Biden's support for vaccine patent waivers faces uphill effort in Europe

Under growing pressure, the European Union — whose approval would be needed — said Thursday it would consider the Biden administration’s decision to reverse course and support a waiver of patents for COVID-19 vaccines as many poor and middle-income nations struggle to secure lifesaving doses.

But in a speech Thursday, the European Commission president, Ursula von der Leyen, did not endorse the plan, raising questions about whether the bloc would agree to waive patents, something she has said previously she was staunchly against. That position was underscored by a statement from Germany, the bloc’s de facto leader, later in the day, that the U.S. proposal could trigger “significant implications” for the production of vaccines.

“The limiting factor in vaccine manufacturing is production capacity and high quality standards, not patents,” a spokeswoman for Chancellor Angela Merkel of Germany said in the statement.

In her speech, von der Leyen, said that the European Union was “ready to discuss any proposals that address the crisis in an effective and pragmatic manner.”

But she also suggested that the focus should instead be on getting more vaccines to countries that needed them by following the bloc’s example in permitting the ample export of doses. The United States has so far balked at that approach, keeping most doses produced domestically for use at home. “We call upon all vaccine-producing countries to allow export and to avoid measures that disrupt the supply chains,” von der Leyen said.

The two European statements emphasized the challenges of winning critical EU support for securing the patent waivers. Many experts feel the waivers are needed to step up the manufacturing of vaccines and getting them to poorer parts of the world, where inoculations have far lagged those of richer countries. The European Union is a significant force within the World Trade Organization, where unanimous approval by member countries would be required for any proposal to waive patents.

The European Union — and the United States, until this week — have been major holdouts at the World Trade Organization over a joint proposal by India and South Africa to suspend some intellectual property protections, which could give drugmakers access to the protected details on how the vaccines are made.

The European Union is one of the world’s largest producers, exporters and consumers of vaccines. Pharmaceutical companies around the world have also opposed patent waivers, which could cut into profits after large investments on developing vaccines. They say that waiving patents could be dangerous for the public, raising the risks of a wave of counterfeit doses.

The threat of the patent waiver increases the pressure on these companies to eliminate the need for such a move by reaching deals that increase vaccine supply to countries with vaccine shortages, industry and patent law researchers said. That could mean donating more vaccine doses or selling them on a not-for-profit basis. It could also involve striking more partnerships and licensing agreements with local manufacturers around the globe to produce doses, as some vaccine makers have done.

The calls to change course on patent waivers have grown stronger in recent weeks as a catastrophic coronavirus wave in India has plunged the country into the worst outbreak the world has seen since the start of the pandemic. Most experts — and even India — acknowledge that the move would not a silver bullet, because of how difficult it would be to quickly start new production of complex vaccines.

Eighty-three percent of shots that have been administered worldwide have been in high- and upper-middle-income countries. Just 0.2% of doses have been administered in low-income countries. In North America, 48 out of 100 adults have received at least one dose of a vaccine; the figure is 31 per 100 adults in Europe. In Africa, it is 1.3, according to figures compiled by Our World in Data.

A pharmaceutical industry body on Thursday decried Biden’s move, saying it could “undermine our global response to the pandemic and compromise safety.” Stephen J. Ubl, the president of the Pharmaceutical Research and Manufacturers of America, said the decision would “sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.”

Albert Bourla, the chief executive of Pfizer, has said his company has been doing its best to step up production and is also selling its vaccines at cost to the world’s poorest countries.

But, in an interview in late April, two weeks before the U.S. shift in policy, he said, there was little chance of his signing off patents or even contracting outsiders to produce the Pfizer-BioNTech vaccine and that his company had already heavily invested to step up capacity to produce 4 billion doses a year.

“The only reason we have vaccines right now is because there was a vibrant private sector that was able to jump into various efforts with the speed of light and deliver solutions,” he said, adding that patent protection was essential to that.

Pfizer rung up $3.5 billion in vaccine revenue in the first three months of the year, which would translate to hundreds of millions in profits based on the company’s forecasting. Moderna’s vaccine brought in $1.7 billion in revenue in the first three months of this year, the company said Thursday. AstraZeneca, by comparison, has pledged to forgo all profits from COVID-19 vaccine sales for a period of time.

In addition to the European Union, countries like Britain, Japan and Switzerland have also expressed reluctance to waive vaccine patents. Since the United States changed its stance late Wednesday, other nations have voiced support, including Australia and New Zealand.

President Emmanuel Macron of France said on Thursday that he welcomed the Biden administration’s support for patent waiving, but he argued that the short-term priority was to donate existing doses to poorer countries. Leaders from the bloc’s 27 members will discuss the issue at a meeting in Portugal over the weekend.

India and South Africa are preparing a revised version of their waiver plan, which they first proposed in October.

The waiver should make it possible for cheaper versions of the vaccine to be manufactured. India, as the world’s largest producer of generic pharmaceuticals, could eventually play a major role in producing cheaper versions of vaccine.