english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2016 Recap > Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, MA (10/2016)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

Advancing healthcare policy

A recap of actions in 2016
Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, market authorisation (October 2016)

Paris, 31 October 2016

Summary

The European Medicines Agency (EMA) has released a concept paper for public consultation on the revision of its guideline on the clinical evaluation required to apply for European marketing authorisation for antidiabetic drugs. In its response to this consultation, Prescrire reminds the EMA of the importance of evaluating the efficacy of antidiabetics using clinical endpoints useful to patients, and of evaluating their risks properly, in particular their cardiovascular risks, before authorisation rather than afterwards.

> Click here to download Prescrire's response to the consultation (pdf, 243 Ko)

2025 Recap

Errors related to brand names: the EMA can still do more (march 2025)

2024 Recap

EMA: two surveys about the patient leaflet (december 2024)
New data after marketing authorisation: European Commission consultation (continued) (december 2024)
French Senate hearing on drug shortages (november 2024)
Revision of European pharmaceutical legislation: a disappointing vote in the Parliament (november 2024)
European "pharmaceutical package": letter on clinical data exclusivity (October 2024)
Prescrire's contribution to the EMA's consultation on the "Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials" (September 2024)
Prescrire's review of drug packaging in 2023: reconciling ease of use with safety is an ongoing challenge (September 2024)
New data after marketing authorisation: European Commission consultation (July 2024)
Non-comparative trials for marketing authorisations: EMA consultation (July 2024)
Drug shortages: Prescrire calls for transparency (July 2024)
European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response (May 2024)
First version of the European list of critical medicines: Prescrire's comments (April 2024)
Revision of European pharmaceutical legislation (February 2024)

2023 Recap

Proposed multi-stakeholder platform to improve clinical trials in the European Union (December 2023)
Publication of clinical trial protocols (October 2023)
Prescrire: a cosignatory of letters to various European institutions (October 2023)
Prescrire's annual review of drug packaging: progress is too slow (September 2023)
Impending changes to European pharmaceutical regulations: part II (January 2023)

2022 Recap

Impending changes to European pharmaceutical regulations: part 1 (December 2022)
The European Implementing Regulation on Pharmacovigilance Activities (September 2022)
Prescrire's annual review of drug packaging: choose high-quality packaging for safer health care (September 2022)
EMA's response to Prescrire's analysis of EMA's transparency policy over the last 10 years (September 2022)
Delays in access to EMA documents: the Agency confers with Prescrire (July 2022)
Prescrire is taking action at the European level (July 2022)
Prescrire's analysis of EMA's transparency policy over the last 10 years: EMA's reply with Prescrire's comments (6/2022)
Prescrire's response to public consultation on the revised Guideline on the acceptability of names for human medicinal products (3/2022)

2021 Recap

Prescrire's response to the public consultation on the revision of European pharmaceuticals legislation (12/2021)
Pharmacovigilance activities: the Commission's proposed changes to the 2012 Regulation encourage greater independence, better quality control and disclosure, but further improvements still needed (10/2021)
Revision of the EU's general pharmaceutical legislation in 2022: Prescrire's remarks on the European Commission Roadmap (4/2021)
Prescrire’s response to the European Commission public consultation on the Inception Impact Assessment on a "European Health Emergency Preparedness and Response Authority" (2/2021)

2020 Recap

Prescrire’s response to the EC's consultation on the pharmaceutical strategy roadmap (7/2020)
White paper on artificial intelligence: Prescrire's response to the EC's public consultation (6/2020)
Corporate influence on medicines policy and on regulatory decision-making needs more scrutiny (2/2020)
Independent information does exist, but deserves more attention and visibility (2/2020)

2019 Recap

Access to clinical study reports: EMA's transparency policy and disclosure of vital documents should not be scaled back (12/2019)
EMA's independence is paramount: concrete alternatives to the fee-for-service system must be found (10/2019)
Drug-device combinations: EMA's consultation on quality requirements is an opportunity to strengthen patient safety (8/2019)
Electronic product information: EMA and competent authorities must guarantee public access to quality information, and uphold the ban on DTCA (7/2019)
Prescrire's response to the EMA Regulatory Science strategy to 2025: refocus on public health mission as gatekeeper and strengthen pharmacovigilance (6/2019)
Orphan drugs: affordability is at risk due to abuse of orphan drug incentives (4/2019)
Patient-centered authorisation and supervision of health products cannot be based on hope and promises: the use of big data needs to rely on facts, trustworthy evidence and transparency (4/2019)
Last chance to safeguard citizens' protections by removing "Innovation Principle" from Horizon Europe (3/2019)
A call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed (2/2019)
It is high time to put an end to EMA's opaque and confidential practice of early scientific advice (1/2019)

