E-DRUG: Next steps in Colombia: time for a compulsory license
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Last week we reported that drug giant Abbott Labs had finally acceded
to a Colombian order to cut the price of HIV and AIDS drug Kaletra
(lopinavir+ritonavir, or LPV/r). This is a victory - and a
beginning. Now it's time the government follow with simple measures
that will bring drug prices to competitive levels.
Colombia recently declared a Social Emergency “to avert the grave
crisis affecting the [financial] viability of the General System of
Social Security in Health.” The declaration has public health
advocates questioning why their government has yet to use available
cost-controlling tools.
On February 8, NGO representatives Francisco Rossi, Luz Marina
Umbasia and German Holguin wrote to suggest the ministry of health
reopen a compulsory license request for Kaletra. A compulsory
license would authorize price-lowering generic competition with
Abbott's patented product.
The letter presents three concerns:
* Price. Even under the government order, Kaletra's Colombia price is
several times greater than available generic prices. The order sets
prices at $1067 for the public sector and $1591 for the private
sector. But generic LPV/r is now commonly available at prices well
under $500, including a low of $396 in neighboring Peru. Only
competition can take prices to a comparable level in Colombia.
* Increased use. The number of people taking Kaletra in Colombia has
quadrupled over the past five years, including prescriptions for
first-line treatment, even though Colombia's treatment guidelines
list Kaletra as a second-line drug - raising costs and questions
about Abbott's aggressive marketing practices.
* System disorder. High drug costs exacerbate failures in Colombia's
complex and imperfect health system, and increase incentives for care
providers to pass costs on to patients - from coverage gaps to
treatment exclusion, from partially-filled prescriptions to stockouts.
On February 16, the Archbishop of Bogota, Cardinal Pedro Rubiano
Saenz, wrote to Colombian President Alvaro Uribe in a letter joined
by Colombian NGOs and the President of the Colombian Medical
Federation. The Archbishop disagreed with government assertions that
the health system crisis was unforeseeable or the result of a sudden
acceleration in claims. Rather, cost burdens have grown consistently
since at least 2003, and drug monopolies are a key factor.
Citing cost figures and provisions of law, the Archbishop suggested
the government make use of three policy tools "inexplicably" left out
of the government's recent Legislative Decrees:
* Permit the registration of generic versions of new medicines.
Colombia's data exclusivity law gives multinationals control over
test data for many new medicines, keeping affordable generics off the
market. But Article 4(c) of the same law allows for exceptions to
protect public health - a basic protection the Colombian government
has yet to use.
* Issue compulsory licenses on patented medicines, starting with
Kaletra.
* Shop on the world market for best prices. Overturn a 1995 decree
that has kept Colombia from using parallel importation since the
inception of the TRIPS Agreement. In other words, import medicines
that are already on sale in other countries, at prices often several
times lower than prices in Colombia.
Meanwhile, Abbott told the National Medicines Pricing Commission
(CNPMD) that its compliance with the price order "does not imply our
agreement with it." But is Abbott getting the best of Colombia anyway?
The government intends its price order to bring Colombia Kaletra
prices in line with other countries in the region. (Putting aside,
for the moment, the better generic prices available regionally.) But
countries like Brazil and Ecuador rely primarily on public purchases
for HIV treatment. Colombia relies on many private purchasers, as
well - likely skewing the average price Colombia pays for Kaletra
toward the higher private sector price of $1591. In this case,
Colombia will still pay more for Kaletra than its neighbors.
Colombia's President Alvaro Uribe recently complained that medicines
in Colombia are "among the most expensive on the continent." The
Technical viceminister for health commented, "prices have risen a
great deal, especially for medicines that have no competition."
But what will Colombia do about it?
Peter Maybarduk
Public Citizen
See:
http://www.ifarma.org/web/?p=472
http://www.portafolio.com.co/economia/economiahoy/iglesia-pide-
competencia-para-bajar-precios-de-medicinas-en-colombia_7298011-3
http://www.eltiempo.com/colombia/politica/ARTICULO-WEB-
PLANTILLA_NOTA_INTERIOR-7143350.html
peter maybarduk <peter.maybarduk@essentialinformation.org>