A recent resolution at the WHO shows it will be a long, winding path before all can afford cancer drugs
In a world that sees far-from-perfect global healthcare systems, lack of access to cancer treatment – a disease which currently is the second leading cause of death – is the most unjustifiable fissure in the global health terrain resulting in more than 8.2 million deaths every year. The inhumanity of the situation apart, where a person dies even when medicines for her cure exist, non-communicable diseases (NCD), which include cancer, is a growing economic strain that is squeezing health budgets. A group of governments and non-government organisations (NGOs) working on global health came together to kick-start a conversation on redressing the situation during the 70th World Health Assembly (WHA) held between May 22 and May 31. Common sense decrees that it should have been easy to get governments to speak in one voice around the issue, since the economic health of a country has proved to be an irrelevant factor as far as soaring cancer drug prices are concerned, but the battle has not been easy for the initiators of the dialogue.
On May 31, the WHA adopted a landmark cancer resolution proposed by Brazil, Canada, Colombia, Costa Rica, France, Netherlands, Nigeria, Panama, Peru, Russia, Thailand and Zambia (India and some other countries later co-sponsored the resolution), to improve prevention, diagnostics, treatment, and implement evidence-based protocol for cancer management, including palliative care for cancer.
It asks the World Health Organisation (WHO) director-general (DG) “to develop, before the end of 2019, the first periodic public health- and policy-oriented world report on cancer, in the context of an integrated approach”. It also asks the DG “to promote cancer research” and “to promote the availability and affordability of quality, safe and effective medicines (in particular, but not limited to, those on the WHO Model List of Essential Medicines), vaccines and diagnostics for cancer”.
Importantly, it asks the UN health agency chief “to prepare a comprehensive technical report to the Executive Board at its 144th session [January 2018] that examines pricing approaches, including transparency, and their impact on availability and affordability of medicines for the prevention and treatment of cancer, including any evidence of the benefits or unintended negative consequences, as well as incentives for investment in research and development on cancer and innovation of these measures, as well as the relationship between inputs throughout the value chain and price setting, financing gaps for research and development on cancer, and options that might enhance the affordability and accessibility of these medicines”.
Governments have been asked to take steps to cut down on tobacco and alcohol consumption, increasing vaccine coverage for human papillomavirus and hepatitis B. It also “reaffirms” the rights of WHO member states to “the full use of the flexibilities in the WTO Agreement on Trade-related Aspects of the Intellectual Property Rights (TRIPS) to increase access to affordable, safe, effective and quality medicines, noting that, inter alia, intellectual property rights are an important incentive in the development of new health products”.
The resolution is also important in terms of shining the spotlight and recognising that there are disparities in access to treatment.
Strength of the resolve
However, the resolution is not as strong as health activists hoped it would be.
Some 29 civil society organisations and 33 health professionals, activists, and economists including the Nobel Prize-winning economist Joseph Stiglitz had written to the WHA for governments to support a feasibility study for progressive delinkage of costs of research and development (R&D) from cancer drug prices. The study would also expose the actual costs of R&D to pharmaceutical companies bringing greater transparency to drug prices.
That text had to be removed due to objection by some governments including the US and the UK.
“Union for Affordable Cancer Treatment (UACT) is, of course, disappointed by the weakening of the earlier versions of the text that called for transparency of prices and R&D costs, access gaps, and a feasibility study of delinkage,” said Dr Manon Ress, founder and acting director of UACT, in a statement.
Calling the resolution “ambitious and much needed”, Ellen ‘t Hoen, member of the UACT expert advisory board, said that the “implementation of the plan will require courageous steps by political and global health leaders to ensure cancer prevention, treatment and care are affordable and available to all in need”.
In spite of US president Donald Trump’s surprising proclamation just ahead of his inauguration that the drug industry is “getting away with murder”, the American administration in multilateral forums, on the face of it, is encouraging some of this “murder”.
“The Trump Administration opposed a specific reference to a feasibility study for delinkage. Some European countries, such as Portugal and France, and some developing countries, such as India and Brazil, were supportive of studying alternatives to high drug prices.”
