Debates caught between focusing on existing antibiotics and developing new agents.
As Europe’s healthcare community holds its breath for the European Commission’s wide-ranging proposals on reform of the EU’s pharmaceutical rules, lobbying efforts on all sides are mounting preemptive campaigns on the most controversial issues likely to be covered by the legislation, with incentives for antibiotic research the latest topic in the spotlight.
There is no controversy over the need for urgent action as antimicrobial resistance (AMR) continues to erode the dwindling arsenal of effective therapies for infectious disease, but the emphasis varies on whether to focus on protecting existing antibiotics or whether—and how—to promote the development of new agents.
The debates have been given added urgency by disconcerting reports from European Union institutions on the growing risks of AMR. “We see concerning increases in the number of deaths attributable to infections with antimicrobial-resistant bacteria, especially those that are resistant to last-line antimicrobial treatment,” said Andrea Ammon, director of Europe’s disease control center, ECDC, in November. “Each day, nearly 100 people die from these infections” in the 30 countries covered by her agency’s estimates—“more than 35,000 people each year,” she stressed. The burden on healthcare systems and society has an economic cost, too, with healthcare expenditures and productivity losses totalling nearly $2 billion in the EU.
For ECDC, the focus is on reducing unnecessary antimicrobial use, improving infection prevention and control practices, and ensuring “adequate microbiological capacity at national level.” A decrease of 23% in total antimicrobial consumption in humans over the last 10 years masks a worrying increase in the proportion of broad-spectrum antibiotics used in hospitals.
The World Health Organization identifies AMR as one of the top current global public health threats—it’s up there alongside climate change, air pollution, famine, poverty, and war. European Commission President Ursula von der Leyen listed it as a priority when she took office in 2019, and her health commissioner, Stella Kyriakides, sees the threat as “potentially catastrophic.” The head of the Commission’s AMR unit, Sabine Pelsser, warns that “we must act as one to avert the worse consequences of AMR,” insisting that “no single action will, in isolation, provide an adequate solution.” In light of the experience of COVID-19, her emphasis is on a comprehensive response to help prevent the next health crisis. She foresees progress being made with the upcoming revision of the pharmaceutical legislation, with its dual plan for stimulating development and marketing of new antimicrobials while also addressing appropriate use. She sees “the failure to develop effective new antibiotics” as one of the drivers of the predicament, despite the EU’s injection of close to a billion dollars in antibacterial research and innovation since 2014.
Combatting the threat “is a high priority” too for the European Medicines Agency (EMA), which underlines how the lack of new antibiotics entering the market exacerbates this “global public health problem.” EMA is supporting the development of new medicines and treatment approaches in concert with the Japanese and US regulatory authorities, to provide a single development program that satisfies the requirements of each of the three agencies and to agree on an aligned approach to clinical trial design. There is even a Transatlantic Task Force on Antimicrobial Resistance.
In a Europe where one in two citizens still think that antibiotics are effective against viruses, the European Parliament is helping to spread the message of appropriate use, supporting a campaign under the slogan “Let’s keep antibiotics working.”
But policy statements and slogans are not going to solve the problem, industry executives mutter increasingly loudly in the corridors of the European institutions. “Action is needed to address the market failure for antimicrobials, so as to drive sustained private research and development investments,” says the European Federation of Pharmaceutical Industries and Associations (EFPIA), the main industry body in Europe. And what it wants the EU to introduce in its legislative rewrite is a new incentive in the form of a transferable exclusivity extension (TEE), “to revitalize antimicrobial R&D.”
Skeptical of the ability of current EU schemes to incentivize at the scale required, industry insists that successful innovation depends on reward at a level that is sufficient to attract the investment required, and to take on the substantial risks. In EFPIA’s view, a TEE, entitling a company successfully bringing a priority antimicrobial to the market to a transferable right to extend the exclusivity period of another product, could provide the incentive required.