“I was diagnosed with breast cancer in 2013. My insurance refused to cover my Herceptin treatment because of the high price. Now the cancer has spread all over my body. I need Herceptin so that I can live and bring up my two boys”.
These were Tobeka Daki’s words to the audience during a session at the International AIDS Conference in Durban last week. The session, titled ‘A call to world leaders to enhance research and development (R&D) and access to medicine, and an appeal to the UN High Level Panel (HLP) on human rights and access to medicine’, was co-sponsored by Treatment Action Campaign, Stop AIDS, Open Society Foundation and Oxfam.
Tobeka is deprived of the medicine that can save her life because Herceptin costs half a million Rand ($35,049) per patient per year in South Africa. Meanwhile, Roche is celebrating its successful financial results of June 2016:
“The net income increased 4% to 5.5 billion Swiss francs ($5.57 billion) in the six months to June 30, beating analyst estimates of 5.3 billion. Revenue rose 6% to 25 billion francs, in line with estimates”. ’
The global R&D system for health technologies results in such high prices of new medicines because it is based on maximisation of profits to incentivise investment in R&D. The system has generally failed to deliver affordable health technologies to prevent and treat diseases. While governments (except Least Developed Countries ) are obliged to implement intellectual property protection as part of the agreement on Trade Related Aspects on Intellectual Property Rights (TRIPS), they are also obligated under international human rights law to fulfill their citizens’ rights to health and access to treatment.
The mandate of the HLP, established by the UN Secretary General, is to make recommendations to remedy “the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”
Sixteen years ago at the International AIDS Conference held in Durban in 2000, civil society sent a strong message to world leaders that people living with HIV must have access to life-saving antiretroviral medicines (ARVs). At that time, ARVs were available only in the “North”, while the majority of people living with HIV lived in Southern countries. At this year’s conference, people celebrated the fact that 17 million women, men and children are now accessing treatment. Thanks to generic competition that dramatically reduced the price of ARVs, it was possible to mobilise global public funding to pay for treatment programmes. However, will it take another 16 years before the 19 million people living with HIV – but without access to treatment – can receive the medicines they urgently need?
Generic competition for new medicines is almost completely limited because India, commonly known as the pharmacy of the developing world, has adopted TRIPS and is now under great pressure to increase its intellectual property protection even beyond TRIPS.
Meanwhile the world is waking to the reality that cancer is not a disease of rich countries but is affecting increasing numbers of people everywhere. According to the World Health Organisation, 70% of cancer mortality (5.5 million people) now occurs in the developing world. Other diseases such as multiple sclerosis – which used to be considered “Northern” conditions – are increasingly being diagnosed in developing countries. The prices of medicines for these diseases are beyond the means of patients, governments and insurers.
It is in this context that the scope of the HLP covers all diseases and is not limited to neglected diseases in developing countries. The HLP recognises that new cancer medicines are priced beyond the capacity to pay even of governments in the North. Both the public and the private sectors are struggling to provide these medicines to patients in Europe and in the US.
And it is not only cancer medicines that are unaffordable. At the conference I met two people from Sweden working to support women living with HIV. We talked about medicine prices and they assured me several times that they did not face any problem in Sweden because medicines are free in the public sector. One of them compared her “good luck” to people in Africa who face high prices for hepatitis C treatment. She then said that she herself suffered from hepatitis C but could not get the medicine because according to national guidelines her liver “is not bad enough” to qualify for treatment. It was eye-opening to see how Europeans are unaware of the relationship between high prices and the rationing of treatment. Today England was criticised for rationing hepatitis c treatment by limiting the number of people who get the medicines every year.
As civil society we see the need to revitalise the access to treatment movement in order to promote much needed global reforms in the R&D system for health technologies. The HLP provides an important opportunity for UN member states to address the conflict between securing the human right to health and medicine, and countries’ obligations under the TRIPS agreement, taking account of access problems in all countries, for all diseases. These reforms could be a vital first implementation of world leaders’ commitment to “leaving no one behind”.
In 2001, I stood in the UN building in front of a huge picture of a woman dying with somebody next to her holding her hand. The writing under the poster read: “you mustn’t die alone”. I wanted to shout: “she mustn’t die full stop”. At that time the new antiretroviral medicines had started to work miracles, bringing people from their deathbeds back to life. Yet as a Ugandan doctor truly said: ‘the medicine is in the North but the disease is in the South’. The pharmaceutical industry was happy to sell the medicines at very high prices in rich countries while turning a blind eye to the rest of the world.
