By Toby McIntosh
Contracts to buy Covid-19 vaccines are being kept secret, completely or substantially, by the global purchasing entity started by the World Health Organization and by national governments.
The confidentiality obscures not only the price per dose, but also key contract provisions about delivery, ownership, licensing and legal liability.
A backlash against the lack of transparency is developing, but the confidentiality is strongly encouraged by the pharmaceutical companies and supported by government entities making the purchases.
Limited International Purchase Information
The COVAX Facility, the global mechanism for pooled procurement and distribution of COVID-19 vaccines, does not provide detailed information on its deals or the text of the agreements, saying that confidentiality serves the goals of getting good deals.
The limited disclosure of information is in the interest of getting better deals, according to Iryna Mazur, a spokesperson for GAVI, a public-private partnership based in Geneva and Washington that is leading on procurement and delivery for Covax.
“COVAX is currently in negotiation with various manufacturers of promising vaccine candidates, meaning publishing deals achieved already could be detrimental to our future deals,” she wrote via email.
“As soon as vaccines are procured, UNICEF Supply Division, acting as procurement coordinator for COVAX, will publish vaccines prices as has always been the process for Gavi procurement,” according to Mazur, referring to the United Nations Children’s Fund (UNICEF).
She wrote, “We do not make commercial agreements with manufacturers public, as they contact proprietary information. We will make the prices public after all the steps of the procurement process have been completed, as is usually the process with our procurement.”
Covax has announced new agreements, such as a major contract with Pfizer on Jan. 22 for up to 40 million doses of the Pfizer-BioNTech vaccine candidate, but without mentioning the contract price or other specifics. Covax was launched in April 2020 by the World Health Organization (WHO). Its goal is to use contributions from developed countries and philanthropies to purchase billions of doses for more than 90 low- and middle-income economies.
For overview information on Covid-19 vaccines, the Economist Intelligence Unit’s COVID-19 Health Funding Tracker aggregates the pledges to COVAX ($13.8 billion as of Jan. 28) and disbursements ($2.7 billion as of Jan. 28). Bloomberg publishes a Covid-19 Deals Tracker.
The WHO’s ACT-Accelerator Commitment Tracker reports the funding commitments made to the umbrella pandemic fighting fund, the ACT-Accelerator, of which Covax is a part.
UNICEF FOI Policy in Play?
If the contracts are formally issued by UNICEF, their transparency may by governed by the UNICEF disclosure policy.
Like most such policies, it includes an exemption for “[c]ommercial information, if disclosure would harm either the financial interests of the organisation or those of other parties involved.”
There is a qualifying clause stating, “The definition of ‘Confidential Information’ should be understood in a way that favours disclosure as much as possible without contravening this Policy.”
UNICEF does not appear to routinely disclose contract texts, but does disclose basic information about the parties and the subject of the contracts here. Emails to the UNICEF Supply Division for further information generated no replies.
UNICEF Runs Database
About 140 contracts to purchase vaccines have been signed by Covax (7) and governments worldwide as of Jan. 28, 2021.
The best public collection of information about the purchases is the COVID-19 Vaccine Market Dashboard, created by UNICEF.
It is based on public sources, such as news reports. It usually shows the numbers of doses purchased, but much less often the contract price. Links go to the news source, but not to contracts themselves.
Still, the dashboard is kept current and can be filtered by country and manufacturer. The comparative list of prices is significantly shorter than the list of countries with supply agreements, a gap which reflects the sensitivity of the price data. The cost per dose, UNICEF reports, varies from $2.19 to $44.
Transparency at CEPI Challenged
Transparency questions also have been raised about the work of the Coalition for Epidemic Preparedness Innovation (CEPI) a global non-profit that has invested in vaccine research and is allied with Covax. CEPI is a Norwegian association whose governing body is the Board, which has 12 voting members (four investors and eight independent members and five observers.
The lack of transparency makes it difficult to analyze the contacts for more than $1 billion that CEPI has with nine manufacturers, according to a November 2020 report by Zain Rizvi, law and policy researcher in Public Citizen’s Access to Medicines Program.
CEPI beneficiaries are required to abide by its “equitable access policy,” providing that “equitable access to epidemic vaccines in the context of an outbreak means that appropriate vaccines are first available to populations when and where they are needed to end an outbreak or curtail an epidemic, regardless of ability to pay.” CEPI can put conditions in the contracts to further this goal, such as to require technology sharing.
