A streamlined proposal to facilitate clinical trials

On 24 September 2012 EPF attended a lunch debate organised by European Voice on the European Commission’s legislative proposal for a Regulation on clinical trials. At this event, EPF highlighted three issues of concern to our members that were not explicitly addressed by the other discussants: information to patients and informed consent; patients’ access to results of clinical trials; and patient involvement in clinical trials. Whilst the Clinical Trials Directive introduced some important provisions for the protection of patients participating in trials, it has been widely criticised by patients, researchers and industry alike for its regulatory requirements which are considered disproportionate. According to the Commission, the new proposal aims to cut the “red tape” and bring patient-oriented research back to Europe, while restoring the Union’s competitiveness in clinical research and foster the development of new innovative therapies to address unmet medical needs.

The new legislation will take the legal form of a Regulation, to ensure that identical rules are applied consistently in all Member States. (Unlike a Directive, a Regulation is directly applicable and does not need to be transposed into national laws.) The draft Regulation introduces a streamlined application process through use of one single electronic application dossier, submitted through an electronic EU portal. The assessment of trial applications is partially coordinated – certain aspects follow a joint assessment procedure by those Member States where the trial would be conducted, led by a “reporting Member State”, while others will be assessed by each Member State separately. The Commission did not wish to specify how Member States should internally conduct the assessment of clinical trial applications, as long as they respect the timelines and specific requirements in the Regulation. Thus, the Regulation does not specifically refer to ethics committees although it poses certain criteria for the assessment and people involved in it. 

The Commission furthermore wants to adopt a more proportional approach to the assessment of clinical trials, because the current directive was heavily criticised for imposing the same burden on all trials regardless of the risks involved.  The draft Regulation introduces a new category of “low-intervention clinical trials”, for which the assessment timelines are shorter and simpler admin requirements. The new category can help foster vital non-commercial research addressing some of patients’ priorities that are currently poorly addressed, such as comparing medical vs. non-medical strategies for chronic disease management or testing established compounds in new applications.

The patients’ perspective is recognised

Importantly, Article 9 of the draft Regulation addresses to some extent EPF’s long-standing demand to incorporate patient perspective in assessment of clinical trials. The Article provides that the view of “at least one patient” must be taken into account, while leaving it up to Member States to decide how they do this. EPF strongly welcomes this recognition by the Commission of the importance of patient involvement. Patients have an obvious and central role within clinical trials: they provide the information, and they ultimately manage the personal risks attached to trials. Patients therefore have a moral right to be involved in the way clinical trials are developed, managed and evaluated. Moreover, it has been demonstrated that patient involvement leads to better trial design and outcomes of trials. EPF’s previous statement on clinical trials gives a number of examples on how patient involvement improves the relevance and outcomes of clinical trials.

As the Commission did not wish to define what “patient” means in this context, EPF can see several possibilities for implementing this provision, and we are seeking our members’ views and recommendations on this point.

Next steps

The new proposal has started its legislative journey: It will be discussed in the European Parliament during the second part of the year, with a vote in Committee being scheduled on a provisional basis 24 April 2013.

The lead committee in the Parliament is ENVI, while opinions will be submitted by IMCO and ITRE. The ENVI rapporteur is Glenis Willmott (S&D/UK) with Philippe Juvin (EPP/FR) and Milan Cabrnoch (ECR/CZ) being the shadow rapporteurs.
The debates in Council are likely to take until 2014. The Commission would like to have the first reading finalised before the European Parliament elections (June 2014) but the legislative process is likely to be disrupted by the elections to some extent.
EPF is currently consulting its membership on the proposal, based on previous views expressed by our members and new questions raised by the draft Regulation. Following this consultation, we will finalise a formal position statement.

For more information about the event, please go on European Voice's website.