EU to reform pharma market rules – to reward antibiotic innovation

Drugmakers that develop new antibiotics are set to benefit from longer market protection in Europe after the EU agreed a wide-ranging reform of pharmaceutical rules seeking to boost innovation and tackle antimicrobial resistance.

European governments and lawmakers reached a deal on an overhaul of current regulations that aims to foster research, secure drug supplies and make life easier for patients across the 27-nation bloc.

"We are strengthening incentives for priority antibiotics, reducing red tape for the life science industry, and safeguarding the availability of essential medicines," said Sophie Lohde, the health minister of Denmark, which holds the European Union's rotating presidency.

First proposed by the European Commission in 2023, the so-called "pharma package" tweaks patent protections to spur companies to produce new, needed drugs.

In line with current rules, drugmakers will benefit from eight years of data protection – the exclusive rights to data from pre-clinical tests and clinical trials.

The following two years of market protection, which shields producers from competition from generic medicines, will be cut down to one.

But for certain drugs, producers will be allowed to add 24 months of protection on top of that – for a maximum total of 11 years coverage.

These include medicines that address an unmet need or a disease with no current treatment, or bring new and significant clinical benefits.

Developers of new antibiotics in particular will be granted a transferrable "voucher" – a bonus allowing them to give 12 months of market protection to any medicine, except so-called "blockbuster" drugs with annual sales of more than $574 million.

Producers will also have to include warnings about the growing threat posed by drug-resistant superbugs in antibiotics packages to increase public awareness on the issue.

The number of drug-resistant infections has been soaring across the globe, as bacteria develop resistance against medicines designed to fight them.

Fuelled by the massive use of antibiotics to treat humans, animals and food, the issue is compromising the effectiveness of life-saving treatments and rendering minor injuries and common infections potentially deadly.

Antimicrobial-resistant superbugs directly cause over a million deaths and contribute to nearly five million deaths every year, according to the World Health Organization.

Among other changes approved, lawmakers and government representatives agreed to speed up the process by which the European Medicines Agency EMA deals with market authorization requests for new drugs.

They also moved to require drugmakers to update their shortage prevention plans – and include QR codes leading to digital versions of medication guides in all drug packaging, so that patients can consult them online, and in their preferred language.

The deal is provisional and needs to be officially endorsed by the European Council representing member states and the parliament before it is formally adopted.