Open letter from the European Medicines Agency

“Our activities in relation to COVID-19 deserve the highest possible level of transparency and, in keeping with our commitment, the Agency will take appropriate action to share information publicly. We are currently discussing how to enhance the level of transparency for COVID-19 procedures, including the possibility of rapidly publishing clinical data for these products. The need for rapid evaluation during the current emergency will require us to depart from our usual procedures. In some cases, we will be evaluating evidence as it emerges (i.e. ‘rolling review’) and putting information in the public domain in these circumstances will be subject to additional challenges which we are currently looking to address….

Inevitably, this disruption [Brexit] required the Agency to shift all its focus to core activities that are essential for public health. Regrettably, our efforts to publish clinical data had to be put on hold in these very trying circumstances. 

In view of this and the extra effort needed to deal with COVID-19 related activities, I can’t yet commit

to reinitiate all activities related to clinical data publishing for medicines evaluated by the Agency.

However, as stated above, COVID-19 related medicines deserve special consideration because of the

overriding public interest and the need to support the international research community and foster the

collaborative effort. Further information on the concrete proposals to increase transparency of COVID19 related activities will be communicated once agreed within EMA and the EU Regulatory Network….”

Open letter from the European Medicines Agency

“Our activities in relation to COVID-19 deserve the highest possible level of transparency and, in keeping with our commitment, the Agency will take appropriate action to share information publicly. We are currently discussing how to enhance the level of transparency for COVID-19 procedures, including the possibility of rapidly publishing clinical data for these products. The need for rapid evaluation during the current emergency will require us to depart from our usual procedures. In some cases, we will be evaluating evidence as it emerges (i.e. ‘rolling review’) and putting information in the public domain in these circumstances will be subject to additional challenges which we are currently looking to address….

Inevitably, this disruption [Brexit] required the Agency to shift all its focus to core activities that are essential for public health. Regrettably, our efforts to publish clinical data had to be put on hold in these very trying circumstances. 

In view of this and the extra effort needed to deal with COVID-19 related activities, I can’t yet commit

to reinitiate all activities related to clinical data publishing for medicines evaluated by the Agency.

However, as stated above, COVID-19 related medicines deserve special consideration because of the

overriding public interest and the need to support the international research community and foster the

collaborative effort. Further information on the concrete proposals to increase transparency of COVID19 related activities will be communicated once agreed within EMA and the EU Regulatory Network….”

Pharma CEOs and IFPMA comment on WHO proposal for COVID 19 technology pool. – YouTube

“At a May 28 press briefing organized by the international Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharma CEOs and the IFPMA DG comment on WHO proposal for global pool for rights in technologies for the diagnosis, prevention and treatment of COVID-19. Pascale Soriot, the CEO of AstaZeneca, a company receiving a reported $1.2 billion in funding from the US agency BARDA, claims he was “not aware” of the WHO proposal. Pfizer CEO Albert Bourla is the most negative, calling the proposal, dangerous. At 2:30 on this clip, Thomas Cueni of IFPMA claims that a focus on vaccine patents is misplaced since know-how is the larger issue, and he claims that there has never been a compulsory license on a vaccine patent.

There have been, of course, many disputes over patent rights for vaccines, and know-how, data and even access to cell lines, is actually part of the Costa Rica/WHO proposal for a COVID-19 technology pool, which, Thomas Cueni, a former journalist, certainly understands. The full IFPMA briefing is here: https://www.youtube.com/watch?v=0wMMwDshed0 …”

Pharma CEOs and IFPMA comment on WHO proposal for COVID 19 technology pool. – YouTube

“At a May 28 press briefing organized by the international Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharma CEOs and the IFPMA DG comment on WHO proposal for global pool for rights in technologies for the diagnosis, prevention and treatment of COVID-19. Pascale Soriot, the CEO of AstaZeneca, a company receiving a reported $1.2 billion in funding from the US agency BARDA, claims he was “not aware” of the WHO proposal. Pfizer CEO Albert Bourla is the most negative, calling the proposal, dangerous. At 2:30 on this clip, Thomas Cueni of IFPMA claims that a focus on vaccine patents is misplaced since know-how is the larger issue, and he claims that there has never been a compulsory license on a vaccine patent.

There have been, of course, many disputes over patent rights for vaccines, and know-how, data and even access to cell lines, is actually part of the Costa Rica/WHO proposal for a COVID-19 technology pool, which, Thomas Cueni, a former journalist, certainly understands. The full IFPMA briefing is here: https://www.youtube.com/watch?v=0wMMwDshed0 …”

Microsoft commits patents to help fight COVID-19 – Microsoft on the Issues

“I am very pleased to announce that, today, Microsoft is committing to the Open COVID Pledge by making its patents available free of charge for use in efforts to end the COVID-19 pandemic and minimize the impact of the disease.  This step joins our other efforts to use technology and innovation to help track the disease and develop solutions, such as mobilizing AI for Health to fight COVID-19 and the Bing COVID19 Tracker. Additional information about Microsoft’s COVID-19 efforts can be found here.

