The first sentence of the official press release for the new UN report on access to medicines captures all the problems with the report, probably inadvertently. Here is the monster sentence
Whether it’s the rising price of the EpiPen, or new outbreaks of diseases, like Ebola, Zika and yellow fever, the rising costs of health technologies and the lack of new tools to tackle health problems, like antimicrobial resistance, is a problem in rich and poor countries alike.
We all understand that everyone wants her or his pet idea in the lead sentence but it’s anyone’s guess what this means. The panel seems to be saying that its report will address
- Big price rises for old technologies like the EpiPen, now priced at $600 a pop in the US market
- The lack of health technologies to combat infectious disease threats such as Ebola, Yellow Fever and Zika
- How to produce new technological solutions to new health threats such as antimicrobial resistance
It’s a tall order: what have they all got in common? Winnie Byanyima, executive director of Oxfam, and a member of the High-Level Panel, said, “This report gets to the heart of the problem with access to medicines – that the intellectual property rules promoted by the pharmaceutical industry are at odds with the human right to health. If implemented the report’s recommendations will go a long way towards ensuring all people have access to affordable quality medicines.” Winnie is, though, confused — at least if the press release is anything to go by. The three examples in that press release are, in fact, linked by having nothing to do with patents, intellectual property or trade rules.
The EpiPen example
The EpiPen is an injector device for people with life-saving allergies that has been at the centre of a media storm in the US. It’s not sold at a hyper-inflated price by a wicked big pharma company but by Mylan, one of those generics companies that has long been the darling of a certain kind of ideological health activist. Mylan, in fact, donated a lot of money to the Clinton Foundation, to support the Foundation’s efforts to get generics companies the right to copy and sell advanced HIV medicines, big business for Mylan.
The problem is not that Mylan has a patent on the EpiPen — the product is old and any patents expired long ago. It’s that the product used to be cheap so, competitors were slow to start trying to sell rival versions in the US. As Mylan jacked up prices, would-be competitors (among them a big pharma company) hit various domestic regulatory hurdles.
Much worse things have happened in the generic — and wholly patent-free — market for old chemotherapy drugs in the US. The problem is similar, a historic lack of a profitable market. A 2012 academic commentary concluded, “Manufacturers have little incentive to produce drugs with low profit margins and often shift their resources to drugs for which higher profit margins can be anticipated.”
The problem is not big pharma or IP, it is a marketplace that needs to be made more efficient. Many members of the panel have never worked in a business environment so this isn’t what they’re comfortable recommending
Ebola, Zika and Yellow Fever
Which brings us to the panel’s analysis of infectious disease threats. Andrew Witty, a panel member, summarises it neatly in a commentary published with the report. He says, “the Report states that ‘Ebola and Zika are a stark reminder of the need for delinkage’. In fact the lack of treatments for these outbreaks has nothing to do with the market-driven IP model. The lack of preparedness was caused by many factors, not least of which is that these diseases were not regarded as global health priorities by the WHO or others, as the report acknowledges. There is no evidence that delinkage would have made a difference to readiness for these outbreaks.”
Witty could have added that there were several vaccines in development against Ebola ten years ago but they stalled for two reasons. The most important is that it was impossible to conduct clinical trials because there were no Ebola infections. If no-one was at risk, it was impossible to assess whether a vaccine reduced the risk of contracting Ebola. Even the most publication-driven of the academic vaccine research community could no longer justify running yet more tests on hapless monkeys: the researchers needed at-risk humans. I might have rounded up boy band members or Daily Mail readers, vaccinated half of them and then exposed them all to Ebola. If some of the vaccinated ones had survived, they would finally have done something useful for society. I’m told, though, that this would not be ethical.
As soon as there was an Ebola outbreak, the vaccines were rushed, by big pharma companies, into highly ethical and very innovative trials. Two seem to work well. They will probably be licensed soon.
The other reason that work on vaccines, diagnostics and therapeutics for Ebola stalled was that funding from state sources slowed in the first decade of this century. It ceased to be a political hot topic so research waned. That’s what happens when politicians decide which health priorities to fund.