The equitable access provisions vary from contract to contract, according to Rizvi’s analysis. “We were able to obtain only two CEPI contracts (i.e., with Novavax and CureVac), the report says, with footnotes indicating that the redacted texts were found in filings at the US Securities and Exchange Commission.. The report also relies on minutes of CEPI’s Equitable Access Committee Meeting Minutes (for example of Feb 13. 2020.)
“The precise contours of the conditions remain unclear due to a lack of transparency,” Rizvi wrote.
What’s in a Contract?
Although price-per-dose data may make the headlines, health care policy experts and transparency advocates say other elements of the contracts are just as important to examine.
Such non-price contract clauses may:
- limit the manufacturer’s financial risk,
- describe the manufacturer’s liability,
- prevent the purchaser from sending the vaccines to other countries,
- address who owns the rights to the vaccine,
- describe who owns the know-how on processes to make the vaccine,
- state whether the government has so-called “march-in rights” that allow the government, in specified circumstances, such as price gouging, to require the contractor to license the product to others,
- cover whether or not the government gets access to data develop b the contractor about the vaccine,
- give timetables for delivery,
- provide for penalties for nonperformance, and
- detail who controls information about the contract.
The European Parliament’s Committee on the Environment, Public Health and Food Safety has called for five key pieces of information public to be made public:
– the cost structure and price of each vaccine,
– the production locations,
– the intellectual property arrangements, including non-exclusive labeling,
– the liability and indemnification agreements, and
– agreements regarding access to the vaccines.
Johns Hopkins Doctor Calls Transparency ‘Critical’
“Transparency of the purchase arrangements with vaccine manufacturers is critical to ensuring equitable allocation of vaccines for various reasons,” according to Dr. Anthony D. So, Department of International Health, Johns Hopkins Bloomberg School of Public Health, who published an article in December comparing vaccine prices.
“If the COVAX Facility and countries do not share how these purchase arrangements work, COVAX will face the challenge of “double dipping,” particularly by high-income countries that have both secured and that will source vaccine doses both through the Facility and also through bilateral agreements with vaccine manufacturers,” So said.
Poorer countries can’t turn to bilateral agreements with vaccine manufacturers, he said, continuing, “Absent transparency, high-income countries could draw down the COVAX supply of vaccines while also sourcing millions of doses already secured from bilateral agreements with vaccine manufacturers, leaving much of the rest of the world without access.”
The contracts being made with the leading vaccine manufacturers “may carry options for scale up and incentive bonuses for accelerated delivery—clauses that make it difficult for other governments and COVAX to place timely vaccine orders in the queue,” So said.
“It is challenging enough to vaccinate a globe, but who thinks it is a brilliant idea to do it blindfolded?”
He disputed the value of confidentiality, writing:
Without transparency, it also becomes more challenging for elected policymakers to hold accountable those making procurement decisions with public monies.
Policymakers should have the full context to assess technology transfer arrangements, gauge the costs of switching to superior vaccines when they become available, decide on whether to invest in publicly owned production facilities, and reshape follow-on contracts with better conditions for public procurement.
Transparency is also core to ensuring fair returns on public investments. What possible rationale could there be for commercial confidentiality in these purchase arrangements with vaccine manufacturers? The public is paying for the R&D, either upfront or when buying the vaccines. The procurement of these vaccines is being managed by governments, not by markets. So what competitive disadvantage could result from disclosure of what the public has bought and paid for entirely, and how could this possibly override the public’s interest in knowing how taxpayer dollars are spent? The salient questions are who and what are being harmed by hiding the details in these contracts. Efforts to curb unbridled vaccine nationalism and “double dipping” in the COVAX facility, fair returns on public investments, and equitable allocation of vaccines to those most in need—these are the potential casualties of such secret deals.
Controversies Arise in EU Over Confidentiality
Secrecy appears to be common for purchases by regional governmental organizations and individual governments around the world.
In the European Union, initial information on the cost of vaccines came through a leak. A Belgian government minister released, then deleted, a Twitter post containing prices that the EU had negotiated. See this Guardian article, a New York Times story and this Washington Post article.
The EU ombudsman is conducting a fast-track investigation after complaints filed by Corporate Europe Observatory (CEO) over the rejection of several Freedom of Information (FOI) requests.
CEO’s request for the vaccine contract with AstraZeneca was rejected on the grounds of protecting AstraZeneca’s commercial interests and because there was no overriding public interest in the information. The case is on appeal. The European Commission also refused to disclose documents related to the vaccine negotiations.
After protests by members of parliament, a redacted CureVac contract was made available for members to read in under strict conditions in a reading room and later posted. An analysis of the CureVac by Euractiv found that “nearly a quarter” has been redacted.
