The quest of balance between encouraging medical innovation and the imperative of broad access to medicines has so far been elusive. Two Harvard University programmes jointly organised a workshop this week with the aim of encouraging a conversation between global health actors and see if some “outside the box” thinking is possible.
The Harvard Global Health Institute and the Berkman Center for Internet and Society & Global Access in Action co-organised an event on practical strategies to expand access to medicine and promote innovation on 13 June. The event was partly webcast.
In his introductory remarks, Ashish Jha, K.T. Li professor of international health, Harvard T.H. Chan School of Public Health, and director of the Harvard Global Health Institute, talked about the tension between two communities with two competing sets of ideas.
The first set, he said, is the real practical need for more innovation for treating diseases and diagnostic tests. However, innovation fundamentally is expensive, “and there is no shortcut that we know of to make innovation happen without anybody’s forces,” he said.
The opposing factor, he said, is that a very large proportion of the world’s population that cannot afford to pay for the innovation. “The idea that innovation would only benefit those who can afford to pay for it is an idea that we feel is both from a moral, economic, and intellectual perspective, unsustainable.”
“We have to move forward beyond this tension, beyond this point of contention … and find practical solutions” that both support innovation yet ensure that there is broad access, he said.
The event aimed at first identifying concrete best practices, he said, and then to “think outside the box, get beyond those concrete examples and think about what else we can do, where else we can go, how else we can push this envelope,” he said.
Differential Prices, Generic Licensing
Quentin Palfrey, co-director, Global Access in Action and executive director, Abdul Latif Jameel Poverty Action Lab North America (Massachusetts Institute of Technology), moderating the first panel on identifying best practices that are replicable and scalable, presented some thoughts for participants to consider.
The first was that differential pricing may offer possibilities, in particular intra-country differential pricing, which provides drugs at different prices to different populations in the same jurisdiction. Increasingly, the poor of the world live in jurisdictions where they are surrounded by affluent populations, he said, and it is very difficult to ask the pharmaceutical industry to adopt a policy that simply reduces prices for the entire developing world, he noted.
However, the entire structure of innovation for investment for research and development (R&D) depends upon some notion of recouping some of the investments made in R&D, he said. Inter-country price discrimination allows for a possible mechanism that could allow the charging of different prices to different populations in the same jurisdiction while simultaneously creating a replicable profit structure for industry and also enable and facilitate public health programmes.
The second thought was the possibility of non-exclusive generic licensing partnerships as a mechanism for increasing the reach of corporate social responsibility programmes, he said. One thing that is attractive about this model, he said, is that it incorporated enough of a profit structure so that it could potentially be scaled across many jurisdictions.
One of the shortcomings of traditional corporate social responsibility, he said, is that it often relies on mechanisms that are net negative. The advantage of the non-exclusive generic licensing partnership scheme is that it contains the seed of a mechanism for scaling itself.
The last thought was the notion that one of the greatest challenges of R&D in areas primarily affecting poor populations is the lack of knowledge about some “great research that exists in other parts of the innovation ecosystem.”
In R&D, in the quest for solutions to solve a particular problem there are often false starts that could be useful for other indications, but which are proprietary and difficult to access for those trying to solve other problems, he said.
If false starts and the intellectual property that is developed on the corporate side could be shared with entities which are primarily doing research into the drugs for diseases affecting the global poor, “we may have opportunities to unlock that hidden treasure,” and to allow for greater progress in case of lack of commercial incentives, for example, he said.
Gilead Efforts, Licensing, Tiered Pricing
Gregg Alton, executive vice president for Gilead Sciences, said the pharmaceutical industry needs to be profitable but at the same time needs to provide access to medicines. He described Gilead’s HIV access programme launched in 2003 and said there now are close to 9 million people on this programme in the developing world.
Gilead is working on Ebola and Zika viruses, and Gilead was the first company to join the Medicines Patent Pool, he said. He underlined challenges met in their efforts to widen access to medicines, and in particular the registration of products in different jurisdictions.
Alton talked about the success of its licensing experiences with large Indian manufacturers for HIV drugs. Gilead also has licensed outside of India such as South Africa and China.
