[e-drug] E-Drug: Joint open letter on access to clinical study reports

e-drug
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E-DRUG : Joint open letter on access to clinical study reports
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https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx

At the initiative of Prescrire, over 30 organisations representing independent drug bulletins, researchers, healthcare professionals, health technology assessment (HTA) bodies as well as patient, consumer and public health organisations expressed their concerns in a joint open letter in view of an expected European Court ruling in January 2020. It is about a lawsuit filed by pharmaceutical companies against the European Medicines Agency which threatens public access to Clinical Study Reports. A legal opinion published by an Advocate General in September 2019 supported the company's arguments, setting off alarm bells among patient and transparency advocates.

The co-signing organisations stress that EMA's transparency and access to document policy must not be watered down: instead it deserves greater attention as it is a cornerstone of enlightened research and decision making, as well as public scrutiny and trust in the European regulator.

Access to Clinical Study Reports allows for independent research, assessment of trial reporting and bias, detailed evaluations of harms and adverse events, trial re-analyses and their integration in systematic reviews and meta-analyses. Disclosure of clinical data, including Clinical Study Reports, is of vital interest for patients, and also needed for researchers, HTA bodies, independent drug bulletins, healthcare payers and the global health community.

Full transparency - not secrecy - is the way forward!

The joint open letter is available here: https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx

For further information please contact:
Rita Kessler, European Advocacy Officer, Prescrire
rkessler@prescrire.org
Rita Kessler <ritakessler@gmail.com>

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R-DRUG: Joint open letter on access to clinical study reports (2)
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Hi E-Druggers,
Can I encourage as many E-Druggers as possible to write in support of this initiative by Prescrire.
[Dec 18 Rita Kessler. http://lists.healthnet.org/archive/html/e-drug/2019-12/msg00010.html\]

Many regulatory authorities in Low and Middle Income countries (LMICs) lack the capacity to undertake full dossier reviews for new product registration. They are encouraged to register products because they are already registered by EMA and other Stringent Regulatory Authorities (SRAs). EMA have taken the lead in being more transparent in their processes but this court case could turn things back to "Trust us we are an SRA!"

A Regulatory Agency is a public health organization that is responsible for ensuring that medicines circulating in a country are safe, of assured quality and efficacious. Only if the data that is used to document efficacy of the product is in the public domain can a regulatory agency approve a product. Secrecy will be a bar to access and the European Court of Justice should understand the implications of such a regressive decision for the billions of people who live in LMICs.

I have been in touch with Rita Kessler and she will be putting together an additional list of supporters and sending that to the court.

Please send your letters of support to her at rkessler@prescrire.org

Best wishes for the holidays,

Richard

Richard Laing
Professor, Department of Global Health
Boston University School of Public Health,
801 Massachusetts Avenue Boston MA 02118
Tel 617 358-2445 (Office) 617 435 7860 (Mobile)
E mail richardl@bu.edu

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E-DRUG : Joint open letter on access to clinical study reports
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https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx

At the initiative of Prescrire, over 30 organisations representing
independent drug bulletins, researchers, healthcare professionals, health
technology assessment (HTA) bodies as well as patient, consumer and public
health organisations expressed their concerns in a joint open letter in
view of an expected European Court ruling in January 2020. It is about a
lawsuit filed by pharmaceutical companies against the European Medicines
Agency which threatens public access to Clinical Study Reports. A legal
opinion published by an Advocate General in September 2019 supported the
company's arguments, setting off alarm bells among patient and transparency
advocates.

The co-signing organisations stress that EMA's transparency and access to
document policy must not be watered down: instead it deserves greater
attention as it is a cornerstone of enlightened research and decision
making, as well as public scrutiny and trust in the European regulator.

Access to Clinical Study Reports allows for independent research,
assessment of trial reporting and bias, detailed evaluations of harms and
adverse events, trial re-analyses and their integration in systematic
reviews and meta-analyses. Disclosure of clinical data, including Clinical
Study Reports, is of vital interest for patients, and also needed for
researchers, HTA bodies, independent drug bulletins, healthcare payers and
the global health community.

Full transparency - not secrecy - is the way forward!

The joint open letter is available here:
https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx

For further information please contact:
Rita Kessler, European Advocacy Officer, Prescrire
rkessler@prescrire.org
Rita Kessler <ritakessler@gmail.com>

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Открытое письмо по доступу к отчетам по клиническим испытаниям

Перевод из E-DRUG : Joint open letter on access to clinical study reports
Перевод: Потапов Александр Сергеевич, аспирант КФУ

По инициативе Prescrire более 30 организаций, представляющих независимые
бюллетени по лекарствам, исследователей, работников здравоохранения, органы
по оценке технологий здравоохранения (HTA), а также организации пациентов,
потребителей и общественного здравоохранения, выразили свои опасения в
совместном открытом письме с учетом ожидаемого решения Европейского суда в
январе 2020 года. Речь идет о судебном иске, поданном фармацевтическими
компаниями против Европейского агентства по лекарственным средствам,
который угрожает публичному доступу к отчетам о клинических исследованиях.
Юридическое заключение, опубликованное Генеральным адвокатом в сентябре
2019 года, поддержало аргументы компании, вызвав тревогу среди пациентов и
сторонников прозрачности.

Соавторские организации подчеркивают, что прозрачность ЕМА и доступ к
политике в отношении документов не следует ослаблять: вместо этого она
заслуживает большего внимания, поскольку она является краеугольным камнем
просвещенных исследований и принятия решений, а также общественного
контроля и доверия к европейскому регулятору.

Доступ к отчетам о клинических исследованиях позволяет проводить
независимые исследования, оценку отчетов и предвзятости испытаний,
детальные оценки вреда и неблагоприятных событий, повторный анализ
испытаний и их интеграцию в систематические обзоры и мета-анализы.
Раскрытие клинических данных, в том числе отчетов о клинических
исследованиях, представляет жизненно важный интерес для пациентов, а также
необходимо для исследователей, органов ОЦЗ, независимых бюллетеней по
лекарственным средствам, плательщиков здравоохранения и мирового сообщества
здравоохранения.

Полная прозрачность - не секретность - это путь вперед!

Открытое письмо здесь:
https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx

Для получения детальной информации и поддержки открытого письма,
пожалуйста, обращайтесь к:

Rita Kessler, European Advocacy Officer, Prescrire
rkessler@prescrire.org
Rita Kessler <ritakessler@gmail.com>