“In the end, the resolution provides a sufficient mandate for the WHO secretariat to address delinkage, by referencing the ‘value chain’ of drug development and pricing, and ‘options that might enhance the affordability and accessibility of these medicines’,” said Jamie Love, the founder-director of Knowledge Ecology International (KEI), one of the NGOs at the forefront of this debate. He added that the text dealing with pharmaceuticals and access was “the most controversial issue”.
The New York Times, quoting data from the Center for Responsive Politics, says that $78 million has been spent by the pharmaceutical and health products industry on lobbying in the first quarter of this year, which is a 14 percent jump over last year. “The industry pays some 1,100 lobbyists – more than two for each member of Congress,” the Times states.
Evidently, much is at stake for the Big Pharma, the representatives of which will fight till the last dregs of their energy to protect profits.
In a side-event on May 24 at the WHA arranged by KEI, Oxfam and Stichting Health Action International (HAI) on addressing access barriers and affordability challenges for cancer medicines, Brazilian deputy permanent representative to the UN Guilherme Patriota said that “you are dealing with investors directly sitting on the decision-making rooms”.
“Everywhere you go, decision-making is beginning to be shared with representatives from the private sector that have a very inflexible perception on how to deal with these issues,” he said.
Calling the resolution “a great beginning”, he said that it is getting “every day more difficult” to get an international commitment on a resolution, such as the one on cancer.
The issue of cancer treatment, of course, ties into the larger efforts of enhancing access to medicines, treatment and diagnostics for all, especially the global poor.
In a rare instance of partnership at the WHO, a proposal by India that the issue of access to medicines be included as an agenda item in the EB for January 2018 was supported by the US. However, a stronger proposal by South Africa that the issue be made a standing agenda item at the WHA – a proposal that garnered support of many countries – “ was discarded by the secretariat somewhat abruptly at the end of the discussion today [May 27],” reports IP Watch.
Even though the US supported the above-mentioned Indian proposal, it (along with other host governments of pharmaceutical companies like the UK) still has not warmed up to the recommendations of the UN Secretary General’s High-Level Panel on Access to Medicines (UNHLP), which provides crucial missing links to the access puzzle. As such, there would, presumably, be only very limited gains of such an India-US partnership at the global health body.
India, speaking on behalf of 11 countries in Southeast Asia region, said that cancer kills 1.1 million people in the region, many of which are premature deaths.
“It is an unfortunate fact that most of cancer cases in SEAR are preventable, treatable, curable and careable. Lung, liver, cervical, breast, and oral cancers are leading cancers in our region,” the Indian delegate said. The high cost of cancer prevention is diagnosis, treatment and palliative care can lead to “catastrophic illness”.
“We, therefore – Chair, call upon WHO and other partners to promote availability and accessibility of affordable, safe, effective, and quality medicines, vaccines, and diagnostics and other technologies, including through exercising TRIPS flexibility,” India said stressing on the need for delinkage between drug prices and R&D.
Profits and deaths
“After you get the first $67 billion, you think it might be appropriate to say let’s make the drug available for cheap now, let’s be a good sport,” Love said at the cancer drugs side-event in the context of the huge profit that Roche, a Swiss pharmaceutical company got after sale of T-DM1, a breast cancer drug.
“The usual argument from companies in the face of efforts to bring down the prices is that the result will be less R&D,” he added, arguing that for these rich governments the patent system and the shareholders get priority over sick people.
Terming the profit margins of the drug industry “astronomical”, Ress said that the global market for pharmaceuticals is about $1trillion. The global sales of cancer drugs are projected to increase by $77 billion between 2015 and 2020, according to some reliable estimates.
Ellen ‘t Hoen, citing the instance of a chemotherapy medicine to treat cancer imatinib that costs $119-159 to make but has a market price between $30,000 and $1,00,000 per year, said that “there is enormous” space for making medicines more accessible and affordable.
Drug companies argued that there is a need for developing countries to strengthen their own health systems to enhance access rather than faulting the patent system. It is not only manufacturing costs but also the infrastructure that is needed to make innovative medicines, and that access issue cannot be seen in isolation but within a broader context, a representative from the International Federation of Pharmaceutical Manufacturers and Association (IFPMA) said at the side-event.
