Service on Health Issues (Nov20/06)
Geneva, 11 Nov (D. Ravi Kanth) – The global battle for a waiver to suspend several key provisions in the WTO’s TRIPS Agreement to combat the COVID-19 pandemic could not have come at a more opportune time, as new vaccine candidates being developed by Pfizer, AstraZeneca, and other pharmaceutical companies remain strewn with “opaque and burdensome” licensing conditions, said analysts.
The licensing conditions underlying the new vaccine candidates being developed by the big pharmaceutical companies could make affordable access by vulnerable populations to new vaccines almost impossible.
Insistence on exclusive licensing agreements, including the setting of prices, which are not open for public scrutiny, could pose serious problems to the developing countries, said analysts.
The licensing and pricing rules governing the new vaccine candidates have reinforced the demand for a waiver from implementing several provisions in the TRIPS Agreement, said a person, who asked not to be quoted.
Concerning the vaccine being developed by the German-based BioNTech company along with Pfizer and China’s Fosun Pharma, the BNT162b2 vaccine candidate is based on the mRNA, or messenger RNA, route.
It has shown to prevent infection by the SARS-CoV-2 virus in 90 percent of the trial participants, according to the press release issued by Pfizer on 9 November.
“The jab injects genetic material (code) from the virus into the body, which uses this material to create a protein normally seen on the surface of Covid virus particles, which in turn stimulates the immune system,” according to a report in The Economist magazine on 9 November.
The problem is that the vaccine based on mRNA is unstable and fragile.
An article titled, “The Vaccine News Is Good. Here’s the Bad News,” by Laurie Garrett in Foreign Policy, an American publication, on 10 November, suggested that “to prevent breakdown, it must be stored right up until the time of injection at a temperature of at least -103 degrees Fahrenheit – well below anything a standard freezer unit can manage.”
In its first interim analysis, Pfizer said that the vaccine trial was conducted when 94 confirmed COVID-19 cases were reported, while the final analysis will happen at 194 cases.
The American pharma giant, which has a somewhat controversial history for blocking attempts by developing countries in relaxing intellectual property rights (IPRs) or for using compulsory licenses, said the Phase 3 clinical trial of BNT162b2 began on 27 July.
The company has enrolled 43,538 participants to date, while 38,955 of whom have received a second dose of the vaccine candidate by 8 November.
Pfizer said that “the study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2 as well as vaccine prevention against severe COVID-19 disease.”
“In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis will now include, with the approval of the FDA (the US Food and Drug Administration), new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well,” the company said.
Pfizer and BioNTech intend to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Figures provided by Pfizer suggest that all the doses to be produced in the next two months will go to patients in the US, the European Union, and the United Kingdom.
Indications are that the vaccine developed by BioNTech and Pfizer has put the AstraZeneca and Oxford University vaccine (ChAdOx1 nCOV-19), which is currently undergoing Phase 3 clinical trials, behind.
However, serious concerns are being expressed about producing Pfizer’s vaccine for COVID-19 due to enormous logistical challenges, including how to store and transport the vaccine, which needs to be kept at around -50-80 degrees centigrade. The company has not released any published data yet.
In addition to these two vaccine candidates in the late stage trials, the Russian vaccine Sputnik V developed by Gamaleya Institute, the Chinese vaccine, and the Moderna Therapeutics mRNA vaccine are also in the race.
On 9 November, the US regulators authorized pharmaceutical giant Eli Lilly’s antibody drug treatment with earlier stage COVID-19.
The FDA suggested that the drug is authorized for patients at high risk of progressing to severe COVID-19, including people 65 and older, or who have certain chronic medical conditions.
CONCERNS OVER TERMS OF BIG PHARMA DEALS
In the past, there were numerous issues that had cropped up concerning the licensing agreements and pricing policies when Big Pharma came up with new therapeutics and vaccines that were beyond public scrutiny.
