EU to test disputed incentive scheme to develop novel antibiotics

The revamp of the bloc’s regulatory framework for pharmaceuticals, presented by the European Commission on Wednesday (26 April), features a new and somewhat controversial system of incentives to promote the development of new antimicrobials.

The development of novel antibiotics is seen as a solution to this ‘silent pandemic’ that claims more than 35,000 lives per year in Europe.

In its reform of the EU pharma rules, the Commission proposed a 15-year trial of a ‘transferable data exclusivity voucher scheme’ for novel antibiotics to incentivise their developers.

In practice, the voucher will grant an additional year of regulatory data protection to the developer of the novel antibiotics, which can either be used for one of its own products or sold to another marketing authorisation holder.

“We’re the first regulators to go down this road,” said EU’s health chief Stella Kyriakides when presenting the measures, adding that the Commission had to think out of the box and “be a little bit innovative to solve a problem that has been out there for the last number of years”.

Incentivising novel antibiotic development

Misuse and overuse of antibiotics in recent years have led some microorganisms, also called superbugs, to develop antimicrobial resistance (AMR), meaning that medicines become less effective and infections persist in the body, increasing the risk of spreading to others.

However, the availability of new antibiotics in many countries across the EU has proved particularly problematic as some of them are not commercially launched despite being approved by the authorities.

“We know today that there is a huge issue of a totally dry pipeline in terms of novel antimicrobials and we know that we have a public health crisis because of AMR. So, we need to work at different levels,” Kyriakides said.

“Vouchers cannot be transferable over and over again – but just once,” said Kyriakides, asked by EURACTIV about the risks of having some sort of parallel trade of vouchers.

The Commissioner also stressed that vouchers will be granted ‘under very strict and clear conditions’ pursuing the aim of rewarding innovation only on the exceptional novel antibiotics that will be eligible under the incentive system.

EU ponders new incentives for novel antibiotics

The European Commission will examine specific incentives and a new pricing system to develop innovative antibiotics in its pharmaceutical strategy, in a bid to take a more ambitious stance against the rising threat of anti-microbial resistance (AMR).

Already highly criticised

According to a Commission official, the voucher system will “really change the business model” of pharmaceutical companies.

However, the EU official acknowledged that “it is, of course, an approach which is not without organisational costs to the health care systems.”

The controversial aspect of the scheme is that it will transfer the costs of the vouchers to member states’ health systems, as it will delay the market entry of generics of products covered by the vouchers.

“But nobody has come forward with a better idea,” said the EU official, adding that it is “bold, innovative but it can make a difference in truly stimulating investment, research and development, innovation, and bringing to market of novel antibiotics.”

Last November, a coalition of 14 EU member states led by the Netherlands expressed their concerns about the voucher system in a three-page non-paper addressed to the Commission.

“Vouchers are an indirect and non-transparent form of financing; costs incurred by national healthcare systems in the EU are unclear and unpredictable,” the document read.

Although backed by the industry, the system is also contested by some stakeholders, including the EU’s consumer association BEUC, which recently warned in a policy paper that vouchers were “a big mistake” that would end up harming patients and markets.

These vouchers would give developers of a new antibiotic the possibility to extend its exclusivity period on another medicine of its choice, undermining the reform’s other gains, commented BEUC director general Monique Goyens after the presentation.

“There are fairer ways to develop new antibiotics,” she added.

For French liberal MEP Véronique Trillet-Lenoir, antimicrobial resistance should instead be addressed through innovative solutions, reduced prescriptions, the dissemination of good practices, and a strengthening of the role of HERA (Health Preparedness and Response Authority) rather than through the voucher system.

According to Anthony McDonnell, a senior policy analyst at the Center for Global Development, the Commission is right to promote the prudent use of antimicrobials.

“However, market exclusivity vouchers are not the best way to do this,” he told EURACTIV, adding that a year of protected sales of the best-selling drugs in Europe would cost taxpayers and patients up to €5 billion.

For him, much of this money will go to the company that buys the voucher, rather than the innovator that they want to encourage.

“They will likely disrupt the generics market, and harm patients who need these expensive treatments,” he concluded.

EU action to turn the AMR tide looks at different incentive models

EU policymakers are being urged to consider the full range of new incentive systems and pilot innovative approaches to tackle antimicrobial resistance (AMR), including Netflix-style subscription services and pull incentives.

[Edited by Nathalie Weatherald]

Read more with Euractiv

(In)accessible contraception

Despite the availability of various family planning tools, worldwide 121 million unintended pregnancies occur every year, or 331,000 per day on average, revealing striking disparities in contraceptive provision and accessibility.