[Ip-health] Press Release: Coalition for Affordable T-DM1 Asks UK Government to grant compulsory licenses on Roche breast cancer drug

Thiru Balasubramaniam thiru at keionline.org
Wed Sep 30 20:48:30 PDT 2015


Press Release: Coalition for Affordable T-DM1 Asks UK Government to grant
compulsory licenses on Roche breast cancer drug

Submitted by James Love on 1. October 2015 - 3:51

Press Release: Coalition for Affordable T-DM1 Asks the UK Government to
Employ Crown Use Authority to Lower Price of Expensive Cancer Drug sold by


Diarmaid McDonald
email: accessdiarmaid at gmail.com

Susannah Markandya
email: s.markandya at gmail.com

Zack Struver
email: zack.struver at keionline.org
Cell: +1.914.582.1428
Office: +1.202.332.2670 (between 2:00 PM and 10:00 PM BST)

London, 1 October 2015 — The Coalition for Affordable T-DM1, a group of
cancer patients, doctors, and access to medicines advocates, sent a letter
today to Secretary of State for Health Jeremy Hunt asking that the U.K.
Government authorise the manufacture or importation of generic versions of
the expensive breast cancer treatment T-DM1, also known as trastuzumab
emtansine or by its trade name Kadcyla.

A copy of the letter is available here:


On 8 August 2014, the National Institute for Health and Care Excellence
(NICE) decided that T-DM1 should not be made available on the National
Health Service (NHS), citing its extraordinarily high cost. NHS patients in
England continued to get access to T-DM1 through the Cancer Drug Fund
(CDF), but, following a review sparked by huge budget overruns on expensive
medication, it was decided on 3 September 2015 to de-list T-DM1 from the
Cancer Drug Fund. After 4 November 2015, no new patients will be able to
access T-DM1 on the NHS. NICE estimates that 1,500 women in the UK could
benefit from treatment with T-DM1 every year.

Concerned that the high price of T-DM1 presents an undue access to barrier
for patients with an aggressive form of breast cancer, the Coalition for
Affordable T-DM1 formally asked the Government to employ its authority
under the Crown Use provisions in the U.K. Patents Act 1977 to allow for
the use of T-DM1 patents to import or manufacture generic versions of T-DM1
without the permission of Roche, subject to affordable compensation.

T-DM1 is used to treat late-stage breast cancer patients who test positive
for human epidermal growth factor receptor 2 (HER2), a protein that causes
an aggressive form of breast cancer. Roche owns the patents on T-DM1, and
charges extraordinarily high prices. A year of treatment for the average
patient costs £102,405, roughly 3.9 times the 2014 UK per capita income of

The letter from the Coalition for Affordable T-DM1 to Secretary of Health
Jeremy Hunt states, “The future affordability of T-DM1 matters, for both
patients and taxpayers, and every journey has to start somewhere. But
perhaps more importantly, the measures described in our proposal, embraced
in part or more extensively, would be a forward-looking model for
addressing the challenges of ensuring universal access to medically
important drugs, without putting patients at risk. We propose an approach
that addresses the effects of a drug’s monopoly, when prices are
unreasonable and/or unaffordable as a result, and which creates a more
sustainable model for innovation and access going forward, as the
population of the UK ages, and medical science provides new hope for
treating disease.”

The following are quotes from several of the persons signing the letter to
Secretary of Health Jeremy Hunt. To arrange interviews please contact Zack
Struver using the details at the top of this release, or contact the
individuals directly using the details below.

Philippa Saunders, Union for Affordable Cancer Treatment

“The time has come to challenge pharmaceutical manufacturers charging ever
higher prices for important medicines because they can. Roche's Kadcyla
(Trastuzumab emtansine or T-DM1) could benefit 1,500 women with breast
cancer in the UK annually, but the cost - £5,908 per 3 week cycle, or
£102,405 per patient per year - is unaffordable by the NHS or by ordinary
patients. UACT urges the government to use its legal entitlement to issue a
compulsory licence for Kadcyla, which would open the door for the
manufacture of biosimilar versions and. thus reduce the price through

Dr. Manon Ress, Knowledge Ecology International
Contact: manon.ress at keionline.org
+1 (202) 332-2670 (US-based)

“I am a stage 4 breast cancer patient who is alive today and leading an
active life because I have access to T-DM1. The Roche price for T-DM1 is
excessive, and a barrier for patients. By being proactive, and standing up
for patients, the UK government has the power to change this. It can make
the drug more affordable, and more available to patients facing a painful
and unnecessarily early death. If the UK government begins a serious review
of this petition, it instantly improves its short term bargaining position
with Roche, and it begins to map out a future where cancer patients have a
better chances to get the drugs they need.”

