Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO

“ICMRA1 and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest….

Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used….

 

Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.”

 

 

Completeness of open access FluNet influenza surveillance data for Pan-America in 2005–2019 | Scientific Reports

Abstract:  For several decades, the World Health Organization has collected, maintained, and distributed invaluable country-specific disease surveillance data that allow experts to develop new analytical tools for disease tracking and forecasting. To capture the extent of available data within these sources, we proposed a completeness metric based on the effective time series length. Using FluNet records for 29 Pan-American countries from 2005 to 2019, we explored whether completeness was associated with health expenditure indicators adjusting for surveillance system heterogeneity. We observed steady improvements in completeness by 4.2–6.3% annually, especially after the A(H1N1)-2009 pandemic, when 24 countries reached?>?95% completeness. Doubling in decadal health expenditure per capita was associated with?~?7% increase in overall completeness. The proposed metric could navigate experts in assessing open access data quality and quantity for conducting credible statistical analyses, estimating disease trends, and developing outbreak forecasting systems.

 

Vigilance for Medical Products of Human Origin—Progress on t… : Transplantation

Abstract:  World Health Assembly Resolution WHA 63.22 mandated WHO to facilitate Member State access to appropriate information on Medical Products of Human Origin (MPHO), including collecting data on serious adverse events and reactions. To meet this challenge, the Italian National Transplant Center, with a mandate from WHO, has built and maintains an open access searchable database of instructive records on disease transmission and other MPHO adverse occurrences.

 

Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps – Stephen H Bradley, Nicholas J DeVito, Kelly E Lloyd, Georgia C Richards, Tanja Rombey, Cole Wayant, Peter J Gill, 2020

Abstract:  In recent years there has been increasing awareness of problems that have undermined trust in medical research. This review outlines some of the most important issues including research culture, reporting biases, and statistical and methodological issues. It examines measures that have been instituted to address these problems and explores the success and limitations of these measures. The paper concludes by proposing three achievable actions which could be implemented to deliver significantly improved transparency and mitigation of bias. These measures are as follows: (1) mandatory registration of interests by those involved in research; (2) that journals support the ‘registered reports’ publication format; and (3) that comprehensive study documentation for all publicly funded research be made available on a World Health Organization research repository. We suggest that achieving such measures requires a broad-based campaign which mobilises public opinion. We invite readers to feedback on the proposed actions and to join us in calling for their implementation.

 

Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps – Stephen H Bradley, Nicholas J DeVito, Kelly E Lloyd, Georgia C Richards, Tanja Rombey, Cole Wayant, Peter J Gill, 2020

Abstract:  In recent years there has been increasing awareness of problems that have undermined trust in medical research. This review outlines some of the most important issues including research culture, reporting biases, and statistical and methodological issues. It examines measures that have been instituted to address these problems and explores the success and limitations of these measures. The paper concludes by proposing three achievable actions which could be implemented to deliver significantly improved transparency and mitigation of bias. These measures are as follows: (1) mandatory registration of interests by those involved in research; (2) that journals support the ‘registered reports’ publication format; and (3) that comprehensive study documentation for all publicly funded research be made available on a World Health Organization research repository. We suggest that achieving such measures requires a broad-based campaign which mobilises public opinion. We invite readers to feedback on the proposed actions and to join us in calling for their implementation.

 

The World Health Organization and Wikimedia Foundation expand access to trusted information about COVID-19 on Wikipedia

“The World Health Organization (WHO) and the Wikimedia Foundation, the nonprofit that administers Wikipedia, announced today a collaboration to expand the public’s access to the latest and most reliable information about COVID-19. 

The collaboration will make trusted, public health information available under the Creative Commons Attribution-ShareAlike license at a time when countries face continuing resurgences of COVID-19 and social stability increasingly depends on the public’s shared understanding of the facts. 

Through the collaboration, people everywhere will be able to access and share WHO infographics, videos, and other public health assets on Wikimedia Commons, a digital library of free images and other multimedia. 

With these new freely-licensed resources, Wikipedia’s more than 250,000 volunteer editors can also build on and expand the site’s COVID-19 coverage, which currently offers more than 5,200 coronavirus-related articles in 175 languages. This WHO content will also be translated across national and regional languages through Wikipedia’s vast network of global volunteers.”

[KEI recommendations to WHO on COVID-related research]

“The WHO secretariat should request in writing that the funders of COVID-19 R&D including in particular governments and philanthropies include language in contracts and use their financial leverage to enable sharing of know-how, cell lines and rights in data and patents, for COVID-19 related technologies.

The WHO secretariat should request in writing that the funders of COVID-19 R&D including in particular governments and philanthropies include language in contracts and use their financial leverage to enable sharing of know-how, cell lines and rights in data and patents, for COVID-19 related technologies.

