Countries Consider Pandemic Pooling of Rights And Compulsory Licensing

Transparency of R&D Costs Also Requested

Intellectual property rights are under the microscope as countries prepare to provide affordable and timely access to pandemic technologies.

Coronavirus
Countries Consider How To Make COVID-19 Technologies Accessible

In an important move in the fight against the pandemic, Costa Rica has requested that the World Health Organization head an initiative to pool intellectual property rights relating to coronavirus technologies. Meanwhile Chile and Ecuador have paved the way for compulsory licenses, and the demand for more transparency on the costs of R&D and public financing is growing.

More from Latin America

Brazil Consults On How To Price Advanced Therapies

 

Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.

England’s NICE Leads Global Effort On Surrogate Endpoints For Cost-Effectiveness

 

Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.

Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity

 

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Mexico Launches ‘Regulatory Certainty Strategy’ For Biosimilars

 

Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines. 

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EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

Recent And Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.