The tense battle between drug makers and patient advocates over patents and access to medicines is moving to a new venue. The latest clash is taking place in Colombia, where a government committee late last month recommended that a compulsory license should be issued for the Gleevec cancer treatment sold by Novartis (NVS).
A compulsory license allows a company to make a patent-protected product without the consent of the patent holder.
In announcing its decision, the committee explained that doing so would be in the public interest by widening access and saving health care dollars. It added that the purpose in issuing a compulsory license would “restore competition for this product in the Colombian market.” The health ministry, however, must still make a final decision.
The annual cost of Gleevec is roughly $15,000, which patient advocacy groups say is excessive in a country where the nation’s per capita gross national income is about $8,000. “The public interest is obviously affected when a patient or family is obligated to pay these prices, which constitutes a violation of (a) fundamental right to health,” the groups wrote in November 2014 petition to the government.
The dispute is the latest example of rising tension between the pharmaceutical industry and some governments over the prices for prescription medicines. In response, a growing number of countries have been pressing drug makers for discounts or, in some cases, issuing compulsory licenses.
Countries may grant such licenses to a generic drug maker, a right that was memorialized in a World Trade Organization agreement known as Trade-Related Aspects of Intellectual Property Rights, or TRIPS. According to WTO rules, a country may cite a health emergency as a reason for issuing a license.
A few countries have issued compulsory licenses for patented medicines over the past decade, although Colombia is not one of them. Consequently, the licenses are a sore point for the pharmaceutical industry, which has argued that governments may issue licenses inappropriately and, in the process, violate intellectual property rights. This was one of the arguments Novartis made in response to the recommendation by the Colombian committee.
“Novartis is concerned about the implications that disregarding intellectual property rights might have for foreign investment. Furthermore, the company believes that it damages industries like pharmaceuticals that spend significant resources on research and innovation, and negatively impacts the patients who benefit from their innovative efforts,” a company spokeswoman wrote us.
She added that patients in Colombia are able to obtain Gleevec — which is often called Glivec outside the United States – thanks to price regulations. “Although Novartis respects and abides by the Colombian regulatory framework, the company is concerned that the technical and factual arguments presented before the authorities have not been taken into account during the process,” she added.
Patient advocacy groups, however, argue that some efforts to enforce intellectual property rights may come at the expense of patients who cannot afford medicines.
“You don’t have ‘access to medicine for all’ unless the budget has enough money to buy all the medicines that everyone needs. And when resources are limited, prices can’t be unlimited. Providing universal access is, indeed, in the public interest,” wrote Jamie Love of Knowledge Ecology International, which focuses on access and patent issues, in an email.
In recent years, Thailand pursued compulsory licensing in order to lower costs for different medicines and, more recently, India issued a license as well. But the issue has become especially heated there since so many large generic drug makers are based in the country, and global drug makers are concerned the country has favored its domestic industry at their expense.
Two months ago, the Indian Patent Office rejected an application from a domestic generic drug maker that sought a compulsory license to make a generic version of the Onglyza a diabetes pill sold by AstraZeneca (AZN). The decision was seen by some as a sign that the Indian government may alter its approach toward protecting patent rights.