Report by the NGO Representative
Agenda Item 1.4
Delivered by John Rock, Asia-Pacific NGO Delegate
When Rights Cause Wrongs: Addressing Intellectual Property Barriers to Ensure Access to Treatment for all People Living with HIV
For those of you who may be new to the PCB I just wanted to explain that in the ToRs of the NGO Delegation, once a year we get to write a report on a subject of our choice and present it to the PCB. Part of the value of the NGO Delegation is that it allows issues of importance in the HIV response to be brought to the table that others for a variety of reasons may not. The choice of subject is one that we take very seriously and it is done through consultations with our civil society constituencies, and so reflects issues that important to civil society in general and community in particular.
The 2014 NGO Report to the PCB is entitled “When Rights cause Wrongs: Addressing Intellectual Property Barriers to ensure access to treatment for all people living with HIV”. Input was received through NGO Delegation members from a wide cross section of civil society in North America, The Caribbean, Latin America, Africa, Eastern and Western Europe and Asia. Thanks and appreciation are extended to them all.
We have come from all corners of the globe, from all sorts of backgrounds and circumstances, and we are here because we are united by one goal: To End AIDS. A lot of progress has been made. 12.9 million people in developing countries are on treatment. But that only represents about half of the number that should be on treatment according to WHO guidelines. The situation is even worse among many Key Affected Populations such as PWID, MSM, sex workers, transgender people and adolescents. Of those who are on treatment we often do not know whether the treatment is really working, because there is no regular VL testing in many developing countries. The reality is that many have developed resistance to the drugs they are on, and they are no longer effective. But neither they nor their doctors know. They should be on second or third line treatments, and this is where the problem of access becomes exceptionally difficult. We recognize that there are of course many barriers to treatment access, however we believe that by far the most significant are those due to pricing as a result of lack of competition due to IP impediments, and that is the subject of this NGO report, and it is on these specific IP barriers that we are seeking action today.
On the path to ending AIDS it is appropriate to set targets, and these targets must be more than aspirational. Achieving two of the three zeros, zero new infections and zero deaths, and the vital one of the 90, 90, 90 targets, the one related to viral load suppression, depend on effective treatment to the point where community viral load is under control. That will only be possible if everyone living with HIV has access to affordable and effective treatment. This means more political will from governments and the manufacturers of drugs to ensure that better and more robust first line treatments, and second and third line regimens are available.
These drugs are generally still on patent and in many cases have many years to run. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the WTO, set certain minimum standards on IP for medicines. But in so doing the WTO also recognized the potential negative impact on access to health in developing countries. It reaffirmed in the Doha Declaration that TRIPS ‘can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and in particular, to promote access to medicines for all’. It reiterated TRIPS flexibilities, such as compulsory licensing and parallel imports as examples of mechanisms to ensure access to cheaper and quality assured medicines. In practice is has proven difficult for TRIPS flexibilities to be used effectively, largely as a result of pressure from developed countries that, not by coincidence, are usually the countries where the companies that produce the drugs are located. Generic versions of the better first line and second and third line drugs are generally not available.
Yet it is generic competition which has delivered us the progress we have made so far. The success of PEPFAR and the Global Fund has been based on generics. Generic competition came mainly from India, but also a few other countries which did use TRIPS flexibilities, and saw prices for the same regimen in one case drop from $10,000 to $200 per patient per year. But the likelihood of this happening now, and especially for second and third line, is remote. The fact that several smaller generic manufacturers in India have been acquired by foreign pharma companies has reduced competition again.
The problems are especially acute in Middle Income Countries where currently nearly 8 million people living with HIV are located. As epidemics grow and many countries move into MIC status the percentage of the total number of PLHIV located in Middle Income Countries will rise dramatically. Michel referred to modeling that predicts 87% of PLHIV will live in MICs in ten years. Most of these countries have not been included in special access schemes, are excluded from VLs such as those through the MPP, and have substantially given away their right to use TRIPS flexibilities as a result of TRIPS+ clauses in the FTAs which they pursue for trade reasons as their economies develop, and they want access to developed markets.
Originator pharma companies see these MICs as a huge potential for large profits from their products, and have successfully lobbied their governments to include clauses that go way beyond those in TRIPS to protect and extend their patent protection on medicines. Why should these TRIPS+ clauses be included in FTAs? Who benefits and at whose expense? All governments should uphold the right to health of their own citizens, and the governments of the more powerful nations should respect that and not coerce weaker countries into compromising that principle. Yet we can see from leaked texts in the huge TPP still being negotiated in secret, that ever more protective clauses are being proposed by the countries where powerful pharma industries are located. It is accepted that research into new drugs and even a cure is essential, but there is no evidence whatsoever that implementing TRIPS in developing countries encourages more research.
The NGO report details examples of higher prices for medicines as a result of TRIPS+ clauses in FTAs. It is clear that without generic competition treatment for HIV and co-infections such as TB and HCV, as well as many opportunistic infections, becomes unaffordable.
