Pile of colorful pills in blister packs

The Age of Orphans

Join the author today for the 2021 CeBIL Symposium. Register here!

By Sarah Rickwood

The 2020s are the age of orphan medicines.

Orphan medicines are available for a larger number of diseases and patients than ever before, a testament to the success of legislation established decades ago encouraging the development of these medicines in both the U.S. and European Union.

Orphan medicines were the majority of European Medicines Agency (EMA) approvals for the first time ever in 2016 (59%) and the majority of U.S. Food and Drug Administration (FDA) approvals for the first time ever in 2018 (58%).

Read More

person cuts salami sausage on a wooden cutting board.

Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives

Join the author on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Sven Bostyn

The development of orphan drugs, so named for the rare diseases they treat, has been incentivized through regulation in the European Union. The primary reward is 10 years’ market protection (or exclusivity).

But are these incentive mechanisms working as they should? To date, only 131 orphan drugs have been brought to market. Findings from the European Commission’s long-awaited evaluation of the orphan drug system in Europe, 20 years after its inception, suggest there may be cause for concern.

Read More

Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

Mortal Sins of Orphan Drug Development: How to Save the Lost Souls

Join the authors on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Jakob Wested and John Liddicoat

In a working paper from November 2020, the EU Commission finds a significant inefficiency in the EU orphan drug regulation (a pan-EU piece of legislation): that it does not contain a provision to safeguard the affordability and accessibility of orphan medicines.

The working paper then entertains the idea of inserting such a provision into the regulation. But, is the orphan drug regulation the right place for this type of law?

Diagnosing the problem behind orphan drug pricing is the key issue to address before jumping to consider ways to address excessive pricing.

Read More

A range of contraceptive methods: DMPA, vaginal ring, IUD, emergency contraceptive, contraceptive pills.

Connecting the Dots: Reproductive Justice + Research Justice = Health Justice

By Monica R. McLemore

I believe that together, reproductive justice and research justice should result in health justice.

I am choosing to focus on research because it is the evidence base that is foundational to clinical care provision and because teaching is generated by research.

Thus, research serves as one root cause of harm associated with clinical care and teaching, and a potential barrier to realizing health justice, which has been outlined as a comprehensive approach to resolve the social determinants of health and develop jurisprudence toward health equity. Research justice is critical to the conceptualization, development and implementation of these measures.

However, the law cannot establish health justice without reproductive justice, at least not for pregnant-capable people. Reproductive health, rights, and justice have been the proverbial canaries in the coal mine when considering the loss of bodily autonomy and human rights.

Read More

police cars lined up.

Health Justice and the Criminal Legal System: From Reform to Transformation

By Aysha Pamukcu and Angela P. Harris

Using health justice to reframe and reshape the criminal legal system

The demand to “defund the police,” circulated by the Movement for Black Lives and allies after the brutal 2020 murder of George Floyd, was a departure from the usual discourse of police reform. The demand garnered backlash as being both politically unrealistic and potentially dangerous. But in our view, it demonstrates the transformative potential of social movements focused on justice for marginalized communities. As these justice movements build and strengthen partnerships with public health and civil rights advocates, we see the potential of using the health justice framework to reimagine the future of the criminal legal system.

Calls to deploy the American criminal legal system to enforce national health anxieties are not new, but they too often have produced unjust outcomes, such as adopting criminal punishments for people who are HIV-positive or who are dependent on drugs and pregnant.

In contrast, the health justice framework centers the leadership of social movements for justice and inclusion. Such movements have the capacity to rapidly shift the terms of public debate, making previously unimaginable policy initiatives first discussable, and then doable. And centered in values of anti-subordination, justice movements can challenge biases within elite, highly professionalized disciplines like law and public health.

Policy innovations that emerge from this triple alliance of law, public health, and social movements stand a better chance of improving the lives of marginalized communities than those that treat these communities as targets of discipline or charity. The call to defund the police demonstrates some of these possibilities.