It was largely thanks to a huge global mobilisation of civil society led by people living with HIV that leaders and pharmaceutical companies started to feel embarrassed about denying access to life-saving medicines to millions of people. But it was only after generic competition kicked in that access to medicines became something policymakers talked about. An offer by an Indian company to sell a cocktail of the three basic medicines for one dollar a day slashed the prices of antiretrovirals, meaning that today over 9 million people are on treatment,, including over 7 million in Africa.
Generic competition was possible because India had not at that time implemented the Trade Related Aspects on Intellectual Property Rights (TRIPS) and thus was able to manufacture the medicines. Since adopting TRIPS, India’s ability to produce medicines has been limited. Yet the country has been under immense pressure from multinational pharmaceutical companies, the US and the EU to tighten its IP rules even further and thus to limit access to medicines to those who need them.
It seems that the world is obsessed by granting more and more monopoly power to pharmaceutical companies rather than by investment in research and development (R&D) for medicines and vaccines that are needed for public health.
For this reason Ebola is the other side of the coin to HIV as the intellectual property rights system allows the market to shape R&D priorities, rather than public health needs. That same system allows companies to charge high prices that are unaffordable in developing countries as the HIV crisis taught us.
The fear of Ebola crossing borders and affecting people in the US and Europe has changed the situation – clearly there is now a market for travelers, but more importantly the threat of a global epidemic means that donors may be willing to pay for products that contain the spread of Ebola and other hemorrhagic fevers.
The most promising vaccines that are now being rushed through clinical trials have been developed with public money, mainly from the governments of the US, Canada and the UK.
It is not ethical, sustainable nor safe to leave commercial interests decisions and financing for R&D for products, capable of modifying global health threats, to be dictated by the commercial interests of pharmaceutical companies.
Governments, under pressure from multinational companies, have agreed to a profit -based system (TRIPS) instead of looking for more innovative ways of financing R&D.
Throughout the history of medicine’s development, public funding has played an essential role in developing breakthrough medicines, including for the treatment of HIV and now prevention of Ebola. We need to change the present monopoly ownership system to allow public funds their proper place in stimulating accessible and affordable technologies that make our world a safer and more humane place.
With great enthusiasm I started my 33 hours flight from Bolivia to the big country-continent: Australia. But my first night in Melbourne was filled with tears as I turned on the television and heard of the attack to the Malaysian flight MH17.
The opening ceremony of the 20th International AIDS Conference paid respect to the scientists and advocates who died in this tragedy. Throughout the conference, almost all plenary speakers spoke about the “now more than ever” feeling and the importance of Stepping Up the Pace of the AIDS response. In this blog I share some of my reflections from my week in Melbourne.
• I was reinvigorated by the effective activism on Hepatitis and HIV as activists protested against the hypocrisy of the big pharmaceutical industry pricing life-saving medicine beyond the means of people and governments
• It was interesting to learn about the issue of “Grey HIV” as we are seeing people living with HIV getting older in developing countries. Getting old with medications and with HIV looks scary for me because I am also living with HIV and I am already 37!
• It was inspiring to hear daring talks about sexuality in conservative contexts such as those in some Muslims countries and Christian conservative settings. I was pleased to hear that faith leaders are increasingly tackling this issue and talking to their peers
• Although the theme of the conference was “No one left behind”, I heard a lot of the discourse of “shared responsibility” in the AIDS response. Ultimately, this is the idea that countries will have to “find your own funding”. For Middle Income Countries (MICs), the pressure is already mounting and there is a real risk that these countries will be left behind
• I did not hear a lot about women and girls as a key population and the links to gender based violence and HIV. Moreover the debate on vulnerability to HIV infection and impact must recognize that each community and country has its own vulnerabilities that need to be considered in AIDS response
• Children living and affected by HIV were notably absent and this is a fundamental mistake, given the fact that this group is really voiceless and vulnerable. There are huge gaps in the coverage of treatment for HIV and TB for children. I am really enthusiastic about UNITAID because it invests in shaping the market for diagnosis and treatment of children
• As someone coming from Latin America, I felt the strong absence of my region, not only in that very few delegates from Latin American and the Caribbean were present, but also in the fact that the UNAIDS’ “global analysis” included incomplete data from these two regions. At the conference, I realized that there is much misunderstanding about Latin America and the Caribbean. Some donor countries seem to believe these two regions have universal coverage of treatment and prevention services. The reality is that Latin American countries vary a lot and there is huge inequality and disparity.
