Last update: May 08th 2017
August 31th 2016

EMA’s report on adaptive pathways: little data...

A joint press release issued by ISDB, MiEF and Nordic Cochrane Centre regarding the recently published report on EMA's controversial "adaptive pathways" pilot project. The report includes no new factual data, with no information shared about the drug's indications, type...

December 23th 2015

A PRIME example of how EMA is pushing for...

Joint response of Health Action International (HAI), International Society of Drug Bulletins (ISDB), Mario Negri Institute for Pharmacological Research, Medicines in Europe Forum (MiEF), Nordic Cochrane Centre and Wemos to the European Medicines Agency (EMA) public consultation on the...

October 16th 2015

"Adaptive licensing" or "adaptive pathways":...

Joint briefing paper from Health Action International (HAI), The International Society of Drug Bulletins (ISDB), The Medicines in Europe Forum (MiEF), The Mario Negri Institute for Pharmacological Research, The Nordic Cochrane Centre and WEMOS.

"Adaptive pathways"...

March 20th 2015

European Directive on trade secrets: the JURI...

Joint open Letter to the members of the JURI Committee from the Corporate Europe Observatory (CEO), The Medicines in Europe Forum (MiEF) and The International Society of Drug Bulletins (ISDB) calling on the members of the JURI Committee to ensure, through additional and more ambitious...

for members only

Campaigns

Access to clinical data

November 14th 2014

WHO Statement on Public Disclosure of Clinical Trial Results: A welcomed commitment on transparency but one that should capitalise on best practices

The International Society of Drug Bulletins (ISDB), Medicines in Europe Forum (MiEF), Health Action International (HAI) Europe, Nordic Cochrane Centre (NCC) and Public Citizen submitted this joint response to the WHO public consultation on public disclosure of clinical trial results. 

en_jointresponse_who_statement_public_disclosure_ctresults.pdf (485158)

October 16th 2014

EMA’s final policy on access to clinical data: proactive access to some data, but strings attached

On 2 October 2014, the European Medicines Agency (EMA) finally adopted its policy on access to clinical data. From 1 January 2015 onwards, the general public will be able to “view on screen” selected parts of trial reports submitted in support of marketing authorisations, and academic and non-commercial researchers will be allowed to download this data. The policy, unfortunately, also gives pharmaceutical companies the upper hand in deciding the contents of the clinical reports by allowing them to redact data on the grounds of “commercial confidentiality”. The implementation of the policy will need careful monitoring. 

Click the link below to read the Joint Statement by Association Internationale de la Mutualité (AIM) Medicines in Europe Forum (MiEF), Health Action International (HAI) Europe, International Society of Drug Bulletins (ISDB) and Nordic Cochrane Centre (NCC).
 

20141016_jointstatement_ema_newtransparencypolicy.pdf (722494)

September 23th 2014

New EU Clinical Trials Regulation: a major advance in transparency, to be confirmed

Joint briefing paper by 7 organisations. The major advance in transparency brought by the adoption of the EU regulation on clinical trials needs to be preserved from neutralisation by industry lobbies.

20140923newclinicaltrialsregulation.pdf (888323)

April 04th 2014

Clinical trial data disclosure protects the public from preventable harm

In their Joint Response to a consultation by the US Institute of Medicine (IOM), HAI Europe, ISDB, MiEF and TACD encourage the active implementation of a data sharing policy that ensures full public access to clinical data in the US, in alignment with the new European requirements. 

PDF attached 

20140404_consultationtransparencyiom.pdf (359093)

Conflict of interest

November 30th 2014

A Civil Society Response to the Big Pharma wish list in TTIP

The analysis of the most worrying proposals of the pharmaceutical industry's wish list for the EU-US trade agreement reveals a real threat to European public health systems and democracy. 

Joint position paper produced by Commons Network in cooperation with Medicines in Europe Forum (MiEF), International Society of Drug Bulletins (ISDB), Health Action International Europe (HAI-Europe), Universities Allied for Essential Medicines - Europe (UAEM-Europe), Salud por Derecho Foundation and The Working Group on Health, Medicines & Innovation (GTSMI).

Click below to download the position paper, which is also available at http://commonsnetwork.eu 

a_civil_society_response_to_the_big_pharma_wish_list_nov2014.pdf (1364332)

November 02th 2011

Pharmacovigilance in Europe. Signal detection left to pharmaceutical companies: danger!

