Do We Need A Global Body To Set Priorities For Diseases And Research? 14/02/2018 by William New and Catherine Saez, 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)A recent panel of health experts gathered at the hallowed Swiss Intellectual Property Institute in Bern (which counts Albert Einstein among its alumni) tackled some of the toughest questions facing global health policymakers with an eye toward actually solving them and not just restating polarised positions. One of the ideas discussed at the event was how priorities for diseases and research can be handled at the global level. The Swiss Intellectual Property Institute, Bern The event, entitled, “Stakeholder Discussions on Innovation: availability and affordability of medical products. Can we achieve it all?” took place on 1 February. It included representatives from across Swiss government, as well as leading thinkers from different sides of the issues – industry, health advocates, international organisations, and academia, all speaking in their own capacities. With high prices and availability of medicines a key topic of debate, Paris-based Ecole des Mines Professor Margaret Kyle suggested that a global body is needed to rank priorities, highlighting the most important areas where a global commitment and global financing are needed. But, she asked, “Do you trust that global body not to be captured by one country or another, or one political party or another. As an example, she referenced the United States congressional debate over the budget for the National Institutes of Health (NIH), which is responsible for about $30 billion of investment per year. “Do you now trust Congress to be deciding on what the NIH priorities should be?” she asked, adding that some would have a lot of doubts. A key question in creating these kinds of structures is to ask if we trust the governance to work well, and what do we put in place to check those kinds of potential problems, she said. And finally, she touched on the system of using prices as an incentive for innovation. A lot of national pricing systems are “out of whack,” she said, where “we are paying too much for drugs that don’t do too much,” leaving no budget for the really important breakthroughs when they do come along. That is going to distort incentives, said Kyle. If it is less expensive to develop a marginal kind of product, a marginal innovation, than it is to develop a big breakthrough, but the price is the same, companies will go after products with minor breakthroughs. This issue of pricing in national systems needs to be discussed at the country level as well as across countries at the international level, she said, and that means accepting that rich countries contribute more, and that there will be price differences across countries and across treatments. It is easier to work on the pricing and reimbursement than tinker with the patent system. “We have much more information about the value of a product at the time it is brought to market than at the time the patent application is filed,” she said. [Note: a follow-on story will look more deeply into the discussion of pricing] Panel moderator Alexander Schulze, co-head of the Division Global Programme Health at the Swiss Agency for Development and Cooperation, summarised that speakers talked about how to direct R&D funding to highest priorities more directly. He noted the mention of antimicrobial resistance (AMR) by the WHO representative, and raised a question of whether national priorities would be enough to create the needed incentives, and what to do about countries without sufficient resources. On the global body, Schulze asked if it is acceptable for countries to identify priorities, then invest together. He highlighted efforts at the WHO, with the R&D Observatory, and priority lists for areas like GARD-P, but noted that these are by disease category, so still have the problem of not necessarily priority-setting across diseases. He asked how these plans can be developed with recognition of national reimbursement schemes. Peter Beyer, senior advisor in the Department of Essential Medicines and Health Products at the WHO, replied to Kyle’s question: “Easy. We have this global body. It’s WHO. We can do priority-setting. Certainly it’s a bad idea to have parliaments do priority-setting,” because they lack the knowledge, and are not driven by scientific evidence. He seconded Schulze’s point, saying WHO has done this for priority pathogens. It does the priority-setting for TB and drives investment for antimicrobial resistance (AMR), and it works “fantastically well” with the priority pathogens list, which is used by many mechanisms, he said. CARB-X is the US mechanism, for example, and they use the WHO priority pathogens list to see in which research projects they will invest, he said. It takes a “really small” amount of money, perhaps $300,000 from the German government, and “the impact is huge,” said Beyer. Beyer said he does not think it would work to prioritise diseases against each other, for instance it doesn’t make sense to prioritise diabetes and Ebola. Rather, prioritisation should happen within groups. He gave the example that it has to be at the international level because if it is at the national level, for instance for Latin America they would identify Chagas disease, while the rest of the world would say, “we don’t care” and would leave them alone. And Africa has many neglected diseases, and others would say, “we don’t care.” So, he said, it has to be handled at the international level and then there has to be solidarity for high income countries to do the R&D. Schulze then asked, how do you reimburse these when it might be