Multibillion-dollar contracts give drug makers liability shields, patent ownership and leeway on delivery dates and pricing — and promises that much of it will not be made public.
BRUSSELS — When members of the European Parliament sat down this month to read the first publicly available contract for purchasing coronavirus vaccines, they noticed something missing. Actually, a lot missing.
The price per dose? Redacted. The rollout schedule? Redacted. The amount of money being paid up front? Redacted.
And that contract, between the German pharmaceutical company CureVac and the European Union, is considered one of the world’s most transparent.
Governments have poured billions of dollars into helping drug companies develop vaccines and are spending billions more to buy doses. But the details of those deals largely remain secret, with governments and public health organizations acquiescing to drug company demands for secrecy.
Just weeks into the vaccination campaign, that secrecy is already making accountability difficult. The drug companies Pfizer and AstraZeneca recently announced that they would miss their European delivery targets, causing widespread concern as dangerous virus variants spread. But the terms of their contracts remain closely guarded secrets, making it difficult to question company or government officials about either blame or recourse.
Available documents, however suggest that drug companies demanded, and received, flexible delivery schedules, patent protection and immunity from liability if anything goes wrong. In some instances, countries are prohibited from donating or reselling doses, a ban that could hamper efforts to get vaccines to poor countries.
Governments are cutting at least three types of vaccine deals: Some are buying directly from pharmaceutical companies. Others are buying through regional bodies like the European Union or the African Union. Many will turn to the nonprofit Covax program, an alliance of more than 190 countries, which is buying from the drug makers with an eye toward making vaccines available worldwide, especially to poor countries free or at reduced cost. Some governments have signed deals with manufacturers and Covax alike.
The United States has secured 400 million doses of the Pfizer-BioNTech and Moderna vaccines, enough for 200 million people, and is close to arranging 200 million additional doses by summer, with options to buy up to 500 million more. It also has advance purchase agreements for more than 1 billion doses from four other companies whose inoculations do not yet have U.S. regulatory approval.
The European Commission, the European Union’s executive branch negotiating on behalf of its 27 member states, has nearly 2.3 billion doses under contract and is negotiating for about 300 million more, according to data collected by UNICEF and Airfinity, a science analytics company.
Covax says it has agreements for just over 2 billion vaccine doses although it, too, is keeping its contracts secret. Only about a dozen of the 92 countries that qualify for vaccine subsidies under the alliance have managed to secure separate deals with individual companies, for a combined 500 million doses.
Despite the secrecy, government and regulatory documents, public statements, interviews and the occasional slip-up have revealed some key details about the vaccine deals. Here is what we learned.
Governments Helped Create Vaccines
Vaccine development is a risky venture. Companies rarely invest in manufacturing until they’re sure their vaccines are effective and can win government approval. That’s part of why it typically takes so long to develop and roll them out.
To speed up that process, governments — primarily the United States and Europe — and nonprofit groups like the Coalition for Epidemic Preparedness Innovations, or CEPI, absorbed some or all of that risk.
The United States, for example, committed up to $1.6 billion to help the Maryland-based company Novavax develop its coronavirus vaccine, according to regulatory filings. CEPI kicked in up to about $400 million in grants and no-interest loans.
Other companies have received even more help. The Massachusetts biotech company Moderna not only used government-developed technology as the foundation of its vaccine, it also received about $1 billion in government grants to develop the drug. In August, the government then placed an initial order for the vaccine for $1.5 billion. The company has said that the project was paid for entirely by the federal government.
These types of arrangements were designed to help companies jump-start manufacturing and cover costs such as clinical testing.
But Companies Keep the Patents
Despite the tremendous taxpayer investments, typically the drug companies fully own the patents. That means that companies can decide how and where the vaccines get manufactured and how much they cost. As the CureVac contract explains it, the company “shall be entitled to exclusively exploit any such” property rights.
This has been a matter of contention for months. A coalition of countries, led by India and South Africa, have petitioned the World Trade Organization to waive intellectual property rights so generic drug makers can begin producing the vaccines. The World Health Organization has endorsed the idea, but it is all but doomed by opposition from the United States and Europe, whose drug makers say patents, and the profits that flow from them, are the lifeblood of innovation.
“Governments are creating artificial scarcity,” said Zain Rizvi of the watchdog group Public Citizen. “When the public funds knowledge that is required to end a pandemic, it shouldn’t be kept a secret.”
Prices Will Vary
One of the key terms of the vaccine contracts — the price per dose — is frequently redacted in the public versions of government contracts. The companies consider this a trade secret. Some drug companies have included clauses in their supply contracts that allow them to suspend deliveries if countries reveal the price.
By insisting that their pricing remains confidential, the drug makers have the upper hand over government negotiators who do not know what others countries are paying.
While governments accepted that provision, leaks and some official reports show some of the disparities. The European Commission paid $2.19 for every dose of the vaccine developed by the University of Oxford and AstraZeneca, while South Africa paid more than twice as much, $5.25, according to media reports.
Drug companies did not respond to requests to view their unredacted contracts or explain why secrecy was necessary. A spokeswoman for Moderna pointed only to a regulatory document that said the contract “contains terms and conditions that are customary.”
