A key drug to treat hepatitis C has been licensed to the Medicines Patent Pool, enabling generic production and expanding affordable access to the drug in low and middle-income countries, excluding the very largest. The agreement between the Pool and AbbVie had been over a year in the making. Intellectual Property Watch reports that this is according to MPP executive director Charles Gore. The new royalty-free licence agreement was with AbbVie for the drug glecaprevir/pibrentasvir (G/P), a key drug recommended by the World Health Organisation (WHO) for the treatment of chronic hepatitis C (HCV).
“The licence will enable quality-assured manufacturers to develop and sell generic medicines containing G/P in 99 low- and middle-income countries (LMICs) and territories at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens.”
Claiming over one million lives each year, viral hepatitis is one of the world’s major public health challenges and disproportionately affects people living in LMICs. Therefore, access to safe, quality-assured treatments, affordable for all, has to be the fundamental aim of the public health community,” Raquel Peck, CEO of the World Hepatitis Alliance, said. “This is a big step in that direction. The next step is to see more territories included in the agreement. Each step makes the dream of hepatitis C elimination more real.”
The report says this agreement has been in the making for over a year, and it is the result of the mutual interest of MPP and AbbVie to expand access to the HCV drug, according to Charles Gore, executive director of MPP.
“It’s a non-exclusive licence, so we won’t be just getting one generic company,” Gore said. “Our model is to get a number of generic companies, so that there is competition and it drives down the prices. It’s a royalty-free licence, so we can give non-exclusive royalty-free sub-licences to any manufacturer that meets the criteria… Sub-licensees need to meet WHO prequalification standards, or standards of a stringent regulatory authority as defined by WHO.”
AbbVie will provide the MPP with technical data and other non-commercial and non-manufacturing documents “that will help generic manufacturers licence the drugs in the territories,” he said. Additionally, “data exclusivity is waived.”
Gore explained that many of the countries included in the agreement “are WHO target tier-one countries, for example Vietnam, Philippines, Indonesia, [but] generally not the middle and particularly upper-middle income countries.”
He explained that this is because companies generally “see those as commercial markets, so we would never get China or Brazil for example in our licences.” Of the BRICS (Brazil, Russia, India, China, South Africa) countries, only South Africa is included, he said.
In previous licensing agreements for HIV drugs, MPP was able to add additional countries to the list covered by the agreement. It remains to be seen, however, if more countries will be added to this list in the future.
Gore went on to explain that he thinks that “access programs” for public health licences,
such as this licensing agreement with AbbVie, will soon become the “general way of doing things.” “In a few years’ time, it will be unacceptable to launch a product without a proper access programme,” he said. “In other words, the companies will have to think, ‘we want to get this drug to everybody who could benefit, wherever they live, and here’s how we’re going to do it.’”
“If you look at a lot of the pronouncements from the WHO, or the Lancet Commission on Access, this is where we’re going,” said Gore. “We’ve got to move toward a much better way of doing access, not as an afterthought, but right up there at the beginning.”
[link url="http://www.ip-watch.org/2018/11/12/key-hepatitis-c-drug-licensed-medicines-patent-pool-access-expanded-lmics/"]IP Watch report[/link]