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Pauline Londeix’s presentation at the International AIDS conference on HCV pricing and “the future of HCV and HIV treatments”
Thursday 24 July 2014 Pauline Londeix, leader of the Hepatitis C Act Up Campaign in Bangkok in February (http://actupbasel.org/actupbasel/?Pharma-refuses-to-ensure-access-to) made an important speech today in Australia at the International AIDS Conference. Drug pricing policy is a very controversial topic internationally, particularly with the onset of the highly expensive and highly effective pharmaceuticals coming out for hepatitis C which, if given to everyone who has the disease, could potentially wipe the disease from the face of the earth. We at HepCBC listen to all sides of this debate, and in the interest of objectivity, feel our readers should have access to Pauline’s point of view as well as those of the pharmaceutical companies whose press releases we regularly post here. Watch video of Pauline’s speech HERE (https://www.youtube.com/watch?
“I would like to start my presentation by thanking a few people and organizations, including the International AIDS society, and two people who are in this room, two people who have done so much against this disease : Françoise Barré-Sinoussi, Eric Fleutelot.
I have been asked to present on Hepatitis C treatment pricing. I will refer a lot to the report I worked on which was published by Médecins du Monde in March 2014. It is estimated that 15% of people infected with chronic HCV live in HIC, 13% in Low income countries, and the rest 72% in MIC. The HCV pandemic is concentrated in MIC.
Typically, pharmaceutical companies apply 3 different commercial strategies according to the status of countries. “Standardized prices in HICs, Tiered pricing in MICs and Voluntary licence in LICs”.
Based on the information we had in our hands when working on this report, it has clearly appeared that : Standard pricing in High Income Countries does not work, that Tiered pricing in MICs at the prices set by Gilead and other pharmaceutical companies : does not work, and finally that Voluntary licencing in LIC does not work and worse, that these licenses could even threaten the ability of Middle Income countries to access generics. According to a team led by Andrew Hill, from the Liverpool University, the cost of production of Sofosbuvir for a 12 weeks treatment would cost between $68 and $136 to produce. But Gilead, the originator company who has been marketing SOF is not selling it at this price. In the U.S. a 12 weeks treatment of SOF for one person is charged US$84,000.
In France, US$76,000 (50,000euros). To put people with F3 to F4-stage liver disease at the price set by Gilead would take up the entire budget of public hospitals in Paris (7 billions euros). How can these prices be sustainable for the French national health system? Or in even in other high income countries?
But SOF will not be used alone in the treatment of HCV; it must be combined with other drugs. For now, it is used for 12 weeks with PEG-IFN and RIB or with ribavirin alone.
Soon, as other new DAAs come to market, they will need to be used with SOF or in other combinations. The most promising drugs in the pipeline are Datasclavir (BMS), & Gilead’s GS-5816 which will be probably sold in a FDC with SOF.
SOF has also been used for 24 weeks with Ribavirin only for G4 (the most common in Egypt where 14 millions people are chronically infected with HCV).
In Egypt, Gilead has recently announced a deal with the government in their price negotiation of SOF. Gilead’s communication about this deal has been totally misleading. Gilead announced a deal to sell SOF in Egypt for a 99% discount, compared with the global price. But 99% of what price? 99% of the U.S price which has been entirely arbitrary. Unfortunately, at the price set by Gilead (For 24 weeks, at 1800 dollars), access to SOF will remain unaffordable for the public health system. In other MICs, in particular those where there is no generic competition, unlike Egypt, the pricing will probably be much higher than in Egypt. So even, at around 2000$ access to SOF will be unaffordable in MICs, where the most of the HCV pandemic is concentrated. The example of Indonesia also illustrates it well.
What about low income countries? According to recent declaration of Gregg Alton, only 60 to 80 countries will be included in the scope of a voluntary license for SOF. These countries are mostly low income countries and least developed countries, including about 10 to 15 small islands of Pacific with few to no people with HCV. Least developed countries have an extension to implement the TRIPS agreement, so in theory, patents DO NOT have to be granted.
