Info Service on Intellectual Property Issues (Jan21/09)
Geneva, 27 Jan (D. Ravi Kanth) — As COVID-19 cases crossed the 100 million mark globally with loss of more than 2 million lives, the European Union and other industrialized countries appear to have entered into a tit-for- tat vaccines war over the dwindling supply of pandemic vaccines developed by their respective companies.
The only way to overcome the grim “cascade of crises” is to agree to the TRIPS waiver at the World Trade Organization, said people familiar with the development.
The proposed TRIPS waiver has called for the temporary suspension of several provisions in the WTO’s TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information so as to ramp up production of medicines and vaccines for combating the COVID-19 pandemic.
On 26 January, the European Union and the United Kingdom entered into a war of words over the dwindling supply of vaccines produced by AstraZeneca, with Brussels accusing the United Kingdom for not allowing AstraZeneca to comply with its contractual obligations for which it had paid billions of dollars.
AstraZeneca has conveyed to the EU that it will not be able to supply the promised number of vaccines because of production-related problems.
Pfizer has also indicated to several governments with contracts involving billions of dollars that the company will not be able to supply vaccines because of the growing shortages in the distribution of vaccines in the United States.
At the annual virtual meeting of the World Economic Forum (WEF) on 26 January, the European Commission President Ms Ursula von der Leyen severely criticized the companies for failing to meet their contractual obligations.
In her statement delivered at the meeting, Ms Von der Leyen said that the EU has provided billions of dollars of support for developing the COVID-19 vaccines.
“So take the vaccine that will hopefully protect us all from COVID-19,” she said, arguing that “what normally takes five to ten years, to develop a vaccine, was achieved in ten months”.
She said that it was made possible “because the world pooled its resources, scientists shared their expertise and different manufacturers worked together.”
The EU Commission president claimed that the EU and others “helped with money – large sums were invested – to build research capacities and production facilities early.”
The EU “invested billions to help develop the world’s first COVID-19 vaccines,” she said, suggesting that it was done primarily “to create a truly global common good.”
“And now, the companies must deliver” and “they must honour their obligations,” Ms Von der Leyen said, in reference to AstraZeneca’s and Pfizer’s failure to meet their contractual obligations.
“This is why we will set up a vaccine export transparency mechanism,” she said, without explaining how the new mechanism will address issues that revolve around profit maximization by the Big Pharma and the “me-first” problems.
A vaccine export transparency mechanism appears somewhat akin to what Albert Einstein had said about “doing the same thing repeatedly, and expecting different results,” said a TRIPS analyst, who asked not to be quoted.
At a press conference on 26 January, the spokesperson for US President Joe Biden was asked whether the new administration will lift the embargo on export of vaccines and vital medicines imposed by the previous Trump administration.
The spokesperson merely said that the Biden administration has joined the World Health Organization (WHO), suggesting that it may reconsider the ban.
Against this backdrop, when “vaccine nationalism” appears to be the order of the day globally, none of the current multilateral arrangements such as the much-claimed COVAX facility will be able to address the distributional challenges equitably, the analyst said.
Therefore, the only way to put human lives before the patents and profits of Big Pharma is to pursue a bold proposal like the TRIPS waiver as proposed by South Africa, India, Kenya, Eswatini (formerly Swaziland), Mozambique, Zimbabwe, Egypt, Bolivia, and Venezuela among others, the analyst said.
That waiver, according to the analyst, will enable developing countries of all sizes as well as least-developed countries to ramp up production of medicines and vaccines on a gigantic scale by ensuring that the TRIPS provisions on copyrights, patents, industrial designs, and protection of undisclosed information do not become a barrier in the global effort.
More importantly, there is a groundswell of support from international civil society organizations, particularly in Washington and Brussels, the analyst said.
However, the EU and the US along with Switzerland, Japan, Canada and Australia among others continue to stall progress on the waiver by adopting “diversionary” tactics time and time again, the analyst said.
While the EU Commission President talked about “working together – across borders and across sectors” for tackling global challenges, as “no private company or public authority can do it alone,” Brussels continues to turn a deaf ear when the proponents of the TRIPS waiver called for “working together” in “solidarity” towards a “public good.”
Ms Von der Leyen called for “new forms of blended partnerships” for preparing and protecting countries “against the next big risk.”
“This is a blueprint for cooperation in today’s world,” and “we need to bring together the innovation and the capability of the private sector, and the long-term vision and predictability and the funding of the public sector,” she emphasized.
“It is in this spirit that Europe will propose to create a bio-defence preparedness programme,” she said, suggesting that it “will be a public-private partnership – and it will sit within our new European Health Emergency Response Authority, or in short HERA.”
Elaborating on this new programme, she said it will be permanent and it will be fully dedicated to discovering and preparing for known and emerging pathogens, and then developing and manufacturing vaccines at scale to respond to them.
She said that the new arrangement “will secure long-term and predictable funding for this task, rather than reallocating resources every time,” by bringing “together cutting-edge tech-companies, blue-chip manufacturers, as well as regulators such as the European Medicines Agency or the European Commission.”
Yet, the EU is now appearing to cry foul that the companies are not sticking to their contractual obligations, knowing full well that Big Pharma is more interested in profits and patent protection to ensure that the monopoly chain of profits is not disrupted.
When the proponents of the TRIPS waiver have repeatedly emphasized that the waiver could also pave the way for addressing new big risks and on a shared understanding of treating the production and distribution of vaccines as a public good, the EU scoffed at the waiver proposal, the analyst said.
In its intervention at an informal WTO TRIPS Council meeting on 19 January (see SUNS #9268 dated 21 January 2021), the EU refused to accept the merits of the waiver proposal by repeatedly arguing that “TRIPS flexibilities are absolutely legitimate tools for members in need, as many are, in the midst of pandemic.”
In the face of growing evidence as to how the TRIPS provisions remain a barrier for addressing the specific challenges posed by the COVID-19 pandemic, the EU maintained that “the IP system is crucial in providing a legal framework for the collaboration and dissemination of any new technology.”
Even though none of the pharmaceutical companies – AstraZeneca, Pfizer, Moderna, Johnson & Johnson, and Eli Lily – have disclosed their research results, the EU had argued that “the objective of an IP system is not merely to create exclusivity for the owner of the intellectual property, but also to ensure the publication and dissemination of research results, when otherwise they will remain secret.”
The “dissemination is precisely what we need now,” but such dissemination of research results has not happened at all during the past one year of the COVID-19 pandemic, the analyst said.
The EU had said that the “IP system enables commercialization of the research results, and their transfer through licensing agreement.”
But the World Health Organization said that it is concerned that none of the pharmaceutical companies have shared their research results with its C-TAP (COVID-19 Technology Access Pool) mechanism, the proponents of the TRIPS waiver have argued.
At the TRIPS Council meeting on 19 January, the EU had said, “one of the main concerns with the suspension of intellectual property rights, like the proposed TRIPS waiver, is it will not enhance such collaboration, [and] it will not enhance the needed transfer of technology and know-how,” suggesting that IP is “only a small part of a broader massive financial, manufacturing and logistical response to COVID-19.”
However, the proponents of the TRIPS waiver, particularly South Africa, India and Pakistan, had systematically rebutted the EU’s claims with evidence at that TRIPS Council meeting.
Sadly, today when “the chickens are coming home to roost” with the escalating number of deaths and a rising second wave of COVID-19 cases in EU-member countries amidst the worsening situation of the supply and distribution of vaccines, it sounds somewhat surreal to hear Brussels’ complaints against the pharmaceutical companies, the analyst said. +