Commission lures pharma industry back into antibiotics

Europe’s pharmaceutical companies have agreed to put their weight behind a five-year action plan to promote development of new antibiotics whilst taking steps to preserve the effectiveness of existing drugs. In return the European Commission has committed to introduce an accelerated approval process for new antibiotics, improve pricing and provide R&D funding.

The plan is much needed, according to Andrew Witty, CEO of GlaxoSmithKline, one of the few big pharma companies not to have abandoned antibiotic research. “The current commercial model doesn’t stimulate the innovation needed in this area,” he believes. A fundamentally different approach is required. “Public private collaboration, with the sharing of information and funding, provides us with a significant opportunity to reduce the hurdles in our way,” Witty said.

Witty is the current president of the European Federation of Pharmaceutical Industries and Associations (EFPIA) a body representing 2,000 companies across Europe, which is backing the plan, jointly announced by the Health Commissioner John Dalli and R&D Commissioner Máire Geoghegan-Quinn. The Commission says action is needed to stem the rising tide of antibiotic resistant infections, which now cause 25,000 deaths per annum in Europe alone.

Dalli said resistance is being passed between microbes that infect animals and those that infect humans as a result of the inappropriate administration of veterinary medicines and the continuing use of antibiotics in animal feed. Resistance is also readily passing from country to country, “underlining the need for cooperation,” Dalli said.

Stop indiscriminate use

The Commission’s ‘Action plan against the rising threats of antimicrobial resistance’ will include moves to ensure antibiotics are not used indiscriminately, education on hygiene measures to prevent and limit the spread of infection, and the development of new antibiotic drugs. “This plan is only the first step, but it is a key first step,” Dalli said.

In return for its cooperation the EFPIA says the industry should be adequately rewarded for developing new, effective antibiotics claiming, “That is not the case today.” There needs to be a dialogue about how the commercialisation and use of new antibiotics should be dealt with in future, the EFPIA argues, saying, “We recognise the contradiction in relying on volume sales to earn revenue when authorities are seeking to conserve use.”

Rather, the industry should be engaged with public authorities in monitoring use, and incentivised to conserve the value of antibiotics. In terms of developing new antibiotics EFPIA said the Innovative Medicines Initiative (IMI) the €2 billion public-private initiative, jointly funded by EFPIA and the European Commission is drawing up a new large-scale programme to develop treatments for the most urgent infections.

Richard Bergström, Director-General of EFPIA said the programme of collaborative research should involve large and small pharmaceutical companies and the antimicrobial research community at large. “This is very new ground for the industry and over the course of the next few months we will be finalising the details, but the shape we hope to create for the initiative is clear,” Bergström said.

Competitive dynamic

The collaboration will support activities across the whole research and development process. “In all of this, we believe that it is important to retain a competitive dynamic which will ensure that innovative approaches are developed,” said Bergström. “We face not just a lack of new antibiotics, but also a lack of novelty in those that are coming forward.”

The EFPIA will build on what it is learning through IMI and integrate that into Commission's vision for Horizon 2020, the next EU research programme. “I hope that we will see more companies participating in this collaborative structure. Above all we need to ensure that investment in antibiotic R&D is strengthened,” Bergström said.

Speaking at the launch of the action plan Geoghegan-Quinn said the fight against antimicrobial resistance presents a prime example of the need for joint programming. “Excellent research is being carried out across Europe, but efforts are still too fragmented,” she said, calling on EU member states to develop a common vision and coordinate this through an initiative to pool research efforts.

Over Framework Programmes 6 and 7, the Commission has awarded a total of €600 million for antibiotic research. Now, Geoghegan-Quinn said, the Commission aims to set up an agreement with the industry. Under the next round of Framework Programme 7 calls, several will be devoted to antimicrobial resistance research. “We will mobilise SMEs to research in the area,” Geoghegan-Quinn said.