New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

By Timo Minssen

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

Recognizing that both global & local (i.e. glocal) responses and international collaborations, such as the EU/US TATFAR taskforce, are necessary to tackle AMR, I then concentrated on recent EU & US initiatives. Concerning Europe the discussion focused on new Public Private Partnerships, i.e. the EU’s Innovative Medicine’s Initiative (IMI) and the COMBACTE and TRANSLOCATION projects under NewDrugs4BadBugs program, involving the EU Commission and the pharma industry. But also national initiatives, such as the successful Danish ban and regulations on antibiotic use in animal production, as well as educational efforts (the European Antibiotic Awareness Day) were addressed. These developments were then analyzed and compared to recent US initiatives, i.e. in particular the 2009 Gain Act & the proposed ADAPT Bill (December 2013).

I concluded that many EU/US initiatives are now taking effect but that much needs to be improved, such as specific MA procedures for antibiotics and more international co-operation. This raised the important question of how to proceed from here? How germane are current EU & US push & pull initiatives for the fight against AMR in the developing world. Which solutions would be sustainable from both a conservational and reactive perspective? In that regard I believe that A. Kesselheim’s and K. Outterson’s  ideas about “antibiotic delinkage models” and “integrated approaches”, which combine value-based reimbursement with conservation-based market exclusivities, deserve further careful consideration (see i.a. Kesselheim & Outterson, Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals (2010) & Outterson; New Business Models for Sustainable Antibiotics (2014).

The discussion that unfolded after the presentation and the competent comments by the Broad community were very stimulating. I am currently incorporating this input into a collaborative paper with A. Kesselheim and remain very thankful for having had the opportunity to speak at this exciting institution.

Special thanks go to Ellen Law & her team at the Broad Institute for organizing this event!

Timo Minssen

Timo Minssen

Timo Minssen is Professor of Law at the University of Copenhagen (UCPH) and the Founder and Managing Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL). His research concentrates on Intellectual Property-, Competition & Regulatory Law with a special focus on new technologies in the pharma, life science & biotech sectors including biologics and biosimilars. His studies comprise a plethora of legal issues emerging in the lifecycle of biotechnological and medical products and processes - from the regulation of research and incentives for innovation to technology transfer and commercialization.

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