UK Health Minister Filibusters Bill To Use Off-Patent Drugs To Provide Effective New Treatments At Low Cost
from the and-why-on-earth-would-he-do-that? dept
Here on Techdirt we often write about pharmaceutical companies doing what they can to string out their drug monopolies as long as possible, sometimes resorting to quite extraordinary approaches. But whatever tricks they use to extend their monopolies, one day those end, and at that point generic manufacturers can make the drug in question without needing a license. You'd think governments would be delighted by the downward pressure this exerts on prices, since it means that they can provide life-changing and life-saving treatments much more cheaply. But last week, we had the bizarre spectacle of a UK government health minister filibustering a Bill that would have encouraged doctors to prescribe more off-patent medicines. As the Independent newspaper reports:
A Conservative health minister has deliberately blocked a new law to provide cheap and effective drugs for the [UK's National Health Service] by championing medicines whose patents have expired.
The Off-Patent Drugs Bill attempted to address a particular problem that off-patent drugs suffer from. Although anyone can manufacture and sell them for their original purpose, more innovative uses require a new license for that application. Since the drugs are off-patent, the profit margins are lower, and generic manufacturers are reluctant to pay for the re-licensing process. An article in the online law journal "Keep calm and talk law", reporting on an earlier unsuccessful attempt to have off-patent drugs used more widely, gave the following examples of how cheap drugs could have a major impact:
Alistair Burt spoke for nearly half an hour to "filibuster" the proposed Off-Patent Drugs Bill, a plan that had cross-party support from backbenchers.
Simvastatin was originally licensed for treating individuals with high cholesterol and although recently shown to slow brain atrophy in later stages of multiple sclerosis by over 40 per cent, it has not been relicensed for that purpose. Further, Lixisenatide and liraglutide, two common diabetes drugs, have been found to have a use in the prevention of Alzheimer's but is now also off patent.
The Bill in question would have required the UK government to carry out the re-licensing, thus allowing generic manufacturers to market the cheap off-patent drugs for new treatments. But the UK government minister rejected this approach, saying "there is another pathway", without spelling out what that might be. Perhaps he had in mind the possibility of prescribing off-patent drugs "off label", which in theory is an option open to UK doctors. But doing so means they would assume the legal responsibility for both negligent and non-negligent harm to the patient -- something that many are understandably reluctant to do. However, the "Keep calm and talk law" article offers a possible solution to that problem:
the introduction of a charitable organisation which would insure doctors against any negligence claims resulting from the prescription of specified off-patent drugs for unlicensed purposes. This could reassure doctors enough that they would more readily prescribe some useful off-patent drugs such as the examples given above. Although much research would still need to be done into whether a charity such as this could work in reality, in principle this is a solution which seems sensible.
It's possible that the UK government minister had precisely this approach in mind when he unceremoniously blocked a Bill that was trying to save both lives and money. But it's hard not to suspect that his "another pathway" might turn out to involve lots more lucrative pharma patents instead.