4. Patients’ involvement in medicines regulation at the EMA

Patients’ involvement in medicines regulation at the EMA

Patients actually take the medicine and are ultimately the most important stakeholders in the approval of new medicines. Are they involved in the processes? Do they have a voice in the decisions?

The legislation outlines a number of scenarios where patients are involved.

• This page describes how the EMA works with patients: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000317.jsp&;

• Each year the EMA publishes an annual report on patient involvement in the Agency’s work. The report for 2018-2019 can be found here: https://www.ema.europa.eu/en/documents/report/stakeholder-engagement-report-2018-2019_en.pdf

Patient organisations hold two seats on the EMA Management Board. In addition to that, patient organisations have formal members in the following scientific committees:

Evaluation of medicines for marketing authorisation is primarily the responsibility of the Committee for Human Medicinal Products (CHMP). While the committee membership does not include patients, when needed the CHMP invites patients to attend meetings in person and also consults patients in writing.

During the evaluation of a medicine, the pharmaceutical company may be invited to attend the CHMP meeting to respond to questions raised by the committee. Depending on the specific issues raised, a patient may also be invited to give their perspective and provide input and share their opinions on the benefits and the risks related to the medicine under discussion.).

Prior to submitting an application for MA, a pharmaceutical company may ask for scientific advice from the EMA. Clinical trials can be very costly. Therefore, advice may be advantageous to avoid using a wrong design of the trial. The CHMP has a particular working party for this purpose, the SAWP (Scientific Advice Working Party). More specific advice from the SAWP, known as ‘protocol assistance’, may also be sought for new medicines designated as ‘orphan medicines’. The SAWP most often involves patient organisations in a scientific advice process.

In many cases, CHMP may ask for advice from a Scientific Advisory Group (SAG) or an ad hoc expert panel. SAGs are set up in a number of therapeutic areas. Patient organisations may be involved in the SAG or expert group handling of a CHMP request. This is happening quite frequently.

EMA Video on SAG        

EMA has created a working party to facilitate collaboration with patients. The Working Party with Patients’ and Consumers’ organisations (PCWP) meets four times a year.