Will these VL improve access? Probably not. As their main purpose is to bind generic producers in order to prevent the supply outside the territory of the license, in particular in Middle Income Countries such as China, Brazil, Thailand, Indonesia, Egypt, Ukraine, Russia. On top of that, pharmaceutical companies often do not bother registering in these low- income countries, which simply prevents any generic producer to register a generic version even when the originator does not have any intellectual property right in the country.
So how to reduce the price of Hepatitis C drugs? Clearly not by negotiating with originator companies such as Gilead, who clearly do not have any interest in selling drugs at a cheaper price. Clearly not in extending the mandate of a mechanism such as the Medicines Patent Pool, which is definitely not designed to resolve the access issues in Middle Income countries and for HCV, as the announcement made by the MPP and Gilead on TAF confirms it. Until now, all the VLs the MPP has signed have failed to enable access to HIV drugs in the excluded countries. And even for the included countries, we still do not have access to hard data estimating the number of people who got access to these treatments thanks to this mechanism.
The solution is also clearly not in WHO negotiating with pharmaceutical companies. These so-called access initiatives, such as “accelerating access” in the early 2000s for HIV have failed to resolve the issue of access. We DO NOT want another “accelerating access” for HCV, as we know these initiatives do everything but accelerating access.
The solution exists. They are there, they exist starting from here in this country Australia, they exist in France, Thailand, Brazil, Indonesia, Egypt and many other countries. This solution is called “generic competition” and is possible including through the use of TRIPS flexibilities, including through the article 31 of the TRIPS agreements which states that any country may use compulsory licenses, and “allow someone else to produce the patented product or use the patented process without the consent of the patent holder”.”
In France, organizations working on access to health have been discussing and calling for the use of compulsory licensing on SOF. In Spain too, as well as in other European countries. Other solutions exist, such as patent oppositions. In many countries, it’s possible for a patent office to reject a patent for a drug, which is only considered as being a mere improvement of a previously patented drug. This is the case of SOF, which is very close to Tenofovir at the molecular level (and as you can easily understand, this is also the case of TAF who is a only a new formula of a previous and already patented drug. We can doubt that this new formulation deserves a new patent). Several colleagues here in this room, from Brazil, Argentina, India, Thailand, have been filling oppositions on Sofosbuvir based on its lack of novelty at the molecular level. And we will do it in every country where it is possible, because enough is enough.
So how to reduce the price of Hepatitis C drugs ? France recently made a proposal at the European level, but price reduction has shown its limits. By understanding that this is not a one- time problem, it is a systemic problem. The systems to negotiate pricing need to be urgently reformed in countries such as the United States and in France.
When the cost of one molecule exceeds the health budget of a country, this means that there is something wrong in the system. When the US accepts a price such as $1000 for one pill for a pill that costs less than $3 to produce, there is something wrong in this system. When the interests of the private sector come first before the interests of the right to health of people, when people have to sell their house or all their goods to buy a treatment to survive in the United States or in a developing country, something is really going wrong in this world. In the past months, more and more people have been realizing this. These people are not only access to medicines advocates, these people are also high-level governmental officials, health authorities, health workers, doctors, hepatologists across the world.
M. Gogtay, as you are representing Cipla, I would like to tell you that I strongly hope that your company WILL NOT sign any VL with Gilead and be able to supply middle income countries. M. Perry, as you’re representing the MPP and the UN agencies, we strongly hope that the MPP WILL NOT launch any negotiation for voluntary licensing on HCV, and you will fight for the universal access to these treatments, that you won’t give up one more time MICs. Because other solutions exist. The solutions include a deep reform of the price negotiation systems, of the patent laws and the use of TRIPS flexibilities.
M. Alton, as you are sitting here, next to me on this panel, I simply would like to tell you my deep disgust of the policy of your company. Do you realize that just because your company wants to maximize its profits, millions of people do not have access? M. Alton, unless your company makes drastic changes in its policy, you will remain an enemy in our war against this disease.”
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