something that is not a national priority. Beyer said he thinks it works, because of the concern that, for instance, Ebola might spread to Europe. He compared the Ebola vaccine to an insurance model: “you want it there as insurance” in case the outbreak gets worse. The reimbursement can be given for someone to make the stockpiles where needed. Antibiotics is the same, he said, as you don’t want to use it very often. It’s an insurance model, and for this insurance you have to pay a premium, which is more difficult for some countries. At another point in the conversation, Beyer told the story of the Ebola crisis, where he said what “saved us” was that some research had already been in the process, mainly from a military standpoint as Ebola was seen as a possible risk. They were able to quickly conduct trials and develop candidates. Many of his colleagues at the WHO went to get a shot during the safety trials they ran in Lausanne at the time, he said. And companies also came to offer drugs they had that they said would work for Ebola. So they had to go through this list of drugs and candidates, many with very little data, for Ebola in particular, to look at whether there was any chance to use them. They recognised that they needed to invest much more work in priority-setting and looking at the pipeline. So they looked at these and others with an eye toward the health priorities, and identified cases where there are no vaccines, no diagnostics, no treatments. Then they looked at the pipeline to see who is investing. For a particular disease they met with all of the players and ask what are the priorities to use the limited funds they had for the less attractive diseases and then use the limited public funds they had for each of the viruses and pathogens to choose two candidate treatments in phase two, two candidate vaccines in phase two, so that when there is a big outbreak they are not confronted with having to do safety trials. Then a big group of vaccine companies said they were ready under a no-profit, no-loss model to develop these vaccines. GSK said they could set up a manufacturing facility in the US for $150 million and produce vaccine candidates for these pathogens. The vaccine industry has the problem that when there is an outbreak and they have to stop and focus on Ebola, they don’t earn money. So a system needs to be set up for that. Peter Braun, head of Global Access Strategy and Health Policy at Roche in Switzerland, said there are successful examples of planning for a pandemic. But he said it is “extremely difficult” because you need to have the capacity in place to be able to ramp up manufacturing from maybe a million or two doses to well over a billion or two or three billion, all within weeks. How do you do that in a sustainable way? he asked. You have to have the material stockpiled in countries. To prepare for a pandemic influenza required a lot of coordination among manufacturers, pharma companies, WHO and many governments, he said. But even there, with WHO stating very clearly that governments need to put aside a certain amount of material, many – in fact most – countries did not do it, he said. It does require very significant accountability of all parties to make this work. For Ebola, and AMR, Braun said it has to be asked how to do that, and it requires a lot of discussion and conversation. And he said he is happy to say there is a “robust” discussion around AMR ongoing, noting, “We haven’t figured it out yet though.” Kyle responded that she is interested in learning more about the agreement on AMR, and asked how much global agreement there is about how to do it, who is willing to kick in to the prize fund, or to the research grants, plus what arguments have been used that have been successful or not. Beyer replied that for AMR, some of the biggest investors include the US, UK, the Netherlands, Switzerland, South Africa, Germany, Luxembourg, and others. He agreed that it is difficult, even to convince the minister of health, as the minister has no money for R&D. And if you go to, say, Switzerland, they have a plan and advanced universities, but they have no free money that they can just give, he said. But he noted that they now have a directorate in the Ministry of Education and Science for global health R&D, which is well-funded and has some Chf 500 million for AMR. They invest in CEPI (a WHO R&D initiative called the Coalition for Epidemic Preparedness Innovations, meant to accelerate the development of pipeline vaccines for these diseases through Phase II trials so that they can be ready for use in the next outbreak), and the Global Innovation Hub. “That’s what we want to see,” said Beyer, ministries of science and technology investing directly in global health R&D, where the market is not attractive enough. And then for manufacturing, capability can be transferred to facilities in developing countries, because you can’t have a facility doing nothing until there’s a pandemic, he said. The idea was that they do vaccines because there’s a market, and then they can change to pandemics. But then they will have to charge higher prices so you will have to pay more for locally produced vaccines, so that’s not very attractive either. So he said he completely agrees that it is not easy to have pandemic production. Note: this story is one of a series from the Swiss IPI event. Image Credits: Wikipedia 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) Related William New may be reached at firstname.lastname@example.org.Catherine Saez may be reached at email@example.com."Do We Need A Global Body To Set Priorities For Diseases And Research?" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.