The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College, London, who told in-Pharmatechnologist.com the key to encouraging antibiotics manufacture is lightening companies’ regulatory burden.
European regulators must find faster ways of getting antibiotics authorised and on sale, and also protect their exclusivity for longer once they are on the market, said Luigi Martini, also a Fellow of the Royal Pharmaceutical Society.
Patent changes: ‘Controversial’
Martini pointed to the 2012 US FDA (Food and Drug Administration)’s GAIN (Generating Antibiotics Incentives Now) Act, which allows antibiotics dossiers to be given priority review by the US regulator. The EMA could enact similar legislation, he said, to help expedite antibiotics to market.
A second key aspect of the GAIN Act is its guaranteed five years of market exclusivity for approved antibiotics, regardless of patent expirations. Companies producing antibiotics in low volumes struggle to recoup costs before rival versions hit the market, said Martini:
“If you’re not using them too often, the pharmaceutical company will not have the time to recover its investment before it loses exclusivity.”
Aside from changes by regulators, governments should think about changing their patent laws, said Martini – not an easy step, as these laws can stretch internationally.
“I’m a supporter of changing the patent law for antibiotics – I know it’s controversial.” But, he said, “You’re asking large companies with responsibilities to their shareholders to invest – they need some kind of special protection or enhancements.”
UK Prime Minister David Cameron this week appealed for action against the threat of antibiotic resistance, commissioning an economic review led by the prominent economist Jim O’Neill and co-funded by the medical research charity the Wellcome Trust.
UK bodies including the Royal Pharmaceutical Society and the ABPI (Association of the British Pharmaceutical Industry) Antibiotics Network have responded by calling for greater financial incentives for pharma companies to develop and manufacture antibiotics.
Scientists’ suggested incentives – other than easing the regulatory burden – include partnering companies more closely with academics to keep down costs, and a change to compensation so that drug developers are partly paid upfront for their work.
"Some antibiotics are only used for short periods and therefore the volume of sales often isn't enough to recoup the investment in development,” said Prof Jayne Lawrence, Chief Scientist at the RPS.
“Consequently it is currently more profitable for pharmaceutical firms to make drugs for long term conditions. The last new class of antibiotics was discovered in 1987 and new initiatives are needed to spur on companies to discover new antibiotics, or people will start dying from simple surgery.”
David Cameron’s choice in appointing economist Jim O’Neill (former Chairman of Goldman Sachs Asset Management) to head the review is “interesting” and bodes well, said Martini, who added that governments must take the first step in encouraging a “multi-modal” collaboration with industry.