The European Commission (EC) has unveiled a comprehensive action plan against antimicrobial resistance that includes provisions to promote R&D as well as the possibility of establishing fast-track procedures for marketing authorizations. According to an EC press statement, approximately 25,000 patients die every year in the EU from infections caused by drug-resistant bacteria, with associated costs of more than EUR 1.5 billion ($2 billion) in healthcare expenses and productivity losses.
In a press statement released to welcome the action plan, GlaxoSmithKline (GSK) explained the difficulties of developing new antibiotics. “The discovery of new antibiotics is an inherently difficult area of pharmaceutical R&D and can take many years and involve significant investment. In addition, once licensed new antibiotics are generally used only when patients have failed to respond to existing treatments. This significantly limits the commercial return that is needed to encourage continued investment in this area and fund future R&D.”
Among other areas, the EC has highlighted the development of new, effective antimicrobials or alternatives for treatment as a priority. In response, a funding program for R&D into this area will be initiated through the Innovative Medicines Initiative, and the EC will also establish an overarching framework agreement within the industry that defines the long-term objectives, commitments, priorities, principles, and modes of action for public–private collaborations. In addition, the action plan recognizes the importance of ensuring conditions for and implementing fast-track procedures for the marketing authorization of new antimicrobials.
As well as being welcomed by pharmaceutical companies, such as GSK, the action plan has also received a positive reaction from other industry stakeholders, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA). In particular, EFPIA welcomed the news that the Innovative Medicines Initiative is considering a large-scale program to boost the discovery and development of novel antibiotic drugs. In a statement, however, EFPIA Director-General Richard Bergström added, “In the short-term we emphasize the need to identify improved regulatory pathways that will enhance the feasibility of clinical trials in this area. Currently, there are too many situations in which it is no longer feasible to conduct trials.”
In the GSK statement, CEO Andrew Witty said, “Antibiotic resistance is a global problem and we face the continued threat of one day coming up against an infection to which we don’t have an effective antibiotic.” “Unfortunately, the current commercial model doesn’t stimulate the innovation needed in this area. We need a fundamentally different approach and public–private collaboration, with the sharing of information and funding, [that] provides us with a significant opportunity to reduce the hurdles in our way.”
The action plan covers seven areas where the EC believes that measures are most necessary:
The plan also sets out 12 “concrete” actions: