Revision of the pharmaceutical legislation

Majority of Member States against vouchers for antimicrobial medicinal products

UM – 12/2022

In the run-up to the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on 9 December, 14 Member States expressed their concerns about the proposed amendment to the European legislation on pharamceutical products in a "non paper". Led by the Netherlands and knowing that the European Council is to be briefed by the European Commission on this, the countries have clearly rejected the idea of introducing transferable exclusivity vouchers (also known as vouchers or TEE – Transferable Exclusivity Extension). It has thus become questionable whether the European Commission will pursue its original idea of introducing vouchers when it revises the general legislation on pharmaceutical products next spring.

Vouchers are expensive

A voucher should initiate a pharmaceutical manufacturer to bring a new and effective antimicrobial medicinal product onto the market. The voucher can be used to extend the exclusivity period during which a company can sell one of its other medicinal products without competition from generic suppliers. A lot can be earned if the voucher is redeemed for a profitable "blockbuster". The European Commission assesses the value of a voucher used for a particularly profitable pharmaceutical product at an average of about 360 million euros per year, after deduction of production, distribution and capital costs. However, patients and funding bodies bear a higher burden; in addition to the incentive funds, also in the form of delayed generic competition, which ultimately leads to higher expenditures for pharmaceutical products.

Non-transparent, anti-competitive, counterproductive

The country group also holds that the voucher system increases the costs of healthcare systems in an unpredictable way. It impairs patients' access to medicinal products and does not guarantee the development of new types of antibiotics. In contrast, the transfer of exclusivity rights rewards the development of medicinal products in more profitable indications.

With the rejection of the voucher, the countries are also criticising the existing legal framework. The existing incentive system alone would encourage product development where sales expectations are high and where high prices promise good profits. The latter is the case with orphan drugs. In indications where innovations are urgently needed, there are none.

Pull incentives

Therefore, in addition to suitable direct financial rewards, so-called pull incentives would have to be developed. These are designed to encourage desired product development, such as with market entry bonuses where revenue is decoupled from sales. Models for this exist, such as the so-called "Netflix model". Under this approach, the manufacturer would be guaranteed a fixed revenue amount regardless of prescription numbers. Direct research and development funding that rewards progress would also be conceivable. However, incentives should be linked to strategic goals, such as supplying all Member States, production in Europe or promoting the responsible use of antimicrobial agents.

Integrating HERA

The European Health Emergency Preparedness and Response Authority (HERA) could also play a special role in researching and procuring new products. A proposal for this was made by the Joint Action on Antimicrobial Resistance and Healthcare Associated Infections (JAMRAI). In July, HERA identified the threat of antimicrobial resistance as one of the three priority cross-border health threats in the EU which call for countermeasures at the Community level.