E-DRUG: Colombia's decision on compulsory license & access to LPV/r
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dear e-Druggers,
The Colombian ministry of health has decided not to declare access to
HIV/AIDS medicine lopinavir + ritonavir a matter of public interest.
The ministry's decision halts government consideration of a
compulsory license request, initiated in July 2008, that would
introduce price-lowering competition with Abbott's Kaletra.
Colombian networks of people living with HIV/AIDS are criticizing the
health ministry's process in considering the request – which seems to
have deeply engaged Abbott while excluding treatment advocacy groups
and the organizations that filed the request – and are describing
the decision as a missed opportunity to work toward the U.N.
Millennium Development Goals.
The government argues insurers are required to provide Kaletra to
those who need it, and so price is not a primary factor impeding
access. But Kaletra's high price passes on unnecessary costs to
consumers, taxpayers and people living with HIV/AIDS, and diverts
healthcare investments from critical priorities – for example, access
to other needed medicines and universal HIV/AIDS coverage. Colombian
civil society groups also note high medicine prices exacerbate
inefficiencies and failures in the health and insurance systems, and
make it too expensive to find alternatives when coverage failures do
occur – therefore prices do impede access to treatment.
The decision also follows a government order establishing maximum
prices for Kaletra at $1,067 per person, per year for the public
sector, and $1,591 for the private sector, down from around $3,400
and representing average price reductions around 54% - 68%. This
price ceiling is a direct result of the compulsory license request,
and according to government figures will save the healthcare system
about $10.2 million U.S. per year.
Price, then, clearly does matter to the Colombian government – just
not enough to challenge Abbott's monopoly. At least, in the
ministry's words, "for the moment."
The reductions are significant, represent an overdue challenge to
Abbott's pricing practices, and signal a positive shift in civil
society groups' ability to influence health policy.
But the health ministry seems to be treating monopoly price reduction
as a substitute for competition. It is inadequate in this regard.
New Clinton Foundation agreements with three generics firms offer LPV/
r for $470, and Peru recently obtained LPV/r from Eske Group – a
Cipla affiliate – for the low price of $396. Colombia will continue
to pay considerably more than a competitive market would bear.
Further, Colombia's new public sector price – roughly equivalent to
Abbott's monopoly price in other regional markets – applies to only a
small percentage of Colombia's market (possibly, it seems, even less
than 8%). In practice, Colombia will continue to pay more than its
neighbors, even those that share the dilemma of an Abbott monopoly.
We've heard no official word as to whether Abbott has agreed to sell
at Colombia's new price. Competition remains the only way Colombia
can access the far better generics prices, and ensure prices continue
to fall with time. Deep cost savings enable health programs to scale
up treatment.
To that end, the Colombian HIV/AIDS groups have called for
supervision of savings obtained through the price reduction, and
concomitant investments in sectors of the medicines provision system
most prone to failure.
Colombian treatment advocates richly deserve congratulations, and
thanks, for significantly reducing Abbott's prices and shaking up
Latin America healthcare politics. They're not content with this,
though – the groups are already investigating avenues of appeal and
further proposals to introduce generic competition.
Below, I've pasted a Scrip News article (in English) on the
ministry's decision. Note the Scrip article states, "INVIMA, the
medicines regulator, rejected applications from Ranbaxy and Focus
Pharmaceuticals to register generic versions of the combination
product." It's worth mentioning INVIMA stated its reason for keeping
the generics off the market was Abbott's claimed patent. But
Colombia has no linkage provision in its law – marketing approval in
Colombia should, by law, be a pure assessment of safety and efficacy,
separate from any private patent disputes. The pharmaceutical
industry's monopoly politics are touching an agency where they do not
belong.
The Colombian civil society groups' analysis and press release (in
Spanish) can be found here:
http://www.miradalatina.org/joomla/
An archive of articles on the compulsory licensing request (in
Spanish) can be found here:
http://www.miradalatina.org/joomla/index.php?
option=com_content&task=view&id=438&Itemid=128
Previous Essential Action statements on the Colombia case are
available here, here, here and here.
We have on file the Colombian health ministry's decision (Resolución
001444) and a number of other documents relevant to the license
request. We will look into posting these online. In the interim,
please contact us to obtain documents, and with any questions.
Thank you,
Peter Maybarduk
Essential Action
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Colombia says no to Kaletra compulsory licence
01 June 2009
Francesca Bruce
The Colombian government will not be declaring Abbott's
antiretroviral Kaletra (lopinavir plus ritonavir) to be of public
interest, leaving the patent on the product intact until 2016. Civil
society has accused the government of putting politics first.
The decision comes soon after the government set a price ceiling for
Kaletra (scripnews.com, May 13th, 2009). NGOs had been pushing for
the government to declare the drug to be of public interest and to
issue a compulsory licence, claiming that Kaletra's high price barred
access to the drug (scripnews.com, July 29th, 2009).However, the
government rejected this, largely on the grounds that all patients
who required Kaletra were covered by some sort of health insurance
and did not have to pay for the medicine. This was also one of the
main arguments put forward by Abbott, according to the government in
its justification for the decision.
Antiretrovirals (ARVs) are included on Colombia's essential medicines
list, and all health insurers – public and private – must offer these
drugs. However, in Colombia there is no single ARV purchaser and
different public and private institutions compete within the national
health system. This leads to wide price discrepancies throughout the
country, say civil society organisations.
The cost of the drug creates barriers to access, while having health
insurance does not automatically give access to the ARV, maintains
RECOLVIH, which represents the organisations petitioning for a
compulsory licence. For example, problems arise when HIV/AIDS
patients lose their jobs and also when there are delays in provision.
The high level of stigma and bureaucracy involved in accessing ARVs
can also deter patients from following their regime.
The government also went on to say that the main problems hindering
access were to do with failures within the health system, including
reaching vulnerable populations or providing adequate diagnosis. Such
issues did not merit declaring the drug to be of public interest, it
said.
Added to this, the financial impact of declaring the drug to be of
public interest was unclear and difficult to calculate, the
government said. However, this was poor reasoning, Peter Maybadurk, a
spokesperson for the NGO Essential Action, told Scrip. "The
government has decided not to save more money, but to protect
Abbott's monopoly," he said. Although RECOLVIH estimates that the
price ceiling will save the government around $10 million each year,
greater savings could have been made through introducing competition,
he said. "Competition could lead to even lower prices, which could
free up more resources to eliminate other barriers," he added.
RECOLVIH accuses the government of ignoring societal needs and basing
its decision on politics. Colombia is in the middle of negotiating a
free trade agreement with the EU, alongside Peru and Ecuador. It is
also waiting for the US to ratify a bilateral FTA.
Moreover, the civil society groups behind the move were not given the
chance to participate in the process, said Mr Maybadurk. "During the
whole process, which began a year ago, the government never allowed
HIV/AIDS patients to participate in the negotiation process to arrive
at the price recently negotiated," says RECOLVIH. Abbott's
involvement in the process is unclear.
Abbott declined to comment.Kaletra is patented in Colombia until
December 2016. INVIMA, the medicines regulator, rejected applications
from Ranbaxy and Focus Pharmaceuticals to register generic versions
of the combination product.
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