2018 Recap

"Implant Files" : Campaign for an effective marketing authorisation for high-risk medical devices (12/2018)
Health technology assessment: the European Parliament's position improves substantially upon the Commission proposal (10/2018)
Cochrane's sinking ship and conflicts of interest (9/2018)
Public funding is key for the independence of the EMA (7/2018)
Drug prices, therapeutic value and access to medicines: civil society adds its voice to the debate in France, to defend the public interest (6/2018)
Methotrexate: room for improvement in packaging and patient information (5/2018)
Medicines shortages: drug companies have a duty to produce medicines in sufficient quantity and quality (5/2018)
Prescrire's position paper on the proposed European Regulation on health technology assessment (HTA) (3/2018)
Electronic access to EU product information might improve access to updated patient leaflets, but should not open the door to advertising (2/2018)
Drug therapy and medication safety for older people clearly require more attention (1/2018)

2017 Recap

Horizon 2020: need to improve public return on public investment for EU's investment in research in the area of health (12/2017)
No to EMA's provision of confidential scientific advice to drug companies (11/2017)
French drug agency's recommendations on packaging labelling: a welcome first step, to be optimised (11/2017)
Supplementary protection certificates (SPCs) delay access to affordable medicines (9/2017)
French drug agency's recommendations on dosing devices: a step forward (9/2017 )
Prescrire applauds the work of the European Ombudsman over the past several years (7/2017)
Proposed changes to EMA's access to documents policy fall short on proactive disclosure (5/2017)
Response to the EU Commission consultation on the Paediatric Regulation (2/2017)
Health technology assessment: joint response to the EU Commission Consultation (1/2017)

2016 Recap

Proposed recommendations on drug brand names by France's Health Products Agency maintain dangerous confusion (12/2016)
Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, MA (10/2016)
Open letter to the EC on "Strengthening the Balance in the Pharmaceutical Systems" (9/2016)
EMA's report on adaptive pathways: little data and much ado about nothing (8/2016)
The need for a critical review of the intellectual property system and incentives for medical innovation (6/2016)
Prescrire's response to EMA consultation on pharmacovigilance and risk management (5/2016)
Member States ought to support the EU Presidency's vision on access to affordable medicines (4/2016)
Trilogue Meetings: increase transparency to level the playing field (3/2016)
Representatives of civil society call for an R&D framework driven by global public health needs (2/2016)
Why You Should Be Concerned About TTIP and Access to Medicines (2/2016)
Joint response to the EMA public consultation on "Scientific guidance on post-authorisation efficacy studies" (1/2016)

2015 Recap

A PRIME example of how EMA is pushing for accelerated market approvals, but at what cost for patients? (12/2015)
"Adaptive licensing" or "adaptive pathways": Deregulation under the guise of earlier access (10/2015)
Marketing authorisation flexibilities should only respond to true needs and must protect patients' safety (9/2015)
European medicines agencies must address independence and transparency problems (7/2015)
EU directive on trade secrets: amendments needed! (3/2015)
EU Clinical Trials Regulation: EMA steers away from transparency (2/2015)
European Directive on trade secrets: A threat to access to public health data (2/2015)

2014 Recap

Approval of a dangerous amphetamine drug: unacceptable EMA recommendation (12/2014)
EU trade secrets directive: statement by a multi-sectoral NGO coalition (12/2014)
Medicinal products used in weight control: first, do no harm (12/2014)
EMA softens its conflict of interest policy (11/2014)
WHO statement on public disclosure of clinical data: joint response (11/2014)
Medicines are not just a commodity (follow-up) (10/2014)
EMA's final policy on access to clinical data (10/2014)
EU Pharmacovigilance public hearings (10/2014)
Clinical trials regulation: a major advance in transparency (9/2014)
INNs of biologics and biosimilars: consistency must be preserved (9/2014)
Mr Juncker, medicines are not just a commodity... (9/2014)
A step backwards on pharmaceutical policy at the EU Commission (9/2014)
EMA's policy on pharmacovigilance data (9/2014)
Providing "scientific advice" to pharma industry undermines the independence of regulatory authorities (7/2014)
'Investor-to-state dispute settlement' in EU–US trade deal threatens access to affordable medicines (7/2014)
EMA's new policy on access to clinical data (6/2014)
Backpedalling on EMA’s "proactive publication of clinical-data" draft policy (5/2014)
Clinical trial data disclosure policy in the US (4/2014)
The US-EU Trade Agreement Proposals by the pharmaceutical industry undermine European public policy making and public health (3/2014)
EU Regulation on clinical trials: close to the finish line (3/2014)
Is the EMA's window of opportunity as widely open as described? (1/2014)
EU trade secrets directive: statement by a multi-sectoral NGO coalition (12/2014)

