GAiA seeks to address access to medicines challenges by conducting a rigorous and comprehensive review of the intellectual property laws and policies, competition laws, drug regulatory systems, and anti-counterfeiting measures. We work with participating country governments and in-country partners to identify context-specific barriers to access, build local technical capacity, and implement these reforms in a sustainable manner.

Once these barriers have been identified, GAiA’s team works with in-country partners and other stakeholders to recommend options for reform based on best practices, a detailed consideration of contextual factors, and a comparative analysis of effective reforms carried out in other low- and middle-income countries.

Learn more about our work.

According to the report published by WHO in November 2017 on public health and socioeconomic impact of substandard and falsified (S&F) medical products, one out of ten medical products circulating in developing countries is either substandard or falsified. These products are most likely to be found in places that have limited access to affordable, safe, and quality medical products, lack of good governance, and weak technical capacity and tools. Three common approaches to combat the problem of S&F medical products are prevention, detection, and response, which often require a functioning national regulatory agency to allow the approaches to be effective.

GAiA is implementing a multifaceted pilot program in sub-Saharan Africa, providing technical advice to local governments on public-health-sensitive legal, policy, and regulatory reform.  As part of this program, GAiA is working with Global Good to demonstrate a new falsified-drug detection technology that, in conjunction with other complementary drug-quality monitoring systems, can help to reduce the morbidity and mortality associated with treatment failure from the use of falsified medicines. In concert with public health initiatives, such technologies can help to reduce the regional burden of communicable and non-communicable disease by simplifying the identification of falsified medicines.

This project is part of an ongoing collaboration between GAiA and the respective governments which aims at revising or drafting a regulatory framework which will promote public health interests while allowing for the use of innovative technology in healthcare. Our team provides advisory services that takes into consideration the specificities of each country.

GAiA is committed to reducing barriers to lifesaving medicines through legal, policy, and regulatory reform. We promote practical strategies to expand global access to medicines and promote research and development for diseases that primarily affect the world’s most under-resourced populations. GAiA seeks to address to reduce global disparities in access to medicines: insufficient incentives for research and development, lower-income individuals being priced out of the market, and polarization and paralysis around access to medicines solutions. We advocate for sharing of best practices by the pharmaceutical industry such as ifferential pricing, non-exclusive licensing agreements, and patent pooling.

GAiA’s Co-Director Q.Palfrey detailed his proposal for improving and expanding the above strategies in “Expanding Access to Medicines and Promoting Innovation: A Practical Approach”, Quentin A. Palfrey, Georgetown Journal on Poverty Law & Policy, Volume XXIV, Issue 2. Winter 2017.
Listen to Quentin Palfrey on Access to Affordable Medicines and Research and Innovation

As the novel coronavirus (COVID-19) sweeps the world in devastating fashion, scientists are scrambling to develop effective vaccines and treatments. But how should those medicines be priced globally?

Following Donald Trump’s “America First” policy with respect to vaccine and drug pricing would be tragic, argue Quentin Palfrey and John Stubbs. Instead, Palfrey and Stubbs propose a pharmaceutical pricing policy modeled on progressive taxation to distribute costs equitably worldwide. This discussion was moderated by Ashveena Gajeelee.

Download original video and audio from this event

Download the transcript

Subscribe to the Berkman Klein events series podcast

Google, Apple Struggle to Regulate Covid-19 Tracing Apps

June 5, 2020. Quentin Palfrey led research study of more than 100 apps  in the Google app store via the International Digital Accountability Council, of which he is president.

“We’ve seen bad privacy practices,” Palfrey said. “The fact that we have not yet observed those bad privacy practices translating into demonstrable ongoing harm doesn’t mean that the harm isn’t happening or might not be happening in the future.”

Read more in The Wall Street Journal

Our previous work on pandemics

The Ebola outbreak in West Africa has triggered substantial debate about what should be done in the future to prevent global public health crises of this kind.  Developing mutually agreeable legal terms and conditions for vaccine development and deployment among donors, recipients, governments, and intergovernmental organizations has been a significant challenge. Waiting to manage liability concerns until after an outbreak has begun can lead to significant delays and losses in public benefit. While a variety of approaches have been developed to address liability and indemnification within individual countries, there is no agreed-upon global model to manage liability for manufacturers and others involved in vaccine development during public health emergencies of international concern exists.

In this effort to tackle liability concerns associated with international development and deployment of emergency vaccines, GAiA attended a meeting in Geneva in September 2017 with the Harvard Global Health Institute, and hosted by the Coalition for Epidemic Preparedness Innovations. This collaboration aims at:

• Taking stock of the concerns and challenges faced during prior outbreaks and related to liability and indemnification (e.g., 1976 Swine Flu, 2009 H1N1, Ebola);
• Examining relevant national-level solutions and the key values/elements that underpin them; and
• Bringing together different stakeholders’ proposals to resolve liability and indemnification issues during public health emergencies of international concern.

In addition to reinforcing the legal framework to fight pandemics, the WHO seeks to promote the use of technology to detect and fight the next pandemic. We are today able to access and relay data faster to policy makers. While technology cannot prevent a pandemic it can provide real-time monitoring and surveillance, educate, and empower healthcare personnel to take actions that would significantly reduce the impact of the outbreak. GAiA, in partnership with the Petrie Flom Center, seeks to provide a framework for how applications designed to address global epidemics can be integrated into healthcare systems while still protecting the privacy and liberty rights of individuals.  Our work focuses on how best to address the challenges surrounding health data governance through regulations and policies. We will explore the intersection of big data and healthcare as applied to pandemics.

Read more for our past work on pandemics.

The quality of medicines has an enormous impact on mortality and morbidity in the developing world. In 2013, the consumption of poor-quality antimalarial was associated with over 120,000 deaths in children under 5 years of age in 39 Sub-Saharan African countries (Renschler et al., 2015). These problems highlight the need for an inexpensive, efficient method of testing purchased medicines. In partnership with Global Good, GAiA’s team is piloting a project in Sub-Saharan Africa deploying a drug-quality assessment technology through the use of miniature spectrometers. This low-cost technology would increase the government’s ability to regulate drug distribution and empower individuals to confirm the authenticity of the drugs they purchase, ultimately increasing the use of therapeutically effective medicines.

In addition, GAiA in collaboration with Berkman Klein Center hold speaker series to facilitate stakeholders’ engagement at the intersection of health, law, policy and technology. The Digital Health @ Harvard project has been the main hub of discussion at the Center for those working in and around the health technology space. The project has brought together an interdisciplinary community of scholars, researchers, practitioners at Harvard and local hospitals who have interest and expertise in digital health issues, broadly conceived. In the form of luncheon speaker series, the project aims to discuss ongoing research and new developments in health, identify opportunities for collaboration, and expose the community to the broad digital health ecosystem.

Read more on

• Big Data, Health Law, and Bioethics http://cyber.harvard.edu/publication/big-data-health-law-and-bioethics
• Digital Health @ Harvard http://cyber.harvard.edu/events/digitalhealth