Dzintars Gotham, National Coordinator, Universities Allied for Essential
Medicines UK

“Women with breast cancer will be devastated to discover that Kadcyla,
which could extend their lives by months, is not available in England
because of the inordinate price demanded by the manufacturer. When they are
approaching the end of their life, they will reasonably expect that all
options for their treatment have been exhausted. This includes options for
procuring the best medicines available. Nobody should accept that we are
out of options for getting Kadcyla until Crown Use has been considered and
attempted by the Department of Health. Our proposals are feasible, are
written by experts, and the alternative is doing nothing. As a medical
student, I hope that the Department of Health does not ignore these legal
provisions that can be used to guarantee access to medicines in the UK.
Those of us who have seen cancer in our work and in our families will not
be satisfied with simply giving up when a manufacturer drives an
excessively hard bargain.”

Dr. Tido von Schoen-Angerer, Board Member, KEI Europe

“The UK government can take simple steps to get women with breast cancer an
affordable version of the life saver TDM-1, priced out of reach by Roche.
It is the obvious thing to do, so we urge the government to move fast.”

Diarmaid McDonald
Contact: accessdiarmaid at gmail.com

“Drug prices will not go down unless governments take action to bring them
down. It is very likely that women will die before they have to as a result
of Roche's pricing policy on Kadcyla. The UK should be pursuing every
credible opportunity to secure a fair price for this breast cancer
treatment - including this proposal to produce a generic version of the
treatment - as well as exploring the broader reforms to pharmaceutical R&D
policy that would tackle the root cause of these high prices.”

Chris Redd, Peninsula College of Medicine and Dentistry

“This proposal achieves something subtle but significant: it creates a
choice. The status quo is no longer simply the default, it becomes an
explicit decision which must be justified. It becomes a decision with which
the British public can hold the government to account.

There are 1,500 UK citizens living with breast cancer right now who could
be kept alive by this medication. The solutions are all there in the
document. The only question that remains is whether our government is more
interested in protecting its citizens or the shareholders of a
multinational drug company.

Our drug system has not been there forever, and it was not chosen because
it is the most effective way to make medications. It was chosen because it
was the best way for drug companies to make money. An unfortunate
side-effect of this system, is that millions of people have died from lack
of access to medicines. People everywhere are suffering, simply because of
their financial capacity. Is that right? At moments like this, we have the
chance to change things, to improve them. It's simply a question of public
and political will. We have to ask ourselves 'what sort of world do we want
to live in?”

Susannah Markandya, Barrister
Contact: s.markandya at gmail.com

“The campaign seeks to secure a life-saving treatment for breast cancer
sufferers whilst protecting the limited resources of the NHS. It also goes
further than that: the [Coalition's] recommendations would give the
government a proper strategy for making these sorts of drugs available to
patients in a financially sustainable way.”

Sandeep P. Kishore, MD/PhD, President of Young Professionals Chronic
Disease Network

"The World Health Organization added 16 modern cancer treatments to the
Essential Medicines List in 2015 and called upon governments and
pharmaceutical manufacturers alike to ensure treatments are affordable to
patients the world over, from the UK to Uruguay. We look forward to the
UK's use of crown use provisions to overcome obstacles to treatment and
stand with patients -- now, not decades from now. T-DM1 is a life-saving
medicine and should be affordable now, not decades from now. Tackling
cancer is a social justice issue and deserves to be treated as such."

For comments from Roche, contact:

Roche UK Media Relations
Phone: +44 01707 367807

For additional information about the issue, see the Frequently Asked
Questions here:


More information about the Ip-health mailing list