EU Parliament says no and no again to EMA: Independent groups echo decision

read (298 KB)

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)

Open letter to Brown University re journal article misrepresenting efficacy and safety of paroxetine

read (20 KB)

Action is needed to enforce the European Medicine Agency’s policy on conflicts of interest

read (178 KB)

EMA: Safeguards against post-employment conflicts of interest. Need for a review of Staff Regulations

read (412 KB)

EMA’s policy on conflict of interest: improvements needed

read (157 KB)

Letter to WHO director general about conflict of interest disclosure

read (214 KB)

A cautionary message on information to patients

read (147 KB)

Parliament’s stand against conflicts of interest: Is it enough to ensure medicines safety?

read (147 KB)

Conflict of interest for former EMA Executive Director Thomas Lönngren

read (336 KB)

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)

Final proposals on pharmacovigilance

read (140 KB)

Pharmaceutical companies “informing” the public

One step closer to legalising reminder advertising for prescription drugs?

read (213 KB)

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

Upholding patients’ rights to reliable information

read (232 KB)

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)

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)

"Patient information" by pharmaceutical companies comes up against almost unanimous opposition from civil society

read (368 KB)

Time to act for Patient Safety in Europe

read (205 KB)

Direct-to-consumer advertising of President drugs in New Zealand

read (232 KB)

Declaration of Helsinki, draft text for public consultation

helsinki_comments_from_nordic_cochrane_centre_and_international_society_of_drug_bulletins.pdf (101409)

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”.

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)

Access to EU Institutions' documents is essential to advance trasparency and to serve public health

read (216 KB)

Answer to the open letter on information to patients

reaad (193 KB)

EMA: conflicts of interest and the review of Staff Regulations

read (410 KB)

Parliament’s stand against conflicts of interest: Is it enough to ensure medicines safety?

read (147 KB)

EMA suggestions on comparative clinical trials fall back behind ethical and scientific standards

read (104 KB)

Submission of comments on 'EMA Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available'

read (141 KB)

European drug regulator challenged over revolving door case involving former Director

read (215 KB)

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)

Action is needed to enforce the European Medicine Agency’s policy on conflicts of interest

read (178 KB)

EMA’s policy on conflict of interest: improvements needed

read (158 KB)

Open letter to European Commission

read (173 KB)

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)

Towards centralised and trasparent marketing authorisations for all medicines

read (181 KB)

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)

Safeguard Geneesmiddelenbulletin's independence

read (240)

Stopping a reliable source of comparative drug information in the UK will harm patients

read (204 KB)

Letter to President of the Canadian Medical Association about CMAJ

read (32 KB)

ISDB General Assembly Meeting - 2012