Last week on October 26, a new organization was launched that will accelerate the development of new treatments for global health, or so it was said. With much fanfare (and a webcast), WIPO, the World Intellectual Property Organization (WIPO), one of the 16 specialized agencies of the United Nations (whose hyperbolic tagline is “Encouraging Creativity and Innovation”), BIOVentures for Global Health (BVGH), other prominent organizations, universities, and pharma companies launched a “consortium” called Re:Search (BVGH press release). As I understand it, Re:Search is not the kind of consortium whose members combine money, personnel, and effort toward a common goal, but is a “voluntary endeavor” to “to encourage and support research and development of Products [sic] for NTDs [neglected tropical diseases]” (Guiding Principles). While Re:Search will include, at some point, a Partnership Hub and Supporting Activities (details not given), the only function up and running is a searchable database of “available intellectual property [IP] assets, information, and resources” provided by the pharma companies, NIH, and others. The idea is that academic researchers and companies will license the big pharma leftovers and, my assumption, use them to write publications (academics) or develop global health products (companies). As a few readers may remember, I have posted on a similar effort managed by BVGH, the Pool for Open Innovation Against Neglected Tropical Diseases (NTD Pool, NTD Pool) (“Checking the Pool’s Temperature,” 5/26/11) and on the NTD Pool’s predecessor, a database of 800 patents provided by GlaxoSmithKline (GSK) and Alnylam (“Swimming in the Patent Pool,” 10/5/10).
In my previous posts, I noted a number of problems that limited the pools’ usefulness and, after reading through the Re:Search site (Re:Search) found the same problems:
- academic researchers don’t need licenses since no patent-owner will seek an injunction against research (bad publicity and a damage award would be zero);
- although the licenses are to be royalty free, the rights are limited to the least developed countries (the LDCs are listed) and the “neglected tropical diseases” (NTDs also listed), tuberculosis, and malaria; hence major opportunities, both in terms of public health and in making a profit, are excluded. For examples, Chagas disease is a listed NTD but none of the countries where it is endemic except for Haiti are LDCs (Mexico, Central America, and South America have 8 to 11 million people infected, CDC Chagas). Similarly, dengue is endemic in at least 100 countries in Asia, the Pacific, the Americas, Africa, and the Caribbean with 50 to 100 million infections yearly, mostly among children (CDC Dengue) and fewer than half are on the LDC list. The Re:Search Guiding Principles acknowledge this problem and request that licensors “consider in good faith the issue of access to these products for all developing countries” (Guiding Principles), but good faith consideration only goes so far. And the focus on NTDs ignores the fact that non-infectious disease (e.g., heart disease, diabetes, cancer) are major health burdens in the developing world;
- licenses will be negotiated on a case-by-case basis, meaning lots of lawyers, time, and money will be required; and
- there is no requirement to provide the stuff that is really needed for product development. As stated in the Principles, “physical materials, regulatory data or know-how, including information relevant to manufacturing” are not necessarily available. All assets are provided and licensed at the providers’ discretion.
I checked out the Re:Search database (Search) and found it pretty limited, containing a total 140 items, 63 of which are from companies and most of the rest from NIH. Individual items have lots of data fields for useful information, but most fields are blank. I looked at the Preclinical Candidates category, in which there are 16 entries, all from AstraZeneca (AZ) or Esai, and most are identified as potential inhibitors of noninfectious disease pathways, which is OK but not encouraging as starting points for NTD drugs. In the Resources category, GSK and AZ are offering guest researcher positions at their facilities to guest researchers and funding for projects (GSK), but apparently these are not for people from companies. I’m sure the intent is to add to the database, but right now it is slim pickins.
I also noted that it looks like BVGH scored some contractual money from WIPO since it will be the “Partnership Hub Administrator” and will be responsible for helping interested persons find “available licensing and research collaboration opportunities, networking possibilities, and funding options.” I’m guessing this means BVGH will host more conferences with nice receptions, but since the orientation of Re:Search is research at non-profit institutions as opposed to product development by low/no-profit companies, I don’t see how it fits with BVGH’s mission “to engage companies to drive partnerships and invest in global health initiatives” since the “investment” by the big pharma providers is negligible and small companies and startups are not welcome. I also noted that my alma mater, MIT, is involved in some way, but they are not listed as a provider, user, or supporter. A collaborator without commitment or consequence? As I have noted before, pools of IP available for licensing for global health product development are a nice start, but without commitment of all the needed information, technical expertise, and funding and an orientation toward commercialization, they are pretty useless.
Well, I hope all involved enjoyed their trips to Geneva last week.