Voucher proposal from the EU Commission is a potential game changer

Everyone agrees that antimicrobial resistance (AMR) poses a growing global health threat, but no one wants to foot the bill for the development of new types of antibiotics. However, with the EU Commission's proposal to revise EU pharmaceutical legislation, there is hope on the horizon. The allocation of a voucher that the recipient can sell at a high price will significantly change the situation.

Date: May 18, 2023

Author: Jonas Hink

Published: Dagens Medicin

Alone in the EU, more than 35,000 people die each year as a result of antimicrobial resistance (AMR), incurring significant costs for the healthcare systems of member countries, estimated at over 10 billion DKK annually.

With an increasing number of elderly individuals and more people living with chronic illnesses, immunosuppression, or cancer, AMR is expected to become a much more significant problem in just a few years.

Despite the recognized growing health threat posed by AMR and the anticipated future demand for new treatment options in infectious diseases, it is currently not economically attractive to develop and market new antibiotics.
 
The dilemma lies in the fact that new and different types of antibiotics are reserved for patients whose infections are resistant to conventional and inexpensive drugs, which are already widely available in pharmacies and hospitals.

Consequently, new and different types of antibiotics cannot expect substantial sales revenue, and thus, interest in investing in companies focusing on AMR has long been limited.
 
However, the upcoming revision of the EU pharmaceutical legislation may change this situation.

Prerequisites for the issuance of a voucher

One of the proposals from the EU Commission for the new pharmaceutical legislation is the introduction of a transferable data exclusivity voucher.

According to the proposal, such a voucher should be awarded to an applicant marketing a ‘priority antimicrobial’ drug that has a significant clinical advantage concerning AMR.
 
To be eligible for such a voucher, the drug must also represent a new class of antimicrobial drugs, have a different mechanism of action than existing approved antimicrobial products in the EU, or contain an active substance that has not previously been EU-approved for a drug targeting serious infections caused by multidrug-resistant organisms.
 
Furthermore, to be granted a voucher, the applicant must have the capacity to supply the ‘priority antimicrobial’ in quantities sufficient to meet the expected demand across the entire EU.
 
A voucher, of which a maximum of 10 can be issued, must be used within 5 years from the date of allocation, and it will provide the holder with an additional 12 months of data protection for a single centrally authorized drug, first registered in the EU within a period of up to 4 years from the time of use.

The company can either choose to use the voucher to extend data protection for one of its own drugs or sell the voucher to the highest bidder. In the latter case, the buyer can then use the voucher in a similar manner to extend data protection for one of their own drug products.

Why the voucher could be a game changer

The value of a transferable data exclusivity voucher can be substantial.

It is estimated that the willingness to pay for a voucher can be up to 30% of the expected annual revenue of a top-selling drug in the year leading up to the expiration of data protection for the relevant drug.
 
The prospect of a voucher with such value will create a much-needed economic incentive for biotech and pharmaceutical companies developing ‘priority antimicrobials,’ and it can increase investor appetite for investing in these companies.
 
While it may initially seem like a clear opportunity for the EU to push AMR down the list of serious health threats, the proposal must first be adopted by member states.

In this process, there is a risk that the focus may primarily be directed toward other parts of the overall revision proposal, and a lack of attention may result in the voucher initiative not being adopted or perhaps being altered into a less attractive incentive for developers of new antibiotics.

What can be done from a Danish perspective?

If we in Denmark believe that the voucher is a crucial element in combating the AMR threat, we should also play an active role in the upcoming decision-making process.

For example, the Danish Health Authority and other professional actors can raise the alarm about the AMR situation and advise politicians on the health consequences of the status quo.
 
Additionally, various patient associations can prioritize this issue collectively, as the risk of infection and the AMR challenge are relevant to all patient associations across disease categories.

Finally, the industry should persistently continue to address the current lack of commercial incentives. It is crucial that the industry fully supports the current voucher proposal and does not prioritize altering or adopting other parts of the legislative proposal at the expense of a less attractive (or unrealized) voucher model.