MPP-AbbVie License on Glecaprevir and Pibrentasvir (G/P): Backtracking on Geographic Coverage but with Options for Oppositions, Compulsory Licenses, and Negotiated Territorial Expansion
By: Brook K. Baker, Senior Policy Analyst, Health GAP
AbbVie and the Medicines Patent Pool (MPP) have negotiated a royalty-free licensing and sublicensing agreement on a priority hepatitis C direct-acting antiviral, glecaprevir and pibrentasvir (G/P). This G/P combo is recommended by the World Health Organization (WHO) as a pan-genotypic adult first-line regimen with ongoing Phase 3 trials for adolescents and children. G/P has a high resistance barrier and the shortest treatment duration of any HCV regimen to date.
The main drawback of the MPP-AbbVie license is its limited geographic scope—particularly its exclusion of India, a high burden country with a significant population of people living with HCV. Not only are there fewer countries and territories included in the license (95 and 4 respectively, Table 1) than in previous licenses for direct-acting antivirals (DAAs) for HCV, but the percentage of the global population living with HCV covered—47.5%—is lower than Gilead’s bilateral license for sofosbuvir (105 territories, 62.3% coverage) and Bristol-Myers Squibb’s license for daclatasvir (112 territories, 54.3% coverage). Consistent with previous licenses, AbbVie has prioritized exclusion of so-called “emerging markets” and upper-middle-income markets, in order to maximize profit in those markets.
President Trump has jumped at every opportunity to falsely blame other countries’ drug pricing decisions for Big Pharma’s grossly excessive prices in the U.S. Following this false premise, the proposal, announced yesterday, to cut drug prices is far more bark than bite.
Casting himself as the savior of US patients whom he falsely claims pay for “virtually all” global biopharmaceutical research and development, Trump touted three experiments to reduce Medicare prices:
- limiting doctors’ percentage mark-ups on certain prescriptions to encourage better prescribing practices (so that clinicians’ earnings are not tied to the higher price of a prescribed medicine);
- letting private sector vendors negotiate with pharmaceutical corporations on Medicare drug prices for a limited number of medicines and in limited geographic regions; and
- setting prices for medicines used by doctors in their offices and hospitals in only 50% of the country by resetting those prices gradually over time to amounts paid for those same medicines by procurers in sixteen reference countries.
Almost three years ago a 19 year-old Ugandan woman, Irene Kyakunda, was found dead in a swamp in Wakiso town, just outside of Kampala (Uganda's capital). She had suffered massive internal bleeding from an unsafe abortion. Her death made the news briefly—but only because her body appeared to be so brutalized that police first investigated her death as a murder.
In Uganda, I hear countless stories like this that never make the news—women and girls who died because their health system failed to deliver what they desperately needed: a safe abortion.Read more
Health GAP turns 20 next year and over the past few months, I’ve spent some time reflecting on the state of the global HIV response and our role in it. One thing is clear: we need creative disruption and relentless activism to dismantle the systems of injustice that fuel the pandemic, now more than ever. While we have made tremendous progress in advancing access to lifesaving HIV treatment and prevention, the path ahead is still long and steep.Read more