Category News

Acting Public Advocate and Speaker Johnson, Elected Officials, The Prep4all Collaboration, and Advocates Rally for Affordable HIV Prevention Medication

[NYC Councilmember Press Release] cting Public Advocate and New York City Council Speaker Corey Johnson, Council Member Carlina Rivera, Assembly Member Dick Gottfried, former State Senator Tom Duane, founders of the PrEP4All Collaboration (and organizers of the #BreakThePatent campaign), and advocates held a rally to call on the National Institutes of Health (NIH) to exercise its march-in rights and break Gilead’s patent of Truvada, the brand name medication for pre-exposure prophylaxis, also known as PrEP. March-in rights, as granted by the Bayh-Dole Act of 1980, allow the federal government to break patents in certain cases involving patents that resulted from publicly funded research. Breaking the patent in this case would make PrEP more affordable and accessible by allowing generic versions to enter the market.

The Text of Article 13 and the EU Copyright Directive Has Just Been Finalised

[Julia Reda, MEP] In the evening of February 13, negotiators from the European Parliament and the Council concluded the trilogue negotiations with a final text for the new EU Copyright Directive. For two years we’ve debated different drafts and versions of the controversial Articles 11 and 13. Now, there is no more ambiguity: This law will fundamentally change the internet as we know it – if it is adopted in the upcoming final vote. But we can still prevent that!

Joint Letter from 71 Civil Society Groups to Congress on NAFTA 2.0 and Medicine Prices

The undersigned organizations representing healthcare providers, patients, public health experts, workers, people of faith, and consumers are committed to advancing public health and promoting access to affordable medicines. Access to affordable healthcare and medicines is one of few demands that now unites the American public. We write to you today with concern that provisions currently included in the proposed NAFTA 2.0 (referred to by the Trump administration as the United States-Mexico-Canada Agreement) would entrench and expand prescription drug monopoly protections, thwart competition and thus undermine efforts to expand access to affordable medicines.

MPP-AbbVie License on Glecaprevir and Pibrentasvir (G/P): Backtracking on Geographic Coverage but with Options for Oppositions, Compulsory Licenses, and Negotiated Territorial Expansion

AbbVie and the Medicines Patent Pool 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 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.

Biological Drugs – Challenges to Access

[Third World Network] In this paper Dr. Sengupta examines the landscape of biological medicines, and locates this analysis in the characteristics of biological drugs which set them apart from small molecule drugs (SMDs). These characteristics of biological drugs impact on the way these drugs are manufactured; on the development of follow-on versions of innovator biological drugs; on the way biological drugs – both innovators and follow-ons – are regulated; on the way these drugs are protected by different kinds of intellectual property rights (IPRs) and data protection mechanisms; and on the opportunities and challenges in the introduction of biological drugs, including biosimilars, in a range of countries.

EU Parliament Vote: An Unprecedented Copyright Giveaway

[Communia Association] There is no way around it, the outcome of today’s vote on the copyright directive in the European Parliament is a big loss for user rights and the open internet. MEPs have decidedly sided with the demands of the creative industries to hand them more control over how we access, use and share copyrighted works. Out of the seven issues that we listed this morning the European parliament voted against our position every single time.

Open Letter to Johnson & Johnson: Calling for Affordable Access to Critical TB Drug Bedaquiline

[Medicins Sans Fronteirs] Dear Dr Stoffels: For the past decade, Médecins Sans Frontières (MSF) has been in dialogue with Johnson & Johnson (J&J) about the critically important TB drug bedaquiline, including on access to bedaquiline for MSF-run clinical trials, compassionate use of bedaquiline for people with extensively drug-resistant TB (XDR-TB), and routine use of bedaquiline to treat multidrug-resistant TB (MDR-TB) in MSF medical projects. We are writing now to J&J regarding the need for all countries to secure an affordable and sustainable supply of bedaquiline given the expanded use of bedaquiline to treat more forms of MDR-TB globally.

I-MAK & Delhi Network of Positive People File Opposition to Prevent AbbVie Patent Grant on Hepatitis C Treatment

[I-MAK & Delhi Network of Positive People] On July 21, the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) filed a pre-grant patent opposition with the Indian Patent Office in Delhi against pibrentasvir (PIB), part of the drug combination that forms AbbVie’s hepatitis C (HCV) product, Mavyret. Filed on the eve of the 2018 International AIDS conference, the opposition has significant implications for millions of patients and families struggling to afford and access hepatitis C treatment: if granted, a pibrentasvir patent could block generic entrants from supplying the product in India and other low and middle-income countries, where the majority of people with HCV live.

PIJIP Professor Carroll Co-authors National Academies of Science Report: Open Science by Design

PIJIP Director Michael Carroll served on an ad hoc committee under the N.A.S. Board on Research Data and Information which has completed a study on the challenges of broadening access to the results of scientific research, described as “open science.” The study, Open Science by Design: Realizing a Vision for 21st Century Research, will be formally released on Tuesday, July 17 at the National Academies of Sciences, Engineering and Medicine Keck Center.

From Lab to Commons: Shifting to a Public Interest Biomedical System

[Sophie Bloemen and David Hammerstein] ... a commons approach in biomedical research & development (R&D) can help pull us out of the current crisis of over-diagnosis, over-prescription, low innovation, secrecy and sky-rocketing costs for both patients and health systems. While not exhaustive in our analysis of the many factors affecting biomedical innovation and public health, we propose entry points in the form of policies with the power to transition society away from the current proprietary, centralised and extractive model. In a second step, we put forward a vision for future initiatives in line with commons principles, where the EU should be investing for long-term benefit.

Klobuchar, Grassley Urge Federal Trade Commission to Examine Whether “Pay for Delay” Tactics Are Keeping Cheaper Biosimilar Medicines Off the Market

[Office of Sen. Klobuchar, Press Release] U.S. Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, and Senator Chuck Grassley (R-IA), Chairman of the Senate Judiciary Committee, urged the Federal Trade Commission (FTC) to examine whether makers of biologic medicines are using strategies like “pay for delay” to hinder or delay biosimilars from entering the market. Biologics are a fast-growing class of medicines that are often more expensive than traditional pharmaceutical products. The use of “pay for delay” deals—the practice of brand-name and generic drug companies using pay-off agreements to delay the introduction of cheaper substitutes—and other anti-competitive tactics for biologics could make some critical prescriptions unaffordable for patients.