UNCTAD Shows Role As Convenor On Investment In Antimicrobial Resistance 30/10/2017 by William New, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)The United Nations Conference on Trade and Development (UNCTAD) this month gathered a wide range of key stakeholders to have a frank discussion about how to solve rising global resistance to existing antibiotics. While not a negotiation, stakeholders in the expert group opened up and shared perspectives, leading to some informal conclusions. Among them: more public and private investment, and a shift in the R&D system to new-style incentives, are needed. The daylong, invite-only event hosted by UNCTAD on 5 October was entitled, “New Investment Models in Health-related R&D – the Case of Antibiotic Resistance.” It was organised by the UNCTAD Intellectual Property Unit. The ad hoc expert group included representatives from all sides of the issue, including relevant UN agencies, the World Trade Organization, international health R&D agencies, national governments, innovative and generic pharmaceutical industries, public health advocates, academia, and others. The discussion covered issues such as “potential models and the means for incentivizing R&D, national level measures to combat antibiotic resistance, and the related question of how to incentivize the continuous availability of existing antibiotic treatments,” according to participants. A primary issue for the global response to antimicrobial resistance is investment in research and development, and UNCTAD has a unique role as the de facto secretariat within the UN on the international investment regime, which consists of over 3,000 bilateral and regional investment treaties, according to sources. An UNCTAD official opened the meeting by setting out some of the key issues at hand, such as incentivizing investment for the development of new classes of antibiotics. He pointed out the projected costs of antibiotic resistance to human health, farming and the global economy, and noted that it affects both the demand and supply sides. From the discussions, it was explained that on the demand side, a key question is how to make new antibiotics affordable and accessible in accordance with UN Sustainable Development Goal 3 (ensure healthy lives and promote wellbeing for all at all ages). On the supply side, there is a lack of R&D due to limited markets, so a question would be how governments, the World Health Organization and UNCTAD can help find ways to encourage the development of new products. It has been said for a number of years that the pipeline for truly innovative new classes of antibiotics is relatively dry, while variations of existing antibiotics are being worked on, but might face the same resistance. A WHO report released last month highlights this issue and was mentioned in the discussion. Problems leading to rising resistance were discussed during the day as well, including the incessant use of antibiotics in livestock or the over-the-counter ease people in some countries have to obtain antibiotics without prescriptions – or too-easily obtained prescriptions. Stewardship was not the primary focus of the gathering, but was specified as equally critical to a successful outcome as overuse, inappropriate use, or incomplete courses of treatments must be curtailed to stop resistance from rising no matter what treatment is being used. On business models, it was indicated in discussion that there are a variety of proposals on delinking the cost of research and development from sales volume and drug prices, but that governments have not yet committed sufficient funding to bring about a shift in the R&D system from the volume-oriented business model to one of effective market entry rewards (MERS). It was also shown that there is a serious risk of shortages in older, existing antibiotics due to poor market conditions for producing them. In both new classes of antibiotics and older ones, innovative pull mechanisms were seen as needed to make it economically possible to produce them over time. A reference was made to the comparison of antibiotics to the market for fire extinguishers made famous by John H. Rex, an operating partner at Advent Life Sciences in London. His point is that fire extinguishers are not purchased when a fire occurs but rather in advance. And while there was some discussion about a larger vision of a global regime for addressing the problem, most of the experts saw value in designing new investment models from a flexible, small-step and case-by-case approach, as summarised by participants. The Medicines Patent Pool, a spinoff from Unitaid, was mentioned as a potential model for managing a global MER system, with IP licensing has a role in monitoring the adherence of licensees to stewardship programs. Discussion of Innovative Investment Models Participants talked about current efforts to boost investment in innovation for antibiotics. These include much-praised “push” incentives, or up-front funding for pre-clinical research, such as the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), and for clinical trials, such as the Global Antibiotic Research and Development Partnership (GARDP). One participant called GARDP “a deliverable” of the WHO Plan of Action on Antimicrobial Resistance, and it is a joint project of WHO and the Drugs for Neglected Diseases initiative (DNDi). But participants said other ideas on improving post-registration product surveillance and patient care (the stewardship issue) in order to prevent overuse are not well-tested, in part due to a lack of public commitment to provide sufficient funding. Stories were given in the meeting of countries where anyone may purchase antibiotics over the counter without a prescription, or where antibiotics are automatically pumped into livestock whether sick or not. A case was described where a visitor to a region of a country later tested positive for an ecoli that corresponds to an old antibiotic, which on further investigation turned out to still be being used in livestock in that region – against a longstanding government ban. And showing the state of production of some older antibiotics for which there is little ability for producers to make revenue, a case was mentioned of the last remaining facility producing one antibiotic suffering a shutdown, leading to the worst-case scenario for that treatment. Pull mechanisms were suggested for the older existing antibiotics, reimbursing the service of keeping important antibiotics on the market. And the use of local production facilities was mentioned as an opportunity for developing countries. And it was pointed out that for market entry awards (MERs), it can be difficult to define what is sufficiently innovative to pay it. For instance, an animal antibiotic now used for humans is a new class for humans but not really innovative. One way to raise funds that was discussed was public funding to universities leading to spin-offs that can raise funds from the market. It is possible for publicly funded projects to “in-licence” products developed in the private sector. An example could be a GARDP partnership with a company for phase III clinical trials and non-clinical studies for a novel molecule against drug-resistant gonorrhoea. In that case, upon marketing approval GARDP will have a licence with sublicensing rights in most low- and middle-income countries and the right to commercialize the product in developed countries, according to the participants. Another suggestion was for more research into combinations of antibiotics, as this might help overcome or limit resistance. It was also noted that there is a growing network of entities involved in antibiotics R&D, including venture capital, startups and publicly funded projects. On intellectual property rights, experts had different views on arrangements, such as full buy-outs by the public sector, joint management or full control by the originator of the IP of any IP in new antibiotics. But there was concern about losing control over IP rights. In closing, UNCTAD made it known that it is prepared to host informal follow-up dialogues on investment and AMR in the future. 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