Monkeypox threat forces EU to tear up vaccine rules to buy more, faster – Reuters

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The EU’s best-laid plans are put to the test and again proven insufficient.

As the bloc now faces two health emergencies – the COVID-19 pandemic and monkeypox – it has become clear that it is ill-equipped to quickly procure medicines and vaccines for its 450 million people.

The European Commission’s newest authority – the Health Emergency Preparedness and Response Authority (HERA) – was designed to do just that. In addition to preparing the bloc for future health threats, it has a crisis response role. And that includes procuring the necessary vaccines and medicines as soon as possible, to ensure that all EU citizens have equal access to these vaccines when needed.

Launched in the midst of the pandemic, in October 2021, HERA has strived to be fully staffed and up-to-date. Despite this, he has not signed any 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 additional test.

The Commission, together with HERA, announced an order for more than 163,000 doses of the monkeypox vaccine alone. But this order, purchased directly with EU funds, pales in comparison to the 250,000 doses already purchased by France and the 130,000 purchased by the United Kingdom.

HERA is also pursuing other contracts, both for the vaccine and for the only authorized antiviral treatment. But their makers, as well as some countries, have expressed frustration with the glacial pace of those talks. A surefire indication of countries’ stance on the EU’s role as an emergency medicine buyer is their decision to buy vaccines and medicines directly, and more quickly, from suppliers – at least for those who have the capacity.

The good news is that the Commission is aware of the problems, but don’t expect changes too soon.

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

Who is to blame?

Europe has exemplified the power of joint procurement to provide equitable access to life-saving COVID-19 vaccines when gripped by fear of the deadly pandemic.

It was a new role for the European Commission in the event of a health emergency. And although it was initially criticized for being slower than the US and UK, doses quickly rolled in and vaccination campaigns caught up.

At that time, the Commission was leading these talks. He acted as a broker for all EU countries and negotiated directly with vaccine manufacturers. The details contained in the contracts required the agreement of all countries, but at the height of the emergency, these texts were quickly agreed.

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

HERA liaises between companies and EU countries to get agreement on the number of doses needed, price and delivery times. These virtual chats come and go for months. As the pandemic situation evolves over time, countries’ sense of urgency and requirements are also likely to change. This has left discussions of 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 prices. And the number of doses was likely dictated by the manufacturer’s limited supplies.

Many doses of Bavarian Nordic had already been sold to countries such as France, the United Kingdom, Belgium and Denmark. The rest of its supplies, stored in bulk, belong to the United States 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 company. Any new orders will be delivered in the first quarter of next year, he said.

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

As good as your tools

People familiar with negotiations with HERA and the Commission over the past year said the procurement process was cumbersome.

HERA acts on behalf of EU countries, initiating joint procurement talks at their request. But, to reach an agreement, all countries must reach a final agreement on the number of doses and the price. These must ultimately be approved by the participating manufacturer, which involves months of back and forth discussions.

Adding to the complexity is that these contracts are not binding, so even if an EU country asks for 10,000 doses, they are under no obligation to buy them. The contracts are also non-exclusive, so countries can enter into bilateral agreements with companies – in parallel and often faster than HERA. This devalues ​​the EU process and widens the health inequality gap between member countries.

These contractual flexibilities were bones of contention between the Commission and the European Parliament and the European Council in long-running discussions to agree a new regulation on cross-border health threats, which is virtually approved. Dropping this sort of option could have given Europe a much stronger hand in delivering medicines and vaccines in emergencies – but they stuck.

“So that still means, again, you have this rather cumbersome procedure where the Commission does have the mandate to buy, but at the same time the members will still do the same thing. Again, that will lead to lengthy procedures said Elizabeth Kuiper of the European Policy Center think tank, who previously worked for the pharmaceutical lobby EFPIA.

Revising joint procurement rules—again—can solve these problems. But others think Europe needs to designate HERA as an EU agency, as opposed to a Commission service, to give it the power it needs in an emergency.

This “would have allowed HERA to be more agile and efficient in an emergency,” said Rosa Castro of the European Public Health Alliance. But, she warned, this must be accompanied by “robust mechanisms to ensure transparency and periodic review”.

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

And if we are to believe the Commission’s assessment of its new authority to date, we should not expect major changes: “In less than a year of existence, HERA has proven its ability to respond quickly and effectively to public health emergencies, supporting Member States and demonstrating the benefits of a coordinated response at EU level,” the Commission official said. “HERA has so far shown a high added value.”

This article is part of POLITICO Pro

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