‘t Hoen added that it is not just patents but “a myriad of exclusivity, rules and regulations” that the pharma argue will increase innovation are things to worry about in the access to drugs issue.
In the meanwhile, well-known multinationals that make branded medicines and ones that make generic medicines blame each other for drug prices shooting through the roof.
After the University of California challenged an Indian court decision to patent prostate cancer drug Xtandi, more than 50 health advocacy groups, including UACT, KEI and Oxfam, wrote a letter to university president Janet Napolitano on May 24, arguing that patenting Xtandi would stop the supply of generic drug at an affordable price.
“The high price of Astellas branded Xtandi in India is shocking to anyone who thinks cancer drugs should be accessible and affordable, regardless of where you live,” reads the letter noting that the University of California developed the drug with federal funds currently sold in India by Astellas at an “exorbitant” price of $44.77 a pill.
“Generic competition in India has historically driven down prices and significantly improved access to cancer drugs in India and other countries that are currently sourcing from India, and this will also apply to [Xtandi] as it goes into production and registration,” the letter further said.
On June 13, South Africa's Competition Commission announced that it has launched an investigation examining alleged over-pricing of cancer drugs by three pharmaceutical giants that includes Africa's biggest generic drug maker Aspen Pharmacare, Roche Holding and American drug maker Pfizer.
The South African competition watchdog said that lung cancer treatment xalkori crizotinib sold by Pfizer, breast cancer drugs Herceptin and Herclon sold by Roche, Leukeran, Alkeran and Myleran cancer treatments sold by Aspen may be excessively priced.
Fix the Patent Laws coalition welcomed the investigation, calling it a "major victory in our struggle to ensure that all people in South Africa can access the medicines they need to stay healthy and alive".
Such bold action by governments will go a long way -- in addressing an awfully skewed situation disfavouring patients, rather than getting cowed down by powerful lobbies.
Cancer is a leading cause of morbidity globally and a growing public health concern, with the annual number of new cancer cases projected to increase from 14.1 million in 2012 to 21.6 million by 2030, the WHO resolution says.
A “long-term R&D funding reform is needed”, ‘t Hoen argued.
The UNHLP report, however, has had some positive impact on laying bare the access issue influencing richer countries as well, including Netherlands. The Dutch delegation had been active on the WHA resolution expressing its support for enhancing access to cancer drugs. Drug prices are high on the agenda of the EU after the Dutch assumed presidency of the EU, a WHO official told the audience at the cancer resolution side-event.
Additionally, from September 26 this year, members of the European parliament will host two days of meetings on delinkage, where the proposal for a Cancer Innovation Fund will also be discussed.
Outgoing WHO DG Margaret Chan has been particularly unhelpful with pushing the UNHLP report and, therefore, the conversation on enhancing access. “Going forward, much will depend upon the new leadership at the WHO, as these reforms were previously blocked by the outgoing WHO director-general Margaret Chan, as well as the level of support for delinkage in member states,” Love said.
“Without decent political leadership on delinkage at the national level, it won’t happen,” he added pointing out that “several members of the US Congress are now calling for feasibility studies of delinkage, and even some persons in the Trump Administration have signalled some new openness on this issue”.
WHO DG-designate Tedros Adhanom Ghebreyesus, a former Ethiopian health minister, was much more vocal than Chan in his support for the UNHLP recommendations. In a letter published in the Lancet in the beginning of the year, Tedros advocated full use of compulsory licenses to manufacture generic medicines and supported the idea of delinking drug prices from cost of R&D.
“The World Health Organization has a fresh mandate that we think can be used to address the most transformative reforms to make cancer drugs available at affordable prices, but it will take a lot of work to move this forward. We look for Dr Tedros to take the bull by the horns to lead WHO’s work on transparency, affordability, and delinkage,” Thiru Balasubramaniam, Geneva Representative of KEI, told the WHA after the adoption of the resolution.
(The article appears in June 30, 2017 edition)