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An inclusive discussion to design an ideal PULL mechanism (Guest Blog)

A silent pandemic is around the corner: antimicrobial resistance. The problem? The innovation engine, meant to provide the means to fight it, has stalled. Restarting this engine requires introducing incentives to fix the market failure. While the need for such market incentives is well acknowledged, policymakers are still grappling with the most appropriate solutions. Meanwhile, the innovation ecosystem is now starting to collapse. Urgent action is required - and SMEs are willing to step up to the plate.

 

In the multi-millennial chase against microbes, a double countdown has begun.

The first countdown measures the time we have left until a deadly epidemic of antimicrobial resistance is on our doorstep. The recent EU figures by the ECDC show that antimicrobial resistance and the associated death toll continue to rise. The situation in other parts of the world is even more dire.

The second countdown shows the end-life of the AMR innovation ecosystem. In recent months, we have observed the accelerating pace with which AMR clinical-stage companies are closing down or shifting to more promising sectors (e.g., Da Volterra, Deinove, Nabriva, Summit Therapeutics). Most big pharma companies have already left the AMR market. Who will discover the therapies of tomorrow once SMEs and the last remaining experts are gone?

Not all hope is lost. SMEs hold onto the hope that a long-awaited PULL incentive will finally see the light of day to repair the market failure that has hit the sector. It’s time for action.

The next move will be carefully scrutinized by all the stakeholders in the AMR innovation ecosystem. It is an opportunity for Europe to take the lead on this important global health issue.

It’s crucial to make the right move. In order to avoid jeopardising the balance of health systems, a PULL mechanism has to meet a number of conditions[1] to provide the necessary incentive.

We call on decision-makers to not dogmatically scrutinize the models currently on the table, as there is no obvious solution. We see the solution as a compromise of fine-tuned adjustments and combinations of existing mechanisms.

The BEAM Alliance firmly believes that the Transferable Exclusivity Extension voucher implemented at the European level will offer sufficient flexibility and guarantees. It may become an integral part of the solution, particularly when coupled with a complementary mechanism at the national level.[2] We recognize that TEE as a novel mechanism may, naturally, elicit reservations, so we remain open to discussing other incentive options as long as they meet a series of conditions, mentioned above, and have the potential to be equally effective.

As SMEs are likely to be the main beneficiaries of the scheme, it is imperative that we have a seat at the table and contribute to the discussions on this European PULL mechanism.

The European Commission has brought forth clear proposals in their review of the Pharmaceutical Legislation.

We count on Members of the European Parliament and Member States to act urgently.

 

[1] BEAM’s reflection paper (here): Features of a right PULL incentive mechanism for Europe (2023)

[2] BEAM’s reflection paper (here): Pull Incentive Mechanisms suitable for SMEs developing AMR Products in Europe (2022)

BEAM Alliance

Launched in June 2015, the BEAM Alliance (Biotech companies from Europe innovating in Anti-Microbial resistance...
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