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

EMA reviews transparency criteria

The European Medicines Agency (EMA) has launched an internal review of the transparency criteria that patient and consumer organisations need to fulfill in order to be eligible to work with the Agency.

Read the eligibility criteria approved in 2005 (transparency guidelines are on page 2)

HAI Europe proposes these changes to the transparency criteria (added text in bold):

Transparency: The organisation should publicly disclose its sources of funding both public and private by providing the name of the public and/or private bodies and their individual financial contribution both in absolute terms and in terms of percentage of the organisation budget.

HAI research on financial disclosure featured in article: European politicians' call for greater transparency

The physicians’ magazine Deutsches Aerzteblatt highlights HAI Europe’s research on financial dislcosure & transparency of patient and consumer groups in an article examining European politicians’ call for greater transparency of the relationships between European patient organisations and the pharmaceutical industry

Read the article Europäische Patientengruppen: Fragwürdiges Finanzgebaren (in German)