[Ip-health] Pharmalot: Colombia to Novartis: Lower the price of your cancer drug, or else

Zack Struver zack.struver at keionline.org
Wed May 18 09:36:02 PDT 2016


<SNIP>“The Colombian health minister is raising the right question,” said
Jamie Love of Knowledge Ecology International, a nonprofit group that
tracks intellectual property and access to medicines issues. “What can
governments do when prices are too high?

“Rather than put the patients at risk, with restrictive conditions on
reimbursements and access, Colombia has put the monopoly at risk,” he
continued. “This is why Novartis, Senator Hatch and PhRMA (the
pharmaceutical industry trade group) are so concerned. The Colombian
precedent should be followed not only in Latin America, but also in the
US.”</SNIP>

Colombia to Novartis: Lower the price of your cancer drug, or else

By ED SILVERMAN @Pharmalot
MAY 18, 2016

The Colombian government and Novartis appear to be headed toward a showdown
over the widely used Gleevec cancer treatment. In the latest twist, Health
Minister Alejandro Gaviria is giving the drug maker a few more weeks to
reduce its price for the medicine, or he will issue a so-called “compulsory
license” that will allow generic companies to sell lower-cost versions.

“For us, it’s a question of survival,” he told the Associated Press.

The ultimatum comes amid heightened tension over the government’s plan to
widen access to the medicine. After Gaviria last month indicated he would
issue a license to serve the public good, the Colombian Embassy in
Washington DC sent him a letter suggesting that US government support for a
peace initiative and a free-trade treaty may be jeopardized.

A similar letter was sent to another Colombian government minister. The
Obama administration recently pledged $450 million for assistance in
cementing a peace deal with Marxist rebels and also signaled a willingness
to allow Colombia to join the proposed Trans-Pacific Partnership trade
zone. Colombia and the United States already have their own trade agreement.

The warnings were prompted after embassy officials met with staff from the
Senate Finance Committee and the US Trade Representative’s office. The
Senate committee is headed by Orrin Hatch, a Republican from Utah who has
close ties to the pharmaceutical industry. And the US Trade Rep recently
maintained Colombia’s status on its annual list of countries that fail to
sufficiently enforce patent rights.

Over the past four years, Colombia has tried to negotiate a lower price but
without success. The drug maker rejected a proposal to cut the price to
less than half of the currently regulated price, which the Associated Press
noted would still be above what generics cost before they were banned. In
2012, a Colombian court awarded Novartis an exclusive patent on one of two
forms of the drug.

For its part, Novartis has consistently maintained that it is “actively
seeking a resolution” to the dispute, while arguing that compulsory license
should not be used to force price negotiations. The company has also
insisted that the price for Gleevec in Colombia is subject to government
controls and that generics are available in the country.

The episode has quickly become another heated example of the clash over
intellectual property rights and access to medicines between the
pharmaceutical industry and cash-strapped governments. Global drug makers
argue that compulsory licenses should be reserved for public health
emergencies and as a measure of last resort, not a tool to use in
negotiations for a lower price.

But patient advocacy groups counter that a health emergency is “not
necessarily” required to issue a license, according to the World Trade
Organization. The right to issue compulsory licenses, which allow a generic
company to make a brand-name medicine without the consent of the company
holding a patent, was memorialized in a WTO agreement.

Colombia’s health care system guarantees patient access to all approved
drugs, and the budget is straining after years of price hikes from drug
manufacturers, the Associated Press explained. In 2009, the government
declared a public health emergency after spending rose tenfold in a few
years. Colombia would save approximately $12 million annually by issuing a
license for generic Gleevec production.

To Gaviria, the lobbying pressure reflects anxiety among global drug
makers. “They’re very afraid that Colombia could become an example that
spreads across the region,” he told the news service.

One consumer advocate, who supports the Colombian health ministry in its
quest to obtain a lower price or a license, agreed with his assessment.

“The Colombian health minister is raising the right question,” said Jamie
Love of Knowledge Ecology International, a nonprofit group that tracks
intellectual property and access to medicines issues. “What can governments
do when prices are too high?

“Rather than put the patients at risk, with restrictive conditions on
reimbursements and access, Colombia has put the monopoly at risk,” he
continued. “This is why Novartis, Senator Hatch and PhRMA (the
pharmaceutical industry trade group) are so concerned. The Colombian
precedent should be followed not only in Latin America, but also in the US.”
​​

-- 
Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
keionline.org



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