Revenge of the Microbes II

This past spring I wrote a post about the increase in the volume in public, governmental, medical, and industrial voices on the challenge of microbial resistance to the current drug arsenal (“Revenge of the Microbes,” 4/21/11).  As is pretty well known, the rates of occurrence of multi-drug resistant infections by microbes (aka “super bugs” that have evolved resistance to first-, second-, and now third-line antibiotics) has doubled over the past few years (Moellering 2010 and  Guardian article) with the potential result that we in the developed world (despite our clean water and lots of medical infrastructure) may find our infections untreatable and limb- and life-threatening.  I drew a parallel between the panic and call for new antibiotics with the need for new drugs for the many other “uneconomical” infectious diseases out there in the rest of the world.

So I noted the announcement last week of an “action plan” from the Commission to the European Parliament, which I learned is the executive branch of the European Union, to tackle anti-microbial resistance, a plan that had the endorsement of the European big pharma trade group, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and GlaxoSmithKline (Fierce Biotech story and Reuters story).  Hoping to find a novel initiative that would connect the over-abundance of publicly-supported biomedical research and the drug discovery and development expertise of companies and with substantial financial incentives to encourage companies to trade off some profit margin for societal benefit, I read the Action Plan (Plan) and was disappointed.  The Plan is to be implemented over five years (I guess that’s bureaucracy in action) and has twelve aims, ten that deal with regulation of anti-microbial use, monitoring, policy, and education and two of which address R (mostly) and D for new drugs.  The R and D centerpiece is a new program to be added into existing EU public-private collaboration, the Innovative Medicines Initiative (IMI) which started in 2006 and is jointly funded by 1 billion euros in cash from the EU and 1 billion euros in-kind support from the EFPIA (IMI).  The problem is that the IMI primarily funds a wide variety of research projects into tools and models for drug R and D, and not drug discovery or development (IMI Scientific Research Agenda).  The authors of the Action Plan may have recognized this problem since they call for “unprecedented collaborative research and development efforts,” “unprecedented open sharing of knowledge,” and “an overarching framework agreement with the industry, defining objectives, commitments, priorities, principles and modes of action for public-private collaboration in a longer term perspective.”  But then to make the task even harder, the new drug program of the IMI effort will also address speeding up drug approval and “the establishment of adequate market and pricing conditions for new antibiotics,” which are important but policy, not R and D, objectives.

So if the Commission asks me (unlikely) what their Antimicrobial Resistance Action Plan should include, what are my ideas?  Here’s a quick sketch:

  • expand the program to include any/all infectious microbes, not just those that may afflict the wealthy world, since the early stage of anti-infective drug discovery is about (anti-) biological activity and the ultimate target organisms aren’t known;
  • push the “open sharing of knowledge” obligation as late as possible in the process, e.g., through Phase I to allow for better valuation of the opportunities by potential licensees;
  • require IP owners to register products in all markets or, alternatively, license by indication, geography, and market (insured, self-pay, and public) at affordable, even no-cost, terms (see my post on non-exclusive licensing, “Starting Uphill,” 1/27/11);
  • fund a wide range of unconventional, non-small drug approaches, like mRNA interference and therapeutic vaccines;
  • award grants that start small but increase with progress and with matching by potential licensees;
  • include start-ups and growth-stage companies;
  • require minimum resource commitments based on the size of the participant and grant awarded;
  • require participants to grant mutually non-exclusive licenses (or sign on to a mutual non-assert agreement) for all IP except specific drug product composition and synthesis;
  • build a database of low-cost discovery and development tools and vendors; and
  • require participants to “re-fund” grants when a product’s sales reach a threshold.

As for the financial incentives, there seem to be several out there that have been discussed and implemented to fund and incentivize “unattractive” products:  advanced market commitments by governments wanting to create emergency stockpiles, tax credits, and regulatory vouchers (see Kettler presentation).

For a successful, although overly-long, example of a public-private collaboration that succeeded in getting a drug for a neglected disease to market (almost), see my posting of last week about Ranbaxy’s new malaria drug (“A Long Strange Trip,” 11/18/11).  If there is an opportunity to influence and speed up the Action Plan, I’d like to know.  Happy Thanksgiving, y’all.

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