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Clinical trials directive: The Parliament’s political dilemna

Topic: clinical trials

Health & Consumers 21-10-2016

Andriukaitis: Health Technology Assessment will make EU healthcare ‘sustainable’

EXCLUSIVE / National healthcare systems should embrace the digital era and use Health Technology Assessment (HTA) to become truly sustainable and cost-effective, European Commissioner for Health and Food Safety Vytenis Andriukaitis told in an interview.
Health & Consumers 01-09-2016

EU’s sunbed safety assessment clouded by bias

An upcoming assessment by a European Commission committee on the risks of UV radiation and sunbeds is hamstrung by in-built bias and a failure to comprehensively address all the issues, warns Frank Harbusch.
Development Policy 23-08-2016

Brexit casts doubt over Uganda development project on lung disease

The UK's vote to leave the European Union has come at a crucial moment in the development of an international medical project that throws into sharp relief the state of flux Brexit has cast over collaborative research, says Jack Barton.
Health & Consumers 01-08-2016

EU drugs agency to unveil results on 'early medicines' project this week

The European Medicines Agency (EMA) will this week publish the much-awaited results of a pilot project on the early marketing authorisation of drugs, EurActiv has learnt.
Health & Consumers 26-07-2016

Pharma expert: new 'value added medicines' offer cheaper, customised treatment

A new breed of drugs, called “value added medicines”, could help patients improve their everyday life while in treatment, without increasing healthcare budgets, Christoph Stoller said in an interview with
Health & Consumers 13-06-2016

New medical devices rules should avoid ‘unnecessary’ red tape, industry says

The implementation of new rules on medical devices should avoid extra burdens and unnecessary bureaucracy, health industry officials have told

EU project hopes to phase out animal-testing

When chemicals are considered too dangerous to be tested on humans, animals have long been the answer to some scientific quandaries. The EU project ToxRisk will act as Europe's flagship for safety assessments that do not require the use of animals. EurActiv Germany reports.
Agriculture & Food 20-11-2015

Food industry wants common science principles to boost trust

The EU's food and drinks industry has developed a set of principles for research conduct that will apply to the sector.
Health & Consumers 22-10-2014

Ben Goldacre: Pharma industry has destroyed its own reputation

EXCLUSIVE: The great tragedy for the pharmaceutical industry is that it keeps denying that it lobbies against transparency in clinical trials, says Ben Goldacre.

EU Ombudsman: Clinical trials face new transparency challenges

Medical researchers in Europe are facing new challenges over access to clinical trials data, according to the European Ombudsman Emily O'Reilly.

Cancer research at a crossroads in Germany

A new EU regulation is meant to make clinical trials easier and more transparent, a pivotal tool in the fight against deadly diseases like cancer. But researchers in Germany warn that the country may lose its role as a leader in international medicine. EurActiv Germany reports.
Health & Consumers 11-06-2014

Growing concerns over medicines agency's proposed rules for transparency

A growing number of health and consumer advocacy organisations are urging the European Medicines Agency (EMA) to rethink its proposals to restrict the viewing of clinical trial results ahead of a board meeting Thursday (12 June).
Health & Consumers 21-05-2014

EU Ombudsman worried over lack of transparency at medicines agency

The European Ombudsman, Emily O'Reilly, has written to the European Medicines Agency (EMA), expressing concern about a significant change of clinical trial data transparency policy.

EU rules ‘mean children can't get life-saving cancer drugs’

Children with cancer are being denied access to potentially life-saving medicines because European Union rules allow drug firms to waive the need to test some drugs in paediatric trials, researchers said on Monday (10 February).
Health & Consumers 20-12-2013

EU Parliament, ministers agree to more clinical trial transparency in clinical trials

MEPs reached on Friday (20 December) an agreement with member states on the clinical trials directive.
Health & Consumers 22-10-2013

Ending drug trial secrecy is a boon for R&D, says EU agency

Europe's medicines regulator has come out fighting for greater transparency for clinical trials, arguing that its controversial policy to end data secrecy will be "a boon to drug developers".
Health & Consumers 29-08-2013

Health experts critical of pharma industry's new transparency rules

The European pharmaceutical industry association EFPIA has published new ethical commitments on clinical trials aimed at allaying accusations that a lack of transparency on how new drugs are tested is hurting patients. Critics however are unconvinced.
Health & Consumers 25-07-2013

Pharma industry downplays lobbyism with patient groups

In a blog entry posted yesterday (24 July), the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Richard Bergström, rebuffed reports that the pharmaceutical industry is trying to limit transparency as it seeks to work together with patient groups on clinical trials.
Health & Consumers 23-07-2013

Pharma industry tries to mobilise patient groups in clinical trials battle

The pharmaceutical industry is trying to 'mobilise' patient groups into lobbying against EU plans that will force companies to publish data from their clinical trials, according to an e-mail seen by a British newspaper.
Health & Consumers 30-05-2013

MEPs give resounding ‘yes’ to new clinical trial rules

A panel of European Parliament lawmakers gave unanimous backing on Wednesday (29 May) to new draft EU rules on clinical trials that could represent a huge step forward for research on new, life-saving drugs.
Health & Consumers 02-05-2013

Court orders EU medicines agency to withhold clinical trial results

The General Court of the European Union has ordered the European Medicines Agency (EMA) not to release documents on clinical trials, after two access-to-documents were requested, at least until the Court has issued a final ruling.
Health & Consumers 30-04-2013

Health NGO pushes for more transparency in clinical trials

The European Commission's proposed revision on the Clinical Trials Directive is an important step forward, but does not go far enough, says the Cochrane Collaboration, a healthcare NGO which advocates more transparency in clinical trials.
Health & Consumers 19-04-2013

Clinical trials debate shifts from research to transparency ahead of EU vote

Since the European Commission tabled its proposal to revise the Clinical Trials Directive last July, the focus in the debate has broadly shifted from supporting European research to patient safety and transparency, suggesting health campaigners have gained the upper hand over big pharmaceutical firms. The legislation will be debated in the European Parliament’s Environment Committee on 24 April.
Health & Consumers 04-04-2013

Clinical trials directive: The Parliament's political dilemna

The most contentious political questions in the Clinical Trials Directive relate to disclosure – whether, how and when the results of clinical trials should be made public and whether pharmaceutical companies can claim ownership over the data generated by them. But if anyone owns the results of clinical trials it is the volunteers who participated, writes Jim Murray.