View from Brussels

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Articles

After issuing a conditional marketing authorization issued just a week ago for the Moderna vaccine and receiving applications for more, the EU has reserved vaccines sufficient to treat more than 80% of the European population. 

Battling COVID on the Policy Front in Europe

As the EMA gives Moderna's COVID vaccine the thumbs up, the European Commission has quickly followed up with its own approval.

Three Kings Come Through with Another COVID Vaccine for Europe

Despite all the hopes and wishes for a better new year, the start to 2021 in Europe is proving to be grimly similar to the end of 2020.

Plus Ça Change…Nothing Changes With a New Year!

The EU has its first COVID vaccine authorized. 

EU Joins the COVID Vaccine Gang

Europe's leaders find themselves in a strange situation as their defense of their systematic approach to drug registration via the EMA has come under fire not only externally, but from some of their own politicians as well. 

COVID Vaccines' Collateral Damage to EU

As the UK's Medicines and Healthcare products Regulatory Agency gave approval to the Pfizer/BioNTech COVID vaccine—questions about how they had been so quick, or why the EU had been so slow, have risen.

Brexit's Last Gasp Throws a Spanner into the First COVID Vaccine Approvals

European health ministers are meeting later this week to review what has been, and what can be, done to strengthen future defenses to counter the COVID pandemic.

Will Health Technology Assessment Talks Show Europe's Countries Can Work Together—Or Prove They Can't?

While the UK's departure from the EU is imminent, NICE will continue to influence thinking around the continent. 

The Ever-Changing Face of NICE Guidance on Drug Innovation

Dilemmas are multiple and stakes are high as the framework for thinking about medicines development frequently fluctuates because of the COVID-19 pandemic, making it harder to foresee all implications for the future.

COVID-related Changes have Implications Not Just for Innovation but Also for Public Acceptance of Innovation

As the EU moves towards the next stage in its review of intellectual property incentives for pharmaceuticals, some unusually direct exchanges occurred between those who advocate patents—and those who oppose them.

Patents as a Barrier or an Enabler to Innovative Medicines: Europe's Debate Sharpens Up

Declarations made by Beate Wieseler don't align with those of many regulators and HTA bodies in Europe and will prove tough to transform.  

Gold Standards Remaining Gold Standards for Germany's HTA

Europe's research ministers are will meet to attempt to reach agreement on European Union research plans for the next seven years, including a cluster devoted to a broad range of health goals that range from general objectives to subjects of more specific interest to the community.

Europe Edges Towards a Health Research Plan

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available. 

Europe's COVID Vaccine Bids Still Veiled in Secrecy

EMA has launched a "communication perception survey" looking for honest views from among the widest audience on how well it is doing. 

EMA Looks to Its Image

Teenagers with cancer could benefit from a proposed initiative to lower the age barrier for participation in trials for new oncology drugs.

EU Specialists: Ease the Age Barrier for Cancer Clinical Trials

Social media uses transparency to highlight alleged gaps in clinical trial transparency and offers a more powerful approach to health campaigners.



Trial Non-Reporting a European as Well as U.S. Problem

Peter O’Donnell explores where the EU stands today in R&D pursuits for new antibacterial therapies.    

How to Boost Research for New Antibiotics—And How Not To

The regulatory path for virtual studies is nebulous and potentially difficult to navigate-finding a way forward requires a thorough understanding of the terrain and how to apply existing legal frameworks.

Virtual Clinical Studies: Finding a Path to Execution

Higher screen failure and patient dropout rates are raising the imperative to pilot and implement new study conduct models in trial recruitment and retention.