Read More

illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Expanded Reimbursement Codes for Remote Therapeutic Monitoring: What This Means for Digital Health

By Adriana Krasniansky

New reimbursement codes for virtual patient monitoring may soon be incorporated into Medicare’s fee schedule, signaling the continued expansion and reach of digital health technologies catalyzed by the COVID-19 pandemic.

In July 2021, the Centers for Medicare & Medicaid Services (CMS) proposed adding a new class of current procedural terminology (CPT) codes under the category of “remote therapeutic monitoring” in its Medicare Physician Fee Schedule for 2022 — with a window for public comments until September 13, 2021. While this announcement may seem like a niche piece of health care news, it signals a next-phase evolution for virtual care in the U.S. health system, increasing access possibilities for patients nationwide.

Read More

Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

How Social Movements Have Facilitated Access to Abortion During the Pandemic

By Rachel Rebouché

Before the end of 2021, the U.S. Food and Drug Administration (FDA) will reconsider its restrictions on medication abortion. The FDA’s decision could make a critical difference to the availability of medication abortion, especially if the Supreme Court abandons or continues to erode constitutional abortion rights.

Under that scenario of hostile judicial precedents, a broad movement for abortion access — including providers, researchers, advocates, and lawyers — will be immensely important to securing the availability of remote, early abortion care.

Read More

police cars lined up.

Policing Public Health: Carceral-Logic Lessons from a Mid-Size City

By Zain Lakhani, Alice Miller, Kayla Thomas, with Anna Wherry

When it comes to public health intervention in a contagion, policing remains a primary enforcement tool. And where a health state is intertwined with carceral logics, enforcement becomes coercive; emphasis is placed on the control of movement and behavior, rather than on support and care.

Our experience in New Haven during the first few months of the COVID-19 pandemic well illuminates this, while also revealing a logic of exceptional force lying dormant in municipal health practices.

Attending to the local is all the more important, albeit difficult, for fast moving and intensely quotidian practices, as COVID in the U.S. seems to be settling in as a pandemic of the local.

Our experience as activist-scholars working with a New Haven-based sex worker-led harm-reduction service and advocacy group, SWAN, suggests that by focusing on municipal practices, we can better understand what public health police power actually is. By orienting our scholarship toward the way social movements engage with local politics, we can then address how these police powers complicate the ability of those most at risk of both disease exposure and police abuse to engage with local authorities. Absent this engagement and critique, progressive policies for constructive state public health powers may be more vulnerable to attack from the right.

Read More

Globe and vaccine.

Access-to-Medicines Activists Demand Health Justice During COVID-19 Pandemic

By Brook K. Baker 

It was apparent from the outset of the COVID-19 pandemic that a business-as-usual approach — perpetuating the biopharmaceutical industry’s intellectual property-based monopolies and allowing artificial supply scarcity and nationalistic hoarding by rich countries — would result in systemic failure and gross inequity.

The world had seen it all before, from the Big Pharma blockade of affordable antiretrovirals to treat HIV/AIDS, to the hoarding of vaccines by the global north during the H1N1 bird flu outbreak in 2009 and its stockpiling of Tamiflu.

Activists in the access-to-medicines movement quickly mobilized to combat the threat of vaccine/therapeutic apartheid.

Read More

mask

COVID-19 is Still a Crisis for All

By Chloe Reichel

Recently, a narrative that COVID-19 is now a “pandemic of the unvaccinated” has emerged.

Setting aside the callousness of the claim, the biggest problem with this narrative is that it’s wrong. COVID-19 continues to threaten the health and well-being of all, regardless of vaccination status.

As we now know, vaccinated individuals can be infected with and transmit the delta variant. “Breakthrough” infections are not rare — countries with better data collection efforts than the U.S., including Israel and the United Kingdom, estimate vaccine efficacy against infection by the delta variant at around 40-50%.

This isn’t to say that the vaccines are worthless. We should continue to work to promote vaccine uptake, as the vaccines do provide a level of protection against the most severe outcomes.

But we need to understand: We can’t end this pandemic with vaccines alone.

Read More