and/or improve vaccine production capacity in the world; (ii) facilitate and promote the licensing and transfer of technology between drug innovators and vaccine producers ; and (iii) identify any trade barriers that prevent the use of production capacity in accordance with the provisions of the TRIPS agreements.[5]


This reflects a clear global inclination to consider that patents are not the bottleneck in the production and distribution of vaccines. On the contrary, collaborative models of technology transfer and improvement of production capacities on a voluntary basis seem to be the most practical way out of the low levels of global vaccination . As an example, large pharmaceutical companies have sought alliances with generic companies through non-exclusive voluntary licenses to produce treatments for COVID 19 as happened in the case of Gilead , who reached an agreement with generic companies around the world to ensure production and distribution of Remdesivir ® during the time of the pandemic.


Although patents have caught great attention within the WTO , the real limitations that low and middle income countries find, as is the case of Colombia, are the lack of capacity of its industry to produce vaccines for the COVID 19 and the difficulties of distributing them throughout their territory . Bringing back disputes that have been partly addressed could only lead to further deepening the divisions between the global north and south  at a time when international cooperation is of vital importance to overcome the most difficult challenge of our time.


[1] Tedros Adhanom Ghebreyesus, ‘A “me First” Approach to Vaccination Won’t Defeat Covid | World Health Organization | The Guardian’ (The Guardian, 5 March 2021) <> accessed 24 March 2021.

[2] Council of TRIPS (WTO), ‘Waiver from Certain Provision of the TRIPS Agreement for the Prevention, Containment and Treatment of Covid 19 (Communication From India Nd South Africa)(IP/C/W/669)’ (WTO, 2 October 2020) <> accessed 24 March 2021.

[3] Carlos Augusto Conde Gutiérrez and Luisa Fernanda Herrera Sierra, ‘La Estandarización Internacional de Las Patentes y Sus Efectos En El Acceso a Medicamentos’, Derecho de Patentes (2016).

[4] For further information on the pharmaceutica industry capacity in the light of intellectual property see Carlos Agusto Conde Gutierrez, Innovación y Capacidades En La Industria Farmacéutica: Una Perspectiva Desde Colombia (Universidad Externado de Colombia 2020).

[5] General Council (WTO), ‘Enhancing the Role of the WTO in the Global Effort Toward the Production and Distribution of Covid 19 Vacines and Other Medical Products (Comunication from Australia, Canada, Chile, Colombia, New Zeland, Norway and Tukey) (WT/GC/230)’ (2021).