On Jan 29, the Commission published the contract with AstraZeneca after the company agreed to its release, with redactions. (text). Spanish Civio is annotating with additional information of the redacted sections.
The 67-page CureVac contract also was critically analyzed in this Jan. 22, 2021, CEO’s analysis. See another look by Knowledge Ecology International, a Washington group. A Sept. 21, 2020 CEO analysis examined 2020 industry efforts to influence vaccine contract terms in general. Contract interpretation questions have popped up as EU officials tangle with AstraZeneca over delivery issues.
AstraZeneca chief executive Pascal Soriot, in a Jan. 26 interview with Italian newspaper la Republica, said the company isn’t contractually obligated to deliver doses on a specific timeline, only to make its “best effort” to deliver on its promise. EU officials then said AstraZeneca should publicly release its contracts, Reuters reported Jan. 27.
Released US Vaccine Contracts Redacted
In the United States, the vaccine contracts disclosed are heavily redacted, as described in this September 2020 National Public Radio report by Sydney Lupkin.
The vaccine contracts are not following standard templates, but instead are being created with “other transaction authority” that makes the content less standard. “This contractual heterogeneity has consequences in terms of predictability which makes the calls for transparency even stronger,” concluded the Washington NGO, Knowledge Ecology International, which has obtained some contracts through the Freedom of Information Act, and has filed FOI suits to get more.
KEI’s website has collected quite a bit of information, mainly about US vaccine contracts. See KEI’s contracts database and a US COVID-19 contract spreadsheet to that tracks, when possible, the details of the agreements.
NPR’s Lupkin has continued to document the rollout of limited contract details, finding interesting details to report
“While the publicly posted Moderna contract includes previously unknown details, extensive redactions leave the public in the dark about some of the company’s obligations as well as the extent of protections for taxpayers,” she reported in October.
Interestingly, Moderna posted more of their contracts with the US government in filings with the Securities and Exchange Commission. See this KEI description. KEI also analyzed a Sanoff Pasteur contract, finding it “more favorable to the public in terms of intellectual property (IP) and data than the majority of U.S. government (USG) COVID-19 contracts available for inspection in the public domain.”
When a redacted version of a contract with Pfizer was issued in November, Lupkin’s analysis showed was that the agreement “didn’t include government rights to intellectual property typically found in federal contracts.”
In January, Lupkin reported that a contract with Emergent BioSolutions has a clause “that could move a company’s employees and their families to the front of the vaccination line.”
Debate in Israel Prompted Disclosure
Israel’s Ministry of Health on Jan 17 published a redacted copy of a contract with drugmaker Pfizer that will provide some public medical data in return for a supply of Covid-19 vaccines.
“Prime Minister Benjamin Netanyahu had people guessing and concerned over the potential for privacy violations from the exchange after first announcing it earlier this month, but according to what can be seen of the document, it seems set to include only data that’s publicly available,” reported CTECH. “The redacted parts of the 14-page article appear to concern only the commercial and some operational details of the agreement.”
Ukraine Sidesteps Disclosure Rules
In the Ukraine, the confidentiality requests from the vaccine manufacturers caused the government to exclude the state-owned purchasing corporation, the Medical Procurement Company, from vaccine negotiations because it was required by law to disclose the terms of all contracts. This New York Times piece describes the pressures.
Calls for Transparency
The Open Contracting Partnership told EYE Jan. 29:
It can’t be that the whole world is speculating about vaccine prices and delivery dates. Vaccine procurement is a matter of public health, recovery, but most of all, of inclusion. When contracts and prices are not routinely published, companies have the power to dictate the terms. No country will want to be left out. Only an open and transparent process can guarantee a fair deal for every country, and enable collaboration to reach a solution for a global problem. In 2021, procurement has one job: get everyone their shot. It has to start with opening up the terms and prices of the contracts.
“Transparency should be an embedded norm, not an exception granted by accidental leaks.,” wrote Natalie Rhodes, a policy officer for the Transparency International Health Initiative in a Jan. 19 article.
The International Anti-Corruption Conference (IACC) issued a statement Dec. 4 warning, “The same devastating lack of transparency in public contracting and the misuse of Covid-19 funds that we’ve seen during the pandemic cannot be allowed to undermine the purchase and distribution of vaccines. “
Kate Elder, senior vaccines policy advisor at Médecins Sans Frontières (MSF) said in November, “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. Without decisive action from governments demanding more transparency from companies, equitable access to covid-19 vaccines is in jeopardy. The public has the right to know. There is no place for secrets during a pandemic, there is too much at stake.”
The New York Times on Jan. 28 published an article “Governments Sign Secret Vaccine Deals: Here’s What They Hide.”
