[Ip-health] IPLeft Statement Roche’s Proposal of Compassionate Access Programme for HIV/AIDS Patients in South Korea

[Heesob Nam]

IPLeft Statement Roche’s Proposal of Compassionate Access Programme
for HIV/AIDS Patients in South Korea

Roche contacted us on February 25, 2009 and informed of its plan to
provide Fuzeon for HIV/AIDS patients in Korea under the title of
“Compassionate Access Programme.” In the conversation with us, Roche
pledged to supply Fuzeon to patients free of charge through the Korea
Orphan Drug Center. Fuzeon has been completely out of reach for
patients for more than four years since its official marketing
approval in Korea. The main reason is Roche’s policy to maintain the
price of Fuzeon at the same level as in the advanced seven countries.
Korean government approved on November 2004 the importation and
marketing of Fuzeon at a price $18,000 per patient per year. However,
Roche denied accepting the price and demanded higher price of $22,000.
During the negotiation with the Korean government, Roche has persisted
in the price increase, and has never put the medicine on the market.

Now Roche changed its four-year-long tactic and committed to make
Fuzeon available for needed patients. In the light of urgent needs of
patients, we welcome the Roche’s decision. This is a positive step
forward in ensuring access to affordable treatment. No doubt, this
result stems from the public pressure and worldwide actions organized
by diverse groups including AIDS activists and public health
communities.

Yet we point out that the programme suggested by Roche is far from the
ultimate solution to resolve the problem of lack of access to
affordable treatment. As the accessibility to Fuzeon is entirely in
the hand of Roche, our concerns remain about an unexpected halt or
threat of halt, or misuse of the programme proposed under the
misleading title of “Compassionate Access Programme.” By definition,
the “compassionate access programme” refers to a programme intended to
facilitate early access of drugs under development or a measure to
provide patients with an experimental therapy. Neither of these
definitions applies to the suggested programme. Fuzeon was approved in
2004 and its global net sales already surpassed the arguable R&D cost
(800 million USD), amounting to one billion USD for five years from
launch.

Therefore, we urge Roche to commence the programme immediately and run
it in transparent, trustworthy and consistent manners. We remember
that the executive staffs of Roche Korea alleged last year “no drugs
for patients who are unable to pay for the drug”, and “saving lives is
none of our business.” The suggested programme can be welcomed only
when the supply meets the patients needs in continuous and reliable
ways and with putting ‘saving lives’ before ‘making money.’

Further, the suggested programme shall not be misused for the purpose
of diverting public attention and hiding a real cause of the problem.
The denial of providing Fuzeon for patients cannot last for several
years without Roche’s position of a sole supplier, which is backed by
a patent system. In addition, under no circumstances, the suggested
programme is misused to avoid granting of a compulsory license which
we requested last year on December 23.

Finally, we call on Roche to expand the suggested programme to cover,
not only the Korean patients, the patients around the world those who
are denied affordable treatment and their rights to life. The first
step to Roche has to take is to make public in detail the programme of
its own initiative and then to look into areas where the programme is
to be expanded.

February 27, 2009

IPLeft (Intellectual Property Left)
www.ipleft.or.kr