2013 Recap

EU Regulation on clinical trials: The protection of clinical trial participants must not be undermined (12/2013)
EU Regulation on Medical Devices: Patient safety should be of paramount importance (11/2013)
EU Regulation on clinical trials: An urgent call for support to clinical data transparency (11/2013)
"Biosimilars": the EMA makes a timid shift towards a more pragmatic approach (10/2013)
Medical devices: EU parliament missed needed improvements (10/2013)
Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives (9/2013)
Confusion between commercial names: EMA more concerned with defending trademarks than patient safety (8/2013)
EU Regulation on clinical trials: the Council must further enhance transparency and participants' protection (7/2013)
The debate over EU Clinical Trials Regulation: towards a model that meets real public health needs (7/2013)
Medical devices: joint communication campaign (7/2013)
Revision of the Helsinki Declaration on Ethical Principles: Prescrire's response (6/2013)
EMA refusing access to administrative documents: Prescrire denounces an unacceptable retrogression (6/2013)
Clinical Trials Regulation (amendment analysis): ignorance = harm! (5/2013)
Medical devices legislation: regaining the trust of European citizens (5/2013)
Amended proposal for a new directive on transparency measures regulating the prices of medicinal products: still threatening Member States' health systems (4/2013)
Clinical trials regulation: choose transparency! (4/2013)
New proposal for a Regulation on clinical trials: Protect human subjects; Strengthen citizens' right to information (2/2013)

2012 Recap

Medicinal products used in weight control: first, do no harm!(12/2012)
Is there a need for insulin at 200 units per ml? Why use a new and poorly established analogue? (12/2012)
Safety and usability of packaging and labelling: assessment prior to marketing authorisation for all medicinal products (11/2012)
Who benefits from the European Paediatric Regulation? (11/2012)
Medical devices: an entire overhaul of the medical legislation is needed (10/2012)
French sunshine act: is the French government backing down on industry gifts? (10/2012)
European Medicines Agency and pharmacovigilance: no to a fee-for-service system (9/2012)
Black triangle for medicines: Positive move but poor implementation plan (8/2012)
Proposal for a new Directive on transparency of measures regulating the prices of medicinal products: EC oversteps its role (7/2012)
Access to EU's documents is essential (6/2012)
EU Parliament says no and no again to EMA (5/2012)
Fighting "counterfeit medicines" should not be used as a pretext to track sales data (4/2012)
Amended proposals on "information" to the public: opening the door to advertising of prescription-only medicines (4/2012)
Fingolimod (Gilenya°): EMA's lack of transparency spells danger for patients (2/2012)

2011 Recap

Packaging of medicines for paediatric use: Prescrire's response to EMA (12/2011)
Signal detection left to pharmaceutical companies: danger! (11/2011)
Revised proposals on "information" to patients: Still an open door to advertising (10/2011)
Simplified examination of variations? Yes, but first re-evaluate old authorisations (10/2011)
Response to HMA/EMA on identification of commercially confidential information (8/2011)
Packaging for non-prescription medicines: Prescrire's response to EMA (6/2011)
EMA suggestions on comparative clinical trials fall back behind ethical and scientific standards (3/2011)

2008-2010 Recap

Final proposals on pharmacovigilance: Some progress, but a missed opportunity (12/2010)
Towards DTC advertising for prescription drugs? The autumn will be crucial (continued) (11/2010)
Towards DTC advertising of prescription drugs in Europe? (7/2010)
EMA's policy on conflict of interest: improvements needed (6/2010)
EMA road map: independence should be the priority (4/2010)
DTC Communication? Europeans deserve better (3/2010)
Medicines placed under the DG-SANCO’s competence (12/09)
EU Commission's proposals endanger the population (10/2009)
Future Commission: need for change in health goods governance (10/09)
EMEA transparency policy falls short: a weak and irresponsible project (9/2009)
EU Commission's proposals on pharmacovigilance dismantle the entire system (6/2009)
Legal proposals on "information" to patients by pharmaceutical companies (3/09)
Pharmaceutical package: a short-sighted vision that puts patients at risk (3/2009)
Joint open letter on the "Pharmaceutical Package" (11/08)
Recast of Medical Devices Directives (7/08)
"Patient information" by pharmaceutical companies: unanimous opposition (6/08)
Pharmacovigilance : overwhelming opposition to the EC proposals (5/2008)
Time to act for Patient Safety (5/08)
EC's "Information" proposal serves firms, not patients (4/08)
New European pharmacovigilance legislation: getting it right (2/08)

2005-2007 Recap

EC puts companies before public health (7/07)
Pharmaceutical Forum's working group: a sham consultation (5/07)
Joint Declaration "Relevant information for citizens" (12/06)
Advanced therapy medicinal products (4/06)
Draft regulation on medicines for paediatric use (7/05)
Medicines for paediatric use: take the time to improve an important project (5/05)
Medicines for paediatric use (1/05)
Conditional marketing authorisation procedure (1/05)

The 2002-2004 campaign