On Hepatitis C, he said it is a complicated disease to go after as there are different genotypes of the disease and drugs work differently on different genotypes. Gilead has licensed its Hepatitis C drugs in India, but also in Pakistan and Egypt, and is considering licensing to other countries as well, he said.
Gilead also provided tiered pricing in those countries, he said, and established the price of Sovaldi at US$300 per bottle of treatment, which “for many countries was well accepted,” but Gilead did not want to go much lower than that, he said, remarking that US$300 is not the cost of manufacturing the drug.
“We really wanted to go above our cost of manufacturing to allow generic companies to compete and create a robust business model,” he said. “We did not want to squeeze them out.”
Generic companies are having a hard time seeing business opportunities around the world for Hepatitis C, he said, because there is very limited government and donor funding, he explained.
Access, Innovation, Public Health Shapes R&D
Suerie Moon, research director and co-chair of the Forum on Global Governance for Health, Harvard Global Health Institute, chaired the second publicly aired panel on new approaches to access and innovation. She said one “of the phenomenal shifts in mind that I have seen” since the start of the United Nations Secretary-General High-Level Panel on Access to Medicines, is the growing recognition that the issues of affordability and innovation are not just problems of developing countries.
Innovation is a complex adaptive system and it is not really possible to change just one stage of the innovation process because it would create a number of other changes, she said. If access issues are to be addressed, incentives for innovation have to be addressed at the same time, and access should not come as an afterthought once the innovative process is over, she said.
So it is not just a need to balance innovation access, but rather how to achieve both jointly, she said.
Kevin Outterson, a law professor at Boston University, talked about the complex case of antibiotics. He said there is an “immense” access problem for generically-available antibiotics in the world. There is also a sustainable use problem, he said, with antibiotics not used in appropriate ways and also given to animals, and finally there is an innovation problem, he added.
However, it is not useful to address one of those issues at a time and they need to be addressed concomitantly.
In the past seven years, contrary to what people have been hearing, a lot of new antibiotics have come to market, he said, coming mainly from small and medium companies. So efforts should focus on products that can be handled by those small companies where early stage work is happening, he said.
R&D efforts on antibiotics were redirected to R&D on antivirals in the 1990s, in response to public health need and public pressure, he said, adding, “public health actually shifts the way pharmaceutical innovation occurs.”
Talk Time Over, Coordination Needed
According to Thomas Bollyky, senior fellow for global health, economics and development, at the Council on Foreign Relations medical R&D is failing to meet the needs.
Ebola and Zika have shown once again that investments are needed, he said. Investments are needed to build health systems, have adequately trained health workers, laboratories, and multilateral health institutions such as the WHO that has the ability to coordinate and effectively respond to dangerous disease events, he said.
“Unfortunately, we have needed all these things for a long time,” he said.
Multiple outbreaks and epidemics have been happening recently and each time “we convene together and talk about all that needs to change,” he said.
Medical R&D is important, said Bollyky, underlining the fact that it has been more than two years since the West African Ebola outbreak. There have been more than a dozen drug and vaccine candidates, hundreds of millions of dollars were spent in clinical trials, mainly by companies voluntarily, he said. However, no drug or vaccine for Ebola has been submitted for regulatory approval, he remarked.
A year after the association between Zika and birth defects was established, no effective diagnostic is available, he said.
It is important to coordinate the upstream R&D of medical tools, such as vaccine platform technologies and diagnostics to respond to the next epidemic, which nobody can predict, he said.
It is also important to coordinate downstream testing, manufacturing and delivery as part of the larger humanitarian response to outbreaks, he added.
There is a need to have a roadmap of priority goals because the rush to spur more development for neglected diseases has had “some major hiccups” he said. For example he cited a “very large rush” to form product development partnerships to develop candidates without much thinking about how the late stage funding of those candidates would occur and how they would come to market, he said. That led to a significant transition period in global health, he added.
There is also the need to have a better geographical distribution of partners, he said. The current focus is on low-and middle-income countries emerging local manufacturers, which have better cost structures and the ability to respond to their own domestic market, he said.
Jami Taylor, senior director, Global Public Health Systems Policy & Partnerships at Johnson & Johnson, said the company has a new global public health organisation and strategy that combines all J&J sectors.
Source: Intellectual Property Watch