Answer to the consultation on the "Concept paper on pharmacovigilance implementing measures"
read (292 KB)

March 24th 2014

The US-EU Trade Agreement Proposals by the pharmaceutical industry undermine European public policy making and public health

A report by the civil society partners shows that the pharmaceutical industry's wish list for the Transatlantic Trade and Investment Partnership (TTIP) is detrimental for public health, will increase the cost of medicines and undermines democratic processes. 

PDF attached 

20140324civilsocietyresponsebigpharmawishlist_final.pdf (589236)

Pharmacovigilance & Direct-To-Consumer Advertising

September 16th 2014

A step backwards on pharmaceutical policy at the EU Commission: the move to directorate general (DG) Enterprise and Industry is unacceptable

Joint open letter to President Juncker by 28 organisations. Promoting profit over public health puts European citizens at risk. No, medicinal products are not just a commodity like any other.

20140916openletterpharmapolicy.pdf (631962)

September 15th 2014

EMA's policy on pharmacovigilance: access to qualitative data is needed, pharmacovigilance data are not "trade secrets"

Joint response to the EMA consultation by the Cochrane AEMG, HAI Europe, ISDB and MiEF. “Protection of personal data” must not be used as a pretext to strengthen intellectual property over pharmacovigilance data.

20140915jointresponseaccesspolicy.pdf (678201)

October 21th 2011

Revised proposals on "information" to patients: still an open door to advertising of prescription-only medicines

Direct-to-consumer "information" on prescription medicines by manufacturers exposes citizens to misleading messages, puts public health at risk and threatens Member State's social protection systems.
read (180 KB)

October 21th 2010

Pharmaceutical companies “informing” the public

One step closer to legalising reminder advertising for prescription drugs?

read (213 KB)

September 14th 2010

Towards direct-to-consumer advertising of prescription drugs in Europe?

Upholding patients’ rights to reliable information

read (232 KB)

May 03th 2010

No way to industry-sponsored health information

ISDB joint action against EU Commission's initiative: an open letter everyone has their part to play and should keep to it

read (176 KB)

October 13th 2009

Joint open Letter to President Barroso

Future Commission: need for change in health goods governance:
EU pharmaceutical and medical device policies and regulations should be under the competence of
Health and Consumer protection’s Commissioners

read (168 KB)

September 15th 2012

European Medicines Agency and pharmacovigilance: no to a fee-for-service system

On 18 June 2012, the EU Commission published a draft concept paper for public consultation on the “Introduction of fees to be charged by the European Medicines Agency for pharmacovigilance”.

August 16th 2012

Comments on Quality Review of Documents (QRD): revision of the product information - Draft

Submission of comments on 'Quality Review of Documents (QRD) human product information annotated template: revision of the product information - Draft' (EMA/468498/2012)

read (268 KB)

Regulatory issues

December 23th 2015

A PRIME example of how EMA is pushing for accelerated market approvals, but at what cost for patients?

Joint response of Health Action International (HAI), International Society of Drug Bulletins (ISDB), Mario Negri Institute for Pharmacological Research, Medicines in Europe Forum (MiEF), Nordic Cochrane Centre and Wemos to the European Medicines Agency (EMA) public consultation on the Draft Reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)
In this joint response, we highlight concerns with current attempts to weaken marketing authorisation requirements in the EU, most notably through the EMA’s adaptive pathways project. The PRIME scheme appears to be a complementary move to entrench the provision of confidential, customised advice to pharmaceutical companies in the regulatory system for expedited approval and coverage of new, expensive medicines which as evidence suggests will rarely bring therapeutic advance but often safety concerns. Click below to read this joint response. 

ngojointresponse_emaconsultationonprimescheme_4.pdf (883492)

October 16th 2015

"Adaptive licensing" or "adaptive pathways": Deregulation under the guise of earlier access

Joint briefing paper from Health Action International (HAI), The International Society of Drug Bulletins (ISDB), The Medicines in Europe Forum (MiEF), The Mario Negri Institute for Pharmacological Research, The Nordic Cochrane Centre and WEMOS.

