FRANKFURT (Reuters) – Germany is looking to encourage the development of more powerful antibiotics against the growing threat of drug-resistant superbugs, the country’s pharmaceutical industry association said on Wednesday.
The health ministry in Berlin is to hold talks later this year with Germany’s pharma lobby VFA, which will propose loosely modeling any new rules for antibiotics on the so-called orphan drug status that is awarded to experimental treatments of rare diseases, VFA’s chairman Hagen Pfundner said.
One of the biggest deterrents for drugmakers is that any new, more powerful antibiotics would need to be used sparingly because overuse could give rise to even more resistant bacteria, he said.
“When you develop, produce and market an antibiotic that is not supposed to be used in the first place unless all other existing therapies have failed, you need a special regulatory environment,” said Pfundner, who is also head of Swiss drugmaker Roche’s German unit, speaking at a media gathering.
“There is a legitimate concern among our members that there is not a sufficient market in the end for a product against multi-resistant germs.”
The World Health Organization has warned that unless something drastic is done, many antibiotics could become redundant this century, leaving patients vulnerable to deadly infections, particularly during operations.
A review backed by the British government concluded this month that a global fund should be created to speed development of new antibiotics.
In the United States, drug industry and public health experts warned lawmakers in September that financial incentives and a more flexible regulatory approach were needed to persuade drug companies to develop new antibiotics.
Negotiation about new antibiotics reimbursement prices in Germany might also be modeled on the orphan drugs status, Pfundner suggested. Orphan drugs are currently exempt from a separate benefit assessment procedure that newly approved drugs have to undergo in Germany.
But a European or even multi-national approach was eventually needed, he added.
Germany’s health ministry has said on its website that Berlin would seek to address drug-resistant superbugs as part of the country’s presidency of the G7 group of nations, leading up to the G7 summit in Bavaria in June.
(Additional reporting by Thorsten Severin in Berlin; Editing by Arno Schuetze and Mark Potter)