December 19, 2022

News from the European Medicines Agency 

Jose Drabwell, IPOPI Board member, took part in the meeting organised by the Patient and Consumer Working Party (PCWP), on November 15, 2022. After three years of online meetings, this was the first in-person meeting taking place in the EMA offices in Amsterdam (the Netherlands).

The meeting’s agenda was very busy and three main topics were discussed:  

  • Antimicrobial resistance and other emerging threats
  • Availability and accessibility of medicines
  • Patient involvement in medicine development and regulation

The discussions on antimicrobial resistance pre-empted World Antimicrobial Awareness Week (November 18-24) and European Antimicrobial Awareness Day (November 18). The meeting introduced the topic to all attendees and explained the concept of One Global Health, by which all stakeholders are connected. Antimicrobial resistance is a silent pandemic causing many deaths each year and no new class of antibiotics has been developed since 1984. Alternative therapies are being used such as bacteriophages, monoclonal antibodies, and certain vaccines. Last resort antibiotics are now also facing antimicrobial resistance. This is such an important subject, especially for our PID patients.

The EMA has seen its mandate extended to include activities in the area of availability and accessibility of medicines. In March 2023, a multi-stakeholder meeting will take place on this important subject.  A list of critical medicines, which should be available at all times, ought to be published. Patient organisations should play a vital role and report shortages. There is also a need to communicate the level of availability in each country. The EMA website lists a catalogue of shortages and the use of this has increased by 350% during the last 6 years. If medication is in short supply, a recommendation for patients and HCPs on the best use of a limited supply should be available.

Patient Experience Data

There were also discussions on the EMA Multistakeholder Workshop on Patient Experience Data (PED). PED needs to be useful for other decision-makers such as health technology assessments. There is a call for global harmonization in PED. A further need exists for regulatory guidance. Integration in EU health data space and the Big Data work plan DARWIN EU will explore how to include data from PED. PED results should be used in a marketing application. However not every country allows patients’ data, although every regulator in the EU agreed and therefore this data should be accepted.

More information on the PCWP meeting (agenda and presentations) is available here.