Monkeypox threat forces EU to rip up vaccine rules to buy more, faster

The EU’s best-laid plans are being put to the test and found wanting — again.

With the bloc now facing two health emergencies — the COVID-19 pandemic and monkeypox — it’s become clear that it’s ill-equipped to buy medicines and vaccines for its 450 million people in short order.

The European Commission’s newest authority — the Health Emergency Preparedness and Response Authority (HERA) — was designed to do exactly that. On top of preparing the bloc for future health threats, it has a crisis response role. And that includes buying the vaccines and drugs needed ASAP, to ensure all EU citizens have equitable access to them in times of need.

Launched in the midst of the pandemic, in October 2021, HERA has been gunning to get fully staffed and up to speed. Even so, it has signed no new contracts for the COVID-19 antivirals Paxlovid or molnupiravir, nor for the antibody therapy Regkirona. Now, monkeypox — declared an international public health emergency by the World Health Organization last month — is an added test. 

The Commission, with HERA, has announced an order for over 163,000 doses of the only monkeypox vaccine. But this order, purchased directly with EU funds, pales in comparison with the 250,000 doses already bought by France and the 130,000 purchased by the U.K.

HERA is also pursuing further contracts, both for the vaccine and the only authorized antiviral treatment. But their manufacturers, along with some countries, have expressed frustrations at the glacial pace of these talks. A surefire indication of countries’ position on the EU’s role as emergency drugs buyer is their decision to buy vaccines and drugs directly, and more quickly, from the suppliers — at least for those with the ability to do so. 

The good news is that the Commission is aware of the issues — but don’t expect any changes too soon.

“The Commission is currently conducting an assessment of the joint procurement mechanism, to identify and analyze possible opportunities for improvement,” an EU official told POLITICO by email, adding: “The results should be available by the end of this year.”

Who’s to blame?

Europe illustrated the power of joint procurement in delivering equitable access to life-saving COVID-19 vaccines when gripped by the fear of the deadly pandemic. 

It was a new role for the European Commission in a health emergency. And while it was criticized initially for being slower than the U.S. and the U.K., the doses soon rolled in and vaccination campaigns caught up.

At that time, the Commission led these talks. It acted as a broker for all EU countries and negotiated directly with the vaccine makers. Details contained in the contracts needed agreement from all countries, but at the peak of the emergency, these texts were agreed quickly.

Today, however, that heightened fear of the early stages of pandemic has subsided. And, as one person close to ongoing EU talks for a COVID-19 medicine said, it’s likely that this is to blame for the lack of a deal.

HERA goes between the companies and the EU countries to get agreement on the number of doses required, the price and delivery schedules. These virtual talks go back and forth for months. With the pandemic situation changing over time, countries’ sense of urgency and their demands are also likely to change. That’s left talks for COVID-19 drugs in limbo.

For monkeypox, the vaccine contract was slightly different. HERA used EU funds, eliminating the need for back-and-forth agreements with countries on price. And the number of doses is likely to have been dictated by the manufacturer’s limited supplies.

Many of Bavarian Nordic’s doses had already been sold to countries including France, the U.K., Belgium and Denmark. The remainder of its supplies, stored in bulk, are owned by the U.S. under a long-standing agreement. These countries “didn’t want to wait for HERA,” said Rolf Sass Sørensen, head of investor relations at the Danish firm. Any new orders will be delivered in the first quarter of next year, he pointed out.

Meanwhile, Phil Gomez, chief executive officer of SIGA, the U.S. pharmaceutical company with the only approved monkeypox antiviral, described the joint procurement talks with HERA as “frustratingly slow.”

Only as good as your tools

People close to negotiations with HERA and the Commission over the last year say the procurement process is cumbersome.

HERA acts on behalf of EU countries, launching joint procurement talks at their request. But, to complete a deal, all countries have to reach a final agreement on dose numbers and price. These ultimately have to be agreed on by the participating manufacturer, involving months of back-and-forth discussions.

Added to the complexity is that these contracts are non-binding, so even if an EU country requests 10,000 doses, it has no obligation to actually buy them. Contracts are also non-exclusive, so countries can secure bilateral deals with companies — in parallel and often more quickly than HERA. This devalues the EU process, and widens the health inequity gap between member countries.

These contractual flexibilities were bones of contention between the Commission and the European Parliament and the European Council in longstanding talks to agree upon a new Cross-border Threats to Health Regulation, which is all but rubber-stamped. Dropping this kind of optionality could have handed Europe a much stronger hand in delivering drugs and vaccines in an emergency — but they were kept in.

“So it still means, again, that you have that rather burdensome procedure where indeed the Commission has the mandate to purchase, but in parallel members will still do the same. So again, it will lead to lengthy procedures,” said Elizabeth Kuiper of the European Policy Centre think tank, who previously worked at pharma lobby EFPIA.

Reviewing the joint procurement rules — again — may solve these issues. But others think Europe needs to designate HERA as an EU agency, as opposed to a Commission department, to give it the power it needs in an emergency.

This “would have allowed HERA to be more agile and effective during emergencies,” said Rosa Castro at the European Public Health Alliance. But, she cautioned, this needs to be coupled with “strong mechanisms to ensure transparency and periodic scrutiny.”

In time, HERA can reasonably be expected to gain these greater powers, but any change would likely come too late to deal with today’s health crises. The authority will undergo its first Commission review in 2024, covering the “implementation of the operations of HERA,” the Commission said.

And if the Commission’s report card on its new authority to date is anything to go by, we can’t expect any major changes: “In less than one year of existence, HERA has proved its capacity to respond quickly and efficiently to cross-border public health emergencies, supporting member states and demonstrating the advantages of a coordinated EU-level response,” the Commission official said. “HERA has so far shown a strong added value.”