European Union to introduce a transferable exclusivity voucher to incentivize the development of new antimicrobials

In Art. 40 et seq., the new proposed Regulation to replace Regulation 2004/726 (Draft Regulation), includes for the first time in the EU the concept of a transferable data exclusivity voucher as an incentive for the development of priority antimicrobials. The voucher gives the holder the right to one additional year of data exclusivity for one authorised medical product, which can be a completely different product in a different therapeutic area from the priority antimicrobial.

The EU estimates that antimicrobial resistance is responsible for an estimated 33,000 deaths per year in the EU and costs the EU EUR1.5 billion per year in healthcare costs and productivity losses. The market has failed to respond to the need for new antimicrobials, especially those with a new mechanism of action, because such products will have a very small market, as their use will be confined to the most serious cases where existing treatments do not work. As a consequence, antimicrobial development has not been seen as an attractive commercial prospect for pharmaceutical companies.

Requirements

The EU proposes that an applicant may request a transferable data exclusivity voucher for a “priority antimicrobial” at the time of marketing authorisation.

A “priority” antimicrobial needs to meet at least one of the following characteristics:

• it represents a new class of antimicrobials;
• its mechanism of action is distinctly different from that of any authorised antimicrobial in the EU; 
• it contains an active substance not previously authorised in a medicinal product in the EU that addresses a multi-drug resistant infection or a serious or life threatening infection.

The assessment of whether these criteria are met will be based on preclinical and clinical data that must support a significant clinical benefit with respect to anti-microbial resistance. The European Medicines Agency will conduct the assessment, also taking into account the “WHO priority pathogens list for R&D of new antibiotics”.

The applicant for a transferable data exclusivity voucher will also need to demonstrate the capacity to supply the priority antimicrobial in sufficient quantities for the needs of the Union market. In addition, they must provide information of all funding received for research related to the development of the priority antimicrobial and have to make this information available to the public via a dedicated webpage.

Voucher

The voucher, which can be transferred to another marketing authorisation holder once or retained by the applicant, may only be used once by the holder to extend the data exclusivity period either for the priority antimicrobial or for any other centrally authorised product. It can only be used during the first four years of data exclusivity of the receiving medicinal product and provided the marketing authorisation for the priority antimicrobial, for which the right was originally granted, has not been withdrawn. The EC may revoke the voucher prior to its transfer, if a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. The voucher ceases to be valid, when it is not used within five years from the date it was granted.

The provisions regarding the transferable exclusivity voucher will only apply within the first 15 years after the Draft Regulation has entered into force or until ten vouchers have been issued. Depending on the impact of the measure, the provisions might be extended after this period. 

Discussion

Alike any initiative the establishment of a transferable data exclusivity voucher can be controversially discussed. On the one hand, it has been argued against the voucher that by decoupling payment from accessibility the member states would be forced to indirectly pay for the new antibiotic through extended monopoly prices of e.g. a blockbuster medicine with no guarantee of access to the antibiotic.  Given the resulting costs, it is criticised that antimicrobial resistance should rather be addressed by infection prevention and control as well as antibiotic stewardship measures.

On the other hand, the research based pharmaceutical industry in Europe has historically welcomed the concept of a transferable data exclusivity voucher. The Office for Health Economics (OHE) estimated that a European incentive needs to provide developers at least EUR280 million for a new product in an existing class of antibiotic products and EUR440 million for a new class of antibiotic products. Depending on the number of vouchers issued per year, the OHE estimates that each voucher would generate net revenues between EUR350 million and EUR500 million to sellers.

Therefore, the transferable exclusivity voucher could be at least a first step to address antimicrobial resistance in the upcoming years.