Last update: September 06th 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

Press Release

Conflict of Interest

November 28th 2014

European Medicines Agency (EMA) softens its conflict of interest policy: Does this further open the door to undue influence instead of closing it?

28 November 2014 

Joint Press Release

At the end of November 2014, the European Medicines Agency has announced the adoption of a “more balanced approach to handling conflicts of interests” to become effective on 30 January 2015. In reality, this revised EMA COI policy relaxes EMA’s position in relation to the conflicts of interest of experts with pharmaceutical companies. The evaluation of the efficacy and harms of medicines must be free from undue influence and be based on scientific data, so that the Agency’s work can benefit public health. The Agency’s integrity is at stake

Download the press release from the link below. 

20141128conflitsinteretsema.pdf (634128)

Pharmacovigilance & Direct-To-Consumer Advertising

December 01th 2011

Revised proposal for a Directive on "information" to patients

Some improvements, but risks of DTCA (direct-to-consumer advertising) remain

read english (164 KB) read french (173 KB)

October 21th 2011

Joint analysis

Revised proposals on "information" to patients: still an open door to advertising of prescription-only medicines by pharmaceutical companies
read (279 KB)

October 16th 2009

Pharmacovigilance: a crucial issue for the health and safety of all Europeans

Prescrire and its partners continue in their campaign to reorient the European Commission’s proposals on pharmacovigilance toward public health and a real reinforcement of safety for European citizens.

February 22th 2008

Direct-to-Consumer Communication by pharmaceutical companies

European Commission pushes ahead despide civil society's opposition
read (112 KB)

EMA & other regulatory issues

August 31th 2016

EMA’s report on adaptive pathways: little data and much ado about nothing

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 of clinical trial data to be submitted or which patient representatives were consulted. In the absence of any real information the pilot is clearly a failure and should be retracted. If “commercial sensitivities” prevent detailed reporting to the public, it is doubly a failure. No fundamental shift to regulation should be based on such secrecy. 

Click below to read this press release.

31082016_emaadaptivepathways_press_release.pdf (111433)

February 18th 2015

EU Clinical Trials Regulation: EMA steers away from transparency by misinterpreting exception provisions

Joint response to an EMA public consultation

The European Medicines Agency (EMA) must stay true to the Clinical Trials Regulation: non-disclosure has to remain the exception, not become the norm! 

Press release and joint response attached as PDF: 

2015_02_jointpressrelease_addendumema.pdf (1212539)

July 15th 2014

Providing "scientific advice" to pharma industry undermines the independence of regulatory authorities

Joint consultation response by AIM, HAI Europe, ISDB and MiEF. Confidential discussions between pharma, EMA and health technology assessment (HTA) bodies threaten independence of pricing and reimbursement decisions.

PDF attached

20140715scientificadvice.pdf (612174)

July 11th 2014

'Investor-to-state dispute settlement' in EU–US trade deal threatens access to affordable medicines

Joint response to EU Commission consultation. Non-governmental organisations (NGOs) coalition urges European Commission to exclude mechanism from Transatlantic Trade and Investment "Partnership" (TTIP).

PDF attached

20140711_isdsinttip.pdf (431890)

June 24th 2014

EMA's new policy on access to clinical data: About to privatise pharmaceutical knowledge? The proof will be in the pudding

EMA's controversial policy on access to clinical data is to be adopted by mid-July 2014 while restrictive measures and legal loopholes are left unaddressed. AIM, ISDB, MiEF and the Nordic Cochrane Centre call on the EMA to not succomb to pressures from pharmaceutical companies and the European Commission.

PDF attached

20140624_emanewpolicyaccessclinicaldata.pdf (575221)

May 20th 2014

Backpedalling on EMA’s "proactive publication of clinical-data" draft policy: Was it all just a window-dressing exercise? Who or what is the EMA afraid of?

In a Joint Press Release, AIM, ISDB, MiEF and the Nordic Cochrane Centre call on the European Medicines Agency to ensure that its long-awaited policy on proactive publication of clinical data actually improves public access to scientific evidence about the effects of medicines on human health. 

PDF attached

20140520_ematransparencypolicy.pdf (218303)

November 18th 2013

EU Regulation on clinical trials: An urgent call for support to clinical data transparency

At the ENVI Committee’s vote on the Clinical Trials Regulation on 29 May 2013, Members of the European Parliament (MEPs) took a clear stance in support of enhanced data transparency.

Read More

letter_to_corepers_ctr.pdf (554321)

September 27th 2013

TRANSPARENCY IN THE PUBLIC INTEREST: How the EMA policy on publication and access to clinical-trial data could help save lives

The European Medicines Agency (EMA) draft policy on “publication and access to clinical-trial data” could pave the way to a new era in the disclosure of clinical data on medicines.

Read More

sept2013_ema_transparencypolicy.pdf (519866)

August 16th 2012

Black triangle for medicines: positive move but poor implementation plan

The draft paper on the quality review of documentssubmitted for consultation by the EMA does not reflect the spirit of the new pharmacovigilance legislation, which is to prevent druginduced harm.

read (264 KB)

September 24th 2009

EMA transparency draft is just window dressing

HAI Europe, ISDB and MiEF find that “EMEA’s draft transparency policy”  fails to restore citizens’ trust in its decision-making.

read (210 KB)

March 02th 2009

EMA: excessive secrecy beyond the law!

Trasparency should be the norm

read (255 KB)

Other issues

October 22th 2014

Medicines are not just a commodity

Medicines are not just a commodity: the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Nordic Cochrane Centre (NCC) welcome the decision to leave responsibility for medicinal products with Health Commissioner (joint press release). 

20141016_dghealth_juncker.pdf (292932)

February 15th 2012

Pharmacovigilance data

Broadening access to signal is a positive step, but access to VigiBase is also needed
read (161 KB) 

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