We are always looking for ways we can use our patents to contribute to positive outcomes, and the fight against COVID-19 is one of the most urgent issues of our time. Pledges and open licensing of this kind can help spur innovation, especially in a crisis like this one. Researchers, scientists and others working to fight the virus should be able to develop and deploy effective solutions at scale without obstacles such as being threatened with patent litigation….”

Microsoft is Launching an Open Data Campaign

“Today, Microsoft is launching an Open Data Campaign to help address the looming “data divide” and help organizations of all sizes to realize the benefits of data and the new technologies it powers. We believe everyone can benefit from opening, sharing and collaborating around data to make better decisions, improve efficiency and even help tackle some of the world’s most pressing societal challenges.

The goal of our campaign is to advance a much-needed discussion about how the world uses and shares data. To start, today we’re announcing three steps:

First, we’re publishing new principles that will guide how Microsoft itself approaches sharing our data with others.
Second, we’re committing to take action by developing 20 new collaborations built around shared data by 2022. This includes work with leading organizations in the open data movement like the Open Data Institute and The Governance Lab (GovLab) at the New York University Tandon School of Engineering. And we’ll seek to lead by example by making our Microsoft social impact initiatives “open by default,” beginning with sharing data on broadband access from our Airband initiative and combining it with data from others to help accelerate improvements in broadband connectivity.
Finally, we’ll invest in the essential assets that will make data sharing easier, including the required tools, frameworks and templates….”

Tech Giants Join the CC-Supported Open COVID Pledge

Momentum continues to swell in support of the Open COVID Pledge, with the announcement today by Amazon, Facebook, Hewlett Packard Enterprise, IBM, Microsoft, and Sandia National Laboratories, that they are pledging their patents to the public to freely use in support of solving the COVID-19 pandemic. Following in the footsteps of Intel, Fabricatorz Foundation, and many others, these companies join as Founding Adopters of the Pledge by releasing hundreds of thousands of patents for use worldwide by researchers, scientists, and others who are working to end the and minimize the impact of the disease, including through research, diagnosis, prevention, and containment.

Creative Commons announced its formal support for the project earlier this month, joining forces with legal experts, researchers, and scientists to create the pledge and licenses. This included the publication of two new licenses last week. The licenses now give adopters the ability to choose between licensing all of their copyrights and patents, and licensing only their patents. You can learn more about the licenses on the website.

CC’s involvement in this coalition is a natural fit given our goal of supporting and promoting the sharing of intellectual property freely with the public in order to advance the dissemination of knowledge. Our work since the announcement has focused on building informational resources including a new set of FAQs, drafting and updating the licenses, connecting with those wishing to adopt the pledge and license their IP, and strategizing with other members of the coalition about how the project can best connect adopters with those using the licensed IP to maximize impact. We look forward to continuing this work and sharing these success stories.

Companies, universities, organizations, and individuals can make or support the Open COVID Pledge by visiting https://opencovidpledge.org or contacting opencovidpledge@gmail.com.

The post Tech Giants Join the CC-Supported Open COVID Pledge appeared first on Creative Commons.

Exploring complexity: the two sides of Open Science

“One may see Open Science (which some prefer to call Open Research) as an altruistic movement towards opening up research methods and especially its outputs for the sake of their visibility and open availability to the wider society. The legitimate right for any citizen to read research outputs resulting from public funding is regularly raised by every Open Access advocate – including yours truly – when explaining the rationale for Open Science. Patients, schoolteachers, doctors are highlighted as the sort of citizens that may need to access scientific literature and may be forced to pay for such access unless we succeed in our push towards Open Science. And SMEs. Yes, one always mentions SMEs here as well. In fact anyone who happens to be outside the institutional subscription bubbles.

There is another take to Open Science though, a far more pragmatic and hence more likely to succeed approach. This other take, although not unconcerned with access to research results by the average citizen, is mostly about the possibility of exploiting the synergies between research and industry by making not only research results but other areas such as research facilities or expertise as openly available to industry (and the wider outside world) as possible. This is the approach driven by innovation that sees research and its commercial application as a continuum and understands the value of openness for the purpose of realising that continuum….”

Data sharing from clinical trials: lessons from the YODA Project – STAT

“This week, the National Academies of Science, Engineering, and Medicine are convening the workshop “Sharing Clinical Trial Data: Challenges and a Way Forward” just shy of five years after the Institute of Medicine released its seminal report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.”

During this time, the scientific culture regarding data sharing has shifted. Just last week, the National Institutes of Health requested public comments on its draft “Policy for Data Management and Sharing.” In 2018, the International Committee of Medical Journal Editors began requiring data-sharing plans for clinical trials as a condition for publication in member journals. And platforms such as ClinicalStudyDataRequest.com, Project Data Sphere, and BioLINCC have emerged or grown. These platforms use a variety of different governance structures and models for data access, developed both with and without the support of industry or government….

The Yale Open Data Access (YODA) Project, which two of us (J.S.R. and H.M.K.) co-direct, launched in 2011 and formed a partnership with Johnson & Johnson in 2014. This five-year partnership offers an opportunity to reflect on some of the questions about sharing clinical trial data that may inform ongoing and future efforts….”