The US Congress sought to involve the private sector by promising to buy a $1 billion stockpile of vaccines and drugs for Ebola when they had been developed. Sadly, no-one else promised to buy anything. Many African countries continued to fritter away money on subsidised airlines, fuel subsidies and other perks for the élites. The Center for Global Development estimates that Nigeria alone underspends on health by about $11 billion a year. Imagine if some of that had been promised to companies working on Ebola diagnostics. That, of course, is outside the Panel’s remit too.
On Zika, the report says, “prior to 2015, Zika was an obscure virus that received little attention from the global community.” There are, in fact, at least three vaccines in development against Zika. One comes from a government-funded programme; two are the products of the pharma industry. All were underway long before 2015.
There is a high-profile Yellow Fever vaccine shortage because the state-owned supplier in Brazil has failed to supply the vaccines it promised. As UNICEF put it delicately earlier this year, “In 2015, the supply situation should have improved with the return of one manufacturer from temporary WHO suspension. However, the vaccine could still not be supplied to UNICEF due to lack of compliance with UNICEF requirements.” There is a little more detail in UNICEF’s 2015 report, “The loss of a Good Manufacturing Practice (GMP) license by one manufacturer for one of its facilities also led to a reduction in availability and suspension of WHO prequalification.” Despite the hype in the press release, Yellow Fever is not actually mentioned in the report. Maybe it got edited out by Celso Amorim, a panel member and a tireless booster of the Fundação Oswaldo Cruz, the Brazilian parastatal which owns the vaccine producer in question
The Panel’s Report sets out the issue that will be discussed at the General Assembly this week. “AMR represents a fundamental commercial dilemma for private sector companies: developing new antibiotics is often an expensive, long-term proposition. The resulting medicines, to retain their power and effectiveness, must be used judiciously and for a limited time, which limits the market potential and curtails profits.”
I admit that I didn’t do well in economics but it seems to me that a solution might just be to pay a lot for new, rarely-used antibiotics. Paying a lot for cancer medicines is what turned multiple myeloma from a death sentence to a manageable chronic condition; paying quite a lot is what has given people with HIV a normal life expectancy. Both are bargains because keeping people with those diseases healthy is cheaper than managing their slow deaths in expensive hospitals.
According to the US National Institutes of Health, sepsis (the most serious consequence of an uncontrolled infection, usually caused by bacteria) is the most expensive condition treated in U.S. hospitals, costing more than $20 billion in 2011. So, charging a lot for even a short course of medicines to avoid it would, presumably, be fine.
Prices that are fine in the US would not be fine in the Central African Republic so there needs to be a way of getting these new antibiotics to properly-qualified doctors in suitable hospitals with access to adequate diagnostics in poor countries. Sadly, given what most poor countries choose to spend on health, this won’t be a big issue.
Instead of decent rewards, the report suggests an extraordinarily complex binding Research and Development Convention “that delinks the costs of research and development from end prices to promote access to good health for all.” A major focus should be antimicrobial resistance, it says. We’ll look at this suggestion in more detail in a future post but, for now, think about how well some international conventions work. Saudi Arabia, for example, has been elected to the UN Human Rights Commission. It chairs a panel of independent experts linked to the Commission. In the week Saudi Arabia was appointed to the chair, it advertised for eight new executioners. It is that very Commission that will feature this report prominently as part of a special session at its meeting in March 2017. For all their faults, I think I’d rather take my chances with big pharma
In the interests of transparency, we should say that Hyderus works for all sorts of clients with an interest in this report: companies, foundations, governments, international NGOs, multilateral institutions, professional bodies, trade associations and universities. I’m confident that most will disagree with most of what I have to say. The views in this piece are, thus, entirely personal
The long-awaited UN report on access to medicines was launched this week. We’ll review it in more detail over the coming weeks.
Our sister site, Health Issues India, has a marvellous special section reviewing access issues in India from every perspective. It includes interviews, case studies and features by several of India’s leading journalists.