Whether generic competition can thrive depends not only on the barriers created by TRIPS+ clauses, but by whether patents are granted at all. Least Developed Countries under the WTO rules had until 2016, now extended until 2021, to introduce patents on medicines. Yet many countries have felt either compelled or pressured into doing so before they have to. Furthermore there are huge differences in the strictness of patent law. Ideally patent law should only allow patents for innovations, and indeed it is the very strict conditions for patentability enshrined in Indian patent law, that has allowed India to develop and retain its global position in generic manufacture. The advice countries receive on patent law is often biased towards the interests of developed nations. It was reported that leaked information suggested that when South Africa announced that it was going to review its patent law with the intent of making it harder to get patents on medicines, pharma raised a fund of over $400 million to fight it. Whatever the truth is, countries need good independent advice on how to protect their public health interests when introducing patents on medicines.
Once patent law is in place many countries struggle with the issue of whether a particular product should be given a patent or not. Pharma has embarked on a campaign of lodging applications in as many countries as they can and as many different patent applications as they can. This creates a very complex environment for patent offices in developing countries to deal with. The workload is huge and very technical. No wonder then that such patent offices in developing countries often look to London and New York and make a decision which is not right for them and not in the interests of public health in their countries.
What is required is the ability of countries to independently ensure their right to health. Why shouldn’t Africa have its own independent pharmaceutical manufacturing capability? Mechanisms such as restricted voluntary licenses and tiered pricing are all approaches that leave the power in the hands of those multinational players who seek to maintain their monopolies and manage competition. While recent licences let through the MPP have improved terms and conditions compared to the first ones, they are still far short of creating the sort of competition that is required to bring prices down, and still leave the market dynamics in the hands of the originator pharma companies.
It is not as if the access problems IP creates have not been recognized before. Apart from the initial caveats and concerns expressed by the WTO itself in introducing patents on medicines, there have been many international declarations and recommendations specifically relating to HIV, which have either been ignored or dismissed. Most notable perhaps are the UN HIV Political Declaration of 2011 and the Global Commission on HIV and the Law, but there are many others including those of the UNAIDS and Lancet Commission. Governments can no longer avoid delivering on these commitments they have made on this issue, and the global community is not blind about the commitments that have been made.
The best strategy is always to prevent people from getting HIV. As we now know, once infected people are on effective treatment their ability to pass on the virus is hugely reduced, so that even more weight must be placed on the need for treatment . Viral load suppression however depends on good effective treatments that are more robust to resistance and when resistance does occur, as it inevitably will, access to good second and third line treatments. There will be no PreP or TASP for everyone unless these IP barriers are addressed.
And what about a cure? We need to think now about how we can be sure that when it does come that it will not get bound up in access issues as a result of IP and patents. It seems that some believe appropriate pricing for a Hep C cure should be at a similar level to the cost of a liver transplant. We would not want pricing of a cure for HIV to be pitted against the cost of lifelong HIV treatment.
Civil society has always been at the centre of attempts to address IP barriers to treatment access, coming both from a rights perspective, and from a truly public health perspective. The NGO report refers to case studies where some success has been achieved. But overall civil society, while on the one hand being fully aware of the consequences of these barriers, on the other hand is poorly funded or equipped to do this work, and has little access to or influence with decision makers. Civil Society cannot fight this battle alone.
UNAIDS has a critical role and a unique mandate to act. Indeed addressing IP barriers will be a crucial step in the implementation of the fast track strategy Michel spoke about this morning. Working through the Joint Programme it is strategically positioned to support countries to at least get the best out of the current system, and ideally placed to lead a dialogue on how best to improve the system for the sake not just of HIV and co-infections, but total public health. including treatments for NCDs such as cancer, diabetes and heart disease.
In order to address treatment access there is a need to understand and analyse the impact of the current IP frameworks on the availability of HIV treatment; to ensure that action on IP is reflected appropriately within UBRAF; to intensify technical support to allow countries to maximize their ability to work within the current framework; while leading a dialogue on developing a more sustainable mechanism to ensure availability and affordability of treatment and diagnostics; and to report back to the PCB on progress.
It surely must be clear by now that the current TRIPS framework cannot deliver to the world community what it needs from medicines, and we have to work towards agreeing a framework that does. Such a future mechanism should also address other barriers that impact on treatment access. In the meantime we have to work with what we have and make sure we get the best out of it.
For me this is a matter of life and death. I lost my dearly loved partner to AIDS on February 26th1986. Khalil died an awful and painful death in my arms at the age of 34, a wonderful young life lost because there was no treatment. And I managed to survive but because of monotherapy and then older treatments in those dark days, a lot of damage was done to my immune system. Today I have access to the best treatment. It costs the Australian government $30,000 a year, for which I am exceptionally grateful. Without it I would have died years ago. While I recognize that it is my right to have treatment, I feel uncomfortable that it costs so much, especially when I see the huge annual profits of the companies that manufacture them, and that such treatment is not available to my brothers and sisters in the same situation in most developing countries.
HIV drugs have been developed by human endeavour for all humanity and they should be available to everyone, nobody should be left behind. It should not depend on what country you live in whether you live or die as a result of HIV.
We are here to work to End AIDS. But it will only be possible if we act now on addressing IP barriers to access to treatment. There is no other way forward.