At the end, I left Melbourne without seeing the sun nor one Kangaroo!
Reflections on AIDS 2014 – Stepping up the Pace and Leaving No one Behind By Georgia Burford (CAFOD) The International AIDS Conference in Melbourne 20-25 July 2014 is the 20th gathering of the largest regular conference of any health or development issue, bringing together politicians, scientists, epidemiologists, practitioners, policy makers, the private sector and communities of people living with and affected by HIV. There is uniqueness in this fight against HIV in that it is a social movement, pulling people together and putting people at the forefront of the response to sustain our efforts on addressing HIV. It’s a powerful reminder that HIV has not gone away and is still affecting the lives of many today. The theme of this year’s conference was ‘Stepping up the Pace,’ summarised by Bill Clinton when he said ’It says much good work has been done, but it’s not an excuse to slow down. Right now we must redouble our efforts on areas like stigma and discrimination, which after 30 years is still increasing in some regions. We have the tools; we need to step up the pace.’ There has been remarkable progress since the 1980s, when HIV was a condition that had no name, no tools to diagnose, prevent or treat it. Today, there are 15 million people on treatment, yet there are still alarming challenges that must be tackled in order to even contemplate an AIDS free generation. Statistics from 2013 show there were 1.5 million HIV deaths, 2.1 million new infections and 35 million people living with HIV. Of the 35 million people living with HIV, 55% (19 million) don’t know they have the virus. They haven’t been tested and if they don’t find this out, they will die. The conference highlighted many reasons as to why people do not access or drop out of treatment. Reasons can be due to lack of services; however, a large part is due to stigma. Studies and personal testimonies have shown that:
In many cases it may be easier to ignore the positive status than deal with the consequences of seeking support. The need for this is highlighted in a recent report produced by STOPAIDS Entitled “Increasing DFID’s contribution to Addressing HIV among key populations which makes a series of recommendations about ways to advance the rights of communities who are disproportionately affected by AIDS. The report was launched at the conference alongside a recent film focusing on people who use drugs in Moldova. We must tackle stigma and discrimination at every level including state policies. The AIDS 2014 conference organisers released the AIDS 2014 Melbourne Declaration, calling for an end to discrimination against people with HIV and the eradication of criminalising laws and practices.  Another key issue highlighted at the conference is the importance of monitoring viral load to ensure PLHIV are able to access necessary medication in order for treatment to be optimally effective. However, currently very few high-burden countries routinely offer viral load testing to people receiving HIV treatment. Since 2012, UNITAID has supported projects working to make viral load testing technologies available in resource-limited settings in Sub-Saharan Africa, but these do not yet address viral load monitoring needs on the large scale required. More efforts are needed to make new viral load testing technologies must be affordable and appropriate for poor resource settings in order to be used effectively. In Melbourne, UNAIDS launched the Diagnostics Access Initiative which calls for improving laboratory capacity to ensure that all people living with HIV can be linked to effective, high-quality HIV treatment services. Lack of access to Treatment is still a huge concern especially that there is a 10 fold price increase from 1st line to 2nd line treatment. In reality, the international community is facing huge challenges to control HIV. Therefore, governments, policy makers, funders, and civil society need to:
In the expressive words from Sir Bob Geldof, ‘We have come so far but there is a preposterous reluctance to fund the last mile. The advocates get tired, the same message goes out to the same people and it becomes less effective.’ I can’t help but think that many of the UK based members of the STOPAIDS network feel the same. It’s not only a challenge on the global stage, but often within many of the organisations we work in. We must not become those tired advocates beating the same drum, but come back from the conference championing the successes of our work over the last 30 years and enter a phase of renewed energy to ensure we step up the pace and most importantly leave no one behind.
