James Packard ‘Jamie’ Love is the founder and director of Knowledge Ecology International (KEI), a Washington- and Geneva-based non-governmental organization concerned with intellectual property- and access to knowledge issues, as well as a key contributor to Fire in the Blood.
Q: Many people who watch Fire in the Blood might come away with the feeling that the forces arrayed against access to medicine are almost insurmountably powerful, yet at the same time you and others portrayed in the film have clearly demonstrated that it's possible to change the world even when all the cards seem to be stacked against you. What would you say to people who are interested in getting involved with this issue after seeing the film?
As powerful as are the big companies that hold patents and other intellectual property on medicines, a handful of people from all walks of life have been able to break monopolies and expand access to affordable generic drugs . There are social movements in dozens of countries around the world, north and south, east and west. In some very important cases, an individual or a handful of people have made all the difference. There are always things to be done, such as researching issues, questioning and engaging government officials and company executives, creating blogs, videos and messaging to the broader public. Some people have done a lot as volunteers, while others find jobs in the handful of non-profit organizations resourced to work on these issues.
Others can influence things from their positions in governments or even companies. I certainly wish more staff persons working for Congress would take an interest, or someone working in the White House or in other government agencies would do something to change US policy. But I would also like have a conversation with someone who in their spare time would write FOIA (Freedom of Information Act) requests, contact elected and appointed government officials, and help raise awareness about any of a dozen pressing issues.
The area that I am most interested today is so-called de-linkage, which aims to transform the whole business model for drug development. This movement is relatively new and small right now, but it could change things the most...
Q: Along with your own (KEI), which US and international organizations are doing particularly important work on the access issue (recognizing that some groups primarily focus on certain regions, etc.)? And which international policymakers and countries have shown leadership on the issue, and how can they be supported?
On the global level, Doctors without Borders (MSF), Health Action International (HAI), Third World Network (TWN), the South Centre, the Peoples Health Movement, HealthGap, Act Up Paris, Oxfam, TACD and KEI have all worked on these issues for more than a decade, but the role of local social movements have been quite important also, including in particular the early leadership of NGOs in Thailand, India, South Africa and Brazil, and more recently groups in many other developing countries.
There are now today several new or newly engaged NGOs in these issues around the world, including in the United States groups like Public Citizen or Universities Allied for Essential Medicines (UAEM). Actually, I should go on and on, because so many different groups have make such a difference on topics as diverse as influencing domestic legislation, engaging in patent oppositions on weak patent claims, pushing for compulsory licenses on drug patents, and opposing restrictive trade policies. And, in addition to the great work by NGOs, there is very important work being done by academic experts, non-affiliated individuals and spunky generic drug companies, such as CIPLA or NATCO.
The work of the Medicines Patent Pool (MPP) is also quite important. They are seeking licenses to enable generic competition for HIV drugs in developing countries. So far, some big drug companies like Johnson and Johnson (J&J) have broken off talks, while others such as Bristol-Myers Squibb (BMS) are in talks, but have not done anything yet.
One problem area is the Bill and Melinda Gates Foundation. They are hugely influential in the field of global public health, and now fund most of the journalism on this topic, and they have been hardline advocates for strong patent protection on drugs, since the 1990s. This creates more problems than you might think, because they influence the Obama Administration, the WHO and the Global Fund on these issues, not to mention the press coverage and most academics and NGOs working on global health issues.
Developing countries in general have been willing to push a pro-access agenda in global negotiations, and some countries such as India, Thailand, Brazil, Bolivia, Kenya, South Africa and Egypt have been particularly active. Among higher income countries, it is more common that global policies are shaped by big pharmaceutical companies -- the Obama Administration currently being the worst in this regard.
In some cases, activists in developing countries are concerned that activism in Geneva lags reforms back home. India just issued its first compulsory license on a drug patent in 2012, a case still being litigated in the courts. Brazil has just issued a single compulsory license, and in Latin America only Ecuador has done more than that. Many countries are torn between a desire to obtain inexpensive drugs and the aspiration to be the suppliers of high technology medicines and other goods.
In high income countries, you see a growing breakdown of the existing system as new drugs for cancer and other diseases are becoming so expensive that no country can afford them, and resources for R&D are often squandered on unimportant products or scientifically weak clinical trials used for marketing purposes, and the evidence base for evaluating drugs is severely compromised due to conflicts of interest.