That is why it caused such a stir last month when a Belgian official mistakenly revealed a price list, which showed that United States taxpayers were paying $19.50 per dose for the Pfizer vaccine, while Europeans paid $14.70.
Dag Inge Ulstein, Norway’s minister of international development, said countries and international organizations must do more to make contracts public. He also called on countries to share vaccine technology and said rich governments should donate vaccines to poor countries early — even while still vaccinating their own citizens, as Norway plans to do.
“There must be transparency related to the agreements on procurements,” he said in an interview. To that end, he shared with The New York Times his country’s purchase agreement with Covax. That organization has refused to make public its deals — either with the drug makers or with the countries it is selling to.
Covax contracts with countries assume a cost of $10.55 per dose but warn that the final cost could be higher after including an “access/speed premium,” which Covax said is used to help companies rush their vaccines to market.
Donations and Resales Are Restricted
Public health advocates have called on wealthy countries — which have all but cornered the market on the early doses — to donate or sell vaccines to poor countries. But contracts may restrict buyers’ ability to export doses, which could depress drug company sales.
The CureVac contract, for example, prohibits European countries from reselling, exporting or donating doses — including to Covax — without permission from the company. Some contracts in the United States have similar restrictions.
Covid-19 Vaccines ›
Answers to Your Vaccine Questions
Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.
Probably not. The answer depends on a number of factors, including the supply in your area at the time you’re vaccinated. Check your state health department website for more information about the vaccines available in your state. The Pfizer and Moderna vaccines are the only two vaccines currently approved, although a third vaccine from Johnson & Johnson is on the way.
That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.
Employers do have the right to compel their workers to be vaccinated once a vaccine is formally approved. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation” — with a coronavirus vaccine, for example, a worker might be allowed to work if they wear a mask, or to work from home.
If you have other questions about the coronavirus vaccine, please read our full F.A.Q.
A spokesman for the European Commission has said the companies included that provision to guarantee that, wherever their drugs were used, they were covered by the same legal protections.
And governments are trying to find other ways to restrict exports.
On Tuesday, Germany lobbied the European Commission to allow its member states to block exports of vaccines to countries outside of the bloc after the stuttering start of vaccine distribution in Europe.
Vaccines Arrive When They Arrive
Delivery times are considered proprietary information, so there are no public benchmarks to measure a company against.
Nowhere is that clearer than in the European Union’s fight with AstraZeneca over the company’s announcement that it would not deliver the expected number of doses in the first quarter of this year. European officials say they received specific, contractual assurances for such deliveries. The company says it promised only to make its best efforts to hit those targets.
European officials, who initially agreed to keep the contract secret, have now asked the company to make it public. Unless that happens, there’s no way to assess who is responsible.
But there is no question that the drug makers have built themselves plenty of wiggle room for such an ambitious, complicated rollout. The CureVac contract says that the delivery dates (which are all redacted) should be considered estimates. “No product or only reduced volumes of the product may be available at the estimated delivery dates,” the contract reads. Similar provisions exist in other contracts.
Nearly every vaccine maker has similarly told investors that they might not hit their targets. “We may not be able to create or scale up manufacturing capacity on a timely basis,” Pfizer warned in a corporate filing last August.
That uncertainty has frustrated health officials. When Pfizer recently told Italy that it was temporarily cutting deliveries by 29 percent, the government said it was considering taking the company to court. That lawsuit, if it materializes, could make public some details of the European Union’s contract with Pfizer, which remains entirely secret.
“At one point they promised more vaccines or faster vaccines,” said Steven Van Gucht, the Belgian government’s top virologist. “And in the end they couldn’t deliver.”
Some Governments Are Profiting
Early in the pandemic, the European Investment Bank, the lending arm of the European Union, provided a $100 million loan to the German company BioNTech, which partnered with Pfizer in producing a vaccine.
In addition to the interest on the loan, the European bank will receive up to $25 million in vaccine profits, according to a redacted version of the contract that BioNTech filed with securities regulators.
The bank said profit-sharing arrangements reflect the risk involved in early financing. Mr. Rizvi, of Public Citizen, argued that it puts governments on the same side as the drug makers and reduces any incentive to make drugs cheap and widely available.
Companies Get Liability Protection
In the United States, drug companies are shielded from nearly all liability if their vaccines don’t work or cause serious side effects. The government covered Covid-19 drug makers under the PREP Act, a 2005 law intended to speed up access to medicine during health emergencies.
That means that people cannot sue the companies, even in cases of negligence or recklessness. The only exceptions are cases of proven, “willful misconduct.”
Drug companies are seeking similar liability waivers in negotiations with other countries. European negotiators have balked at such requests. Covax also insists that countries accept all liability as part of its contracts.
The CureVac-E.U. contract does shield the company from significant liability, but with exceptions. Those exceptions are redacted.
Monika Pronczuk contributed reporting.
"here" - Google News
January 29, 2021 at 03:25AM
https://ift.tt/2NLthRG
Governments Sign Secret Vaccine Deals: Here’s What They Hide - The New York Times
"here" - Google News
https://ift.tt/2z7PfXP
https://ift.tt/2Yv8ZPx
No comments:
Post a Comment