A highly influential and long-awaited report from the United Nations has attacked the market-based R&D approach used by the biopharma industry, but an industry group has hit back at its “narrow focus.”
What is it attacking? Well, yesterday the UN published the results of its high-level panel, set up last year by UN Secretary-General Ban Ki-moon, as part of the group’s search to find better ways of addressing health needs around the globe.
In recent months, this has been made the more urgent by Ebola and more recently the rise of the Zika virus, as well as the greater spotlight on pricing, notably in the U.S., with Mylan, Valeant and others coming under increasing pressure to lower the prices of their meds.
The UN’s report didn't whitewash these issues; in fact, it went further than many thought it would, essentially blaming the market-based approach used to fuel the industry and its R&D as the primary culprit for high prices.
Its report wants to delink R&D costs and drug prices, with a particular focus on doing this with diseases that impact the poorest countries, as well as the need to hunt for new antibiotics in the wake of antimicrobial resistance.
The panel is urging Ban Ki-moon to kick-start “negotiations for a binding R&D Convention that delinks the costs of research and development from end prices to promote access to good health for all.”
Clinical trial transparency, which is becoming a bigger issue in the U.K. and Europe with pro-transparency lobby groups, such as the BMJ and GSK-backed AllTrials campaign, was also high on the agenda--as well as greater transparency on just what it costs to develop a new medicine.
Figures on this vary wildly and depend on who you talk to, but the cost of bringing a medicine from preclinical to market has been estimated, on average, at anywhere between £200 million and more than $4 billion. Biopharmas are notoriously secretive when it comes to disclosing the actual cost for an individual medicine, with the implication being that it may be charging a major premium that goes well beyond recouping its R&D costs.
The panel also wants disclosure on the real prices paid by insurers and governments for drugs, after discounts--again something that the industry is as a whole reluctant to share.
But pharma is not happy about the report, with Joseph Damond, SVP of international affairs at the Biotechnology Innovation Organization, saying “While we are still reviewing the full report released today by the UN High Level Panel on Access to Medicines, it is clear from an initial review that this report ignores the real issues that impact or delay delivery of innovative treatments and cures throughout the developing world, while focusing on policy recommendations in the one area--intellectual property--that would actually undermine ongoing research and development by hundreds of companies, universities and researchers.
“The Panel’s report fails to recognize the complexity around biopharma research and development and the many efforts already taking place to advance access to care. Without the innovation incentivized through strong intellectual property protections the costly and challenging work will simply not take place.”
Damond added that the authors: “Chose a narrow focus on issues that are tangential, and developed policy recommendations that are actually detrimental to research and development of new cures and treatments.”
Even one of the panel members, the outgoing Glaxo ($GSK) chief Sir Andrew Witty, disagreed with his UN peers, saying he had serious doubts about how well the R&D Convention idea would work in practice.
Other panel representative members came from across academia, health activism and industry, under the leadership of Ruth Dreifuss and Festus Mogae, the former presidents of Switzerland and Botswana.
Dreifuss said: “I am aware of all the hopes, and I cannot say we responded to all of them but the report will allow some steps forward. The most important thing is to act.
“There are some great priorities that are neglected by the traditional way that innovation and access is dealt with--important challenges such as neglected diseases like Ebola and Zika, which didn’t mobilise enough innovation.”
She says that the problem of drugs pricing affects rich countries as well as poorer nations. “We see this in oncology and with hepatitis C--because of the […] financialisation of the pharmaceutical industry they are not available for all in need. There is a trend to ration some [drugs] and this idea of a two-tier medicine is just unacceptable.”