"Adaptive pathways" raise numerous concerns from a public health perspective. The organisations that endorse this statement have closely monitored developments in EU pharmaceutical regulation for many years and put forward a critique of the "adaptive pathways concept". Implementing adaptive pathways could lead to a situation where premature marketing authorisations become the rule, even when no genuine public health need exists, therefore putting EU citizens' health unnecessarily at risk.

europe_med_octobre_2015.pdf (372476)

March 20th 2015

European Directive on trade secrets: the JURI Committee must profoundly improve this text

Joint open Letter to the members of the JURI Committee from the Corporate Europe Observatory (CEO), The Medicines in Europe Forum (MiEF) and The International Society of Drug Bulletins (ISDB) calling on the members of the JURI Committee to ensure, through additional and more ambitious amendments, that both freedom of speech for journalists and their sources, including whistle-blowers, and access to regulatory and scientific data of public interest, are preserved. 

Link to the PDF of the joint open letter below: 

jointopenletterjuri_meps.pdf (441308)

December 17th 2014

EU trade secrets directive a threat to health, environment, free speech and worker mobility

Joint statement

The proposed trade secrets directive could obstruct recent EU developments on transparency and endangers freedom of information and expression of European citizens. A multi-sectoral NGO coalition calls for greater protections for consumers, journalists, whistleblowers, researchers and workers. Joint statement attached. 

20141217_tradesecrets.pdf (422891)

March 17th 2014

EU Regulation on clinical trials: close to the finish line

If adopted in early April 2014, the new Regulation on clinical trials could bring along greater transparency concerning clinical trial data and results. However, the proposed Trade Secrets directive (published in November 2013) may curb the advances gained in the Clinical Trials regulation.

PDF attached

20140317_clinicaltrialsregulation.pdf (641889)

December 02th 2013

EU Regulation on clinical trials: The protection of clinical trial participants must not be undermined

In a joint letter, six organisations call upon the Permanent Representatives of the EU Member States to ensure that the new Clinical Trials Regulation does not undermine the protection of participants in clinical trials.

PDF attached

20131202corepersclinicaltrialparticipants.pdf (534378)

November 19th 2013

EU regulation on medical devices: patient safety should be of paramount importance

AIM, ISDB and MiEF open letter on the proposal for a regulation on medical devices.

PDF attached 

20131119jointlettercorepersmedicaldevices.pdf (152323)

June 20th 2013

Declaration of Helsinki, draft text for public consultation

14 June 2013 - Comments from The Nordic Cochrane Centre and the International Society of Drug Bulletins 

helsinki_comments_from_nordic_cochrane_centre_and_international_society_of_drug_bulletins.pdf (101409)

February 05th 2013

New Proposal for a Regulation on Clinical Trials

The protection of human subjects must be upheld & citizens’ right to information must be strengthened

en_clinicaltrials_analysis_final.pdf (339363)

April 09th 2013

Clinical Trials Regulation Protect public health: Choose transparency!

The International Society of Drug Bulletins issued a statement today to the members of European Parlament to request:

  • support amendments that require the public disclosure of a complete clinical studyreport (CSR) as outlined by ENVI rapporteur MEP Glenis Willmott;
  • reject amendments strengthening the protection of so-called “commercially confidential” or “commercially sensitive” informationwhich would be a major step back and undermine the accountability of the European pharmaceutical regulation system.

Read More (303 KB)

jointlettertransparency.pdf (302761)

April 23th 2013

Choose Transparency: A message to the Members of the European Parliament

The Clinical Trial Regulation is currently being discussed. As patients, researchers, doctors, scientists and civil society representatives we would like to draw your attention not only to the dangers it encompasses but also to the opportunities it brings along.

message_to_meps.pdf (138374)

September 19th 2014

INNs of biologics and biosimilars: consistency must be preserved

Joint response by HAI, ISDB and MiEF to a WHO public consultation. The WHO proposal to assign a "biological qualifier" after the International Nonproprietary Name (INN) of glycosylated biosimilars offers an acceptable solution at global level.

20140919whoconsultationinnbiosimilars.pdf (488491)

February 10th 2015

European Directive on trade secrets: A threat to access to public health data

Joint briefing paper

The proposed EU directive on the protection of trade secrets currently being studied by the European Parliament threatens freedom of speech for journalists and whistle-blowers, and access to scientific data of public interest.
Link to attached document.

en_tradesecrets_analysis_final.pdf (368432)

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