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….”

The Global Research Data Alliance community response to the global COVID-19 pandemic | RDA

“Data drives rapid response and informed decision making during public health emergencies. There is a need for timely and accurate collection, reporting and sharing of data with the research community, public health practitioners, clinicians and policy makers. Accurate and rapid availability of data will inform assessment of the severity, spread and impact of a pandemic to implement efficient and effective response strategies.

The Research Data Alliance (RDA) is a volunteer community of over 10,500 professionals from 145 countries across the globe. In less than two months, the community responded to an urgent call for action and defined much needed, comprehensive recommendations and guidelines for data sharing under the present COVID-19 circumstances. 
Today, 28 May 2020, we publish the pre-final version of the RDA COVID-19 Recommendations and Guidelines covering four research areas – clinical data, omics practices, epidemiology and social sciences. This document is also complimented by overarching areas focusing on legal and ethical considerations, research software, community participation and indigenous data.
The detailed guidelines in this body of work aim to help stakeholders follow best practices to maximise the efficiency of their work and act as a blueprint for the current and future health emergencies. The recommendations aim to help policymakers and funders maximise timely, quality data sharing and appropriate responses to health emergencies, particularly COVID-19. 

The report specifically emphasises the importance of the following during the COVID-19 emergency response:  …”

The Global Research Data Alliance community response to the global COVID-19 pandemic | RDA

“Data drives rapid response and informed decision making during public health emergencies. There is a need for timely and accurate collection, reporting and sharing of data with the research community, public health practitioners, clinicians and policy makers. Accurate and rapid availability of data will inform assessment of the severity, spread and impact of a pandemic to implement efficient and effective response strategies.

The Research Data Alliance (RDA) is a volunteer community of over 10,500 professionals from 145 countries across the globe. In less than two months, the community responded to an urgent call for action and defined much needed, comprehensive recommendations and guidelines for data sharing under the present COVID-19 circumstances. 
Today, 28 May 2020, we publish the pre-final version of the RDA COVID-19 Recommendations and Guidelines covering four research areas – clinical data, omics practices, epidemiology and social sciences. This document is also complimented by overarching areas focusing on legal and ethical considerations, research software, community participation and indigenous data.
The detailed guidelines in this body of work aim to help stakeholders follow best practices to maximise the efficiency of their work and act as a blueprint for the current and future health emergencies. The recommendations aim to help policymakers and funders maximise timely, quality data sharing and appropriate responses to health emergencies, particularly COVID-19. 

The report specifically emphasises the importance of the following during the COVID-19 emergency response:  …”

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 …”

German universities report record number of clinical trial results

“German universities have uploaded the results of 76 clinical trials over the past six months. Universities have uploaded twice as many results over the past six months than during the preceding six years combined….”

Scandinavian universities perform dismally at reporting clinical trial results

“Universities across Finland, Norway and Sweden have failed to upload the results of hundreds of clinical trials onto the EU Clinical Trial Register, in violation of EU transparency rules….”

Availability of research articles for the public during pandemic – a case study

Abstract:  The coronavirus 2019 (COVID-19) disease has affected millions of lives, forcing most of us to stay at home and work. However, there is an immediate need to conduct research on potential drugs against COVID-19. In this article, the extent to which major publishers have provided access for the public to read research articles relevant to potential drug candidates for the COVID-19 disease are presented.

A systematic search of five electronic databases (Elsevier’s ScienceDirect, Taylor & Francis, SpringerLink, Wiley, and New England Journal of Medicine (NEJM)) was conducted on April 12-17, 2020. The total number of research articles containing terms ‘Ribavirin’, ‘Remdesivir’, ‘Hydroxychloroquine OR Chloroquine’, ‘Favipiravir’, ‘Lopinavir OR Ritonavir’, ‘Sarilumab’, and ‘Tocilizumab’, available for the public to read for free were determined. In this study, there was a lack of full access to research articles related to potential drugs of COVID-19 in commercial academic databases, except for ‘Remdesivir’ and ‘Favipiravir’ from NEJM.

Pharmaceutical patents: reconciling the human right to health with the incentive to invent – ScienceDirect

“Highlights

Drug discovery is exciting and transformative but conflicts exist between the incentive to invent and the rights of others to access medicines
Tensions between fundamental rights to access essential medicines and rights of the inventor and investors are considered 
Effective incentives to innovate in developed countries can lead to global improvements in access to medicine if the intellectual property system is calibrated to permit this 
Compulsory licensing and alternative mechanisms facilitating global access to drugs in the context of rights to the highest attainable standard of health and intellectual property are also discussed…”

The Role of Scientific Publishing in the SARS?CoV?2 Pandemic – DeVane – – Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy – Wiley Online Library

“One of the lessons of the current pandemic is that scientific data need to be transferred from discoverers to the practitioners who can utilize it as quickly as possible. This occurs at variable rates according to the need for scientific review, the timeliness of administrative approval in some settings, and the motivation of individuals to share their data with the broader scientific community. Subsequent benefits to the public are increased by shortening the time interval from discovery to impact.

The increased pace of scientific investigation and the rapid dissemination of data through traditional channels of peer review and publication during the current pandemic have been remarkable. What has often taken months to occur has in many cases been reduced to weeks or days. The biomedical publishing industry has widely embraced its role in the SARS?CoV2 pandemic. Pharmacotherapy, with contributions from authors, reviewers, editors, and publishing staff, is pleased to participate in bringing timely and reliable scientific insight to our readership to promote public health.”