A Year at the Heart of Regulatory Decision Making

by ANCEL.LA SANTOS, Senior Policy Advisor – Europe

It’s that time of year when we reflect on our activities and achievements of the last 12 months. It’s been a busy year across the organisation, and our European Projects have been no exception! Our Senior Policy Advisor, Ancel.la Santos, looks back at a year of hard work at the heart of regulatory decision making in the European Union (EU),

What Role Can Civil Society Play in the European Regulatory Process?

by ANCEL.LA SANTOS, Senior Policy Advisor

The formal engagement of patients and consumers in the pharmaceutical regulatory process helps ensure that important decisions about medicines take into account the thoughts and views of the people they most affect. The European Medicines Agency (EMA) has a long tradition of this kind of stakeholder involvement.

Clinical Trial Data Transparency on Trial – EMA Under Pressure From Pharma Lawsuit

Thursday 1 December 2016 | Clinical Trial Data | |  Updated 22 December 2016

By Ancel.la Santos, Policy Advisor, Health Action International

For too long, pharmaceutical companies have endangered patient safety by providing biased information about a medicine’s effect on their users.

Abysmal decisions: Why the EC’s medicinal units shouldn’t be moved to DG Industry

Last week, European Commission (EC) president-elect, Jean-Claude Juncker, announced his plan to move the units responsible for pharmaceutical policy from their rightful place at DG Health to the commercially-focused DG for Internal Market, Industry, Entrepreneurship and SMEs.
Health Action International (HAI) Europe and other civil society organisations working on medicines policy were shocked and outraged.

Setting precedents: EMA must get clinical trial data policy right to truly act in public interest

by Ancel.la Santo Quintano

Following its management board meeting on 12 June, the European Medicines Agency (EMA) announced that it had agreed on a “more user-friendly” policy on the publication of clinical trial data. The policy, according to the EMA, will enable the Agency to “proactively publish clinical trial data that are submitted as part of marketing authorisation applications” and provide “the possibility [for users] to download,

HAI Europe calls on EMA's Management Board to stand for data transparency


The European Medicines Agency (EMA) Management Board
is expected to vote tomorrow on a new policy on clinical trial data transparency. 

Previously, the EMA appeared committed to passing a policy that would grant full public access to clinical trial data—a move that is critically important for protecting public health.

European drug regulator challenged over revolving door case involving former Director

Public health and transparency advocates ask the European Commission if rules regarding conflicts of interest have been sufficiently and duly respected in light of the EMA’s decision to allow its former Executive Director to work within the private pharmaceutical sector just weeks after leaving his position with the drug regulatory agency.

Read the joint open letter

Read the joint press release