he controversy over access to medicines took a twist this week when two Indian drug makers disclosed they would no longer seek government licenses to make generic versions of two brand-name medicines. And they cited pressure from the global pharmaceutical industry on the Indian government as their reason for ending their efforts.
BDR Pharmaceuticals and Lee Pharma are not pursuing so-called compulsory licenses that would allow them to make and sell lower-cost versions of drugs made by Bristol-Myers Squibb and AstraZeneca, according to Reuters. These licenses allow generic drug makers to make low-cost versions of brand-name medicines without the consent of the brand-name company holding a patent.
Both drug makers had been appealing government rejections of license applications. Lee sought to sell a version of the Onglyza diabetes medicine made by AstraZeneca, but was rebuffed earlier this year, while BDR hoped to market a version of the Sprycel cancer medicine from Bristol-Myers Squibb, although that bid was rejected three years ago.
But “there is no point in pursuing it anymore,” Dharmesh Shah, BDR’s managing director, told the news service.
The companies claim they were thwarted by Prime Minister Narendra Modi and his administration’s desire to boost foreign investment by acquiescing to multinational drug makers. The global pharmaceutical industry has long argued the Indian government has been lax about enforcing intellectual property rights in order to favor its domestic drug makers, many of which sell generics.
Brand-name drug makers remain angry over a 2013 court ruling that denied a patent for the Gleevec cancer medicine sold by Novartis. And the US Trade Representative regularly places India on its priority watch list for countries that fail to sufficiently protect and enforce patent rights. In response, Modi formed a “high level” working group on intellectual property after taking office two years ago.
Indian officials declined to respond to requests for comment from Reuters, but the decision by these drug makers comes shortly after confusion over the government policy toward compulsory licenses. Earlier this year, two prominent business groups filed documents with the US Trade Representative’s Office suggesting the Indian government had agreed to restrict compulsory licenses.
Last month, however, the government issued a brief, but pointed statement saying its policy has not, in fact, changed. Nonetheless, this latest development is worrying advocacy groups, which argue that any moves to discourage Indian drug makers and restrict licenses would hurt patients who are unable to, otherwise, afford medicines. Many of these generics are sold not only in India, but in other countries, as well.
“We don’t have full details from the companies, but we think this may be a case of external pressure placed on India through bilateral discussions with the United States,” Yuan Qiong Hu, a legal and policy adviser with the Access to Medicines campaign at Doctors Without Borders, told us. “So we are concerned about the broader implications of this case.”
One industry analyst, however, suggested the frustration expressed by Lee and BDR is misplaced and may not reflect a move by the Indian government to take a harder line on compulsory licenses. Instead, the situation can be traced to the varying circumstances under which the government can issue these licenses to meet public health needs.
“I would not characterize” this skirmish as the result of global brand-name industry influence, said Vince Suneja, chief executive of TwoFour Insight Group, a consulting firm that works with Indian drug makers.
He noted that there are two different types of compulsory licenses that India can issue. One stems from a World Trade Organization agreement that allows countries to override patents in the event of a national emergency. But the license sought by Lee was based on commercial reasons that required permission from the Indian Patent Office.
Suneja explained that the patent officials rejected the application because the company failed to convince them that the needs of India’s diabetics were not being met by the AstraZeneca drug or others like it. Three similar medicines are sold in the country. Moreover, another generic version was already available at a lower price when Lee sought a license.
“This is being termed as a public health (need),” said Suneja, “but the provision used by the company to seek a compulsory license requires (those factors and others) to be met, and the Indian patent office determined that these factors were not met.”
As for BDR, the drug maker also needed approval from the patent office, but the agency determined the company did not negotiate in good faith with Bristol-Myers for a voluntary license — a required step before filing an application in such instances when a national emergency is not involved. And last June, an Indian court upheld the Bristol-Myers patent.
We asked Lee Pharma for comment and will update you accordingly. BDR could not be reached for comment.