A new documentary film opening in UK and Irish cinemas this week tells the story of what its makers call “the Crime of the Century” – how available low-cost antiretroviral medicine was blocked from reaching Africa and other parts of the global south in the years after 1996. The film signals the dangers of the increasingly-perilous outlook for access to essential medicine in developing countries.
Fresh from its much-talked-about premiere at the Sundance Film Festival in Park City, Utah, last month, Fire in the Blood opens at the Irish Film Institute (IFI) in Dublin and the Prince Charles Cinema in London later this week. The film will be released in cinemas across the UK on Monday 25th February. The film tells a harrowing story of inhumanity and heroism, with a highly compelling cast of characters. It details how it could come to pass that millions upon millions of people, primarily in Africa, were left to die horrible, painful deaths, while the drugs which could have saved them were being safely and cheaply produced and distributed just a short airplane ride away.
“I was curious to see what the reaction in the US would be”, says writer-director Dylan Mohan Gray. “So much indoctrination about the necessity of high drug prices has gone on there that the Big Pharma Research & Development (R&D) defence is very much a sacred cow… even those with profound reservations about how the industry behaves tend to grudgingly accept its validity. This is very easy for me to understand, since I was more or less that way myself when I began digging into all this.” Gray was, however, gratified to discover that the American audiences who waited in line to attend six sold-out screenings at Sundance had much the same reaction after seeing the film that he had had when he began to work on the story. “There is a very strong sense of betrayal when people find out what their governments have done in their name… and a very powerful conviction that the prevailing system of developing and commercialising medicine has to change”.
As the film points out, drug companies actually do very little basic research for drug discovery. “84% of drug discovery research is funded by government and public sources”, says Gray, citing the landmark work of Professor Donald Light, “Pharmaceutical companies fund just 12% of such research, while the lion’s share of their spending goes into marketing and administration.” These facts will come as little surprise to those familiar with the industry, but many have never really contemplated the repercussions of pricing essential medicines at levels only a tiny sliver of the world’s population can afford.
While the film tells the story of how multinational drug companies and the Western governments collaborated to keep low-cost generic AIDS drugs out of the hardest-hit countries at the height of the HIV/AIDS pandemic – at a cost of ten million or more lives – it also tells the fascinating story of the unlikely group of people which came together in order to try and break this blockade. Among this number were front-line doctors, HIV-positive activists, generic drugmakers, intellectual property specialists and individuals of global stature such as Desmond Tutu and Bill Clinton (both interviewed in the film). “That’s what really set this story apart for me”, says Gray. “It was a real-life David versus Goliath tale, full of incredibly interesting, daring, courageous mavericks who took on the world’s most powerful companies and governments to do what virtually everyone else at the time said was impossible (i.e. mass treatment of HIV/AIDS in Africa), and against all odds they won…”
While the inspirational story of how low-cost generic AIDS drugs, first and foremost from India, came to save millions upon millions of lives in Africa (and beyond) is at the heart of FIRE IN THE BLOOD, the film concludes on a distinctly alarming note. “The story this film tells was on the verge of being forgotten, something we can’t afford to let happen”, says Gray. The film details the tireless efforts of Western governments, working on behalf of industry, to impede and cut off supplies of affordable generic medicine from countries like India and Thailand to other parts of the global south, primarily by means of bi- and multilateral trade agreements which low- and middle-income countries are placed under enormous pressure to sign.
“The drug industry is stagnant, its pipeline is anemic and it has pinned all its future hopes on China and India”, notes Gray. “Almost all these companies are publicly-traded, which means their bosses have to keep turning profits quarter-by-quarter if they want to try and keep their jobs… as they see it, they simply can’t afford to take a humanitarian view on issues of access.” With the World Health Organisation having estimated that one-third of all deaths worldwide are attributable to treatable and preventable diseases, largely due to lack of access to medicine, the stakes could not be higher.
Meanwhile, for all its insistence that high prices are the only practical trade-off for an industry that spends so much money on R&D to find new and innovative medicines, Gray noted with a wry smile that the who’s who of senior pharma executives will be gathering in London for the industry’s can’t-miss event, the Pharma Summit, just a few days after FIRE IN THE BLOOD opens theatrically in the UK. “I was amused, but not surprised, to read that the theme of this year’s summit is Should pharma cut its losses and get out of R&D?”.
Araddhya Mehtta is a global heath campaigner for Oxfam GB.