There should be no monopolies on patents, regulatory exclusivities, data or know-how in this pandemic. All relevant technology for COVID-19 products should be available either free or openly licensed with non-discriminatory, reasonable and affordable royalties….”

Countries Are Adapting Intellectual Property Laws to Prioritise Health During COVID-19

“Intellectual property (IP) rights can potentially impede mass production of existing health products, as well as innovation and research and development of new products. IP rights can be exercised by their owners to grant or withhold from licensing the technology required for manufacturing or further developing a product. If a license is denied, the technology will not be available for other firms to manufacture or supply.

Usually, a bundle of several IP rights can exist around a particular technology. It is very common patenting strategy in the pharmaceutical industry to take separate patents on the main compound of a drug and a large number of secondary patents on different formulations and combinations, dosage, as well as other possible therapeutic use of a drug. This can make it difficult for follow on innovators to invent around the thicket of IP rights….

Through a resolution of the World Health Assembly on COVID-19, member states of the WHO have recognised the possible need for countries to adopt measures to ensure that IP rights do not constrain global equitable access to health technologies for COVID-19 through the full use of the flexibilities of the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as well as voluntary pooling of patented technologies, data and know-how….

A number of flexibilities available under the TRIPS Agreement can be applied by governments to ensure that IP rights do not constrain innovation and availability of health technologies required for responding to COVID-19….

It is time for developing countries to review the extent to which such measures can be adopted, or what changes, if any, need to be introduced into their legal regimes so as to be able to act effectively and timely to address the devastating effects of the COVID-19 pandemic….”

New COVID-19 Legal Database | O’Neill Institute

“Launching today, the COVID-19 Law Lab initiative gathers and shares legal documents from over 190 countries across the world to help states establish and implement strong legal frameworks to manage the pandemic. The goal is to ensure that laws protect the health and wellbeing of individuals and communities and that they adhere to international human rights standards.

The new Lab (at www.COVIDLawLab.org) is a joint project of United Nations Development Programme (UNDP), the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the O’Neill Institute for National and Global Health Law at Georgetown University….”

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 …”

Equitable access to COVID-19 diagnostics, vaccines and treatments

“In the interests of global public health, we ask you to commit to the following steps:

• Impose public interest conditions on all UK funding committed to develop COVID19 vaccines, treatments and diagnostics. These should ensure the final product is affordable, accessible and available for everyone who needs it, within the UK and developing countries. This can be done by stipulating that there should be no monopolies or exclusivities attached to any medical products developed using UK public funding. Furthermore, conditions should include full transparency in all stages of R&D, including registration and public reporting of clinical trial data, R&D costs, manufacturing costs and product prices. Any contracts agreed with companies and partners using public funds should also be made publicly available.

• Make a public statement in support of the proposal from the President and Minister of Health of Costa Rica for the WHO to create a global pooling mechanism for rights in COVID19 related technologies for the detection, prevention, control and treatment of the COVID-19 pandemic.

• Where patents, monopolies or exclusivities already exist on medical products that are potentially useful for tackling COVID-19, the UK government should issue crown use licenses where necessary to ensure scale up of production and ensure affordable access to these products. COVID-19 is unprecedented as a public health emergency, and access to these medical products cannot be restricted by intellectual property rights.”

Big drugmakers under pressure to share patents against coronavirus | Financial Times

“Drugmakers are facing mounting calls to give up their patent rights for potentially life-saving treatments and vaccines for coronavirus as authorities worldwide race to curb the pandemic’s death toll. The heads of the World Health Organization and Unitaid, a UN-backed group funding global health innovation, have welcomed a proposal devised by Costa Rica for companies voluntarily to pool their intellectual property for all medical interventions — including treatment, vaccines and diagnostics….”

WHO Director General ‘Welcomes’ Costa Rica Call For Pooled Rights To COVID-19 Treatments; G-20 Pledges Broad Support To Emergency Response – Health Policy Watch

“World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has welcomed the call by Cost Rica’s President, Carlos Alvarado Quesada, for WHO to launch an initiative that would “pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic.”…”

WHO asked to create voluntary intellectual property pool for Covid-19 work

“Seeking to widen access to medical products for combating Covid-19, the Costa Rican government has asked the World Health Organization to create a voluntary pool to collect patent rights, regulatory test data and other information that could be shared for developing drugs, vaccines and diagnostics.

The move comes amid a worldwide race to fight the novel coronavirus, but also mounting concerns that some products may not be accessible for poorer populations. By establishing a voluntary mechanism under the auspices of the WHO, Costa Rican officials are hoping to create a pathway that will attract numerous governments, as well as industry, universities and non-profit organizations….”