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Uncertainty swirls on just how effective policy competition between the EU and UK on these much-needed products will be.
This summer has given plenty of evidence to skeptics everywhere about the imminence and reality of the threat of global warming, and may well embolden hesitant governments to propose more determined responses. But the other global disaster waiting in the wings—a world without effective antibiotics—has yet to give similarly dramatic warning signals to drive public policy formation, so it remains something of a Cinderella threat, still largely overlooked. European health authorities are, however, now upping their game in a bid to promote research and development of new antibacterials, giving rise to the spectacle of two rival schemes now in preparation.
The bigger—and better known—of them is the early 2023 proposal for major reform of the pharmaceutical rules of the European Union,1 which includes specific investment incentives for new antibiotics among its encyclopaedic plans for regulating the pharma sector. The aim is to introduce a transferable data exclusivity voucher that would give developers of new antimicrobials an extra year of regulatory data protection, in the hope of attracting innovation without advance public finance. It is an intricate and controversial scheme that is unlikely to have any impact for years, given the cumbersome EU legislative process it is now entering.
By contrast, the other plan2—from erstwhile EU member state UK—envisions payments up-front to encourage new product development in this field. The UK government likes to present itself as a more nimble operator now that it has left the 26-member block, and its focus is tight with this just-announced scheme.
This scheme also has a head start, in that the UK—fresh from Brexit—already launched a pilot project in 2019 (which it claims was "the first in the world") to pay companies a fixed annual fee for antimicrobials based primarily on their value to the health service rather than on the volumes used. Now it is planning to expand the same approach to more antimicrobials, with a subscription-style contract for a fixed annual fee delinked from volume. It has set out the commissioning route for antimicrobials that offer exceptional value to the national health service based on definedclinical criteria, tied to requirements to guarantee security of supply.
In response to annual invitations to tender, aspirant suppliers will need to demonstrate that the company and product meet clear clinical and non-clinical eligibility criteria, includingactivity against pathogens on the World Health Organization (WHO) priority list and contractual assurance of continuous supply to meet need and demand. Candidate products must also have a marketing authorization or a high probability of receiving one in the upcoming 12 months. Based on the award criteria a product will be granted up to $23 million a year for a "breakthrough antimicrobial" (the top level of four value bands rangingfrom £5m per year to £20m per year) for up to 15 years. The evidence requirements are extensive and demanding, covering relative effectiveness and unmet clinical need, pharmacological benefit, novelty of chemical entity and of target, penetration to relevant anatomical sites of infection, and absence of cross resistance, among many others.
The UK has given no firm date for introducing the new scheme, but it managed to shift its 2019 pilot scheme along smartly so that by 2022, contracts were already awarded to two products. The contrast with the EU is stark. The voluminous EU proposals, initially scheduled for 2022, did not appear until April 2023, and are now bogged down in discussions in the European Parliament and the Council of Ministers as the clock ticks down to parliamentary elections in June 2024. If a position is not agreed by MEPs by the spring, the entire pharmaceutical reform could be ditched, as the new parliament that will start work a year from now will be under no obligation to pick up where its predecessor left off.
Unsurprisingly, the European Commission—the EU body that generated the proposals—has been pushing legislators to speed up, and fighting back against widespread accusations that the complex voucher scheme is a giveaway to Big Pharma. Senior health official Stella Kyriakides has been insisting that vouchers would amount to a free pass for drug firms to increase their revenues. "This will be granted under extremely strict conditions to minimize the cost to health systems," she insisted just before the summer break in Europe. And she also emphasized that alongside the voucher scheme, a set of—equally complex—procurement mechanisms the Commission is proposing for access to new and existing antimicrobials "would guarantee revenue for marketing authorization holders regardless of sales volumes."
Competition is, by common consent among pharmaceutical executives, a mechanism conducive to efficiency in business processes, but it is less clear how effective policy competition between the EU and UK will prove in the much-needed development of new antibacterials.
Reflector is Pharmaceutical Executive’s correspondent in Brussels.