It is very difficult to regulate drug monopolies. As hard as it is to eliminate drug monopolies, it is even harder to regulate them . That's why the monopoly-smashing de-linkage approach is so promising.
How do you support the NGOs working on these issues? People can start by making a donation. We at KEI always struggle to make ends meet, and we don't have our current year's budget funded. And there is no question that many other groups are facing the same challenges finding the resources to change the world.
Q: What are some of the impending news stories and developments which are unfolding now and throughout 2013 which people interested in access to medicine and global public health should be paying attention to, and why?
The decision in India on the grant of patents on drugs for cancer and hepatitis will be very important, and in some ways decisive for access to drugs for diseases other than HIV/AIDS, because India really is the primary source of low cost generic drugs. I am in Chennai India today attending a court case on a compulsory license to NATCO on patents for the cancer drug Nexavar, which Bayer has priced at nearly k per year, in India. Now the government of India is considering compulsory licenses to patents for other important cancer drugs including trastuzumab (Herceptin). The United States government and Congress has placed enormous pressure on India to withdraw the Nexavar compulsory license and block the other licenses.
In 2013 the Obama Administration will try to wrap up negotiations on the Trans Pacific Partnership (TPP) agreement, a huge new super NAFTA style agreement involving countries in North and South America and Asia. The TPP text is being negotiated in secret, or at least secret to the general public, but according to some early leaks of the text, the agreement will impose all sorts of restrictive measures to extend drug monopolies in developing countries.
Quite soon we expect the NIH to decide on a KEI petition requesting compulsory licenses be granted on NIH funded inventions, when those inventions are more expensive in the USA than in other high income countries.
In May 2013, the World Health Organization will debate a proposal to create a new treaty on medical R&D financing. There have been some setbacks in this negotiation, but the May talks will be important.
The Medicines Patent Pool (MPP) negotiations with HIV drug patent holders will be important.
The US Supreme Court will make several rulings on drug patent issues, including patents on human genes.
Congress will make another attempt to move forward the discussions on de-linkage, by asking the National Academy to consider the costs and benefits of eliminating monopolies on medicines and creating new non- monopoly innovation inducement prize incentives for drug developers, and a new open source dividend to reward the royalty free sharing of data, technology and knowledge.
UNITAID may consider a larger work program on the de-linkage of R&D costs and drug prices in the field of HIV drugs.
Q: What do you see happening if current trends continue? Are you concerned for the future? And conversely, what would a world you would like to see five or ten years down the road look like in terms of access to medicine?
If we don't change the current trends, drugs for cancer and other illnesseswill be so expensive that no government can provide universal access to the best drugs, and only a minority of the world population will benefit from new drugs for an entire generation after the products are first registered for sale. People will die even though we have the treatments they need, and people who get drugs will pay too much of their hard earned money for those drugs. Insurance companies and reimbursement entities will find all sorts of ways to restrict access to expensive drugs. This is not the future we want. It is not the future that I want for myself, for my wife, for my children, or for anyone else.
What I would like to see is a radical change in the drug development business model – one that completely eliminates drug monopolies. This is not only financially and practically feasible, it is ridiculously more efficient and fair – a reform that saves governments money while expanding both access and innovation. The barrier to the de-linkage reform is the belief by many that you can't change the business model, so why even try? But if people thought this way, the Internet would not exist. Business models can and do change, when something much more beneficial and cost-effective is given a chance.
We need competition among business models, and more importantly, we need innovation in business models. We need to go beyond granting monopolies on life saving drugs as the reward for investments. It is ironic that the people resisting the changes the most justify their conservatism on the grounds they are defending innovation. They are opposing innovation in the business model for one or a combination of three reasons, all of which are wrong. Either they think (1) that equal access to new drugs is not important, a position often associated with a position of privilege, or (2) thatit is impossible or impractical to provide incentives to drug developers unless you grant monopolies on products, a view that ignores the fact that we already have third parties evaluate drug reimbursements, and that de- linkage mechanisms (including innovation prize funds) are actually easier to implement, or (3) that you can fix the current mess with better regulation of the monopolies -- a view that is much more naive than the view that you can introduce de-linkage. Yes, it will be hard to implement de-linkage. But it not as hard as regulating drug monopolies in the public interest.