In a press release on 11 November, Medecins Sans Frontieres (MSF) expressed serious concern over “the worrying terms of a deal struck between pharmaceutical corporation AstraZeneca and Brazilian public research body Fundacao Oswaldo Cruz (Fiocruz) [that] were disclosed recently.”
It is imperative for governments to “urgently demand transparency from pharmaceutical corporations on all COVID-19 vaccine licensing agreements, as well as clinical trial costs and data, especially considering the billions of dollars of public, taxpayer money that have gone towards the development of these potential vaccines,” MSF said.
Explaining the steps taken by the Brazilian organization on the licensing agreement with AstraZeneca to produce at least 100 million vaccine doses (AZD1222), MSF said that “although the agreement was published with redactions, it nonetheless represents a step that should encourage other governments to follow suit and take action towards more transparency.”
According to MSF, “a previous agreement showed that there are limits to AstraZeneca’s public “no profit” commitments, and that the company has given itself the power to declare the pandemic over as soon as July 2021.”
It implies that AstraZeneca could charge governments and other purchasers high prices for its vaccine after July 2021, MSF said, arguing that “the original exclusive license between AstraZeneca and Oxford University has still not been made public, the terms of which largely determine the terms of the company’s subsequent deals with other vaccine manufacturers around the world.”
There are growing fears that AstraZeneca could charge as much as 20% more than the costs associated with producing the vaccine, according to MSF.
“Other than the agreement [by AstraZeneca] with Fiocruz, sub-licenses with other manufacturers in South Africa, India and other countries, have also not yet been disclosed,” MSF argued, suggesting that “public scrutiny of the terms of these deals is critical to ensure equitable and affordable access to these future life-saving vaccines.”
MSF said it is well known that “pharmaceutical corporations have a very poor track record of transparency across the board – from licensing deals and technology transfers to costs of R&D and clinical trial data – and the little information that has been revealed around AstraZeneca’s not-for-profit promises should be a warning sign that pharma cannot be trusted to act in the interest of public health.”
“As long as we don’t know what’s in these deals, pharma will continue to hold the power to decide who gets access, when, and at what price,” said Kate Elder, Senior Vaccines Policy Advisor for MSF’s Access Campaign.
THE TRIPS WAIVER
Much of these IPR concerns were echoed by India and South Africa during the discussion at the TRIPS Council on their proposal “for a waiver from certain provisions of the TRIPS Agreement for the prevention, containment, and treatment of COVID-19” pandemic.
At the TRIPS Council meeting on 15-16 October, South Africa said that “there are reports about IPRs hindering or potentially hindering timely provisions of affordable medical products to the patients.” (See SUNS #9214 dated 20 October 2020).
Further, there are also reports that some WTO members have carried out urgent legal amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses, South Africa noted, suggesting that “beyond patents, other intellectual property rights may also pose a barrier, with limited options to overcome those barriers.”
India said at the TRIPS Council meeting that “the often-repeated argument that monopoly rights are needed to allow the inventors to recoup their investment does not seem to apply in case of development of health products and technologies required for handling the ongoing COVID-19 crisis.”
In their joint proposal at the TRIPS Council meeting, India, South Africa, Eswatini (formerly Swaziland) and Kenya called for “a waiver to be granted to all WTO members so that they do not have to implement, apply, or enforce certain obligations related to COVID-19 products and technologies under Sections 1 (copyrights and related rights), 4 (industrial design), 5 (patents) and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement.”
The four countries emphasized that the proposed waiver is only to tackle the COVID-19 crisis, suggesting that “the waiver is limited and does not suggest a waiver from all possible TRIPS obligations, nor does it suggest a waiver beyond what is needed for COVID-19 prevention, containment and treatment.”
In the face of the new COVID-19 vaccine candidates being announced by Pfizer, AstraZeneca, and Eli Lily among others, the TRIPS waiver appropriately demanded that it should continue “until widespread vaccination is in place globally, and the majority of the world population has developed immunity.”